Harmonise Europe's hospital exemption for academic cell therapies, with one registry
Spain lets hospitals make and use their own CAR-T under a special rule; most European countries do not. A common rule with shared outcome tracking would spread affordable academic products.
The EU ATMP Regulation's hospital exemption is implemented very differently by member states: Spain has authorised academic CAR-T products (ARI-0001, ARI-0002h) at far lower cost than commercial products, while other countries apply the exemption so narrowly that academic products cannot be used routinely. The 2023 EU pharmaceutical reform proposals address this partly. The proposal is a harmonised hospital exemption with common GMP and pharmacovigilance requirements, mandatory participation in a European outcomes registry, and cross-border recognition so an exempted product from one member state can be used in another.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
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