During the last Health Council meeting (8 and 9 June 2009), Member States reviewed the three pieces of legislation forming the “pharmaceutical package”: fighting counterfeiting, European pharmacovigilance and information to patients.

With regard to preventing falsified medicinal products from entering the legal supply chain, ministers broadly welcomed the proposal, highlighting the importance of the draft directive on the safety of medicinal products. However, individual elements of the proposal need further discussion. This concerns in particular definitions e.g. of "falsified medicinal products", the scope of the proposal and the safety features.

Concerning pharmacovigilance ministers warmly welcomed the Commission proposals for regulation and a directive, and highlighted their contribution to the protection of patients. No agreement has been found yet on the composition, role and mandate of the proposed Pharmacovigilance Committee and its interaction with other preparatory bodies of the European Medicines Agency (EMEA).

Many ministers expressed their concerns over the regulation and directive on the provision of information on medicines by marketing authorisation holders. While agreeing that there is a need to improve the information to the general public on prescription-only medicinal products, many delegations fear that the suggested system will be overly burdensome for competent authorities without leading to significant improvements in the quality of the information provided to patients. In addition, many delegations hold that the distinction between "information" and "advertising" is not sufficiently clear. So they fear that the proposals will not provide adequate guarantees, and that the prohibition of advertising of prescription-only medicinal products to the general public will be circumvented.

Health-related and patient associations, in parallel with the Council discussions, are also debating the question of information to patients. A wide range of organisations representing key healthcare stakeholders – patient groups, family and consumer bodies, social security systems and health professionals – met on 2 June 2009 to discuss the European Commission’s proposed Directive. They highlighted the need for relevant health information, as a fundamental part of healthcare, centred on patient and consumer needs as well as public health priorities, and provided by reliable independent sources.

Participants called upon the European Commission to work on a new and more ambitious strategy, truly recognising the legitimacy of patients and their family circle, patient organisations, consumers, users and their organisations as real partners on the process.

They proposed key elements requiring attention, such as:

• improving the readability of the packaging and the patient information leaflet (better enforcement of article 59 of Directive 2001/83/EC modified by Directive 2004/27/CE);

• optimising communication between patients and health professionals;

• encouraging national health authorities to become proactive and more transparent providers of information on the efficacy and safety of medicines;

• developing and sustaining existing sources of comparative information that help patients weigh up the pros and cons of existing treatments in order to participate in informed treatment choices.