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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.

While the final version of the deal has not yet been published in full, the commission has confirmed that the...

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