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EU – Export and stockpiling exception

21 Feb 2019

The EU is about to introduce an export and stockpiling exception, limiting the protection granted to SPC holders.

From the press release:

“The EU is adopting new rules which should boost the competitiveness of EU producers of generic medicines and biosimilar products. Member states’ ambassadors meeting today in Coreper endorsed a deal reached on 14 February with the European Parliament on a draft regulation which introduces an exception to the protection granted to an original medicine by a supplementary protection certificate (SPC) for export purposes and/or for stockpiling.

“Thanks to the exception, EU-based manufacturers of generics and biosimilars will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the SPC either for the purpose of exporting to a non-EU market where protection has expired or never existed or (during the six months before the SPC expires) for the purpose of creating a stock that will be put on the EU market after the SPC has expired.

“The agreed text, following the usual legal/linguistic scrutiny, will be submitted for formal adoption to the European Parliament and the Council.”

A copy of the press release can be read here.