Brussels, 10/06/2008 (Agence Europe) - EU Health Ministers, meeting in, Luxemburg on Tuesday 10 June, have adopted conclusions on, information for patients.
In the text, the Council acknowledges the need for an adequate response at European level to changes in society and the ever more active role of patients, as well as the need to reduce disparities in patients' access to information in the different member states. It believes, nonetheless, that this response should take account of each country's specific circumstances, including the general state of health and needs of the population, mechanisms and information technology currently used at EU and member state levels, patients' needs and the role of the various stakeholders, in particular member states' health authorities and professionals. The Council stresses that it is important to ensure that patients have access to good quality, objective, impartial, reliable, complete, understandable, relevant, appropriate, patient-based and non-advertising information on the pharmaceutical products and other treatments, in line with legal requirements, and that they have access to information which promotes reasonable and appropriate consumption of medicines. The Council takes a stance in favour of keeping the ban on advertising in place for medicines that are only delivered by medical prescription to the public. It also notes that the new proactive role of patients, that can help to improve treatments and the quality of life, is closely linked to the possibility of gaining access to specific and relevant information on illnesses, medicines and other treatments. Nonetheless, this “proactive” role requires, among other things, that quality standards be defined and approved for such information.
The Council is calling for the ban on mass-advertising for medicines that are only supplied on medical prescription to be maintained. It also points out that a “new pro-active role for patients that can help towards improving treatment and the quality of life, is closely linked to opportunities for accessing accurate and relevant information on diseases, medicines and other treatments”. This “proactive” role, however, demands, amongst other things, that quality standards are defined and approved for this information.
The Council takes formal note of the Commission's intention to elaborate a legislative proposal on patients' information on medicines. It instructs the Commission to continue to update the means for distinguishing information advertising by providing a clear definition of non-advertising information. At the same time, it underlines the need to carry out a far-reaching reflection on the question of promoting more rational consumption of medicines and how to prevent superfluous administrative costs for stakeholders, particularly the competent authorities and those that have marketing authorisation rights, in compliance with the principles of “better regulation”. (O.J./transl. rh)