E-DRUG: HAI Europe Press release: EC Pharma Package Article 100b: Opening the door to advertising
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11 December 2008
As DG Enterprise's pharmaceuticals package came up for discussion at the
college of Commissioners yesterday, all eyes were on the contentious
proposal on 'information to patients' that is undoubtedly a relaxation
on regulations for direct-to-consumer-advertising (DTCA) of
prescription-only medicines in Europe.
Advertising or promotion of prescription medicines stimulates widespread
use of new medicines before their potential for harm is fully
understood. Yet, the proposals open the door to such promotion by
allowing pharmaceutical companies to publish 'information' in
health-related printed media, including health supplements, despite the
fact that advertorials are known to be more influential than outright
advertising.
Article 100b gives pharmaceutical companies a free reign to present "the
summary of product characteristics, labelling and the patient
information leaflet of the medicinal product...in a different way" than
is currently permitted under EU regulations. This is a redundant public
health measure given that this information is already available on the
European Medicines Agency (EMEA) website for centrally approved products
and on some national regulatory agencies websites for other products.
The only real rationale for a change in the law is the commercial
benefit of expanding the marketing reach for pharmaceutical companies
operating in Europe.
The same article foresees the provision of "Factual informative
announcements" on prescription medicines by the industry, which are of
little value for patients' treatment regimes but of enormous value as
reminder adverts for their products. They are hugely effective at
inflating sales through emotive branding images and messages.
The proposed system of self-regulation or co-regulation to review
information prior to dissemination is of little comfort, given that
those with a clear conflict of interest would be handed authority over
the information provided to patients and consumers.
HAI Europe is urging Parliamentarians to consider carefully whether the
Member States of the European Union really want to join the minority
club of two (The United States and New Zealand) that allow
prescription-only medicines to become just another branded commodity.
For more information on DTCA in Europe, please go to:
http://www.haiweb.org/10122008/Issue%20Quick%20Sheet%20DTCA.pdf
http://www.haiweb.org/10122008/DTCA%20Chronology%20Document.pdf
The proposal is available at:
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/pharmpack_en.ht
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Terri - Louise Beswick
HAI Europe
Terri@haiweb.org
www.haiweb.org