At the EU Pharmaceutilcal Law Forum, which took place 17-20 May 2021, our Partner Christian Jervelund and Managing Economist Julia Wahl presented insights on the revision of the Orphan Medicinal Products Regulation, the affordability of medicines, price transparency, and market access.
Christian Jervelund participated in a workshop on Market Access for Innovative Therapies. Successful innovative pricing models manage to build trust between payers and industry around a transparent financial modelling framework that allows both parties to gauge consequences of various innovative models. As if this is not difficult enough, to truly scale innovative pricing models, companies and payers need to adapt their organisations and leadership approach to fit the partnership driven approach inherent in scalable innovative pricing models.
Julia Wahl participated in a dual dialogue on IP regulatory rights: New developments in orphan and paediatric medicines. The revisions of the regulations for both orphan and pediatric medicines bear the challenge of finding policy incentives that can steer development to areas of unmet need. These are often areas where incentives to invest are particularly week in particular due to small patient populations. Economic analysis has an important role in identifying novel incentives that will allow tackling underserved areas.
Julia Wahl and Christian Jervelund led a roundtable discussion on “OMP Regulation Revision – an Economist’s Perspective”. The last 20 years have shown remarkable innovations in the OMP space, resulting in many more therapies available to patients suffering from rare diseases. The current OMP regulation focused on OD designation (ODD) and Market Exclusivity (ME) has been a key driver for this success. However, continued innovation in areas where no or no satisfactory treatment exists, requires a different tool box. Our research and advisory work over the past years suggest that partnership type approaches removing barriers and improving incentives across the entire value chain are what is needed. These are solutions that often require collaboration between academics, industry, regulatory bodies and national payers and healthcare systems to produce impact. This is a more complex part of the tool box, which may explain why many policy and decision makers would like to keep discussing tweaks to ODD and ME as the vehicle to deliver innovation in areas where none exists.