Meeting of the Working Group on Regulatory Matters in Munich

The Act on Medication for Compassionate Use and the topic of Advanced Therapy Medicinal Products (ATMP) were the main subjects discussed at a meeting of BIO Deutschland’s Working Group on Regulatory Matters in Munich on 8 June. The experts spoke about the Federal Health Ministry’s draft of an Act on Medication for Compassionate Use and its impact. In this act, the supply of medication free of charge in cases of hardship (so-called compassionate use), which is included in clause 21, 2^nd paragraph, no. 6 of the Medical Drugs Law, is expanded in terms of procedures and the persons involved. There are some areas of tension, particularly concerning the restrictions on when a compassionate use programme should be set up, the planned deadlines, and the display mode with a reservation clause.

In the ATMP Act (VO 1394(2007/EG), the effects of the stipulated deadlines were discussed. The members of the working group gathered information about the procedure from the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA). The experts also discussed the existing problems that arise due to the current different requirements of the supply points in the individual federal states.

BIO Deutschland members are welcome to request a copy of the minutes of the meeting from the association’s office (tel: +49-30-3450593-30; e-mail: info@biodeutschland.org).