LS&HC Horizons 2022 - Flipbook - Page 8
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
8
Precision and Regenerative Medicine
Potential liability risks associated with administration of gene therapies and ATMPs in Europe
The advent of products that use gene therapy, somatic cell therapy
and engineered tissues for preventing, treating or even curing human
diseases represents a new era in medicine, and probably the biggest
innovation in the pharmaceutical industry since the introduction
of biologic medicines in the 1980s. The treatment with Advanced
Therapy Medicinal Products (ATMPs) brings with it unique and novel
legal issues and liability risks particularly for those who manufacture
and supply ATMPs.
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. The supply chain management of ATMPs, which involves
several stakeholders, and the lack of standardization in manufacturing
procedures regarding those products are additional critical factors.
The traditional model of the relationship between manufacturer and
customer has been a simple transaction point in which the customer
pays for a manufactured good and, provided that the good is fit for
purpose and as described, the responsibilities on both sides are rather
easy to define. With the advent of ATMPs the boundaries are less well
defined especially as more players may be involved.
The question “where does the manufacturing begin and end?” is not
an easy one to answer. The manufacturing process for a medicinal
product using autologous cells indeed involves several steps, including
initial harvest of cells from the patient tissue, isolation of cells from
that tissue, transfer of the construct to the clinic, removal of construct
from the carrier container, preparation of the implant site, final
Christian di Mauro
Partner, Milan
preparation (such as by trimming) of the construct, and implantation.
Which of these steps actually constitutes manufacturing? The
manufacturer is in any case just one of the key players as the role of
health care practitioners and hospital teams is pivotal. The outcome
of the 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. The liability for successful outcome is therefore
shared between the legal manufacturer of the ATMP, the contract
manufacturer or other service providers, and those who harvest the
tissue and who carry out the implantation.
ATMPs moreover raise specific issues concerning data management
and data privacy. This may include data from hospital electronic
health records, generation of patient related data for end product, data
in CAD files describing the end product, etc. These all challenge the
existing regime for patient data protection because customization and
traceability for product safety make patients identifiable, anonymity
difficult, and data can be breached and stolen.
The development of more personalized treatments thus requires an
individual analysis of each situation, at the intersection of general
liability regimes (tort liability, contractual liability) of each EU
member states and specific regimes concerning product liability,
clinical trials or data protection deriving from EU legislation.
Charles-Henri Caron
Counsel, Paris
