REGIMUL JURIDIC AL PRODUSELOR MEDICAMENTOASE DE TERAPIE AVANSATĂ (ATMP) ÎN DREPTUL UNIUNII EUROPENE
THE LEGAL REGIME OF ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPS) IN EUROPEAN UNION LAW

Summary/Abstract: The article examines the legal framework governing advanced therapy medicinal products under European Union law, highlighting how the development of medical biotechnologies has required the adaptation of the traditional medicinal products regime to products operating through genetic, cellular, or tissue-based mechanisms of action. The study begins with the definition and classification of ATMPs pursuant to Regulation (EC) No 1394/2007 on advanced therapy medicinal products, Directive 2001/83/EC establishing a Community code relating to medicinal products for human use, and Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products, emphasizing their hybrid nature, situated at the intersection of medicinal products, medical intervention, and advanced biological technology. The article separately analyzes gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products, focusing on the legal criteria for their classification, their mechanisms of action, and the practical consequences arising from their legal qualification. The article then examines the mandatory centralized marketing authorization procedure, the role of the European Medicines Agency (EMA), the Committee for Advanced Therapies (CAT), and the Committee for Medicinal Products for Human Use (CHMP), as well as the special mechanisms of regulatory flexibility, such as conditional marketing authorization, authorization under exceptional circumstances, compassionate use, and the “hospital exemption” mechanism. Particular attention is devoted to legal liability in relation to ATMPs, including the difficulties arising from the application of the defective products regime, proof of causation, development risk, and scientific uncertainty. The article also highlights the importance of the precautionary principle in managing the risks associated with these products, together with the strengthened pharmacovigilance framework introduced through the amendments brought to Directive 2001/83/EC concerning medicinal products safety monitoring (Directive 2012/26/EU). The analysis further considers the recent evolution of the European legal framework concerning substances of human origin intended for human application, especially following the repeal of Directive 2002/98/EC and its replacement by Regulation (EU) 2024/1938 establishing quality and safety standards for substances of human origin, a legislative instrument particularly relevant for the traceability, quality, and safety of biological materials used, inter alia, in certain advanced therapies. The article concludes that, although European Union law provides an advanced and coherent regulatory framework, it remains affected by limitations concerning adaptation to the pace of biotechnological innovation, fragmentation in national implementation, effective access to treatment, and the predictability of legal liability.

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