Check out our latest publication: "Revision of the General Pharmaceutical Legislation: Impact Assessment of Key Orphan Proposals on Member States". https://bit.ly/3JPQxb0
Though the revision of the General Pharmaceutical Legislation targets EU-level frameworks and processes, proposed changes are sure to have immediate as well as downstream consequences at the country level.
This paper in collaboration with Sanofi explores these potential consequences, focusing on a selection of proposals by the European Commission aimed at improving access and affordability of orphan products.
Key findings highlight:
- Risks to future orphan development and availability in Europe via proposed reductions in key incentives (although these may help bring down prices in the short term).
- Challenges with the calibration and predictability of conditional supplementary incentives aimed at encouraging orphan development in areas of high unmet need and faster launch of medicines across Europe.
- Potential impact on national pricing and reimbursement processes due to changes impacting evidence availability, and risk that this fails to align with country needs and priorities.
- The revised Legislation that is ultimately adopted will set the stage for the European pharmaceutical market for decades to come, particularly for orphans 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.
Authored by Isabelle Laurence, Emilie Neez and Elena Nicod.
#EUPharmaLegislation #EuropeanCommission #OrphanMedicines #Dolon