Unlike conventional therapies, ATMPs generate intrinsic and peculiar risks for patients, which are associated with the use of human biological material and with its potential for stimulating immune reaction. Supply chain management of ATMPs involves several stakeholders, the expansion of individualized medicine, and, correlatively, the lack of standardization in manufacturing procedures regarding those products.
The legal definition of a “manufacturer” – and the regulatory obligations that this title entails – is not an easy one to answer categorically for companies operating in Europe. Further, for a medicinal product using autologous cells, the manufacturing process involves several steps, including initial harvest of cells from the patient tissue, isolation of cells from that tissue, transfer of the material to the clinic, removal of material from the carrier container, preparation of the implant site, final preparation (e.g. by trimming), and implantation. Therefore, legal risk analysis for any company operating in the ATMP space requires assessment of which of these steps actually constitutes “manufacturing.”
While the “manufacturer” plays a pivotal role in administration of ATMPs, the unique importance of health care practitioners and hospital teams also provides those parties with potential new legal risks in this emerging arena. The outcome of an ATMP procedure can be adversely affected at each step through the introduction of adventitious microorganisms, contamination, or inappropriate manipulation, such as over-trimming or poor temperature control. Legal liability may therefore be shared between the legal manufacturer of the ATMP, the contract manufacturer (or other service providers that may be involved), and those who harvest the tissue and who finally carry out the implantation.
Examples of other specific legal issues raised by ATMPs include:
- data management and data privacy,
- issues regarding hospital electronic health records,
- generation of patient related data for end-product, and
- data in Computer-Aided Design (CAD) files describing the end-product.
These concerns challenge existing regimes for patient data protection, as customization & traceability for product safety may make patients identifiable, and anonymity difficult. In addition, patient data is always at reach of breach and theft, creating product liability risks.
The development of ATMPs and more personalized treatments thus requires individual analyses of each situation, with regulatory hurdles existing at the intersection of general liability regimes (e.g., tort liability and contractual liability) of each EU member state, and of specific regimes concerning product liability, clinical trials, or data protection deriving from EU legislation.
This article is the tenth in our 2022 series, “Trends in Cell, Tissue, and Gene Therapies,” which aims to help you stay informed about the broad array of legal and regulatory issues affecting companies operating in the regenerative medicine space. From clinical studies, to obtaining patents, to scaling up manufacturing, our global team will discuss novel issues arising in all parts of the world, including unique deal-making, litigation, and inspections concerns for CTGT companies. Ensure you are subscribed to Hogan Lovells Engage to receive these new insights weekly!
