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Clarity ‘Urgently Needed’ Over EU SPC Manufacturing Waiver

Industry Body Calls For Legislative Simplification In Wake Of German Court Decision

 
• By Dave Wallace

In the wake of a German court decision that Medicines for Europe says “adopted an inordinately restrictive interpretation of the SPC manufacturing waiver,” the association has called for clarity and simplification of the SPC manufacturing waiver legislation, claiming that its use could otherwise be undermined.

Classes showing eye test with "SPC" letters visible
Clarity is needed over the EU SPC manufacturing waiver legislation • Source: Shutterstock/David Wallace

A German court decision that adopted an “inordinately restrictive interpretation” of the EU supplementary protection certificate manufacturing waiver risks undermining the use of the mechanism by European generics and biosimilars manufacturers, off-patent industry body Medicines for Europe has warned.

The SPC manufacturing waiver was hard-won by the generics and biosimilars industry, allowing manufacturing for export outside the EU – as well as stockpiling for

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