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MEPs in the European Parliament committee for legal affairs today backed new rules that will make it cheaper for European consumers to access medicines and make European industries more competitive. The new rules affect manufacturers of generic drugs, who produce exact copies of brand-name drugs when their intellectual property rights have expired.

S&D Group spokesperson for the report Tiemo Wölken said:

 “The new rules we have backed today will benefit European consumers by making drugs cheaper and will help EU manufacturers by creating a level playing field with those producing generic drugs in the rest of the world. Generic and biosimilar drugs can be produced and sold at a fraction of the cost of their name brand equivalents, meaning improved access and lower costs for EU patients. This new waiver will help ensure the sustainability of EU healthcare systems by lowering costs for national healthcare budgets and improving security of supply, reducing counterfeits and uncertainty due to relying on imports.

“These new rules affect EU-based manufacturers of generics and biosimilars making medicinal products protected by a supplementary protection certificate (SPC). This is an intellectual property (IP) right that extends the legal effects of a patent on a medicinal product that has been authorised by national or European regulatory authorities. The new rules mean EU companies will be able to manufacture products for the purpose of exporting to third countries where the SPC does not apply. Companies will now also be able to stockpile the drugs during the final two years before the SPC expiration in Europe, meaning they can launch the new generic drug in the EU market directly on day one of the certificate expiring.

“We want to see these new waivers apply to certificates for which the basic patent will expire on or after January 1, 2021.”

 

 

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Published: 09/01/2019