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PJ Online homeThe Pharmaceutical Journal
Vol 280 No 7498 p457
19 April 2008

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EC plan to relax patient information rules opposed

Industry sets out its position

A spokeswoman for the Association of the British Pharmaceutical Industry pointed out that its code of practice prevents manufacturers from advertising prescription-only medicines to patients and that it has never called for the opportunity to provide information on prescription medicines to patients via television or radio programmes.

But she added that the ABPI is keen for patients to have the most accurate information about their medicines, especially because of “unauthorised” information that patients can find on the internet and which may not be accurate.

Pharmaceutical companies will be allowed to publicise information about prescription-only medicines in radio and TV programmes if proposals being drawn up by the EC are approved.

The suggestion, which would be included in a new EU directive for all its member states, has caused disquiet in the UK even though the EC insists that the current ban on companies being able to advertise their prescription drugs to the public will still apply.

Opposition to the idea outlined in a consultation paper “Legal proposal on information to patients” (PDF 80K) from the Directorate General for Enterprise and Industry, comes from several pharmacy organisations, including the Royal Pharmaceutical Society, the Guild of Healthcare Pharmacists, the Pharmaceutical Group of the European Union, as well as patient organisations such as the Picker Institute.

They all share the same concern that giving the industry the chance to use the media to disseminate patient information is little different from allowing them to advertise their products.

In its response to the consultation, the guild says: “This is advertising, even if technically in law it is not, and will have the same effect as advertising, eg, requests to clinicians to prescribe particular drugs even though this may not be in the best interests for [patients].”

The Society has similar reservations. In a statement it said: “We do not consider that the industry can be regarded as an objective source of information given the nature of its financial interest in prescription medicine, and hence we consider this proposal is not consistent with the broad objectives set out in the consultation document.”
(PDF 40K)

The PGEU, which represents community pharmacists in 30 European countries, including EU states, believes the proposal from the EC is severely flawed.

Providing information through television, radio and other media will not address the individual needs of patients, it points out in its response to the consultation, which ended earlier this month. The proposal would threaten the integrity and confidence that patients have in information about their prescribed medicines, the organisation warns.

“The sole justification of any change in this area can only be to help patients, and not grant more commercial freedom to the pharmaceutical industry. The consultation gives the impressions that that principle has been overlooked,” the PGEU says.

The Picker Institute, a charity that considers the patient’s perspective in healthcare policy and practice, strongly opposes the EC plan which it says is “clearly driven by the pharmaceutical industry’s interests — not by the interests of the patient”.

The institute also believes that the distinction between advertising and information would be unworkable in practice and would undermine the ban on direct-to consumer advertising.

The EC is consulting on a new legal directive in an attempt to harmonise the quality and detail of information from drug companies to patients about their prescription-only medicines across the EU. It argues that the rules vary across EU member states leading to unequal access to information.

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