Intellectual property rules could soon change to allow pharmaceutical companies to produce generic drugs for export to countries and regions where they are not under extended patent protection. The changes to current rules were tabled by the European Commission on May 28.
While such drugs would still be protected inside the European Union under the new proposal, companies could make generic versions inside Europe for export to countries where no additional patent protection existed.
“Our initiative will help us open a market of €95bn worldwide,” EU Industry Commissioner Elzbieta Bienkowska told a news conference. “The same kind of tool worked very well in Canada and helped the pharmaceutical industry to grow and to employ people. That was our reference.”
As reported by the Reuters news agency, the Commission said the proposal, which still needs to be approved by the European Parliament and member states, could generate some €1bn of net additional sales per year.
The aim, according to the Commission, is to help Europe’s pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU.
“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 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.”
In turn, Elżbieta Bieńkowska, Commissioner for Internal Market, Industry, Entrepreneurship and SMEs, said the proposal will create growth and high-skilled jobs in the EU. She said it could generate €1bn net additional sales per year and up to 25,000 new jobs over 10 years.
“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,” said Bieńkowska. “With the waiver, intellectual property protection for medicine production in Europe will remain the strongest in the world.”