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Deal On European SPC Manufacturing Waiver Is An Acceptable Compromise

 
• By Dave Wallace

A deal on the European SPC manufacturing waiver has been agreed by the European Council, Parliament and 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 Council, Parliament and Commission on a proposed waiver for manufacturing during the term of supplementary protection certificates (SPCs) - for both export and stockpiling for ‘day-one’ launch within the European Union (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 compromise agreement reduces the period during which generics and biosimilars firms can stockpile for day one launch within Europe from a previous suggestion of two years to six months

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