EU – Export and stockpiling exception

Posted: February 21st, 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.

One Response

  1. Andrew Brown says:

    An excellent initiative. The EU manufacturing base for medicines has been completely degraded. In the USA they can launch for day 1 due to the safe-harbour provisions. Canada has enacted legislation that protects manufacturing during the new patent term extension. This is an essential strategic industry in the EU that has to survive otherwise all medicines well be manufactured by third countries over time. The proposal appears to be balanced as it only affects SPCs and not patents. EU medicines also have preference in many other markets around the world. It is also critical that we no longer degrade our ability to develop and manufacture biosimilars domestically.

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