LSHC Horizons Brochure 2024 - Flipbook - Page 81
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Europe
France implements stringent measures to address medicinal
product shortages: Impacts on pharmaceutical industry
The legal and regulatory framework aiming
at addressing medicinal product shortages in
France has been recently completed with a
particularly stringent measure impacting the
pharmaceutical industry. Since the adoption of
a law dated 26 December 2023, pharmaceutical
companies marketing mature medicinal
products of major therapeutic interest (MITMs)
may be forced to find a buyer if they wish to
suspend or cease the marketing of such MITM,
under specific conditions. This requirement
applies when available alternatives do not
permanently cover the medical needs.
In addition to the current declaration of
suspension or ceasing of MITM marketing,
companies will now need to submit an analysis
of the foreseeable impact on the French
population's needs in case of such suspension
or cease. If the French National Agency for
Medicines’ and Health Products’ Safety
(ANSM) considers the available alternatives
insufficient, the marketing authorization
holder (MAH) must notify potential buyers
for taking over the marketing of the concerned
medicinal products, respond to each offers
received, and provide necessary information
to enable the buyer to acquire and market the
MITM. The marketing authorization holder has
a nine month timeline for notifying the ANSM
of the offer it intends to accept.
This new obligation is particularly challenging
for pharmaceutical companies for the
following reasons:
Mikael Salmela
Partner
Paris
• the timeline is particularly short considering
the timing usually required in the context of
a business transfer;
• companies targeted by this new regime are
often facing economic difficulties, are in an
unfavorable competitive context, and would
therefore be weakened by this new procedure
as their power of negotiation with potential
buyers would be particularly decreased. Such
system could potentially benefit companies
interested in acquiring MITMs at lower prices;
• this new procedure seems better suited
for long-term sales rather than temporary
suspensions;
• the ANSM’s discretionary attributions limits
companies’ visibility and ability to plan;
• disclosing strategic information during
negotiations may weaken companies or
compromise sensitive data;
• if no buyer is found, companies may have to
provide the medicinal product for the French
market, free of charge, to a public entity for
up to two years, with financial penalties for
non-compliance;
In addition, the ANSM can unilaterally categorize
medicinal products as MITMs, adding
unpredictability and complexity for companies.
An implementing decree is awaited and will
provide for detailed criteria and conditions
under which this new procedure will be applied.
Joséphine Pour
Senior Associate
Paris
81
