EBA opposes restriction of Hospital Exemption of ATMPs

The European Blood Alliance has recently endorsed two separate statements in defence of the Hospital Exemption in the development of Advanced Therapy Medicinal Products (ATMPs). The Hospital Exemption allows Member States to permit the manufacture and use of ATMPs in their territories without requiring a marketing with the EMA, while complying with “requirements equivalent to the good manufacturing practices and traceability” for ATMPs. The Hospital Exemption is a vital recourse for patients requiring personalised treatment and/or battling (ultra) rare diseases, whose medical needs cannot otherwise be met. For this reason, EBA is joining several other professional associations in opposing amendments proposed in the European Parliament to restrict its use, within the negotiations of the future EU pharmaceutical rules.

Since 2008, the Hospital Exemption has ensured access to safe and affordable innovative therapies through regulatory flexibility for the small scale developmental activities in hospitals, academic and other non-commercial settings under the scope of national competent authorities. It has also helped European public and non-profit establishments achieve a leadership position in the ATMP field, as most of ATMP therapeutic concepts and commercial treatments originate in academia. Finally, the Hospital Exemption has helped mitigate the risks to accessing these therapies, which are often unaffordable to many and sometimes withdrawn from the market for commercial reasons. This means that in addition to improving patients’ access to life-saving therapies, the hospital exemption also contributes to the sustainability and resilience of national health systems.

You can read the statement coordinated by the European Alliance for Vision Research & Ophthalmology (EU EYE)and the Lymphoma Coalition here, and the statement coordinated by the European Hematology Association (EHA) and the Association of European Cancer Leagues (ECL) here.