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How EU Pharma Reform Changes Could Affect The ATMP ‘Hospital Exemption’

 
• By Ian Schofield

One of the key challenges facing the Hungarian presidency of the Council of the EU in the second half of 2024 will be the proposals for an overhaul of the EU pharmaceutical legislation, which were amended by the European parliament in April. In the latest in a series of articles on progress with the reform, the Pink Sheet examines the issues surrounding the hospital exemption for advanced therapies.

cell culture experiments at cell culture laboratory
Some advanced therapies can be made in EU hospitals under specific circumstances • Source: Shutterstock

One feature of the EU pharmaceutical reform that has perhaps received less attention than some others is the “hospital exemption,” which since 2007 has allowed the manufacture of advanced therapy medicinal products (ATMPs) in hospitals under certain circumstances, without the need for a marketing authorization. ATMPs include gene therapies and cell- and tissue-based therapies.

When it launched its pharma reform package in April 2023, the European Commission said that the hospital exemption (HE) provision needed overhauling, mainly because

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