E-drug: EC moves towards "direct to consumer" advertising
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[This is a news item from BMJ concerning the proposed changes in the EU
pharmaceutical legislation, one subject being a move towards DTCA. Many of
us strongly opposes DTCA which today you find in New Zealand and the USA.
Both countries consider stopping it. Here are some points from a very good
colleague on this: On the DTCA decision, I'll be interested to see how it
develops. On the one hand I loathe the idea of anything resembling DTCA -
but on the other hand, I can't help thinking it is just possible that the
the EC has got off quite lightly, considering the intense pressure they've
been under from the industry. If they can hold off for 5-years (the
duration of their pilot, they say) and stick to the principle that all such
information be requested by patients and patient groups (ie contintuing to
prohibit messages in mass media) it may not be too bad - and might just be
long enough for the US to have decided that DTCA was a disaster after all.
I'm still not quite sure how to read the EC decision (and all the
references to DTCA could in fact be a response to the kind of press
statements HAI and others have been putting out about this being the thin
end of a wedge). However, I do realise it would tactically be quite wrong
to praise them at all. A US Senate Subcommittee is now investigating DTCA
(increasingly recognised in the US as a major cause of crazy price hikes).
Further information from Commerce Consumer Affairs Subcommittee
http://www.senate.gov/~dorgan/press/01/06/2001724915.html.
"U.S. Senator Byron Dorgan (D-ND) said the Commerce Consumer Affairs
Subcommittee hearing he'll chair today will look at the impact direct to
consumer marketing of prescription drugs has on the cost of prescription
medicines and utilization of those medicines". Several states have also
initiated moves to stop it, see
http://www.quintiles.com/products_and_services/informatics/scot.../1,222
7,245,00.html (NB long URL). In New Zealand there is a discussion paper out
and can be found on the web. A few other points in the proposed new
legislation are also mentioned. KM]
BMJ 2001;323:184 ( 28 July )
News roundup
EC moves towards "direct to consumer" advertising
Rory Watson Brussels
Pharmaceutical companies will be able to provide information on
prescription drugs directly to patients with AIDS, diabetes, or asthma
under legislative proposals tabled by the European Commission. Announcing
the scheme, the enterprise commissioner, Erkki Liikanen, insisted that it
was not intended to undermine the existing ban on public advertising of
prescription medicines in Europe. "This is not direct to consumer
advertising. We are not introducing advertising for prescription drugs. I
am against direct marketing as massive advertising could place a lot of
pressure on the health costs that are covered by public authorities," he
said.
Companies will be able to offer details of their medicines - possibly on
websites or in specialised publications - for the three long term, chronic
diseases only if they are requested to do so by patients or patient groups.
They would also have to abide by a code of conduct, which will be drawn up
by the end of the year.
The pilot scheme is one of a number of proposals made by the commission as
part of a wide ranging overhaul of the European Union's pharmaceutical
legislation, which has been in place since 1995. However, before any
changes can be made to existing procedures, they must first be approved by
EU governments and the European parliament.
Liikanen insisted that the reform package was designed to guarantee the
highest possible level of health protection for European citizens, while
encouraging innovation and competitiveness in the pharmaceutical industry.
It aims to accelerate both the centralised authorisation procedure-which
involves the commission and the London based European Medicines Evaluation
Agency-and individual national procedures by reducing existing delays.
"We want to increase the availability of new and innovative medicines on
the European market, while at the same time ensuring that the basic
criteria of safety, quality and efficacy are met," explained Liikanen.
The commission is proposing to follow the United States by introducing a
fast track registration procedure for products of major therapeutic
interest, allowing them to be assessed and authorised quickly and
efficiently. It is also recommending the possibility of conditional
marketing authorisation. This would enable a company to market a product
for one year if there is an important expected health benefit for the
patients concerned, provided that the company undertakes to carry out
additional monitoring and clinical studies.
A third innovation would introduce a Europe-wide system to make medicines
available before they are authorised, on grounds of compassionate use. The
commission maintains that this would ensure that patients are not
discriminated against on the basis, in particular, of the location of
clinical trials performed by a particular company.
The reform package also recommends various changes to the European
Medicines Evaluation Agency. These are designed to extend the agency's role
beyond its existing remit of evaluating whether medicinal products should
be given marketing authorisation to allow it to provide scientific advice
to pharmaceutical companies.
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Kirsten Myhr
Head of Eastern Region Drug Information Centre
RELIS Ost
Ulleval University Hospital
0407 Oslo, Norway
Tel.: +47 23 01 64 11(o) Fax: +47 23 01 64 10
+47 22 56 05 85 (h) mobile: +47 416 38 747
myhr@online.no (p); kirsten.myhr@relis.ulleval.no (o)
www.relis.no
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