Participation in the Hearing on Compassionate Use at the Federal Health Ministry in Bonn
The Federal Ministry of Health is currently drafting a bill on distributing medical drugs, which have not been authorised or licensed, in compassionate use cases (Act on Medication for Compassionate Use). This aims to regulate the procedure at the responsible Federal Higher Authority and among the individuals involved in cases of distributing as yet unlicensed medical drugs for compassionate use in accordance with clause 21, paragraph 2, no. 6 of the Medical Drugs Act in connection with Article 83 of Regulation (EU) No. 726/2004 (so-called compassionate use). BIO Deutschland issued a statement on the draft law on 10 May 2010 and attended a discussion with the parties involved in the matter at the invitation of the Federal Ministry of Health on 27 May 2010 in Bonn.
The demarcation of the Compassionate Use Act to individual case distribution in accordance with clause 73, paragraph 3 of the Medical Drugs Act and the procedure for registering a compassionate use programme in particular were discussed from a critical angle. BIO Deutschland made clear that the requirements and prerequisites for compassionate use must be formulated in such a way that the companies that provide the as yet unlicensed medication free of charge are not subject to additional burdens.
The position paper by BIO Deutschland on the draft of the Act on Medication for Compassionate Use is available online in German at (http://www.biodeutschland.org/positionspapiere.html ).