EHA-ECL led statement calls for protection of the Hospital Exemption
The hospital exemption (HE) is a vital provision within the EU's pharmaceutical legislation, currently subject to a revision. As the name suggests, the hospital exemption allows for the use of ATMPs produced by licensed hospitals, after being duly approved by national medicines agencies, without going through EMA’s marketing authorization procedure.
The target of HE is very clear: patients in need of personalized treatments and/or battling (ultra) rare diseases, that are not perceived as commercially viable by pharmaceutical companies and therefore do not see their medical needs addressed. Despite its clear value as a complement to the commercial pathway, there have been recent attempts by policymakers to curtail the scope and usability of the hospital exemption, codified in Article 2 of proposed Directive 2023/0132(COD).
EHA has therefore worked with the Association of European Cancer Leagues (ECL) to express shared concerns in a joint statement, endorsed by multiple patient organizations, the European Blood Alliance, and access to medicines advocates. In this statement, circulated to policymakers and shared by major news outlet Politico, we emphasize the importance of HE for patient access to ATMPs and addressing unmet medical need, and advise against disproportionate restrictions.
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