Political agreement by European Parliament and Council on Commission proposal

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Political agreement by European Parliament and Council on Commission proposal to introduce an export and stock-piling waiver to SPC legislation

On February 14, 2019 the European Commission has issued a Press Release informing that the European Parliament and Council have reached a political agreement on a targeted adjustment that the Commission proposed in May 2018 to Supplementary Protection Certificates (SPCs), i.e. an intellectual property (IP) arrangement related to pharmaceutical products.

The new Regulation introduces a carefully framed exception (‘export manufacturing waiver’) to the patent protection of an original medicine for export and stock-piling purposes.

Supplementary Protection Certificates (SPC) extend patent protection for medicinal products, which must undergo lengthy testing and clinical trials before obtaining regulatory marketing approval. Thanks to the waiver, EU-based companies will be entitled to produce and export a generic or biosimilar version of an SPC-protected medicine during the term of the certificate. The waiver will support Europe’s pharmaceutical manufacturing base and Europe’s pioneering role in research and development of biosimilars.

Further details on the Commission proposal here.


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