LS&HC Horizons 2023 - Flipbook - Page 8
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Precision and Regenerative Medicine
Research & development of gene and cell therapeutics and other advanced
therapy medicinal products (ATMP) in Europe
The development of cell, tissue, and gene
therapies (CTGT) has been significantly
increasing. Bringing such products successfully
to market requires addressing specific aspects
during the R&D phase of these products.
In particular:
• These therapies use human tissues/
cells. Such material is not patentable in
many jurisdictions. The core of the patent
protection must be looked at carefully:
the compound developed on the basis of
human/cells, if possible, or the process of its
manufacture (or a hybrid option).
• Development work must comply with and
anticipate ATMP regulations (e.g., on current
good manufacturing practices (cGMP)).
Further, national laws still provide their own
rules (e.g., manufacture, collaboration with
collection centers for autologous or allogenic
products, privacy and health care provider
(HCP) compliance).
• Cells and tissue can be treated differently
across jurisdictions. In borderline cases,
like stem cells, local law may lead to
different classifications (e.g., as blood or
tissue). As a consequence, different rules
may apply for collection on patient level,
processing at collections centers, the
need for a manufacturing license, as well
as the manufacture at specialty contract
manufacturing organizations (CMOs) and
related agreements.
When dealing with clinical trial centers and
setting up the clinical trial agreements (CTA),
sponsors must take into account items such as:
• aligning and linking the CTA with the specific
supply chain for the product;
• adapting privacy structuring and
requirements;
• educating and supporting treatment centers
– but not providing any undue transfer
of value;
• considering the potential later
reimbursement (e.g., side costs for payors);
and
• cautiously transferring know-how to
clinical trial centers. Due to the so-called
hospital exemption, they will be allowed
to offer similar in-house treatment and
may be a pharmaceutical company’s future
competitor.
In any event, EU players must stay alert as the
upcoming substances of human origin (SoHO)
regulations on blood, tissues and cells will
substantially impact the above.
Mikael Salmela
Partner, Paris
Dr. Jörg Schickert
Partner, Munich
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