The European Parliament’s Committee on the Environment and Public Health will be grappling with the toughest part of the pharmaceuticals package, namely information to patients, on the basis of the new draft report by Christopher Fjellner (EPP, Sweden), on 16 March. He recommends a patient-focused approach that contrasts with the proposal drafted in 2008 by DG Enterprise and Industry.

«When you read the proposal, you can tell it was written for industry. It speaks of what companies could be authorised to distribute. I would have preferred to see them obliged to publish information based on the principle of the patient’s right to be informed,» he said at a recent European Parliament conference. Information must be made available to the patient who wishes to be informed (newspapers and magazines are therefore excluded, though they of course still have the right to express opinions or views). He also proposes giving more of a role to patients’ organisations and regulating the information available on internet properly.

PHARMOCOVIGILANCE

The same day, the EP committee will also review draft amendments to the report by Linda McAvan (S&D, UK) on pharmacovigilance, another element of the pharmaceuticals package. As suggested by Commissioner John Dalli at his hearing, the emphasis is on these «less problematical» aspects of pharmacovigilance and falsified medicines (the latter representing the third element of the package).

There is a great deal of reluctance on information to be provided to patients on prescription medicines. Many states are critical of the confusion that could arise between information and advertising. They also think that the control mechanisms proposed are too costly and would needlessly increase the administrative burden. Another concern is that information on medicines delivered on prescription only should be put out by the competent health authorities rather than directly by the pharmaceutical industry.

Doctors do not seem to be won over either. At a workshop sponsored jointly by the Environment and Internal Market Committees on 4 March, the Standing Committee of European Doctors took a stand: «I don’t trust the industry, which has no interest in providing too much information,» declared its Chair, Doctor Frank Ulrich Montgomery. «More generally, amendment 2008/0256/COD is incompatible with the paradigm of Directive 2001/83 which defends protection of public health. It allows an extension of information on internet and other related information and presents too few control mechanisms and sanctions,» he added. In Christopher Fjellner’s view, pharmaceutical companies should be able to publish information that is necessary to patients but will be exposed to sanctions if they overstep the mark. This is the position he will defend on 16 March in committee.

The report is available at www.europolitics.info > Search = 268264

Background

The draft regulation (COM(2008)0662 – amendment of Regulation 726/2004 and of Directive 2001/83/EC) states that the provision of information to the public on prescription medicines is allowed, without prejudice to the prohibition on advertising. It establishes harmonised conditions on the content of information and determines authorised channels of dissemination. The member states would be obliged to set up a monitoring system (with monitoring taking place after information is released). At the December European Council, the Swedish Council Presidency stressed the concerns of many states, while the Commission said it was «prepared to show flexibility in order to work out a common basis for the future negotiations».