Position Paper

EBE-EFPIA Set Out Policy Positions in Their Personalised Medicines Manifesto

18 Sep 2017

The EBE-EFPIA Personalised Medicine Working Group have developed a Manifesto that aims to highlight policy elements that are considered essential to ensure that personalised medicines and their paired diagnostic tests, also called companion diagnostics, successfully reach patients.

The Manifesto consists of three distinct parts, supported by a glossary, addressing the following policy needs:

  • A clear and coordinated process for the regulatory approval of personalised medicine (Part I)
  • A clear and predictable process for the economic/value assessment of and access to personalised medicine (Part II)
  • A European regulatory framework that is supportive of innovation – creating a flexible and “forward-looking” regulatory and reimbursement environment (Part III) – which includes:

o   The use of multi-marker signatures
o   The use of electronic health record systems that facilitate clinical research, ease the collection and processing of real-world data and improve clinical practice
o   Data protection legislation that effectively facilitates the use of “big data” in healthcare research.

For each of the three parts above, barriers as well as related solutions are highlighted.

EBE EFPIA PMWG Manifesto Part 1

EBE EFPIA PMWG Manifesto Part 2

EBE EFPIA PMWG Manifesto Part 3

EBE EFPIA PMWG Manifesto Glossary