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European Council Move Brings SPC Manufacturing Waiver A Step Closer

 
• By Dave Wallace and Ian Schofield

A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.

Generic
An EU SPC Manufacturing Waiver For Generics & Biosimilars Is A Step Nearer • Source: Shutterstock

The European Council has approved a mandate for negotiations with the European Parliament on a draft regulation outlining a waiver to allow manufacturing during the term of supplementary protection certificates (SPCs).

The move brings the long-awaited SPC manufacturing waiver a step closer to fruition, although it remains uncertain whether key elements of the proposed Regulation desired by the off-patent industry will be included in the draft regulation – including a

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