Forslag til europaparlaments- og rådsforordning om endring av forordning (EF) nr. 469/2009 om det supplerende beskyttelsessertifikat for legemidler
Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products
Dansk departementsnotat offentliggjort 13.7.2018
BAKGRUNN (fra Kommisjonens pressemelding 28.5.2018)
Pharmaceuticals: Commission refines intellectual property rules
The Commission is proposing today a targeted adjustment to intellectual property rules to help Europe's pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU. 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 (SPCs). Vice-President Jyrki Katainen, responsible for Jobs, Growth Investment and Competitiveness, said: "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 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." Supplementary Protection Certificates 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. With the waiver, intellectual property (IP) protection for medicine production in Europe will remain the strongest in the world and 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. 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.
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