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25 November 2020GenericsRory O'Neill

EC plans to lower barriers to generic drugs

The European Commission wants to increase access to generic medicines and crack down on anti-competitive behaviour in the pharmaceutical industry, a new plan has said.

The EU executive adopted its Pharmaceutical Strategy for Europe today, November 25. In the document, the Commission said it would consider “targeted policies that support greater generic and biosimilar competition”.

These policies will be based on the “sound functioning of the single market, appropriate market protection mechanisms, the removal of barriers that delay their timely entry to market and increased uptake by health systems,” the strategy document said.

The Commission also pledged to enforce the bloc’s competition rules, noting that “originator companies sometimes implement strategies to hinder the entry or expansion of the more affordable medicines of their generic and biosimilar competitors”.

According to the document, the Commission will put forward specific proposals to improve the level of competition in the pharmaceutical industry in 2022.

These will include proposed revisions of the “incentives and obligations in the pharmaceutical legislation taking into account the relationship with IP rights, to support innovation, access and the affordability of medicines across the EU”.

“The coronavirus pandemic has highlighted the vital need to strengthen our health systems. This includes access to safe, effective and high-quality medicines at an affordable price,” said Commission president Ursula von der Leyen.

Health and Food Safety commissioner Stella Kyriakides added that the strategy underlined the Commission’s goal of ensuring that “medicines are accessible and affordable at all times and to all patients across the EU”.

Last year, the EU adopted a new law allowing generic makers to bypass extended marketing exclusivity for certain drugs, despite opposition from major pharmaceutical companies.

The Supplementary Protection Certificate (SPC) manufacturing waiver allows companies to manufacture generic or biosimilar versions of original medicines, as long as they are for export outside the EU market.

This can be done even if the originator company holds an SPC, which grants an extra term of marketing exclusivity for a drug beyond the life of a patent.

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More on this story

Generics
16 May 2019   The European Union has adopted the proposed supplementary protection certificate manufacturing waiver, despite criticism from parts of the pharmaceutical industry.
Big Pharma
1 July 2020   Japan-based Nitto Pharmaceutical Industries has been blocked from using its ‘Noster’ brand in the EU, in a win for Italian drugmaker Chiesi Farmaceutici.