European partnership fostering a European Research Area (ERA) for health research

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” and destination 1 “Staying healthy in a rapidly changing society”. To that end, proposals under this topic should aim for delivering results that are contributing to all of the following expected outcomes:

• Based on a trusted governance and effective working modalities, research funders, health policy-makers and the research community work together in order to identify and prioritise topics of common interest and European benefit;
• Research funders and policy-makers:
  • support the generation of knowledge related, but not limited, to cardiovascular diseases, diet related diseases and nano medical technologies, and have access to and make use of the evidence on the benefits and drawbacks of health interventions, in particular for optimising clinical management, personalised medicine (coordinating with the future Partnership on Personalised Medicine) and avoiding overtreatment;
  • overcome the main obstacles to test health interventions at European level. Therefore, the research community, independently from private interest, can conduct large-scale Investigator-Initiated Clinical Studies (IICSs)^[1] of various health interventions addressing important public health needs in a seamless way, effectively addressing known challenges related to, for example, appropriate study design, ethics (including special patient groups^[2]), regulatory and institutional approvals, patient recruitment, management of informed consent, as well as, bio banking of human samples;
• Public health research systems in the ERA are more effective and integrated. Utilization of health services, preventative measures, technologies, tools and digital solutions are more cost-effective;
• Health and care authorities, policymakers and other stakeholders use the research results to develop evidence-based strategies and policies, and deploy good practices to European countries and regions;
• Patients and citizens are more knowledgeable about disease threats and contribute to a patient-centred decision-making process, assuring better adherence to knowledge-based disease management strategies and policies (including for controlling outbreaks and emergencies);
• Countries cooperate better and use context-specific knowledge and evidence to make their health and care systems more sustainable and resilient with respect to upcoming needs and crises (Complementary with the Co-Funded Partnership on Transforming Health and Care Systems with which strong links will be established).

The “ERA for Health” Partnership will be a leading European initiative for the flexible joint programming of health related research and innovation programmes, effectively involving a wide variety of European funding organisations.

This Partnership will be open in particular to public funders of Health research at both national and regional level in the Member States, countries associated to Horizon Europe and to other funders such as philanthropic organisations. Special attention will be placed on engaging with and including many research funders with relatively small budgets.

The Partnership will integrate research and innovation areas covered by previous ERANET co-fund actions, Joint Programming Initiatives (JPIs), as well as IICSs. It will be composed of two phases.

Phase 1 will integrate European initiatives selected as most relevant by the partners^[3] and initially implement joint calls on nutrition- and lifestyle-related diseases, cardiovascular diseases and nano-medicine. In parallel, it will test the possibility to carry out joint calls for proposals for R&I activities on IICSs. Phase 1 will last for 2 years. After this period, the Horizon Europe Health Programme Committee will decide whether to extend and intensify the focus on IICSs. This decision will be based on objective criteria to be specified in the final proposals. They will only affect the focus area and budget of the partnership, not its existence over the 7 years.

Phase 1 will start by co-creating an accepted and effective governance mechanism to achieve the following objectives:

1. To jointly identify and implement a common good/best practice funding strategy in priority areas of common interest and European benefit to advance health research and develop innovation. Partners will implement jointly calls to be funded each year. These will prioritize areas that are not adequately covered by (or can complement) existing programmes (i.e. Horizon Europe Work Programmes, other existing or planned partnerships and other actions).

2. To define and have a first measure of coordinated investment in Public Health Research for the European Research Area (EU and Associated countries). This entails agreeing towards the end of Phase 1, on (i) boundaries (what is and what is not “Health research”), (ii) a taxonomy (which programmes are in or out) and (iii) a methodology according to the JOREP^[4] data, JRC and EUROSTAT standards for measuring the baseline of this Key Performance Indicator.

3. To develop new approaches that overcome known bottlenecks and challenges to implement multinational IICS. This will be achieved in close collaboration with ongoing initiatives^[5] to support the conduct of multinational non-commercial studies. This would result in establishing appropriate mechanism(s) to identify topics, pool-funding sources, and to launch (joint) calls for EU wide multinational IICSs on various health interventions^[6] addressing important public health needs.

By the end of Phase 1, all necessary procedures and support should be operational to launch a first call for IICSs involving several countries on selected health interventions that address important public health needs.

During Phase 2, additional multinational calls for IICSs and joint calls for other priority areas will be launched in accordance with the decision of the Health Programme Committee taken at the end of Phase 1 on the focus of the Partnership and the distribution of the budget between IICSs and other areas.

The Clinical Trials Regulation (EU) 536/2014 will become applicable in January 2022. The overall aim of the new Regulation is to make Europe more attractive for clinical trials. With these changes, the Regulation intends to provide additional support to multinational trials. As a new concept, it also introduces low-interventional trials (e.g. pragmatic trials to optimise treatment) with risk-proportionate regulatory requirements. This type of trials can also be supported by actions of this partnership.

The continuously growing arsenal of health interventions, whether it is a new pharmaceutical product, a medical device, a surgical intervention, or other measures utilised during health and care provision, reflecting the increasing demand for better quality of care by citizens, force decision makers of public health systems to optimally allocate limited resources in a well-informed manner. Large-scale IICSs generate data on safety and effectiveness of a health intervention, often in real-world settings, and thus provide evidence to answer questions that clinicians face in their day-to-day practice in order to optimise the clinical management of patients beyond the context of marketing authorisation application for medicinal products. Such studies deal with potential diagnostic and therapeutic interventions that do not attract, or could go counter commercial interest. These clinical studies are critical to support endorsement of healthcare strategies (repurposing, comparative effectiveness, treatment combination or optimisation studies, personalised medicine trials).

By pooling existing resources, eliminating redundancies and reducing fragmentation, the implementation of multinational IICSs covered by this Partnership will benefit from better access to high number of study participants/patients, medical expertise and facilities, enhanced methodological standards; and shared costs, tools and procedures. All these aspects will contribute to generate robust and reliable clinical evidence, increase the potential for broad implementation of research outcomes; prevent duplication of research efforts and allow broad uptake by health systems.

IICSs supported by this partnership should i) establish new indications of a given existing health intervention for a condition where alternative solutions do not exist or are sub-optimal; ii) optimise or develop new, personalised care pathways including for high-priced medical interventions/treatment modalities; iii) introduce new health interventions with clear relative clinical efficacy/effectiveness compared to existing alternatives (including preventative measures); iv) accelerate the uptake of new interventions by health care systems.

Support by European research infrastructures, required to perform multinational clinical studies at scale, will, in particular, build on the asset of existing research infrastructures, such as the European Clinical Research Infrastructure Network (ECRIN)^[7] for sponsor-delegated study responsibilities, and Biobanking and Biomolecular Resources Research Infrastructure (BBMRI)^[8] for the management of biosamples and linked data that are generated under the studies.

The partnership should bring together a broad range of actors with a common vision of future. 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

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 objectives of the Commission proposal for the new EU4Health Programme (COM(2020) 405 final).

This partnership should also contribute to achieving the objectives of the Pharmaceutical Strategy for Europe^[9], in terms of fulfilling unmet medical needs 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, health and care institutions, innovators, policy makers), to create a critical mass of resources and to implement a long-term Strategic Research and Innovation Agenda (SRIA), the partnership will address the following objectives:

• Improve the utilisation of existing health technologies in clinical practice
• Support research in relevant medical fields and intervention areas (prevention, diagnosis, treatment)
• Implement and develop Responsible Research & Innovation (RRI) in multiple ways (in partnership operationalization, in calls and in project evaluation and monitoring)
  • Engage society through citizens and patients
  • Promote formal and informal science education
  • Ensure gender equality, in both the research process and research content
• Provide support and build capacity, in particular in conducting IICSs at European scale
• Promote open access and data sharing^[10]
• Communicate and disseminate research outcomes, in particular to decision makers

This Partnership should 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;
• Framework to overcome challenges in conducting IICSs
• Capacity building activities;

The Partnership is open to all EU Member States, as well as to countries associated to Horizon Europe and will remain open to those 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 health and care authorities, organisations and providers.

The Partnership may also encourage engagement with other relevant Ministries and research funders. It will 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. The governance should involve 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 (institutionalized and co-funded) and missions as set out in the working document on ‘Coherence and Synergies of candidate European partnerships under Horizon Europe’^[11] 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^[12], the Digital Europe Programme (DIGITAL)^[13], the European Social Fund Plus (ESF+)^[14], the European Regional Development Fund (ERDF)^[15], InvestEU^[16], the Recovery and Resilience Facility (RRF)^[17] and the Technical Support Instrument (TSI)^[18].

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 primary activities of this action in order to be able to achieve its objectives.

The expected duration of the partnership is seven years.

For Phase 1 (2 years) the EU contribution will be limited to a maximum of 30% of the total eligible costs of the action with a maximum of EUR 30 million. The total EU contribution for the overall duration (2 years of Phase 1 + 5 years of Phase 2) is expected to be EUR 110 million (EUR 30 million for Phase 1 and EUR 80 million for Phase 2, provided Member State commit matching funds).

[1] In this text, IICS means a clinical study in which a health technology (e.g. a medicinal product, a medical device, an in-vitro diagnostic medical device, a surgical or other medical intervention) is tested in humans, independently from commercial interest and for public health benefits.

[2] The Pharmaceutical Strategy for Europe refers to including representative participation of population groups, for example gender and age groups, that are likely to use the medicinal product investigated in the clinical trials to ensure appropriate safety and efficacy.

[3] Horizon 2020 ERA-NETs addressing Cardiovascular Diseases (ERA-CVD), Nano Medical Technologies (EuroNanoMed), and the JPI A Healthy Diet for a Healthy Life (HDHL, Diet related diseases)

[4] Handbook on data collection on joint and open research programmes (JOREP) - Publications Office of the EU (europa.eu)

[5] Examples are the European Clinical Research Infrastructure Network (ECRIN) and the EU wide clinical trial networks set up for COVID19 vaccines https://www.vaccelerate.eu/ and therapeutics https://www.recover-europe.eu/coordination-of-european-covid-19-adaptive-platform-trials/Handbook on data collection on joint and open research programmes (JOREP) - Publications Office of the EU (europa.eu)

[6] Wide definition of health intervention: medicinal products, medical devices, surgical or other invasive procedures, other medical interventions including preventative measures

Examples are the European Clinical Research Infrastructure Network (ECRIN) and the EU wide clinical trial networks set up for COVID19 vaccines https://www.vaccelerate.eu/ and therapeutics https://www.recover-europe.eu/coordination-of-european-covid-19-adaptive-platform-trials/

[7] Facilitating European Clinical Research | ECRIN

[8] Home | BBMRI-ERIC: Making New Treatments Possible

[9] COM(2020) 761 final

[10] Also adhering to the FAIR (findability, accessibility, interoperability, and reusability) data principles

[11] https://ec.europa.eu/info/horizon-europe/european-partnerships-horizon-europe_en#synergies

[12] EU4Health 2021-2027 – a vision for a healthier European Union | Public Health (europa.eu)

EU4Health Programme (COM(2020) 405 final) Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1).

[13] Digital Programme | Shaping Europe’s digital future (europa.eu)

[14] Home | European Social Fund Plus (europa.eu)

[15] European Regional Development Fund - Regional Policy - European Commission (europa.eu)

[16] InvestEU | InvestEU (europa.eu)

[17] Recovery and Resilience Facility | European Commission (europa.eu)

[18] Technical Support Instrument (TSI) | European Commission (europa.eu)