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May 30, 2018

EC proposes adjustment to pharma intellectual property rules

The European Commission (EC) has proposed a targeted amendment to intellectual property rules covering pharmaceuticals to improve the existing system and eliminate competitive disadvantage for manufacturers in the European Union (EU).

The European Commission (EC) has proposed a targeted amendment to intellectual property rules covering pharmaceuticals to improve the existing system and eliminate competitive disadvantage for manufacturers in the European Union (EU).

The adjustment is called the export manufacturing waiver and is intended to facilitate entry of European pharmaceutical companies into emerging global markets and expected to promote growth, investments and jobs in the EU.

These adjustments target Supplementary Protection Certificates (SPCs), which extend patent protection for medicinal products that require lengthy testing and clinical trials prior to authorisation for marketing.

The waiver will allow EU-based companies to manufacture a generic or biosimilar of an SPC-protected therapeutic during certificate term. This is applicable only when the new product is exclusively meant for export to a non-EU market with expired or non-existent protection.

“Today’s proposal strikes a balance between ensuring the attractiveness of Europe to innovative pharmaceutical companies and the urgency to allow EU based generics and biosimilars to compete on the global market.”

The amendment is also expected to support Europe’s pharmaceutical research and development footprint.

EC Internal Market, Industry, Entrepreneurship and small and medium-sized enterprises commissioner Elżbieta Bieńkowska said: “Today’s proposal strikes a balance between the imperative to ensure the attractiveness of Europe to innovative pharmaceutical companies and the urgency to allow EU based generics and biosimilars to compete on the global market.

“This will help create growth and high-skilled jobs in the EU. It could generate €1bn 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.”

The EC also outlined certain measures to generate transparency and avoid products that infringe intellectual property rules.

Meanwhile, the commission expects the waiver to protect patients from counterfeited drugs, while supporting the EU’s overall strategy to enable free and fair trade for local manufacturers.

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