The seminar will be hosted by Karolinska Institutet Innovation and will address topics such as:
• The EU legal framework and steps after orphan drug designation to ensure that orphan status is maintained at the marketing stage and following addition of new indications by variation.
• The importance of scientific advice/protocol assistance and specifically to discuss questions of significant benefit. Potential role of the Innovation Task Force.
• Market exclusivity issues in the EU including what constitutes a “similar product” and issues that arise in relation to rewards for paediatric research where orphan designation is surrendered.
• New US legislation on orphan drugs.
• Pricing/reimbursement trends (and new/innovative models/schemes) for orphan drugs seen in Europe and the US.
• Strategies at the market access stage in Europe and the US (for example, “do’s and don’ts” when having parallel discussions with different European pricing/reimbursement counterparts).
Speakers that will participate in the seminar are: Lincoln Tsang and Ian Dodds-Smith (partners, Arnold & Porter Kaye Scholer LLP, London), Dan Kracov (partner, Arnold & Porter Kaye Scholer LLP, Washington D.C), Per Hedman and Anders Burén (partner and senior counsel, Lindahl, Stockholm) and Göran Arvidsson (CEO, Hansa Medical).