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Off-Patent Industry Proposes Extensions To EU Market Protection Rather Than Data Exclusivity

 
• By Chloe Kent

Medicines for Europe proposed several alterations to the European Commission’s planned changes to exclusivity incentives at its recent Regulatory and Pharmacovigilance Conference in Brussels, most notably suggesting that the proposed extensions to data exclusivity should instead apply to market exclusivity.

Sergio Napolitano speaking at Medicines for Europe's 22nd Regulatory Affairs and Pharmacovigilance Conference
Napolitano explained Medicines for Europe's proposals at its 22nd Regulatory Affairs and Pharmacovigilance Conference • Source: Medicines for Europe

The off-patent industry association, Medicines for Europe, has put forward an alternative approach to the European Commission’s proposed new incentives scheme, in a move to facilitate earlier access to generic and biosimilar medicines.

Key Takeaways

  • Instead of multiple conditions which can extend an originator’s data exclusivity period, off-patent industry trade group Medicines for Europe has recommended that the European Commission use these conditions to grant extended periods of market exclusivity.

In its planned overhaul of the EU pharmaceutical legislation, the commission is proposing to cut the regulatory data protection (RDP)...

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