[india-drug] E-drug: "Direct To Consumer" advertising

[Edrug <e-drug@usa.healthnet.org>]

(Cross posted from Edrug. Thanks ???.SS)

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 continuing 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 realize it would tactically be
quite wrong to praise them at all. A US Senate Subcommittee is now
investigating DTCA (increasingly recognized 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.../1,2227,245,00.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.
--------------------

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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