European Partnership on Personalised Medicine

ExpectedOutcome:

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 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:

• 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 Medicine^[1] 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.

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’^[2] 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+, ERDF^[3], InvestEU, RRF and TSI.

The Partnership should align with EU-wide initiatives on open access and FAIR data^[4].

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.

[1]More information on the planned European Partnerships is available on the Horizon Europe Webpage.

[2]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_coherence-synergies-of-ep-under-he_annex.pdf

[3]“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

[4]See definition of FAIR data in the introduction to this work programme part.