MEP Christofer Fjellner (EPP, Sweden) considers the European Commission’s proposals on information to the general public on medicinal products subject to medical prescription to be too centred on the rights of pharmaceutical companies. Consequently, he would like to shift the focus to patients’ rights. This is one of the aspects he will defend, in his capacity as rapporteur, during an exchange of views on these proposals in the European Parliament’s Committee on Environment (ENVI), on 3 June.

Two texts are concerned: a proposal for a regulation amending Regulation (EC) N° 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use; and a proposal for a directive amending Directive 2001/83/EC on a Community code relating to medicinal products for human use. These proposals, submitted in December 2008, aim to fill a gap in the current pharmaceutical legislation, while ensuring that the direct advertising ban on prescription-only medicines is maintained. This approach has been highly contested by the Council, where work on these two texts has made little progress.

For Fjellner, the proposals must be focused around “patients’ rights to information”. In the reasons for his draft report, he underlined that “the possibility to make information available to patients may not be used as an advertisement opportunity for the pharmaceutical companies”. Information, he believes, must be made “available and easily accessible” and this availability should be based on the ‘pull’ principle (active search for information). In other words, information should be made available to those patients who are searching for it themselves. He supports the use of more traditional channels, such as correspondence, and is not in favour of using printed media to convey this information.

He also wishes to make a clearer distinction between advertisement and information, specifying in particular that “no promotional material on prescription-only medicines could be made available”. He advocates the active involvement of patients’ organisations in the implementation of the directive and the regulation.

Furthermore, Fjellner welcomes the idea of having guidelines and a code of conduct drafted concerning the information made available to patients, and wants the Commission to cooperate with patients’ organisations when drafting those guidelines and code of conduct, emphasising the important relationship between doctor and patient. Lastly, he believes that patients’ information should be the subject of a more global strategy, complementing the provisions proposed in the directive and the regulation, and calls on the Commission to make a proposal in this direction.

In total, no less than 300 amendments were submitted. The following were singled out in particular: the current wording raises the question of the definition of ‘advertising’ and ‘information’ distributed by the holder of the marketing authorisation; as is, the patient information leaflet is incomprehensible to the patient and does not respond to his real needs: work undertaken by the European Medicines Agency to render these leaflets more comprehensive to patients must continue and must lead to a best practice model for national regulatory authorities; the internet being an essential source of information, it would be appropriate to set up officially approved health sites benefiting from a quality label; competent national authorities and health professionals are the main sources of reliable and objective information on drugs - market authorisation holders may provide additional information but would not be able to replace competent national authorities and health professionals.