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Pharma sees European generics export plan as anti-innovation

EFPIA condemns plans - but European Commission says changes would create jobs in Europe

Plans to make it easier for European generics companies to compete in global markets outside the EU have been unveiled – and promptly attacked by the pharma industry as anti-innovation.

Generics firms based in the EU are currently barred from manufacturing generics of drugs still covered by Supplementary Protection Certificates (SPCs). This puts them at a disadvantage to generics firms in places such as India, and means European generics firms can’t launch on ‘Day 1’ of patent expiry.

The European Commission is now proposing what it calls a 'targeted amendment' to EU intellectual property (IP) rights, a so-called 'export manufacturing waiver' to Supplementary Protection Certificates.

This would allow the generics firms to begin work on their copies before the SPC expires, as long the drugs were intended only for export out of the EU.

The European Commission says the changes could generate €1bn net additional sales per year, and up to 25,000 new jobs over 10 years. It says the change would particularly benefit the many small and medium-sized enterprises in the field. In the medium term, it says more competition will improve patients' access to a wider choice of medicines and alleviate public budgets.

Jyrki Katainen

European Commission Vice-President Jyrki Katainen (pictured) responsible for Jobs, Growth Investment and Competitiveness, commented yesterday: "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.”

He added: “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."

While the proposals have been warmly welcomed by Europe’s generics association Medicines for Europe, pharma industry organisation EFPIA has condemned the proposals.


Nathalie Moll, EFPIA’s Director General says Europe has long benefited from a framework of IP and incentives that has given investors and companies the assurance they need to invest in drug development.

She concluded: "The Commission’s proposal to de-value this framework puts Europe at a serious disadvantage in the global race to attract life science investments.”

Even though the plans wouldn’t directly affect patent-protected medicines in Europe, EFPIA nevertheless says the move would be interpreted negatively by pharma, and says it has a ‘very real concern’ it would lead to R&D investment going elsewhere.

EFPIA’s experts say the plans to introduce an SPC manufacturing waiver is “all the more striking given the extent to which other geographies, notably China, are moving in the opposite direction by strengthening their IP frameworks; aiming to become the Europe of tomorrow.”

EFPIA is likely to maintain its opposition to the plans, and will look for support from EU governments to support its concerns.

The European Commission insists, however, that the EU’s IP protection for medicine production in Europe will remain“the strongest in the world” and that SPC-protected medicines will retain their full market exclusivity in the EU, and that the plans would boost the region’s economy.

Article by
Andrew McConaghie

29th May 2018

From: Marketing



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