The EU has a strong intellectual property rights framework in place which protects Europe's know-how and sustains the pharmaceutical industry's world-class innovation capacity. To improve the current system further and remove a major competitive disadvantage of EU manufacturers, the Commission proposes a targeted amendment: the so-called 'export manufacturing waiver' to Supplementary Protection Certificates.
Supplementary Protection Certificates (SPCs) extend patent protection for medicinal products which must undergo lengthy testing and clinical trials prior to obtaining regulatory marketing approval. Thanks to the waiver, in the future EU-based companies will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed. The waiver will support Europe's pioneering role in pharmaceutical research and development.
Vice-President Jyrki Katainen, responsible for Jobs, Growth Investment and Competitiveness, said: "Europe is and should remain at the forefront of pharmaceutical research and manufacturing. Our rules on intellectual property protection of pharmaceuticals promote innovation and creativity. We are committed to the core rights and the length of this protection, which remain unchanged. Today we are proposing a well-calibrated adjustment to the current regime to remove a legal barrier that was preventing our companies from competing on equal terms on global markets where competition is fierce. We want to make sure that our pharmaceutical industry reaps the benefits of such competition."
Elżbieta Bieńkowska, Commissioner for Internal Market, Industry, Entrepreneurship and SMEs, added: "Today's proposal strikes a balance between the imperative to ensure the attractiveness of Europe for innovative pharmaceutical companies and the urgency to allow EU based generics and biosimilar to compete on the global markets. This will help create growth and high-skilled jobs in the EU. It could generate €1 billion net additional sales per year and up to 25 000 new jobs over 10 years. It will particularly benefit the many small and medium-sized enterprises in the field. In the medium term, more competition will improve patients’ access to a wider choice of medicines and alleviate public budgets."
With the waiver, intellectual property (IP) protection for medicine production in Europe will remain the strongest in the world. SPC-protected medicines will retain their full market exclusivity in the EU.
The proposal is accompanied by a series of safeguards which will create transparency and prevent IP-infringing products from entering Member State markets. It goes hand in hand with other EU initiatives to defend Europe's know-how and innovation leadership and protect patients against counterfeited medicines. It also complements the EU’s overall approach to ensure free and fair trade, characterised by open markets, for EU-based manufacturers.
Today's proposal amends Regulation 469/2009 on the supplementary protection certificate for medicinal products. Once adopted by the European Parliament and Council, it will be directly applicable in all EU countries.
Today’s proposal was announced in the Commission's 2015 Single Market Strategy, and follows various studies, an extensive consultation and a European Parliament resolution endorsing the need to introduce before 2019 an SPC manufacturing waiver.
Full press release: Commission refines pharmaceutical intellectual property rules