LSHC Horizons Brochure 2024 - Flipbook - Page 82
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Europe
France's new 2024 security finance bill for 2024 comes into force:
Between promoting therapeutic innovation and budgetary constraints...
One of the most controversial aspects of the
new law concerns the so-called “safeguard
clause”, the mechanism for financial regulation
of the pharmaceutical product market, which
in recent years has reached record levels in
terms of the financial burden imposed on
French pharmaceutical companies. This
mechanism has been thoroughly overhauled
to correct one of its main criticisms, namely its
opacity. From now on, it will be based on the
amounts reimbursed by health insurance for
pharmaceutical products, rather than sales.
However, this reform is only a superficial
solution to the imperfections of the system,
and the litigation initiated several years ago by
pharmaceutical companies against the Ministry
of health will continue.
Several measures have also been introduced
in line with one of the French government's
priorities: the security of supply for all patients.
These include the obligation to find a buyer in
the event of end of the marketing of a product
of major therapeutic interest having lost its
patent, and measures in favor of hospital
preparations, which are open to challenge.
Substitution of biosimilars is also to be extended,
with a new system of “automatic” substitution
at the end of a two-year period during which
the biosimilar is marketed. However, this
automaticity is relative, and the complexities and
administrative authorizations remain.
Charlotte Damiano
Partner
Paris
As for early access, this has been strengthened,
with an obligation for pharmaceutical companies
that sign up to this attractive system to supply
all patients. Pharmaceutical companies must
therefore be sure of their production capacity
before applying for early access.
The mechanism for setting the price of innovative
therapies had also been extended to include
the collection of real-life data, but the French
Constitutional Council censured this measure,
which will therefore not come into force.
Finally, “anti-waste” measures have been
introduced, with the welcome inclusion in
the criteria for setting the price of innovative
medical devices of the health authorities’
assessment of their ecological performance - a
future-oriented subject in line with the French
government's roadmap.
In short, innovation in health care products is
still at the heart of the French government's
concerns, albeit with severe budgetary
constraints and funding obstacles.
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