The EU adopts regulation to promote the competitiveness of EU producers of generic medicines and biosimilar products. This regulation 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 EU measures will help new pharmaceutical companies start up and scale up in high growth areas and contribute to Europe’s competitiveness as a hub for pharmaceutical R&D and manufacturing.
Next steps: The regulation still has to be signed and published in the Official Journal of the EU. It is expected to enter into force by 1 July 2019.