France

Health systems in transition France 159
One of the major changes since 2010 has been a move towards more
transparency in the system, particularly with respect to conflicts of interest of
experts. In 2011, weaknesses in the French regulatory system for health products
were underscored in the wake of the scandal over Mediator (benfluorex), an
anti-diabetes drug that remained on the French market until 2009 despite
mounting evidence of serious side-effects that led other countries to ban it
as early as 1997. In a report on the investigation into Mediator, the Inspector
General of Social Affairs (Inspection générale des affaires sociales; IGAS)
identified multiple weaknesses in the regulatory system for drugs, including
what it termed a structural and cultural conflict of interest on the part of the
French Health Products Safety Agency because of its institutional cooperation
with the pharmaceutical industry, as well as the reluctance by the Ministry in
charge of Health to de-list drugs found to have an insufficient SMR for fear of
opposition by prescribing doctors and patients (IGAS, 2011). The scandal led
to fast-track reform legislation.
The main objectives of the reform legislation were to:
• restore confidence in the administrative decision-making process for
health products, particularly drugs;
• provide greater transparency and reduce the influence of the
pharmaceutical industry on experts and treating physicians; and
• strengthen drug safety and surveillance.
Enacted in December 2011, the Health Security Act (Loi No. 2011–2012 du
29 décembre 2011 relative au renforcement de la sécurité sanitaire du
médicament et du produits du santé) established a new national agency, the
ANSM, to evaluate the benefits/risks of all human health products and provide
ongoing surveillance. ANSM, which replaced the French Health Products
Safety Agency, has expanded authority, including the ability to require drug
manufacturers to undertake comparative trials to measure the increased benefit
of a new drug over an existing one and the power to impose criminal sanctions.
To address the issue of conflicts of interest raised by the Mediator affair, the
Health Security Law requires experts providing input into the decision-making
process (e.g. members of commissions reporting to the ministries in charge of
health and social security) to disclose their direct and indirect interests for the
five preceding years in a declaration available to the public and kept up to date
by the expert.