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Legislative Overhaul 'Will Not Make EU A Global Leader' In Pharma R&D

Industry Says 'Flexible And Coherent’ Regulatory System Needed

 
• By Ian Schofield

National pricing and reimbursement systems remain a key barrier to medicines access, and requiring companies to market their products in all EU countries and to notify regulators of their launch intentions is not the answer, according to EuropaBio, which represents a wide range of biotech firms operating in Europe.

Extruded political Map of European Union with relief without United Kingdom after anticipated Brexit
The EU is in search of an improved legislative environment for medicines • Source: Alamy

Efforts by the EU authorities to improve the drug regulatory environment have met with a lukewarm response from industry body EuropaBio. It says the proposed revision of the EU pharmaceutical legislation “does not align with the European Commission’s bid to promote the EU as a competitive global leader in biopharmaceutical R&D.”

EuropaBio claims that “little in this revision seeks to address the issues we face for next-generation medicine development, and errs on the side of pinning EU affordability and access issues solely on industry when a plethora of issues lie outside industry and EU control

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