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Revision of the General Pharmaceutical Legislation: Impact Assessment of Key Orphan Proposals on Member States

Isabelle Laurence, Emilie Neez, Elena Nicod
May 2024

While the revision of the General Pharmaceutical Legislation (GPL) targets EU-level frameworks and processes, proposed changes are sure to have immediate as well as downstream consequences at the country level. This paper explores these potential consequences, focusing on a selection of proposals by the European Commission aimed at improving access and affordability of orphan medicinal products (OMPs). The revised GPL that is ultimately adopted will set the stage for the European pharmaceutical market for decades to come, particularly for OMPs which are more reliant on incentives to be viable for development and launch in the region. It is therefore critical that revisions are calibrated to meet Member States’ needs and assure future availability of these products in Europe.

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