In 2008 the transposition of European Directive 2004/27/EC on drugs for human use into French law was nearly complete (la revue Prescrire 303 p. 14).

However, it will now be necessary to ensure that these provisions are properly implemented, in patients’ interests, and that any loopholes are not exploited.

Transparency of French healthcare authorities: totally inadequate
The 2004 EU Directive places certain obligations on the health authorities with respect to transparency.

In particular, the authorities must publish the agendas and minutes of their committee meetings, as well as public assessment reports, and any conflicts of interest of committee members.

The French Health Products Safety Agency (Afssaps) does not always fulfil these obligations. Agendas are not made public and there is a delay in the publication of minutes, with no guarantee of exhaustiveness. In addition, marketing authorisation committee reports contain a bare minimum of information (la revue Prescrire 303 p. 14).

The process of placing documents online has been very slow: on 31 December 2008, only 9713 summaries of product characteristics and about 100 assessment reports were available for 19 535 authorised products.

Agendas of the Transparency Committee of the French National Authority for Health (HAS) are placed online before meetings, but there is a delay in reporting the minutes and reports are often incomplete. The voting details on drug pricing are welcome, but the reports of the proceedings are often too brief.

Pharmacovigilance in Europe: vigilance required In early 2008 the European Commission launched public consultations on some troubling proposals concerning the organisation of pharmacovigilance in Europe (Prescrire International 99 and www.prescrire.org). In particular, the Commission proposed to simplify pre-marketing assessment procedures and to make the drug companies responsible for pharmacovigilance. Some of these unwelcome proposals were dropped in the face of public mobilisation. We will continue to monitor the situation.

Patient “information” provided by drug companies: massive opposition from health stakeholders

In 2007 and 2008 the European Commission launched several public consultations with the ultimate goal of allowing drug companies to communicate directly with the public on the subject of prescription drugs (see www. prescrire.org). Almost all healthcare stakeholders in Europe opposed these proposals. Each stakeholder has a specific role to play. The role of drug companies is to discover, develop and manufacture useful new drugs of the highest pharmaceutical quality (including high-quality packaging). BigPharma should have no say in treatment choices.

©Prescrire April 2009

Source: Prescrire Int 2009; 18 (100): 84-88.