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Expanding Hospital Exemptions For ATMPs Could Make Europe Less Attractive To Investors

 
• By Francesca Bruce

The forthcoming overhaul of the EU pharma legislation should not include an expansion of the hospital exemption provision for advanced therapies, warn industry and regulators.

Blood gene therapy
EU legislative overhaul should not allow for wider use of ATMP hospital exemptions • Source: Shutterstock

Rather than increasing access to medicines, expanding the hospital exemption provision for advanced therapy medicinal products (ATMPs) as part of the European Commission’s pharmaceutical legislative overhaul could make industry less inclined to launch such products in the EU.

This warning was issued by speakers at a recent symposium hosted by the Alliance For Regenerative Medicines (ARM), which represents small and large companies, academic

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