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European Commission proposes SPC exemptions for generics selling outside the EU

06/06/2018

The European Commission has proposed amendments to the EU’s supplementary protection certificate (SPC) regime to allow manufacturers based in the EU to develop and sell generic versions of patented treatments outside of the bloc.

The 28 May proposal introduces the idea of an “export manufacturing waiver” for generics, allowing them to get around the restrictions imposed by SPCs – which allow innovative drug companies a five-year extension on the patent exclusivity for medicinal products within the EU.

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