[e-drug] EC shift on DTCA

[Peter Mansfield <peter.mansfield@Flinders.edu.au>]

E-drug: EC shift on DTCA
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[Copied as fair use.]

Scrip No 2662 July 20th 2001 p2

EC shift on pharma advertising

The EC Commission has altered its proposal to relax the ban on the
advertising of prescription medicines to the public by creating a
monitoring role for the European Medicines Evaluation Agency.

It has also clarified the scope of the proposal. In future patients
with diabetes, AIDS and asthma will be able to request information
on prescription medicines approved for these diseases. Industry will
be able to provide this information directly to patients and patient
groups provided it is first vetted by the EMEA. A still-to-be drafted
code of conduct will set the framework for the industry promotions,
according to the Commission.

"This is not direct to consumer advertising. We are not introducing
advertising for prescription drugs," Erkki Liikanen, the EC's
enterprise Commissioner, told a press briefing in Brussels.

Scrip understands the decision to include the EMEA in the process
was taken at the last minute after the proposal had been reviewed
by member states and the EC Pharmaceutical Committee. The
earlier proposal, which envisioned a code and limited promotions by
pharmaceutical companies for the disease areas, had sparked strong
opposition from consumer groups who claimed it would stimulate
company sales but distort prescribing behaviour.

Philippe Brunet, head of the Commission's pharmaceutical unit,
explained that the EMEA would essentially be asked to validate
information that pharmaceutical companies propose to put on their
Internet sites or send to consumers in brochures.

Current EC law prevents any direct promotion of prescription
medicines to patients, and this ban needs to be relaxed to allow
even limited product promotions to end users. The code will spell
out how this information will be disseminated. The current thinking,
however, is that television would not be included because it is a
broadcast rather than an interactive medium, Mr Brunet said.

The motivation for relaxing the ban on promotions is to catch up
with developments on the Internet and to try and impose standards
on the information vendors, officials said. Because of the ban,
patients who want information must at present go to websites
operated by companies domiciled outside Europe.

"The availability of information on non-EU websites, in combination
with the current ban in Europe on providing information to
consumers, has created a differentiation between patients who can
go on-line and those who cannot and a differentiation between
those who understand American English and those who do not," Mr
Liikanen told the conference.

In its monitoring function, the EMEA would look at information
assembled by companies. If it did not object within one month, the
information would be authorised. The agency would also issue an
annual report on the workings of the code.

Mr Liikanen said diabetes, AIDS and asthma were selected because
the patient groups lobbied for it and the diseases are relatively easy
to define. By comparison, cancer was less easy to define from the
point of view of treatment. If the limited promotions work,
however, other disease areas might be considered. DTC advertising,
similar to that in the US, was rejected because of its perceived
impact on government health budgets. Since public authorities pay
most of the drug bills in Europe, anything that might artificially
stimulate demand would represent a cost, he said.

Regards,

Peter

Dr Peter Mansfield
GP and consultant on marketing and appropriate therapeutics.
Visiting lecturer, Universities of Adelaide, Flinders, Queensland,
South Australia, Tasmania
Action against cardiovascular Risk Checklist (ARC) Project Officer,
Adelaide
Western Division of General Practice
Director, Healthy Skepticism formerly MaLAM (Medical Lobby for
Appropriate Marketing)
Defending health care from misleading and harmful marketing.
Advocacy, Research and Education.
e-mail: peter.mansfield@flinders.edu.au
www.healthyskepticism.org
PO Box 172 Daw Pk SA 5041 Australia
ph/fax +61 8 8374 2245



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