European partnership fostering a European Research Area (ERA) for health research (Phase 2)

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of Destination “Tackling diseases and reducing disease burden”. To that end, the proposal under this topic should aim to deliver results that are directed, tailored towards and contributing to all the following expected outcomes:

• Based on a trusted governance and effective working modalities, research funders, health policymakers and the research community work together in order to identify and prioritise topics of common interest and European benefit;
• Research funders and policymakers support the generation of knowledge related, but not limited, to cardiovascular diseases, prevention and public health, 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, patient safety, personalised medicine (coordinating with the European Partnership for Personalised Medicine) and avoiding overtreatment;
• In addition to the well-established regular Joint Transnational Calls in the area of pre-clinical research, research funders and policymakers use the funding scheme developed in the Phase 1 of the European partnership fostering a European Research Area (ERA) for health research (ERA4Health) to support testing of health interventions in the clinical setting at European level. Therefore, the research community, independently from private interest, can conduct large-scale multi-country Investigator-Initiated Clinical Studies (IICSs)^[1] of various health interventions addressing important public health needs in a seamless way, effectively addressing known challenges and obstacles 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, biobanking of human samples;
• Public health research systems in the ERA are more effective and integrated. Utilisation 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;
• 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 other current and future co-funded European Partnerships with which strong links will be established).

There is a need for health research at the EU and Associated Countries level to be more efficient in delivering safer, better and higher-quality solutions for prevention, detection, diagnosis, treatment, and management of diseases, as well as providing better and equal access and affordable healthcare systems to the citizens. Additionally, the high quality of evidence generated by the large multi-country clinical trials comparing to fragmented national or regional efforts confirmed the added value of multinational collaboration, supported by multinational funding schemes. In this regard, a European partnership proposing a new model for impactful multinational collaborations in funding health research is a key initiative to play a central role in addressing public health needs.

ERA4Health^[3] - “Fostering a European Research Area for Health Research” - (Grant Agreement: 101095426) is a co-funded European Partnership in health research that aims to increase European transnational collaborative research funding by creating a funding body for joint programming in priority areas addressing European public health needs. It started in November 2022 and brings together 33 entities from 22 countries from the EU as well as Associated and Third countries. During Phase 1 (first 2 years), the main activities of the ERA4Health consortium were:

• organisation of 4 Joint Translational Calls (JTCs) focused on prevention and public health, nutrition and lifestyle-related diseases, cardiovascular diseases and nanomedicine;
• analysis of challenges and bottlenecks for investigator-initiated clinical research in the EU and Associated Countries, preparation of the supporting framework and a launch of a pilot JTC on multi-country IICS;
• developing collaboration on transversal activities, including for instance Responsible Research and Innovation guidelines, enhancing the ERA and health ecosystem, capacity building, patient safety, etc.

Taking into account that the present action is a continuation of the topic HORIZON-HLTH-2022-DISEASE-03-01 “European partnership fostering a European Research Area (ERA) for health research” and foresees an amendment to the existing grant agreement, the proposal should present the additional activities (including additional partners) to be covered by the award primarily in terms of grant agreement revisions.

The award of a grant to continue the Partnership in accordance with this call should be based on a proposal submitted by the coordinator of the consortium funded under HORIZON-HLTH-2022-DISEASE-03-01 “European partnership fostering a European Research Area (ERA) for health research” and the additional activities (which may include additional partners) to be funded by the grant should be subject to an evaluation. This evaluation should take into account the existing context and the scope of the initial evaluation as relevant, and related obligations enshrined in the grant agreement.

In this context, based on the funding scheme to support non-commercial clinical research developed during Phase 1, the main activities of the ERA4Health partnership in Phase 2 will mostly focus on additional JTCs on multi-country IICS in well-defined priority areas. In addition, the partnership’s activities initiated in Phase 1 will also be continued in Phase 2. The unique composition of the consortium gathering national funders with their competency and experience in funding health research, and links to respective ministries of research and/or health in their home countries or regions guarantees successful continuation of the current partnership via this non-competitive call under an Article 24(2) Horizon Europe Regulation action that allows for the addition of new activities to existing grant agreements (also including new additional partners where relevant).

Phase 2 will benefit from the already established effective governance mechanism to achieve the following additional objectives:

• Bringing together different stakeholders (e.g. research funders, health authorities, health and care institutions, innovators, policymakers), to update and implement the Partnership’s long-term Strategic Research and Innovation Agenda that should reflect more extended focus on multi-country IICS in the EU and Associated Countries.
• Using the novel funding mechanism developed during Phase 1, to enlarge the Partnership’s activities related to non-commercial clinical studies, including identification of specific topics, pooling of funding, and launching JTCs for EU- and Associated Countries-wide multi-country IICSs on various health interventions^[4] addressing important public health needs.
• To continue providing support and building capacity, in particular in conducting multi-country IICSs at European scale.

All types of clinical studies falling under the Clinical Trials Regulation (EU) 536/2014, including low-interventional trials (e.g. pragmatic trials to optimise treatment), may be supported by this Partnership. In particular, proposed multi-country IICSs should i) establish new indications of a given existing health intervention for conditions where alternative solutions do not exist or are sub-optimal (repurposing); ii) optimise or develop new, personalised care pathways (avoiding overlaps with activities of the European Partnership for Personalised Medicine^[5]); iii) support the development of new health interventions with clear relative clinical efficacy/effectiveness compared to existing alternatives (including preventative measures); iv) accelerate the uptake of new interventions by healthcare 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)^[6] for sponsor-delegated activities related to implementation of clinical studies, and Biobanking and Biomolecular Resources Research Infrastructure (BBMRI)^[7] for the management of biosamples and linked data that are generated under the studies.

Through pooling existing resources, eliminating redundancies and reducing fragmentation, the implementation of multi-country IICSs supported by this Partnership will benefit from better access to a high number of study participants/patients, medical expertise and facilities, enhanced methodological standards and shared costs, tools and procedures. Additionally, large-scale IICSs generate data on safety and effectiveness of a health intervention, often in real-world settings. They 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. 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.

In the context of new activities of Phase 2, this Partnership will be open to public funders of health research at both national and regional levels in the Member States, countries associated to Horizon Europe and to other health research funders such as philanthropic organisations. Additional, special attention should be placed on inclusion or engagement 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.

Cooperation with international organisations, and non-European institutions and experts may be considered. Participation of third countries is encouraged. The commitments to the partnership of entities not eligible for funding will not be counted towards the calculation of the EU funding to the partnership. Third country applicants should describe in their proposal the modalities for their collaboration and the aims they want to achieve with this kind of collaboration.

The proposal should pool the necessary financial resources from the participating 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.

When defining calls for proposals, this partnership needs to consider sex and gender-related differences and it 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.

The expected duration of Phase 2 of the partnership should not exceed nine years.

[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] https://era4health.eu

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

[5] https://www.eppermed.eu

[6] https://ecrin.org

[7] https://www.bbmri-eric.eu