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EU pharma waiver to boost generic drugs exports

EU pharma waiver to boost generic drugs exports

Photo Rodrigo Senna

(BRUSSELS) - The EU Commission proposed Monday to adjust intellectual property rules to help Europe's pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU.

Through its 'targeted amendment': the so-called 'export manufacturing waiver' to Supplementary Protection Certificates (SPCs), the EU executive says it wants to remove a major competitive disadvantage of EU manufacturers.

The EU's intellectual property rights framework protects Europe's know-how and sustains the pharmaceutical industry's world-class innovation capacity.

"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," said EC vice-president Jyrki Katainen, responsible for Jobs, Growth Investment and Competitiveness: "We want to make sure that our pharmaceutical industry reaps the benefits of such competition."

The Commission believes the proposal could generate EUR 1 billion net additional sales per year and up to 25,000 new jobs over 10 years. The proposal will particularly benefit the many small and medium-sized enterprises in the field, according to Commissioner Elzbieta Bienkowska, responsible for Internal Market, Industry, Entrepreneurship and SMEs: "In the medium term, more competition will improve patients' access to a wider choice of medicines and alleviate public budgets," she said.

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.

The proposals follows a number of studies, extensive consultation and a European Parliament resolution endorsing the need to introduce before 2019 an SPC manufacturing waiver.

Supplementary protection certificate for medicinal products - background guide

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

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