Full steam ahead on France medtech and pharmaceutical regulatory reforms

From 3rd October 2013, the French High Health Authority was given authorisation to carry out medico-economic evaluations of pharmaceutical products and medical devices in France.

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 "efficiency opinion".

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 more complicated.

We would be pleased to help you with this process or to answer your questions about how the change might affect your products.