2021 LS&HC Horizons - Flipbook - Page 60
Innovative therapies market access in France
With the expected wave of innovations, market
access of innovative products is a priority for the
industry. The French government has initiated
regulatory changes in this respect.
The French Social Security Financing Act for
2021 amended early access and compassionate
use of innovative products for patients. In
parallel, the health authorities are initiating new
methodologies for the scientific evaluation of
innovative products (fast tracking, comparative
approach, conditional assessment, organizational
impact, etc.). These changes should result in the
development of performance-based managed
entry agreements, already negotiated in recent
years with French pricing authorities, especially
for gene therapies.
France is part of a European context of changes
in the regulation of therapeutic innovations.
Taking action concerning one of the most
innovative field in pharmaceuticals, on 17
November 2020, the European Commission
announced the revision of the “Tissues and
Cells Directive” and the “Blood Directive” to
fill the gaps in the current legislation, in
particular for gene and cell therapies. A few
days later, the Commission published a new
Pharmaceutical Strategy, including as a main
objective the accessibility and affordability of
The steps taken by the Commission are
important for the evolution of national
legislations on market access - which remains
a prerogative of member states.
These developments, though anticipated and
called for by the industry, also happen in the
context of the COVID-19 crisis. The availability
of health products is now a major sovereignty
issue. As announced by the French Government
in September 2020, industrial presence will be
included in the criteria for setting the price of
pharmaceuticals and medical devices.
It might be too early to conclude whether this
reflects the “dawn of a new era.” The nature of
the pharmaceutical and medical devices market
is shifting from “blockbusters” improving
patients’ living conditions to “one-shot”
therapies/products that cure long-term and rare
diseases, such as the artificial heart of Carmat.
The immediate prices of these innovations might
be high for the payer, but the global impact on
care management and reimbursement can be
positive for all parties.
All of these elements should have an impact in
the months and years to come on pricing and
reimbursement negotiations for innovative
products as well as their legal and regulatory
framework, in France and across the EU.