MEPs' personalised medicine Interest Group launches with call for rules to ‘keep up with science’

"The pace of change in health is breathtaking," Tapani Piha (pictured), of the European Commission’s DG Sanco, told a high-level meeting in Brussels' European Parliament this week.

The Commission official was one of several speakers addressing a European Alliance for Personalised Medicine (EAPM) Regulatory Affairs workshop on 10 December.

The workshop also acted as the official launch of the Alliance’s STEPs MEPs Interest Group, made up of 15 cross-party members.

STEPs stands for Specialised Treatment for Europe’s Patients, an EAPM campaign running successfully for the last year.

Representing the Interest Group’s MEPs were Nessa Childers, Phillipe De Backer, Kay Swinburn and Cristian Busoi, all of whom delivered speeches on topics ranging from the EU Semester to research and ‘Big Data’.

The meeting was opened by former commissioner for health and consumer affairs David Byrne, co-chair of EAPM, who explained that much had changed in the area of health, and especially personalised medicine, since his days in the Berlaymont.

The former attorney-general for Ireland also impressed upon the meeting that legal frameworks and regulations had to reflect these changes and keep up with science.

Byrne added: "The field of regulatory affairs in the European Union is by its very nature a complex one. Perhaps nowhere is it more complex than in the arena of health – and certainly this is the case when it comes to legislating for the exciting advances and growing expectations brought about by personalised medicine.

"The issues and rules surrounding, for example, in vitro diagnostic devices and data protection are labyrinthine. Yet despite the complexity, these topics need to be addressed swiftly and effectively if we are to be able to give the right treatment to the right patient at the right time, while simultaneously offering equal access to the best treatment available."

Speaking to journalists after the meeting, Strasbourg-based urologist and EAPM treasurer Didier Jacqmin said: “It is vital that all stakeholders in personalised medicine engage directly with MEPs and, of course, the European Commission to get their points across to parliament, DG Sanco and other connected directorates-general.

“For example, the huge moral, ethical and legislative issues surrounding data protection and in vitro diagnostic medical devices are currently hot topics for discussion in Europe. Workshops such as this allow stakeholders and legislators to engage directly with each other.”

Jacqmin added: “It is only in working together that Europe can move forward and bring personalised medicine closer to patients and, thus, create a healthier EU. This workshop is designed to be a step in that direction and will be followed by many more in the Eiropean Parliament covering the topics being addressed by EAPM’s Working Groups, all of which include several MEPs.”

On Big Data, Jacqmin further added: “Most patients will share their medical data - within agreed limits - yet some regulations can be over-cautious and create barriers. Regulators must find a balance between protecting the privacy of the patient while allowing a flow of vital information that could benefit society as a whole.”

The meeting was also addressed by EORTC’s Anastassia Negrouk, as well as Paolo Casali from ESMO, Céline Bourguignon of Johnson & Johnson (representing EDMA), Mario Romao of INTEL and Mark Lawler of Queen’s University Belfast.

Video of high-level meeting.

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