The Commission welcomes the political agreement reached by the European Parliament and Council on a targeted adjustment it proposed in May 2018 to intellectual property (IP) arrangements for pharmaceutical products.
The amended rules preserve the strong existing IP rights in order to encourage innovation and research in the EU, but will make it easier to for EU companies to export generic and biosimilar medicines to third countries where IP protection has expired or never existed. Commissioner Elżbieta Bieńkowska, responsible for Internal Market, Industry, Entrepreneurship and SMEs, said: “With this well-calibrated adjustment to intellectual property rules, we are helping Europe’s pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU. We are removing a major competitive disadvantage of EU manufacturers who will soon be able to compete on equal terms on global markets where competition is fierce.” 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. These patents called 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. It is expected to generate extra growth of at least €1 billion per year in net additional export sales, creating up to 25,000 extra high-skilled jobs over 10 years. The agreement reached by the co-legislators is now subject to formal approval by the European Parliament and Council.