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EU directive on medicinal products: progress transposed into French law at last

The progress made thanks to campaigning by civil society needs to be defended in the face of the industry lobby and ambivalence on the part of the government.

After a long delay, measures benefiting patients contained in the 2004 EU Directive on medicinal products have finally been transposed into French law, thanks to campaigning by civil society.

Progress has been made in the areas of improved public access to drug regulatory agency data and the re-evaluation of drugs after 5 years on the market, making it easier for drugs to be withdrawn as a result of adverse effects, etc.

However, other measures are worrying such as numerous relaxing procedures for marketing authorisation and measures that are unfavourable to generic drugs.

Curiously, the French draft law transposing the Directive included the legalisation of pharmaceutical companies’ “compliance support programmes”, which is not included in the Directive. Massive hostility to the planned legalisation of these programmes by government order, with no parliamentary debate on the issue, has led to a temporary withdrawal of this project. But it has been announced that the Senate will table a new proposal on the subject in the autumn.

Another cause for concern, the banning of direct-to-consumer advertising of prescription drugs, even though it is enshrined in the Directive, is the subject of a major offensive by the European Commission, the pharmaceutical industry and some EU deputies. The ban may be challenged. The fragile progress made must be defended.

©La revue Prescrire

Prescrire Rédaction “Directive européenne sur le médicament : les succès des citoyens finalement transposés en droit français” Rev Prescrire 2007 ; 27 (285) : 540-545.