Drug companies must provide “unbiased information” to patients, say MEPsBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c5511 (Published 05 October 2010) Cite this as: BMJ 2010;341:c5511
Governments would have to ensure that “objective, unbiased information” about prescription drugs is made available to the public under legislation now being drafted by the European parliament.
The information would have to include a summary of product characteristics, the labelling and package leaflet, and a publicly accessible version of the drug’s assessment report. The data would have to be available electronically on dedicated websites established by national authorities and in printed form.
The obligation was introduced into the draft legislation last week by the European parliament’s environment committee as part of moves to provide patients with better access to high quality information on prescription drugs.
Aware of the thin dividing line between advertising and information, the members of the parliament amended the European Commission’s original draft. This had made it optional for drug companies to provide information. The text now emphasises patients’ rights by specifying which data have to be made available by companies, which information is optional, and the channels through which information should be supplied.
Mandatory information would include the most recent contents of summaries of product characteristics and the labelling and package leaflet. Companies, provided that they receive prior authorisation from the competent authorities, may provide other well defined non-promotional information such as the product’s environmental impact, any price or pack changes, and instructions on its use.
The information would have to be available electronically and in print. Printed material could be sent to members of the public only at their request. MEPs also voted not to allow information on prescription drugs to be broadcast on radio or television or to be published in newspapers and magazines.
After the committee voted, Christofer Fjellner, the Swedish centre right MEP steering the legislation through the parliament, said, “We are shifting the focus from producers’ rights to patients’ rights. All Europeans should have the right to as much information as they want about their medication.”
Patients’ groups and the industry have welcomed the draft legislation, which must still be approved by the full parliament in December and by European Union governments before it can take effect.
Nicola Bedlington, director of the European Patients’ Forum, noted that the current wording “acknowledges the constructive role that industry can play while setting clear limits and maintaining the ban on advertising.”
Speaking for the industry, Brian Ager, the director general of the European Federation of Pharmaceutical Industries and Associations, said that the amended legislation “represents a step forward in the long running debate on patients’ rights.”
However, the Standing Committee of European Doctors is considerably more cautious about the latest developments. Its secretary general, Birgit Beger, said, “We need to keep a careful watch on this. There seems to be some dubious wording. For instance, health professionals have to actively provide information. It is not very clear what this means.”
Cite this as: BMJ 2010;341:c5511