Europe: Discussions on Orphan Drugs and the Clinical Trials Directive in Brussels

On 5 September 2012, experts from European Biopharmaceutical Enterprises (EBE) and the European biotech association EuropaBio met in Brussels for the meeting of the Joint Rare Diseases and Orphan Medicinal Products Task Force. BIO Deutschland was also represented at the meeting. The purpose of the meeting was for the participants to learn more about progress in the licensing of medicinal products for rare diseases (orphan drugs) and to discuss how patients can be given easier access to such drugs. The participants discussed progress on the recommendation by the European Commission, which is currently being drafted by the European Union Committee of Experts on Rare Diseases (EUCERD). The objective of the recommendation is to help the national licensing authorities to reach better decisions by improving the flow of information on the clinical added value of orphan drugs.

BIO Deutschland has been active for a long time in the field of orphan drugs and will continue to attend the joint task force meetings. The next meeting is scheduled to take place in mid-November.

The following day (6 September 2012), a BIO Deutschland representative attended the meeting of EuropaBio’s working group on clinical trials to present its positions at the European level and to discuss developments with other member states. BIO Deutschland also reported on its recent meeting with the Federal Ministry of Health in Bonn.

During the discussion, the participants were critical of the EU’s Proposal for a Clinical Trials Regulation, which was adopted on 17 July 2012, and identified the same problems that BIO Deutschland had previously listed in its statement. EuropaBio is also planning to produce a statement. BIO Deutschland will continue to accompany this process.