LS&HC Horizons 2022 - Flipbook - Page 7
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
7
Precision and Regenerative Medicine
Gene and cell therapeutics and advanced therapy medicinal products (ATMP) in Europe
Gene and cell therapeutics are currently the most innovative area
in the treatment of patients. While the EU provided a harmonized
legal framework with the ATMP Regulation (No. 1394/2007)
in 2007, there are still many pitfalls for launching them. Local
laws of the EU Member States also provide a layer of complexity.
We remain constantly engaged with the agency on behalf of our
pioneer clients to make sure the science and the law add up.
In many therapies, cells are taken from the patient in clinical centers,
are reengineered and then administered as autologous products.
This manufacturing process can present several legal challenges:
• C
ell collection may in many jurisdictions be regulated as a
(first) manufacturing step, thereby requiring a manufacturing
license or the need to act under the control and the license of
the engineering manufacturing site such as the cell/tissue or
blood collection center. This has a material impact on the GMP
requirements that the company must secure with collection
centers (e.g., sample
testing against infectious diseases).
• T
he cells can be regulated as tissue or as blood and this may
vary between countries. For example, stem cells from blood are
regulated differently in different member states. The procedures
applied in local markets need to be adapted accordingly.
• Supply chain from cell collection to treatment of autologous
products must be properly designed from a privacy standpoint
due to sensitive health data being processed (e.g., controller-tocontroller (C2C) or controller-to-processor (C2P) structure, info
notices, contract clauses).
• Packaging and labelling of ATMPs must comport with specific
guidelines.
• In view of the above, unique liability risks may arise
(see separate write-up).
Gene and cell therapeutics are often curative but their
personalized nature can also make them expensive.
Pricing and reimbursement can be a challenge:
• Will clinical collection centers be paid by health insurance or
by the company?
• The company should not pay for efforts which are supposed to
be covered by insurance reimbursement.
Finally, companies may see competition from clinical centers.
Particularly in certain Member States, academic or non-industrial
ATMPs may provide alternative services under interpretation of
the 'hospital exemption rule' (see write-up below).
• S
hipping cells and autologous product across EU borders
or even within the EU may trigger import/export issues and
notification/authorization requirements.
Dr. Jörg Schickert
Partner, Munich
Mikael Salmela
Partner, Paris
Visit our website to
learn more about our
Cell, Tissue, and Gene
Therapies work.
