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Monitoring To Start As EU 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 is expected to gain final approval shortly. However, the European Commission will be watching closely to see whether the provision is actually used by industry.

Waiver
Industry's use of the EU SPC waiver will be under scrutiny • Source: Shutterstock

The European Commission is preparing to start monitoring the impact of a waiver that will allow generics and biosimilars developers to manufacture products in the EU while the originators' supplementary protection certificates (SPCs) are still in force. A plenary vote by the European Parliament in mid-April is expected to be one of the final steps in the approval of the waiver, the commission's Alfonso Calles-Sánchez told delegates at Medicines for Europe’s 15th legal affairs conference in the Dutch capital Amsterdam last week.

Noting that the inter-institutional agreement between the European Council, the European Parliament and the commission unveiled in mid-February this year had permitted stockpiling for day-one launch in the EU up...

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