Orphan Drugs on the European Agenda

In mid-September, BIO Deutschland attended the meeting of the Joint Task Force Orphan Medicinal Products run by the European associations EuropaBio and EBE, as well as EUCOPE’s Working Group on Orphan Drugs, to discuss the latest developments on orphan drugs. BIO Deutschland’s three European partner organisations campaign for better access for people suffering from rare diseases to medical therapies.

This means that patients need faster access to orphan drugs. The European Commission has recognised this need, and noted it in its final report on the Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) Working Group. This group was set up in 2010 as part of an initiative by Antonio Tajani, Vice-President of the European Commission, with the aim of furthering coordinated access to orphan drugs via voluntary collaboration between manufacturers, patients and the relevant authorities. Following the conclusion of the MoCA Working Group, a pilot project will explore how access to orphan drugs can be improved via better collaboration between all of the stakeholders. The Medicine Evaluation Committee (MEDEV) – an informal group composed of experts from the relevant authorities and health insurance organisations and run by the European Social Insurance Platform (ESIP) – has offered to develop and run the pilot project.

During the meeting in Brussels, the participants also discussed the restructuring of the European Union Committee of Experts on Rare Diseases (EUCERD). New members, including industry representatives, will be appointed to the committee. BIO Deutschland’s European partner organisations will suggest suitable candidates. The aim of having industry representatives on the committee is to make the links between patients, the authorities and industry even better.