Many of our most common medicines are not effective in treating large numbers of the patients they are supposed to help and more than six percent of acute hospital admissions are caused by serious adverse reactions to medicines. Moreover healthcare costs across the EU are rising as the population ages and chronic diseases become more prevalent. Personalised medicine addresses these challenges, with tailor-made prevention and treatment strategies for individuals or groups of individuals. As a result, patients receive the specific therapies that work best for them, and no money is wasted on trial and error treatments. Personalised medicine is a fast-growing market and Europe's healthcare industry has the potential to build on its leading position, providing economic growth and jobs.
Although there is no universally accepted definition, the Horizon 2020 Advisory Group has defined personalised medicine as "a medical model using characterization of individuals’ phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention". This definition was also used by EU Health Ministers in their Council conclusions on personalised medicine for patients, published in December 2015.
It is important to note that that personalised medicine does not only concern medicines or medicinal products. A better understanding of the biological mechanisms and environmental interactions that govern health and disease will impact the entire health care continuum, from health research to patient care. The move towards personalised medicine can be seen as an evolutionary rather than revolutionary process. Although some personalised medicine approaches have already been introduced into practice in Europe, we are still at an early stage of implementation. Significant paradigm shifts will need to take place in medical research and health care for this innovative area to be fully exploited.
On the agenda
Over 30 European and international members representing research funders and policy-making organisations, together with the European Commission as observer, have established an initiative called the International Consortium for Personalised Medicine, or "ICPerMed". The ICPerMed was officially launched in November 2016.
Together, the member organisations of ICPerMed will work to:
- Establish Europe as a global leader in personalised medicine research
- Support the personalised medicine science base through a coordinated approach to research
- Provide evidence to demonstrate the benefit of personalised medicine to citizens and healthcare systems
- Pave the way for personalised medicine approaches for citizens
ICPerMed will focus on fostering and coordinating research and innovation actions to deliver on its mission statement. Over the past year, the members of ICPerMed have developed a common Action Plan with central research and research-supporting activities in all areas relevant to personalised medicine.
Read more about the initiative and the Action Plan.
The Personalised Medicine Conference 2016 held in Brussels on 1-2 June 2016 explored personalised medicine through a research policy lens. It also informed the continued work with ICPerMed's Action Plan. You can find more information about the conference, including all presentations, session videos and a report on the conference website.
Further readingAn overview of the progress made in personalised medicine, with a specific focus on '-omics' technologies and a discussion about the opportunities and challenges it presents for healthcare systems in Europe, can be found in the staff working document published by the Commission on 31 October 2013.
Towards a common European data space
The European Commission put forward measures to foster development of new data-based products, boost EU competitiveness in the global market and improve healthcare data sharing in Europe. The Communication on “enabling the digital transformation of health and care in the digital single market; empowering citizens and building a healthier society” was adopted on 25 April 2018. It focuses on the digital aspects of health and care, and outlines actions under three pillars:
- Citizens' secure access to their health data, also across borders
- Personalised medicine through shared European data infrastructure
- Citizen empowerment with digital tools for user feedback and person-centred care
Pillar 2 is related to research. The case is made for the need for coordination mechanisms between authorities and other stakeholders to share, at EU-level, data and infrastructure for prevention and personalised medicine research and to develop the needed building blocks that would guarantee secure access and the feasibility of cross-border data exchanges for health research purposes. This coordinated effort of pooling data and resources across the EU will further materialise as pilots in three research areas, rare diseases, infectious diseases and the use of real-world data, to ensure that (i) EU citizens affected by life threatening or chronically debilitating rare diseases get faster diagnosis and better care (ii) better anticipate epidemics and accelerate EU-wide identification of infectious threats and (iii) use real world data to ensure that medical products, innovative technologies and therapies meet the patient's needs and lead to outcomes.