Ahead of the first congress of the European Alliance for Personalised Medicine (EAPM) “Personalising your health: A global imperative!” on 27-30 November 2017 in Belfast, the Joint EBE-EFPIA Personalised Medicine Working Group, in its Manifesto on personalised medicine, highlights essential policy elements that are necessary to ensure that personalised medicine and its paired diagnostic tests (also called companion diagnostics) reach patients successfully.

Personalised medicine has been defined 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 in the Council conclusions on personalised medicine for patients in December 2015.

In three complementary documents, the Manifesto sets out the necessary next steps that will enable a change in the European policy environment, and calls for:

• A clear and coordinated process for regulatory approval of personalised medicine (Part 1). This section stresses and details the need to clarify the role and responsibility of each player participating in the various phases of bringing personalised medicine (medicinal product and diagnostic test) to patients.
• A clear and predictable process for the assessment of and access to personalised medicine (Part 2). Evidence for this section is being collected currently and analysed by Charles River Associates and will result in concrete recommendations aimed at improving patient access to personalised medicine (these results are expected by January 2018).
• A European regulatory framework that supports innovation by creating a flexible and “forward-looking” regulatory and reimbursement environment (Part 3). This section highlights the impact of evolving science (multi-marker signatures, electronic health records, big data) and the need to adapt European regulatory and reimbursement frameworks to be supportive of this type of innovation.

“Personalised medicine represents a paradigm shift departing from the traditional ‘one-size-fits-all’ approach,” says Barbara Freischem, EBE Executive Director. “With an increased understanding of molecular disease mechanisms, we are now better able to tailor treatments to patients in a way that enables them to benefit fully from the right treatment at the right time. This also means that we can identify patients who would not benefit from a given medicine, while avoiding a potential high risk of adverse reactions. However, despite this significant advantage, personalised medicine is not yet fully accessible to patients and decision-makers must still be convinced of its positive contribution to the sustainability and efficiency of healthcare systems in Europe”.

The Manifesto, supported by a glossary, is available here.

About EBE
The European Biopharmaceutical Enterprises (EBE) represents the voice of biopharmaceutical companies of all sizes in Europe and is a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA). Established in 2000, EBE is recognised as the leading biopharmaceutical association in Europe. To learn more about EBE, visit www.ebe-biopharma.eu

About EFPIA
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world. To learn more about EFPIA, visit: www.efpia.eu

Media Contact
Barbara Freischem, Executive Director
European Biopharmaceutical Enterprises – EBE
Tel: +32 2 626 25 64
email: barbara@ebe-biopharma.org