Back on stage! This year’s RAPS Euro Convergence in Amsterdam gave Dr. Meriem Bouslouk-Marx the floor to outline the interdependencies of EU and national legislative reviews. She analysed the implications of potential changes of the EU Orphan legislation such as orphan designation, market exclusivity and other incentives currently in place for the German benefit assessment in the light of upcoming legislative changes in Germany. Her presentation was also a great opportunity to discuss with experts different strategies for regulatory and health technology assessment in Germany in anticipation of the hypothetical framework changes for rare diseases.
Meriem Bouslouk-Marx presents the role of legislation for patient access to orphan drugs
From right: Beate Schmidt, Regulatory Benefits and Meriem Bouslouk-Marx, MBM Future Health
Background
International collaboration has been a focus of my work from the outset. At the Federal Joint Committee (G-BA) in Germany, a more intensive collaboration in Heath Technology Assessment (HTA) hence intrigued me. In fact, we call it benefit assessment in Germany. The interdependencies between European policy and the benefit assessment of orphan drugs is a fascinating field. From the outset, I was in favour of a dialogue between the different HTA bodies to work on solutions for the challenges of orphan drug HTA.
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