Actions in support of the International Consortium for Personalised Medicine

Each action should focus on one of the following fields:

1. International aspect: The action should focus on building links with third countries by analysing the potential and advantages of collaboration in personalised medicine (PM) with those countries, studying areas of interest for Europe in PM collaboration and promoting international standards in the field. In particular the uptake of personalised approaches in health systems and healthcare should be addressed, taking into account social, cultural, ethical and legal aspects, health economy issues and equitable healthcare. For the 2018 call, the project should focus on CELAC[[Antigua and Barbuda, Argentina, Bahamas, Barbados, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominica, Dominican Republic, Ecuador, El Salvador, Guatemala, Haiti, Grenada, Guyana, Jamaica, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Saint Lucia, Saint Kitts and Nevis, Saint Vincent and the Grenadines, Suriname, Trinidad and Tobago, Uruguay,Venezuela]] as a group of countries, and for the 2019 call on China. For the 2020 call, the project should focus on countries in Africa[[African Union Member States]], linking also into the EU-AU (African Union) policy dialogue and taking into account the new Africa-Europa Alliance for Sustainable investment and Jobs[[https://www.africa-eu-partnership.org/en/stay-informed/news/european-commission-unveils-new-africa-europe-alliance-sustainable-investment-and]]. Alignment with activities of the Global Alliance for Chronic Diseases (GACD) and The European and Developing Countries Clinical Trials Partnership (EDCTP) activities should be explored. Special attention should be given to prediction and prevention, and to promoting well-being for all at all ages. Furthermore, the project should seek to integrate local knowledge and practice. Data safety and privacy should be addressed in line with existing standards and legislation. The project should have a duration of at least four years and address sustainability beyond that to ensure longer term structuring effect. Due to the specific challenge of this topic, in addition to the minimum number of participants set out in the General Annexes, proposals shall include at least one participant based in the international partner region; CELAC (2018 call), China (2019 call) and Africa (2020 call).
2. Regional aspect: The action should establish and support networking between regions and interregional cooperation in different European countries, in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and PM expertise while taking into account broader socio-economic and cultural aspects. The focus of the action can include aspects of genomic analysis, me-Health (mobile and electronic Health), telemedicine etc. but should aim at structuring PM application at regional level. Linkage to existing inter-regional projects (financed by INTERREG programmes) or interregional partnerships of Thematic Smart Specialisation Platforms will be actively encouraged. (2018 call).
3. Healthcare- and pharma-economic models for personalised medicine, interlinking European public health approaches with medical practice and financing. The action should carry out studies in support of research in and development of new health- and pharma economic models for PM, including prevention, to capture value and to develop relevant health financing models. Analysing mid- and long-term impacts of innovative products designated for sub-sets of patient populations on the patients themselves and on public health systems. Assessing the benefits of personalised medicine development for citizens and their broader social environment while ensuring patient safety, access, equity, solidarity, data safety and financial sustainability of public health systems in the EU. The action should involve different relevant stakeholders and take into account work being carried out by other EU funded initiatives, such as EUnetHTA[[European Network for Health Technology Assessment: http://www.eunethta.eu/]]. SME participation is encouraged. Results of the studies and workshops should be actively disseminated to a wider audience, including relevant authorities, professionals and the wider public. (2018 call).
4. Standardisation for clinical study design. Establishment of innovative clinical trial design methodology for PM, including guidelines for research and reflection papers. The action should take into account sex/gender differences as well as the work done by relevant stakeholders and authorities such as EMA[[European Medicines Agency: www.ema.europa.eu]] and the HMA network[[Heads of Medicines Agencies: http://www.hma.eu/]] as well as the European legal framework[[Especially the clinical trials regulation (EU) No 536/2014 and the data protection regulation (EU) 2016/679]]. SME participation is encouraged. The results of the studies and workshops should be actively disseminated to a wider audience, including, industry, researchers and other professionals. (2019 call).
5. ICPerMed secretariat: The project should continue the work done by the secretariat for ICPerMed, e.g. maintenance of existing services, organising the meetings of the ICPerMed Executive Committee, convening dedicated workshops and preparing and issuing updates of the ICPerMed Action Plan. Furthermore maintaining the network of policy makers and funders gathered in ICPerMed and expanding the membership to new interested and complementary partners as well as maintaining communication with all EC funded activities related to ICPerMed (2020 call).

For grants awarded under this topic for Coordination and Support Actions it is expected that results could contribute to European or international standards. Therefore, the respective option of Article 28.2 of the Model Grant Agreement will be applied.

The Commission considers that proposals requesting a contribution from the EU of between EUR 1.5 and 2 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Personalised Medicine is a very broad and multifaceted area where success relies on a well-functioning collaboration between several disciplines and different actors. While great advances have been made in some fields of medicine, in particular in stratification of cancer patients and in addressing rare diseases, most of today's healthcare protocols do not include personalised approaches apart from occasional division into broad age groups (children/adults/elderly), sex or ethnicity. Furthermore the prevention aspect of personalised medicine, i.e. identifying individuals prone to develop certain diseases, is largely isolated from treatment options. As is the case for a relatively nascent field there is a need for standardisation of approaches, including for sampling, data storage, interpretation and data exchange and also for clinical trials design and reimbursement models. European countries with their social model of healthcare along with (in several cases) centralised cost reimbursement, are ideally placed to lead the way for an integrated health management system. Many needs for coordination and support activities have been identified by ICPerMed[[http://icpermed.eu]] an EU Member States led initiative which includes representatives from most EU countries along with several other European countries, Brazil and Canada. The EC currently supports ICPerMed with a grant to operate its secretariat until October 2020[[H2020 Grant Agreement 731366]]. Wider internationalisation of ICPerMed can be underpinned by coordinating networking activities with third countries.

Contributing to the implementation and reach of the ICPerMed initiative; furthermore:

1. International aspect: Integrating the country/group of countries into ICPerMed activities. Support wider adoption of standards developed in Europe. Support the EU-AU policy dialogues relevant to research and health (2020 call). Contribute towards the UN Sustainable Development Goal 3: Ensure healthy lives and promote well-being for all at all ages.
2. Regional aspect: Strengthened links between European regions setting up or planning personalised medicine healthcare approaches. Aligning research funding with ongoing and foreseen investments e.g. from Structural Funds. Recommendations on best practice in implementing PM at regional level.
3. Healthcare- and pharma-economic models: Increased understanding of personalised medicine perspectives on how to capture value, develop institutional support and design relevant payment models. Recommendations for faster translation from discovery to patients'/citizens' access. Contributing to understanding of trends and dynamics in the pharmaceutical markets in relation to increased emphasis of research and development efforts on PM. Suggestions on how savings through prevention can be included in payment and reward models and contribute to the sustainability of public health systems in the EU. Improved knowledge and understanding among healthcare professionals and the wider public of potential benefits of PM approaches.
4. Standardisation for clinical study design: Contribute to standardisation of PM clinical trial design. Demonstrate feasibility and importance of PM approaches. Underpin accelerated market uptake. Improved knowledge and understanding among healthcare professionals, regulatory authorities and industry how best to adapt clinical trials designs to stratified patient populations.
5. ICPerMed secretariat (2020 Call): Ensure continuity of the operations of ICPerMed beyond 2020. Increase the visibility of the consortium and ensure openness of the structure. Provide harmonised vision for the further development of personalised medicine. Contribute to the convergence of members' approaches to personalised medicine and further alignment of research efforts in the field.