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‘We Tried It, It Does Not Work’ – The Problems With The EU’s SPC Manufacturing Waiver

Industry Leaders Outline Difficulties With Mechanism At European Legal Affairs Conference

 
• By Dave Wallace

While the European SPC manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.

Medicines for Europe Legal Affairs Conference Panel
A legal affairs conference panel discussed the SPC manufacturing waiver • Source: Medicines for Europe

Back in June 2019, the European generics and biosimilars industry was celebrating the imminent arrival of the supplementary protection certificate (SPC) manufacturing waiver. The mechanism had been long-sought by the off-patent industry, and promised to allow European manufacturers to compete on an equal footing with non-EU competitors by permitting manufacturing for export outside the EU, as well as stockpiling for day-one launch within the EU, during the term of SPCs (see sidebar).

Five years on, however, it is clear that many are not happy with how the SPC manufacturing waiver functions in...

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