Orphan Drugs and Biosimilars Discussed by BIO Deutschland’s Working Group on Health Policy

Topics discussed at the sixth meeting of BIO Deutschland’s Working Group on Health Policy, which took place in Munich on 15 October 2010, included further scrutiny of the Law on the New Regulation of the Medication Market, inspection of the Orphan Drug Regulation and its positive impact on research and development on medication for rare diseases, and biosimilars and biobetters.

The Law on the New Regulation of the Medication Market is currently at the final stage of discussion in the Bundestag, with the second and third readings in the chamber of the Bundestag scheduled for 11 November. Before this date, the Bundestag’s Standing Committee on Health will deal with the many suggested amendments and applications.

The working group had already contributed statements and positions to the legislative process from an early stage. The planned exemption of orphan drugs from benefit assessment, as stated in the coalition’s current amendment application, was positively received. The further shaping of the contents of the regulations and methods for early benefit assessment, as well as framework agreements between manufacturers’ associations and the Council of Statutory Health Insurance (GKW-Spitzenverband) as regards pricing negotiations are directly related topics on which the working group experts will represent the interests and suggestions by BIO Deutschland member companies in order to prevent small and medium-sized enterprises in particular from being overloaded.

In addition, the review of the European Orphan Drug Regulation is pending. The working group members plan to cooperate actively on this with European partner associations. The benefits and therapeutic progress for the affected groups of patients made possible by the promotion of research and development on rare diseases under the Orphan Drug Regulation are to be listed clearly and concisely in order to create a positive image among the public. The working group also plans to produce concrete suggestions for further improvements to this promotion.

Furthermore, the working group experts decided to produce information on the topic of biosimilars and biobetters in order to enable biotech companies and entrepreneurs to acquire an insight into this field of work.

BIO Deutschland members are welcome to request a copy of the minutes from the association’s office.