Hospital Exemptions: Friend or foe to Pharma?

By: Richard Wang, Adama Anozie Akshay Kumar & Bruce Chin

What is Hospital Exemption?

In recent years, we have seen rapid commercial development of advanced therapy medicinal products (ATMPs), like cell and gene therapies (CGTs). Such commercial therapies have become prominent in the treatment of rare diseases, but they are often associated with uncertainties in long-term efficacy, along with a large price-tag for payers. Furthermore, given the vast number of rare diseases and many not being commercially viable, there is a real gap in available CGT treatments. Therefore, there is a significant unmet need for novel, effective, and affordable treatments outside the commercial space.

Hospital Exemption (HE) is a scheme that provides patients access to innovative, and potentially life-saving, treatments where no centrally authorised products are available. HE allows manufacturing of unlicensed ATMPs that are “prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient” (Regulation European Commission (EC) 1394/2007, Article 28(2); ATMP regulation).

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