SPC Waiver Builds Momentum After EU Vote

06 Dec 2018

Several EU-level endorsements for a proposed SPC manufacturing waiver – which would allow manufacturing within Europe during the SPC period for export, as well as stockpiling for ‘day one’ launch upon SPC expiry – have been applauded by the region’s off-patent industry. However, originators are doubling down on lobbying efforts against such changes.

EU parliament — Parliament endorses SPC waiver • Source: Shutterstock

A vote by the European Parliament’s international trade committee, INTA, endorsing a proposed waiver allowing manufacturing during the term of supplementary protection certificates (SPCs) has been applauded by off-patent industry association Medicines for Europe. It follows recognition by the EU’s competitiveness council as well as “constructive amendments” to the current SPC waiver proposal that were recently offered by the Parliament’s health committee.

Welcoming the trade committee vote, Medicines for Europe said that it had introduced “several important amendments to improve the original...