Exploring Solutions to Foster ATMP Development and Access to Patients in Europe

In: European Journal of Health Law
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  • 1 Professor of European Union Law, University of Insubria, Former Head, Legal Service, European Medicines Agency, Of counsel, Team Leader Healthcare and Life Sciences, BonelliErede Law Firm, Varese, Italy

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There are several critical factors that have influenced the (un)success rate of advanced therapy medicinal products (ATMPs) over the first ten years since the EU Regulation 1394/2007 entered into force. This article provides an overview of the current regulatory scenario and outlines the outstanding challenges to be faced in order to further promote research and development of ATMPs and the issues to be considered in the perspective of a possible legislative reform.