From 3rd October 2013, the French High Health Authority
(Haute Autorité de Santé - HAS) was
given authorisation to carry out medico-economic evaluations of
pharmaceutical products and medical devices in France. These
evaluations will be done via the Commission for Economic
Evaluations and Public Health (Commission
d'évaluation économique et de santé
publique - CEESP), whose team has been expanded and which is
attached to the HAS, in the same way as the Transparency Commission
(Commission de la transparence) or the National Commission
for the Evaluation of Medical Devices and Healthcare Technology
(Commission nationale d'évaluation des dispositifs
médicaux et des technologies de santé -
CNEDIMTS). The HAS and its related commissions have not
previously performed this type of evaluation. Economic evaluations
were previously carried out by the Healthcare Products
Economic Committee, (Comité économique des produits
de santé - CEPS), which is still the case. The principle
reason for this change is the expenditures of French national
healthcare insurance which remains in a delicate situation.
In practice, manufacturers must now provide the authorities with
a medico-economic evaluation for any request for listing or renewal
of listing on the reimbursed products list, in order to obtain an
This concerns only products having a high level of improvement
of medical services rendered (amélioration du service
médical rendu - ASMR) for drugs or improvement of
services rendered (amélioration du service rendu -
ASR) for medical devices. According to the law, this
will involve those having a level I, II, or III ASMR or SMR
(which are the usal categories used in France for several years).
Therefore, for the time being, level IV category will be excluded
although currently seems to represent a significant expenditure
level. Over time, this situation may change.
The idea is that this concerns only those products generating a
turnover of over 20 million Euros in France per calendar year. Last
summer there was talk of a 30 million Euros limit, but this
has been reduced. In theory, this can be expected to exclude
various biotechnology products for treatment of certain rare
diseases. However, the HAS has already indicated that
although it set the limit, it might itself choose to ignore it from
time to time.
The HAS has stated that products which are no long patented
and which are "committed to price decreases
pursuant to agreements" with the CEPS will be excluded from
the evaluation process.
The procedure for submitting files is explained on the HAS site,
and the change has the practical effect of making the
commercialization of healthcare products in France just a little
We would be pleased to help you with this process or to answer
your questions about how the change might affect your products.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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