The 2nd HPD report - Health Policy Monitor

From 1994 to 2003, prices for all pharmaceuticals were negotiated
between the manufacturers’ LEEM (Les Entreprises de
Médicament) and the CEPS (Comité économique des produits de
santé), the economic committee on health products. Negotiations
were based on a medical assessment of the drug (by the “Commission
de Transparence” according to the six-tiered ASMR system)
and on expected sales, research and marketing costs as well
as available funds.
Idea
Pilot
Policy Paper
Legislation
Adoption
Evaluation
Change
The bill on liberalization of prices sought to exclude from this
negotiation process those pharmaceuticals demonstrated to have
a major added medical value. These drugs were to be defined by
ministerial order according to the ASMR determined by the
“Commission de Transparence.” After intensive industry lobbying,
the definition of the drugs in question was made part of the
negotiations between CEPS and LEEM. CEPS merely retains the
right to veto the price in the weeks after the drug is introduced to
the market.
The only independent journal on pharmaceuticals in France,
“Prescrire,” has accused the “Commission de Transparence” of
inconsistent decisions. Furthermore, the French Court of Account
strongly criticized the negotiation process for lack of transparency
and inability to regulate the pharmaceutical market. CEPS was
suspected of favoring industry goals over health policy goals.
As a result of the reform on liberalization of prices for innovative
drugs, pharmaceutical companies can define prices for new
innovative drugs without negotiation through public institutions.
Such a policy is completely new to France. The primary aim was
to advance the development and market entry of innovative medications
and to accelerate patients’ access to such drugs. Whether
this policy will effectively promote the development of innovative
products and speed access to these drugs remains to be seen.
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New products
excluded from
price negotiations
Intransparent negotiation
process
New product
prices no longer
negotiated