The European Biopharmaceutical Enterprises (EBE) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) Joint Personalised Medicine Working Group have released a Manifesto on personalised medicine. The Manifesto sets out the required future steps that will allow a change in the European policy environment.
The essential policy elements that are necessary to ensure that personalised medicine and its paired diagnostic tests (companion diagnostics) reach patients successfully are highlighted in the Manifesto. The Manifesto has been released ahead of the first congress of the European Alliance for Personalised Medicine (EAPM) “Personalising your health: A global imperative!” which runs from 27th-30th November 2017 in Belfast, Northern Ireland.
Personalised medicine can be defined as “a medical model using characterization of individuals’ phenotypes and genotypes 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”.
The Manifesto addresses the following policy needs:
- Part 1 – a clear and coordinated process for the regulatory approval of personalised medicine
- Part 2 – a clear and predictable process for the economic assessment of and access to personalised medicine
- Part 3 – a European regulatory framework that is supportive of innovation, creating a flexible and “forward-looking” regulatory and reimbursement environment. This includes: use of multi-marker signatures; use of electronic health record systems that facilitate clinical research and data protection legislation that effectively facilitates the use of “big data”.
A paradigm shift from the traditional ‘one-size-fits-all’ approach to personalised medicines may occur and it is now more possible to tailor treatments to patients in a way that enables them to benefit fully from the right treatment at the right time. Another advantage of personalised medicines is that patients who would not benefit from a given medicine could be identified, while avoiding a potential high risk of adverse reactions.
Despite the advantages, personalised medicine is not yet accessible to patients and decisions are still to be made with regards to its positive contribution to the sustainability and efficiency of healthcare systems in Europe.