english.prescrire.org > Spotlight > Archives : 2011 > France's medicines policy: the proposed measures are positive, but need to go further, and above all need to be implemented

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France's medicines policy: the proposed measures are positive, but need to go further, and above all need to be implemented

The scandal caused in France by the dangerous weight-loss drug Mediator° has resulted in a vast review of the country's medicines policy. Several institutions and official bodies have undertaken a broad debate aimed at proposing improvements in drugs policy.

  • On 8 March 2011, Prescrire published 57 proposals to reorient medicines policy towards the interest of patients. Final recommendations by, on the one hand, France's National Assembly, Senate, General Inspectorate for Public Welfare (Inspection générale des affaires sociales, or IGAS), and a team commissioned by the French President, and on the other hand the recommendations of the national conference "Les Assises du Médicament" convened for the occasion, include a large proportion of the recommendations put forth by Prescrire in March.
  • In his speeches, France's Health Minister picked up a large proportion of the proposals from the "Assises du Médicament" conference, which often matched the recommendations from other institutions, which is commendable.
  • However, several essential points are missing from the proposed measures:
    • the development of a robust and independent system of publicly funded clinical trials;
    • public access to clinical evaluation and pharmacovigilance data;
    • reinforcement of a decentralised, publicly funded system of pharmacovigilance;
    • the inclusion of packaging safety and ease of use in the evaluation of medicines;
    • a change in the job description and the mode of compensation for pharmacists in community pharmacies, so as to allow them to expand their role as healthcare professionals.  
  • Several points need to be spelled out:
    • registers of financial ties must be searchable by the name of the healthcare professional, and not just by the name of the pharmaceutical company;
    • the development of vigilances (pharmacovigilance, etc.) and the training of healthcare professionals in matters of healthcare safety must also include medical practices (healthcare-related errors) and not just adverse effects of healthcare products;
    • the video recordings of the proceedings of the various committees must be made available in their entirety.
  • Prescrire will evaluate the scope of these reforms based on results, and most notably, in the short term, based on the extent to which the recommendations and the planned measures are incorporated into the new law, and into the decrees by which it is to be implemented. Also in the short term, France must ensure that its representatives to the European Medicines Agency are in a position to bring about the necessary changes.
  • Prescrire will maintain its independence and will carry on with its demanding evaluation of medicines'  harm-benefit balances, and of whatever therapeutic progress they may represent, while also evaluating decisions made by agencies and political entities.
  • Today, France's political establishment must make sure it does not dash the hopes that it has nourished. What's more, it is faced with an historic opportunity to effect a change of course, to reorient medicines policy towards patients' interests first and foremost, in France as well as in Europe.

©Prescrire 1 September 2011

"Politique du médicament en France : de bonnes mesures annoncées, à compléter, et surtout à faire appliquer" Rev Prescrire 2011 ; 31 (335) : 697-700. (pdf, in French, Free)

For more information:

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

See also:

Politique du médicament :
de bonnes mesures annoncées,
à compléter, et surtout à
faire appliquer
(The French version of
this text contains links to
the draft law and the principal
reports from France's review
of medicines policy)