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).
‘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
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.
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