Pharmaceuticals: Parliament endorses agreement to boost EU exports
Members of the European Parliament endorsed today an agreement reached on adjustments to intellectual property (IP) arrangements for pharmaceutical products, which will make it easier for EU companies to export generic and biosimilar medicines to third countries where IP protection has expired or never existed. The new rules will boost jobs, growth and investments in the generic industry — a fast-growing sector within the EU
Jean-Marie Cavada, Shadow Rapporteur on this file, said today:
“Throughout the negotiations, we made sure that EU companies will be able to reap the benefits of the new generic and biosimilar market, while upholding strong intellectual property protection. With these new rules, we will significantly improve the competiveness of Europe’s pharmaceutical industry and foster jobs, growth and investments in the EU.”
Note to editors:
The so-called supplementary protection certificate (SPC) is an EU intellectual property right that extends the legal effects of a patent on a medical product in order to compensate for the loss of effective patent production due to the time required to obtain marketing authorisation, including research and clinical trials. During the SPC period of protection of the product in the EU, European companies cannot manufacture for any purposes, including export outside to the EU where SPC protection has expired or never existed, while manufactures based outside the EU can do so. Today’s voted regulation introduces now a carefully framed exception (“manufacturing waiver”) to the patent protection of an original medicine for export and stock-piling purposes. 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.
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