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Monitoring To Start As SPC Waiver Nears Finishing Line

 
• By Aidan Fry

A manufacturing waiver to allow EU-based companies to produce generics and biosimilars during the SPC term should be approved imminently. But the European Commission is watching closely to see if the provision is used by industry.

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The SPC Waiver Regulation Is Nearing The Finish Line • Source: Shutterstock

The European Commission is preparing to start monitoring the impact of the planned manufacturing waiver that will allow generics and biosimilars developers to produce products within the term of European supplementary protection certificates (SPCs). Alfonso Calles-Sánchez, administrator within the Commission’s directorate general Grow, told delegates to Medicines for Europe’s 15th Legal Affairs Conference that he anticipated a vote in the plenary of the European Parliament in mid-April as one of the final steps to the waiver being approved.

Noting that the inter-institutional agreement between the European Council, Parliament and Commission unveiled in mid-February this year had permitted stockpiling for day-one launch in the EU up to six months ahead of SPC expiry, as well as notification requirements as a safeguard against abuse, Calles-Sánchez pointed

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