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Deal On European SPC Manufacturing Waiver Is An Acceptable Compromise

 
• By Dave Wallace

A deal on the European supplementary protection certificate manufacturing waiver has been agreed by the European Council, Parliament and the European Commission, providing a concrete path for a regulation to move forward, albeit with compromises on several key provisions. Meanwhile, the European off-patent and brand industries remain at odds over the benefits of the waiver.

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The Three European Institutions Have Agreed A Compromise Deal On The SPC Waiver • Source: Shutterstock

A compromise deal reached between the European Commission, Council and Parliament on a proposed waiver for manufacturing generics during the term of the supplementary protection certificates (SPCs) for originators – for both export and stockpiling for "day-one" launch within the EU – has been broadly welcomed by the European off-patent industry, albeit with reservations over certain alterations that have been made to key aspects of the mechanism.

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