Orphan drugs after GSAV

The law for more safety in the provision of medicinal products (Gesetz für mehr Sicherheit in der Arzneimittelversorgung/ GSAV) passed the German Federal Council without discussion or amendment on the 28^th of June 2019. The Federal Ministry of Health and its federal minister Jens Spahn had passed the bill through the legislature within only seven months. As soon as the law comes into force, essential framework conditions for market access and the reimbursement of drugs for the treatment of rare diseases, so-called orphan drugs, will change in Germany.

The article includes a summary of the decisive points of the GSAV and a discussion of its strategic importance for the pricing and reimbursement of orphan drugs. The full text of this publication can be found in Healthcare Marketing No. 7 /2019: "Orphan Drugs - New framework conditions for approval and reimbursement".