A series of initiatives on medicines and public health is expected to arrive on the table of the French EU Presidency during the second half of the year. The degree of progress made will depend on the European Commission’s schedule. Of particular importance for the Commission are the packages of directives, one of which it plans to publish in the autumn on medicines. This promises to be an ambitious and perilous exercise.

France will also put the fight against Alzheimer’s disease on the agenda, which is one of French President Nicolas Sarkozy’s national priorities. “This choice was obvious, as the French reflection on this point is so advanced,” French Health Minister Roselyne Bachelot-Narquin said recently.

PRESCRIPTION MEDICINES

This has not prevented the EU executive from launching a stormy debate on the reform of information relating to medicines, which Paris will have to handle following an initial exchange of views between EU health ministers on 10 June under the Slovenian Presidency. The Commission wants to authorise the pharmaceutical industry to communicate directly with patients on products sold by prescription. This has triggered the anger of health professionals: doctors, insurers, pharmacists and the majority of patients’ associations (the principal sources of information). Consumer associations have also been warning against lifting the ban on advertising. As for member states, they do not intend to abandon their prerogatives and control over the information provided on these medicines.

Other medicine dossiers will be added and will, on the whole, aim to increase the industry’s influence on EU legislation. This is particularly the case for a pharmacovigilance project on the supervision of medicines authorised in the EU, which has also angered health professionals: “On the pretext of simplifying administrative procedures and ‘rationalising the system’, the Commission’s proposals undermine the European pharmacovigilance system and represent a major backward step for the evaluation of medicinal products,” warned Health Action International (HAI), an association which brings together patients, NGOs, health services and academics. “Entrusting pharmaceutical companies with the task of gathering and analysing data, issuing warnings and informing about their products’ adverse effects is unacceptable due to in-built conflict of interests,” it explains.

The fight against counterfeit medicines could also be controversial. While they initially affect developing countries in horrendous proportions and with tragic consequences, counterfeit medicines are now penetrating into Europe. The Commission wants to strengthen the security of the distribution chain. The controversy could bear on the fate of the parallel trade in medicines – whose activity rests on price gaps and the free circulation of goods within the EU – and its practices (reconditioning and new labelling). Laboratories have made parallel traders their preferred target, accusing them of unfair competition and losses of €3.5 billion to €5 billion per year. On the request of Bachelot-Narquin, the pharmaceutical forum will gather, on 2 October in Brussels, on the topic of the fight against counterfeiting.

Lastly, the Commission anticipates a recasting of the European legal framework for medical provisions, to extend it to new technologies, such as cosmetic implants.

CROSS-BORDER CARE

With regard to public health, the illustrious – and highly controversial – project on cross-border health care is awaited. Also anticipated for November are: a directive on the quality and security of organ donations and an initiative to promote tobacco-free public places. The Commission will make recommendations to the Council to combat infections associated with health care and will publish a communication on patient security. Rare diseases will also be the subject of recommendations. An action plan against cancer has been announced for 2009.

Important dates 

Health ministers will gather informally on 8-9 September in Angers. The Health-Employment Council will take place on 2-3 October and 15-16 December.