EN
Horizon Europe
Work Programme 2023-2024
4. Health
(European Commission Decision C(2022)7550 of 6 December 2022)
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Health
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Table of contents
Introduction .........................................................................................................7
Destination 1 – Staying healthy in a rapidly changing society......................13
Call - Staying Healthy (Single stage - 2023)......................................................................... 16
Conditions for the Call ......................................................................................................... 16
HORIZON-HLTH-2023-STAYHLTH-01-01: The Silver Deal - Person-centred health and
care in European regions...................................................................................................... 17
Call - Staying Healthy (Two stage - 2024)............................................................................ 20
Conditions for the Call ......................................................................................................... 20
HORIZON-HLTH-2024-STAYHLTH-01-02-two-stage: Towards a holistic support to
children and adolescents’ health and care provisions in an increasingly digital society ..... 22
HORIZON-HLTH-2024-STAYHLTH-01-05-two-stage: Personalised prevention of noncommunicable
diseases - addressing areas of unmet needs using multiple data sources..... 25
Destination 2. Living and working in a health-promoting environment.....31
Call - Environment and health (Single stage - 2023)........................................................... 34
Conditions for the Call ......................................................................................................... 34
HORIZON-HLTH-2023-ENVHLTH-02-01: Planetary health: understanding the links
between environmental degradation and health impacts...................................................... 35
HORIZON-HLTH-2023-ENVHLTH-02-02: Evidence-based interventions for promotion of
mental and physical health in changing working environments (post-pandemic workplaces)
.............................................................................................................................................. 39
HORIZON-HLTH-2023-ENVHLTH-02-03: Health impacts of endocrine-disrupting
chemicals: bridging science-policy gaps by addressing persistent scientific uncertainties . 44
HORIZON-HLTH-2023-ENVHLTH-02-04: Global coordination of exposome research.. 48
Call - Environment and health (Two stage - 2024) ............................................................. 51
Conditions for the Call ......................................................................................................... 51
HORIZON-HLTH-2024-ENVHLTH-02-06-two-stage: The role of environmental pollution
in non-communicable diseases: air, noise and light and hazardous waste pollution ........... 53
Destination 3. Tackling diseases and reducing disease burden ....................59
Call - Tackling diseases (Single stage - 2023)....................................................................... 63
Conditions for the Call ......................................................................................................... 63
HORIZON-HLTH-2023-DISEASE-03-01: Novel approaches for palliative and end-of-life
care for non-cancer patients ................................................................................................. 64
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HORIZON-HLTH-2023-DISEASE-03-03: Interventions in city environments to reduce
risk of non-communicable disease (Global Alliance for Chronic Diseases - GACD)......... 67
HORIZON-HLTH-2023-DISEASE-03-04: Pandemic preparedness and response: Broad
spectrum anti-viral therapeutics for infectious diseases with epidemic potential................ 72
HORIZON-HLTH-2023-DISEASE-03-05: Pandemic preparedness and response:
Sustaining established coordination mechanisms for European adaptive platform trials
and/or for cohort networks ................................................................................................... 74
HORIZON-HLTH-2023-DISEASE-03-06: Towards structuring brain health research in
Europe .................................................................................................................................. 77
HORIZON-HLTH-2023-DISEASE-03-07: Relationship between infections and noncommunicable
diseases ........................................................................................................ 80
HORIZON-HLTH-2023-DISEASE-03-17: Pandemic preparedness and response:
Understanding vaccine induced-immunity........................................................................... 82
HORIZON-HLTH-2023-DISEASE-03-18: Pandemic preparedness and response:
Immunogenicity of viral proteins of viruses with epidemic and pandemic potential .......... 84
Call - Partnerships in Health (2023)..................................................................................... 86
Conditions for the Call ......................................................................................................... 86
HORIZON-HLTH-2023-DISEASE-07-01: European Partnership on Rare Diseases......... 87
Call - Tackling diseases (Two stage - 2024).......................................................................... 91
Conditions for the Call ......................................................................................................... 92
HORIZON-HLTH-2024-DISEASE-03-08-two-stage: Comparative effectiveness research
for healthcare interventions in areas of high public health need.......................................... 93
HORIZON-HLTH-2024-DISEASE-03-11-two-stage: Pandemic preparedness and
response: Adaptive platform trials for pandemic preparedness ........................................... 96
HORIZON-HLTH-2024-DISEASE-03-13-two-stage: Validation of fluid-derived
biomarkers for the prediction and prevention of brain disorders......................................... 99
HORIZON-HLTH-2024-DISEASE-03-14-two-stage: Tackling high-burden for patients,
under-researched medical conditions................................................................................. 102
Call - Tackling diseases (Single stage - 2024)..................................................................... 105
Conditions for the Call ....................................................................................................... 105
HORIZON-HLTH-2024-DISEASE-08-12: Pandemic preparedness and response:
Maintaining the European partnership for pandemic preparedness ................................... 106
HORIZON-HLTH-2024-DISEASE-08-20: Pandemic preparedness and response: Hostpathogen
interactions of infectious diseases with epidemic potential................................ 108
Call - Partnerships in Health (2024)................................................................................... 111
Conditions for the Call ....................................................................................................... 111
HORIZON-HLTH-2024-DISEASE-09-01: European Partnership: One Health AntiMicrobial
Resistance.......................................................................................................... 112
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Destination 4. Ensuring access to innovative, sustainable and high-quality
health care........................................................................................................117
Call - Ensuring access to innovative, sustainable and high-quality health care (Single
stage - 2023)........................................................................................................................... 121
Conditions for the Call ....................................................................................................... 121
HORIZON-HLTH-2023-CARE-04-01: Maintaining access to regular health and care
services in case of cross-border emergencies..................................................................... 122
HORIZON-HLTH-2023-CARE-04-02: Resilience and mental wellbeing of the health and
care workforce.................................................................................................................... 125
HORIZON-HLTH-2023-CARE-04-03: Environmentally sustainable and climate neutral
health and care systems...................................................................................................... 129
Call - Partnerships in Health (2023)................................................................................... 132
Conditions for the Call ....................................................................................................... 132
HORIZON-HLTH-2023-CARE-08-01: European Partnership on Personalised Medicine133
Call - Ensuring access to innovative, sustainable and high-quality health care (Two stage
- 2024) .................................................................................................................................... 138
Conditions for the Call ....................................................................................................... 138
HORIZON-HLTH-2024-CARE-04-04-two-stage: Access to health and care services for
people in vulnerable situations........................................................................................... 139
Destination 5. Unlocking the full potential of new tools, technologies and
digital solutions for a healthy society ............................................................145
Call - Tools and technologies for a healthy society (Single stage - 2023) ........................ 148
Conditions for the Call ....................................................................................................... 148
HORIZON-HLTH-2023-TOOL-05-01: Clinical trials of combined Advanced Therapy
Medicinal Products (ATMPs) ............................................................................................ 149
HORIZON-HLTH-2023-TOOL-05-03: Integrated, multi-scale computational models of
patient patho-physiology (‘virtual twins’) for personalised disease management............. 151
HORIZON-HLTH-2023-TOOL-05-04: Better integration and use of health-related realworld
and research data, including genomics, for improved clinical outcomes ................ 154
HORIZON-HLTH-2023-TOOL-05-05: Harnessing the potential of real-time data analysis
and secure Point-of-Care computing for the benefit of person-centred health and care
delivery............................................................................................................................... 158
HORIZON-HLTH-2023-TOOL-05-08: Pandemic preparedness and response: In vitro
diagnostic devices to tackle cross-border health threats .................................................... 160
HORIZON-HLTH-2023-TOOL-05-09: Developing a Data Quality and Utility Label for the
European Health Data Space.............................................................................................. 163
Call - Tools and technologies for a healthy society (Two stage - 2024) ........................... 165
Conditions for the Call ....................................................................................................... 166
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HORIZON-HLTH-2024-TOOL-05-06-two-stage: Innovative non-animal human-based
tools and strategies for biomedical research ...................................................................... 167
Call - Tools and technologies for a healthy society (Single stage - 2024) ........................ 169
Conditions for the Call ....................................................................................................... 170
HORIZON-HLTH-2024-TOOL-11-02: Bio-printing of living cells for regenerative
medicine ............................................................................................................................. 171
Destination 6. Maintaining an innovative, sustainable and globally
competitive health industry............................................................................174
Call - A competitive health-related industry (Single stage - 2023) .................................. 177
Conditions for the Call ....................................................................................................... 177
HORIZON-HLTH-2023-IND-06-01: Supporting the uptake of innovative Health
Technology Assessment (HTA) methodology and advancing HTA expertise across EU. 178
HORIZON-HLTH-2023-IND-06-02: Expanding the European Electronic Health Record
exchange Format to improve interoperability within the European Health Data Space.... 181
HORIZON-HLTH-2023-IND-06-04: Modelling and simulation to address regulatory needs
in the development of orphan and paediatric medicines.................................................... 183
HORIZON-HLTH-2023-IND-06-05: Mapping the hurdles for the clinical applications of
Advanced Therapy Medicinal Products (ATMPs)............................................................. 186
HORIZON-HLTH-2023-IND-06-07: Development and harmonisation of methodologies
for assessing digital health technologies in Europe ........................................................... 188
Call - A competitive health-related industry (Single stage - 2024) .................................. 191
Conditions for the Call ....................................................................................................... 191
HORIZON-HLTH-2024-IND-06-08: Developing EU methodological frameworks for
clinical/performance evaluation and post-market clinical/performance follow-up of medical
devices and in vitro diagnostic medical devices (IVDs).................................................... 192
HORIZON-HLTH-2024-IND-06-09: Gaining experience and confidence in New Approach
Methodologies (NAM) for regulatory safety and efficacy testing – coordinated training and
experience exchange for regulators.................................................................................... 195
Other Actions not subject to calls for proposals ..........................................198
Grants to identified beneficiaries........................................................................................ 198
1. Contribution to the Coalition for Epidemics Preparedness Initiative (CEPI) - vaccine
development for priority diseases ...................................................................................... 198
2. Presidency event - Sweden. Life sciences: The era of precision medicine.................... 200
3. Presidency event - Spain. Genomics-based health strategies: towards personalised and
precision medicine.............................................................................................................. 201
4. Presidency event - Belgium. R&I policies for Better Health, Wellbeing and Prosperity
............................................................................................................................................ 202
5. Presidency event - Hungary. Hungarian priorities in Health research........................... 204
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Other Instruments................................................................................................................ 205
1. External expertise........................................................................................................... 205
2. Mobilisation of research funds in case of Public Health Emergencies .......................... 206
3. Studies, conferences, events and outreach activities...................................................... 207
4. Subscription to the Human Frontier Science Program Organization............................. 208
Budget...............................................................................................................209
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Introduction
The Union and the world are gradually learning how to live with the COVID-19 pandemic.
The pandemic laid bare the vulnerabilities of our societies, economies and health care systems
and made evident the need for a strong European crisis preparedness and response in which
Europe is now decidedly investing. The European Health Emergency Preparedness and
Response Authority (HERA) created in September 2021 is key to this endeavour. The present
work programme will support HERA and Europe’s pandemic preparedness by investing in
research into better management of epidemics, adaptable clinical networks for drugs and
vaccines and better comprehension of the emergence of cross-border health threats. Particular
attention is paid to translational research, to facilitating the development and implementation
of new ways to prevent, diagnose, and treat infectious diseases, including the growing
problem of antimicrobial drug resistance. Focus is not only on immediate health threats, but
also on the wider societal impacts of health crises e.g. on peoples’ mental health and
wellbeing and on health care system resilience. Research conducted during the pandemic and
following its sequels is pivotal to inform preparedness for potential similar events in the
future. The pandemic has also demonstrated the downside of globalisation in which the
dependence on global value chains can quickly result in shortages of critical supplies, such as
essential medicines or other health technologies.
To help repair the economic and social damage caused by the coronavirus pandemic, the
European Commission, the European Parliament and EU Member States leaders agreed on a
Recovery Plan for Europe that will lead the way out of the crisis and lay the foundations for a
modern and more sustainable Union. The Health cluster will continue to benefit from
financial resources of this Multiannual Financial Framework and from NextGenerationEU
(NGEU), the Union’s financing instrument to boost the recovery. It requires research and
innovation supporting the recovery of people and communities from COVID-19 but also for
making society more resilient and national health systems better prepared to any future public
health emergency.
The Recovery Plan aims the Union to building back better, including through support for the
twin digital and green transitions by unlocking the full potential of data-enabled research and
innovation for digitised health systems and a competitive and secure data-economy, including
on the basis of European Electronic Health Records as well as the establishment of the
European Health Data Space. The digital transformation of health and care will help increase
the capacity of health care systems to deliver more personalised and effective health and care
with less resource wasting. It will contribute, but is not sufficient, to making the Union the
first climate-neutral continent by 2050, with zero pollution and zero waste. Additional efforts
are needed to also make the delivery of health care, the design of health technologies and their
manufacturing more sustainable by reducing energy consumption, waste, pollution and the
release of harmful substances, including pharmaceuticals, into the environment.
Even though research and innovation have the power to uncovering the knowledge and
developing the technologies to serve societal well-being, economic prosperity and
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environmental sustainability, it only can succeed through cooperation of the best research
teams with the prospective users of such knowledge and technologies. It is thus of outmost
importance to involve those users - like patients and healthy citizens, health care professionals
providers and payers, public health authorities and regulators, researchers or innovators from
academia and industry - early in the knowledge generation or technology development
process, including through patient/citizen engagement, community involvement or other
forms of social innovation approaches, such that research and innovation activities are
adjusted to the users’ particular expectations, needs, constraints and potential. Any
cooperation would benefit from adequate intellectual property management strategies.
Beyond cooperating along the value chain of knowledge and know-how production and
valorisation or within the knowledge triangle (research-education-innovation), it is in the
EU’s strategic interest to also reach out and cooperate with other countries outside the EU and
on other continents. This applies in particular for multi-lateral cooperation on (global) health
issues with countries associated to Horizon Europe but also with other partner countries and
regions in the world. In line with the EU’s Global Approach to Research and Innovation1
,
participation in Cluster 1 of Horizon Europe is open to third countries. In support of the
Global Gateway Strategy2
, projects involving international partners should lead to increased
scientific knowledge and transfer of technology among partner countries allowing to address
global health challenges across the world, thus creating sustainable growth and jobs.
Cooperation should take place in a value-based way, creating linkages, not dependencies”.
The pandemic has demonstrated the importance of effective coordination among EU Member
States in the area of health. The European Commission is building a strong European Health
Union, in which all EU Member States work together to improve prevention, diagnosis,
treatment and aftercare for any disease, including cancer. Research and innovation actions
under the Health Cluster will deliver relevant complementary inputs to “Europe’s Beating
Cancer Plan”3
, contributing to actions covering the entire cancer care pathway, including
prevention, early detection, diagnosis, treatment, cancer data monitoring, as well as quality of
life of cancer patients and survivors.
For topics in this cluster, consortia could consider their voluntary contribution in terms of
data, indicators and knowledge to relevant Joint Research Centre (JRC) platforms for
capitalising the knowledge developed in their projects and become more policy relevant4 5 6 7
8
.
Horizon Europe is the research and innovation support programme in a system of European
and national funding programmes that share policy objectives. Through the programme,
1
COM(2021) 252 final
2
JOIN(2021) 30 final
3
https://health.ec.europa.eu/system/files/2022-02/eu_cancer-plan_en_0.pdf
4
The European Cancer Information System (ECIS) and the European Network of Cancer Registries
(ENCR)
5
European Commission Initiatives on Breast and Colorectal Cancer
6
European Cancer Inequalities Registry
7
European Platform on Rare Disease Registration (EU RD Platform) – for rare cancers
8
Health Promotion and Disease Prevention Knowledge Gateway
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special attention is given to ensuring cooperation between universities, scientific communities
and industry, including small and medium-sized enterprises, and citizens and their
representatives, in order to bridge gaps between territories, generations and regional cultures,
especially caring for the needs of the young in shaping Europe’s future. Moreover,
accelerating the performance and boosting the use and impact of research and innovation also
requires it to make use of complementary capacities, such as European research, innovation
and space infrastructures and services, or to develop complementary activities in synergy with
other European Union funding programmes. Applicants could consider and actively seek
complementarities and synergies with, and where appropriate possibilities for further funding
of additional activities not covered by their proposal from EU, national or regional
programmes such as: EU4Health, Digital Europe Programme, European Regional
Development Fund (ERDF), European Social Fund (ESF+), Structural Reform Support
Programme (SRSP), Just Transition Fund (JTF), European Maritime and Fisheries Fund
(EMFF), European Agricultural Fund for Rural Development (EAFRD), European Defence
Fund (EDF) or InvestEU. This could involve dedicated calls (EU synergies calls), meaning
that actions that have been awarded a grant under such a call could have the possibility to also
receive funding under other EU programmes, including relevant shared management funds.
Additionally, to encourage multi-actor approaches and to be more effective in achieving
impact, applicants could consider synergies with other relevant initiatives funded under the
Horizon Europe programme, including the Knowledge and Innovation Communities (KICs)
of the European Institute of Innovation and Technology (EIT) or the interregional networks
funded under the European Innovation Ecosystems (EIE) component of Pillar III. The
innovation ecosystems created and nurtured by the EIT-KICs or the EIE can in particular
contribute to building communities or platforms for coordination and support actions, sharing
knowledge or disseminating and fostering the exploitation of project results. The proposals
are also encouraged to explore other forms and means of service provisions distinct to the
EIT-KICs, in particular EIT-KIC Health and EIT-KIC Digital.
All could help to support the development of skills and capacities in research or health
systems, as well as accelerating the take-up and use of scientific evidence, new technologies
and best practices in health care and by health systems, industries and markets, at national or
regional level.
As examples, the EU4Health programme could help to ensure that the best use is made of
research results and facilitate the uptake, scaling-up and deployment of health innovations in
healthcare systems and clinical practice. Thereby unlocking the potential of innovation in
health, and improving efficiency by avoiding the duplication of activities and optimising the
use of financial resources.
The ERDF focuses, amongst others, on the development and strengthening of regional and
local research and innovation ecosystems and smart economic transformation, in line with
regional/national smart specialisation strategies. It can support investment in research
infrastructure, activities for applied research and innovation, including industrial research,
experimental development and feasibility studies, building research and innovation capacities
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and uptake of advanced technologies and roll-out of innovative solutions from the Framework
Programmes for research and innovation through the ERDF9
.
The EU’s Recovery and Resilience Facility (RRF) offers support to Member States in
financing reforms and investments that improve their resilience and their growth potential,
mitigate the economic and social impacts from the COVID-19 crisis, including in the area of
health, and support the twin green and digital transitions. For project ideas that go beyond the
remits of an R&I proposal and directly contribute to the objectives of the RRF it is advisable
to check access to funding available at national level in line with the Member States’
approved recovery and resilience plans for a fast and targeted support.
Notwithstanding the synergies mentioned above, the work programme 2023-2024 of cluster 1
‘Health’ captures synergies with other clusters based on the challenges and areas of
intervention of each destination. Further synergies are encouraged with regard to
complementary funding opportunities provided by topics in other clusters and other pillars of
Horizon Europe, notably in the European Research Infrastructure work programme (under
pillar I) and the European Innovation Council work programme (under pillar III). Additional
synergies could also be explored at project-level, i.e. between the portfolio of projects funded
either under the same topic or by establishing a portfolio of projects funded under different
topics (of the health cluster, of the other clusters 2-6, or of the pillars I/III of Horizon Europe).
In particular, applicants to calls of the health cluster are encouraged to consider, where
relevant, the services offered by the current and future EU-funded European Research
Infrastructures, including the European Open Science Cloud.10 11
Moreover, if projects use
satellite-based earth observation, positioning, navigation and/or related timing data and
services, they must make use of European space technologies and services provided by
Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).12
In the context of the work programme 2023-2024 of cluster 1 ‘Health’, a clinical study covers
clinical studies/trials/investigations/cohorts and is defined as any systematic prospective or
retrospective collection and analysis of health data obtained from individual patients or
healthy persons in order to address scientific questions related to the understanding,
prevention, diagnosis, monitoring or treatment of a disease, mental illness, or physical
9
“Synergies between Horizon Europe and ERDF programmes (Draft Commission Notice)”
https://research-and-innovation.ec.europa.eu/news/all-research-and-innovation-news/synergies-
guidance-out-2022-07-06_en
10
2018 Roadmap of the European Strategy Forum on Research Infrastructures (ESFRI) with the ESFRI
research infrastructures list (pp 15-17),
https://ec.europa.eu/info/sites/info/files/research_and_innovation/esfri-roadmap-2018.pdf; European
Research Infrastructures, Commission website: https://ec.europa.eu/info/research-andinnovation/strategy/european-research-infrastructures_en;
List of entities legally established as
European Research Infrastructure Consortium (ERIC) https://www.eric-forum.eu/the-eric-landscape.
11
European Open Science Cloud (EOSC) https://www.eosc-portal.eu; European COVID-19 Data
Platform / COVID-19 Data Portal https://www.covid19dataportal.org.
12
European space technology based earth observation, positioning, navigation and timing services
provided by: Copernicus, the European Union's Earth observation programme
https://www.copernicus.eu/en/copernicus-services; Galileo, the European Global Satellite Navigation
System (GNSS) https://www.gsc-europa.eu/galileo/services/galileo-initial-services; and the European
Geostationary Navigation Overlay Service (EGNOS) https://www.gsa.europa.eu/egnos/services.
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condition. It includes but it is not limited to clinical studies as defined by Regulation
536/2014 (on medicinal products), clinical investigation and clinical evaluation as defined by
Regulation 2017/745 (on medical devices), performance study and performance evaluation as
defined by Regulation 2017/746 (on in vitro diagnostic medical devices).
In the context of the work programme 2023-2024 of cluster 1 ‘Health’, FAIR data are data
which meet principles of findability, accessibility, interoperability, and reusability. Data can
include exploitation of information and data from European data infrastructures and
programmes such as Copernicus, European Space Agency and the GEO initiative. For further
details, see the FAIR principles website 13
, the FAIR cookbook 14
and the guides for
researchers on how to make your data FAIR.15
Where relevant, applicants are encouraged to take advantage of synergies with the Euratom
Research and Training Programme (2021-2025).16
The work programme 2023-2024 of cluster 1 ‘Health’ is directed towards two Key Strategic
Orientations (KSOs) for research and innovation set by Horizon Europe’s strategic plan 2021-
2024, notably to creating a more resilient, inclusive and democratic European society (KSOD)
and promoting an open strategic autonomy by leading the development of key digital,
enabling and emerging technologies, sectors and value chains (KSO-A). It aims to complete
the targets set out in the Strategic Plan 2021-2024, mainly along the four impact areas: Good
health and high-quality accessible health care; A resilient EU prepared for emerging threats;
High quality digital services for all; and A competitive and secure data-economy. More
specifically, cluster 1 strives to contribute to six expected impacts as set out by the Strategic
Plan, which are the following six destinations of this work programme:
Destination 1 - Staying healthy in a rapidly changing society: Citizens of all ages stay
healthy and independent in a rapidly changing society thanks to healthier lifestyles and
behaviours, healthier diets, healthier environments, improved evidence-based health policies,
and more effective solutions for health promotion and disease prevention.
Destination 2 - Living and working in a health-promoting environment: Living and
working environments are health-promoting and sustainable thanks to better understanding of
environmental, occupational, social and economic determinants of health.
Destination 3 - Tackling diseases and reducing disease burden: Health care providers are
able to better tackle and manage diseases (infectious diseases, including poverty-related and
neglected diseases, non-communicable and rare diseases) and reduce the disease burden on
patients effectively thanks to better understanding and treatment of diseases, more effective
13
https://www.go-fair.org/fair-principles
14
https://faircookbook.elixir-europe.org/content/home.html
15
https://www.openaire.eu/how-to-make-your-data-fair
16
The Euratom programme supports research on the protection of citizens, including patients, benefiting
from screening, early detection, diagnostics, cancer therapy and care involving radiation sources. It
aims at better understanding the effects of medical exposure to ionising radiation, optimisation of
radiological protection, and safe use and reliable supply of medical radionuclides.
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and innovative health technologies, better ability and preparedness to manage epidemic
outbreaks and improved patient safety.
Destination 4 - Ensuring access to innovative, sustainable and high-quality health care:
Health care systems provide equal access to innovative, sustainable and high-quality health
care thanks to the development and uptake of safe, cost-effective and people-centred
solutions, with a focus on population health, health systems resilience, as well as improved
evidence-based health policies.
Destination 5 - Unlocking the full potential of new tools, technologies and digital
solutions for a healthy society: Health technologies, new tools and digital solutions are
applied effectively thanks to their inclusive, secure and ethical development, delivery,
integration and deployment in health policies and health care systems.
Destination 6 - Maintaining an innovative, sustainable and globally competitive healthrelated
industry: EU health industry is innovative, sustainable and globally competitive
thanks to improved up-take of breakthrough technologies and innovations, which makes the
EU with its Member States more resilient and less dependent from imports with regard to the
access to and supply of critical health technologies.
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Destination 1 – Staying healthy in a rapidly changing society
Calls for proposals under this destination are directed towards the Key Strategic Orientation
KSO-D ‘Creating a more resilient, inclusive and democratic European society’ of Horizon
Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination
should contribute to the impact area ‘Good health and high-quality accessible health care’
and in particular to the following expected impact, set out in the Strategic Plan for the health
cluster: ‘citizens of all ages stay healthy and independent in a rapidly changing society thanks
to healthier lifestyles and behaviours, healthier diets, healthier environments, improved
evidence-based health policies, and more effective solutions for health promotion and disease
prevention’. In addition, research and innovation supported under this destination could also
contribute to the following impact areas: ‘High quality digital services for all’, ‘Sustainable
food systems from farm to fork on land and sea’, and ‘Climate change mitigation and
adaptation’.
People´s health care needs are different, depending on their age, stage of life and socioeconomic
background. Their physical and mental health and well-being can be influenced by
their individual situation as well as the broader societal context they are living in.
Furthermore, health education and behaviour are important factors. Currently, more than 790
000 deaths per year in Europe are due to risk factors such as smoking, drinking, physical
inactivity, and obesity. Upbringing, income, education levels, social and gender aspects also
have an impact on health risks and how diseases can be prevented. Moreover, people´s health
can be impacted by a rapidly changing society, making it challenging to keep pace and find its
way through new technological tools and societal changes, which both are increasing
demands on the individual´s resilience. In order to leave no one behind, to reduce health
inequalities and to support healthy and active lives for all, it is crucial to provide suitable and
tailor-made solutions, including for people with specific needs. Preventing diseases from
developing in the first place is at the core of successful public health programmes in the
future.
As set out in the Strategic Plan 2021-2024, destination 1 focuses on major societal challenges
that are part of the European Commission’s political priorities. This is why destination 1 in
the work programme 2021-2022 covered immediate urgencies, notably a better understanding
and prevention of mental illness, prevention of obesity, digital empowerment in health
literacy, understanding the transition from health to disease and making use of AI tools to
predict the risk for onset and progression of chronic diseases. The work programme 2023-
2024 will complete the ambitions of the Strategic Plan by focussing on holistic and integrated
approaches to disease prevention and health promotion, notably healthy ageing, on a life
course approach to physical and mental health starting in early childhood and on personalised
approaches to prevention of diseases.
More specifically, research and innovation supported under this destination will provide new
tools, digitally enabled solutions and evidence-based health and care services to prevent and
delay progression of age-related diseases. Research and innovation will also provide tailor
Horizon Europe - Work Programme 2023-2024
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made strategies and solutions to support children and adolescents adopting and maintaining
person-centred healthy lifestyles. Specific measures will be developed to educate and
empower citizens of all ages and throughout their life to play an active role in the selfmanagement
of their own health and self-care, to the benefit of an active and healthy ageing.
This destination will also call for proposals specifically aiming to develop integrated and
holistic personalised disease prevention strategies, making use of multiple data sources,
including real-world health data. This initiative will build on the impressive advances made in
the area of personalised medicine to treat diseases, but here the focus will be on personalised
approaches to prevent rather than treat diseases.
Dialogue and coordination between stakeholders and policymakers as well as integration
across different settings will be needed to develop more effective cross-sectoral solutions for
holistic approaches to health promotion and disease prevention and deliver improved
evidence-based health for all.
In view of increasing the impact of EU investments under Horizon Europe, the European
Commission welcomes and supports cooperation between EU-funded projects to enable
cross-fertilisation and other synergies. This could range from networking to joint activities
such as the participation in joint workshops, the exchange of knowledge, the development and
adoption of best practices, or joint communication activities. Opportunities for potential
synergies exist between projects funded under the same topic, but also between other projects
funded under another topic, cluster or pillar of Horizon Europe. In particular, this could
involve projects related to European health research infrastructures (under pillar I of Horizon
Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of
Horizon Europe), or in areas cutting across the health and other clusters (under pillar II of
Horizon Europe). For instance, with cluster 2 “Culture, Creativity and Inclusive Society” such
as on health inequalities, on other inequalities affecting health, or on citizens’ behaviour and
engagement; with cluster 4 “Digital, Industry and Space” such as on digital tools,
telemedicine or smart homes; with cluster 5 “Climate, Energy and Mobility” such as on urban
health or on mitigating the impact of road traffic accidents and related injuries; with cluster 6
“Food, Bioeconomy, Natural Resources, Agriculture and Environment” such as on the role of
nutrition for health (incl. human microbiome, mal- and over-nutrition, safe food), personalised
diets (incl. food habits in general and childhood obesity in particular) and the impact of foodrelated
environmental stressors on human health (incl. marketing and consumer habits).17
Expected impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to
staying healthy in a rapidly changing society, and more specifically to one or several of the
following impacts:
 Citizens adopt healthier lifestyles and behaviours, make healthier choices and maintain
longer a healthy, independent and active life with a reduced disease burden, including at
old ages or in other vulnerable stages of life.
17
Strategic Plan 2021-2024 of Horizon Europe, Annex I, Table 2.
Horizon Europe - Work Programme 2023-2024
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 Citizens are able and empowered to manage better their own physical and mental health
and well-being, monitor their health, and interact with their doctors and health care
providers.
 Children and adolescents are empowered to better monitor and manage their physical,
social and mental health with a view to lifelong healthy lifestyles.
 Society benefits from reduced economic and health burden from avoidable sickness,
disease and premature death. Efficiency is increased by targeting scarce resources in
appropriate, cost-effective ways, to areas of high social return, contributing to an
improvement and optimisation of health and well-being of citizens and reduction of
health inequalities.
 Citizens´ trust in knowledge-based health interventions and in guidance from health
authorities is strengthened, including through improved health literacy, resulting in
increased engagement in and adherence to effective strategies for health promotion,
disease prevention and treatment, while digital literacy inequalities are minimised.
 Health policies and actions for health promotion and disease prevention are knowledgebased,
people-centred, personalised and thus targeted and tailored to citizens' needs, and
designed to reduce health inequalities.
The following call(s) in this work programme contribute to this destination:
Call Budgets (EUR million) Deadline(s)
2023 2024
HORIZON-HLTH-2023-
STAYHLTH-01
40.00 13 Apr 2023
HORIZON-HLTH-2024-
STAYHLTH-01-two-stage
80.00 19 Sep 2023 (First
Stage)
11 Apr 2024
(Second Stage)
Overall indicative budget 40.00 80.00
Horizon Europe - Work Programme 2023-2024
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Call - Staying Healthy (Single stage - 2023)
HORIZON-HLTH-2023-STAYHLTH-01
Conditions for the Call
Indicative budget(s)18
Topics Type
of
Action
Budgets
(EUR
million)
Expected EU
contribution
per project
(EUR
million)19
Indicative
number
of
projects
expected
to be
funded
2023
Opening: 12 Jan 2023
Deadline(s): 13 Apr 2023
HORIZON-HLTH-2023-STAYHLTH-01-01 RIA 40.00 20
15.00 to
20.00
2
Overall indicative budget 40.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
18
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
19
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
20
Of which EUR 24.00 million from the 'NGEU' Fund Source.
Horizon Europe - Work Programme 2023-2024
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Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2023-STAYHLTH-01-01: The Silver Deal - Person-centred health
and care in European regions
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
15.00 and 20.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 40.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several impacts of destination 1 “Staying healthy in a rapidly changing society”. To
that end, proposals under this topic should aim for delivering results that are directed at,
tailored towards and contributing to all of the following expected outcomes:
Horizon Europe - Work Programme 2023-2024
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 Citizens and patients will get effective, preventive, integrated, coordinated, evidencebased
and people-centred high-quality health and care services to identify and tackle or
prevent multi-morbidities, frailty, biologically or mentally reduced capacities, (sensory)
impairments, dementia and/or neurodegeneration, fostering mental and physical health,
wellbeing and quality of life. These could include, but are not limited to, assistive
technologies, nutrition and physical activity, adaptation of work and workplace, healthpromoting
age-friendly working, home and community environments, better equality of
access to health and care services through community-based and integrated care models,
also digitally enabled.
 Primary and community-based health and care services will be better equipped to early
identify people at risk of developing non-communicable diseases (NCDs) and multimorbidities.
They will have integrated and cost-effective intervention tools to help
prevent, monitor and manage progression of age-related diseases, conditions and
disabilities, while promoting healthy lifestyles, ageing in place21
, as well as physical and
mental wellbeing among the elderly.
 Older people, including those receiving long-term care, will be empowered to take an
active role in the management of their own physical and mental health, as well as
increase their social interactions and wellbeing through better health literacy, educational
programmes, trainings and platforms, including with the help of innovative and digitally
enabled solutions.
 Citizens, all relevant stakeholders, public authorities, cities and rural environments, as
well as health care providers will be engaged to ensure the introduction to and the
integration of age-friendly, mental and physical health promoting innovative care
pathways and digitally enabled solutions into the daily life and wellbeing of the ageing
population, with the aim of leaving no-one behind.
The proposals should provide appropriate indicators to measure performance and progress
towards the relevant expected outcomes.
Scope: This topic aims to implement strategies and actions in line with the Green Paper on
Ageing22
, the EU Long-term care report23
, the ‘Healthier Together’ – EU Non-Communicable
Diseases Initiative24
, the new EU Care Strategy25
, which strive to address demographic
change and enable better health and care for Europe’s growing ageing societies, as well as to
harness the potential of the Silver Economy26
. NCD prevention is highly relevant to reduce
21
‘The ability to live in one's own home and community safely, independently, and comfortably,
regardless of age, income, or ability level’.
22
https://ec.europa.eu/info/sites/default/files/1_en_act_part1_v8_0.pdf
23
https://ec.europa.eu/social/main.jsp?catId=738&langId=en&pubId=8396
24
https://ec.europa.eu/health/non-communicable-diseases/overview_en
25
https://www.europarl.europa.eu/legislative-train/theme-promoting-our-european-way-of-life/file-
european-care-strategy
26
A new multi-policy approach is recommended by the “Silver Economy Study”: the ageing population
promises more economic growth and jobs. Silver Economy Study: How to stimulate the economy by
hundreds of millions of Euros per year | Shaping Europe’s digital future (europa.eu)
Horizon Europe - Work Programme 2023-2024
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the need for long-term care. New tools and integrated care models are needed, reinforcing
primary, community- and home-based health and long-term care provision, through better
early detection and management of diseases among older people in an increasingly ageing
society and overburdened health and care systems.
The topic encourages the participation of small and medium-sized enterprises (SMEs), as well
as of European, national and regional authorities and civil society, in order to strengthen the
scientific and technological expertise of SMEs in the health and care domain, promote the
European Health- and Age-Tech; and improve the uptake of innovative health and care
solutions in the EU and Associated Countries.
The applicants should ensure that the developed solutions, technologies and adoption policies
are driven by the needs of citizens and patients of old age and ensure their involvement. Cocreation,
co-design with end-users and particular consideration of the diversity of the needs,
mental and physical abilities, living and socio-economic conditions as well as life-situations
of older people are required, including provision of training to citizens, patients, formal and
informal carers.
The proposed research and innovation should focus on all of the following aspects:
 Consolidate high-quality effective, integrated, innovative and digitally enabled personcentred
health and long-term care services and solutions, both in primary care, hospital
and home settings, around older people's needs for physical and mental health, care and
wellbeing, strengthened disease prevention, rehabilitation and for staying active and
healthy as people age. Such integrated and holistic solutions could include, but are not
limited to, integrated care solutions, serious games, connected wearables, ambient
sensors, social robots, assistive technologies, age-friendly environments, diagnostic
screenings, self-monitoring devices, robotics and others27
, tackling age-related physical
and mental diseases and co-morbidities.
 Develop and provide evidenced-based new approaches, coordinated care models and
pathways, for delivering effective, person-centred health and long-term care solutions at
the system and community level. These should be based on the needs of healthy and
vulnerable older people for increased physical, mental and nutritional resilience vis-à-vis
inequality of access to health and care, rapidly changing societies and health and care
systems, and ensure better skills, empowerment and improved health and digital literacy
through appropriate trainings and activities.
 Support adoption and market innovation of novel health and care solutions, co-created
with and designed for older age-related health conditions. The support could be provided
through large-scale testing and deployment piloting, guidance on relevant HTA and CE
procedures, demonstrating cost-effectiveness, as well as through stakeholder
involvement and policy collaboration on European 28
, local, regional 29
, and
27
EU-funded large-scale pilots on Active and Healthy Ageing https://www.opendei.eu/healthcare-sector/
28
https://digital-strategy.ec.europa.eu/en/policies/eip-aha and http://www.aal-europe.eu/ and
http://www.rscn.eu/
Horizon Europe - Work Programme 2023-2024
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international30 , 31
level, exchange of best practices (twinnings), and, when relevant,
collaboration with the EC-funded large-scale pilots on Active and Healthy Living32
and
the Reference Sites Collaborative Network.
This topic addresses consortia including research partners and innovative technology
providers, such as SMEs and/or organisations that can offer the range of activities required to
address the objectives of the topic; the latter could for example be based on Digital Innovation
Hubs, digital health accelerators, incubators and knowledge hubs, Centres offering Pilot Lines
or similar technology, business and/or knowledge transfer organisations.
The proposals should be highly integrated, ambitious, go beyond simple networking and
provide appropriate indicators to measure progress, impact, cost-effectiveness and adoption in
the Europe. Dissemination and involvement of policymakers, both at national and regional
level, as well as civil society organisations in a European wide geographical balanced matter
is essential, as the results of this action are expected to have European wide impact.
Selected projects under this topic are strongly encouraged to participate in joint activities as
appropriate. These joint activities could, for example, take the form of clustering of projects
and involve joint coordination and dissemination activities such as the participation in joint
workshops, the exchange of knowledge, the development and adoption of best practices and
adoption strategies on regional, national and European level. The details of these joint
activities will be defined during the grant preparation phase with the European Commission.
Applicants should plan a necessary budget to cover this collaboration.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
Call - Staying Healthy (Two stage - 2024)
HORIZON-HLTH-2024-STAYHLTH-01-two-stage
Conditions for the Call
Indicative budget(s)33
29
Such as the Reference Sites Collaborative Network, http://www.rscn.eu/
30
International cooperation EU-Japan: Digital health and ageing Smart living environments for ageing
people. September 2021; DOI: 10.2759/13059; Luxembourg: Publications Office of the European
Union: ISBN 978-92-76-38187-7
31
https://idih-global.eu
32
https://www.opendei.eu/healthcare-sector/
Horizon Europe - Work Programme 2023-2024
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Topics Type
of
Action
Budgets
(EUR
million)
Expected
EU
contribution
per project
(EUR
million)34
Indicative
number
of
projects
expected
to be
funded
2024
Opening: 30 Mar 2023
Deadline(s): 19 Sep 2023 (First Stage), 11 Apr 2024 (Second Stage)
HORIZON-HLTH-2024-STAYHLTH-01-02-
two-stage
RIA 30.00 8.00 to
10.00
3
HORIZON-HLTH-2024-STAYHLTH-01-05-
two-stage
RIA 50.00 8.00 to
12.00
5
Overall indicative budget 80.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant The rules are described in General Annex G.
33
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
34
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
Horizon Europe - Work Programme 2023-2024
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Agreements
Proposals are invited against the following topic(s):
HORIZON-HLTH-2024-STAYHLTH-01-02-two-stage: Towards a holistic support to
children and adolescents’ health and care provisions in an increasingly digital society
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
8.00 and 10.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 30.00 million.
Type of Action Research and Innovation Actions
Admissibility
conditions
The conditions are described in General Annex A. The following
exceptions apply:
Applicants submitting a proposal under the blind evaluation pilot (see
General Annex F) must not disclose their organisation names,
acronyms, logos, nor names of personnel in Part B of their first stage
application (see General Annex E).
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Award criteria The criteria are described in General Annex D. The following
exceptions apply:
For the second stage, the thresholds for each criterion will be 4
(Excellence), 4 (Impact) and 3 (Implementation). The cumulative
threshold will be 12.
Procedure The procedure is described in General Annex F. The following
exceptions apply:
This topic is part of the blind evaluation pilot under which first stage
proposals will be evaluated blindly.
Horizon Europe - Work Programme 2023-2024
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Legal and financial
set-up of the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
Eligible costs will take the form of a lump sum as defined in the
Decision of 7 July 2021 authorising the use of lump sum contributions
under the Horizon Europe Programme – the Framework Programme for
Research and Innovation (2021-2027) – and in actions under the
Research and Training Programme of the European Atomic Energy
Community (2021-2025). 35
.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several impacts of destination 1 “Staying healthy in a rapidly changing society”. To
that end, proposals under this topic should aim for delivering results that are directed at,
tailored towards and contributing to all of the following expected outcomes:
 Children, adolescents and their parents/carers are educated and empowered in prevention
strategies involving personalised approaches and solutions (also through the use of
digital tools) to manage, maintain and improve children’s and adolescents' own health,
physical activity, nutrition habits, leisure needs, mental and social well-being, in full
respect of the privacy of individuals.
 Children and adolescents, including those from vulnerable contexts, monitor their health
risks, adopt healthy lifestyles at home, at school and in the community and interact with
their doctors and carers (receiving and providing feedback), also through the means of
digitally enabled solutions, better health literacy, training and critical thinking.
 Thanks to better co-creation, training, digital and health literacy, children, adolescents,
parents and carers across Europe access and use person-centred, widely available
solutions for children and adolescents’ health, care and wellbeing, appropriate to a
rapidly changing and increasingly digitalised society, also considering the risk of digital
addiction.
The proposals should provide appropriate indicators to measure the progress towards the
relevant expected outcomes.
Scope: Laying the ground for a healthy life starts in childhood. Accordingly, and in line with
the HealthyLifestyles4All Initiative36
, the ‘Healthier Together’ – EU Non-Communicable
Diseases Initiative37
, and the Communication of the Commission on enabling the Digital
Transformation of Health and Care38,39
, the main goal of the research and innovation should
35
This decision is available on the Funding and Tenders Portal, in the reference documents section for
Horizon Europe, under ‘Simplified costs decisions’ or through this link:
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-
decision_he_en.pdf
36
https://sport.ec.europa.eu/healthylifestyle4all
37
https://ec.europa.eu/health/non-communicable-diseases_en
38
https://digital-strategy.ec.europa.eu/en/policies/ehealth
39
https://digital-strategy.ec.europa.eu/en/library/communication-enabling-digital-transformation-health-
and-care-digital-single-market-empowering
Horizon Europe - Work Programme 2023-2024
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be to promote healthier societies by developing holistic solutions that foster healthy lifestyles
from early age with long-term impact(s).
Digitalisation poses risks but can also be a driving force for empowering young citizens, who
are growing up in an increasingly digitised world, in taking an active role in the management
of their own health conditions, mental and social well-being, and promote healthy lives and
disease prevention, through innovative solutions, coordinated person-centred care models and
better health literacy.
The topic encourages the participation of small and medium-sized enterprises (SMEs), as well
as of European, national and regional authorities and civil society, in order to strengthen the
scientific and technological expertise of SMEs in the health and care domain to promote the
uptake of innovative health and care solutions in Europe.
The proposed research and innovation should focus on several of the following aspects:
 Develop and advance person-centred, evidence-based and coordinated disease
prevention intervention solutions to support children and adolescents’ health and care in
an increasingly digital society. The effectiveness of the intervention solutions should be
evaluated, inter alia, in terms of health outcomes, (comparative) cost-effectiveness,
implementation facilitators and barriers. The target group should include children and
adolescents up to 25 years of age from different socio-economic backgrounds.
 Develop and integrate innovative, privacy preserving tools and technologies, such as
(but not limited to) activity trackers, sensors, serious games, platforms and robotics,
Massive Open Online Courses (MOOCs) in coordinated and integrated care models, to
help children and adolescents lead healthy, active and social lifestyles, prevent diseases,
as well as to better monitor and manage their physical, social and mental health.
Empower children and adolescents to navigate the health and care systems, interact with
their doctors, formal and informal carers, social circles, as well as better manage their
own health at home, in the community and at school, taking into account specific youth
psychiatric risk factors, the risk of addiction, as well as the geographic, social and
economic determinants of health and digital literacy inequities.
 Stimulate the adoption of person-centred approaches and solutions for better health, care
and well-being of children and adolescents, by including stakeholders from all the
relevant sectors (including but not limited to education, leisure, social innovation,
healthcare, Medtech, media and citizens) in the co-creation, design, planning and
adoption of the solutions, as well as the training of their end-users.
 Develop and disseminate evidence-based guidance and tools for children and adolescents
promoting healthy balance between a sedentary digitised lifestyle and a more active nondigitised
lifestyle in support of their physical, mental and social health and well-being on
short- and long-term basis.
Horizon Europe - Work Programme 2023-2024
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 Develop, implement (pilot and/or scale-up) and promote person-centred tools and
interventions for better physical and mental wellbeing, addressing the risks of digital
addiction and overconsumption, isolation and mental illness, by promoting physical,
intellectual or artistic activities, social interaction and providing mental health support
and treatment.
In all instances, gender as well as demographic, geographic and socio-economic aspects
should be duly taken into account.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise and the involvement of youth throughout the project in order to
produce meaningful and significant effects enhancing the societal impact of the related
research activities.
Moreover, greater involvement of non-health sectors directly affecting risk factors and
determinants of health, for example (physical) environment, food and nutrition, security,
education, sports, finance, industry is desirable/encouraged, as relevant.
Proposals should be highly integrated, ambitious, go beyond simple networking and provide
appropriate indicators to measure progress and impact.
Selected projects under this topic are strongly encouraged to participate in joint activities as
appropriate. These joint activities could, for example, take the form of clustering of projects
and involve joint coordination and dissemination activities such as the participation in joint
workshops, the exchange of knowledge, the development and adoption of best practices and
adoption strategies on regional, national and European level. The details of these joint
activities will be defined during the grant preparation phase with the Commission. Applicants
should plan a necessary budget to cover this collaboration.
Applicants invited to the second stage and envisaging to include clinical studies should
provide details of their clinical studies in the dedicated annex using the template provided in
the submission system. See definition of clinical studies in the introduction to this work
programme part.
HORIZON-HLTH-2024-STAYHLTH-01-05-two-stage: Personalised prevention of noncommunicable
diseases - addressing areas of unmet needs using multiple data sources
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
8.00 and 12.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 50.00 million.
Horizon Europe - Work Programme 2023-2024
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Type of Action Research and Innovation Actions
Admissibility
conditions
The conditions are described in General Annex A. The following
exceptions apply:
Applicants submitting a proposal under the blind evaluation pilot (see
General Annex F) must not disclose their organisation names,
acronyms, logos, nor names of personnel in Part B of their first stage
application (see General Annex E).
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Award criteria The criteria are described in General Annex D. The following
exceptions apply:
For the second stage, the thresholds for each criterion will be 4
(Excellence), 4 (Impact) and 3 (Implementation). The cumulative
threshold will be 12.
Procedure The procedure is described in General Annex F. The following
exceptions apply:
This topic is part of the blind evaluation pilot under which first stage
proposals will be evaluated blindly.
Legal and financial
set-up of the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
Eligible costs will take the form of a lump sum as defined in the
Decision of 7 July 2021 authorising the use of lump sum contributions
under the Horizon Europe Programme – the Framework Programme for
Research and Innovation (2021-2027) – and in actions under the
Research and Training Programme of the European Atomic Energy
Community (2021-2025). 40
.
40
This decision is available on the Funding and Tenders Portal, in the reference documents section for
Horizon Europe, under ‘Simplified costs decisions’ or through this link:
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-
decision_he_en.pdf
Horizon Europe - Work Programme 2023-2024
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Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several impacts of destination 1 “Staying healthy in a rapidly changing society”. To
that end, proposals under this topic should aim at delivering results that are directed at,
tailored towards and contributing to several of the following expected outcomes:
 Citizens have access to and use effective personalised prevention schemes and health
counselling (including through digital means) that take into account their individual
characteristics and situation. Individuals can be assigned to particular groups based on
their characteristics, and receive advice adequate to that group. Stratification of a
population into groups showing similar traits allows for effective personalised disease
prevention.
 Health professionals use effective, tried and tested tools to facilitate their work when
advising both patients and healthy individuals. Public health programme owners gain
insight into the specificities and characteristics of disease clusters within the population
through stratification. This can then be used to facilitate the identification of population
groups with elevated risk of developing certain diseases and improve the programmes,
update them and design effective strategies for optimal solutions and interventions.
 National and regional programmes make better use of funds, data infrastructure and
personnel in health promotion and disease prevention, primary and secondary healthcare.
They can consider the use of new or improved ambitious policy and intervention options,
with expected high population-wide impact, for effective health promotion and disease
prevention.
 Companies generate opportunities for new product and service developments to cater to
the needs of the healthcare service and individuals.
Scope: Non-communicable diseases (NCDs) are responsible for the majority of the disease
burden in Europe and are the leading cause of avoidable premature death. The human and
financial cost of NCDs is high and expected to grow. Reducing the burden of NCDs requires a
holistic approach and tackling health inequalities across the board. Preventing NCDs from
developing in the first place will be at the core of successful public health programmes in the
future.
Personalised approaches and the development of targeted interventions have led to an
impressive progress in several fields of medicine and have been included in many treatments.
However, the use of stratification and individualisation in guiding prevention strategies is still
not widely in use even though examples of its potential are accumulating. Identifying people
at risk of developing a particular disease before the disease starts to manifest itself with
symptoms greatly improves treatment options. It is estimated that about two thirds of all
NCDs are preventable, many affecting people who are unaware of their disease risks or do not
have access to information pertaining to the management of the condition.
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Personalised prevention is the assessment of health risks for individuals based on their
specific background traits 41
to recommend tailored prevention 42
. This can include any
evidence-based method 43
. Personalised prevention strategies complement general public
health prevention programmes without replacing them, optimising the benefit of both
approaches. Personalised prevention is ideally suited to the use of large data sets,
computational and omics approaches, with design and use of algorithms, integrating in-depth
biological and medical information, machine learning, artificial intelligence (AI) and ‘virtual
twin’ technology, taking into account explainable and transparent AI44
.
The funded projects will work towards reducing the burden of NCDs in line with the
‘Healthier Together’ – EU Non-Communicable Diseases Initiative45
. This does not limit the
scope of projects under this topic to particular diseases as any disease area of interest, comorbidities
and health determinants46
can be addressed.
Accordingly, the proposed research is expected to deliver on all of the following points:
 Enable the understanding of areas of unmet need in NCDs prevention, possibly also
addressing disease mechanism, management of disease progression and relapse.
Providing new approaches for prevention, focussing on the digitally supported
personalised dimension, that can be adopted and scaled up.
 Devise new or improved ambitious policy and intervention options, with expected high
population-wide impact on the target groups in question. To be proposed and made
available for effective health promotion and disease prevention including targeted
communication strategies to successfully reach out to the risk groups.
 Design an integrated, holistic approach that includes several of the following aspects:
genetic predisposition to NCDs, meta-genomics, epigenomics, the microbiome,
metabolomics, sleep disorders, large cohorts, molecular profiling in longitudinal health
screening, impact of lack of physical activity, novel predictive biomarker candidates,
diets and nutrition, eating habits for designing customised dietary patterns (geographical
variation), and the influence of choice environment on personal choices.
 Study the ethical, legal and social aspects as well as health economics of the
personalised prevention tools and programmes being developed. Consider optimal health
counselling and communication to the patients/citizens. Address legal aspects of
balancing the right not to know and the obligation of helping people in danger.
Furthermore, the proposed research is expected to deliver on several of the following points:
41
(Epi-)genetic, biological, environmental, lifestyle, social, behavioural, etc.
42
Possibly along with digitally supported disease management schemes.
43
For example: medication, diet programmes, early diagnostics, monitoring, lifestyle advice and
modification, specific training/exercise, psychosocial interventions, meditation, etc.
44
See: European strategic research agenda in artificial intelligence: https://www.elise-ai.eu/work/agenda-
and-programs
45
https://ec.europa.eu/health/non-communicable-diseases/overview_en
46
Social and economic environment; physical environment; individual characteristics; behaviour.
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 Develop and validate effective strategies to prevent NCDs and optimise health and wellbeing
of citizens (including the most vulnerable). Propose the strategies to policymakers
along with mechanisms to monitor their progress. The strategies need to be aligned with
relevant national and European health laws and policies.
 Provide scientific evidence on interactions between the genetic predisposition to
multifactorial diseases and environmental factors or environmental triggers. Propose
scientifically supported personalised prevention strategies that ensure how to modify the
environmental drivers of behavioural risk factors.
 Develop new computational tools combining and analysing comprehensive data with
different dimensions47
to identify risk factors and modifiers. Creating procedures and
algorithms to combine information from different sources (with standardised common
data models) to generate risk scores for several diseases and provide health promotion
recommendations for the individual as advised by healthcare professionals. Furthermore,
develop advanced computational modelling techniques48
for predicting disease risk and
predisposition (addressed together in an integrative approach) and identifying the
optimal solution/intervention for different target groups and individuals.
 Develop tools and techniques to increase the efficiency and cost- effectiveness of on the
one hand interventions, adjusting their scope, characteristics and resources, and on the
other hand healthcare infrastructure and how it promotes and delivers health promotion,
disease prevention, and care effectively to the different population groups.
 Design tools to collect various data to advance health promotion and disease prevention
and strategies for providing omics essays for the general patient with a focus on costeffectiveness
and flexibility.
 Determine how to optimise the benefits of physical activity, smart monitoring of
physical activity and sedentary behaviour with measurable data, addressing barriers to
uptake and implementation of healthy lifestyles in daily life, understanding what
promotion methods work and why, behavioural science to understand healthier choice
environments. Balancing the ecosystem associated with the economic, social, and health
consequences of NCDs. Affordability related consideration should be taken into account
to ensure accessibility of new tools and techniques.
 Conduct data mining of real-world data and develop quantifiable and distinguishable
indicators from wearables data, taking into account ‘light-weight’ AI means to ensure
patient privacy and short reaction times.
47
For example, genomic, biomarkers, metagenomics, diet, synthetic data, lifestyle, wearables (physical
activity), mental health, gender, age, physical and social environment.
48
Computational techniques, e.g., virtual twin; deep, fair and/or federated machine learning; AI and
symbolic AI.
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 Demonstrate with a practical prototype on a given health challenge: from multimodal
data collection to identification of an effective prevention strategy to be tested and
validated for one or several NCDs.
Where relevant, the projects should contribute to and create synergies with ongoing national,
European and international initiatives such as the European Partnership for Personalised
Medicine, the ‘Healthier Together’ - EU Non-Communicable Diseases Initiative49
, Europe’s
Beating Cancer Plan and the Mission on Cancer, WHO’s 9 targets for NCDs, the EMA
‘Darwin’ network50
etc.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
Where relevant, activities should build on and expand results of past and ongoing research
projects. Selected projects under this topic are expected to participate in joint activities as
appropriate, possibly including also related projects from other call topics. This can take the
form of project clustering, workshops, joint dissemination activities etc. Applicants should
plan a necessary budget to cover this collaboration.
Applicants invited to the second stage and envisaging to include clinical studies should
provide details of their clinical studies in the dedicated annex using the template provided in
the submission system. See definition of clinical studies in the introduction to this work
programme part.
49
https://ec.europa.eu/health/non-communicable-diseases_en
50
https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-
network-darwin-eu
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Destination 2. Living and working in a health-promoting environment
Calls for proposals under this destination are directed towards the Key Strategic Orientation
KSO-D ‘Creating a more resilient, inclusive and democratic European society’ of Horizon
Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination
should contribute to the impact area ‘A resilient EU prepared for emerging threats’ and in
particular to the following expected impact, set out in the Strategic Plan for the health cluster:
‘living and working environments are health-promoting and sustainable thanks to better
understanding of environmental, occupational, social and economic determinants of health’.
In addition, research and innovation supported under this destination could also contribute to
the following impact areas: ‘Good health and high-quality accessible health care’, ‘Climate
change mitigation and adaptation’, and ‘Clean and healthy air, water and soil’. The
environment we live and work in is a major determinant of our health and well-being.
Environmental factors are estimated to account for almost 20% of all deaths in Europe. The
impacting factors on both physical and mental health and wellbeing are not all identified nor
their effects comprehensively understood and accounted for to support evidence-based policyand
decision-making. Therefore, Destination 2 aims at filling knowledge gaps in the
understanding of the impacts on our health and well-being of those environmental,
occupational and socio-economic risk factors that have the most significant or widespread
societal impacts. In this work programme, Destination 2 focuses on pollution, disrupting
chemicals, environmental degradation, climate and other environmental exposures in living
and working environments. The results will support the EU’s environment and health policies
and overarching policy frameworks such as the European Green Deal, the Chemical Strategy
for Sustainability, the EU Adaptation Strategy, the EU Biodiversity Strategy 2030, the 8th
Environment Action Programme, the EU Strategic Framework on Health and Safety at Work
as well as the WHO European Environment and Health Process (EHP). Strong collaborations
across sectors and with other Horizon Europe clusters dealing with issues such as agriculture,
food, environment, climate, biodiversity, mobility, security, urban planning, social inclusion
and gender will be needed to ensure that maximal societal benefits are reached. Thus, in view
of increasing the impact of EU investments under Horizon Europe, the European Commission
welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation
and other synergies. This could range from networking to joint activities such as the
participation in joint workshops, the exchange of knowledge, development and adoption of
best practices, or joint communication activities. All topics are open to international
collaboration to address global environment and health challenges.
Expected impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to
living and working in a health-promoting environment, and more specifically to one or
several of the following impacts:
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 Policymakers and regulators are aware and well informed about environmental, socioeconomic
and occupational risk factors as well as health-promoting factors across
society;
 Environmental, occupational, social, economic, fiscal and health policies and practices at
the EU, national and regional level are sustainable and based on solid scientific
evidence. These include overarching policy frameworks such as the European Green
Deal, the Chemical Strategy for Sustainability, the 8th Environment Action Programme,
the EU Adaptation Strategy, the Farm to Fork Strategy51
, the EU Biodiversity Strategy
2030, the EU Strategic Framework on Health and Safety at Work and the European
Environment and Health Process led by the World Health Organization;
 The upstream determinants of disease - related to choices in energy generation,
agricultural and food processing practices, industrial production, land use planning, built
environment and construction - are known, understood and reduced;
 The health threats and burden resulting from hazardous chemicals, biodiversity
degradation and air, water and soil pollution and contamination is reduced, so that the
related number of deaths and illnesses is substantially reduced by 2030;
 Living and working environments in European cities and regions are healthier, more
inclusive, safer, resilient and sustainable;
 The adaptive capacity and resilience of populations and health systems in Europe to
climate and environmental change-related health risks is strengthened;
 Citizens’ health and well-being is protected and promoted, and premature deaths,
diseases and inequalities related to environmental pollution and degradation as well as
unhealthy lifestyles are prevented;
 Citizens understand better complex environment and health issues, and effective
measures to address them and support related policies and regulation.
The following call(s) in this work programme contribute to this destination:
Call Budgets (EUR million) Deadline(s)
2023 2024
HORIZON-HLTH-2023-
ENVHLTH-02
103.00 13 Apr 2023
HORIZON-HLTH-2024-
ENVHLTH-02-two-stage
60.00 19 Sep 2023 (First
Stage)
11 Apr 2024
51
https://food.ec.europa.eu/horizontal-topics/farm-fork-strategy_en
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(Second Stage)
Overall indicative budget 103.00 60.00
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Call - Environment and health (Single stage - 2023)
HORIZON-HLTH-2023-ENVHLTH-02
Conditions for the Call
Indicative budget(s)52
Topics Type
of
Action
Budgets
(EUR
million)
Expected EU
contribution
per project
(EUR
million)53
Indicative
number
of
projects
expected
to be
funded
2023
Opening: 12 Jan 2023
Deadline(s): 13 Apr 2023
HORIZON-HLTH-2023-ENVHLTH-02-01 RIA 30.00 54
5.00 to 6.00 5
HORIZON-HLTH-2023-ENVHLTH-02-02 RIA 30.00 55
5.00 to 6.00 5
HORIZON-HLTH-2023-ENVHLTH-02-03 RIA 40.00 56
6.00 to 7.00 7
HORIZON-HLTH-2023-ENVHLTH-02-04 CSA 3.00 57
Around 3.00 1
Overall indicative budget 103.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
52
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
53
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
54
Of which EUR 17.00 million from the 'NGEU' Fund Source.
55
Of which EUR 17.00 million from the 'NGEU' Fund Source.
56
Of which EUR 24.00 million from the 'NGEU' Fund Source.
57
Of which EUR 1.50 million from the 'NGEU' Fund Source.
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Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2023-ENVHLTH-02-01: Planetary health: understanding the links
between environmental degradation and health impacts
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
5.00 and 6.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 30.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
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(Implementation). The cumulative threshold will be 12.
Legal and
financial set-up of
the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
In order to optimise synergies and increase the impact of the projects, all
projects selected for funding from this topic will form a cluster and be
required to participate in common networking and joint activities (and in
determining modalities for their implementation and the specific
responsibilities of projects). Depending on the scope of proposals
selected for funding, these activities may include:
 Attendance of regular joint meetings (e.g., common kick-off
meeting and annual meetings).
 Periodic report of joint activities (delivered at each reporting
period).
 Common dissemination and communication activities (which may
include, for example: a common dissemination and
communication strategy, web portal and visual identity, brochure,
newsletters).
 Common Data Management Strategy and Common Policy
Strategy (including joint policy briefs).
 Thematic workshops/trainings on issues of common interest.
 Working groups on topics of common interest (e.g. data
management, communication and dissemination, science-policy
link, scientific synergies).
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 2 ‘Living and working in a health-promoting
environment’. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to most of the following expected outcomes:
 Climate and environmental policies are supported with better knowledge on the Earth
natural systems and human health interactions;
 Sustainable planetary health policies which foster co-benefits to human health and the
health of ecosystems are supported with robust evidence;
 Cross sectorial and multidisciplinary scientific collaborations, including expertise in
public health and One Health, are established;
 Public authorities rely on indicators about the impacts on human health of changes or
degradation of natural systems to support adaptation and mitigation strategies to natural
hazards;
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 Policymakers have better tools to improve the predictive capability and preparedness as
well as to envision prevention strategies to deal with the impacts on human health of
changes or degradation of ecosystems;
 Citizens are engaged and informed about the impact of natural systems’ degradation on
human health and behaviours aiming at the conservation of ecosystems are promoted.
Scope: Globally, life quality and expectancy have increased to unprecedented levels over the
last decades due to the significant public health, agricultural, industrial and technological
achievements of the 20th century. On the other hand, the ongoing trend of environmental
degradation and global climate and environmental changes has introduced new pressures,
which involve large impacts on human health and might put at risk the recent public health
gains.
Among others, climate change, biodiversity loss, biological invasions, environmental
pollution, changes in land use and degradation, deforestation, thawing permafrost (in polar
regions, and particularly in the Arctic), overfishing, new animal diseases and acidification of
water bodies can result in reduced food and water availability and safety and increased
exposure to factors causing infectious and non-communicable diseases. Additionally, changes
in weather and climate extremes have been observed across the globe, resulting in an increase
of the frequency and intensity of extreme weather events such as heavy precipitation and
floods, heat waves and hot extremes, droughts and tropical cyclones.
There is increasing evidence showing that many of these environmental stressors and changes
can cause profound short- and long-term negative impacts on human health and well-being,
contributing to increased morbidity and mortality worldwide. Understanding and acting upon
these challenges calls for a multidisciplinary, cross-sectorial and trans-border approach
ranging from the local to the global scale. The effects can be direct due to increases in floods,
heatwaves, water shortages, landslides, exposure to ultraviolet radiation, exposure to
pollutants, among others, or indirect and complex, as climate change -mediated or ecosystemmediated.
In addition, it is imperative that the solutions and initiatives chosen to prevent
environmental degradation are safe for human health and the environment.
Planetary health is a concept focused on the interdependencies between human health and the
state of earth’s complex natural systems. A key focus is on understanding how the current
trend of human-related environmental degradation can affect the health and well-being of
current and future generations. The Rockefeller Foundation-Lancet Commission on Planetary
Health58
published a report in 2015, laying the foundation for the development of this
important new field of study59
. In 2020 the Helsinki declaration60
was published, resulting
58
https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(15)60901-1.pdf
59
“Our definition of planetary health is the achievement of the highest attainable standard of health, wellbeing,
and equity worldwide through judicious attention to the human systems—political, economic,
and social—that shape the future of humanity and the Earth’s natural systems that define the safe
environmental limits within which humanity can flourish. Put simply, planetary health is the health of
human civilisation and the state of the natural systems on which it depends”
60
A call for urgent action to safeguard our planet and our health in line with the helsinki declaration –
ScienceDirect, https://www.sciencedirect.com/science/article/pii/S0013935120314973
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from a conference where participants discussed how to implement the planetary health
approach in Europe in the context of the European Green Deal. Planetary health is also a
priority topic in the research agenda in environment, climate and health proposed by the
Coordination and support action HERA61
.
Applicants are invited to submit proposals providing actionable evidence for policymakers to
take preventive actions to protect the human health and wellbeing by exploring the links
between human health and environmental degradation in an integrated and comprehensive
manner. More fragmented contributions focused on less studied aspects such as the links
between climate change and health and, between biodiversity and health, will also be
considered.
To advance the knowledge on planetary health to support policymaking in this area, the
applicants should address several of the following activities:
 Provide strengthened evidence for health and wellbeing impacts of planetary changes,
considering a systems thinking framework or a fragmentary approach focused on the
impacts of climate change and biodiversity loss on human health (for biodiversity loss,
proposals should not focus on the connection between the biodiversity loss and
ecosystem degradation with the prevention of zoonotic emerging diseases since this
topic will be covered by CL6-2023-BIODIV: Interlinkages between biodiversity loss and
degradation of ecosystems and the emergence of zoonotic diseases);
 Provide improved understanding and modelling of human–ecological systems
interactions and ecosystem-mediated effects on human health and well-being, including
the attribution of health outcomes to environmental change;
 Provide a methodology to identify and prioritise threats for public health caused by
environmental degradation, with a view to improving preparedness of health systems to
these threats, through structured processes that move from evidence to recommendations
and decisions;
 Investigation how infections agents that might have the capacity to adapt to other host
species can spread via the environment, and how this type of insight might lead to
enhanced monitoring strategies;
 Lay the foundations for integrated surveillance systems considering already established
monitoring systems (e.g. systematic wastewater monitoring) and using available and
newly collected health, socioeconomic, and environmental data for defined populations
over longer time periods. This would provide early detection of emerging disease
outbreaks (e.g. zoonotic diseases, potential permafrost release of new and old pathogens)
or changes in nutrition and non-communicable disease burden and support the
assessment of the integrated health, environmental, and socioeconomic effect of policies
and technologies.
61
https://www.heraresearcheu.eu/
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 Explore strategies to reduce environmental damage and harmful emissions (e.g. air
pollution) including assessment of health co-benefits through engagement with relevant
HE partnerships and missions;
 Explore implications of planetary health for health systems and public health and
identify opportunities to mitigate adverse health impacts of environmental degradation;
 Improve risk communication to policymakers, public authorities, industry and the public
and support evidence-informed decisions by policymakers, by increasing capacity to do
systematic reviews and provide rigorous policy briefs;
 Advance knowledge and actions to reduce the burden of non-communicable diseases
while reducing the environmental pressure in areas like nutrition, physical activity, and
mobility, and to assess the integrated health, environmental, and socioeconomic effect of
those actions (i.e. behaviour change interventions, policies or new technologies);
 Provide better understanding on adaptation to climate and other environmental changes
to protect human health, including the interactions between different planetary
boundaries and the need to integrate adaptation and mitigation strategies;
 Improved health impact assessment approaches accounting for environmental
externalities and estimating the cost and benefits of interventions versus no action.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities. Researchers should carefully integrate
distributive considerations in their analysis by considering, where relevant, disaggregated
effects for different socio-economic groups.
In order to optimise synergies and increase the impact of the projects, all projects selected for
funding from this topic will form a cluster and be required to participate in common
networking and joint activities. Without the prerequisite to detail concrete joint activities,
proposals should allocate a sufficient budget for the attendance to regular joint meetings and
to cover the costs of any other potential common networking and joint activities.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-ENVHLTH-02-02: Evidence-based interventions for promotion
of mental and physical health in changing working environments (post-pandemic
workplaces)
Specific conditions
Expected EU The Commission estimates that an EU contribution of between EUR
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contribution per
project
5.00 and 6.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 30.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Legal and
financial set-up of
the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
In order to optimise synergies and increase the impact of the projects, all
projects selected for funding from this topic will form a cluster and be
required to participate in common networking and joint activities (and in
determining modalities for their implementation and the specific
responsibilities of projects). Depending on the scope of proposals
selected for funding, these activities may include:
 Attendance of regular joint meetings (e.g., common kick-off
meeting and annual meetings).
 Periodic report of joint activities (delivered at each reporting
period).
 Common dissemination and communication activities (which may
include, for example: a common dissemination and
communication strategy, web portal and visual identity, brochure,
newsletters).
 Common Data Management Strategy and Common Policy
Strategy (including joint policy briefs).
 Thematic workshops/trainings on issues of common interest.
 Working groups on topics of common interest (e.g. data
management, communication and dissemination, science-policy
link, scientific synergies).
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Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 2 ‘Living and working in a health-promoting
environment’. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to most of the following expected outcomes:
 Public authorities and regulators are supported with evidence-based guidance to design
occupational health policies;
 Public authorities, employers, organisations and social partners (e.g. trade unions and
employer organisations) are better supported with tools, evidence-based intervention
options and guidelines to promote mental and physical well-being and health in the
workplace;
 Public authorities and the scientific community have access to FAIR data62
and robust
evidence on direct links between psychosocial and physical risk factors at the workplace
(considering also individual differences such as age, gender, cultural background,
bodily/cognitive abilities) and specific health outcomes;
 Public authorities, regulators and social partners are informed by evidence on the costs,
benefits, sustainability and expected challenges of available solutions;
 Public authorities and employers take advantage of the best available knowledge
(including new innovations and ways for action) to support interventions and solutions
on the design of the built working environment and promote healthier behaviours at the
workplace;
 Public authorities and employers develop adequate measures to prevent and reduce the
negative outcomes of exposure to psycho-social and physical risk factors in the
workplace and support recovery;
 Workers are more protected against work-related hazards and informed about effective
prevention approaches based on specific and appropriate measures and health enhancing
behaviours;
 Workers living with a chronic disease and/or recovering from a mental of physical health
problem are supported to continue/return to work.
Scope: The digital and green transitions (referred to as ‘twin transition’) have been changing
the workplace at a rapid pace, leading to new forms of work (e.g. hybrid work, gig economy
jobs) or changes in the forms of management and work organisation (e.g. through algorithmic
decision-making and digital worker performance monitoring) for workers across the
spectrum. These changes have varying impacts on the working conditions, income and health
and occupational safety both for skilled and unskilled workers. Furthermore, they contribute
to the high costs of work-related illnesses and accidents for employers and the European
economy in general.
62
See definition of FAIR data in the introduction to this work programme part.
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Mental health and ergonomic-related problems affect a significant number of EU workers.
Musculoskeletal disorders (MSDs) are one of the most common work-related health problems
in the EU and workers and managers commonly identify stress, depression and anxiety as
serious psychosocial outcomes of workplace exposures. Changes in the organisation of work
can bring flexibility that allows more people to enter the labour force, but may also lead to
psychosocial problems (for example, insecurity, compromised privacy and rest time,
inadequate OSH and social protection, as well as stress due to excessive or atypical working
hours, performance monitoring by algorithms and similar AI applications).
Some workplaces have either become exclusively virtual or they have evolved into a ‘hybrid’
model (e.g. multilocational working, home office), some work tasks and processes performed
virtually and others requiring physical presence63
. A significant number of jobs are performed
at clients’ premises or require workers to commute long distances and/or cross borders
regularly. Such workers are facing additional legal, social, environmental and economic
issues. Data on how these affect their mental/physical health and well-being is scarce.
The emergence and persistence of the COVID-19 pandemic has accelerated the pace of
change, causing, in some cases, additional challenges for workers’ mental health
(differentially affecting certain segments of the working force) and intensifying already
existing physical risk factors (e.g. ergonomic risks). The European Pillar of Social Rights
Action Plan64
aims to promote a healthy, safe and well-adapted work environment in the EU
and relies on Horizon Europe for research and innovation supporting economic and social
resilience and sustainability. The EU strategic framework on health and safety at work 2021-
202765
recognises the needs, challenges and opportunities that technological innovation and
the pandemic bring for the working population and calls for strengthening the evidence-base
for policymaking and implementation.
To address the issues described above, research actions under this topic should include several
of the following activities:
 Provide adequate and robust data on the impact (positive and negative) that the ongoing
changes in the workplace are having on the mental and physical health of different
categories of workers and working sectors (e.g. teleworkers, cross-border commuters,
gig economy workers, and vulnerable groups such as women, migrants and young and
older workers with increased demonstrated risk for MSDs), including gender and
intersectional analyses, where appropriate;
 Generate evidence (including data) not only on mental health, but also on mental wellbeing
at the workplace and how changing work organisation due to the twin transitions
and the pandemic affects workers’ work-life balance and work ability;
63
The future of working in a virtual environment and occupational safety and health,
https://osha.europa.eu/en/publications/future-working-virtual-environment-and-occupational-safety-
and-health
64
https://op.europa.eu/webpub/empl/european-pillar-of-social-rights/en/
65
https://osha.europa.eu/en/safety-and-health-legislation/eu-strategic-framework-health-and-safety-work-
2021-2027
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 Generate evidence (including data) on the importance of risk factors (such as stress
caused by new working environments, static postures and physical inactivity, physically
strenuous and highly repetitive work arising from the workplace design) in the
development of chronic and acute diseases;
 Increase the understanding of the links between different health-promoting factors in the
working-built environment and physical and mental health outcomes, and how these may
be mutually reinforcing;
 Explore the health impacts of changing working times, including excessive and atypical
working hours and work in different time zones that blur work from leisure time,
limiting recovery. Effects should consider a wide range of diseases;
 Provide recommendations for effective interventions to prevent occupational risks and
support the mental and physical health and well-being at individual (worker),
organisation (employer) and policy (government) levels for different sectors/types of
work, including an analysis on their cost-effectiveness, sustainability and barriers to
implementation at national and/or EU level;
 Advance the development of a scientific framework addressing Occupational safety and
health (OSH) across policies and sectors and support new and sustainable (future-proof)
tools, guidelines and policies concerning the evaluation and design of physical and
psychosocial work environment;
 Provide tools and approaches to anticipate new OSH risks, also taking account of lessons
learnt from the COVID-19 pandemic, for instance in relation to digital technologies and
associated new ways of working.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities. Researchers should carefully integrate
distributive considerations in their analysis by considering, where relevant, disaggregated
effects for different socio-economic groups.
Projects are expected to contribute to the New European Bauhaus (NEB) initiative66
by
interacting with the NEB Community, NEBLab and other relevant actions of the NEB
initiative through sharing information, best practice, and, where relevant, results.
In order to optimise synergies and increase the impact of the projects, all projects selected for
funding from this topic will form a cluster and be required to participate in common
networking and joint activities. Without the prerequisite to detail concrete joint activities,
proposals should allocate a sufficient budget for the attendance to regular joint meetings and
to cover the costs of any other potential common networking and joint activities.
66
https://europa.eu/new-european-bauhaus/index_en
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Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-ENVHLTH-02-03: Health impacts of endocrine-disrupting
chemicals: bridging science-policy gaps by addressing persistent scientific uncertainties
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
6.00 and 7.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 40.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
The Joint Research Centre (JRC) may participate as member of the
consortium selected for funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Legal and
financial set-up of
the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
In order to optimise synergies and increase the impact of the projects, all
projects selected for funding from this topic will form a cluster and be
required to participate in common networking and joint activities (and in
determining modalities for their implementation and the specific
responsibilities of projects). Depending on the scope of proposals
selected for funding, these activities may include:
 Attendance of regular joint meetings (e.g., common kick-off
meeting and annual meetings).
 Periodic report of joint activities (delivered at each reporting
period).
 Common dissemination and communication activities (which may
Horizon Europe - Work Programme 2023-2024
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include, for example: a common dissemination and
communication strategy, web portal and visual identity, brochure,
newsletters).
 Common Data Management Strategy and Common Policy
Strategy (including joint policy briefs).
 Thematic workshops/trainings on issues of common interest.
 Working groups on topics of common interest (e.g. data
management, communication and dissemination, science-policy
link, scientific synergies).
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 2 ‘Living and working in a health-promoting
environment’. To that end, proposals under this topic should aim for delivering results that are
directed towards and contributing to all of the following expected outcomes:
 Public authorities including EU risk assessment bodies and regulators are supported with
scientific evidence to implement the comprehensive European Union Framework on
Endocrine Disruptors67
, Chemicals Strategy for Sustainability Towards a Toxic-Free
Environment68
, EU legislation on plant protection products69
and EU occupational safety
and health legislation70
;
 Public authorities improve their risk assessment, management and communication
through access to FAIR data71
and more robust evidence on the causal links between
exposure to endocrine disruptors and health outcomes for which insufficient data exist;
 Research community has better data on the role of endocrine disruptors and other cofactors
(e.g., lifestyle, behavioural, socio-economic) to enable a better understanding of
their individual or combined health impacts;
 Public authorities and the scientific community take advantage of latest methodologies
for advancing the understanding of health impact of exposures;
 Public authorities, employers and citizens rely on practical evidence-informed guidelines
for exposure prevention and reduction;
 Citizens are engaged and informed about the health impact of exposures to endocrine
disruptors and risk-preventing behaviours are promoted.
67
https://ec.europa.eu/info/policies/endocrine-disruptors_en
68
Chemicals strategy (europa.eu)
69
https://www.efsa.europa.eu/en/efsajournal/pub/5311
70
EU Strategic Framework on Health and Safety at Work 2021-2027 | Safety and health at work EUOSHA
(europa.eu)
71
See definition of FAIR data in the introduction to this work programme part.
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Scope: The function and regulation of the endocrine system in humans and other species is of
high biological complexity. Endocrine disrupting chemicals (EDCs or endocrine disruptors)
are chemical substances that alter the functioning of the endocrine system and negatively
affect the health of humans and animals. They may either be of synthetic or natural origin.
EDCs are of increasing importance in chemical regulations in the European Union. According
to the Comprehensive European Union Framework on Endocrine Disruptors, adopted in 2018,
the EU strategic approach on endocrine disruptors for the years to come should be based on
the application of the precautionary principle. This approach would aim at, inter alia,
minimising overall exposure of humans and the environment to endocrine disruptors, paying
particular attention to exposures during important periods of development of an organism,
such as foetal development and puberty, possibly integrating a life course approach, as well as
accelerating the development of a thorough research basis for effective and forward-looking
decision-making. This includes research for the further management of chemicals (including
multi-constituent chemicals as well as chemical mixtures), the understanding of the
mechanistic effects of endocrine disruptors and their dose-response relationships (including at
the molecular and cellular level through the use of new approach methodologies, such as
‘multiomics’, cheminformatics, in vitro 2D and 3D models, in vivo models and computational
approaches), and the collection, sharing, harmonisation and combination of robust data
sources.
Closing existing knowledge gaps in the understanding of EDC effects will support more
effective and evidence-based regulations at the European level.
Bringing together, inter alia, (molecular) epidemiologists, exposure scientists, toxicologists,
endocrinologists, health care practitioners and risk assessors, research actions under this topic
should focus on the understanding of the impact of exposures at critical life stages as regards
development of diseases later in life, focusing on the several health endpoints for which there
is currently less information available. Advantage should be taken of existing biobanks and
disease registries and/or cohorts, with carefully planned measurement strategies and clearly
worked-out hypotheses. The nature of the dose-response relationships and whether effects are
threshold-dependent should be addressed in the study designs. Similarities between endocrine
systems and certain health outcomes across species should be exploited to improve
understanding of functioning of the endocrine system. Finally, research should attempt at
identifying predictive biomarkers (e.g. from liquid biopsies such as saliva, urine, blood) that
would allow the tracing of endocrine disrupter-mediated health effects in a shorter period of
time than normally would be required for epidemiological studies.
Research actions under this topic should provide forward-looking mechanistic information on
potential hazards and health risks of exposures to EDCs, through innovative molecular
epidemiological, multifactorial models and systems biology approaches, exploiting the use of
state of the art non-animal methodologies when relevant, and should include several of the
following activities:
 Studying the impact of EDCs on target organs and in multi-organ models, and
physiological barriers, such as the placenta, the blood-brain barrier, the blood-saliva
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barrier, intestinal, pulmonary and immune cells as well as their interaction with
microbiota. This should include the provision of a thorough understanding of doseresponse
relationships;
 Elucidating health endpoints for which insufficient data exist, such as disturbances in the
development and functioning of the nervous and cardiovascular systems, the immune
system, bone development and disease, obesity, diabetes, hormone-dependent cancers
and fertility (e.g. minipuberty, prepuberty and puberty);
 Providing better biological and imaging biomarkers to predict EDC-mediated health
outcomes, including the quantitative probabilities of having an adverse effect based on
such biomarkers;
 Gaining better insights into the developmental origins of health and disease, especially
for those where less data are available. Assessing the occurrence and relevance of multiand
transgenerationally inherited effects, including molecular and epigenetic
mechanisms that drive multigenerational effects;
 Gaining better insights into the most sensitive windows of susceptibility, during which
exposure are of particular importance for health effects;
 Better understanding of the effects of chemicals and chemical mixtures on the
underlying mechanistic crosstalk between endocrine axes, endocrine pathways and other
key biological systems, including immune, neurological and metabolic functions;
 Improving the understanding of chemical mixture effects, including with other toxins
and at low doses. The role of the microbiome in the activation or detoxification of these
chemicals should be explored where relevant.
 Investigating biological effects of realistic mixtures to get a more detailed understanding
of the endocrine effectome, taking advantage of computational toxicology and
development of up-to-date models;
 Performing comparative analysis between species, assessing similarities to human
endocrine system and health outcomes and exploiting non-mammalian species as test
organisms, e.g. non-mammalian vertebrates and invertebrates to predict effects or raise
concern about potential effects in humans or vice versa;
 Exploiting systems biology approaches in order to understand how exposure to an EDC
results in an altered phenotype, a process that implies complex interactions across
multiple levels of biological organisation.
Aspects such as gender, regional variations, socioeconomics and culture should be
considered, where appropriate. Proposals should ensure that chemical monitoring data are
shared in IPCHEM72
through involvement with the European Commission's Joint Research
72
IPCheM Portal (europa.eu)
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Centre (JRC). Proposals should also consider involving JRC with respect to the value it could
bring in providing an effective interface between the research activities and regulatory aspects
and/or to translating the research results into validated test methods and strategies fit for
regulatory purpose. In that respect, the JRC will collaborate with any successful proposal and
this collaboration, when relevant, should be established after the proposal’s approval.
Applicants should be acquainted with planned activities under the European partnership for
the assessment of risks from chemicals PARC73
. PARC will be informed about successful
proposals. Successful proposals will be invited to establish synergies with PARC and take
advantage of the partnership as a facilitator for open data and methodology sharing with risk
assessors and their scientific networks.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
In order to optimise synergies and increase the impact of the projects, all projects selected for
funding from this topic will form a cluster and be required to participate in common
networking and joint activities. Without the prerequisite to detail concrete joint activities,
proposals should allocate a sufficient budget for the attendance to regular joint meetings and
to cover the costs of any other potential common networking and joint activities.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-ENVHLTH-02-04: Global coordination of exposome research
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of around EUR 3.00
million would allow these outcomes to be addressed appropriately.
Nonetheless, this does not preclude submission and selection of a
proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 3.00 million.
Type of Action Coordination and Support Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, legal entities established in the
73
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-
details/horizon-hlth-2021-envhlth-03-01
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United States of America may exceptionally participate as a beneficiary
or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU
Member State or Associated Country.
The following additional eligibility criteria apply:
In order to achieve the expected objectives, namely the establishment of a
forward-looking cooperation framework in the area of the exposome, the
consortium must include at least one legal entity established in a country
other than a Member State or an Associated Country.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 2 ‘Living and working in a health-promoting
environment’. To that end, proposals under this topic should aim for delivering results that are
tailored towards and contributing to all of the following expected outcomes:
 Environment and health research community, research-policymaking authorities,
research funders and other relevant stakeholders work together at the European and
international level towards establishing a medium-long-term Global Human Exposome
Network;
 Environment and health research community, authorities working at the science-policy
interface and research funders provide options for functioning, financing and governance
of a medium-long-term Global Human Exposome Network also considering the
strengthening of the coordination of the European Human Exposome Network;
 Relevant stakeholders profit from a strengthened coordination and collaboration globally
among different fields of research and innovation with relevance to deciphering the
human exposome;
 A roadmap and a R&I agenda for international cooperation in specified areas of
exposome research and innovation, including, among others, recommendations for
exchange of knowledge and data, policy uptake, technological and conceptual
approaches and promotion of global level coordinated initiatives on the exposome are
made available to the relevant international stakeholders;
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 The coordination of research initiatives, infrastructures, facilities and resources in the
area of the Exposome in Europe is supported and reinforced;
 The interoperability and harmonisation between data and studies is increased facilitating
the exchange and use of information across research disciplines and groups.
Scope: The concept of the exposome refers to the totality of environmental exposures from
conception onwards, including its external (e.g. diet, lifestyle, occupational and environmental
factors) and internal components (e.g. epigenomics, metabolomics). Developing a
comprehensive Human Exposome Project would present a fundamental shift in looking at
health, by moving research away from ‘one exposure, one disease’ understanding to a more
complex picture upon which to build solid, cost-effective preventive actions and policies. At
its most complete, the efforts could resemble in scope the Human Genome Project.
The European Human Exposome Network (EHEN)74
, a cluster of 9 projects funded since
2020 for five years from Horizon 2020, is currently the world’s largest network of projects
studying the impact of environmental exposure on human health with an exposome angle.
Together, the network of projects aims to study the combination of exposures to pollutants
and other stressors, across different life stages and socio-economic conditions, via a number
of exposure vehicles such as consumption patterns, lifestyle and working and living
environment, and their collective effect on human health.
At the international level, some related activities are ongoing in, e.g., the US (National
Institute for Environmental Health Sciences) and Japan. Currently, there is only sporadic
cooperation initiatives between the ongoing research at the EU level and important research
groups outside Europe. However, in order to fulfil the promise of deciphering the human
exposome, a large-scale effort similar to the Human Genome Project could be envisaged, for
which a preparatory coordination and support action would be highly useful to identify and
discuss the research needs and specific areas of potential cooperation at the global level.
Additionally, both at the European and global level better coordination is essential to foster
new opportunities to collect, harmonise, combine and analyse large data sets emanating from
new and evolving technologies. This offers also new possibilities to understand the pathways
leading from a multitude of environmental exposures to the global health burden of common
chronic diseases. Standardisation and interoperability of data is also needed to assure access
to quality data sources at the European and global level.
On the policy side, the outcomes of advancing the exposome research can touch upon and
contribute to a better implementation of a wide range of policies and EU priorities such as the
EU Chemicals Strategy75
, Zero Pollution Action Plan76
, the European Green Deal77
and
climate policies 78
, among others. The benefits of cooperation would also extend to
74
https://www.humanexposome.eu/
75
https://ec.europa.eu/environment/strategy/chemicals-strategy_en
76
https://ec.europa.eu/environment/strategy/zero-pollution-action-plan_en
77
https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal_en
78
https://ec.europa.eu/clima/index_en
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international initiatives such as activities of the World Health Organization related to
environment and health79
and the United Nations activities on climate80
and environment81
.
Accordingly, proposals should cover, among others, most of the following activities:
 Proposal for a common agreed conceptual framework for the exposome;
 Proposal for options for a global governance structure for a Global Human Exposome
Network taking advantage of and connecting to the existing research infrastructures and
services in the area of the Exposome at the European level;
 Agreed technologies needed to decipher the external and internal exposome, support
longitudinal studies and potential for international cooperation;
 Proposal for data mining, analysis, opportunities for harmonisation, interoperability, and
standardisation in data collection, knowledge storage and transfer, and bioinformatics
needs at the European and global level;
 Cooperation between population and patient cohorts, integrating a large number of
variables and comprehensive environmental datasets, and biobanks, also covering the
perinatal period;
 Facilitation of the regulatory uses of results including for regulatory science and risk
assessment.
Proposals should interact with existing research infrastructures, services and research projects
in the area of the exposome (namely the European Human Exposome Network but also other
related projects and actions supported through Horizon 2020 and Horizon Europe) and build
on and integrate the work being developed in these initiatives. The composition of the
applicant consortia should ensure a broad and balanced geographical representation of
Member States and Associated Countries and the proposals should involve also Widening
Member States and Associated Countries. International cooperation beyond EU with
interested parties is required.
Call - Environment and health (Two stage - 2024)
HORIZON-HLTH-2024-ENVHLTH-02-two-stage
Conditions for the Call
Indicative budget(s)82
79
https://www.who.int/health-topics/environmental-health;https://www.euro.who.int/en/health-
topics/environment-and-health
80
https://www.un.org/en/climatechange
81
https://www.unep.org/
82
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
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Topics Type
of
Action
Budgets
(EUR
million)
Expected
EU
contribution
per project
(EUR
million)83
Indicative
number
of
projects
expected
to be
funded
2024
Opening: 30 Mar 2023
Deadline(s): 19 Sep 2023 (First Stage), 11 Apr 2024 (Second Stage)
HORIZON-HLTH-2024-ENVHLTH-02-06-
two-stage
RIA 60.00 7.00 to 8.00 8
Overall indicative budget 60.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
83
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
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HORIZON-HLTH-2024-ENVHLTH-02-06-two-stage: The role of environmental
pollution in non-communicable diseases: air, noise and light and hazardous waste
pollution
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
7.00 and 8.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 60.00 million.
Type of Action Research and Innovation Actions
Admissibility
conditions
The conditions are described in General Annex A. The following
exceptions apply:
Applicants submitting a proposal under the blind evaluation pilot (see
General Annex F) must not disclose their organisation names, acronyms,
logos, nor names of personnel in Part B of their first stage application
(see General Annex E).
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
The Joint Research Centre (JRC) may participate as member of the
consortium selected for funding.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Award criteria The criteria are described in General Annex D. The following
exceptions apply:
For the second stage, the thresholds for each criterion will be 4
(Excellence), 4 (Impact) and 3 (Implementation). The cumulative
threshold will be 12.
Procedure The procedure is described in General Annex F. The following
exceptions apply:
This topic is part of the blind evaluation pilot under which first stage
proposals will be evaluated blindly.
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Legal and
financial set-up of
the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
Eligible costs will take the form of a lump sum as defined in the
Decision of 7 July 2021 authorising the use of lump sum contributions
under the Horizon Europe Programme – the Framework Programme for
Research and Innovation (2021-2027) – and in actions under the
Research and Training Programme of the European Atomic Energy
Community (2021-2025). 84
.
In order to optimise synergies and increase the impact of the projects, all
projects selected for funding from this topic will form a cluster and be
required to participate in common networking and joint activities (and in
determining modalities for their implementation and the specific
responsibilities of projects). Depending on the scope of proposals
selected for funding, these activities may include:
 Attendance of regular joint meetings (e.g., common kick-off
meeting and annual meetings).
 Periodic report of joint activities (delivered at each reporting
period).
 Common dissemination and communication activities (which may
include, for example: a common dissemination and
communication strategy, web portal and visual identity, brochure,
newsletters).
 Common Data Management Strategy and Common Policy
Strategy (including joint policy briefs).
 Thematic workshops/trainings on issues of common interest.
 Working groups on topics of common interest (e.g. data
management, communication and dissemination, science-policy
link, scientific synergies).
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 2 ‘Living and working in a health-promoting
environment’. To that end, proposals under this topic should aim for delivering results that are
tailored towards and contributing to all of the following expected outcomes:
 National and EU authorities apply user-friendly tools to produce and use generated data
on the impact of pollutants on health;
84
This decision is available on the Funding and Tenders Portal, in the reference documents section for
Horizon Europe, under ‘Simplified costs decisions’ or through this link:
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-
decision_he_en.pdf
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 National and EU authorities benefit from access to robust and transparent indicators for
health impact assessment to monitor efficacy of pollution-mitigating actions and
policies;
 Policymakers and other stakeholders, e.g. public authorities such as urban planners,
health professionals, employers, civil society organisations and citizens, use developed
guidelines to take action to prevent pollution-related illnesses and impairments, and
choose healthier lifestyles and behaviours;
 EU, national and regional authorities receive guidance and recommendations for updates
of (1) scientific evidence about health risks caused by environmental pollutants (2)
advice on management and mitigation of these health risks and (3) guidance and
recommendations for updates of limit values for different classes of pollutants in the
environment; these recommendations should take into account vulnerable population
groups and people with increased vulnerability because of pre-existing medical
conditions;
 The implementation of the Zero-Pollution Action Plan, the Chemical Strategy for
Sustainability and the EU legislation on air quality, noise and waste continue to be
supported by a strong evidence-base;
 Relevant actors in our daily lives, e.g. medical personnel, building engineers, teachers,
urban planners etc., have access to information such as training courses on pollution and
health impacts.
Scope: The European Green Deal set out by the European Commission recognises that manmade
environmental pollution is an increasing threat for human health and wellbeing. Opinion
polls85
show that climate change, air pollution, and waste are the three most important
environmental issues that European citizens are concerned about. Over three-quarters (78%)
of respondents believe that environmental issues have a direct effect on their daily life and
health.
Pollution affects a large number of people in Europe and beyond: A 2018 assessment
attributed 16% of total global mortality to pollution-related disease. Over 7 million people die
of exposure to polluted air every year worldwide86
. For 2019, the European Environment
Agency has estimated that around 350 000 premature deaths in the EU can be attributed to air
pollution (namely from particulate matter, nitrogen dioxide and ozone)87
. Today, more than 1
in 4 Europeans is exposed to traffic noise levels dangerous to their health in their homes,
schools and workplaces88
. The increase of artificial light at night (ALAN) in cities has altered
the natural light levels in the environment and extended human activities to the usually dark
hours. It has been estimated that more than 80% of the world population is living under light
85
E.g. Eurobarometer 501 – 2020- https://ec.europa.eu/commission/presscorner/detail/en/ip_20_331
86
Air pollution (who.int)
87
For more details, see Briefing no. 19/2021: Health impacts of air pollution in Europe, 2021
88
EEA 2020 report on Healthy environment, healthy lives: how the environment influences health and
well-being in Europe
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polluted skies89
. Waste90
continues to be a persistent environmental issue in Europe, and it is
estimated that there are 2.5 million contaminated sites in Europe, with potentially significant
adverse health effects91
.
The global burden from non-communicable diseases (NCDs) has consistently increased over
the last decades, being now estimated to account for 70% of deaths globally (World Health
Organization). The growing burden of chronic diseases will also be a challenge for Europe’s
healthcare systems, these diseases already accounting for an estimated 70-80% of healthcare
costs. Currently, around 50 million European citizens suffer from two or more chronic
conditions and most of these people are over 65.92
The most recent WHO environmental
burden of disease estimations suggest that, annually, 13% of deaths (630 000) in the WHO
Europe region are attributable to environmental stressors and an EEA report concluded that,
90% of deaths attributable to the environment result from non-communicable diseases,
including cancers, cardiovascular diseases, stroke, chronic obstructive pulmonary disease,
mental, behavioural and neurological disorders, diabetes, kidney disease and asthma93
. While
early childhood deaths have declined, the years lived with disability have increased,
particularly with chronic disease.
The proposed research should strengthen the knowledge base available to policymakers
regarding pollution-disease associations and causal mechanisms at different phases of the life
course, taking advantage of latest molecular, cellular and computational technologies to
elucidate biological pathways from exposure (including combined exposures) to disease. The
work should bring together toxicology, exposure science, public health engineering and
environmental epidemiology, and build on data from sources such as pollution-related
databases, disease registries, epidemiological studies and biobanks, environmental and human
biomonitoring data and new generated data and could consider citizen science and other
innovative approaches. All exposure routes should be considered where relevant
(oral/digestive tract, inhalation, dermal).
The focus of this topic should be on three areas where the understanding of and evidence on
causality should be strengthened to overcome the current paucity of data and respond to calls
from policymakers. The applicants should focus on at least one of the following three aspects:
 Air pollution, especially in the urban environment, taking into account existing evidence,
notably the latest WHO air quality guidelines of 2021 and their recommendations on
different pollutants94
, including on pollutants of emerging concern, looking at e.g.
89
Evaluating the Association between Artificial Light-at-Night Exposure and Breast and Prostate Cancer
Risk in Spain (MCC-Spain Study) | Environmental Health Perspectives | Vol. 126, No. 4 (nih.gov)
90
https://ec.europa.eu/environment/topics/waste-and-recycling_en
91
Data presented at the Ministerial Meeting on Environment and Health, Ostrava, CZ (2017)
92
European Commission 2020 Report on the Impact of Demographic Change
93
EEA 2020 report on Healthy environment, healthy lives: how the environment influences health and
well-being in Europe
94
World Health Organization. (2021). WHO global air quality guidelines: particulate matter (PM2.5 and
PM10), ozone, nitrogen dioxide, sulfur dioxide and carbon monoxide. World Health Organization.
https://apps.who.int/iris/handle/10665/345329.
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ultrafine particles and interactions with aeroallergens, black carbon, sand and dust
storms and impact on human health;
 Noise pollution and light pollution impact on human health;
 Pollution from hazardous waste (e.g. pharmaceuticals, illicit drugs, e-waste, plastics
(including nano- and microplastics)) in heavily contaminated environments and adverse
health outcomes.
Several of the following activities should be included:
 Research activities to strengthen the evidence base for pollution-disease associations and
underlying causality mechanisms and biological pathways, taking into account combined
exposures and mechanisms of increased sensitivity in susceptible groups;
 Delivery of FAIR data95
on causal associations between environmental risk factors and
health outcomes, in particular for air pollutants of emerging concern, specifically
ultrafine particles, black carbon, and others, taking into account vulnerable population
groups and specific exposure situations in a life-course approach including vulnerable
early-stages of life and transgenerational risks;
 Development of user-friendly tools for systematic mining and assessment of the
knowledge generated and translation into best practices and to improve the assessment of
individual life-exposure to pollutants;
 Proposals for environmental limit values for the studied pollutants and generation of
health impact indicators, where relevant and taking into account existing standards and
evidence;
 Development of guidelines and socio-economic and decision support tools for different
actors including policymakers, health professionals and citizens to take action to prevent
pollution-related illnesses and impairments, and to enable the choice of healthier
lifestyles and behaviours;
 Identification of cross-sectoral interventions (case studies) with the potential for
remediating pollution and risk of exposure and improving human health and well-being
in the short/medium term;
 Development of training courses on pollution and health impacts to inform professionals
impacting our daily lives e.g. medical personnel, engineers, teachers, urban planners;
 Design of best-practice evidence-based communication actions for fact-based risk and
benefit communication and improving citizen awareness of pollution and preventive
actions, offsetting dissemination of misinformation;
95
See definition of FAIR data in the introduction to this work programme part.
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 Undertaking case studies to demonstrate the added societal value of tools, methodologies
and guidelines developed and the implementation of resulting actions to decrease health
impacts of exposures.
Aspects such as gender, regional variations, socioeconomics and culture should be
considered, where appropriate. Proposals should ensure that chemical monitoring data are
shared in IPCHEM96
through involvement with the European Commission's Joint Research
Centre (JRC). In that respect, the JRC will collaborate with any successful proposal and this
collaboration, when relevant, should be established after the proposal’s approval.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
In order to optimise synergies and increase the impact of the projects, all projects selected for
funding from this topic will form a cluster and be required to participate in common
networking and joint activities. Without the prerequisite to detail concrete joint activities,
proposals should allocate a sufficient budget for the attendance to regular joint meetings and
to cover the costs of any other potential common networking and joint activities.
Applicants invited to the second stage and envisaging to include clinical studies should
provide details of their clinical studies in the dedicated annex using the template provided in
the submission system. See definition of clinical studies in the introduction to this work
programme part.
96
IPCheM Portal (europa.eu)
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Destination 3. Tackling diseases and reducing disease burden
Calls for proposals under this destination are directed towards the Key Strategic Orientation
KSO-D ‘Creating a more resilient, inclusive and democratic European society’ of Horizon
Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination
should contribute to the impact area ‘Good health and high-quality accessible healthcare’ and
in particular to the following expected impact, set out in the Strategic Plan for the health
cluster: ‘health care providers are able to better tackle and manage diseases (infectious
diseases, including poverty-related and neglected diseases, non-communicable and rare
diseases) and reduce the disease burden on patients effectively thanks to better understanding
and treatment of diseases, more effective and innovative health technologies, better ability
and preparedness to manage epidemic outbreaks and improved patient safety’. In addition,
research and innovation supported under this destination could also contribute to the
following impact areas: ‘A resilient EU prepared for emerging threats’, ‘Climate change
mitigation and adaptation’, and ‘High quality digital services for all’.
Communicable and non-communicable diseases cause the greatest amounts of premature
death and disability in the EU and worldwide. They pose a major health, societal and
economic threat and burden. Many people are still suffering from these diseases and too often
dying prematurely. Non-communicable diseases, including mental illnesses and
neurodegenerative diseases, are responsible for up to 80% of EU health care costs97
. These
costs are spent on the treatment of such diseases that to a large extent are preventable.
Furthermore, only around 3% of the health care budgets are currently spent on preventive
measures although there is a huge potential for prevention. Infectious diseases, including
emerging infectious diseases and infections resistant to antimicrobials, remain a major threat
to public health in the EU but also to global health security. Deaths caused by antimicrobial
resistance (AMR) could exceed 10 million per year worldwide according to some
predictions98
.
To further advance, there is an urgent need for research and innovation to develop new
preparedness and prevention measures, public health interventions, diagnostics, vaccines,
therapies, alternatives to antimicrobials, as well as to improve existing preparedness and
prevention strategies to create tangible impacts, taking into account sex/gender-related issues.
This will require international cooperation to pool the best expertise and know-how available
worldwide, to access world-class research infrastructures and to leverage critical scales of
investments on priority needs through a better alignment with other funders of international
cooperation in health research and innovation. The continuation of international partnerships
and cooperation with international organisations is particularly needed to combat infectious
diseases, to address antimicrobial resistances, to respond to major unmet medical needs for
97
Currently, around 50 million people in the EU are estimated to suffer from two or more chronic
conditions, and most of these people are over 65. Every day, 22 500 people die in Europe from those
diseases, counting of 87% of all deaths. They account for 550 000 premature deaths of people of
working age with an estimated €115 billion economic loss per year (0.8% of GDP).
98
AMR is estimated to be responsible for 25 000 deaths per year in the EU alone and 700 000 deaths per
year globally. It has been estimated that AMR might cause more deaths than cancer by 2050.
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global health security, including the global burden of non-communicable diseases, and to
strengthen patient safety.
In this work programme, destination 3 will focus on major societal challenges linked to the
Commission’s political priorities such as the fight against cancer and other noncommunicable
diseases, better diagnosis and treatment of rare diseases, preparedness and
response to and surveillance of health threats and epidemics, reduction of the number of
antimicrobial-resistant infections, improving vaccination rates, demographic change, mental
health and digital empowerment in health literacy. In particular, the topics under this
destination will support activities aiming at: i) better understanding of diseases, their drivers
and consequences, including pain and the causative links between health determinants and
diseases, and better evidence-base for policymaking; ii) better methodologies and diagnostics
that allow timely and accurate diagnosis, identification of personalised treatment options and
assessment of health outcomes, including for patients with a rare disease; iii) development
and validation of effective intervention for better surveillance, prevention, detection,
treatment and crisis management of infectious disease threats; iv) innovative health
technologies developed and tested in clinical practice, including personalised medicine
approaches and use of digital tools to optimise clinical workflows; v) new and advanced
therapies for non-communicable diseases, including rare diseases developed in particular for
those without approved options, supported by strategies to make them affordable for the
public payer; and vi) scientific evidence for improved/tailored policies and legal frameworks
and to inform major policy initiatives at global level (e.g. WHO Framework Convention on
Tobacco Control; UNEA Pollution Implementation Plan).
In view of increasing the impact of EU investments under Horizon Europe, the European
Commission welcomes and supports cooperation between EU-funded projects to enable
cross-fertilisation and other synergies. This could range from networking to joint activities
such as the participation in joint workshops, the exchange of knowledge, the development and
adoption of best practices, or joint communication activities. Opportunities for potential
synergies exist between projects funded under the same topic but also between other projects
funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing
projects funded under Horizon 2020). In particular, this could involve projects related to
European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic
challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas
cutting across the health and other clusters (under pillar II of Horizon Europe). For instance,
with cluster 3 “Civil security for society” such as on health security/emergencies
(preparedness and response, medical countermeasures, epidemic outbreaks/pandemics, natural
disasters and technological incidents, bioterrorism); with cluster 4 “Digital, Industry and
Space” such as on decision-support systems or on geo-observation and monitoring (e.g. of
disease vectors, epidemics); or with cluster 6 “Food, bioeconomy, natural resources,
agriculture and environment” such as on health security and AMR (one-health:
human/animal/plant/soil/water health). In addition, while focusing on civilian applications,
there may be there may be synergies with actions conducted under the European Defence
Fund, notably in the field of defence medical countermeasures.
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Based on needs that emerged during the management of COVID-19, some research and
innovation actions under Destination 3 should support the mission of the European Health
Emergency and Response Authority (HERA) to strengthen Europe’s ability to prevent, detect,
and rapidly respond to cross-border health emergencies by ensuring the availability and
access to key medical countermeasures. Other actions should deliver relevant complementary
inputs to the “Europe’s Beating Cancer Plan”99
in order to cover the entire cancer care
pathway, including prevention, early detection, diagnosis, treatment, cancer data monitoring,
as well as quality of life of cancer patients and survivors. Furthermore, synergies and
complementarities will be sought between Destination 3 and the implementation of the
EU4Health Programme (2021-2027)100
. These synergies and complementarities could be
achieved, notably through mechanisms based on feedback loops, enabling on the one hand to
identify policy needs that should be prioritised in research and innovation actions and
facilitating on the other hand the implementation of research results into policy actions and
clinical practice, thereby providing an integrated response across sectors and policy fields.
Expected impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to
tackling diseases and reducing disease burden, and more specifically to several of the
following impacts:
 Health burden of diseases in the EU and worldwide is reduced through effective disease
management, including through the development and integration of innovative
diagnostic and therapeutic approaches, personalised medicine approaches, digital and
other people-centred solutions for health care. In particular, patients are diagnosed early
and accurately and receive effective, cost-efficient and affordable treatment, including
patients with a rare disease, due to effective translation of research results into new
diagnostic tools and therapies.
 Premature mortality from non-communicable diseases is reduced by one third (by 2030),
mental health and well-being is promoted, and the voluntary targets of the WHO Global
Action Plan for the Prevention and Control of NCDs 2013-2020 are attained (by 2025),
with an immediate impact on the related disease burden (DALYs)101,102, 103
.
 Health care systems benefit from strengthened research and innovation expertise, human
capacities and know-how for combatting communicable and non-communicable
99
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12154-Europe-s-Beating-
Cancer-Plan
100
https://ec.europa.eu/health/funding/eu4health_en
101
WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020 (resolution WHA66.10),
https://www.who.int/publications/i/item/9789241506236
102
Including for instance the following voluntary targets (against the 2010 baseline): A 25% relative
reduction in the overall mortality from cardiovascular diseases, cancer, diabetes, or chronic respiratory
diseases; Halt the rise in diabetes and obesity; An 80% availability of the affordable basic technologies
and essential medicines, including generics, required to treat major non-communicable diseases in both
public and private facilities.
103
Disability-adjusted life year (DALY) is a quantitative indicator of overall disease burden, expressed as
the number of years lost due to ill-health, disability or early death.
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diseases, including through international cooperation. In particular, they are better
prepared to respond rapidly and effectively to health emergencies and are able to prevent
and manage communicable diseases transmissions epidemics, including within
healthcare settings.
 Citizens benefit from reduced (cross-border) health threat of epidemics and AMR
pathogens, in the EU and worldwide104, 105
.
 Patients and citizens are knowledgeable of disease threats, involved and empowered to
make and shape decisions for their health, and better adhere to knowledge-based disease
management strategies and policies (especially for controlling outbreaks and
emergencies).
The EU benefits from high visibility, leadership and standing in international fora on global
health and global health security.
The following call(s) in this work programme contribute to this destination:
Call Budgets (EUR million) Deadline(s)
2023 2024
HORIZON-HLTH-2023-
DISEASE-03
224.00 13 Apr 2023
HORIZON-HLTH-2023-
DISEASE-07
50.00 19 Sep 2023
HORIZON-HLTH-2024-
DISEASE-03-two-stage
125.00 19 Sep 2023 (First
Stage)
11 Apr 2024
(Second Stage)
HORIZON-HLTH-2024-
DISEASE-08
52.00 11 Apr 2024
HORIZON-HLTH-2024-
DISEASE-09
100.00 11 Apr 2024
Overall indicative budget 274.00 277.00
104
WHO global action plan on antimicrobial resistance, 2015
105
EU One Health Action Plan against AMR, 2017
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Call - Tackling diseases (Single stage - 2023)
HORIZON-HLTH-2023-DISEASE-03
Conditions for the Call
Indicative budget(s)106
Topics Type
of
Action
Budgets
(EUR
million)
Expected EU
contribution per
project (EUR
million)107
Indicative
number
of
projects
expected
to be
funded
2023
Opening: 12 Jan 2023
Deadline(s): 13 Apr 2023
HORIZON-HLTH-2023-DISEASE-03-01 RIA 50.00 108
6.00 to 7.00 8
HORIZON-HLTH-2023-DISEASE-03-03 RIA 20.00 109
3.00 to 4.00 5
HORIZON-HLTH-2023-DISEASE-03-04 RIA 50.00 110
7.00 to 8.00 7
HORIZON-HLTH-2023-DISEASE-03-05 CSA 3.00 111
1.00 to 2.00 2
HORIZON-HLTH-2023-DISEASE-03-06 CSA 1.00 112
Around 1.00 1
HORIZON-HLTH-2023-DISEASE-03-07 RIA 30.00 113
6.00 to 7.00 5
HORIZON-HLTH-2023-DISEASE-03-17 RIA 20.00 114
7.00 to 8.00 5
HORIZON-HLTH-2023-DISEASE-03-18 RIA 50.00 115
7.00 to 8.00 7
106
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
107
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
108
Of which EUR 30.00 million from the 'NGEU' Fund Source.
109
Of which EUR 11.00 million from the 'NGEU' Fund Source.
110
Of which EUR 30.00 million from the 'NGEU' Fund Source.
111
Of which EUR 1.50 million from the 'NGEU' Fund Source.
112
Of which EUR 0.50 million from the 'NGEU' Fund Source.
113
Of which EUR 17.00 million from the 'NGEU' Fund Source.
114
Of which EUR 11.00 million from the 'NGEU' Fund Source.
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Overall indicative budget 224.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2023-DISEASE-03-01: Novel approaches for palliative and end-oflife
care for non-cancer patients
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 6.00
and 7.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 50.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
115
Of which EUR 30.00 million from the 'NGEU' Fund Source.
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United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to all of the following expected outcomes:
 Reduced health-related suffering and improved well-being and quality of life of patients
in need of palliative and end-of-life care and their professional and family caregivers.
 Patients have early and better access to palliative or end-of-life care services of higher
quality and (cost) effectiveness.
 Patients and their professional and family caregivers are able to engage meaningfully
with the improved evidence-based and information-driven palliative care joint decisionmaking
process.
 Health care providers and health policymakers have access to and use the improved
clinical guidelines and policy with respect to pain and/or other symptoms management,
psychological and/or spiritual support, and palliative or end-of-life care for patients.
 Reduced societal, healthcare and economic burden associated with increasing demands
of palliative or end-of-life care services that is beneficial for citizens and preserves
sustainability of the health care systems.
Scope: The complexity of health conditions related to life-threatening and chronic diseases,
acute and chronic pain, late or long-term side effects as consequences of diseases and also
their treatments affect quality of life of patients and their families and pose an immense
societal and economic burden. Palliative116
and end-of-life care approaches improve quality of
life of patients and professional and family caregivers through the prevention and relief of
suffering by means of early identification, assessment and treatment of pain and other factors
such as physical, psychosocial and spiritual problems. Although a variety of interventions are
in use, they are often not adequately validated or adapted to the specific needs of patients
affected by complex diseases or their co- or multimorbidities. Therefore, a need exists to
strengthen the evidence base for available patient-centred effective interventions improving
quality of life and outcomes of patients of all ages in the domains of palliative and end-of-life
care.
Proposals should address all of the following activities:
116
https://www.who.int/cancer/palliative/definition/en/
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 Demonstrate the effectiveness and cost-effectiveness of newly proposed or specifically
adapted pharmacological and/or non-pharmacological interventions to improve wellbeing
and quality of life of patients suffering from life-threatening and chronic
diseases117
(including disabilities). Whenever relevant, serious late and long-term side
effects of disease treatments or symptoms that occur at the end of life of patients should
be considered. The legal and ethical aspects of the proposed interventions should be
taken into consideration and be fully addressed.
 Prove the feasibility of integrating the proposed interventions in current pain
management, palliative and/or end-of-life care regimes and healthcare systems across
Europe. The complex human, social, cultural and ethical aspects that are necessarily
managed by those care regimes and healthcare systems should be reflected from
patients’ as well as those of their professional and family caregivers’ perspectives. The
views and values of patients and their caregivers (including families, volunteers, nurses
and others) should also be appropriately taken into account in patient-centred care
decisions.
 Identify and analyse relationships between sex, gender, age, disabilities and socioeconomic
factors in health and any other relevant factors (e.g. ethical, familial, cultural
considerations, including personal beliefs and religious perspectives, etc.) that could
affect health equity118
to the proposed interventions, including equitable access.
 Analyse the barriers and opportunities to re-invigorating and enhancing timely social
inclusion and active engagement of patients in need of palliative and end-of-life care and
their caregivers.
 Provide implementation strategies and guidelines of patient-centred communication for
health and social care professionals as well as standards for evidenced based
communication trainings for caregivers, considering the potential of social innovation
approaches or tools.
 When relevant, provide policy recommendations for pain management, psychological
and/or spiritual support, and palliative or end-of-life care of patients.
Randomised clinical trials and observational studies, targeting different age groups, should be
considered for this topic. Proposals should give a sound feasibility assessment, provide details
of the methodology, including an appropriate patient selection and realistic recruitment plans,
justified by available publications and/or preliminary results.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
117
Proposals focused on cancer-related research are not in the scope of this topic. The supportive,
survivorship, palliation and end-of-life care of cancer patients was already covered by the specific topic
in the Cluster Health Work Programme 2021-2022. Applicants are invited to check the Work
Programme of the Mission on Cancer for further funding opportunities for this research areas.
118
https://www.who.int/topics/health_equity/en/
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societal impact of the related research activities. Proposals should consider a patient-centred
approach that empowers patients, increase health literacy in palliative and end of life care,
promotes a culture of dialogue and openness between health professionals, patients and their
families, and unleashes the potential for social innovation.
All projects funded under this topic are strongly encouraged to participate in networking and
joint activities, including internationally, as appropriate. These networking and joint activities
could, for example, involve the participation in joint workshops, the exchange of knowledge,
the development and adoption of best practices, or joint communication activities. This could
also involve networking and joint activities with projects funded under other clusters and
pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are
expected to include a budget for the attendance to regular joint meetings and may consider
covering the costs of any other potential joint activities without the prerequisite to detail
concrete joint activities at this stage. The details of these joint activities will be defined during
the grant agreement preparation phase. In this regard, the Commission may take on the role of
facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-DISEASE-03-03: Interventions in city environments to reduce
risk of non-communicable disease (Global Alliance for Chronic Diseases - GACD)
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 3.00
and 4.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 20.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Award criteria The criteria are described in General Annex D. The following exceptions
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apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to most of the following expected outcomes:
 Health care practitioners and providers in low- and middle-income countries (LMICs)
and/or those in high-income countries (HICs) serving vulnerable populations have access
to and use specific guidelines to implement health interventions that decrease risk factors
of non-communicable diseases (NCDs) associated with city119
environments.
 Public health managers and authorities have access to improved insights and evidence on
the NCDs caused or impacted by city environments and which factors influence the
implementation of preventive actions that address risk behaviours in concerned city
populations. They use this knowledge to design improved city planning policies to
diminish health associated risks.
 Adopting an implementation science approach to studying interventions in different city
contexts, researchers, clinicians and authorities have an improved understanding how
specific interventions can be better adapted to different city environments and how the
interventions could be scaled within and across cities taking into account specific social,
political, economic and cultural contexts.
 Public health managers and authorities use evidence-based strategies and tools for
promoting population health in equitable and environmentally sustainable ways,
enabling cities to better address the challenges of rapid urbanisation, growing social
inequalities, and climate change.
 Communities, local stakeholders and authorities are fully engaged in implementing and
taking up individual and/or structural level interventions and thus contribute to deliver
better health.
Scope: The European Commission is a member of the Global Alliance for Chronic Diseases
(GACD)120
. This topic is launched in concertation with the other GACD members and aligned
with the 8th
GACD call.
The topic is focused on implementation research with the potential to reduce the risks of
NCDs in cities in LMICs and/or vulnerable populations in HICs. Proposals should focus on
implementation science around evidence-based interventions that promote healthy behaviours,
119
Non-rural settings; a densely populated urban or peri-urban environment. Cities may also include
informal settlements and slums surrounding city centres. Applicants can justify why a particular context
may be considered a city.
120
https://www.gacd.org/
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and that have the potential to profoundly reduce the risk of chronic diseases and multi-
morbidity.
Non-communicable diseases, such as diabetes, cardiovascular disease, neurological diseases,
respiratory diseases, certain cancers, and mental health disorders, are the leading cause of
morbidity and mortality in both LMICs and HICs121
. The COVID-19 pandemic has brought
these chronic diseases further into the spotlight, as the majority of those who have
experienced severe illness and/or death have had one or more underlying NCD. Reducing the
burden of NCDs is therefore critical to building more resilient, equitable, and healthier
societies.
Air, water, and soil pollution; lack of greenspace; urban heat islands; lack of safe
infrastructure for walking, cycling, and active living; and wide availability of tobacco,
alcohol, and unhealthy foods and beverages drive the NCD epidemic in city environments122
.
More than half of the world’s population currently live in cities and this number is projected
to rise to 68% by 2050. There is an urgent need to equip local authorities and policymakers
with strategies for maximising the health-promoting potential of cities, while minimising or
reversing environmental degradation and health inequities.
Cities provide tremendous social, cultural, and economic opportunity, and have the potential
to become engines of good health and support climate change adaptation123
. Innovative
health-focused programmes, policies, and infrastructure, such as public smoking bans,
bikeable streets, greenspace, and vehicle emission laws, can shape the behaviours of millions
of people and decrease exposure to environmental contaminants. Applicants to the current call
are invited to conduct implementation research that leads to improved understanding of how
specific interventions can be better adapted to different city environments and/or scaled
within and across cities, taking into account unique local social, political, economic, and
cultural contexts.
The proposed implementation research must be focus on addressing NCD risk factors
associated with city environments and related health inequities. In all cases, the selected study
population(s) must live in cities, which may include informal settlements near urban centres,
peri-urban environments, and city centres. The study population may include people with
existing NCDs, those without existing NCDs, or a combination of both. Applicants are
encouraged to take a life course approach, adapting the intervention to one or more key life
stage(s) critical for reducing lifelong NCD risk.
Proposals should address all of the following activities:
 Select one or more city/ies in which the research will be conducted. Applicants must
justify why a particular context is considered a city.
121
WHO. Noncommunicable Diseases. 2021. https://www.who.int/en/news-room/fact-
sheets/detail/noncommunicable-diseases.
122
WHO Urban health 2022 and https://www.who.int/news-room/fact-sheets/detail/urban-health
123
https://www.who.int/publications/i/item/WHO-NMH-PND-2019-9
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 Select one or more evidence-based interventions known to reduce NCD risk factor(s)
associated with city environments. Applicants should justify the choice of intervention(s)
and provide evidence of the intervention’s effectiveness, acceptability, feasibility, and
potential for long-term health and other impacts. Applicants may also wish to consider
implementation research focusing on the WHO Best Buys, though this is not a
requirement.
 Adapt these intervention(s) for selected study population(s) based in one or more
city/ies, taking into account the unique social, political, economic, and cultural
context(s). Applicants should justify why these adaptations will not compromise the
known effectiveness of the selected intervention(s).
 Provide a research plan for investigating how to promote the uptake and/or scale-up of
the intervention(s) in the selected study population(s), using validated implementation
research frameworks.
 Specifically address issues of equitable implementation to ensure interventions reach the
populations that need them the most.
 Have an appropriate strategy for measuring both implementation research outcomes and
real-world effectiveness outcomes and indicators (related to NCD prevention and, if
feasible, planetary health and/or non-health sectors).
 Demonstrate a commitment to stakeholder engagement.
 Demonstrate a commitment to planetary health in that the proposed intervention,
implementation strategies and research practices minimise the consortium’s ecological
footprint.
 Provide a sustainability plan or describe a pathway to sustain the proposed intervention
after the funding ends.
The proposed interventions of focus may fall under one or both of the following themes:
Theme 1: Behavioural change interventions
These interventions comprise of innovative approaches to helping people live in cities
maintain good physical and mental health despite infrastructural, environmental, climate, and
social challenges. Behavioural interventions might include, but are not limited to,
programmes and policies that target alcohol and tobacco use, sleep, exercise promotion,
healthful nutrition (e.g. in school canteens), addressing the psychosocial impacts of climate
change and climate change related disasters, and reducing exposure to environmental
contaminants.
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Theme 2: Interventions that focus on modifying the built environment124
These interventions focus on modifying the built environment to improve its health-promoting
potential125
. Proposals should aim to inform urban design such that it reduces NCD risks; for
example, by improving a city’s walk- or bike-ability, increasing green space to reduce the
health impacts of air pollution or extreme heat, reducing environmental toxins, addressing
homelessness or unsafe housing, improving accessibility of healthy foods, decreasing
widespread advertising for tobacco and alcohol, or reducing noise and air pollution from road
traffic. For proposals that focus on modifying the built environment, applicants should
demonstrate that the intervention will be able to withstand expected impacts from climate
and/or improve resilience to the health impacts of climate change in city environments.
Applicants should be able to show that the city government or community-based organisation
that they partner with has a dedicated budget for the construction, maintenance, and/or scale
up of the proposed intervention(s), especially for large infrastructure projects. Applicants
should also be able to show that the timelines of the research and construction of
infrastructure projects will align such that it will be possible to answer the proposed
implementation research questions over the proposed duration, and such that the research
results will be available in time to inform stakeholder decisions about how the project is
implemented, improved, and/or scaled up.
Proposals should include a plan on how to measure implementation research outcomes and
the intervention’s real-world efficacy in preventing NCDs. In case health outcomes might not
be apparent over the duration of the study period, and applicants may therefore instead
include plans to measure the intervention’s impact on upstream health indicators, such as
those related to the social determinants of health, or to measure other proxy health outcomes.
Where feasible and relevant, applicants should also describe a plan for evaluating the
planetary health and/or climate impacts of an intervention’s implementation. Applicants are
also encouraged to develop a plan for measuring outcomes or indicators relevant to non-health
or environmental impacts, especially when working on projects with multi-sectoral themes
(for example, themes that cut across health and transportation, social services, waste
management, etc.).
Projects should consider the structural and social determinants of health and discuss their
potential impact on the effective implementation of the intervention(s) in city environments.
Of interest is also the EU Mission on Climate-Neutral and Smart Cities126
.
Projects should be gender-responsive and consider socioeconomic, racial or other factors that
relate to equitable impacts of the intervention or barriers to equitable implementation. The
aim should be to adapt and scale-up the implementation of these intervention(s) in accessible
124
The man-made components of the environment, such as building, traffic, sewage, parks, and other
infrastructure.
125
Proposals are intended for research that helps guide the implementation and/or scale up of the proposed
intervention. Therefore, the execution of infrastructural interventions (e.g., constructing bike lanes or
housing, etc.) is not in the scope of this topic.
126
https://ec.europa.eu/info/research-and-innovation/funding/funding-opportunities/funding-programmes-
and-open-calls/horizon-europe/eu-missions-horizon-europe/climate-neutral-and-smart-cities_en
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and equitable ways in order to prevent or delay the onset of chronic diseases in real-life
settings. Poverty, racism, ethnic discrimination, physical and mental ableism, ageism, and
other inequities are directly associated with reduced potential for health promotion and
disease prevention. If there is a focus on a particular population in this context, then the
reason for this should be justified.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
Proposals should present a strategy to include the relevant policymakers, local authorities, as
well as other stakeholders such as community groups, or other individuals or organisations
involved in the implementation of the intervention, from the development to the
implementation knowledge translation phase.
Applicants are encouraged to propose activities to increase research capacity and capability in
the field of implementation research among researchers, health professionals, and public
health leaders through skill building, knowledge sharing, and networking. In this regard, they
may propose plans for capacity building within their proposal, especially, but not exclusively,
for early career researchers and for members from lower resourced environments, such as
LMICs or indigenous communities.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-DISEASE-03-04: Pandemic preparedness and response: Broad
spectrum anti-viral therapeutics for infectious diseases with epidemic potential
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 7.00
and 8.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 50.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
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Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to all of the following expected outcomes:
 The scientific and clinical communities have an increased knowledge on viruses with
epidemic potential and in particular a better understanding of different potential
mechanisms of action for the development of broad-spectrum anti-viral therapeutics for
these viruses.
 The scientific and clinical communities have access to novel approaches for the
development of anti-viral therapies for emerging and re-emerging infections in the
context of epidemic and pandemic preparedness.
 The scientific and clinical communities have access to experimental broad-spectrum
anti-viral candidates against emerging or re-emerging viral infections for further clinical
investigation.
 A diverse and robust pipeline of broad-spectrum anti-viral drug candidates is available
for emerging and re-emerging viral infections, increasing therapeutic options for clinical
deployment in case of an epidemic or pandemic.
Scope: As shown by the COVID-19 pandemic, infectious diseases remain a major threat to
health and health security in the EU and globally. Viral disease emergence is expected to
accelerate due to among other, climate change, and thus a proactive approach to the
development of anti-viral therapeutics in preparedness for future infectious disease outbreaks
is needed. The availability of broad-spectrum anti-viral therapies would provide a critical
preparedness measure against future health threats, due to infectious disease epidemics or
pandemics.
Proposals should develop and advance broad-spectrum anti-viral compounds and develop
novel approaches to the development of such compounds, which target viruses with high
epidemic or pandemic potential for the EU, such as those included in the list of priority
diseases of the World Health Organization (WHO)127
, with particular attention to those
meeting the criteria identified by the Health Emergency Preparedness and Response Authority
(HERA)128
.
127
https://www.who.int/activities/prioritizing-diseases-for-research-and-development-in-emergency-
contexts
128
https://health.ec.europa.eu/system/files/2022-07/hera_factsheet_health-threat_mcm.pdf
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Proposals should cover viruses for which there are no currently available effective
therapeutics or for which the therapeutics available are sub-optimal, and are expected to
incorporate state-of-the-art screening technology and innovative approaches to identify new
targets for antiviral compound development. Emphasis should be put on the research and
development of broad-spectrum antivirals, which may include repurposing of previously
approved or in-pipeline drugs. Proposals could also include elucidation of mode-of-action for
candidate anti-viral therapeutics.
Proposals should aim to diversify and accelerate the global therapeutic research and
development pipeline for emerging and re-emerging viral infections, and to strengthen the
current leading role of the EU in therapeutic research and development.
Proposals should address all of the following areas:
 Preclinical work and proof-of-concept/first-in-human studies and early safety and
efficacy trials for testing new or improved anti-viral therapeutics, with a clear regulatory
and clinical pathway. Phase IIb/III phase trials will not be supported.
 Innovative delivery systems and suitable safety profiles for broad use should be
considered when possible. Attention should be paid to critical social factors such as sex,
gender, age, socio-economic factors, ethnicity/migration, and disability.
 Application of novel approaches and widely applicable workflows (e.g. artificial
intelligence) for rapid and reliable identification of broad-spectrum anti-viral
therapeutics.
Applicants are expected to engage with regulatory bodies in a timely manner to ensure
adequacy of the actions from a regulatory point of view.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-DISEASE-03-05: Pandemic preparedness and response:
Sustaining established coordination mechanisms for European adaptive platform trials
and/or for cohort networks
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 1.00
and 2.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 3.00 million.
Type of Action Coordination and Support Actions
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Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, legal entities established in the
United States of America may exceptionally participate as a beneficiary
or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU
Member State or Associated Country.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to all of the following expected outcomes:
 The research community sustains appropriate coordination mechanisms 1) among
different EU-wide adaptive platform trials and/or 2) among established cohorts in
Europe and beyond with a view for better pandemic preparedness and response,
 The adaptive platform trial and/or the cohort networks maximise coordination and
harmonisation of their respective studies within their relevant network for maximum
research efficiency and optimal evidence generation.
 The European adaptive platform trial and/or the cohort networks coordinate with the
European Pandemic Preparedness Partnership, and are well connected to each other and
to relevant other regional and global initiatives.
Scope: The COVID-19 pandemic research response has illustrated the importance of clinical
research preparedness, as well as the benefit gained from the coordination between European
clinical research initiatives. Two key pillars of such clinical research in pandemic
preparedness and response are the clinical (interventional) trials and the cohort (observational)
studies.
The large-scale European COVID-19 clinical trials have been gathered under a network for
COVID-19 therapeutic trials129
and a network for COVID-19 vaccine trials130
and strong
common coordination mechanisms between the trials have been established. The recently
launched Ecraid131
is a European clinical research network that has been in development since
129
https://covid19trials.eu/en
130
https://vaccelerate.eu/
131
https://www.ecraid.eu/
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before the COVID-19 pandemic. The EU-funded projects conducting cohort research in
Europe and globally have also come together to establish stronger coordination between them.
This topic aims at maintaining and strengthening existing strategic coordination mechanisms
across adaptive platform trials and across cohort studies in Europe and beyond for avoiding
redundancies, promoting complementarities and facilitating cooperation among EU-funded
clinical research for infectious diseases. Proposals should strengthen the leading role of the
EU in clinical research preparedness for future epidemics and pandemics, through ensuring
coordination of the European adaptive platform trials and of the European cohort studies. The
coordination mechanisms support the longer-term perspective of preparedness for future
infectious disease epidemics and pandemics, where the networks enable the conduct of
perpetual platform trials and of perpetual strategic cohorts with the in-built agility to pivot to
emerging diseases when an epidemic strikes.
Proposals should describe a coordination mechanism for adaptive platform trials and/or for
cohort research. The coordination mechanism builds on existing coordination efforts for these
networks, providing strategic support and vision for the perpetual trials and cohort studies
belonging to the networks in the context of pandemic preparedness. Within the adaptive
platform trial network, the coordination mechanism supports reflections e.g. on the diversity
of the trial target populations (e.g. primary care or hospitalised patients) or on different
possible medical countermeasures (e.g. therapeutics, vaccines), etc. Within the cohort
network, the coordination mechanism supports reflections e.g. on diversity in type of cohorts
and research questions to be addressed, or on harmonised approaches to data collection and
analysis, etc.
Proposals should address proper connections with relevant European initiatives and
organisations, such as the European Pandemic Preparedness Partnership, the European Health
Preparedness and Emergency Response Authority (HERA), as well as the European
Medicines Agency (EMA) and the European Centre for Disease Prevention and Control
(ECDC). Synergies with successful proposals under the HORIZON-INFRA-2023-DEV-01-01
topic should be sought, and collaboration with other relevant research infrastructures should
be envisaged. Proposals should also be open to engage with global initiatives such as the
Global Research Collaboration for Infectious Disease Preparedness (GloPID-R)132
, the Global
Health EDCTP3 Joint Undertaking133
, or the World Health Organization (WHO).
Proposals should address the following areas:
 Fostering a trusted and proactive environment within the coordination mechanism that
supports the timely exchange of research results, allows for discussion on challenges
encountered in their research and finding solutions together to ensure cooperation and
synergy within each network;
132
https://www.glopid-r.org/
133
https://ec.europa.eu/info/research-and-innovation/research-area/health-research-and-
innovation/edctp_en
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 Developing a common approach for the European clinical research to enable pragmatic
solutions to shared challenges across European clinical trials and/or cohorts for
pandemic preparedness and response, guaranteeing the best interest of European trial or
study patients or volunteers;
 Promoting an optimal use of resources, based on a sound scientific approach and
maximising the value added for the generation of scientific evidence, through a common
baseline approach towards protocol development, harmonised and FAIR data 134
collection and analysis leveraging existing initiatives;
 Involving relevant European stakeholders, such as representatives from regulatory
authorities, industry, policymakers, patient organisations, etc., as well as relevant nonEuropean
networks and stakeholders;
 Promoting the visibility and attractiveness of European adaptive platform trials and/or
cohorts for clinical investigators in Europe and beyond ; as well as active
communication with the science community, patient advocacy groups and other
stakeholders, to develop trust, and also promote innovative approaches;
 Partners within the coordination mechanism should develop a plan to ensure its
sustainability. Coordination with the European Pandemic Preparedness Partnership and
the European Health Preparedness and Emergency Response Authority (HERA) is
expected.
HORIZON-HLTH-2023-DISEASE-03-06: Towards structuring brain health research in
Europe
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of around EUR 1.00
million would allow these outcomes to be addressed appropriately.
Nonetheless, this does not preclude submission and selection of a
proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 1.00 million.
Type of Action Coordination and Support Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, legal entities established in the
United States of America may exceptionally participate as a beneficiary
or affiliated entity, and are eligible to receive Union funding.
134
See definition of FAIR data in the introduction to this work programme part.
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Coordinators of projects must be legal entities established in an EU
Member State or Associated Country.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to most of the following expected outcomes:
 Policymakers, funders and other relevant stakeholders135
identify and agree on the
governance structure and implementation modalities, allowing for an efficient
establishment of a potential future partnership.
 Policymakers, funders and other relevant stakeholders build on the knowledge gathered
in past studies performed at EU and national level.
 Policymakers, funders and other relevant stakeholders identify and agree on common
research priorities and research needs, also taking into consideration developments at the
international level where relevant.
 Policymakers, funders and other relevant stakeholders develop and align national and
regional research strategy plans with long-term sustainability in mind.
 Policymakers and funders commit to providing financial support that will allow for a
comprehensive, impact-driven structuring of the field of European brain health research.
Scope: Member States and Associated Countries have agreed to step up their coordination in
the area of brain research, which could take the form of a European partnership on Brain
Health136
in the second Strategic Plan of Horizon Europe137
.
Proposals should address all of the following aspects:
 Develop a structured system of exchange of information between policymakers, funders,
and other relevant bodies138
in order to establish synergies and avoid duplication of
135
Other relevant stakeholders include researchers, health care providers and practitioners, patients,
citizens, regulators and industry.
136
In the context of the partnership, ‘brain health’ should be interpreted as a concept that encompasses
neural development, neuroplasticity, brain functioning, and recovery across the life course, including
mental health and wellbeing elements.
137
This topic does not pre-judge the content of the second Strategic Plan of Horizon Europe.
138
Relevant bodies include EU-supported initiatives, scientific and clinical societies, patient organisations,
regulators and the industry.
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efforts. The aim is to structure brain health research in Europe and pave the way for a
possible future partnership.
 Develop a strategic research and innovation agenda, taking into account the efforts
already undertaken by EU-supported actions139
. The strategic research and innovation
agenda will identify a number of measurable, scientific-technological priorities and
socio-economic objectives, supported by an appropriate analysis.
 Develop plans for a governance structure of a future partnership, as well as
implementation modalities with long-term sustainability in mind, and under the
leadership of an EU Member State or Associated Country.
 Ensure a broad geographical representation of European countries and plan for inclusion
of all main related research initiatives, as well as key organisations and associations. In
this way, the coordination action should reflect the ‘umbrella’ role of a future initiative
that will structure brain health research in Europe, and make it more impactful.
 Consider international initiatives by engaging with global organisations140
, as well as
with global initiatives and research organisations141
in the field.
 Elaborate on platforms and tools for use by the research community, including on how
they can best complement, integrate with each other. In this context, infrastructures
already developed at the European142
or national level that enable sharing of samples,
quality data and advanced analytical tools should be included in the analysis. Reflections
should also be made on how the future initiative can contribute to the development of the
European Health Data Space.
This coordination action implies the preparation and organisation of meetings, as well as
support to information exchange with relevant stakeholder groups and with the public.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
139
This includes the common research agenda developed by the ‘European Brain Research Area’ (EBRA)
project, as well as the strategic research agendas of the partnerships: ‘EU Joint Programme –
Neurodegenerative Disease Research’ (JPND), ‘Network of European Funding for Neuroscience
Research’ (NEURON), ‘Human Brain Project’ (HBP) and the ‘Innovative Medicines Initiative’ (IMI)
and its successor the ‘Innovative Health Initiative’ (IHI).
140
Global organisations include the World Health Organization (WHO), the Organisation for Economic
Co-operation and Development (OECD) and the Global Alliance for Chronic Diseases (GACD).
141
Entities include the global brain initiatives, the International Initiative for Traumatic Brain Injury
Research (InTBIR) and the International Brain Research Organisation (IBRO).
142
EU-supported infrastructures include, for example, the BBMRI-ERIC infrastructure for biobanking, the
EBRAINS research infrastructure, and various platforms developed by the Innovative Medicines
Initiative (IMI) and its successor the Innovative Health Initiative (IHI).
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HORIZON-HLTH-2023-DISEASE-03-07: Relationship between infections and noncommunicable
diseases
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 6.00
and 7.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 30.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to the following expected outcomes:
 All players along the health care value chain are provided with new knowledge for a
better understanding of the links (e.g. causalities) between infectious diseases (IDs) and
non-communicable diseases (NCDs) and comorbidities, including knowledge on host
risk factors that impact the development of disease progression for NCDs and/or IDs.
 Researchers and clinicians are provided with a robust evidence base that will contribute
to the development of new or improved tools to diagnose and prevent the development
and aggravation of non-communicable disease(s) as well as early treatment and
management of patients suffering from co-morbidities following an infectious disease.
 Healthcare practitioners have access to knowledge to guide them on preventive
measures, on early identification of diseases onset and of those patients at risk of
developing severe disease progression, and on the optimal treatment of patients.
When NCDs are related to infectious diseases with pandemic potential, healthcare
practitioners will be provided with new evidence to help them make informed decision on the
management of the diseases in the future. Public health authorities will be better prepared to
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issue targeted recommendations linked or not to the use of specific medical countermeasures
in crisis times.
Scope: Increasing evidence suggests that several infections might influence the development
of many non-communicable diseases (e.g. multiple sclerosis, Alzheimer, post-covid-19
condition143
), or that NCD may be influenced by concurrent presence in the same individual
of one (or more) infections. On the other hand, NCDs might represent risk factors for IDs.
The proposals are expected to elucidate and provide a better understanding of causative links
between infections and non-communicable diseases onsets, and/or the impact of infections on
the exacerbation of existing NCDs or vice versa, in children and/or adults. The analysis of
genetics, immune status, immune or inflammatory responses, microbiome, lifestyle and/or
other relevant factors (e.g. differences in age, sex/gender, vaccination status, ethnicity) should
be integrated to get information for prevention, early diagnosis, risk factors, and to better
understand causative links as well as the progression of those non-communicable diseases.
In determining the connection between one or multiple concomitant infection(s) and the
development of non-communicable disease(s), the proposals might address any infection
including those with pandemic potential (viral, bacterial, or fungal) with non-communicable
diseases of major importance. Research on cancer is excluded as it will be covered by the
Mission on Cancer.
Special attention should be given to vulnerable individuals, such as those with known existing
preconditions.
Preclinical research, observational studies and/or clinical studies can be considered for this
topic. Proposals could include patient follow-up to identify conditions that may appear only
after a patient has recovered from the infectious disease. Those proposals including clinical
evaluation should give a sound feasibility assessment, provide details of the methodology,
including an appropriate patient selection and realistic recruitment plans, justified by available
publications and/or preliminary results.
The applicants are encouraged to incorporate artificial intelligence (AI) tools that enable
advanced quality data analysis and for assessing and predicting the risk of developing a
disease and/or the risk of disease progression/severity where relevant.
Projects funded under this topic that focus on COVID-19 and post COVID-19 condition (also
known as long-COVID) are strongly encouraged to collaborate and build links with (one of)
the relevant EU-funded projects, such as ORCHESTRA144
. They should also pay special
attention and link to the newly established European COVID-19 data sharing platform145
.
143
https://www.who.int/publications/i/item/WHO-2019-nCoV-Post_COVID-19_condition-
Clinical_case_definition-2021.1
144
https://orchestra-cohort.eu/
145
https://www.covid19dataportal.org/
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Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-DISEASE-03-17: Pandemic preparedness and response:
Understanding vaccine induced-immunity
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 7.00
and 8.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 20.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to all of the following expected outcomes:
 The scientific and clinical communities have an increased knowledge of vaccine-induced
immunity and, in particular, a better understanding of factors that affect the magnitude,
breadth, nature and duration of immunity to vaccine antigens.
 The scientific and clinical communities have an increased knowledge of the durability
and breadth of vaccine-induced immunity in vulnerable populations and older age
groups.
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 The scientific and clinical communities have an increased knowledge of correlates of
protection for pathogens with epidemic potential to allow the development of effective
vaccines.
 The scientific and clinical communities have an increased knowledge of the
characteristics that influence vaccine effectiveness to allow for novel approaches for the
development of vaccines for emerging and re-emerging infections, including antigenic
variants, in the context of epidemic and pandemic preparedness.
Scope: As shown by the COVID-19 pandemic, vaccines are a critical component needed to
bring infectious disease pandemics under control. The availability of effective vaccines that
are able to induce a strong and durable immune response are critical to respond to health
threats caused by infectious disease epidemics or pandemics. A proactive approach to
understanding the factors that affect vaccine durability and strength is necessary to ensure
development of effective vaccines for future infectious disease outbreaks.
Proposals should study vaccine-induced immunity in the general population and vulnerable
groups. Proposals should look both at the magnitude and breadth of initial immune responses
and the duration of immunity after vaccination with different vaccine types (mRNA, vector,
inactivated, subunit, attenuated,…). Proposals should assess how sex (e.g. male vs female,
pre- vs postmenopausal), age (childhood vs adolescent vs elderly) and/or lifestyle (e.g.
obesity, drug addiction, diet, sport) affect the immune response. Proposals may also examine
genetic and other molecular factors that may influence immune response in humans.
Proposals should pursue a multi-omics approach in order to foster a deep understanding of
vaccine induced immunity.
Proposals should identify correlates of protection that can be used to develop vaccines against
viruses meeting the criteria for pathogens with high pandemic potential as identified by
HERA146
.
Proposals should also assess how pre-existing conditions or chronic infections influence the
immune response.
Proposals should aim to improve the global vaccine research and development pipeline for
emerging and re-emerging viral infections, and to strengthen the current leading role of the
EU in vaccine development, and therefore contributing to the work of the European Health
Emergency Preparedness and Response Authority (HERA).
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
146
https://health.ec.europa.eu/system/files/2022-07/hera_factsheet_health-threat_mcm.pdf
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Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-DISEASE-03-18: Pandemic preparedness and response:
Immunogenicity of viral proteins of viruses with epidemic and pandemic potential
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 7.00
and 8.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 50.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to all of the following expected outcomes:
 The scientific and clinical communities have an increased knowledge on viruses with
epidemic and pandemic potential and in particular a better understanding of viral targets
for vaccine development.
 The scientific and clinical communities have access to novel approaches for the
prevention and treatment for emerging and re-emerging infections in the context of
epidemic and pandemic preparedness.
 The scientific and clinical communities have access to experimental vaccine candidates
against emerging or re-emerging viral infections for further clinical investigation.
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 A diverse and robust pipeline of vaccine candidates is available for emerging and reemerging
viral infections, increasing therapeutic options for clinical deployment in case
of an epidemic or pandemic.
Scope: As shown by the COVID-19 pandemic, infectious diseases remain a major threat to
health and health security in the EU and globally. Viral disease emergence is expected to
accelerate due to among other factors, climate change, and thus a proactive approach to the
development of vaccines and inhibitors for the cellular uptake of viruses in preparedness for
future infectious disease outbreaks is needed. The availability of vaccines against pathogens
with high pandemic potential meeting the criteria identified by the Health Emergency
Preparedness and Response Authority (HERA) 147
would provide a critical preparedness
measure against future health threats.
Proposals should identify targets for optimal vaccine design for those pathogens where
information on host-pathogen interaction and viral surface structures is already available.
These surface structures may require further characterisation. It is necessary to determine the
extent of genetic variation with a view to develop vaccines with variant efficacy. In addition,
it is necessary to develop animal and alternative models for the testing of vaccine candidates
and for the kinetics, strength, breadth and persistence of the immune response. Proposals
should focus on the following viruses: Hendra and Nipah Virus, Lassa virus, Crimean Congo
haemorrhagic fever virus, Rift Valley fever virus, Ebola and Marburg virus, Dengue virus,
Yellow Fever virus, Zika virus, West Nile fever virus and Chikungunya virus.
Proposals should provide innovative approaches with the aim to diversify and accelerate the
global pandemic preparedness research and development pipeline for emerging and reemerging
viral infections, and to strengthen the role of the EU in therapeutic research and
development, and therefore contributing to the work of the European Health Emergency
Preparedness and Response Authority (HERA).
Proposals should address several of the following areas:
 Identification of key antigenic targets for the priority pathogens as mentioned above.
 Improvement or, if necessary, establishment of animal models for the testing of vaccine
candidates where alternative models are not available.
 Characterisation of the immunogenicity of antigenic targets in appropriate animal or
alternative models and in pre-clinical tests.
 Inclusion, if possible, of proof-of-concept studies in humans of the vaccine candidate.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
147
https://health.ec.europa.eu/system/files/2022-07/hera_factsheet_health-threat_mcm.pdf
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Call - Partnerships in Health (2023)
HORIZON-HLTH-2023-DISEASE-07
Conditions for the Call
Indicative budget(s)148
Topics Type of
Action
Budgets
(EUR
million)
Expected EU
contribution
per project
(EUR
million)149
Indicative
number
of
projects
expected
to be
funded
2023
Opening: 12 Jan 2023
Deadline(s): 19 Sep 2023
HORIZON-HLTH-2023-DISEASE-07-01 COFUND 50.00 Around
50.00
1
Overall indicative budget 50.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
148
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
149
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
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Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2023-DISEASE-07-01: European Partnership on Rare Diseases
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of around EUR
50.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 50.00 million.
Type of Action Programme Co-fund Action
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding. Because
the US contribution will be considered for the calculation of the EU
contribution to the partnership, the concerned consortium of research
funders from eligible EU Members States and Associated Countries
must expressly agree to this participation.
The Joint Research Centre (JRC) may participate as member of the
consortium selected for funding.
Award criteria The criteria are described in General Annex D. The following
exceptions apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and
3 (Implementation). The cumulative threshold will be 12.
Legal and
financial set-up of
the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
Beneficiaries may provide financial support to third parties. The support
to third parties can only be provided in the form of grants. Financial
support provided by the participants to third parties is one of the primary
activities of the action in order to be able to achieve its objectives.
Given the type of action and its level of ambition, the maximum amount
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to be granted to each third party is EUR 10.00 million.
The funding rate is 50% of the eligible costs. This is justified by the
pooling of proposers' in-kind contributions and in-house activities and
by the nature of activities to be performed: in addition of joint calls,
highly integrative activities (EU clinical trial preparedness, training,
patients’ empowerment activities etc.) contributing to enhance the rare
disease research and innovation ecosystem in Europe and beyond.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to several expected impacts of destination 3 “Tackling diseases and reducing disease burden”.
To that end, proposals under this topic should aim for delivering results that are directed,
tailored towards and contributing to all of the following expected outcomes:
 The EU is reinforced as an internationally recognised driver of research and innovation
in rare diseases (RD) and thereby substantially contributing to the achievement of the
Sustainable Development Goals related to rare diseases;
 Research funders align, adopt and implement their RD research policies allowing for the
optimal generation and translation of knowledge into meaningful health products and
interventions responding to the needs of people living with a rare disease across Europe
and globally.
 The RD research community at large benefit from and use an improved comprehensive
knowledge framework integrating the EU, national/regional data and information
infrastructures to improve translational research.
 People living with a rare disease benefit from a more timely, equitable access to
innovative, sustainable and high-quality healthcare, taking stock of highly integrated
research and healthcare systems.
 Researchers, innovators - as well as people living with a rare disease and their advocates
(as co-creators) - effectively constitute and operate into an integrated research and
innovation ecosystem to deliver cost-effective diagnosis and treatments.
 Public and private actors, including civil society (e.g. NGOs, charities), establish
coordinated and efficient multi-stakeholder collaborations at EU and national (including
regional) levels, allowing for more effective clinical research, for example aiming at
improved success rates of therapeutic development.
Scope: The Partnership should contribute to priorities of the “Communication on effective,
accessible and resilient health systems” (COM(2014) 215 final), the “Communication on
enabling the digital transformation of health and care in the Digital Single Market;
empowering citizens and building a healthier society” (COM(2018) 233 final) and support the
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objectives of the new EU4Health Programme (COM(2020) 405 final, Regulation (EU)
2021/522150
).
This partnership should also contribute to achieving the objectives of the Pharmaceutical
Strategy for Europe151
, in terms of fulfilling unmet medical needs (e.g. for rare diseases with
so called “orphan medicinal products”152
) and ensuring that the benefits of innovation reach
patients in the EU.
Thanks to its capacity to bring together different stakeholders (e.g. research funders, health
authorities, healthcare institutions, innovators, policymakers), the Partnership will create a
critical mass of resources and to implement a long-term Strategic Research and Innovation
Agenda (SRIA).
The co-funded European Partnership on rare diseases should be implemented based on the
priorities identified in the SRIA and through a joint programme of activities ranging from
coordinating and funding transnational research to highly integrative and community-driven
‘in-house’ activities such as innovation strategies for the efficient exploitation of research
results, EU clinical trial preparedness activities, optimisation of research infrastructures and
resources, including networking, training and dissemination activities. It should be structured
along the following main objectives:
 Launch joint transnational calls for RD research and innovation priorities as defined in
the SRIA, resulting in financial support to third parties, based on the annual work plans;
 Develop a European Clinical Research Network to accelerate the clinical trial readiness
of the RD research community in Europe, to improve the research and innovation
potential of RD stakeholders and facilitate the cost-effective clinical development of new
therapies;
 Develop and consolidate the capacity building of the RD data ecosystem by supporting
the federated access/sharing of FAIR153
research data, information resources to ensure
the effective and fast translation of the research results to safe and effective health
innovations;
 Integrate basic, pre-clinical and clinical research to reduce the burden for people living
with a rare disease.
 Support research in relevant medical fields and intervention areas (prevention, diagnosis,
treatment), while improving the utilisation of existing health technologies in clinical
practice;
 Support the scientific work of the International Rare Disease Research Consortium.
150
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG
151
COM(2020) 761 final, https://ec.europa.eu/health/medicinal-products/pharmaceutical-strategy-
europe_en
152
https://ec.europa.eu/health/medicinal-products/orphan-medicinal-products_en
153
See definition of FAIR data in the introduction to this work programme part.
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The Partnership is open to all EU Member States, as well as to countries associated to
Horizon Europe and will remain open to third countries wishing to join. The Partnership
should include or engage with the following actors:
 Ministries in charge of R&I policy, as well as national and regional R&I and technology
funding agencies and foundations;
 Ministries in charge of health and care policy, as well as national and regional healthcare
authorities, organisations and providers (including providers members of the European
Reference Networks);
 Research infrastructures;
 Patients organisations;
 Industry;
 Charities.
The Partnership may also encourage engagement with other relevant Ministries and research
funders. It should involve other key actors from civil society and end-users, research and
innovation community, innovation owners, health and care systems owners/organisers and
health and care agencies.
The Partnership’s governance structure should enable an upfront strategic steering, effective
management and coordination, daily implementation of activities and ensure the use and
uptake of the results. Importantly, the EU Member States, as public funders should have a
leading role in the governance and strategic steering of the whole Partnership, including in the
co-design and the strategic orientations of the ‘in-house’ activities, such as consolidating the
research & innovation ecosystem, clinical trial preparedness for the community, contribution
to ERA, training activities etc.). Moreover, the management structure should allow the
coordinated input of key stakeholders, including but not limited to the research and innovation
community, patients and citizens, health and care professionals, formal and informal care
organisations, and innovation owners.
To ensure coherence and complementarity of activities and leverage knowledge and
investment possibilities, the Partnership is expected to establish relevant collaborations with
other Horizon Europe partnerships (institutionalised and co-funded) and missions as set out in
the working document on ‘Coherence and Synergies of candidate European Partnerships
under Horizon Europe’154
as well as to explore collaborations with other relevant activities at
EU and international level. The proposal should also consider synergies with EU
programmes, including but not limited to EU4Health, the Digital Europe Programme
(DIGITAL), the European Social Fund Plus (ESF+), the European Regional Development
154
Directorate-General for Research and Innovation, A4 Partnership Sector, October 2020:
https://ec.europa.eu/info/sites/default/files/research_and_innovation/funding/documents/ec_rtd_coheren
ce-synergies-of-ep-under-he_annex.pdf
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Fund (ERDF)155
, InvestEU, the Recovery and Resilience Facility (RRF) and the Technical
Support Instrument (TSI).
Cooperation with international organisations, and non-European institutions and experts may
be considered. Participation of third countries is encouraged. Their commitments to the
Partnership would not be eligible for the calculation of EU funding. Applicants should
describe in their proposal the methodology for their collaboration and the aims they want to
achieve with this kind of collaboration.
Proposals should pool the necessary financial resources from the participating national (or
regional) research programmes with a view to implementing joint calls for transnational
proposals resulting in grants to third parties. Financial support provided by the participants to
third parties is one of the activities of this action in order to be able to achieve its objectives.
Collaboration with the EU agency involved in authorising orphan medicinal products, the
European Medicines Agency (EMA), should be considered to enhance the sharing of
knowledge and data regarding orphan medicinal products and rare diseases, while national
agencies producing knowledge on orphan medicinal products and rare diseases may also join
the Partnership, e.g. as beneficiaries.
When defining calls for proposals, this Partnership needs to consider the effective
contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH
experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce
meaningful and significant effects enhancing the societal impact of the related research
activities.
Collaboration with the European Commission's Joint Research Centre (JRC) must be
considered to materialise the sharing of (meta)data regarding registries for rare diseases,
exchanging data for clinical studies and research based on a unified pseudonymisation tool
provided by the European Platform on Rare Disease Registration (EU RD Platform) and
related tools and services, as well as in other areas of mutual interest, such as training and
capacity building.
The total indicative budget for the partnership is up to EUR 150 million and subject to the
effective implementation of the commitments made by the members of the consortium. The
Commission envisages to include new actions in its future work programmes to provide
continued support to the partnership for the duration of Horizon Europe.
The expected duration of the partnership is seven to ten years.
Call - Tackling diseases (Two stage - 2024)
HORIZON-HLTH-2024-DISEASE-03-two-stage
155
“Synergies between Horizon Europe and ERDF programmes (Draft Commission Notice)”
https://research-and-innovation.ec.europa.eu/news/all-research-and-innovation-news/synergies-
guidance-out-2022-07-06_en
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Conditions for the Call
Indicative budget(s)156
Topics Type
of
Action
Budgets
(EUR
million)
Expected
EU
contribution
per project
(EUR
million)157
Indicative
number
of
projects
expected
to be
funded
2024
Opening: 30 Mar 2023
Deadline(s): 19 Sep 2023 (First Stage), 11 Apr 2024 (Second Stage)
HORIZON-HLTH-2024-DISEASE-03-08-
two-stage
RIA 45.00 6.00 to 7.00 7
HORIZON-HLTH-2024-DISEASE-03-11-
two-stage
RIA 30.00 8.00 to
10.00
3
HORIZON-HLTH-2024-DISEASE-03-13-
two-stage
RIA 25.00 6.00 to 8.00 3
HORIZON-HLTH-2024-DISEASE-03-14-
two-stage
RIA 25.00 6.00 to 7.00 4
Overall indicative budget 125.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
156
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
157
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
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Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2024-DISEASE-03-08-two-stage: Comparative effectiveness research
for healthcare interventions in areas of high public health need
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
6.00 and 7.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 45.00 million.
Type of Action Research and Innovation Actions
Admissibility
conditions
The conditions are described in General Annex A. The following
exceptions apply:
Applicants submitting a proposal under the blind evaluation pilot (see
General Annex F) must not disclose their organisation names,
acronyms, logos, nor names of personnel in Part B of their first stage
application (see General Annex E).
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following
exceptions apply:
For the second stage, the thresholds for each criterion will be 4
(Excellence), 4 (Impact) and 3 (Implementation). The cumulative
threshold will be 12.
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Procedure The procedure is described in General Annex F. The following
exceptions apply:
This topic is part of the blind evaluation pilot under which first stage
proposals will be evaluated blindly.
Legal and financial
set-up of the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
Eligible costs will take the form of a lump sum as defined in the
Decision of 7 July 2021 authorising the use of lump sum contributions
under the Horizon Europe Programme – the Framework Programme for
Research and Innovation (2021-2027) – and in actions under the
Research and Training Programme of the European Atomic Energy
Community (2021-2025). 158
.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to most of the following expected outcomes:
 Health policymakers are aware of the healthcare interventions (pharmacological, nonpharmacological
or technological interventions; including preventive and rehabilitative
actions) that are identified as working best for the specific population groups from the
point of view of safety, efficacy, patient outcomes, adherence, quality of life,
accessibility, and (cost-) effectiveness.
 Health professionals have access to and use the improved clinical guidelines on the
optimal treatment of patients and prevention of diseases e.g. through vaccines.
Considerations made in the guidelines include the harmonisation and standardisation of
care for high burden diseases or conditions throughout Europe, as well as possible
individualised needs of patients.
 The scientific and clinical communities make effective use of state-of-the-art
information, data, technologies, tools and best practices to develop interventions that are
sustainable.
 Citizens, patients, prescribers, and payers receive more accurate information on available
healthcare interventions via ad hoc communication platforms.
158
This decision is available on the Funding and Tenders Portal, in the reference documents section for
Horizon Europe, under ‘Simplified costs decisions’ or through this link:
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-
decision_he_en.pdf
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 The scientific and clinical communities make wide use of the newly established open
access databases and/or integrate them with existing open access infrastructures for
storage and sharing of collected data according to FAIR159
principles.
Scope: Effective, affordable and accessible healthcare for diverse population groups is
challenging and complex. For example, specific needs underlie the delivery of effective
preventive actions and therapeutic treatments to a rapidly growing elderly population, often
presenting comorbidities and associated polypharmacy. The paediatric population, including
children born preterm, has also its specific needs in specially adjusted therapeutics and early
interventions to address emerging health and developmental problems. Similar to the elderly
population, the paediatric population is often excluded from many clinical trials that generate
the evidence base for healthcare interventions. Women, including pregnant women, are also
often under-represented in clinical studies and access to quality healthcare is frequently
inadequate. Other population groups with limited access to quality healthcare and/or underrepresentation
in clinical studies include low-income groups, and refugees. Intersectionality
within these groups also needs consideration.
Proposals should address most of the following:
 Compare the use of currently existing (pharmacological, non-pharmacological and
technological) healthcare interventions in specific population groups (or selected
subgroups). While there is no restriction on diseases or conditions, preference will be
given to proposals focusing on interventions with high public health relevance160
.
 Ensure acceptability and sustainability of the healthcare intervention through early
involvement of ‘end users’ (e.g. patients, care providers) in the design of the study
(integrating patient valued outcomes) and, where possible, in the research process
including implementation. Additionally, proposals should take into account the diversity
of health systems in different regions of Europe to allow large-scale uptake.
 Consider involving HTA bodies in order to create synergies and accelerate the practical
implementation of the results. Where relevant, existing work of EU-funded projects such
as EUnetHTA161
should be also taken into account.
 Consider issues of particular relevance for the target populations, for example,
multimorbidity, complex chronic conditions, polypharmacy, substance misuse, vaccine
efficacy, compliance, age, gender specificities and diseases with high societal burden
(including but not limited to e.g. musculoskeletal diseases and mental health disorders).
Special consideration should be given to fulfilling all ethical requirements.
 For the chosen population, assess clinical and safety parameters, as well as health and
socio-economic outcomes (e.g. quality of life, patient mortality, (co)morbidity, costs,
159
See definition of FAIR data in the introduction to this work programme part.
160
Interventions addressing diseases or conditions that are particularly frequent, have a high negative
impact on the quality of life of the individual and/or are associated with significant costs where savings
can be achieved.
161
https://www.eunethta.eu/
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and performance of the health system). Agreed core outcome sets (COS) should be used
as endpoints in conditions where they already exist, in other cases, efforts should be
made to agree on such COS. Consider using new instruments and methods for
determining the burden of disease and for evaluating the effects of the interventions.
Low-cost innovations should also be considered.
 Inclusion of patient organisations and associations of caregivers and other healthcare
professionals is recommended.
 Clinical trials, including pragmatic clinical trials, observational studies, use of existing
health data in different study designs, creation of large-scale databases and performing
meta-analyses may be considered for this topic. Use of existing data should always be
considered to add value, increase quality and increase implementation speed of the
study. Regarding databases, sustainability after the proposed action's end also needs to
be considered.
 The proposed research needs to take into account sex and gender aspects.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
The Commission will ensure an overall coordination mechanism between the projects funded
under this topic to catalyse the exchange of knowledge, as well as the development and
adoption of best practices. Proposals are expected to budget for the attendance to regular
meetings. Projects resulting from this call will be invited to share and discuss their case
studies amongst themselves and with relevant stakeholders at the EU level, and necessary
resources should be allocated to this task.
Applicants invited to the second stage and envisaging to include clinical studies should
provide details of their clinical studies in the dedicated annex using the template provided in
the submission system. See definition of clinical studies in the introduction to this work
programme part.
HORIZON-HLTH-2024-DISEASE-03-11-two-stage: Pandemic preparedness and
response: Adaptive platform trials for pandemic preparedness
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
8.00 and 10.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 30.00 million.
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Type of Action Research and Innovation Actions
Admissibility
conditions
The conditions are described in General Annex A. The following
exceptions apply:
Applicants submitting a proposal under the blind evaluation pilot (see
General Annex F) must not disclose their organisation names,
acronyms, logos, nor names of personnel in Part B of their first stage
application (see General Annex E).
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following
exceptions apply:
For the second stage, the thresholds for each criterion will be 4
(Excellence), 4 (Impact) and 3 (Implementation). The cumulative
threshold will be 12.
Procedure The procedure is described in General Annex F. The following
exceptions apply:
This topic is part of the blind evaluation pilot under which first stage
proposals will be evaluated blindly.
Legal and financial
set-up of the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
Eligible costs will take the form of a lump sum as defined in the
Decision of 7 July 2021 authorising the use of lump sum contributions
under the Horizon Europe Programme – the Framework Programme for
Research and Innovation (2021-2027) – and in actions under the
Research and Training Programme of the European Atomic Energy
Community (2021-2025). 162
.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to all of the following expected outcomes:
162
This decision is available on the Funding and Tenders Portal, in the reference documents section for
Horizon Europe, under ‘Simplified costs decisions’ or through this link:
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-
decision_he_en.pdf
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 A diverse and comprehensive EU landscape of multi-country adaptive platform trials
(i.e. able to study multiple interventions in a disease or condition in a perpetual manner,
thus allowing modification to the trial after its initiation without undermining its validity
and integrity) that assess vaccines and therapeutics for infectious diseases, and have the
capacity to pivot rapidly in the case of epidemic or pandemic health threats.
 Innovative and improved design of clinical studies, suited for pandemic preparedness, is
available for the clinical research community, taking into account the high safety
standards in the European regulatory environment.
 Trial sites across multiple countries have the capacity to deliver robust clinical evidence
in a diverse European population, using harmonised research methods, data collection
and analysis.
Scope: As shown by the COVID-19 pandemic, infectious diseases remain a major threat to
health and health security in the EU and globally. Health threats are expected to arise due to
among others, climate change, and thus a need for proactive approaches to ensure timely
availability of medical countermeasures during disease outbreaks is anticipated. The conduct
of perpetual adaptive platform trials, with the in-built agility to pivot when an epidemic
strikes, is key to be prepared for infectious disease epidemics or pandemics.
This topic aims to provide funding to adaptive clinical platform trials that may be
implemented routinely outside of an epidemic or pandemic context, but that are designed to
be ready for the timely assessment of novel diagnostics, therapeutics or vaccines in the face of
an epidemic or pandemic.
Proposals should develop the wide range of elements needed to sustain multi-country adaptive
platform trials, including the trial implementation capacity, laboratory analysis capacity, and a
harmonised approach to the collection, storage, sharing and analysis of FAIR163
data.
Proposals should ensure timely engagement with regulatory authorities and bodies. Proposals
should consider the European regulatory environment and take full use of the European
capacity to deliver quality trials, including the possibility for registration of new medical
products. Proposals should strengthen the leading role of the EU in clinical research
preparedness for future epidemics and pandemics.
The proposals should address the following areas:
 Development of robust clinical evidence that contributes to the knowledge base for the
diagnosis, treatment and prevention of infectious diseases. Sex, gender, age, ethnicity
and socio-economic factors should be taken into account.
 Known hurdles related to ethical, administrative, regulatory, legal and logistical aspects
should be anticipated and addressed to the extent possible, in order to avoid such barriers
when the trial needs to pivot in response to an epidemic or pandemic.
163
See definition of FAIR data in the introduction to this work programme part.
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 Engagement with clinical researchers and biostatisticians, to increase capacity for the
design and implementation of adaptive platform trials across Europe.
Collaboration and coordination with existing adaptive platform trials in the EU is expected,
where relevant, as well as with the coordination mechanisms established under topic
HORIZON-HLTH-2023-DISEASE- 3.05 and with the European Medicines Agency (EMA).
Collaboration and coordination with other organisations and other regional and global
initiatives, such as Global Health EDCTP3 Joint Undertaking 164
, the Global Research
Collaboration for Infectious Disease Preparedness (GloPID-R)165
, the European Pandemic
Preparedness Partnership and the European Health Preparedness and Emergency Response
Authority (HERA) should be envisaged. International cooperation is encouraged.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
Applicants invited to the second stage and envisaging to include clinical studies should
provide details of their clinical studies in the dedicated annex using the template provided in
the submission system. See definition of clinical studies in the introduction to this work
programme part.
HORIZON-HLTH-2024-DISEASE-03-13-two-stage: Validation of fluid-derived
biomarkers for the prediction and prevention of brain disorders
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
6.00 and 8.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 25.00 million.
Type of Action Research and Innovation Actions
Admissibility
conditions
The conditions are described in General Annex A. The following
exceptions apply:
Applicants submitting a proposal under the blind evaluation pilot (see
General Annex F) must not disclose their organisation names,
acronyms, logos, nor names of personnel in Part B of their first stage
application (see General Annex E).
164
https://ec.europa.eu/info/research-and-innovation/research-area/health-research-and-
innovation/edctp_en
165
https://www.glopid-r.org/
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Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following
exceptions apply:
For the second stage, the thresholds for each criterion will be 4
(Excellence), 4 (Impact) and 3 (Implementation). The cumulative
threshold will be 12.
Procedure The procedure is described in General Annex F. The following
exceptions apply:
This topic is part of the blind evaluation pilot under which first stage
proposals will be evaluated blindly.
Legal and financial
set-up of the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
Eligible costs will take the form of a lump sum as defined in the
Decision of 7 July 2021 authorising the use of lump sum contributions
under the Horizon Europe Programme – the Framework Programme for
Research and Innovation (2021-2027) – and in actions under the
Research and Training Programme of the European Atomic Energy
Community (2021-2025). 166
.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to most of the following expected outcomes:
 The scientific and clinical communities make effective use of state-of-the-art
information, data, technologies, tools and best practices to underpin the development of
the diagnostics, and as such can also facilitate the development of effective therapeutics
and/or preventive strategies.
 The scientific and clinical communities advance the field through a better understanding
of mechanisms underlying brain disorders at the molecular, cellular and systemic level.
 The scientific and clinical community make wide use of newly established and where
relevant open access databases and/or integrate them with existing infrastructures for
166
This decision is available on the Funding and Tenders Portal, in the reference documents section for
Horizon Europe, under ‘Simplified costs decisions’ or through this link:
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-
decision_he_en.pdf
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storage and sharing of collected data according to FAIR 167
principles, thereby
encouraging further use of the data.
 Policymakers, funders, scientific and clinical communities, patient organisations,
regulators and other relevant bodies are informed of the research advances made, while
health professionals envisage use of the biomarker tests for early detection of the
disorder and for guiding patients in the selection of personalised
treatments/interventions.
 Patients and caregivers are sufficiently engaged with the research, which also caters for
their needs.
Scope: Treatments for some high-burden brain disorders are potentially on the horizon168
.
Consequently, many patients and citizens will want to know if they are eligible for these
treatments. For some disorders, a definitive diagnosis is difficult, expensive and timeconsuming.
Simple blood or other fluid-derived (e.g. saliva, urine, sweat) tests for markers
that may indicate early signs of the disorder, and which can be deployed for widespread
clinical use are needed.
The brain disorders within the scope of this topic fall under two categories, namely those
listed under chapters six and eight of the International Classification of Diseases169
. Proposals
in the area of mental disorders are encouraged.
Proposals should address all of the following aspects:
 Proposals should aim to validate biomarkers that can reliably confirm early stages of the
human brain disorder and guide treatment/ intervention selection170
.
 Proposals should aim to provide evidence supporting the regulatory acceptance of the
biomarkers171
.
 Exploitation of existing data, biobanks, registries and cohorts is expected, together with
the generation of new key data.
 Inclusion of patients or patient organisations in the research is strongly encouraged, as to
ensure that their views are considered.
 Sex and gender aspects, age, socio-economic, lifestyle and behavioural factors should be
taken into consideration in the study.
167
See definition of FAIR data in the introduction to this work programme part.
168
For example, the Nature news feature (March, 2022): Could drugs prevent Alzheimer’s? These trials
aim to find out. doi: https://doi.org/10.1038/d41586-022-00651-0
169
International Classification of Diseases 11th
Revision (ICD-11), developed by the World Health
Organization (WHO); Chapter 6: ‘Mental, behavioural or neurodevelopmental disorders’; Chapter 8:
‘Diseases of the nervous system’.
170
The biomarker should link to a clinical meaningful endpoint.
171
The European Medicines Agency (EMA) offers scientific advice to support the qualification of
innovative development methods for a specific intended use in the context of research and development
into pharmaceuticals.
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 To enable sharing of samples, quality data and advanced analytical and digital tools,
consideration should be made for using infrastructures already developed at the
European172
or national level.
 To enable the management of brain disorders, consideration should be made in
demonstrating the gained cost efficiency.
 SME participation is encouraged.
Applicants invited to the second stage and envisaging to include clinical studies should
provide details of their clinical studies in the dedicated annex using the template provided in
the submission system. See definition of clinical studies in the introduction to this work
programme part.
HORIZON-HLTH-2024-DISEASE-03-14-two-stage: Tackling high-burden for patients,
under-researched medical conditions
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
6.00 and 7.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 25.00 million.
Type of Action Research and Innovation Actions
Admissibility
conditions
The conditions are described in General Annex A. The following
exceptions apply:
Applicants submitting a proposal under the blind evaluation pilot (see
General Annex F) must not disclose their organisation names,
acronyms, logos, nor names of personnel in Part B of their first stage
application (see General Annex E).
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following
exceptions apply:
172
EU-supported infrastructures include, for example, the BBMRI-ERIC infrastructure for biobanking, the
EBRAINS research infrastructure, and various platforms developed by the Innovative Medicines
Initiative (IMI) and its successor the Innovative Health Initiative (IHI).
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For the second stage, the thresholds for each criterion will be 4
(Excellence), 4 (Impact) and 3 (Implementation). The cumulative
threshold will be 12.
Procedure The procedure is described in General Annex F. The following
exceptions apply:
This topic is part of the blind evaluation pilot under which first stage
proposals will be evaluated blindly.
Legal and financial
set-up of the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
Eligible costs will take the form of a lump sum as defined in the
Decision of 7 July 2021 authorising the use of lump sum contributions
under the Horizon Europe Programme – the Framework Programme for
Research and Innovation (2021-2027) – and in actions under the
Research and Training Programme of the European Atomic Energy
Community (2021-2025). 173
.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to most of the following expected outcomes:
 The scientific and clinical communities make effective use of state-of-the-art
information, data, technologies, tools and best practices to better understand the
condition, underpinning the development of diagnostics, therapeutics and/or preventive
strategies.
 The scientific and clinical community exchange data, knowledge and best practices,
thereby strengthening their collaboration and building knowledge and care networks in
Europe and beyond.
 The scientific and clinical community make wide use of newly established and where
relevant open access databases and/or integrate them with existing infrastructures for
storage and sharing of collected data according to FAIR 174
principles, thereby
encouraging further use of the data.
 Policymakers and funders are informed of the research advances made and consider
further support in light of the sustainability of the studies.
173
This decision is available on the Funding and Tenders Portal, in the reference documents section for
Horizon Europe, under ‘Simplified costs decisions’ or through this link:
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-
decision_he_en.pdf
174
See definition of FAIR data in the introduction to this work programme part.
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 Patients and caregivers are constructively engaged with the research, which also caters
for their needs.
 Health professionals have access to and use improved clinical guidelines on diagnosis
and/or treatment of the condition.
Scope: A number of medical conditions fail to be recognised and/or be correctly diagnosed in
a significant proportion of patients. As a consequence they are inadequately treated and often
can become a chronic burden for the patient. These medical conditions 175
may be
insufficiently researched even though they manifest with high prevalence176, 177
. This topic
excludes rare diseases.
Proposals should address all of the following aspects:
 Proposals should address the gaps in robust, scientific evidence for improved policies
and practices to tackle such medical condition(s), and aim at identifying the
pathophysiological mechanism(s) (e.g. genetic, cellular and molecular) and potential risk
factors (e.g. psychological and environmental) of the medical condition(s) through basic,
pre-clinical and/or clinical research. These efforts should underpin the development of
diagnostics, therapeutics, and/or preventive strategies for the condition.
 Proposals should demonstrate that the medical condition(s) under study is/are
insufficiently understood, inaccurately diagnosed or inadequately treated in a significant
proportion of patients, and as such represent a high burden for patients and society. This
could be through referencing key literature.
 Sex and gender aspects, age, ethnicity, socio-economic, lifestyle and behavioural factors
should be taken into consideration. In addition, the emotional and societal long-term
effects of these chronic disorders for the affected individuals should be addressed.
 Where applicable, the development of biomarkers and other technologies for diagnosis,
monitoring in patients, and stratification of patient groups should be considered.
 Where applicable, the development of clinically relevant, (non-)human model systems
that can complement clinical investigations should be considered.
 Exploitation of existing data, biobanks, registries and cohorts is expected, together with
the generation of new (e.g. genomics, epigenomics, transcriptomics, proteomics) data.
175
High-burden medical conditions could for instance include those that are either life-threatening or lead
to chronic invalidity or a severely reduced quality of life.
176
Examples of medical conditions include Lyme disease, Chronic Fatigue Syndrome and back pain.
177
The European Commission is commissioning an independent scoping study to help identify underresearched
high-burden medical conditions and define the type of research and/or research priorities to
better address the different needs of patients with these conditions.
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 To enable sharing of samples, quality data and advanced analytical tools, it is
encouraged to make use of existing infrastructures developed at the European178
or
national level.
 Inclusion of patients or patient organisations in the research is strongly encouraged, to
ensure that their views are considered.
 SME participation is strongly encouraged.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
Applicants invited to the second stage and envisaging to include clinical studies should
provide details of their clinical studies in the dedicated annex using the template provided in
the submission system. See definition of clinical studies in the introduction to this work
programme part.
Call - Tackling diseases (Single stage - 2024)
HORIZON-HLTH-2024-DISEASE-08
Conditions for the Call
Indicative budget(s)179
Topics Type
of
Action
Budgets
(EUR
million)
Expected EU
contribution per
project (EUR
million)180
Indicative
number
of
projects
expected
to be
funded
2024
Opening: 26 Oct 2023
Deadline(s): 11 Apr 2024
178
A variety of infrastructures have been developed at European level and include, for example, the
BBMRI-ERIC research infrastructure for biobanking, while others are being developed like the
‘Federated European infrastructure for genomics data’.
179
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
180
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
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HORIZON-HLTH-2024-DISEASE-08-12 CSA 2.00 Around 2.00 1
HORIZON-HLTH-2024-DISEASE-08-20 RIA 50.00 7.00 to 8.00 5
Overall indicative budget 52.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2024-DISEASE-08-12: Pandemic preparedness and response:
Maintaining the European partnership for pandemic preparedness
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of around EUR 2.00
million would allow these outcomes to be addressed appropriately.
Nonetheless, this does not preclude submission and selection of a
proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 2.00 million.
Type of Action Coordination and Support Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
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programmes to European researchers, legal entities established in the
United States of America may exceptionally participate as a beneficiary
or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU
Member State or Associated Country.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to all of the following expected outcomes:
 Research funders, policymakers and the research community maintain a consolidated
research and innovation framework for the European partnership for pandemic
preparedness, including the Partnership’s objectives, governance and ways of
working/operationalisation;
 Research funders, policymakers and the research community are aligned towards
common objectives and have a common understanding of the long-term Strategic
Research and Innovation Agenda for the Partnership;
 European research funders are supported by a dynamic and efficient secretariat in their
coordination efforts for pandemic preparedness research;
 Healthcare providers, European and international stakeholders engage with the
appropriate partners through the research and innovation framework for the partnership.
Scope: The COVID-19 pandemic illustrated how unilateral research initiatives may lead to a
fragmented research landscape, with substantial room for efficiency gains in the development
of the highly needed evidence to guide policy actions when facing an emergency. The
European partnership for pandemic preparedness is working to improve the EU’s
preparedness to predict and respond to emerging infectious health threats by better
coordinating funding for research and innovation at EU, national (and regional) level towards
common objectives and an agreed Strategic Research and Innovation Agenda. Such a
partnership contributes to building a coherent European Research Area (ERA), enabling
Member States, Associated Countries and the European Commission to rapidly and jointly
support research and innovation in pandemic preparedness.
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The Partnership is expected to continue to build on existing pandemic preparedness networks
and research infrastructures181
, and work in synergy with the Health Emergency Preparedness
and Response Authority (HERA).
Proposals should foresee administrative and technical support through a secretariat to
maintain and support the European partnership on pandemic preparedness.
Proposals should include all of the following activities:
 Provide an efficient secretariat for the European partnership for pandemic preparedness
 Provide administrative and organisational support to the Members in the European
partnership for pandemic preparedness;
 Provide strong scientific support on topics requested by the GloPID-R Chairs, scientific
advisors or (working) groups;
 Actively engage with relevant stakeholders and initiatives in the area of pandemic
preparedness, ensuring collaboration and coordination, and avoiding duplication; e.g. the
Global Health EDCTP3 Joint Undertaking, GloPID-R, WHO R&D blueprint, ACTAccelerator,
etc.;
 Implement strong communication and dissemination activities at EU level and in
Member States and Associated Countries, on the purpose, activities and outputs of the
European partnership for pandemic preparedness, both outside and during
epidemic/pandemic episodes;
 Establish coordination and collaboration with relevant initiatives related to pandemic
preparedness such as HERA to ensure complementarity and avoid overlaps;
 As relevant, apply a cross-cutting, interdisciplinary One Health approach;
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
HORIZON-HLTH-2024-DISEASE-08-20: Pandemic preparedness and response: Hostpathogen
interactions of infectious diseases with epidemic potential
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 7.00
and 8.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
181
European Research Infrastructures | European Commission (europa.eu), BY-COVID (https://bycovid.org/),
ISIDORe (https://isidore-project.eu/) and PHIRI (https://www.phiri.eu/)
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selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 50.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
The Joint Research Centre (JRC) may participate as member of the
consortium selected for funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to all of the following expected outcomes:
 The scientific and clinical communities have an increased knowledge on viruses with
epidemic potential and in particular a better understanding of pathogen–host interactions
for the targeted development of vaccines and inhibitors for the prevention of viral
infection and the viral transmission during pathogenesis.
 The scientific and clinical communities have access to novel approaches for the
prevention and treatment for emerging and re-emerging infections in the context of
epidemic and pandemic preparedness.
 The scientific and clinical communities have access to experimental vaccine candidates
and candidates that inhibit cellular uptake of viruses against emerging or re-emerging
viral infections for further clinical investigation.
A diverse and robust development pipeline of vaccine candidates and candidates that inhibit
cellular uptake of viruses is available to fight emerging and re-emerging viral infections,
increasing therapeutic options for clinical deployment in case of an epidemic or pandemic.
Scope: As shown by the COVID-19 pandemic, infectious diseases remain a major threat to
health and health security in the EU and globally. Viral disease emergence is expected to
accelerate due to among other factors, climate change, and thus a proactive approach to the
development of vaccines and inhibitors for the cellular uptake of viruses in preparedness for
future infectious disease outbreaks is needed. The availability of vaccines and candidates that
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inhibit cellular uptake of viruses would provide a critical preparedness measure against future
health threats, in particular against pathogens with high pandemic potential meeting the
criteria identified by the Health Emergency Preparedness and Response Authority (HERA)182
.
Proposals should follow innovative approaches to characterise host-pathogen interactions with
a view to inhibit viral replication, viral proteases, viral exit strategies and to develop
therapeutic antibodies and vaccines that target viruses with high epidemic or pandemic
potential for the EU. Proposals should focus on the following viruses: Hendra and Nipah
virus, Lassa virus, Crimean Congo haemorrhagic fever virus, Rift Valley fever virus, Ebola
and Marburg virus, Dengue virus, Yellow Fever virus, Zika virus, West Nile fever virus and
Chikungunya virus. Proposal should take into account sex and gender aspects.
Proposals should aim to diversify and accelerate the global therapeutic research and
development pipeline for emerging and re-emerging viral infections, and to strengthen the
current leading role of the EU in therapeutic research and development, and therefore
contributing to the work of the European Health Emergency Preparedness and Response
Authority (HERA).
Proposals should address several of the following areas:
 Identification and characterisation of receptors on the host cell that enable the docking
and internalisation of a virus with a particular emphasis on the diversity of cellular entry
receptors and tissue specificity.
 Identification and characterisation of viral surface proteins that are capable of interacting
with host target cells.
 Characterisation of the mechanism of viral uptake in the host cell with regard to the
topology and the dynamics of the host receptor – virus ligand interaction.
 Identification of receptor and ligand (sub)units that could be targeted by preventive or
therapeutic intervention.
Proposals could consider the inclusion of the European Commission's Joint Research Centre
(JRC) research infrastructure (Nanobiotechnology laboratory) for biophysical characterisation
of recombinant proteins, antigens and therapeutic antibodies, and its expertise at the interface
between the research activities and regulatory aspects. In that respect, the JRC will consider
collaborating with any successful proposal and this collaboration, when relevant, should be
established after the proposal’s approval.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
182
https://health.ec.europa.eu/system/files/2022-07/hera_factsheet_health-threat_mcm.pdf
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Call - Partnerships in Health (2024)
HORIZON-HLTH-2024-DISEASE-09
Conditions for the Call
Indicative budget(s)183
Topics Type of
Action
Budgets
(EUR
million)
Expected EU
contribution
per project
(EUR
million)184
Indicative
number
of
projects
expected
to be
funded
2024
Opening: 26 Oct 2023
Deadline(s): 11 Apr 2024
HORIZON-HLTH-2024-DISEASE-09-01 COFUND 100.00 Around
100.00
1
Overall indicative budget 100.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
183
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
184
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
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Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2024-DISEASE-09-01: European Partnership: One Health AntiMicrobial
Resistance
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of around EUR
100.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 100.00 million.
Type of Action Programme Co-fund Action
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding. Because
the US contribution will be considered for the calculation of the EU
contribution to the partnership, the concerned consortium of research
funders from eligible EU Members States and Associated Countries
must expressly agree to this participation.
Award criteria The criteria are described in General Annex D. The following
exceptions apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and
3 (Implementation). The cumulative threshold will be 12.
Legal and
financial set-up of
the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
Beneficiaries may provide financial support to third parties. The support
to third parties can only be provided in the form of grants. Financial
support provided by the participants to third parties is one of the primary
activities of the action in order to be able to achieve its objectives.
Given the type of action and its level of ambition, the maximum amount
to be granted to each third party is EUR 10.00 million.
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The funding rate is 30% of the eligible costs.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 3 “Tackling diseases and reducing disease
burden”. To that end, proposals under this topic should aim for delivering results that are
directed, tailored towards and contributing to all of the following expected outcomes:
 The EU’s response to curb antimicrobial resistance (AMR) is improved and the EU is
reinforced as an internationally recognised driver of research and innovation on AMR
thereby substantially contributing to the achievement of the Sustainable Development
Goals related to AMR;
 EU and national agencies, the scientific communities, policymakers and funders enhance
their collaboration and coordination for a strengthened ‘One Health (OH) approach to
fight antimicrobial resistance (AMR)’ forming a strong and structured ecosystem with
shared evidence, tools and methodologies cutting across sectors;
 Research funders, policymakers, relevant agencies and authorities, and the research
community are in a position to close the current gaps and break existing silos on AMR in
accordance with the European One Health Action Plan against AMR185
;
 Research funders align, adopt and implement their research policies and activities
allowing for the optimal generation of novel solutions to prevent and treat infectious
diseases affected by AMR, improved surveillance and diagnosis and control of the
spread of resistant microorganisms, testing and validation of such solutions and
facilitating their uptake or implementation responding to the needs to reduce the burden
of AMR;
 The EU is strengthened as an internationally recognised actor for OH AMR substantially
contributing to global cooperation and coordination by expanding beyond Europe;
 The research community at large benefit from and use an improved comprehensive
knowledge framework integrating the EU, national/regional data and information
infrastructures to improve transnational research.
Scope: The partnership should contribute to the priorities set in the European One Health
Action plan to fight AMR that provides a European framework with actions focused on areas
with the highest added value for Member States, including boosting research development and
innovation.
In this, the European partnership on One Health AMR should allow coordinating, aligning of
activities and funding among countries in the EU and beyond, as well as facilitating national
coherence between different services/ministries with responsibility for the various aspects of
AMR and sectors involved (e.g. human and animal health, agriculture, environment,
innovation).
185
https://ec.europa.eu/health/system/files/2020-01/amr_2017_action-plan_0.pdf
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This partnership should also contribute to achieving the objectives of the Pharmaceutical
Strategy for Europe186
, in terms of fulfilling unmet medical needs on AMR and ensuring that
the benefits of innovation reach patients in the EU, and support the objectives of the new
EU4Health Programme 187
, as well as supporting the objectives of the Farm to Fork
Strategy188
.
Thanks to its capacity to bring together different stakeholders (e.g. research funders, health
authorities, citizens, healthcare institutions, innovators, policymakers), the Partnership will
create a critical mass of resources and implement a long-term Strategic Research and
Innovation Agenda (SRIA).
The co-funded European Partnership on One Health antimicrobial resistance should be
implemented through a joint programme of activities ranging from coordinating transnational
research efforts to other activities such as coordination and networking activities, capacity
building programmes, brokerage and mobility programmes, work on research infrastructures
and resources, including training and dissemination activities.
The implementation of the future European Partnership for OH AMR should contribute to
build a European Research and Innovation Area (ERA) to rapidly and jointly support research
and innovation in the fight against AMR.
It should be structured along the following 3 main objectives:
1. Collaboration and alignment of Research and Innovation agendas on OH AMR
The Partnership should mobilise and link key AMR stakeholders, encompassing the human,
veterinary, agricultural and environmental disciplines and including a broad spectrum of
pathogens, bacteria, fungi, parasites and viruses, through a cross-cutting, interdisciplinary one
health approach. It should provide a framework to close the current knowledge gaps and break
existing silos in the AMR research landscape, facilitating the integration of national and
international scientific and policy communities with industry and the civil society.
For this, the partnership could support, although no limited to, the following activities:
 Joint strategic programming and global coordination of research and innovation through
an agreed One Health AMR SRIA (covering the scientific areas Therapeutics,
Surveillance, Diagnostics, Transmission, Prevention and Intervention, environment and
social behavioural science).
 Target research and innovation efforts to actual needs (challenge-driven) of
policymakers and stakeholders.
 Create a transnational system that supports collaboration between EU, MS and
international initiatives.
186
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0761
187
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.107.01.0001.01.ENG
188
https://food.ec.europa.eu/horizontal-topics/farm-fork-strategy_en
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2. Boost Research and Innovation
The Partnership should strengthen the European Research Area by supporting excellence in
innovative research, capacity building, programmes for development of talent, widening the
engagement of countries and sectors not yet involved.
For this, the partnership could support, although no limited to, the following activities:
 Support excellent OH AMR research and development of new prevention methods,
interventions, treatments and diagnostics through annual joint transnational research
calls and research network calls.
 Develop new tools and instruments to support research and innovation.
 Support networking, training and mobility of researchers.
 Facilitate sharing and use of data and research infrastructure.
3. Develop solutions
 Facilitate translation of scientific knowledge into innovative solutions.
 Connect, merge and align dissemination of outputs with other initiatives to support
evidence-based policy in whole One Health domain.
 Societal engagement by bridging science to society creating awareness of AMR
challenges, value creation, support the wellbeing of citizens and sustainability of the
environment.
The partnership should also:
Strengthen the OH AMR ecosystem with integrating activities engaging key actors for AMR
encompassing the field of human, veterinary and environmental disciplines and the broad
spectrum of pathogens, including fungi and viruses.
Implement collaborative activities with International Organisations such as the World Health
Organization (WHO), the World Animal Health Organisation (WOAH), the Food and
Agriculture Organization (FAO), United Nations Environmental Programme (UNEP), the G7
and G20 fora, and the global AMR R&D Hub, with the aim to avoid duplication of efforts.
International cooperation is encouraged also with low- and middle-income countries where
AMR is highly prevalent and prone to spread to Europe.
Establish robust communication and effective information exchange between diverse
scientific disciplines and among multiple sectors of the society (as patients, clinicians,
veterinarians, pharmacists, food producers, pharmaceutical industry, policymakers and
researchers (including those working in the social sciences and humanities).
The Partnership’s governance structure should engage upfront the relevant actors to
coordinate, steer and frame the research and innovation activities, facilitate the use and uptake
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of the results and contribute to a science-based communication of the risk of spread of AMR.
The Partnership’s governance and operational structures should also foster a dialogue on
sustainability, beyond funding from EU research and innovation framework programmes.
The governance should involve key stakeholders, including but not limited to the research and
innovation community, patients and citizens, health and care professionals, and innovation
owners.
The Partnership is open to all EU Member States, as well as to countries associated to
Horizon Europe and will remain open to third countries wishing to join.
The Partnership should build on, be complementary to and go beyond the existing initiative
JPIAMR189
.
To ensure coherence and complementarity of activities and leverage knowledge and
investment possibilities, the Partnership is expected to establish relevant collaborations with
other Horizon Europe partnerships (institutionalised and co-funded, such as the future Animal
Health and Welfare partnership190
) and missions as set out in the working document on
‘Coherence and Synergies of candidate European partnerships under Horizon Europe’191
as
well as to explore collaborations with other relevant activities at EU and international level.
The proposals should also consider synergies with EU programmes, including but not limited
to EU4Health. The Partnership should align with EU-wide initiatives on open access and
FAIR data192
.
Cooperation with international organisations, private sector and non-European institutions and
experts may be considered. Participation of third countries is encouraged. Their commitments
to the Partnership would not be eligible for the calculation of EU funding. Applicants should
describe in their proposal the methodology for their collaboration and the aims they want to
achieve with this kind of collaboration.
Proposals should pool the necessary financial resources from the participating national (or
regional) research programmes with a view to implementing joint calls for transnational
proposals resulting in grants to third parties. Financial support provided by the participants to
third parties is one of the activities of this action in order to be able to achieve its objectives.
When defining calls for proposals, this Partnership needs to consider if to require the effective
contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH
experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce
meaningful and significant effects enhancing the societal impact of the related research
activities.
189
https://www.jpiamr.eu/
190
Refer to topic HORIZON-CL6-2023-FARM2FORK-01-2
191
Directorate-General for Research and Innovation, A4 Partnership Sector, October 2020:
https://ec.europa.eu/info/sites/default/files/research_and_innovation/funding/documents/ec_rtd_coheren
ce-synergies-of-ep-under-he_annex.pdf
192
See definition of FAIR data in the introduction to this work programme part.
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Destination 4. Ensuring access to innovative, sustainable and high-quality
health care
Calls for proposals under this destination are directed towards the Key Strategic Orientation
KSO-D ‘Creating a more resilient, inclusive and democratic European society’ of Horizon
Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination
should contribute to the impact areas ‘Good health and high-quality accessible health care’
and ‘A resilient EU prepared for emerging threats’, and in particular to the following
expected impact, set out in the Strategic Plan for the health cluster: ‘Health care systems
provide equal access to innovative, sustainable and high-quality health care thanks to the
development and uptake of safe, cost-effective and people-centred solutions, with a focus on
population health, health systems resilience, as well as improved evidence-based health
policies’. In addition, research and innovation supported under this destination could also
contribute to the following impact areas: ‘Climate change mitigation and adaptation’, ‘High
quality digital services for all’ and ‘A Competitive and secure data economy’.
Health systems are affected by limitations in sustainability and resilience, challenges which
have been reinforced by the COVID-19 crisis that has also revealed inequalities in access to
high-quality health care services. Our health systems need to become more effective, efficient,
accessible, fiscally and environmentally sustainable, and resilient in order to cope with public
health emergencies, to adapt to environmental challenges like climate change and to
contribute to social justice and cohesion. Therefore, the transformation and modernisation of
our health systems will be one of the biggest challenges in the economic recovery-bound
future, but it will also be a time of opportunity for generating evidence, taking advantage of
digital and data-driven innovation and developing more flexible and equitable health systems.
Under this destination, research and innovation aims at supporting health care systems in their
transformation to ensure fair access to sustainable health care services of high quality for all
citizens. Funded activities should support the development of innovative, feasible,
implementable, financially sound and scalable solutions in the various dimensions of health
care systems (e.g. governance, financing, human and physical resources, health service
provision, and patient empowerment). Ultimately, these activities should improve governance
and provide decision-makers with new evidence, methods, tools and technologies for uptake
into their health care systems and supporting health care professionals and providers and
allocating resources according to citizens’ health needs and preferences, while ensuring fiscal
and environmental sustainability to assure those needs can be met on the long-term. Funded
activities should adopt a patient-centred approach that empowers patients, promotes a culture
of dialogue and openness between citizens, patients, caregivers, health care providers and
other relevant stakeholders, and unleashes the potential for social innovation.
In this work programme, destination 4 will focus on the following issues:
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 Accelerating the development of personalised medicine in the EU and Associated
Countries, especially through a public-public cofunded partnership on personalised
medicine
 Increasing access to health and care services for patients and citizens, and especially for
people in vulnerable situations and at risk of discrimination
 Improving the resilience and mental wellbeing of the health and care workforce,
including informal carers
 Enhancing development and uptake of research and innovation in health and care
systems, including environmental transformation of the systems and contributions to the
European Green Deal.
In view of increasing the impact of EU investments under Horizon Europe, the European
Commission welcomes and supports cooperation between EU-funded projects to enable
cross-fertilisation and other synergies. This could range from networking to joint activities
such as the participation in joint workshops, the exchange of knowledge, the development and
adoption of best practices, or joint communication activities. Opportunities for potential
synergies exist between projects funded under the same topic but also between other projects
funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing
projects funded under Horizon 2020). In particular, this could involve projects related to
European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic
challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas
cutting across the health and other clusters (under pillar II of Horizon Europe). For instance,
with cluster 2 “Culture, Creativity and Inclusive Society” such as on health economics and
economic models, on cost-effectiveness, fiscal sustainability and accessibility of health care,
or on adaptation of public health systems to societal challenges (climate change,
environmental degradation, migration, demographic change, emerging epidemics and One
Health AMR) thereby contributing to building resilience; with cluster 3 “Civil Security for
Society” such as on security of health care infrastructures, incl. digital health infrastructures,
health systems preparedness and response to disasters and other emergencies, and quality and
safety of medicine (counterfeit and substandard medicine, illicit drugs, One Health AMR);
with cluster 4 “Digital, Industry and Space” such as on cybersecurity of (public) health
systems, products and infrastructures of digitalised health and care, or on health impact
assessment (e.g. related to consumer products, working place innovation); with cluster 5
“Climate, Energy and Mobility”; and cluster 6 “Food, Bioeconomy, Natural Resources,
Agriculture and Environment”.
Expected impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to
ensuring access to innovative, sustainable and high-quality health care, and more specifically
to one or several of the following impacts:
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 Health and social care services and systems have improved governance mechanisms and
are more effective, efficient, accessible, resilient, trusted and sustainable, both fiscally
and environmentally. Health promotion and disease prevention will be at their heart, by
shifting from hospital-centred to community-based, people-centred and integrated health
care structures and successfully embedding technological innovations that meet public
health needs, while patient safety and quality of services are increased.
 Health care providers are trained and equipped with the skills and competences suited
for the future needs of health care systems that are modernised, digitally transformed and
equipped with innovative tools, technologies and digital solutions for health care. They
save time and resources by integrating and applying innovative technologies, which
better involve patients in their own care, by reorganising workflows and redistributing
tasks and responsibilities throughout the health care system, and by monitoring and
analysing corresponding health care activities.
 Citizens are supported to play a key role in managing their own health care, informal
carers (including unpaid carers) are fully supported (e.g. by preventing overburdening
and economic stress) and specific needs of more vulnerable groups are recognised and
addressed. They benefit from improved access to health care services, including
financial risk protection, timely access to quality essential health care services, including
safe, effective, and affordable essential medicines and vaccines.
 Health policy and systems adopt a holistic approach (individuals, communities,
organisations, society) for the evaluation of health outcomes and value of public health
interventions, the organisation of health care, and decision-making.
The actions resulting from the calls under this destination will also create strong opportunities
for synergies with the EU4Health programme and in particular to contribute to the goals
under the general objective “protecting people in the Union from serious cross-border threats
to health and specific objective 4 “to strengthen health systems, their resilience and resource
efficiency”.
The following call(s) in this work programme contribute to this destination:
Call Budgets (EUR million) Deadline(s)
2023 2024
HORIZON-HLTH-2023-
CARE-04
60.00 13 Apr 2023
HORIZON-HLTH-2023-
CARE-08
100.00 13 Apr 2023
HORIZON-HLTH-2024-
CARE-04-two-stage
30.00 19 Sep 2023 (First
Stage)
11 Apr 2024
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(Second Stage)
Overall indicative budget 160.00 30.00
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Call - Ensuring access to innovative, sustainable and high-quality health care (Single
stage - 2023)
HORIZON-HLTH-2023-CARE-04
Conditions for the Call
Indicative budget(s)193
Topics Type
of
Action
Budgets
(EUR
million)
Expected EU
contribution per
project (EUR
million)194
Indicative
number
of
projects
expected
to be
funded
2023
Opening: 12 Jan 2023
Deadline(s): 13 Apr 2023
HORIZON-HLTH-2023-CARE-04-01 RIA 20.00 195
4.00 to 6.00 4
HORIZON-HLTH-2023-CARE-04-02 RIA 20.00 196
4.00 to 6.00 4
HORIZON-HLTH-2023-CARE-04-03 RIA 20.00 197
4.00 to 6.00 4
Overall indicative budget 60.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
193
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
194
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
195
Of which EUR 11.00 million from the 'NGEU' Fund Source.
196
Of which EUR 11.00 million from the 'NGEU' Fund Source.
197
Of which EUR 11.00 million from the 'NGEU' Fund Source.
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Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2023-CARE-04-01: Maintaining access to regular health and care
services in case of cross-border emergencies
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 4.00
and 6.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 20.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 4 “Ensuring access to innovative,
sustainable and high-quality health care”. To that end, proposals under this topic should aim
for delivering results that are directed, tailored towards and contributing to several of the
following expected outcomes:
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 Decision- and policymakers have access to modelling tools and foresight studies
(including cost studies on the non-access to health and care services) on health and care
systems198
for anticipating regular199
and unplanned health and care demand during
large-scale cross-border emergencies200
.
 Decision- and policymakers and health and care providers can better facilitate and
manage access to regular health and care delivery during cross-border emergencies.
 Decision- and policymakers and health and care providers avail of management
frameworks including organisational models for handling unplanned health and care
demand linked to cross-border emergencies, while maintaining necessary regular health
and care provision.
 Health and care professionals have access to training on how to deliver regular health
and care services (including by means such as telemedicine) during cross-border health
emergencies.
 Health and care professionals, citizens and patients access advanced digital tools
enabling managed access to regular health and care services, complemented by other
modes of health and care delivery (e.g., telemedicine, self-care, prioritised care).
 Patients can be involved in the co-design and co-production of health and care delivery
models during cross-border emergencies and can benefit from better access to regular
health and care services during such periods.
 Health and care providers and health and care professionals have access to knowledge
and data on, and innovative solutions to combat, decreasing demand for regular health
and care services resulting from an ongoing emergency (e.g. patients are avoiding visits
to hospitals because they are worried about additional infections or do not want to add
extra burden on the health and care systems).
Scope: Since the outbreak of the COVID-19 pandemic, health and care systems have been
facing unprecedented challenges. Many systems were overwhelmed and fell short on
available supplies, staff, and critical infrastructure. Beyond the initial challenges posed by the
pandemic, its prolonged duration has strained health and care facilities and providers, and had
a negative impact on regular health and care provision. Disruptions in routine and non-
198
“Health and care systems” implies a broader notion than “health systems” or “healthcare systems”
notably encompassing all parts of health systems and health related parts of social care systems.
199
Regular care refers to the care that would be expected to be needed and delivered under normal
circumstances. This includes all types of morbidities (chronic diseases, mental health disorders, trauma
care etc.) and also all parts of the health and care systems (prevention, follow-up, long-term care,
primary care, both in- and out hospital care etc.), as well as related support services such as laboratories.
200
Cross-border emergency refers to an emergent situation that spreads or entails a significant risk of
spreading across the national borders of Member States and Associated Countries, and which may
necessitate coordination at Union level in order to ensure a high level of human health protection (Art.
2(1) Regulation on serious cross-border threats to health). In this topic, only emergency situations with
a high impact on health systems are included.
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emergency medical care access and delivery have been observed. It is hence timely to take
stock and identify lessons for maintaining care delivery.
Another recent emergency situation that has had a great impact on health and care systems is
the war in Ukraine and the resulting migration to bordering countries. Also under these
circumstances, it is important to have the right tools for maintaining access to regular health
and care services, while also accommodating the more urgent needs of migrants, for example.
The goal is to be better prepared for the multiple challenges faced by health and care systems
during emergencies, and ensure that necessary access to regular health and care services can
be maintained.
Proposals for research and innovation should focus on health and care systems, and actions
are expected to address several of the following:
 Analysis and evaluation of different epidemics or other emergencies response measures
in Member States and Associated Countries aimed at maintaining access to regular
health and care services. Cost studies on not maintaining access to health and care
services during cross-border emergencies.
 Development of innovative tools and models for maintaining access to regular health and
care services during cross-border emergencies – for example developing modelling and
foresight tools to assess and anticipate impact of cross-border emergencies on regular
health and care delivery; developing novel technical solutions or organisational
management models, including training, for regular care delivery in future cross-border
emergencies; demonstrating applicability of novel modelling tools, management
frameworks and organisational models in selected areas of regular health and care
services (e.g. chronic diseases, mental health disorders, trauma care).
 Development and implementation of digital tools and of effective communication
strategies based on digital health literacy studies – for example developing,
implementing and generating evidence of benefit of novel digital systems connecting
health and care professionals, citizens and patients at-scale, helping maintain access to
health and care services during emergencies (including but not limited to smart
appointment management, chronic disease self-management applications, primary care
and/or referral caseload prioritisation and management incl. triage, increasing clinical
practice efficiency, management of health care professionals’ caseload, integrated
telecare suites complemented by new computational methods such as AI/machine
learning, etc.).
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities. Interdisciplinary research is thus encouraged,
including the involvement of SSH disciplines considered essential for health and care
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planning and delivery in different social contexts and for the evaluation of health economical
aspects.
All projects funded under this topic are strongly encouraged to participate in networking and
joint activities, as appropriate. Therefore, proposals should include a budget for the attendance
to regular joint meetings and may consider covering the costs of any other potential joint
activities without the prerequisite to detail concrete joint activities at this stage. The details of
these joint activities will be defined during the grant agreement preparation phase.
Synergies should be sought with potentially complementary research initiatives, data
stewards, custodians and research infrastructures such as the European Observatory on Health
Systems and Policies, the Population Health Information Research Infrastructure, the future
European co-funded partnerships201
, such as the partnership on Transforming Health and Care
Systems (THCS), and relevant EU health policy initiatives such as the European Health Data
Space (EHDS)202
and the nascent Health Emergency Response Authority (HERA)203
.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-CARE-04-02: Resilience and mental wellbeing of the health
and care workforce
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 4.00
and 6.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 20.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
201
https://ec.europa.eu/info/research-and-innovation/funding/funding-opportunities/funding-programmes-
and-open-calls/horizon-europe/european-partnerships-horizon-europe/candidates-european-
partnerships-health_en
202
https://ec.europa.eu/health/ehealth-digital-health-and-care/european-health-data-space_en
203
COM(2021) 576 final
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The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 4 “Ensuring access to innovative,
sustainable and high-quality health care”. To that end, proposals under this topic should aim
for delivering results that are directed, tailored towards and contributing to several of the
following expected outcomes:
 Health and care workers receive support (including mental health support), access to
tools and guidance that enhances their wellbeing and ability to adapt to changing
working conditions, as a result of new technologies, new work models or unexpected
adverse events, including during public health emergencies and when under ethical
stress.
 Decision- and policymakers, employers and social partners in the health and care
sectors204
have knowledge of the specific risks for the resilience, mental health and wellbeing
of health and care professionals and informal carers. They have access to solutions
(regulatory, organisational, technological, educational, HR, health services) to prevent
and manage them, based on the integrated development of work processes and wellbeing
at work and on the study of effects of clustered work stressors on work ability and
recovery from work.
 Funders of health and care provision have access to evidence, novel approaches and
cost-effective recommendations for interventions supporting the mental health and wellbeing
of health and care workers at individual, organisation and sector levels.
 Policymakers cooperate with relevant stakeholders, including health and care
professionals associations and social partners to foster specific solutions to improve
resilience and well-being of health workers and carers including informal carers205
, and
fight the accumulation of stressors.
Scope: A resilient workforce in the health and care sectors is essential for the sustainability
and prosperity of our societies. However, careers in the health and care sector can be
physically and mentally taxing by submitting health professionals and carers to psychosocial
risks (for example heavy workload, stressful working conditions, risk of exposure to
infectious agents, precariousness, ethical stress etc.). Many health professionals and carers
also commute to work or have migrated to work in a new country. This adds to the struggle of
health and care systems to attract new people to their workforce, but also to maintain the ones
already working. A combination of factors such as changes in work organisation, budgetary
and administrative pressures faced by health and care systems, systemic shortages of health
204
“Health and care systems” implies a broader notion than “health systems” or “healthcare systems”
notably encompassing all parts of health systems and health related parts of social care systems.
205
OECD definition: “Informal carers are defined as people providing any help to older family members,
friends and people in their social network, living inside or outside of their household, who require help
with everyday tasks.”
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professionals, precarious working conditions, structural inequalities and leaps in technological
innovation may leave health and care workers with feelings of helplessness, physical or
mental vulnerability or moral injury.
Technological innovations (including digitisation, big data and artificial intelligence
applications) provide opportunities for a more efficient provision of health and care services,
and for lightening the workload of health and care workers. However, they also create new
risks, potentially affecting the mental wellbeing of the workforce. For example, new skills,
requirements, new organisational models, performance monitoring by algorithms, lack of
control or accountability in workplace decisions, ethical questions, are elements that can
increase stress and hamper the ability of health and care workers to function in their jobs on a
daily basis.
The COVID-19 pandemic has put a strain on health and care workers’ resilience and
exacerbated mental health issues that were already a problem pre-pandemic, ranging from
anxiety due to increased workload to burnout and post-traumatic stress disorder. Informal
carers suffer from similar stress, potentially caused by different factors, such as the need to
provide care which keeps them away from employment and puts them at an increased risk of
poverty. Lack of acknowledgement that one’s mental health is deteriorating, barriers to
seeking help or the stigma that still surrounds mental illness may impede people from
addressing such problems early enough. Different socio-economic groups are affected to
different extents: in emerging virus outbreaks prior to the COVID-19 pandemic lower
educational level among other things was associated with higher risk for adverse
psychological outcomes among health workers206
.
Successful proposals should address several of the following activities:
 Collect and analyse new evidence and data generation – on occupation-specific factors
building the resilience, mental health well-being of health and care workers, or informal
carers. Where appropriate, evidence should be gathered and analysed on the interplay of
such factors with non-occupation specific factors (e.g. genetic, social etc.). Where
relevant, such evidence should be target-group specific, considering variation of
challenges for professionals working in various settings (primary care, hospitals,
residential care institutions, disadvantaged geographic locations).
 Develop action-oriented recommendations to policymakers, employers, social partners
and relevant civil society organisations at the appropriate levels (EU, national, regional,
local) based on evidence generated by the proposed action. Such recommendations
should suggest (cost-)effective policy interventions or elements for further research
aiming to promote the resilience, mental health and well-being of health and care
workers. They should be based on cost-benefit studies and ex-ante evaluations of
proposed interventions.
206
https://ec.europa.eu/health/system/files/2021-10/028_mental-health_workforce_en_0.pdf
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 Develop, or identify, innovative solutions (including digitally enabled ones),
organisational models and management approaches to support health policymakers,
employers and formal or informal health and care workers in promoting resilience,
mental health and well-being in the workplace.
 Develop financing and resource allocation models to ensure access to support and mental
health services for health and care workers and informal carers.
 Carry out testing and validation activities for new or improved solutions207
improving
conditions for health and care workers or informal carers according to specific factors
influencing their mental well-being.
Proposals can identify one or more worker groups or informal carers as target of R&I
activities, based on credible scientific criteria.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, health and care professionals associations and (informal) carers
associations, in order to produce meaningful and significant effects enhancing the societal
impact of the related research activities.
All projects funded under this topic are strongly encouraged to participate in networking and
joint activities, as appropriate. Therefore, proposals should include a budget for the attendance
to regular joint meetings and may consider covering the costs of any other potential joint
activities without the prerequisite to detail concrete joint activities at this stage. The details of
these joint activities will be defined during the grant agreement preparation phase.
With women making up over 70% of EU health care professionals and employees in the care
sector and a great part of informal carers, an appropriate gender approach is essential in
research and policy interventions, to prevent or mitigate workplace inequalities and
imbalances. Researchers and policymakers should also take into account the inclusion
dimension, as a significant share of health professionals or care workers typically come from
minority groups, whether through declared or undeclared work.
Proposals should consider potential synergies and avoid overlaps with ongoing calls or
actions funded under EU or national programmes for example the future cofunded partnership
on Transforming Health and Care Systems (THCS).
Proposals are encouraged to take into account, when relevant, the EU Strategic Framework on
Health and Safety at Work (2021-2027) 208
, the report on mental health 209
and most
importantly, the recommendations and analysis presented in the Expert Panel on effective
207
Practices can be shared via the Best Practice Portal (pb-portal (europa.eu). Examples of interventions
that were initiated to tackle the mental health impact of the pandemic are also available on the pages of
the dedicated web space on that topic on the Health Policy Platform https://webgate.ec.europa.eu/hpf/
208
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021DC0323&from=EN
209
https://health.ec.europa.eu/system/files/2021-05/ev_20210510_mi_en_0.pdf
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ways of investing in health (EXPH) opinion on supporting the mental health of the health
workforce and of other essential workers.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-CARE-04-03: Environmentally sustainable and climate neutral
health and care systems
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 4.00
and 6.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 20.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 4 “Ensuring access to innovative,
sustainable and high-quality health care”. To that end, proposals under this topic should aim
for delivering results that are directed, tailored towards and contributing to all of the following
expected outcomes:
 Policy and decision makers, providers of health and care, health and care workers and
citizens have increased knowledge on how today’s health and care systems210
are not
environmentally sustainable, what the possible costs of that are (today and future) and
where improvements are possible with maintained or improved quality of care (optimal
patient safety not being jeopardised) and possible investments needed.
210
“Health and care systems” implies a broader notion than “health systems” or “healthcare systems”
notably encompassing all parts of health systems and health related parts of social care systems.
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 Policy and decision makers and providers of health and care services have access to
innovative solutions, organisational models (including financing models), and guidelines
and recommendations that reduce the pollution and carbon emissions stemming from
health and care systems, so that health and care provision can become more sustainable
and cost-effective while maintaining or improving quality of care thanks to the reduction
of energy and materials use, decreased carbon emissions, reduced waste and discharges,
and efficient resource management.
 Monitoring and reporting of carbon emissions and pollution is mainstreamed through a
life-cycle approach and with standard methods in the health and care systems.
Scope: The health care sector is responsible for 4-5% of global total carbon emissions211
, and
generates significant demands for energy and materials, as well as dangerous waste streams
that may cause air, soil and water pollution. At the same time, health and care provision
generally experiences less pressure to decarbonise and improve its circularity than other
sectors of the economy. With the European Green Deal, the EU commits to reducing net
greenhouse gas emission by at least 55% by 2030, and to reach no net emissions by 2050, and
the health and care systems are not exempt. Research and innovation can support by ensuring
a smooth transformation while maintaining or improving quality of health and care services.
Health and care systems are undergoing structural changes, for example by strengthening
primary care and community-based care, strengthening digitalisation and making sure patients
are treated or cared for at the most efficient level. This offers the possibility to connect
structural changes with an environmental transformation.
During COP26, 18 countries (including two EU Member States) have committed to cutting all
carbon emissions from their health systems over the next 10 to 30 years and during the same
period in total fifty countries (including six EU Member States) have committed to creating
climate resilient, low carbon, sustainable health systems.
In February 2022, the WHO published a report on the waste that had been generated as a
result of the COVID-19 pandemic, even more emphasising the need to improve waste
management systems of the health and care systems 212
. The report states that 30% of
healthcare facilities word-wide, and 60% in the least developed countries, are not fit to handle
the waste generated even when not taking the extra waste generated by the pandemic into
account. Not only does this pose environmental risks such as water and air pollution, but it
also poses a risk to health workers’ safety by increasing the risk of being exposed to stick
injuries, burns and pathogenic microorganisms.
Research and innovation activities under this topic should be specific to health and care
sectors. They should include cost studies when relevant (environmental impacts and benefits
to be quantified through the life cycle thinking approach (e.g. LCA/SLCA), to be effectively
implemented in line with the European Green Deal and the Zero Pollution Action Plan) and
211
https://www.thelancet.com/action/showPdf?pii=S2542-5196%2820%2930271-0
212
https://www.who.int/news/item/01-02-2022-tonnes-of-covid-19-health-care-waste-expose-urgent-need-
to-improve-waste-management-systems
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piloting research results onsite in hospitals or other care settings while generating accessible
knowledge could be included. Apart from that, successful proposals should address several of
the following:
 Research and innovative solutions for decarbonisation of hospitals and other care
providers: improvements in new and existing building stock, decarbonisation of energy
supply to premises, reduction in energy demand of hospital sites and other care facilities
(for example heating and cooling, hot water, laundry, cooking, transport systems).
 Research and innovative solutions for increased circularity of hospitals or other care
providers that integrate the zero-pollution ambition: such as solutions to reduce waste,
improved waste management practices (with a possible focus on water effluents and
Antimicrobial Resistance (AMR)), increased circularity (for example sustainable use of
linen).
 Research and innovative solutions for decarbonisation and greening of supply chains and
material inflows: reduction of single-use plastics, substitution of anaesthetic gases and
inhalers with high global warming potentials (GWPs), substitution of conventional
pharmaceuticals with green(er) alternatives, low-carbon supply chains of food, waste
reduction, management models on for example prescription of pharmaceuticals.
 Development of a framework to measure and benchmark the environmental footprint of
the health and care sectors or improving infrastructures for relevant collecting, sharing,
accessing and processing of data.
Projects with interdisciplinary teams representing the health and care sectors, and the
environmental sector or other relevant sectors are welcome.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
All projects funded under this topic are strongly encouraged to participate in networking and
joint activities, as appropriate. Therefore, proposals should include a budget for the attendance
to regular joint meetings and may consider covering the costs of any other potential joint
activities without the prerequisite to detail concrete joint activities at this stage. The details of
these joint activities will be defined during the grant agreement preparation phase.
Applicants are encouraged to consider how their proposals can contribute in the context of the
European Green Deal213
, and to take into account the principles of the Circular Economy
Action Plan214
, the Zero Pollution Action Plan215
as well as the Technical guidance on the
climate proofing of infrastructure in the period 2021-2027.
213
https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal_en
214
https://ec.europa.eu/environment/strategy/circular-economy-action-plan_en
215
https://ec.europa.eu/environment/strategy/zero-pollution-action-plan_en
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Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
Call - Partnerships in Health (2023)
HORIZON-HLTH-2023-CARE-08
Conditions for the Call
Indicative budget(s)216
Topics Type of
Action
Budgets
(EUR
million)
Expected EU
contribution per
project (EUR
million)217
Indicative
number
of
projects
expected
to be
funded
2023
Opening: 12 Jan 2023
Deadline(s): 13 Apr 2023
HORIZON-HLTH-2023-CARE-08-01 COFUND 100.00
218
Around 100.00 1
Overall indicative budget 100.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
216
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
217
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
218
Of which EUR 50.00 million from the 'NGEU' Fund Source.
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Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2023-CARE-08-01: European Partnership on Personalised Medicine
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of around EUR
100.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 100.00 million.
Type of Action Programme Co-fund Action
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding. Because
the US contribution will be considered for the calculation of the EU
contribution to the partnership, the concerned consortium of research
funders from eligible EU Members States and Associated Countries
must expressly agree to this participation.
Award criteria The criteria are described in General Annex D. The following
exceptions apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and
3 (Implementation). The cumulative threshold will be 12.
Legal and
financial set-up of
the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
The funding rate is 30% of the eligible costs.
Beneficiaries may provide financial support to third parties. The support
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to third parties can only be provided in the form of grants. Financial
support provided by the participants to third parties is one of the primary
activities of the action in order to be able to achieve its objectives.
Given the type of action and its level of ambition, the maximum amount
to be granted to each third party is EUR 10.00 million.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 4, notably “Ensuring access to innovative,
sustainable and high-quality healthcare”. To that end, proposals under this topic should aim
for delivering results that are directed, tailored towards and contributing to all of the following
expected outcomes:
 European countries and regions, along with international partners, are engaged in
enhanced collaborative research efforts for the development of innovative personalised
medicine approaches regarding prevention, diagnosis and treatment;
 Healthcare authorities, policymakers and other stakeholders develop evidence-based
strategies and policies for the uptake of personalised medicine in national or regional
healthcare systems;
 Health industries, policymakers and other stakeholders have access to efficient measures
and investments to allow swift transfer of research and innovation into market;
 Health industries and other stakeholders can accelerate the uptake of personalised
medicine through the adoption of innovative business models;
 Healthcare authorities, policymakers and other stakeholders use improved knowledge
and understanding of the health and costs benefits of personalised medicine to optimise
healthcare and make healthcare systems more sustainable;
 Healthcare providers and professionals improve health outcomes, prevent diseases and
maintain population health through the implementation of personalised medicine;
 Stronger and highly connected local/regional ecosystems of stakeholders, including
innovators, are in place and facilitate the uptake of successful innovations in
personalised medicine, thus improving healthcare outcomes and strengthening European
competitiveness;
 Citizens, patients and healthcare professionals have a better knowledge of personalised
medicine and are better involved in its implementation;
 Stakeholders cooperate better and establish a network of national and regional
knowledge hubs for personalised medicine.
Scope: Personalised medicine is a medical model using characterisation of individuals'
phenotypes and genotypes (e.g. molecular profiling, medical imaging and lifestyle data) for
tailoring the right health strategy. Personalised medicine shows great promise and has already
Horizon Europe - Work Programme 2023-2024
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led to ground-breaking developments in treatment of many diseases. Through this approach,
better health outcomes can be achieved by preventing disease and providing patient-centred
care tailored to the needs of citizens. There have been important investments in personalised
medicine over the last decades. However, producing knowledge, translating it into clinical
applications and accelerating innovation uptake are complex, time-consuming and involve
multiple stakeholders. There is a need to facilitate the uptake of health technology innovations
and ensure a rapid and effective implementation of personalised medicine on a larger scale in
Europe. To this end, the creation of a research and innovation (R&I) partnership with a focus
on personalised medicine represents a unique strategic opportunity to bring together
stakeholders, create synergies, coordinate R&I actions and leverage the efforts to accelerate
the evolution of healthcare toward personalised medicine.
The partnership should build on knowledge gained from supportive initiatives like the
International Consortium of Personalised Medicine (ICPerMed), the European Research Area
Network for Personalised Medicine (ERA-PerMed), several Coordination and Support
Actions (CSAs) funded by the EC under Horizon 2020, the one million genomes initiative as
well as with an increasing number of associated and related initiatives, research
infrastructures and capacities in Europe and beyond.
The partnership should facilitate exchange of information and good practices among
countries, provide robust guidance and tools, will network institutional stakeholders and
involve regional ecosystems. It should stimulate service, policy and organisational
innovations, as well as the integration of biomedical and technological innovations for the
benefit of the European citizens and the European industry. The partnership should bring
together a broad range of actors with a common vision of future personalised medicine.
Through the objectives of Horizon Europe, the partnership should contribute to achieving the
following European Commission priorities:
 Promoting our European way of life
 An economy that works for people
 A Europe fit for the digital age
 A European green deal
The partnership will also contribute to priorities of the “Communication on effective,
accessible and resilient health systems” (COM(2014) 215 final), the “Communication on
enabling the digital transformation of health and care in the Digital Single Market;
empowering citizens and building a healthier society” (COM(2018) 233 final) and the
Europe's Beating Cancer Plan.
Thanks to its capacity to bring together different stakeholders (e.g. research funders, health
authorities, healthcare institutions, innovators, policymakers), to create a critical mass of
resources and to implement a long-term Strategic Research and Innovation Agenda (SRIA),
the partnership should address the following objectives:
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 Putting Europe at the forefront of research and innovation through the support of
multidisciplinary actions open to international cooperation;
 Establishing a European national and regional network of research and innovation
systems dedicated to personalised medicine;
 Translating basic research into clinical applications that make a difference for patients,
their families and healthcare professionals;
 Filling scientific knowledge gaps, producing evidence and developing guidance and
tools in priority areas for the development and the deployment of personalised medicine;
 Integrating big data and digital health solutions in research and personalised healthcare;
 Strengthening the European healthcare industry and accelerating the uptake of
personalised medicine solutions;
 Developing appropriate ecosystems for the implementation of successful personalised
medicine approaches and a swift uptake of relevant innovations by healthcare systems;
 Providing socio-economic evidence of the feasibility of personalised medicine
approaches for its uptake by sustainable healthcare systems;
 Improving health outcomes for citizen and patients and ensuring a wide access to
advanced personalised medicine intervention approaches to all.
The European Partnership for Personalised Medicine219
is to be implemented through a joint
programme of activities ranging from research to coordination and networking activities,
including training, demonstration, piloting and dissemination activities, to be structured along
the following main building blocks:
 Joint implementation of the SRIA;
 Joint annual calls for R&I activities, applied R&I, pilots;
 Capacity building activities;
 Activities to enhance the skills of the relevant personalised medicine workforce, and
improve citizen relevant awareness and literacy;
 Deployment activities through pilots, innovation procurement and financial support
mechanisms,
 Flanking measures.
219
More information on the planned European Partnerships is available on the Horizon Europe Webpage.
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The Partnership is open to all EU Member States, as well as to countries associated to
Horizon Europe and will remain open to third countries wanting to join. It should include the
following actors:
 Ministries in charge of R&I policy, as well as national and regional R&I and technology
funding agencies and foundations;
 Ministries in charge of health and care policy, as well as national and regional healthcare
authorities, organisations and providers.
The Partnership may also encourage engagement with other relevant Ministries and will
involve other key actors from civil society and end-users, research and innovation
community, innovation owners, healthcare systems owners/organisers and healthcare
agencies.
The Partnership’s governance structure should enable an upfront strategic steering, effective
management and coordination, daily implementation of activities and ensure the use and
uptake of the results. The governance should leave sufficient space for involving the key
stakeholders, including but not limited to R&I community, patients and citizens, healthcare
professionals, formal and informal care organisations, and innovation owners.
Financial commitments and in-kind contributions are expected to be provided for the
governance structure, the joint calls and other dedicated implementation actions and efforts
for national coordination.
To encourage national coordination and avoid an excess of grant signatories it is
recommended to limit their number to two per country. However, in duly justified cases this
number could differ, including for countries with decentralised administration to allow for
participation of regional authorities in charge of R&I policy and health and care policy.
To ensure coherence and complementarity of activities and leverage knowledge and
investment possibilities, the Partnership is expected to establish relevant collaborations with
other European partnerships and missions as set out in the working document on ‘Coherence
and Synergies of candidate European Partnerships under Horizon Europe’220
as well as to
explore collaborations with other relevant activities at EU and international level. On top of
this, the proposal should consider synergies with EU programmes, including but not limited to
EU4Health, DEP, ESF+, ERDF221
, InvestEU, RRF and TSI.
The Partnership should align with EU-wide initiatives on open access and FAIR data222
.
220
Directorate-General for Research and Innovation, A4 Partnership Sector, October 2020:
https://ec.europa.eu/info/sites/default/files/research_and_innovation/funding/documents/ec_rtd_coheren
ce-synergies-of-ep-under-he_annex.pdf
221
“Synergies between Horizon Europe and ERDF programmes (Draft Commission Notice)”
https://research-and-innovation.ec.europa.eu/news/all-research-and-innovation-news/synergies-
guidance-out-2022-07-06_en
222
See definition of FAIR data in the introduction to this work programme part.
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Cooperation with international organisations, and non-European institutions and experts
should be considered. Applicants should describe in their proposal the methodology for their
collaboration and the aims they want to achieve with this kind of collaboration.
Proposals should pool the necessary financial resources from the participating national (or
regional) research programmes with a view to implementing joint calls for transnational
proposals resulting in grants to third parties.
Call - Ensuring access to innovative, sustainable and high-quality health care (Two stage
- 2024)
HORIZON-HLTH-2024-CARE-04-two-stage
Conditions for the Call
Indicative budget(s)223
Topics Type
of
Action
Budgets
(EUR
million)
Expected
EU
contribution
per project
(EUR
million)224
Indicative
number
of
projects
expected
to be
funded
2024
Opening: 30 Mar 2023
Deadline(s): 19 Sep 2023 (First Stage), 11 Apr 2024 (Second Stage)
HORIZON-HLTH-2024-CARE-04-04-two-
stage
RIA 30.00 4.00 to 6.00 5
Overall indicative budget 30.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
223
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
224
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
Horizon Europe - Work Programme 2023-2024
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Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2024-CARE-04-04-two-stage: Access to health and care services for
people in vulnerable situations
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
4.00 and 6.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 30.00 million.
Type of Action Research and Innovation Actions
Admissibility
conditions
The conditions are described in General Annex A. The following
exceptions apply:
Applicants submitting a proposal under the blind evaluation pilot (see
General Annex F) must not disclose their organisation names,
acronyms, logos, nor names of personnel in Part B of their first stage
application (see General Annex E).
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following
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exceptions apply:
For the second stage, the thresholds for each criterion will be 4
(Excellence), 4 (Impact) and 3 (Implementation). The cumulative
threshold will be 12.
Procedure The procedure is described in General Annex F. The following
exceptions apply:
This topic is part of the blind evaluation pilot under which first stage
proposals will be evaluated blindly.
Legal and financial
set-up of the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
Eligible costs will take the form of a lump sum as defined in the
Decision of 7 July 2021 authorising the use of lump sum contributions
under the Horizon Europe Programme – the Framework Programme for
Research and Innovation (2021-2027) – and in actions under the
Research and Training Programme of the European Atomic Energy
Community (2021-2025). 225
.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 4 “Ensuring access to innovative,
sustainable and high-quality health care”. To that end, proposals under this topic should aim
for delivering results that are directed, tailored towards and contributing to several of the
following expected outcomes:
 Decision- and policymakers, service providers, and health and care workers have better
availability to and make use of knowledge on barriers to access to health and care
services226
experienced by people in vulnerable situations and at risk of stigma or
discrimination (from now on referred to as people in vulnerable situations)227
.
 Decision- and policymakers, providers and health and care workers have access to
innovative solutions to promote and improve access to health and care services for
people in vulnerable situations.
225
This decision is available on the Funding and Tenders Portal, in the reference documents section for
Horizon Europe, under ‘Simplified costs decisions’ or through this link:
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-
decision_he_en.pdf
226
“Health and care systems” implies a broader notion than “health systems” or “healthcare systems”
notably encompassing all parts of health systems and health related parts of social care systems.
227
Groups of people and/or patients vulnerable from a social, financial, or health perspective, or at risk of
discrimination, such as migrants, Roma people, trans and intersex people, specific age and gender
groups (that intersects with other aspects of vulnerability, such as elderly women), indigenous people,
homeless people, people in poverty or at risk of poverty, people with disabilities or patients with
complex conditions.
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 Decision- and policymakers and providers have access to reliable quantitative data on
health inequalities in access to health and care services for people in vulnerable
situations.
 People in vulnerable situations are better equipped in terms of health and digital literacy,
knowledge about their rights etc. when it comes to access to health and care services.
 People in vulnerable situations are involved in the design and implementation of
research and innovation activities concerning access to health and care services.
Scope: Equal and needs-based access to health and care services are important values of the
EU, as well as central principles within the Member States (for example 2006 Council
Conclusions on Common values and principles in European Union Health Systems, European
Pillar of social rights). At the same time, plenty of evidence indicates that there is unmet need
for health and care services. Although financial barriers are an important part of the
explanation228
, it is also evident that even in countries where co-payment is low or even zero,
access to health and care services differs between groups. Certain groups are more at risk of
not accessing all the health and care services they need, depending among other factors, on
their socio-economic and legal status, age, sex and gender identity, (dis)ability, ethnicity and
geographical location.
For example, the life expectancy for the Roma people – the largest ethnic minority in the EU
– is on average ten years shorter than the general population. This is because, due to poor
socio-economic conditions and ethnic segregation, many Roma people live in enclaves where
equal opportunities to services including infrastructure are lacking. Due to these inequalities
that are also rooted in antigypsysim229
, Roma people are facing much greater difficulties
accessing and receiving standard health and care services including prevention compared to
other citizens230
.
There are significant health inequalities between the LGBTIQ community and the population
as a whole. One part of the explanation is reluctance to seek health and care services because
they have experienced or fear hostile reactions. Trans- and intersex people still struggle to
access quality and affordable medication and care, both related to general health services and
specific health care relating to transition, such as a lack of relevant medication or surgical
procedures231
.
Compared to men, older women have a higher poverty risk also due to lower pay and lower
pensions. They face a higher risk to live longer in poorer health, so their overall need for
228
See for example OECD Health at a glance 2021.
229
Antigypsyism (a form of racism against Roma people) is a historically rooted structural phenomenon
that appears at institutional, social and interpersonal levels.
230
The EU Roma strategic framework for equality, inclusion and participation sets up the ambitious goal
to lessen the life expectancy gap and ensure that by 2030 Roma women and men live 5 years longer.
https://ec.europa.eu/info/sites/default/files/eu_roma_strategic_framework_for_equality_inclusion_and_
participation_for_2020_-_2030_0.pdf
231
stateofart_report_en.pdf (europa.eu) The Commission’s Health4LGBTI project concluded that trans and
intersex-focused research is needed that addresses health inequalities and healthcare.
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health and especially care services is therefore higher. People living in difficult socioeconomic
situations, such as homeless people or people at the risk of poverty may experience
similar issues. For migrants and refugees, uncertain legal status, fear of public authorities, or
language difficulties may cause additional barriers to seeking adequate health and care
services.
Whilst factors outside the health and care sector also have an impact on people’s access to
health and care services, health and care systems can influence and facilitate access through
accessibility, costs, referrals and attitudes.
Another aspect concerns access to data regarding certain groups. Whereas data on access to
health and care when it comes to factors related to socio-economic characteristics,
geographical barriers, sex, and age is more accessible, data on people in vulnerable situations
(often due to the problem of sensitivity of data) is often less accessible, contributing to
making the situation of these groups less visible.
Activities under this call should focus on groups that are in vulnerable situations from a
social, financial or health perspective, or at risk of discrimination, such as migrants, Roma
people, trans and intersex people, specific age and gender groups (that intersects with other
aspects of vulnerability, such as elderly women), indigenous people, homeless people, people
in poverty or at risk of poverty, people with disabilities or patients with complex conditions.
Where relevant, activities should use intersectional approaches to consider, inter alia,
socioeconomic factors, geography, citizenship, age, sex and gender identity, and ethnicity.
Next to the above-mentioned, research and innovation activities under this topic should
address several of the following:
 Different types of barriers - different barriers to study could be financial, geographic,
social, marginalisation and discrimination. When relevant, health and digital literacy
aspects should be analysed. The selection of factors should be context specific as groups
suffering from access barriers vary a lot across EU countries and at subnational level.
The principle of needs-based health and care should be taken into account.
 Access to what? – for example: what part of the health and care system (from
prevention, primary care and long-term care to tertiary care, any specific services, e.g.
mental care) do different groups have access to? Is integrated care provided for these
groups taking into account their particular needs? How much health and care services do
different groups access?
 Solutions - What measures are needed to counter inequalities in health and care access
and make sure that vulnerable groups access health and care services and that access is
based on needs (measures to educate, support and empower vulnerable groups can be
included here)? What are the costs, at different levels, to develop these solutions?
Piloting of measures could be included. Community-based and/or co-created initiatives
and peer-support approaches: what works and how can these be supported, sustained
and/or integrated in the wider service landscape.
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 Better data – improving access and quality of data will contribute to identify people in
vulnerable situations’ health needs and implement targeted measures corresponding to
the challenges that each group experiences. The data could for example explore
effectiveness of provided care (metrics helping to assess if provided care addresses the
root causes of inequalities) or new valid methodologies to identify the unmet health
related needs of people in vulnerable situations. Quantitative and qualitative data on
inequalities in prevention, prevalence and treatment of different morbidities.
 Cost analyses - The cost of inequalities in access to health and care services:
Quantitatively and/or qualitatively measure the negative impact on not taking measures
for helping people in vulnerable situations have access to health and care services
including prevention.
Proposals are expected to involve the people/groups studied in the design and implementation
of the research and innovation activities and where relevant service providers and other
stakeholders.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
All projects funded under this topic are strongly encouraged to participate in networking and
joint activities, as appropriate. Therefore, proposals should include a budget for the attendance
to regular joint meetings and may consider covering the costs of any other potential joint
activities without the prerequisite to detail concrete joint activities at this stage. The details of
these joint activities will be defined during the grant agreement preparation phase.
When relevant, funded actions should build on the work done by the European Joint Action
on Health Equity Europe (JAHEE) and the upcoming activities under the EU4Health
Programme (Direct grants to international organisations (WHO): supporting Member States in
improving access to healthcare and effectiveness of health coverage, taking into account
vulnerabilities of specific groups and targeted intervention and access to mental health for
people in vulnerable situations).
Also, when relevant, projects should build on, and are encouraged to consider how their
proposals can contribute to, the Commission’s LGBTIQ Equality Strategy 2020-2025, the EU
Strategy for the rights of persons living with disabilities, EU strategy on the rights of the child
the Child Guarantee, the Gender Equality Strategy, the EU Roma Strategic Framework and
the EU Strategy for the Rights of Persons with Disabilities 2021-2030232
.
232
(under the European Pillar of Social Rights) Delivering on the European Pillar of Social Rights Employment,
Social Affairs & Inclusion - European Commission (europa.eu) Union of equality:
Strategy for the rights of persons with disabilities 2021-2030 - Employment, Social Affairs & Inclusion
- European Commission (europa.eu) https://ec.europa.eu/social/BlobServlet?docId=23598&langId=en
Horizon Europe - Work Programme 2023-2024
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Projects are encouraged to coordinate their activities with the planned European Partnership
on Transforming Health and Care Systems, the Cancer Mission, the Cancer Inequalities
Registry and the EU Non-Communicable Diseases Initiative.
Projects may explore the Health Systems Performance Assessment (HSPA) Report on more
effective ways of measuring access to healthcare, published in 2021. The report provides a
collection of tools used on the ground to better understand needs of people in vulnerable
situations and adapt the health coverage to ensure more effective care.
2021 Country Profiles published in the framework of the State of Health in the EU can be
used as a source of basic comparable data on health inequalities.
Applicants invited to the second stage and envisaging to include clinical studies should
provide details of their clinical studies in the dedicated annex using the template provided in
the submission system. See definition of clinical studies in the introduction to this work
programme part.
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Destination 5. Unlocking the full potential of new tools, technologies and
digital solutions for a healthy society
Calls for proposals under this destination are directed towards the Key Strategic Orientation
KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital,
enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic
Plan 2021-2024. Research and innovation supported under this destination should contribute
to the impact area ‘High quality digital services for all’ and in particular to the following
expected impact, set out in the Strategic Plan for the health cluster: ‘Health technologies, new
tools and digital solutions are applied effectively thanks to their inclusive, secure and ethical
development, delivery, integration and deployment in health policies and health and care
systems’. In addition, research and innovation supported under this destination could also
contribute to the following impact areas: ‘A competitive and secure data-economy’,
‘Industrial leadership in key and emerging technologies that work for people’, and ‘Good
health and high-quality accessible health care’.
Technology is a key driver for innovation in the health care sector. It can provide better and
more cost-efficient solutions with high societal impact, tailored to the specific health care
needs of the individual. However, novel tools, therapies, technologies and digital approaches
face specific barriers and hurdles in piloting, implementing and scaling-up before reaching the
patient, encountering additional challenges such as public acceptance and trust. Emerging and
disruptive technologies offer big opportunities for transforming health care, thereby
promoting the health and well-being of citizens. Unlocking this potential and harnessing the
opportunities depends on the capacity to collect, integrate and interpret large amounts of data,
as well as ensure compatibility with appropriate regulatory frameworks and infrastructures
that will both safeguard the rights of the individual and of society and stimulate innovation to
develop impactful solutions. In addition to existing European Research Infrastructures, the
European Health Data Space will promote health-data exchange and facilitate cross-border
research activities. Moreover, the European Health Emergency Preparedness and Response
Authority (HERA) aims to improve to improve the EU's readiness for health emergencies by
supporting research, innovation and development of technologies and medical
countermeasures needed against potential cross-border health threats. This destination aims to
promote the development of tools, technologies and digital solutions for treatments,
medicines, medical devices and improved health outcomes, taking into consideration safety,
effectiveness, appropriateness, accessibility, comparative value-added and fiscal sustainability
as well as issues of ethical, legal and regulatory nature.
In this work programme destination 5 has a strong focus on the personalisation of health
technologies and will address the following issues:
Developing computational systems for point-of-care applications, developing and validating
computational models of physiological systems and integrating health data from different
sources, for better patient management and improved clinical outcomes;
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Fostering translational biomedical research and advancing regenerative medicine approaches
into clinical settings and manufacturing;
Preparing for potential cross-border health threats through the development of innovative in-
vitro-diagnostics;
Supporting the establishment of the European Health Data Space by designing a data quality
label.
In view of increasing the impact of EU investments under Horizon Europe, the European
Commission welcomes and supports cooperation between EU-funded projects to enable
cross-fertilisation and other synergies. This could range from networking to joint activities
such as the participation in joint workshops, the exchange of knowledge, the development and
adoption of best practices, or joint communication activities. Opportunities for potential
synergies exist between projects funded under the same topic but also between other projects
funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing
projects funded under Horizon 2020). In particular, this could involve projects related to
European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic
challenges on health, the European Innovation Ecosystems (EIE) interregional networks on
health and EIT-KIC Health (under pillar III of Horizon Europe) or in areas cutting across the
health and other clusters (under pillar II of Horizon Europe), like, for instance, with cluster 4
“Digital, Industry and Space” on digitalisation of the health sector or key enabling
technologies.
Expected Impacts
Proposals for topics under this destination should set out a credible pathway towards
unlocking the full potential of new tools, technologies and digital solutions for a healthy
society, and more specifically to several of the following expected impacts:
 Europe’s scientific and technological expertise and know-how, its capabilities for
innovation in new tools, technologies and digital solutions, and its ability to take-up,
scale-up and integrate innovation in health care is world-class.
 Citizens benefit from targeted and faster research resulting in safer, more sustainable,
efficient, cost-effective and affordable tools, technologies and digital solutions for
improved (personalised) disease prevention, diagnosis, treatment and monitoring for
better patient outcome and well-being, in particular through increasingly shared health
resources (interoperable data, infrastructure, expertise, citizen/patient driven co-
creation)233
.
 The EU gains high visibility and leadership in terms of health technology development,
including through international cooperation.
233
Commission Communication on the digital transformation of health and care; COM(2018) 233 final.
Horizon Europe - Work Programme 2023-2024
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 The burden of diseases in the EU and worldwide is reduced through the development
and integration of innovative diagnostic and therapeutic approaches, personalised
medicine approaches, digital and other people-centred solutions for health care.
 Both the productivity of health research and innovation, and the quality and outcome of
health care is improved thanks to the use of health data and innovative analytical tools,
such as artificial intelligence (AI) supported decision-making, in a secure and ethical
manner, respecting individual integrity and underpinned with public acceptance and
trust.
 Citizens trust and support the opportunities offered by innovative technologies for health
care, based on expected health outcomes and potential risks involved.
Legal entities established in China are not eligible to participate in Innovation Actions in any
capacity. Please refer to the Annex B of the General Annexes of this Work Programme for
further details.
The following call(s) in this work programme contribute to this destination:
Call Budgets (EUR million) Deadline(s)
2023 2024
HORIZON-HLTH-2023-
TOOL-05
214.00 13 Apr 2023
HORIZON-HLTH-2024-
TOOL-05-two-stage
25.00 19 Sep 2023 (First
Stage)
11 Apr 2024
(Second Stage)
HORIZON-HLTH-2024-
TOOL-11
25.00 11 Apr 2024
Overall indicative budget 214.00 50.00
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Call - Tools and technologies for a healthy society (Single stage - 2023)
HORIZON-HLTH-2023-TOOL-05
Conditions for the Call
Indicative budget(s)234
Topics Type
of
Action
Budgets
(EUR
million)
Expected EU
contribution per
project (EUR
million)235
Indicative
number
of
projects
expected
to be
funded
2023
Opening: 12 Jan 2023
Deadline(s): 13 Apr 2023
HORIZON-HLTH-2023-TOOL-05-01 RIA 50.00 236
8.00 to 10.00 5
HORIZON-HLTH-2023-TOOL-05-03 RIA 50.00 237
8.00 to 10.00 5
HORIZON-HLTH-2023-TOOL-05-04 RIA 35.00 238
8.00 to 10.00 4
HORIZON-HLTH-2023-TOOL-05-05 IA 35.00 239
8.00 to 10.00 4
HORIZON-HLTH-2023-TOOL-05-08 IA 40.00 240
5.00 to 7.00 6
HORIZON-HLTH-2023-TOOL-05-09 CSA 4.00 241
Around 4.00 1
Overall indicative budget 214.00
General conditions relating to this call
234
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
235
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
236
Of which EUR 30.00 million from the 'NGEU' Fund Source.
237
Of which EUR 30.00 million from the 'NGEU' Fund Source.
238
Of which EUR 20.69 million from the 'NGEU' Fund Source.
239
Of which EUR 20.00 million from the 'NGEU' Fund Source.
240
Of which EUR 24.00 million from the 'NGEU' Fund Source.
241
Of which EUR 2.00 million from the 'NGEU' Fund Source.
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Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2023-TOOL-05-01: Clinical trials of combined Advanced Therapy
Medicinal Products (ATMPs)
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 8.00
and 10.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 50.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
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Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 5 “Unlocking the full potential of new tools,
technologies and digital solutions for a healthy society”. To that end, proposals under this
topic should aim for delivering results that are directed towards and contributing to several of
the following Expected Outcomes:
 Healthcare providers increase their knowledge on the potential of combined ATMPs and
get access to innovative treatment options with demonstrated health benefits for unmet
medical needs;
 Developers and manufacturers of combined ATMPs obtain scientific evidence on the
proposed therapeutic approach;
 Patients benefit from new advanced therapies delivered through the combined ATMPs;
 EU companies get a better market position in the field of combined ATMPs.
Scope: The subjects of this topic are combined ATMPs (Advanced Therapy Medicinal
Products) according to the definition of the ATMP-regulation (EU 1394/2007, Article 2d).
Such combined ATMPs are composed of an ATMP and one or more medical devices or one
or more active implantable medical devices, and their cellular or tissue part must either
contain viable cells or tissues, or non-viable cells or tissues liable for exerting the primary
action on the human body.
The combined ATMPs should be more effective than current state-of-the-art solutions on the
European market owing to improved features like personalisation, accuracy, reliability and
usability and contribute to long-term sustainability (faster and affordable) of European health
systems.
Research should focus on advanced stages of clinical development with regulatory work on
the Medical Device part completed and safety studies of the combination product in an
advanced stage.
Proposals should address all of the following activities:
 Phase 2 clinical trials and above of combined ATMPs focussing on:
 technologies ready to undergo interventional clinical trials in patients/end users
assessing the usability and clinical performance, and/or
 technologies that have demonstrable safety/performance profiles and should
undergo clinical validation in view of their inclusion into guidelines for specific
clinical pathways.
 Delivery of safe and clinically validated combined ATMPs that are compliant with
current European regulatory requirements. The related regulatory work should be
considered as an essential component and the proposed work should involve
consultation/interaction with competent regulatory agencies such as the European
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Medicines Agency (EMA) or national regulatory agency. Applicants are encouraged to
seek regulatory and/or Health Technology Assessment (HTA) advice as appropriate.
The topic invites proposals that include innovative treatments for any medical condition
excluding rare diseases that are ready to be assessed for clinical efficacy (performance and
clinical benefit) in a specific indication on a big number of patient cohorts; already existing
market solutions are not in the scope of this topic.
Sex and gender aspects, age, socio-economic, lifestyle and behavioural factors and any other
non-health related individual attributes should be taken into consideration. SME participation
is strongly encouraged.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-TOOL-05-03: Integrated, multi-scale computational models of
patient patho-physiology (‘virtual twins’) for personalised disease management
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 8.00
and 10.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 50.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
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Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 5 “Unlocking the full potential of new tools,
technologies and digital solutions for a healthy society”. To that end, proposals under this
topic should aim for delivering results that are directed towards and contributing to several of
the following expected outcomes:
 Clinicians and other healthcare professionals have access to and/or use validated multiscale
computational models of individual patients for delivering optimised and costeffective
patient management strategies superior to the current standard of care.
 Healthcare professionals benefit from enhanced knowledge of complex disease onset and
progression by recourse to validated, multi-scale and multi-organ models.
 Clinicians and patients benefit from new, improved personalised diagnostics, medicinal
products, devices, and therapeutic strategies tailored to the individual patient patho-
physiology.
 Citizens and patients have access to validated ‘virtual twin’ models enabling the
integration of citizen-generated data with medical and other longitudinal health data, and
benefit from early detection of disease onset, prediction of disease progression and
treatment options, and effective disease management.
Scope: This topic will contribute to the consolidation of existing virtual twin models and
support research to move towards a more integrated human virtual twin, with the aim to
accelerate translational research towards cost-effective development of new health
technologies. Furthermore, ‘virtual twin’ patient models hold the potential of transforming
clinical processes and healthcare with longitudinal monitoring, making personalised medicine,
disease prevention and individualised patient management a reality.
Proposals are expected to contribute to the virtual human twin roadmap and ecosystem
supported under the Digital Europe Programme242
, with models aligned and interoperable
with those linked to the repository developed thereunder.
The proposals should address all of the following activities:
 Develop multi-scale and multi-organ, dynamic, interoperable, modular computational
models, capable of accurately simulating the individual patient patho-physiology,
spanning different anatomical scales, from the molecular to cell, tissue, organ and
systems level, as necessary. Proposals should be multidisciplinary and focus on groups
of communicable and/or non-communicable diseases with commonalities within the
same or across different medical domains, including co-morbidities. SME(s)
participation is encouraged with the aim to strengthen the scientific and technological
basis of SME(s) and valorise their innovations towards citizen and patient benefit.
242
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/digital-
2021-deploy-01-twins-health;callCode=DIGITAL-2021-DEPLOY-01 DIGITAL-2021-DEPLOY-01-
TWINS-HEALTH
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 Advance the state of the art in multi-scale modelling by employing diverse modelling
methodologies, including but not limited to: mechanistic modelling, artificial
intelligence, agent-based and network physiology as a means for modelling the healthy
state, disease onset, progression, treatment and recovery. Availability of the necessary
diverse data types (e.g. data from lab tests, medical imaging, wearables, sensors, medical
check-ups, mHealth devices, longitudinal health monitoring etc.) should be demonstrated
and the sex/gender dimension should be investigated.
 Integrate standardised spatiotemporal multi-scale models as a basis for developing
personalised ‘virtual twin’ models taking account of patient individual characteristics,
medical and health status history for advancing personalised disease management.
Proposals should ensure that the development of ‘virtual twin’ models is driven by the
end-users/citizens/healthcare professionals needs and their active involvement
throughout the development process. Furthermore, applicants should utilise appropriate
IT solutions for model visualisation and demonstrate their accessibility and usability for
clinical uptake.
 Validate multi-scale patient-specific models and generate evidence that results can
deliver clinically meaningful, real-world observations for the human diseases under
study. Applicants should implement proof-of-concept, feasibility studies in relevant end
user environments and/or real-world settings, and collect evidence of utility vis-à-vis
current clinical practice. Dynamic ‘virtual twin’ models and simulations as clinical
decision support tools will need be shown to improve prognosis, medical diagnosis,
treatments and health outcomes across the continuum of diseases evolution, including
co-morbidities and long-term care as appropriate. An exploitation strategy and a business
plan, including regulatory and industrial input, should be developed for accelerating
clinical and/or market uptake.
The proposals should adhere to the FAIR data243
principles and adopt data quality standards,
GDPR-compliant data sharing, access and data integration procedures based on good
practices developed by the European research infrastructures. In relation to the use and
interpretation of data, special attention should be paid to systematically assess for bias and/or
discrimination (sex/gender, ethnic, minority and vulnerable groups aspects). Proposals are
invited to consider adopting recommendations for in-silico models construction and
validation.244
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
243
See definition of FAIR data in the introduction to this work programme part.
244
ISO-paper under development “Recommendations and requirements for predictive computational
models in personalized medicine research — Part 1: Guidelines for constructing, verifying and
validating models”.
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All projects funded under this topic are strongly encouraged to participate in networking and
joint activities, as appropriate. These networking and joint activities could, for example,
involve the participation in joint workshops, the exchange of knowledge, the development and
adoption of best practices, or joint communication activities. This could also involve
networking and joint activities with projects funded under other clusters and pillars of
Horizon Europe, or other EU programmes. Therefore, proposals are expected to include a
budget for the attendance to regular joint meetings and may consider covering the costs of any
other potential joint activities without the prerequisite to detail concrete joint activities at this
stage. The details of these joint activities will be defined during the grant agreement
preparation phase. In this regard, the Commission may take on the role of facilitator for
networking and exchanges, including with relevant stakeholders.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-TOOL-05-04: Better integration and use of health-related realworld
and research data, including genomics, for improved clinical outcomes
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 8.00
and 10.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 35.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
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Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 5 “Unlocking the full potential of new tools,
technologies and digital solutions for a healthy society”. To that end, proposals under this
topic should aim for delivering results that are directed towards and contributing to most of
the following expected outcomes:
 Researchers, innovators and healthcare professionals benefit from better linkage of
health data from various sources, including genomics, based on harmonised approaches
related to data structure, format and quality, applicable across certain disease areas and
across national borders.
 Researchers, innovators, healthcare professionals and health policymakers have access to
advanced digital tools for the integration, management and analysis of various health
data re-used in a secure, cost-effective and clinically meaningful way enabling the
improvement of health outcomes.
 By linking and using effectively more data and new methods and tools, including
artificial intelligence, researchers, innovators and healthcare professionals are able to
advance our understanding of the risk factors, causes, development and optimal
treatment in disease areas where genomics integrated with other health data, spanning
from clinical to e.g. lifestyle, offer potential for novel and more comprehensive
information.
 Healthcare professionals and health policymakers benefit from data-driven solutions and
reinforced evidence base for decisions addressing health and care challenges.
 Citizens can be offered data-driven patient-focused health interventions, resulting in
improved disease prevention, diagnosis, treatment and monitoring towards better patient
outcomes and well-being.
 Citizens’ trust in the sharing and re-use of health data for research and healthcare
increases due to the application of advanced technologies and data governance
preserving data privacy and security.
Scope: Health data bear vast information potential in many disease areas, to significantly
improve the outcomes and efficiency of healthcare delivery, unlock new research and
innovation avenues, and inform public health policy across Europe. There is a huge need of
integration, use and deployment of health data from multiple sources for effectively
addressing the challenges of medical research underpinning diagnostics, therapy guidance and
implementation decisions on new therapies. Such integration requires linking data of different
types, disease areas and provenance which are scattered in repositories and databases across
Europe.
This topic aims to support proposals focusing on the integration of health data from multiple
sources (e.g. electronic health records, genomics, medical imaging, laboratory and diagnostic
results, pathogen data, public health registries and other clinical research data) by linking real-
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world and clinical research data. The data integration should be exemplified in several usecases,
i.e. well-justified groups of diseases (excluding cancer), within and/or across medical
domains, and pave the way towards improved health outcomes. At least one of those use cases
should build on the use of whole genome sequence data.
The consortium should ensure wide coverage of EU and associated countries, contributing
significantly to health data standardisation, while catering for the diversity of health data
sources.
To enhance synergies and avoid overlaps of activities, the proposals are expected to align with
and complement the relevant European initiatives, in particular the European Health Data
Space (EHDS), the 1+Million Genomes initiative (1+MG) and the European Open Science
Cloud.
The applicants have to demonstrate that the necessary data sources are, or will be, effectively,
timely and legally available for the proposed research activities.
The proposals should address all of the following activities:
 Identification of the barriers to health data integration and access as needed for the
selected use cases, and of specific existing tools, technological solutions and
coordination and standardisation agreements addressing those barriers. Issues to be
covered include semantic ontologies, data standards and formats, data quality, data
storage, management and access modalities, as well as enhanced findability of relevant
datasets through improved metadata standards and data catalogues.
 New approaches to assemble large, easily findable and lawfully accessible high-quality
datasets integrating multiple types of health data leading to improved clinical outcomes
(e.g. new care solutions, personalised disease management, advanced diagnostic tools),
taking into account data FAIRification245
and inter-operability needs.
 New techniques, support tools, mechanisms and modalities to enable GDPR compliant
access to sensitive personal data, including genomics, allowing for their re-use across
borders and integration of different types of data relevant to human health. Legal and
ethical frameworks should duly consider the heterogeneity in national and sectorial rules
and procedures for data access and re-use.
 Data management approaches for cross-border distributed data storage and processing,
enabling remote collaboration, electronic consent management, data provenance
tracking, and scalability of data management resources, ensuring data privacy and
security, and resulting in robust support to advanced, innovative clinical workflows.
Joint data governance is expected to be piloted among several clinical centres across
Europe.
245
See definition of FAIR data in the introduction to this work programme part.
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 Development of a data analytics platform applying distributed learning and artificial
intelligence approaches to query and aggregate efficiently, effectively and securely data
from multiple sources for multiple use cases (groups of diseases), to monitor patients'
health status, analyse causal inference, support diagnosis and health policymakers, and
establish recommendations for patients and other stakeholders.
The proposals should adhere to the FAIR data246
principles and build on existing and justified
tools and harmonisation efforts, such as widely used standards for encoding the different
types of health data and inter-operability for cross-sector collaborations. Also the data
collection, management and/or modelling should build on ongoing EU and international
efforts to avoid possible duplication of efforts and fragmentation. In particular, projects are
expected to take into account the legislation, if available, on the EHDS, so as to align project
activities with pertinent EHDS infrastructure efforts that provide for the secondary use of
health data as regards e.g. cross-border access to data, cross-border infrastructures, data
quality and utility labelling. The achievements of the relevant past and ongoing EU-funded
projects and initiatives, and good practices developed by the European research
infrastructures, should be duly considered and used. Close involvement of patients and endusers
is crucial to ensure that the project outcomes are relevant, widely accepted and feasible
in real-world settings.
The tools developed by the projects are expected to be widely accessible and amenable to
necessary updates after the project’s end for further use by interested parties. Datasets
generated during the project should be accessible to researchers and innovators. For example,
genomic data and linked patient level data are expected to be made accessible for secondary
use through the 1+MG data infrastructure.
This topic requires an effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, in order to produce meaningful and
significant effects enhancing the societal impact of the related research activities.
All projects funded under this topic are strongly encouraged to participate in networking and
joint activities. These networking and joint activities could, for example, involve the
participation in joint workshops, the exchange of knowledge, the development and adoption
of best practices, or joint communication activities. This could also involve networking and
joint activities with projects funded under other clusters and pillars of Horizon Europe, or
other EU programmes. Therefore, proposals are expected to include a budget for the
attendance to regular joint meetings and may consider covering the costs of any other
potential joint activities without the prerequisite to detail concrete joint activities at this stage.
The details of these joint activities will be defined during the grant agreement preparation
phase. In this regard, the Commission may take on the role of facilitator for networking and
exchanges, including with relevant stakeholders.
246
See definition of FAIR data in the introduction to this work programme part.
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Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-TOOL-05-05: Harnessing the potential of real-time data
analysis and secure Point-of-Care computing for the benefit of person-centred health
and care delivery
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 8.00
and 10.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 35.00 million.
Type of Action Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Technology
Readiness Level
Activities are expected to achieve TRL 7 by the end of the project – see
General Annex B.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 5 “Unlocking the full potential of new tools,
technologies and digital solutions for a healthy society”. To that end, proposals under this
topic should aim for delivering results that are directed towards and contributing to all of the
following expected outcomes:
 Healthcare professionals benefit from secure, highly performant Point-of-Care
computing technologies and devices able to process and analyse vast amounts of realtime
data at the point of care, combined with extended reality and visualisation
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techniques, to enable continuous monitoring and/or fast real-time health status checks in
clinical settings and workflows.
 Patients and clinicians benefit from wider access to real-time diagnosis, screening,
monitoring and treatments using novel imaging and/or robotics systems and/or Point-ofCare
devices that are seamlessly integrated in care environments and workflows.
 Quicker reaction times and improved patient safety in care settings.
 Researchers and healthcare professionals have more opportunities to use, extract value
from and contribute to the uptake of real-time health data and/or Point-of-Care
computing; existing technologies and methods are expected to progress from their
current technology readiness levels (TRL), from TRL 3-4 to at least TRL 7247
.
 Health and care settings benefit from reduced energy consumption of Point-of-Care
tools, devices and systems, and/or data analysis.
Scope: The proposals are expected to develop and test innovative tools, devices and systems
for point-of-care applications, including but not limited to robotics, photonics, bio-sensing,
artificial intelligence etc. These would provide clinicians with real-time imaging, data analysis
and interactive visual presentation for understanding and diagnosing diseases, facilitating riskassessment,
prevention, and carrying out medical interventions with improved patient safety.
The proposals should demonstrate advancement and integration of technologies from proofof-concept
to prototype demonstration in operational environment. Devices and systems
should be designed, developed and tested vis-à-vis defined use cases, based on the appropriate
involvement of clinicians and other stakeholders, ensuring they can be seamlessly integrated
into existing digital infrastructures and clinical workflows. The use cases in care settings
could include but are not limited to surgery workflows, Intensive Care Unit workflows and
integration of remote patient monitoring into clinical workflows. Data quality, integration and
interoperability, as well as issues of cybersecurity and data protection have to be addressed.
Design should take gender specificities into account. Clinical studies should be an integral
part of the work proposed, with developmental iteration steps and consultation of regulators
included as appropriate. Establishing synergies with AI Testing and Experimentation
Facilities, European Digital Innovation Hubs and other similar initiatives is encouraged.
Proposals must include a short description of initial business plan as part of the exploitation
activities.
The proposals should address all of the following activities:
 Development and clinical validation of compact, cost- and energy-efficient, extended
reality-enabled and other Point-of-Care devices and systems, with fast/real-time response
247
From proof-of-concept/technology validated in lab to at least prototype demonstration in operational
environment; the definitions used in H2020 for TRLs apply under this topic:
https://ec.europa.eu/research/participants/data/ref/h2020/other/wp/2016_2017/annexes/h2020-wp1617-
annex-g-trl_en.pdf
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times as required, reliable and capable of integration into clinical settings and
workflows.
 Development and validation of instruments, continuous monitoring systems and/or
analysis algorithms, including artificial intelligence approaches, for the analysis of
biological samples, enabling detection of biomarkers in body fluids and tissues in
clinical settings.
 Development and validation of imaging systems with a high spatial resolution down to
the cellular level allowing for immediate clinical interventions. Single imaging
modalities or the combination of different imaging modalities should be made
compatible with other imaging tools and with state-of-the-art and/or novel medical
technologies and devices, for example those used to remove tissues in precision surgery
(e.g. robotic surgery).
 Advancements in the use of Point-of-Care computing, data modelling, extended reality
and/or machine learning/AI technologies applied to diagnosis and risk assessment in
cases requiring very fast, near to real-time response times in clinical settings and
workflows. In addition, projects should showcase how distributed systems bringing
computation and storage physically close to where data is generated and used can most
effectively deliver actionable outputs for person-centred health care, contributing to
improved patient safety, in the areas of for example healthy living support, remote
patient monitoring, surgery workflows or acute care.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-TOOL-05-08: Pandemic preparedness and response: In vitro
diagnostic devices to tackle cross-border health threats
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 5.00
and 7.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 40.00 million.
Type of Action Innovation Actions
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Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
The Joint Research Centre (JRC) may participate as member of the
consortium selected for funding.
If projects use satellite-based earth observation, positioning, navigation
and/or related timing data and services, beneficiaries must make use of
Copernicus and/or Galileo/EGNOS (other data and services may
additionally be used).
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 5 “Unlocking the full potential of new tools,
technologies and digital solutions for a healthy society”. To that end, proposals under this
topic should aim for delivering results that are directed, tailored towards and contributing to
all of the following expected outcomes:
 The scientific and clinical communities, including health care providers and payers, as
well as regulators, health systems and patients benefit from innovative diagnostic
solutions that are better suited to tackle cross-border health threats.
 The scientific and clinical communities have access to novel and improved
methodologies for detection of pathogens with pandemic potential in humans and for
timely discovery of other health threats, such as chemical, radiological and nuclear
threats, including considerations on detection in animals and environmental conditions
(One Health approach).
 A diverse and robust pipeline of in vitro diagnostics248
is available, increasing options
for clinical deployment in case of an epidemic or pandemic.
Scope: As shown by the COVID-19 pandemic, infectious diseases remain a major threat to
health and health security in the EU and globally, this is also the case for other health threats
that can be linked for instance to terror attacks. New cross-border health threats are expected
to emerge in the coming years and therefore it is essential to promote advanced research of
medical countermeasures that can be used to detect, prevent and treat in case of a new health
248
As defined in Guidance on Classification Rules for in-vitro Diagnostic Medical Devices for Regulation
(EU) 2017/746 MDCG 2020-16 rev.1: https://ec.europa.eu/health/system/files/2022-
01/md_mdcg_2020_guidance_classification_ivd-md_en.pdf
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emergency. One of the most important aspects in crisis preparedness times is to ensure the
availability of diagnostics that can contribute to detecting and characterising health threats.
Proposals should develop and advance on new in vitro diagnostics relevant for detecting and
characterising cross-border health threats and develop novel approaches to the development of
medical countermeasures targeting threats identified by HERA249
.
Proposals should cover pathogens with pandemic potential in humans or other health threats,
such as chemical, radiological and nuclear threats for which there are no existing diagnostics
or where clinical practice could benefit from innovation. Emphasis should be put on the
development of new diagnostics, innovative catch-all methodologies, or on the improvement
of existing health technologies advancing diagnostics and characterisation of health threats,
applying the One Health approach when relevant.
Proposals should aim to diversify and accelerate the global diagnostic research and
development pipeline to tackle cross-border health threats, and to strengthen the current
leading role of the EU in research and development, and therefore contributing to the work of
the European Health Emergency Preparedness and Response Authority (HERA).
Attention should be paid to critical social factors such as sex, gender, age, socio-economic
factors, ethnicity/migration, and disability.
Proposals should include a clear regulatory path to market in order to ensure future
compliance with the legal requirements. Proposals should address several of the following
areas:
 Proof-of-concept/early studies linked e.g. to performance evaluation of new diagnostics
that facilitate screening, detection of the presence or exposure to a cross-border health
threat or determination of infectious/disease status through human samples, included but
not limited to the list of high impact health threats identified by HERA, as well
chemical, radiological and nuclear threats for which there is a lack of in vitro diagnostics
or existing diagnostics have a sub-optimal performance.
 Data-driven diagnostic and prognostic platforms with AI and other advanced data
analytics functionalities, adaptable to respond to new and multiple pathogens/threats, e.g.
covering prototype viruses.
 Innovative systems linked to high sensitivity/specificity profiles adaptable for broader
use should be considered, such as portable, faster, more compact or accurate devices and
technologies, including the possibility to develop point of care or self-tests.
 Innovative diagnostics sampling methods or samples bringing a significant
improvement, such as less invasive sampling methods.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
249
https://health.ec.europa.eu/system/files/2022-07/hera_factsheet_health-threat_mcm.pdf
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relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
Proposals should consider the involvement of the European Commission's Joint Research
Centre (JRC) in regard to its experience on the performance evaluation of in vitro diagnostic
devices, with respect to the value it could bring in providing an effective interface between
research activities and regulatory aspects and/or to translating research results into validated
test methods and strategies fit for regulatory purpose. In that respect, the JRC will consider
collaborating with any successful proposal and this collaboration, when relevant, should be
established after the proposal’s approval.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-TOOL-05-09: Developing a Data Quality and Utility Label for
the European Health Data Space
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of around EUR 4.00
million would allow these outcomes to be addressed appropriately.
Nonetheless, this does not preclude submission and selection of a
proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 4.00 million.
Type of Action Coordination and Support Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, legal entities established in the
United States of America may exceptionally participate as a beneficiary
or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU
Member State or Associated Country.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 5 “Unlocking the full potential of new tools,
technologies and digital solutions for a healthy society”. To that end, proposals under this
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topic should aim to deliver results that are directed towards and contributing to all of the
following expected outcomes:
 Data Users (researchers, innovators, regulators, policymakers, clinicians) are able to
identify the most relevant datasets that meet their specific needs through a label
describing accurately and in a standard way the quality and utility dimensions of the
datasets, as proposed in the legal provisions of the European Health Data Space (EHDS).
 Data holders have clear specifications for dataset quality and utility labelling to comply
with the requirements proposed in the EHDS legal provisions. In addition to that, data
holders have access to a maturity model with the requirements a dataset needs to fulfil to
achieve higher levels of data quality and utility.
 European and National public funders ensure that the datasets, for which they provided
funding for the creation and curation of, are more widely available, furthering their reuse
for secondary uses as proposed in the EHDS legal provisions (research, innovation,
regulatory work, policymaking, personalised medicine).
 The European Commission has access to a set of specifications for the data quality and
utility label supporting the implementation of the EHDS legal provisions.
Scope: A vast quantity of health datasets exist across Europe, from multiple sources
(individual care, medical registries, social, environmental behavioural, wellbeing, clinical
trials, research, administrative, etc.), and of varying quality. This represents a tremendous
opportunity for the reuse of this data for purposes other than for the one for which they were
originally collected and spur the development of better prevention strategies, diagnoses,
treatments and care plans.
The European Health Data Space (EHDS) will provide a common EU framework for
secondary use of health data such as research, innovation, regulatory purposes, policymaking
and personalised medicine. It will enable data users to have access to large amounts of health
data through health data access bodies empowered with the EHDS legal provisions to
overcome existing limitations regarding the processing of health data for secondary uses.
To support data users in the discovery and selection of datasets for their purposes, there is a
growing need to develop a data quality and utility framework to articulate the characteristics
and the potential usefulness of datasets. This framework will also support data holders in
identifying and addressing areas of improvement which can, in turn, allow for wider and
better use of these datasets.
Several initiatives have developed or are developing guidelines and recommendations for
health data quality, however, these typically focus on specific data types (i.e. 1+ Million
Genome Initiative250
) or areas of applications (i.e. European Medicines Agency – EMA and
Heads of Medicines Agencies’ Big Data Steering Group activities to support medicines
250
https://b1mg-project.eu/work-packages/wp3
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regulation251
). Similarly, previous studies and initiatives have addressed specific dimensions
of ‘data quality’ for health data but none are offering a framework suitable for the breadth of
data types and encompassing the quality and utility elements proposed in the EHDS legal
provisions. The proposed framework should take into account the various needs of data users
whilst at the same time avoid becoming an excessive burden on data holders which will need
to produce the data quality and utility label.
Proposals should address all of the following activities:
 Perform a mapping of existing data quality and utility principles/initiatives/frameworks
(i.e. EMA/HMA Big Data Stakeholders Group Data quality efforts, TEHDAS Data
Quality Working Group252
, EOSC-LIFE253
Health Data Research UK’s data quality and
utility framework254
, and relevant data principles, resources and tools (FAIR, FAIR
Cookbook, etc.)255
;
 Conduct various stakeholder consultations, integrating all relevant data users and data
holders of health data, EHDS Health Data Access Bodies (HDABs) and other relevant
actors to validate data user needs and adequately take into account relevant initiatives
when developing the proposed framework;
 Develop a framework (set of technical specifications) for the data quality and utility
label that supports the implementation of the EHDS legal provisions and the roll out of
the label by the data holders and EHDS Health Data Access Bodies;
 Pilot and evaluate the use of the proposed framework (as a label and as a maturity
model) on a datasets sample representing the wide-ranging data types (such as electronic
health records, genomics datasets, medical registries, administrative data, etc.) and
taking into account the needs of all data users identified.
 Develop recommendations for the successful implementation and adoption of the data
quality and utility label and maturity model across European Member States considering
the maturity levels regarding secondary of health data.
The consortium should be composed of representatives from data users, data holders, health
data access bodies, and other relevant stakeholders to the scope of secondary use of health
data, adequately covering the diversity of heath data types and users’ needs across European
Member States.
Call - Tools and technologies for a healthy society (Two stage - 2024)
HORIZON-HLTH-2024-TOOL-05-two-stage
251
https://www.ema.europa.eu/en/about-us/how-we-work/big-data
252
https://tehdas.eu/packages/
253
https://www.eosc-life.eu/
254
Development of a data utility framework to support effective health data curation:
https://informatics.bmj.com/content/28/1/e100303?utm_source=twitter&utm_medium=social&utm_ter
m=hootsuite&utm_content=sme&utm_campaign=usage
255
See definition of FAIR data in the introduction to this work programme part.
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Conditions for the Call
Indicative budget(s)256
Topics Type
of
Action
Budgets
(EUR
million)
Expected
EU
contribution
per project
(EUR
million)257
Indicative
number
of
projects
expected
to be
funded
2024
Opening: 30 Mar 2023
Deadline(s): 19 Sep 2023 (First Stage), 11 Apr 2024 (Second Stage)
HORIZON-HLTH-2024-TOOL-05-06-two-
stage
RIA 25.00 4.00 to 8.00 4
Overall indicative budget 25.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
256
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
257
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
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Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2024-TOOL-05-06-two-stage: Innovative non-animal human-based
tools and strategies for biomedical research
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR
4.00 and 8.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 25.00 million.
Type of Action Research and Innovation Actions
Admissibility
conditions
The conditions are described in General Annex A. The following
exceptions apply:
Applicants submitting a proposal under the blind evaluation pilot (see
General Annex F) must not disclose their organisation names,
acronyms, logos, nor names of personnel in Part B of their first stage
application (see General Annex E).
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
The Joint Research Centre (JRC) may participate as member of the
consortium selected for funding.
Award criteria The criteria are described in General Annex D. The following
exceptions apply:
For the second stage, the thresholds for each criterion will be 4
(Excellence), 4 (Impact) and 3 (Implementation). The cumulative
threshold will be 12.
Procedure The procedure is described in General Annex F. The following
exceptions apply:
This topic is part of the blind evaluation pilot under which first stage
proposals will be evaluated blindly.
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Legal and financial
set-up of the Grant
Agreements
The rules are described in General Annex G. The following exceptions
apply:
Eligible costs will take the form of a lump sum as defined in the
Decision of 7 July 2021 authorising the use of lump sum contributions
under the Horizon Europe Programme – the Framework Programme for
Research and Innovation (2021-2027) – and in actions under the
Research and Training Programme of the European Atomic Energy
Community (2021-2025). 258
.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 5 “Unlocking the full potential of new tools,
technologies and digital solutions for a healthy society”. To that end, proposals under this
topic should aim for delivering results that are directed towards and contributing to several of
the following Expected Outcomes:
 Researchers utilise tools and strategies that are more relevant to the human situation as
compared to the currently used animal models.
 Fewer live animals are used in biomedical research.
 Health technology developers will get access to improved human-relevant tools or
strategies allowing for a faster pace of innovation.
 Legislators and regulators will benefit from strengthened EU leadership in non-animal
based biomedical research that is socially accepted and sustainable.
 Healthcare providers and patients will benefit from innovative tools or strategies opening
up novel biomedical concepts enabling improved disease prediction, prevention and
treatment.
Scope: The proposal(s) should develop and/or use tools and strategies that address critical
areas of biomedical research where animal-models are currently used but are of limited
translational value for investigation and development of prevention and treatment. Such
advanced tools and strategies should aim at a better understanding of the pathogenesis of
disorders that feature a high impact on public health and exhibit a high rate of animal use or
severe animal suffering, and enable to develop biomedical concepts with increased
translational value, thereby ultimately leading to improved disease prediction, prevention and
treatment.
The proposals should address all of the following aspects:
258
This decision is available on the Funding and Tenders Portal, in the reference documents section for
Horizon Europe, under ‘Simplified costs decisions’ or through this link:
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-
decision_he_en.pdf
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 The innovative tools and strategies should include a variety of technologies and
methodological approaches such as –omics and other high-throughput procedures,
human-derived cell-based material, organoids, micro-physiological systems, and insilico
models.
 The newly proposed tools and strategies should demonstrably advance the state-of-theart
in specific areas of biomedical research.
 Prospects and avenues for dissemination, knowledge sharing, uptake or translation into
health policies of the proposed tools and strategies within the EU should be provided.
 Aspects such as harm and cost-benefit assessment as well as ease of production with
respect to current practices should also be considered.
 Criteria for model qualification and standardisation should be developed in well-justified
use-case contexts to demonstrate their translational values.
Proposals could consider the involvement of the European Commission's Joint Research
Centre (JRC) to provide added-value regarding such aspects as supporting validation of
emerging approaches, promotion of research results, and the interfacing with the regulatory
community. In this respect, the JRC is open to collaborate with any successful proposal after
the selection process has been completed.
All projects funded under this topic are strongly encouraged to participate in networking and
joint activities. These networking and joint activities could, for example, involve the
participation in joint workshops, the exchange of knowledge, the development and adoption
of best practices, or joint communication activities. Therefore, proposals are expected to
include a budget for the attendance to regular joint meetings and may consider covering the
costs of any other potential joint activities without the prerequisite to detail concrete joint
activities at this stage. The details of these joint activities will be defined during the grant
agreement preparation phase. In this regard, the Commission may take on the role of
facilitator for networking and exchanges, including with relevant stakeholders.
This topic requires the effective contribution of social sciences and humanities (SSH)
disciplines and the involvement of SSH experts, institutions as well as the inclusion of
relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.
Applicants invited to the second stage and envisaging to include clinical studies should
provide details of their clinical studies in the dedicated annex using the template provided in
the submission system. See definition of clinical studies in the introduction to this work
programme part.
Call - Tools and technologies for a healthy society (Single stage - 2024)
HORIZON-HLTH-2024-TOOL-11
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Conditions for the Call
Indicative budget(s)259
Topics Type
of
Action
Budgets
(EUR
million)
Expected EU
contribution per
project (EUR
million)260
Indicative
number
of
projects
expected
to be
funded
2024
Opening: 26 Oct 2023
Deadline(s): 11 Apr 2024
HORIZON-HLTH-2024-TOOL-11-02 RIA 25.00 6.00 to 8.00 4
Overall indicative budget 25.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant The rules are described in General Annex G.
259
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
260
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
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Agreements
Proposals are invited against the following topic(s):
HORIZON-HLTH-2024-TOOL-11-02: Bio-printing of living cells for regenerative
medicine
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 6.00
and 8.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 25.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 5 “Unlocking the full potential of new tools,
technologies and digital solutions for a healthy society”. To that end, proposals under this
topic should aim for delivering results that are directed towards and contributing to several of
the following expected Outcomes:
 Biomedical scientists will access entire bio-printing units for regenerating human tissue.
 Availability of larger-scale bio-printed tissues for biomedical research purposes to both
industry and academia.
 Healthcare professionals acquire information on the safe and effective use of advanced
therapies.
 Healthcare providers dispose of tools enabling them to treat conditions of unmet medical
need.
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 Individual patients will benefit from a personalised approach to their respective medical
condition thanks to the bio-printed regenerative medicine solution.
Scope: Regenerative medicine is a branch of translational research in tissue engineering and
molecular biology which deals with the "process of replacing, engineering or regenerating
human cells, tissues or organs to restore or establish normal function". 3D-printing in general
is considered an advanced manufacturing technique and 3D-printing of non-viable
biomaterials to serve e.g. as scaffold for cell growth or as structure for medical devices is
already broadly used.
However, bio-printing technology involving living cells is still in early stages of development,
but has a huge potential for tissue engineering, drug testing and other biomedical applications.
Tissue-specific functional 3D bio-printing is a new approach for transplantation applications
in regenerative medicine, relying on the fabrication of tissues and organs with respect to the
desired shape and function and their delivery and application in vivo. “In-situ bio-printing”
known as printing cells and biomaterials directly onto or in a patient, or 4D bio-printing,
which introduces a “time” variable that allows 3D printed materials to change shape or
function when external stimulus is applied, are recent developments facing multiple additional
challenges.
Despite some success of 3D bio-printing with thin tissue, thick tissue and complex organs
remain a bottleneck because it is difficult to sufficiently mimic their metabolic needs, and the
scientific knowledge about their intimate architecture and interplay with other tissues are not
sufficiently elucidated. Next to these limitations are a lack of standardised manufacturing
protocols and standardised bio-ink formulations with tuneable properties, unstable cellular
behaviour, material biocompatibility and printability, etc. Taken together, 3D bio-printing is
confronted with several challenges that currently hamper its large-scale deployment.
To overcome these challenges, researchers should work in multidisciplinary teams with
engineers, biomedical scientists, cell biologists and medical doctors and proposals should
address most of the following activities:
 Design the best bio-printing strategy for at least one type of tissue thanks to a better
understanding of the interconnections of the different cell types inside the chosen tissue
or organ
 Develop or improve existing equipment able to print bio-constructs with higher
resolution in a shorter time using various biomaterials and different cell types
 Cover all steps of the bio-printing suite, including cell collection, cell differentiation and
expansion, imaging, modelling, bio-ink formulation, actual bio-printing, nutrient supply,
process monitoring and cell-construct delivery at target site
 Scale-up the chosen bio-printing technology to a GMP-conform manufacturing process
 Combine different bio-printing technologies in order to obtain fully functional synthetic
constructs of complex tissues or organs.
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Regulatory knowledge of the field is desired and should be documented through contacts with
relevant national or international European regulatory authorities.
The chosen medical area (tissue, organ, condition) should be duly justified. Sex differences at
the cellular level should be taken into consideration.
Preclinical stage and early clinical development are eligible. The involvement of SMEs is
encouraged.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
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Destination 6. Maintaining an innovative, sustainable and globally
competitive health industry
Calls for proposals under this destination are directed towards the Key Strategic Orientation
KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital,
enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic
Plan 2021-2024. Research and innovation supported under this destination should contribute
to the impact area ‘A competitive and secure data-economy’ and in particular to the following
expected impact, set out in the Strategic Plan for the health cluster: ‘EU health industry is
innovative, sustainable and globally competitive thanks to improved up-take of breakthrough
technologies and innovations, which makes the EU with its Member States more resilient and
less dependent from imports with regard to the access to and supply of critical health
technologies’. In addition, research and innovation supported under this destination could also
contribute to the following impact areas: ‘Industrial leadership in key and emerging
technologies that work for people’, ‘High quality digital services for all’, and ‘Good health
and high-quality accessible health care’.
The health industry is a key driver for growth and has the capacity to provide health
technologies to the benefit of patients and providers of health care services. The relevant
value chains involve a broad variety of key players from supply, demand and regulatory sides.
In addition, the path of innovation in health is long and complex. The development of novel
health technologies is generally associated with uncertainties and market barriers due to
expensive and risky development (e.g. high attrition rate in pharmaceutical development),
high quality and security requirements (e.g. clinical performance, safety, data privacy and
cybersecurity) and market specificities (e.g. strong regulation, pricing and reimbursement
issues). In addition, the growing concern about environmental issues is putting more pressure
on this industry. Therefore, there is a need for research and innovation integrating various
stakeholders to facilitate market access of innovative health technologies (medical
technologies, pharmaceuticals, biotechnologies, digital health technologies).
In order to address these challenges, in particular green and digital transitions and proper
supply of health technologies and products, destination 6 will focus on research and
innovation activities that aim at:
 Facilitating the production of pharmaceuticals in compliance with the objectives of the
European Green Deal.
 Developing methodologies, guidelines and standards, assessment studies, and structuring
activities adapted to digital solutions and interventions for GDPR compliant translation
into health care practice, including inter-operability, cyber-security and data
confidentiality.
 Supporting public authorities with better methodologies and interdisciplinary approaches
to assess and value new health technologies and interventions.
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In view of increasing the impact of EU investments under Horizon Europe, the European
Commission welcomes and supports cooperation between EU-funded projects to enable
cross-fertilisation and other synergies. This could range from networking to joint activities
such as the participation in joint workshops, the exchange of knowledge, the development and
adoption of best practices, or joint communication activities. Opportunities for potential
synergies exist between projects funded under the same topic but also between other projects
funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing
projects funded under Horizon 2020). In particular, this could involve projects related to
European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic
challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas
cutting across the health and other clusters (under pillar II of Horizon Europe). For instance,
with cluster 4 “Digital, Industry and Space” such as on industrial research and innovation
infrastructures (pilot plants, testing and simulation facilities, open innovation hubs); additive
manufacturing and other production technologies (incl. bio manufacturing); safe, smart and
sustainable materials.
Expected Impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to
maintaining an innovative, sustainable and globally competitive health industry, and more
specifically to one or several of the following expected impacts:
 Health industry in the EU is more competitive and sustainable, assuring European
leadership in breakthrough health technologies and open strategic autonomy in essential
medical supplies and digital technologies, contributing to job creation and economic
growth, in particular with small- and medium-sized enterprises (SMEs).
 Health industry is working more efficiently along the value chain from the identification
of needs to the scale-up and take-up of solutions at national, regional or local level,
including through early engagement with patients, health care providers, health
authorities and regulators ensuring suitability and acceptance of solutions.
 European standards, including for operations involving health data, ensure patient safety
and quality of healthcare services as well as effectiveness and interoperability of health
innovation and productivity of innovators.
 Citizens, health care providers and health systems benefit from a swift uptake of
innovative health technologies and services offering significant improvements in health
outcomes, while health industry in the EU benefits from decreased time-to-market.
 Health security in the EU benefits from reliable access to key manufacturing capacity,
including timely provision of essential medical supplies of particularly complex or
critical supply and distribution chains, such as regards vaccines or medical radioisotopes.
The following call(s) in this work programme contribute to this destination:
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Call Budgets (EUR million) Deadline(s)
2023 2024
HORIZON-HLTH-2023-IND-06 56.00 13 Apr 2023
HORIZON-HLTH-2024-IND-06 12.00 11 Apr 2024
Overall indicative budget 56.00 12.00
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Call - A competitive health-related industry (Single stage - 2023)
HORIZON-HLTH-2023-IND-06
Conditions for the Call
Indicative budget(s)261
Topics Type
of
Action
Budgets
(EUR
million)
Expected EU
contribution per
project (EUR
million)262
Indicative
number
of
projects
expected
to be
funded
2023
Opening: 12 Jan 2023
Deadline(s): 13 Apr 2023
HORIZON-HLTH-2023-IND-06-01 CSA 5.00 263
Around 5.00 1
HORIZON-HLTH-2023-IND-06-02 RIA 8.00 264
3.00 to 5.00 2
HORIZON-HLTH-2023-IND-06-04 RIA 25.00 265
4.00 to 6.00 5
HORIZON-HLTH-2023-IND-06-05 CSA 3.00 266
Around 3.00 1
HORIZON-HLTH-2023-IND-06-07 RIA 15.00 267
7.00 to 8.00 2
Overall indicative budget 56.00
General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
261
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
262
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
263
Of which EUR 2.50 million from the 'NGEU' Fund Source.
264
Of which EUR 4.00 million from the 'NGEU' Fund Source.
265
Of which EUR 14.00 million from the 'NGEU' Fund Source.
266
Of which EUR 1.50 million from the 'NGEU' Fund Source.
267
Of which EUR 8.00 million from the 'NGEU' Fund Source.
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Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2023-IND-06-01: Supporting the uptake of innovative Health
Technology Assessment (HTA) methodology and advancing HTA expertise across EU
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of around EUR 5.00
million would allow these outcomes to be addressed appropriately.
Nonetheless, this does not preclude submission and selection of a
proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 5.00 million.
Type of Action Coordination and Support Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, legal entities established in the
United States of America may exceptionally participate as a beneficiary
or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU
Member State or Associated Country.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
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(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable
and globally competitive health industry”. To that end, proposals under this topic should aim
to deliver results that are directed, tailored towards and contributing to all of the following
expected outcomes:
 Identification of the most innovative HTA methods developed by EU-funded projects,
which respond to the needs of HTA bodies and are ready to be used in real-life settings.
Endorsement by HTA bodies of such innovative methods would allow for advancing
HTA methodology and improve evidence-based decision making, and patient access to
novel health technologies
 Dissemination among EU HTA bodies of robust innovative HTA methods and tools
developed by EU-funded projects.
 Harmonisation of HTA expertise across EU though the development of a training
programme developed in collaboration with academia. The training should address HTA
expertise in general, as wells as expertise in joint HTA to be carried out at EU level in
accordance with Regulation (EU) 2021/2282, based on the methodological guidelines
elaborated by the Coordination Group on HTA.
 Contribution to a successful implementation of the HTA Regulation as well as to
building an EU methodological HTA framework fit for purpose and fit for the future.
Scope: HTA bodies have the responsibility to assess the added value of new health
technologies and advise on its reimbursement and use within a healthcare system. Due to the
rapid pace at which technology advance and in order to support decision making in an
appropriate manner, HTA experts have to adapt/revise regularly their methodology. Whilst
EU-funded projects in the field of HTA have addressed some of the research needs of the
HTA bodies (e.g. methods of analysis, use of real-world data, use of patient reported
outcomes), translation of their results/recommendations into HTA work remains limited.
Advancing HTA methodology and expertise could benefit from a more systematic dialogue
between HTA bodies and academia. Therefore, this action could represent an excellent
opportunity for both those generating and those using the evidence to come together and
discuss the key HTA methodological issues.
Under the newly adopted Regulation (EU) 2021/2282, the Coordination Group on HTA will
have to adopt methodological guidelines for joint HTA work (e.g. joint clinical assessments,
joint scientific consultation), to regularly review, and where necessary update them. The
project could provide input to issues identified by the Coordination Group as important for
future updates/revisions of HTA methodology for joint HTA work.
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The topic is divided into two strands of activities, with applicants tackling both in their
proposals:
 Implementation of innovative HTA methods: EU-funded research projects (e.g.
COMED, IMPACT-HTA, HTx, GetReal, EHDEN) developed innovative methods
aiming at addressing HTA bodies’ needs. Identifying which of these methods are ready
to be used in real-life settings is a first crucial step towards broader uptake and
dissemination. Successful implementation of innovative methods in actual HTA
practices will contribute to provide a timely response to HTA challenges (e.g. use of
real-world data in HTA) also providing a sound scientific resource for updates of
methodological guidelines by the Coordination Group on HTA for joint activities as
requested by the Regulation (EU) 2021/2282. HTA bodies/agencies participating in such
activities will gain expertise in those methods that could be later transferred to other
bodies/agencies using the training framework developed in the second strand of work.
 Advancing HTA expertise across the EU and Associated Countries should be
carried out through a training programme tailored to the needs of HTA bodies, which
may include twinning activities between HTA bodies/agencies to develop expertise and
facilitate knowledge sharing among HTA bodies/agencies in the EU. The training
programme is expected to contribute to the harmonisation of HTA practices in the EU
that will in turn contribute to a greater consistency of health technology assessments
across the EU and Associated Countries. Thus, the training programme should also
support the engagement of HTA experts from Member States and EEA countries in
carrying out joint HTA work starting January 2025 (i.e. implementation date of the
Regulation on HTA), with the aim to produce high-quality and robust joint clinical
assessments. The training programme should include all the necessary elements for
carrying out robust assessments at national and EU level. Regarding the latter, the
training programme should also promote the dissemination of the methodological
guidelines to be adopted by the Coordination Group on HTA (based on the methodology
developed and fine-tuned by EUnetHTA joint actions and EUnetHTA21 service
contract).
The proposals should address all of the following activities:
 Identification of innovative methods and tools, in particular those developed in EUfunded
projects able to address HTA bodies' needs (in different areas: relative
effectiveness assessment, cost-effectiveness assessment, etc.)
 Identifications of barriers to the uptake of these methods (and potential associated tools,
e.g. open-source software to run cost-effectiveness analyses)
 Use cases (based on the needs identified by HTA bodies) to facilitate the endorsement by
HTA bodies of innovative methods
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 Development of an implementation plan including supporting tools and training modules
(by researchers, alone or in collaboration with HTA bodies, to be delivered to HTA
bodies/agencies)
 Recommendations for broader dissemination.
HORIZON-HLTH-2023-IND-06-02: Expanding the European Electronic Health Record
exchange Format to improve interoperability within the European Health Data Space
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 3.00
and 5.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 8.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable
and globally competitive health industry”. More specifically, this topic aims at supporting
activities that are contributing to the following impact area: “High quality digital services for
all.” To that end, proposals under this topic should aim to deliver results that are directed,
tailored towards and contributing to all of the following expected outcomes, and provide
appropriate qualitative and quantitative indicators to measure their progress and specific
impact:
 European Health Record (EHR) stakeholders (e.g. developers, suppliers, integrators, and
operators) have at their disposal and use fit-for-purpose standards, guidelines, and
toolsets for prioritised health information domains to address interoperability of EHRs in
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line with the principles set in the EEHRxF Recommendation268
, contributing also to
security and privacy.
 Stakeholders have at their disposal better quality and better integrated health datasets
within the European Health Data Space,269
to foster innovations in the health sector and
leverage the potential of new analytics solutions such as AI and big data, get new
insights and detect trends from aggregated data, including for cross-border health threats.
 Citizens are provided with an expanded access to their health data, also across borders,
and innovative digital services for high-quality health and care across the EU.
Scope: EHR interoperability has yet to become a reality in a number of use cases and health
information domains. It is a complex, multi-dimensional challenge. EHRs across the Member
States are diverse; so are languages, cultures, and practices in the health sector. Different
technical specifications, technologies and clinical terminologies are used, involving a range of
stakeholders, within and across care settings.
Proposals should address all of the following:
 Research, develop and validate harmonised interoperability formats for sharing data in
specific priority health information domains that should be selected with reference to the
EU policies and priorities. The output formats should enable EHR interoperability across
the Member States and address cross-border health data exchange by design and in line
with the principles set in the EEHRxF Recommendation.
 Leverage and scale up the potential of EHR through enhanced interoperability to
improve the quality, safety, and efficiency of patient care, enforce patients' right to data
portability, enhance care coordination, guide crisis planning, reduce medical errors, and
lower costs. For example, based on the lessons learnt from COVID-19, enable
incorporating EHR data into the early stages of clinical crisis planning and leveraging it
to identify potential cross-border health threats based on analysis of patients’ data trends.
 Address semantic interoperability for prioritised information domains so that the
transmitted health record contains standardised coded data.
 Maximise synergies with relevant initiatives, activities and programmes, building upon
previous and linking to on-going actions270
.
268
Commission Recommendation on a European Electronic Health Record exchange Format (EEHRxF)
(C(219)800)
269
https://ec.europa.eu/health/ehealth-digital-health-and-care/european-health-data-space_en
270
Such as “Support for European eHealth Interoperability roadmap for deployment”
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/sc1hcc-07-2020;
“Prototyping a European interoperable Electronic Health Record (EHR) exchange”
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/sc1-dth-
08-2018; “Setting up a European Electronic Health Record Exchange Format (EEHRxF) Ecosystem”
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-
details/horizon-hlth-2022-ind-13-05
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 Closely coordinate and collaborate with various stakeholders, from patients and
healthcare professionals to EHR providers, healthcare industry (including SMEs),
policymakers and legislators to progress towards a more comprehensive EHR
interoperability.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-IND-06-04: Modelling and simulation to address regulatory
needs in the development of orphan and paediatric medicines
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 4.00
and 6.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 25.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable
and globally competitive health industry”. To that end, proposals under this topic should aim
to deliver results that are directed, tailored towards and contributing to all of the following
expected outcomes:
 Developers and regulators have access to robust modelling and simulation tools to
accelerate the effective development of orphan and/or paediatric medicinal products.
 Clinical researchers, developers and regulators use accurate computational models to
improve the statistical robustness in clinical trials intended for small populations and
guide cost-effective clinical trial designs.
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 Clinical researchers and regulators have access to accurate in-silico tools for assessing
the actionable use of real-world data and for successfully estimating the risk-benefit
effects in clinical trials for small populations.
 Regulators develop guidance for the use of validated computational models to support a
robust extrapolation framework and facilitate the safety and efficacy assessment in the
process of regulatory appraisal of orphan and/or paediatric medicinal products.
Scope: In its "Regulatory Science Strategy to 2025", the European Medicines Agency
included specific recommendations to optimise the capabilities of modelling and simulation in
the medicines development process and in particular to benefit special populations and
neglected patient populations.
Orphan drug development faces numerous challenges, including low disease prevalence,
patient population heterogeneity and strong presence of paediatric patient populations.
Consequently, clinical trials for orphan and/or paediatric medicines are often smaller than
traditional large-scale randomised ones and they require the development of efficient trial
designs relevant to small.
Model-based approaches are significantly advantageous in small populations, as extrapolation
tools for rationalising and increasing the statistical robustness in clinical trial designs and
pharmacometric studies.
The topic will support research and innovation activities focusing on the development of
diverse modelling and simulation methods, as tools for addressing some of the regulatory
needs in the clinical development cycle of new orphan and paediatric medicinal products. The
topic is not intended to implement new preclinical/clinical studies but to use the existing
knowledge/data for assessing and optimising the performance of mature in-silico models in
the regulatory context with the goal of improving the clinical trial designs for small
populations. Availability of the relevant data to address the requirements of the topic is an
indispensable condition that must be demonstrated at the proposal submission.
Proposals should involve national healthcare product regulatory bodies and the European
Medicines Agency (EMA) in order to catalyse an effective collaboration between the
researchers and the regulators. The active involvement of patient representatives is required in
all phases of the research and innovation activities. Furthermore, SME(s) participation is
encouraged with the aim to strengthen their scientific and technological basis.
The proposals should address all of the following activities:
 Establish a multidisciplinary approach for assessing the utility of mature computational
models, as tools for supporting the optimal design of innovative clinical trials for small
populations and as fit-for-purpose solutions for enabling the regulatory scientific advice
and marketing authorisation assessment of orphan and/or paediatric medicines, including
their pharmacovigilance follow-up.
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 Calibrate and optimise mature computational models for enhancing their clinical
performance, by using relevant sources of patient data (e.g. natural history and
observational clinical studies, medical records, registries, pharmacovigilance and
longitudinal studies etc.). The models should include a variety of modelling methods and
in particular hybrid solutions linking quantitative mechanistic modelling with advanced
statistical modelling (e.g. quantitative systems pharmacology, disease mechanistic
models, physiology-based pharmacodynamic/pharmacokinetic models, Bayesian
modelling, artificial intelligence algorithms etc.).
 Assess validated in-silico models for their capability to increase the statistical
robustness, improve the risk/benefit assessment in small population clinical trials, and
for their accuracy to predict and extrapolate the therapeutic and dose effects, taking into
account the patient’s genotypes/phenotypes, disease characteristics/stage variables
and/or clinical/surrogate endpoints for delivering robust evidence of safety and efficacy
of the orphan and paediatric medicines under study. The assessment of the in-silico
models should be demonstrated in use cases representing well-justified group(s) of rare
and/or paediatric diseases with commonalities, such as shared molecular
denominators/disease pathways within the same and/or across different medical areas,
excluding cancer and infectious diseases.
 Benchmark of diverse computational models by showcasing their simulation
performance in virtual patient cohorts and by demonstrating that the models’ synthetic
data estimates match to actual clinical trial data. This should lead to an assessment of the
performance and credibility of a model simulation in the context of their specific use for
regulatory purposes. Benchmark studies should be performed in the use cases mentioned
above. Availability of clinical trials data and other relevant data is an indispensable
requirement that must be demonstrated at the proposal submission.
 Set-up the criteria for the performance and credibility assessment of any relevant
computational models for small population clinical trials to progress on their regulatory
qualification and acceptability. Further develop and disseminate standards for the design,
performance assessment and reporting of modelling and simulation tools with an
emphasis on those of high regulatory value for accelerating the clinical development of
orphan and paediatric medicinal products.
The proposals should adhere to the FAIR data271
principles, adopt data quality standards, data
integration operating procedures and GDPR-compliant data sharing/access good practices
developed by the European research infrastructures, where relevant. Proposals are invited to
consider adopting recommendations for in-silico models construction and validation272
. Dataintensive
proposals, particularly those using data from patient registries, should take stock of
the tools and services provided by the European Platform on Rare Disease Registration (EU
271
See definition of FAIR data in the introduction to this work programme part.
272
ISO-paper under development “Recommendations and requirements for predictive computational
models in personalized medicine research — Part 1: Guidelines for constructing, verifying and
validating models”.
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RD Platform). For example, retrospective registry data are expected to be made accessible via
EU RD platform, if reasonably feasible.
All projects funded under this topic are strongly encouraged to participate in networking and
joint activities. These networking and joint activities could, for example, involve the
participation in joint workshops, the exchange of knowledge, the development and adoption
of best practices, or joint communication activities. This could also involve networking and
joint activities with projects funded under other clusters and pillars of Horizon Europe, or
other EU programmes. Therefore, proposals are expected to include a budget for the
attendance to regular joint meetings and may consider covering the costs of any other
potential joint activities without the prerequisite to detail concrete joint activities at this stage.
The details of these joint activities will be defined during the grant agreement preparation
phase. In this regard, the Commission may take on the role of facilitator for networking and
exchanges, including with relevant stakeholders.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2023-IND-06-05: Mapping the hurdles for the clinical applications of
Advanced Therapy Medicinal Products (ATMPs)
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of around EUR 3.00
million would allow these outcomes to be addressed appropriately.
Nonetheless, this does not preclude submission and selection of a
proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 3.00 million.
Type of Action Coordination and Support Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, legal entities established in the
United States of America may exceptionally participate as a beneficiary
or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU
Member State or Associated Country.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
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(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable
and globally competitive health industry”. To that end, proposals under this topic should aim
to deliver results that are directed towards and contributing to all of the following expected
outcomes:
 Challenging aspects of regulation, policy, safety, efficacy, manufacturing, organisation,
infrastructure, decision-making, and commercialisation are identified for speeding up the
equitable clinical applications of ATMPs.
 European regulatory frameworks are adapted to novel scientific progress, especially
those related to platform approaches, genome editing, interface with medical devices,
artificial intelligence.
 Competent authorities in the Member States can propose adapted pricing and
reimbursement schemes that allow European citizens to benefit from novel ATMPs.
 Academic and SME developers and manufacturers of ATMPs have an increased
knowledge of the regulatory aspects.
 The decentralised manufacturing of ATMPs is consistent across health care centres.
Scope: New pioneering treatments called Advanced Therapy Medicinal Products (ATMPs),
including cell and gene therapies, have the potential to bring new cures to patients affected by
diseases with limited or no available treatments. However, several hurdles impede or slow
down the access of ATMPs to patients in the EU and Associated Countries. These include e.g.
regulatory challenges, underlying scientific uncertainties, differences in assessing the values
of ATMPs by the various Health Technology Agencies (HTA), difficulties to perform
randomised-controlled clinical trials or to obtain long-term safety and effectiveness data, the
lack of harmonised approaches to the reimbursement of the high upfront costs by health
systems, manufacturing processes, etc.
The proposals should address all of the following activities:
 Map the regulatory, safety and efficacy assessment, manufacturing, organisational and
infrastructural needs to improve the translation of ATMPs from preclinical development
to clinical use.
 Address the gaps and uncertainties in regulatory and policy aspects pertinent to complex
innovative ATMPs.
 Address predictivity of preclinical data for safety and efficacy testing of ATMPs.
Improved novel models could be proposed.
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 Tackle decision-making processes relating to ATMPs, such as for instance the
assessment of their values, the demonstration of the long-term safety and effectiveness,
or new pricing and reimbursement frameworks.
 Propose opportunities for an improved knowledge of the regulatory processes among
academic ATMP developers.
 Involve regulatory authorities, Health Technology Agencies (HTA), clinicians, ethics
committees, and patients, with the aim to ensure higher clinical use of ATMPs. The
findings of the project will be available to competent authorities, ATMP developers and
manufacturers as well as to national/regional funding agencies.
HORIZON-HLTH-2023-IND-06-07: Development and harmonisation of methodologies
for assessing digital health technologies in Europe
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 7.00
and 8.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 15.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
The Joint Research Centre (JRC) may participate as member of the
consortium selected for funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at addressing digital transition challenges through
supporting activities that are enabling or contributing to one or several expected impacts of
destination 6 “Maintaining an innovative, sustainable and globally competitive health
industry”. More specifically, this topic aims at supporting activities that are contributing to the
following impact area: “High quality digital services for all”. To that end, proposals under
this topic should aim to deliver results that are directed towards and contributing to all of the
following expected outcomes:
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 Policymakers in the EU have at their disposal a methodological framework and
standardised approaches for assessing digital health technologies, that helps them make
evidence-based decisions regarding the introduction of digital health technologies in
their health and care systems with added value for patients and society.
 Regulators have access to robust, scientifically underpinned evaluation methodologies.
 EU citizens gain faster access to safe and well-performing person-centred digital
technologies and are empowered through these tools.
 Health technology developers are better informed and dispose of more guidance on the
evidence needed to demonstrate the added value of digital health technologies and have
better insights on market predictability.
 (Digital) Health Industry/digital health technology developers and HTA bodies can
contribute to the development of EU harmonised Health Technology Assessment (HTA)
rules based on common principles.
 Improved cross-border use and interoperability of digital health tools and services
throughout the EU and Associated Countries.
 Increased trust in digital health technologies and better integration of digital health tools
and services in health and care systems.
Scope: Digital health technologies have been driving a revolution in health and care ranging
from general use of computers to algorithms designed to assist radiologists and radiotherapists
in detecting and treating diseases, from robotic surgery to artificial intelligence, machine
learning, computer aided decision models, and from mobile apps helping patients to selfmanage
their disease to electronic health records.
Digital health technologies are expected to further contribute to better people-centred health
and care systems and have the vast potential to improve our ability to accurately prevent,
diagnose and treat diseases.
However, assessing the added value and health benefits for patients and society pose a
number of challenges in particular of methodological and technical nature. Best practice for
common approaches in methodology for digital health are lacking, especially in the digital
health tools that include artificial intelligence algorithms. A framework for the assessment of
the digital transformation of health services and its impact is vital to generate the evidence
required for decision-making on stimulating, using and/or funding digital health strategies at
various levels in the health and care systems.
The Expert Panel on effective ways of investing in Health (EXPH) recommended in its report
‘Assessing the impact of digital transformation of health services273
’, further investment in the
273
ASSESSING THE IMPACT OF DIGITAL TRANSFORMATION OF HEALTH SERVICES, Report
of the Expert Panel on effective ways of investing in Health (EXPH) -
https://ec.europa.eu/health/system/files/2019-11/022_digitaltransformation_en_0.pdf
Horizon Europe - Work Programme 2023-2024
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development of assessment methodologies and in a European repository for evaluation
methods and evidence of digital health services.
To date, such assessment frameworks are relatively scarce, especially those addressing the
transformative aspects of healthcare delivery on the organisational and operational level.
The proposals are expected to develop and harmonise methodologies for assessing digital
health technologies (including mhealth apps and telehealth, as well as Artificial Intelligence
powered health technologies) in order to facilitate assessment of their added value at
individual, health system and society levels and facilitate the cross-border deployment of
digital health services within the EU. Existing Health Technology Assessment (HTA)
methodology is well developed for health technologies such as medicinal products, but also
for some categories of medical devices; however digitalisation raises new methodological
challenges to the standardisation of assessment criteria such as privacy, cybersecurity, data
storage and handling, interoperability, usability etc. Also including aspects like learning
curves, iterative development of innovations, variability between settings, determining
optimal timing of evaluations in the development process (maturity) are not yet solved.
Proposals are expected to build on existing frameworks such as (but not restricted to) ‘Model
for Assessment of Telemedicine’ (MAST framework – Kidholm et al., 2012) and the results
of previous EU-funded projects in particular (but not restricted to) COMED, project that
already identified HTA challenges of telehealth and mhealth, and mHealth hub274
.
Proposals should consider involving the JRC to take advantage of its expertise on assessment
frameworks of innovative health technologies and its activities at the interface between
research and regulatory aspects and/or in translating assessment results into best practice
recommendations anchored in EU policies. In that respect, the JRC is open to collaborate with
any successful proposal after its approval.
The proposals should address all of the following activities:
 Develop and/or expand a general methodological framework and standardised
approaches to assess digital health technologies with a particular focus on criteria such
as privacy, cybersecurity, data quality, data storage and handling, interoperability etc.;
 Comply with the relevant requirements proposed in the European Health Data Space
(EHDS) legal provisions;
 Test the robustness of the developed methodologies on minimum 3 different digital
health technology use cases;
 Pilot the development of common specifications to the harmonisation of assessment
frameworks (pre-market and post-market phases) throughout the EU and Associated
Countries;
274
https://mhealth-hub.org/
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 Include end-users of digital health technologies (be it professionals, care users or
citizens), developers of digital health technologies, producers of health services,
regulators and governments;
 Collect best practice for common approaches in methodology for digital health
technology assessment and develop an open access European repository for evaluation
methods, studies, results and evidence of digital health technologies and services;
 Contribute to a framework to evaluate and monitor whether the uptake and use of digital
health services contribute to the overall goals of the health and care system;
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
Call - A competitive health-related industry (Single stage - 2024)
HORIZON-HLTH-2024-IND-06
Conditions for the Call
Indicative budget(s)275
Topics Type
of
Action
Budgets
(EUR
million)
Expected EU
contribution per
project (EUR
million)276
Indicative
number
of
projects
expected
to be
funded
2024
Opening: 26 Oct 2023
Deadline(s): 11 Apr 2024
HORIZON-HLTH-2024-IND-06-08 RIA 10.00 8.00 to 10.00 1
HORIZON-HLTH-2024-IND-06-09 CSA 2.00 Around 2.00 1
Overall indicative budget 12.00
275
The Director-General responsible for the call may decide to open the call up to one month prior to or
after the envisaged date(s) of opening.
The Director-General responsible may delay the deadline(s) by up to two months.
All deadlines are at 17.00.00 Brussels local time.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
276
Nonetheless, this does not preclude submission and selection of a proposal requesting different
amounts.
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General conditions relating to this call
Admissibility conditions The conditions are described in General
Annex A.
Eligibility conditions The conditions are described in General
Annex B.
Financial and operational capacity and
exclusion
The criteria are described in General Annex
C.
Award criteria The criteria are described in General Annex
D.
Documents The documents are described in General
Annex E.
Procedure The procedure is described in General
Annex F.
Legal and financial set-up of the Grant
Agreements
The rules are described in General Annex G.
Proposals are invited against the following topic(s):
HORIZON-HLTH-2024-IND-06-08: Developing EU methodological frameworks for
clinical/performance evaluation and post-market clinical/performance follow-up of
medical devices and in vitro diagnostic medical devices (IVDs)
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of between EUR 8.00
and 10.00 million would allow these outcomes to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of a proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 10.00 million.
Type of Action Research and Innovation Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, any legal entity established in the
United States of America is eligible to receive Union funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
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The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable
and globally competitive health industry”. To that end, proposals under this topic should aim
to deliver results that are directed, tailored towards and contributing to all of the following
expected outcomes:
 Patients gain faster access to innovative, safe and well-performing medical devices;
 Regulators have access to sound scientific resources for clinical/performance evaluation
guidance and development of common specifications as foreseen in Article 9 of the
Medical Device Regulation (MDR);
 Notified bodies, by their direct participation to the production of documents, will have a
harmonised way of assessing the clinical evidence in the pre-market and post-market
phases; furthermore their network277
, will be enhanced;
 Health technology developers gain insight on the evidence needed to demonstrate that
their devices meet MDR clinical requirements throughout their lifetime. They will also
have more guidance on the use of real-world data for their clinical development
strategies.
Scope: The Medical Device Regulation (MDR) and in vitro diagnostic medical device
Regulation (IVDR) provides a new regulatory framework where reinforcement of
clinical/performance evaluation of medical devices and IVDs, and in particular high-risk
medical devices, is a key element. The confirmation of conformity with the relevant general
safety and performance requirements set out in the MDR and IVDR278
is based on clinical
data and its assessment (clinical/performance evaluation), including the evaluation of the
acceptability of the benefit-risk- ratio. Within this new framework, the clinical/performance
evaluation should follow a defined and methodologically sound procedure based on the
critical evaluation of the relevant scientific literature, a critical evaluation of the results of all
available clinical investigations/performance studies, as well as consideration of currently
available alternative treatment options for the device under evaluation. Clinical/performance
evaluation has to be updated throughout the life cycle of the device. Hence,
clinical/performance evaluation can draw on multiple types of data including data from initial
clinical investigations/performance studies and data gathered by the manufacturer's postmarket
surveillance system. To operationalise this new requirement, research is needed to
help regulators develop common methodological frameworks (including common
specifications279
) on the clinical evidence needed to demonstrate safety, performance and
277
Article 49 – Coordination Group of notified bodies
278
Annex I General safety and performance
279
Mandatory applicable “technical standards” providing to the manufacturers means of proving
conformity with the safety and performance legal requirements, issued by Commission as Implementing
Acts.
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clinical benefit all along the life cycle of devices taking into account the type of device and
clinical intended purpose.
Such methodological frameworks and standardised approaches are particularly needed for
high-risk medical devices, e.g. implantable and class III medical devices, class C and D IVDs,
medical device software (including AI enabled devices and next generation sequencing) and
other highly innovative devices.
In order to address the differences between evidence generation for medical devices and
IVDs, the project should be tackled taking into account those differences.
Proposals should address all of the following activities:
 Development of a framework for a life-cycle approach to evidence generation and
evaluation of high-risk and innovative medical devices and IVDs. This framework will
provide a description of the types of evidence i) that meet safety and performance for
market access, and ii) that have to be generated to fulfil post-market responsibilities.
When appropriate it would be beneficial to consider to what extent the framework could
be relevant to demonstrate relative effectiveness as needed for Health Technology
Assessment. As regards highly innovative devices, particular attention may be paid to
defining acceptable levels of uncertainty in terms of benefit-risk ratio at market entry as
well as the type of post-market follow-up to be implemented to generate additional
clinical evidence able to reduce this uncertainty. This could be particularly relevant for
devices e.g. having no or little similarities with existing devices in terms of intended
purpose, mode of action, materials or, for IVDs, with no existing reference materials.;
 For medical devices, a pilot to support development of common specifications which
would set the stage for a common specification ecosystem for medical devices in the
EU280
, including the development of standardised/common endpoints and associated
health outcomes measures by technology type and where relevant by clinical intended
purpose;
 Development of a general methodological approach to define, determine and update the
state of the art for different device technologies. The robustness of the developed
approach should be evaluated on 3 different medical device types and 3 different IVD
types;
 Possible use of registries and other sources of real-world data for demonstration of
regulatory compliance both pre- and post-market: minimum requirements for data
quality, completeness and data reliability, statistical methods for data analysis, methods
for limiting biases, methods for data linkage, determination of what acceptable evidence
can be drawn from registries;
 Methodology for bridging studies for devices and IVDs with iterative development:
assessment of data coming from previous versions of the device and where relevant
280
building on previous initiatives such as PARENT, CORE-MD, JAMS
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integration of that data into the device’s clinical investigation/performance study and gap
assessment between the different versions of the device;
 Identification of relevant quantitative and qualitative methodologies for integrating
evidence derived from various data sources in the clinical evaluation/performance
evaluation;
Proposals should build on relevant completed and ongoing initiatives in the field, in particular
(but not restricted to) EU-funded initiatives.281
Proposals should involve researchers who are
specialised in the clinical/performance evaluation of medical devices/IVDs and in the use of
real-world data to evaluate medical products. Proposals should involve national competent
authorities, notified bodies, IVD laboratories as well as Health Technology Assessment
bodies and could involve patients’ representatives where relevant.
Applicants envisaging to include clinical studies should provide details of their clinical
studies in the dedicated annex using the template provided in the submission system. See
definition of clinical studies in the introduction to this work programme part.
HORIZON-HLTH-2024-IND-06-09: Gaining experience and confidence in New
Approach Methodologies (NAM) for regulatory safety and efficacy testing – coordinated
training and experience exchange for regulators
Specific conditions
Expected EU
contribution per
project
The Commission estimates that an EU contribution of around EUR 2.00
million would allow these outcomes to be addressed appropriately.
Nonetheless, this does not preclude submission and selection of a
proposal requesting different amounts.
Indicative budget The total indicative budget for the topic is EUR 2.00 million.
Type of Action Coordination and Support Actions
Eligibility
conditions
The conditions are described in General Annex B. The following
exceptions apply:
In recognition of the opening of the US National Institutes of Health’s
programmes to European researchers, legal entities established in the
United States of America may exceptionally participate as a beneficiary
or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU
Member State or Associated Country.
The Joint Research Centre (JRC) may participate as member of the
281
e.g. PARENT (PAtient REgistries iNiTiative) Joint Action, CORE-MD (Coordinating Research and
Evidence for Medical Devices) H2020 research project, JAMS (Joint Action on Market Surveillance of
Medical Devices) initiative
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consortium selected for funding.
Award criteria The criteria are described in General Annex D. The following exceptions
apply:
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3
(Implementation). The cumulative threshold will be 12.
Expected Outcome: This topic aims at supporting activities that are enabling or contributing
to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable
and globally competitive health industry”. To that end, proposals under this topic should aim
to deliver results that are directed, tailored towards and contributing to all of the following
expected outcomes:
 European regulators gain state-of-the-art knowledge on different NAMs that are being
proposed for the assessment of the safety and efficacy of chemicals and pharmaceuticals;
 European regulators understand better the shortcomings of the current tools based on
animal procedures for the assessment of chemicals and pharmaceuticals;
 European regulators collaborate on a framework on how to assess the safety of
chemicals based on NAM-data and how to classify the hazardous properties based on
such data;
 European regulators collaborate on a similar framework for assessment of safety and
efficacy of pharmaceuticals based on NAM-data;
 Citizens benefit from the supply and use of chemicals and pharmaceuticals that have
been assessed through NAMs that are better predicting potential effects in humans than
the current assessment methods;
 Industry has an improved competitive position with the availability of harmonised and
standardised NAM-based assessment tools that are faster and more flexible;
 European Commission and Member States regulators are responding to the societal
demand to move away from animal testing.
Scope: There is increasing scientific evidence pointing to the limitations of animal testing for
safety and efficacy assessment of chemicals and pharmaceuticals. Europe is also experiencing
a strong societal demand to move away from animal testing. Scientific progress of the past
two decades has produced a number of animal-free New Approach Methodologies (NAMs)
that have the potential to be used instead of the animal models that are currently employed for
such testing. However, knowledge, experience and confidence on how results from the NAM
assays could be used is still lacking among regulators, which could limit the industry’s use of
NAMs because of lack of legal certainty when generating safety and health data requested by
EU legislation.
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The proposals should focus on alternatives to the use of animals for regulatory safety and
efficacy testing. Applicants should propose activities that bring together NAM developers and
NAM users with European regulators responsible for the safe use of chemicals (e.g. industrial
chemicals, pesticides, biocides and cosmetics) and pharmaceuticals in order to inform on
NAM solutions available and to encourage the building of a framework on how these NAMs
could be most effectively used in the different decision-making contexts. For NAMs
applicable to chemical risk assessment, collaboration with existing initiatives such as the
Partnership for the Assessment of Risks from Chemicals (PARC) and the ASPIS cluster of
projects (Animal-free Safety Assessment of chemicals: Project cluster for Implementation of
novel Strategies) is encouraged.
To build such a framework the proposals should address all of the following:
 develop technical and regulatory readiness criteria
 reflect on how to provide mechanisms to support technology transfer, i.e. bringing
promising NAMs to the market (including optimisation and transferability assessment)
 discuss how to standardise NAMs and NAM-based strategies via OECD, CEN, ISO,
ICH, VICH and other international organisations, as applicable
 provide technical training for Contract Research Organisations (CROs) applying NAMs
for regulatory purposes
 promote dialogue (involving companies, regulatory bodies on EU level, including
ECHA, EMA and EFSA and Member States authorities) on how to integrate and
interpret data from NAMs and facilitate their uptake for safety and efficacy testing of
chemicals (including pesticides) and pharmaceuticals, while addressing the lack of
reliability and shortcomings of the current tools based on animal procedures
 identify obstacles in EU legislation for the regulatory use of NAMs and propose
options/changes in the EU regulatory framework which address these obstacles and
facilitate the uptake and use of NAMs
Proposals should consider involving the JRC to take advantage of its expertise and relevant
activities in bridging research and regulatory communities and facilitating uptake of NAMs
for regulatory application. In that respect, the JRC is open to collaborate with any successful
proposal after its approval.
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Other Actions not subject to calls for proposals
Grants to identified beneficiaries
1. Contribution to the Coalition for Epidemics Preparedness Initiative (CEPI) - vaccine
development for priority diseases
This is a topic for a grant awarded without a call for proposals (Article 195 (e) of the EU
Financial Regulation). CEPI is a key global initiative that comprehensively and systematically
addresses vaccine development for priority pathogens causing epidemic and pandemic threats.
CEPI has been a key partner for implementing the common Union response to the COVID-19
epidemic. With this funding, CEPI will be able to award grants to third parties through
competitive calls for proposals. The focus will be on development of new medical
countermeasures to prevent and contain infectious diseases that have epidemic potential,
before these diseases become global health emergencies. The call(s) will be issued by CEPI,
to fund advanced pre-clinical as well as clinical research on new vaccines for the prevention
of emerging and re-emerging infectious diseases, with a view to preventing future epidemics.
It will be aligned with activities of the European Health Emergency Preparedness and
Response Authority (HERA) and a new Partnership for Pandemic Preparedness.
Expected Outcome:
Proposals should set out a credible pathway to contributing to one or several expected impacts
of destination: “Tackling diseases and reducing disease burden”.
Project Results under this action are expected to contribute to all of the following expected
outcomes:
 Health care providers have access to newly developed medical countermeasures against
prioritised pathogens with epidemic potential.
 Citizens benefit from improvements in prevention and containment of epidemics.
 Research funders, policymakers and the research community will have better tools and
solutions to achieve the Sustainable Development Goal 3.3282
, “to combat communicable
diseases" and to implement 3.B “to support the research and development of vaccines for
the communicable diseases that primarily affect developing countries, and provide
access to affordable essential vaccines”.
Scope:
This grant will be awarded without a call for proposals according to Article 195 (e) of the EU
Financial Regulation and Article 24(3)(b) of the Horizon Europe Regulation to the legal
282
https://sustainabledevelopment.un.org/topics/sustainabledevelopmentgoals
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entities identified below as CEPI has been a key partner for implementing the common Union
response to the COVID-19 epidemic.
The Coalition for Epidemic Preparedness Innovations (CEPI) is an international non-profit
association established under Norwegian Law. It was founded by the Governments of
Norway, Germany, Japan, India, the Bill & Melinda Gates Foundation (BMGF) and the
Wellcome Trust, and launched during the World Economic Forum in Davos 2017. Its
objective is to finance and coordinate the development of new medical countermeasures to
prevent and contain infectious diseases that have epidemic potential, before these diseases
become global health emergencies. The Horizon Europe funding will be used to enhance and
expand CEPI’s activities. This action will also contribute to the implementation of the
Union’s strategy for international cooperation in research and innovation and the EU’s
development policy, in particular attention will be given to the constraints national health
systems face in low- and middle-income countries.
Accordingly, the proposals should cover all of the following activities:
 Vaccine research and development for emerging pathogens to stop future epidemics.
 Research to advance adaptable vaccine technologies that can be used for rapid vaccine
and immunoprophylactic development against previously unknown pathogens.
 Engagement with relevant stakeholders in the area of epidemic preparedness ensuring
collaboration and coordination and avoiding duplication.
This action is expected to engage with other relevant initiatives, such as the new Partnership
for Pandemic Preparedness.
With the grant from the European Union, CEPI will be able to award one or several grants to
third parties through competitive calls for proposals. The call(s) will be issued to fund
advanced pre-clinical as well as clinical research on new vaccines for the prevention of
emerging and re-emerging infectious diseases, with a view to preventing future epidemics.
For this purpose this action is also expected to engage with HERA. The expected recipients of
the grant(s) issued by CEPI include research institutes, universities, SMEs as well as large
companies, all active in research and innovation on new and improved vaccines.
Award criteria:
The criteria are described in General Annex D. The following exceptions apply: The
thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The
cumulative threshold will be 12.
Legal and financial set-up of the Grant Agreements:
The funding rate will be 70%.
Financial support provided by CEPI to third parties is one of the primary activities of this
action in order to be able to achieve its objectives as CEPI does not have the capacity to
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develop new medical countermeasures itself. The maximum amount to be granted to a third
party is EUR 35 million. This is justified by the high cost of development for new vaccines,
that reach tens of millions of Euros283
.
Legal entities:
Coalition for Epidemic Preparedness Innovations, Marcus Thranes gate 2, 0473 Oslo, Norway
Form of Funding: Grants not subject to calls for proposals
Type of Action: Grant to identified beneficiary according to Financial Regulation Article
195(e) - Programme co-fund action
The general conditions, including admissibility conditions, eligibility conditions, award
criteria, evaluation and award procedure, legal and financial set-up for grants, financial and
operational capacity and exclusion, and procedure are provided in parts A to G of the General
Annexes.
Indicative timetable: 4th Quarter 2023
Indicative budget: EUR 35.00 million from the 2023 budget
2. Presidency event - Sweden. Life sciences: The era of precision medicine
This action will cover the organisation of a conference by the Swedish Presidency, focusing
on precision medicine.
The conference aims at creating a forum for knowledge exchange and networking to seize the
opportunities that precision medicine brings to promote a modern healthcare. The conference
will focus on three aspects of precision medicine. The first aspect is data-driven
implementation, with a focus on access to large amounts of data and structures for
implementation in healthcare through EHDS (European Health Data Space). A second aspect
is ethics, which will become even more important with new genetic technologies, increased
use of sensitive personal data and market interests. The third aspect will address precision
prevention through early detection and diagnosis, as well as disease-preventing actions. The
perspectives of sustainability and patient participation will be highlighted across all three
aspects.
Award criteria:
The criteria are described in General Annex D. The following exceptions apply: The
thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The
cumulative threshold will be 12.
Procedure:
283
Gouglas, D. et al.: Estimating the cost of vaccine development against epidemic infectious diseases: a
cost minimisation study. Lancet Global Health Vol. 6 (12) E1386-E1396. DOI:
https://doi.org/10.1016/S2214-109X(18)30346-2,
https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(18)30346-2/fulltext
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The evaluation committee will be composed fully by representatives of EU institutions.
Legal and financial set-up of the Grant Agreements:
The funding rate will be 100%.
Legal entities:
Swedish Ministry of Enterprise and Innovation, Herkulesgatan 17, SE 103 33 Stockholm,
Sweden
Form of Funding: Grants not subject to calls for proposals
Type of Action: Grant to identified beneficiary according to Financial Regulation Article
195(e) - Coordination and support action
The general conditions, including admissibility conditions, eligibility conditions, award
criteria, evaluation and award procedure, legal and financial set-up for grants, financial and
operational capacity and exclusion, and procedure are provided in parts A to G of the General
Annexes.
Indicative timetable: First Quarter of 2023
Indicative budget: EUR 0.30 million from the 2023 budget
3. Presidency event - Spain. Genomics-based health strategies: towards personalised and
precision medicine
This action will cover the organisation of an event by the Spanish Presidency, focusing on
personalised medicine.
Personalised medicine has gained significant attention over the last decade as technologies for
understanding biological differences between individuals have advanced dramatically. There
are many potential benefits of personalised medicine and its development will change the way
in which some health services are delivered. Within the last decade, the EU has launched a
series of initiatives, of different nature, aimed at promoting personalised medicine: regarding
genomic medicine; the European Genome initiative, promoting collaborative consortia; ERA
PerMed and ICPerMed, the construction of the EHDS (European Health Data Space) within
the Digital Health Strategy of the EU and the forthcoming Genomic Data Infrastructure.
However, personalised medicine is a wide area of study which still have some challenges to
tackle.
The Spanish presidency event should be focused on the following aspects of personalised
medicine:
 Innovative health strategies based on genomics and personalised and precision medicine
to respond to unmet medical needs: improvements in cancer treatment, and prognosis of
rare diseases, prevention of common and complex diseases or high sensitivity to
infectious diseases.
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 Transnational joint efforts in personalised healthcare: European consortia and
partnerships.
 Personalised medicine as a scientific tool for global health cooperation for bridging
Europe and the African and Latin American regions.
Award criteria:
The criteria are described in General Annex D. The following exceptions apply: The
thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The
cumulative threshold will be 12.
Procedure:
The evaluation committee will be composed fully by representatives of EU institutions.
Legal and financial set-up of the Grant Agreements:
The funding rate will be 100%.
Legal entities:
Fundación Española para la Ciencia y la Tecnología - FECYT, FECYT, MCIN, C/ Pintor
Murillo 15 - 28100 Alcobendas, Madrid, Spain
Form of Funding: Grants not subject to calls for proposals
Type of Action: Grant to identified beneficiary according to Financial Regulation Article
195(e) - Coordination and support action
The general conditions, including admissibility conditions, eligibility conditions, award
criteria, evaluation and award procedure, legal and financial set-up for grants, financial and
operational capacity and exclusion, and procedure are provided in parts A to G of the General
Annexes.
Indicative timetable: Second Quarter of 2023
Indicative budget: EUR 0.30 million from the 2023 budget
4. Presidency event - Belgium. R&I policies for Better Health, Wellbeing and Prosperity
This action will cover the organisation of two conferences by the Belgian Presidency:
“Europe united against old and new pandemics” and “The convergence of technologies
driving R&I towards the development of healthcare of the future”.
The conference “Europe united against old and new pandemics” will be informed by the
CSAs preparing the EU R&I partnerships on pandemic preparedness and response and on One
Health AMR. The conference should provide a platform to discuss and agree on the next steps
for the EU-partnership on pandemic preparedness and response and its role in supporting
HERA. Taking stock of the lessons learned from the ongoing COVID-19 pandemic and
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embracing a “One Health - Planetary Health” approach, the conference should help prepare
for any pandemic threat - whether from emerging infectious diseases or antimicrobial
resistance.
The conference should reach out to policymakers and stakeholders in science, innovation and
public health as well as the European Commission.
The conference “The convergence of technologies enabling R&I for the healthcare of the
future” should focus on the convergence of technologies such as bio-, nano-, digital
technologies and engineering, which, in combination with omics data supplemented by health
and real-world data have the potential to push the boundaries of R&I in the field health.
However without proper integration of genomic and health data, R&I is hampered. Integrating
the Genome Data Infrastructure (GDI) into the European Health Data Space would enable
breakthroughs.
The conference should address the challenges linked to integrating genomics, and health and
real-world data, as well as the role and potential of converging technologies to accelerate the
development of personalised and preventive health management. Technologies such as single
cell technologies, innovative medical technologies and -omics analyses including human
microbiomics and lab- or cell-on-chip developments can accelerate the insights into what
determines health and disease and allow for true personalisation of health management and
preventive approaches.
The conference should draw on advances in the fields of cancer and rare diseases and may
also focus on the needs for skills of the future related to genomic medicine and data
governance.
The conference should involve the member state ministries of R&I and public health as well
as the European Commission.
Award criteria:
The criteria are described in General Annex D. The following exceptions apply: The
thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The
cumulative threshold will be 12.
Procedure:
The evaluation committee will be composed fully by representatives of EU institutions.
Legal and financial set-up of the Grant Agreements:
The funding rate will be 100%.
Legal entities:
Flemish region the Department of Economy, Science and Innovation, Avenue du Port 88,
1000 Brussels
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Form of Funding: Grants not subject to calls for proposals
Type of Action: Grant to identified beneficiary according to Financial Regulation Article
195(e) - Coordination and support action
The general conditions, including admissibility conditions, eligibility conditions, award
criteria, evaluation and award procedure, legal and financial set-up for grants, financial and
operational capacity and exclusion, and procedure are provided in parts A to G of the General
Annexes.
Indicative timetable: Fourth Quarter of 2023
Indicative budget: EUR 0.30 million from the 2024 budget
5. Presidency event - Hungary. Hungarian priorities in Health research
This action will cover the organisation of two conferences on Hungarian Health priorities in
relation to the Hungarian Presidency, namely Brain Health and the Health impacts of Climate
Change.
The conferences should provide platforms for knowledge exchange and networking and
should draw on contributions from international organisations, research organisations, funders
and policymakers including the European Commission as well as patient representatives.
The Brain Health conference should aim at creating a forum for reviewing existing and
potential brain health research initiatives including a possible future EU R&I partnership in
the area of brain health. Brain Health is an emerging and growing concept that encompasses
neural development, plasticity, functioning, and recovery including mental health aspects in a
life course perspective. Numerous interconnected social and biological determinants (incl.
genetics) play a role in brain development and brain health throughout the life course. Some
of the aspects of brain health are strongly linked to ageing, working, lifestyle and social life
situations. Dementia and other brain disorders will impose an ever-growing burden on the
healthcare systems due to the ageing of Europe’s population. Developing effective and high
quality health and social care for these conditions will require holistic and person-centred
multisectoral and interdisciplinary research collaborations spanning the fields of health
promotion and disease prevention, treatment, care and rehabilitation across the lifespan and
building on the active engagement of citizens and patients, their families and carers, as
appropriate.
The conference on the Health Impact of Climate Change should focus on the protection of the
health and well-being of citizens from the climate change induced risks and impacts. Climate
changes induce events such as changes in biodiversity, disruption of ecosystems and land use,
global warming and heat waves, changes in UV exposure, drought or flooding. These events
are influencing globally the incidence and spread of infectious diseases and increasing
pollution, thereby causing new threats to human health. To tackle the health impacts of
climate change an interdisciplinary approach is needed. The conference should create a forum
to discuss possible solutions and technological development to contain and reduce the health
Horizon Europe - Work Programme 2023-2024
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impact of emerging threats imposed by climate change, to share best practices in climate
policies and actions.
Award criteria:
The criteria are described in General Annex D. The following exceptions apply: The
thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The
cumulative threshold will be 12.
Procedure:
The evaluation committee will be composed fully by representatives of EU institutions.
Legal and financial set-up of the Grant Agreements:
The funding rate will be 100%.
Legal entities:
National Research, Development and Innovation Office, Kéthly Anna tér 1, Budapest 1077,
Hungary
Form of Funding: Grants not subject to calls for proposals
Type of Action: Grant to identified beneficiary according to Financial Regulation Article
195(e) - Coordination and support action
The general conditions, including admissibility conditions, eligibility conditions, award
criteria, evaluation and award procedure, legal and financial set-up for grants, financial and
operational capacity and exclusion, and procedure are provided in parts A to G of the General
Annexes.
Indicative timetable: Second Quarter of 2024
Indicative budget: EUR 0.30 million from the 2024 budget
Other Instruments
1. External expertise
This action will support the use of appointed independent experts for the monitoring of
running actions (grant agreement, grant decision, public procurement actions, financial
instruments) funded under Horizon Europe and previous Framework Programmes for
Research and Innovation, for ethics checks, for the evaluation of large actions annual work
plans, as well as for compliance checks regarding the Gender Equality Plan eligibility
criterion. A special allowance of EUR 450/day will be paid to the experts appointed in their
personal capacity who act independently and in the public interest.
Form of Funding: Other budget implementation instruments
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Type of Action: Expert contract action
Indicative budget: EUR 2.00 million from the 2023 budget and EUR 2.00 million from the
2024 budget
2. Mobilisation of research funds in case of Public Health Emergencies
Expected Outcome:
Proposals should set out a credible pathway to contributing to one or several expected impacts
of destination: “Tackling diseases and reducing disease burden”.
Project results are expected to contribute to the following expected outcome: Allow the Union
to respond to Public Health Emergencies.
Scope:
In case of a public health emergency284
(such as a Public Health Emergency of International
Concern (PHEIC) according to the World Health Organization, a public health emergency
under Decision 1082/2013/EU or under applicable national frameworks and regulations),
funding will be mobilised for:
 The award of grants without a call for proposals according to Article 195 (b) of the EU
Financial Regulation285
in exceptional and duly substantiated emergencies. At that time,
the Funding & Tenders Portal will open a dedicated section where proposals can be
submitted. This will be communicated to the National Contact Points. The invitation to
apply for funding will be open to all eligible entities or be limited to targeted entities,
taking into account the need to achieve the underlying objectives in a quick and efficient
manner considering the exceptional circumstances; and/or
 The award of additional funding for ongoing grant agreements funded through EU
Framework Programmes for Research and Innovation to cover additional activities
specifically linked to the public health emergency, in exceptional and duly substantiated
emergencies. Providing such additional funding to ongoing EU Framework Programmes
for Research and Innovation grants that can support pertinent short- and mid-term
research efforts to confront the public health emergency will save valuable time and
allow addressing the situation with the appropriate urgency. Restricted calls for
expression of interest or proposals will develop such additional activities or add
additional partners to existing EU Framework Programmes for Research and Innovation
actions.
284
Should there be no Public Health Emergency in 2023 or 2024, the indicative budget may be reallocated.
285
Article 195 (b) of the Financial Regulation 2018/1046 "Grants may be awarded without a call for
proposals only in the following cases: […] (b) in other exceptional and duly substantiated
emergencies;”.
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It is expected that quality-controlled data are shared in accordance with the FAIR 286
principles. The use of harmonised protocols in collaboration with other actors is
recommended for this purpose.
The standard eligibility and admissibility criteria, evaluation criteria, thresholds, weighting for
award criteria, maximum funding rate and conditions for providing financial support to third
parties, are provided in the General Annexes.
The beneficiaries must comply with the public emergency related provisions listed in the
General Annexes concerning the project implementation under - Intellectual Property Rights
(IPR), background and results, access rights and rights of use (article 16 and Annex 5) for the
duration of the Public Health Emergency; and under Communication, dissemination, open
science and visibility (article 17 and Annex 5) during the entire duration of the action and for
four years after the end of the action.
The following derogations to the evaluation procedure described in General Annexes D and F
apply to open invitations to submit applications:
In order to ensure a balanced portfolio covering responses to different aspects of the public
health emergency, grants will be awarded to applications not only in order of ranking, but also
to those projects that enhance the quality of the project portfolio through synergies between
projects and avoidance of overlaps, provided that the applications attain all thresholds.
The action may also include justified derogations from the standard limits to financial support
to third parties. Where applicable, the relevant grant agreement options will be applied.
Form of Funding: Grants not subject to calls for proposals
Type of Action: Grant awarded without call for proposals according to Financial Regulation
Article 195 (b)
The general conditions, including admissibility conditions, eligibility conditions, award
criteria, evaluation and award procedure, legal and financial set-up for grants, financial and
operational capacity and exclusion, and procedure are provided in parts A to G of the General
Annexes.
Indicative timetable: Will depend on the Public Health Emergency
Indicative budget: EUR 1.00 million from the 2023 budget and EUR 1.00 million from the
2024 budget
3. Studies, conferences, events and outreach activities
A number of specific contracts will be signed under existing framework contracts in order to:
(i) support the dissemination and exploitation of project results; (ii) contribute to the
definition of future challenge priorities; (iii) undertake citizen surveys such as
286
See definition of FAIR data in the introduction to this work programme part.
Horizon Europe - Work Programme 2023-2024
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Eurobarometers, (iv) carry out specific evaluations of programme parts; and (v) organise
conferences, events and outreach activities. Should existing framework contracts prove
unsuitable or insufficient to support the abovementioned activities, one or more calls for
tender may be launched as appropriate.
Subject matter of the contracts envisaged: studies, technical assistance, conferences, events
and outreach activities.
Form of Funding: Procurement
Type of Action: Public procurement
Indicative timetable: 2023 and 2024
Indicative budget: EUR 10.48 million from the 2023 budget and EUR 2.30 million from the
2024 budget
4. Subscription to the Human Frontier Science Program Organization
An annual subscription to the international Human Frontier Science Program Organization
(HFSPO)287
will allow researchers from EU non-G7 Member States to fully benefit from the
Human Frontier Science Program (HFSP) and contribute to the implementation of the
Union’s strategy for international cooperation in research and innovation.
An amount of EUR 1 Million in 2023 and EUR 1 Million in 2024 is set aside in order to
enable initiatives to help the affected scientific community in and from areas recently severely
ravaged by conflict and/or war on European ground.
Type of Action: Subscription action
Indicative timetable: 2023 and 2024
Indicative budget: EUR 6.30 million from the 2023 budget and EUR 6.30 million from the
2024 budget
287
The European Commission is a member of the HFSP Organization (HFSPO) and has funded HFSP
under previous Framework Programmes
Horizon Europe - Work Programme 2023-2024
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Budget288
Budget line(s) 2023
Budget (EUR
million)
2024
Budget (EUR
million)
Calls
HORIZON-HLTH-2023-STAYHLTH-
01
40.00
from
01.020210
16.00
from
01.020210 -
NGEU
24.00
HORIZON-HLTH-2024-STAYHLTH-
01-two-stage
80.00
from
01.020210
80.00
HORIZON-HLTH-2023-ENVHLTH-02 103.00
from
01.020210
43.50
from
01.020210 -
NGEU
59.50
HORIZON-HLTH-2024-ENVHLTH-
02-two-stage
60.00
from
01.020210
60.00
HORIZON-HLTH-2023-DISEASE-03 224.00
from
01.020210
93.00
from
01.020210 -
NGEU
131.00
288
The budget figures given in this table are rounded to two decimal places.
The budget amounts are subject to the availability of the appropriations provided for in the general
budget of the Union for years 2023 and 2024.
Horizon Europe - Work Programme 2023-2024
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HORIZON-HLTH-2023-DISEASE-07 50.00
from
01.020210
50.00
HORIZON-HLTH-2024-DISEASE-03-
two-stage
125.00
from
01.020210
125.00
HORIZON-HLTH-2024-DISEASE-08 52.00
from
01.020210
52.00
HORIZON-HLTH-2024-DISEASE-09 100.00
from
01.020210
100.00
HORIZON-HLTH-2023-CARE-04 60.00
from
01.020210
27.00
from
01.020210 -
NGEU
33.00
HORIZON-HLTH-2023-CARE-08 100.00
from
01.020210
50.00
from
01.020210 -
NGEU
50.00
HORIZON-HLTH-2024-CARE-04-two-
stage
30.00
from
01.020210
30.00
HORIZON-HLTH-2023-TOOL-05 214.00
from
01.020210
87.31
from
01.020210 -
126.69
Horizon Europe - Work Programme 2023-2024
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NGEU
HORIZON-HLTH-2024-TOOL-05-two-
stage
25.00
from
01.020210
25.00
HORIZON-HLTH-2024-TOOL-11 25.00
from
01.020210
25.00
HORIZON-HLTH-2023-IND-06 56.00
from
01.020210
26.00
from
01.020210 -
NGEU
30.00
HORIZON-HLTH-2024-IND-06 12.00
from
01.020210
12.00
Contribution from this part to call
HORIZON-MISS-2023-CANCER-01
under Part 12 of the work programme
104.82
from
01.020210
104.82
Other actions
Grant to identified beneficiary according
to Financial Regulation Article 195(e)
35.60 0.60
from
01.020210
35.60 0.60
Expert contract action 2.00 2.00
from
01.020210
2.00 2.00
Grant awarded without a call for
proposals according to Financial
Regulation Article 195
1.00 1.00
from
01.020210
1.00 1.00
Public procurement 10.48 2.30
from 10.48 2.30
Horizon Europe - Work Programme 2023-2024
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01.020210
Subscription action 6.30 6.30
from
01.020210
6.30 6.30
Contribution from this part to Expert
contract action under Part 12 of the
work programme
0.24
from
01.020210
0.24
Contribution from this part to Indirectly
managed action under Part 12 of the
work programme
3.00
from
01.020210
3.00
Estimated total budget 1010.45 521.20