english.prescrire.org > Spotlight > Archives : 2011 > France's draft legislation on medicines policy: some progress, but some gaps

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France's draft legislation on medicines policy: some progress, but some gaps

The new medicines bill before France’s National Assembly includes some positive measures, especially in terms of transparency and the management of conflicts of interest by regulatory agencies. But several important points are missing, most notably the need to strengthen pharmacovigilance at a local level, and requiring demonstrated therapeutic advance for marketing approval and for reimbursement by the national health insurance system.

The proposed French legislation includes measures which, if fully implemented, would constitute progress in the country's medicines policy, particularly as regards the management of experts’ conflicts of interest, the transparency of regulatory agencies, the regulation of medical devices and off-label prescription, as well as the regulation of pharmaceutical advertising and sales representatives. But the draft represents a step back from several of the recommendations made by members of the French Parliament and by the national medicines conference, Les Assises du médicament.

For instance, the draft legislation does not mandate systematic transparency of regulatory agencies’ meetings, nor does it provide for systematic access to the data examined prior to agencies' issuing a decision or an opinion.

The draft legislation provides for interests to be declared only above a certain threshold, which is not specified, whereas even modest interests have been shown to have an influence.

The draft law is so imprecise regarding regional pharmacovigilance centres that there is a risk that these centres will be marginalised or even eliminated as the declaration of adverse effects becomes increasingly centralised. The regional centres’ role ought, on the contrary, to be enhanced, in the name of better serving patients, in all transparency and in all independence from pharmaceutical companies.

The draft law says nothing about the need for comparison of new drugs against the already-available drugs of reference, much less about the need to demonstrate therapeutic progress, although the latter had been announced by France's Minister of Health. 

The requirement that drugs be prescribed using their international nonproprietary names (INN) has not been put into practice straight away, but instead has been postponed until the arrival of professional software packages that will not be certified for several years to come.

Finally, the draft law says nothing about evaluating drugs' packaging safety and ease of use as a way to prevent medication errors; nothing about the development of quality public information regarding health, prevention and treatment; nothing about the financing of clinical trials independent of pharmaceutical companies, which is a necessary condition for better drug evaluation and fewer conflicts of interests.

©Prescrire 5 August 2011

For more information:

Medicines policy in France after
the benfluorex (Mediator°) scandal:
the proposed measures are positive
but still need work, and especially
need to be implemented
(June 2011)

Prescrire’s proposals to
France’s national conference
on medicines policy:
patients' interests and public
health should come first
(March 2011)

Drugs placed on a watchlist
by the French medicines
agency: Prescrire's analysis
(February 2011)

France's Mediator° scandal:
take the high road
(January 2011)