english.prescrire.org > Spotlight > Archives : 2007 > Compliance support programmes: don't confuse the issues

Spotlight: Archives

Every month, the subjects in Prescrire’s Spotlight.

2007 : 1 | 30 | 60 | 90

Compliance support programmes:
don't confuse the issues

Pharmaceutical companies wrongly claim that their “compliance support” programmes are mandatory.

At the beginning of 2007, in the face of opposition from numerous stakeholders, the French government abandoned plans for the rapid legalisation of pharmaceutical companies' so-called "compliance support" programmes, designed to "assist" patients during treatment.

However the Senate has been asked to draft a law on the subject for Autumn 2007. The pharmaceutical companies are now back in force, clamouring for these programmes to be legalised. One of their various claims is that such programmes are required under the drug regulatory agencies' "risk management plans" (RMP). RMPs set out the companies' plans for monitoring and minimising their drugs' adverse effects.

But in answer to Prescrire’s question on this subject, on 27 April, the European Medicines Agency replied that no such plan includes any obligation to monitor compliance. Nor do the RMPs published by the French drug regulatory agency require companies to have any direct or indirect contact with patients.

The pharmaceutical companies' compliance support programmes are neither mandatory, nor beneficial to patients. They are simply customer loyalty programmes, and as such should be banned, due to their promotional nature.

A French public audit body, the General Social Affairs Inspectorate (IGAS), has compiled a report on these programmes. But as at 28 October, the Health Minister still has not made this report public, in spite of the promises made by his predecessor.

©Prescrire November 2007

Source: "Programmes d'aide à l'observance": ne pas confondre avec les plans de gestion des risques" Rev Prescrire 2007 ; 27 (289) : 815

- More articles in Prescrire's "Spotlight"...