Release: FOR IMMEDIATE RELEASE

HEALTH ACTION INTERNATIONAL - EUROPE

CONSUMER GROUPS TO EUROPEAN COMMISSION:
"SAY 'NO' TO CONSUMER DRUG ADVERTISING AND 'YES' TO QUALITY OBJECTIVE DRUG INFORMATION"

4 February, 2002

Consumer health groups say recently published research adds further evidence of the potential harm of Direct-to-Consumer Advertising (DTCA) of prescription medicines. Advertising prescription drugs directly to consumers is only legal in the US and New Zealand, yet recent proposed changes to EU law may make the practice legal in Europe. Health Action International (HAI) and the European Public Health Alliance (EPHA) are calling on the EU to reject any legislation that weakens the ban on DTCA.

The authors of a study published in the latest issue of the British Medical Journal (http://bmj.com/cgi/content/full/324/7332/0/d) found that doctors often prescribed medicines requested by patients in spite of personal reservations, leading to an increase in sales of advertised products at the expense of prescribing appropriateness.

"Patients respond to ads by asking for a drug they may not need, and the doctor very likely prescribes it although they wouldn't have chosen it otherwise and it may not be in the best interests of that patient." , said Ms. Barbara Mintzes, from the University of British Columbia in Vancouver, Canada, who headed the study.

Consumer groups are saying that the proposed change in EU law regarding Directive 2001/83/EC which regulates pharmaceutical advertising will likely result in an American style spiral of drug costs and a greater level of inappropriate drug use. The EC stated that this change is necessary to allow the pharmaceutical industry to "provide information to the public" for three disease areas for a trial period.

Consumer groups, patient groups, government regulators and others who attended a meeting co-sponsored by HAI and EPHA on January 10th 2002, raised an alarm that these changes would likely allow two forms of advertising previously banned on public health grounds: advertising of prescription-only drugs to the public for HIV/AIDS, diabetes and asthma, and advertising of treatments for serious diseases listed in Article 88 (2) of the Directive. Two weeks ago, the pharmaceutical industry magazine Scrip reported that a translation error may be at the heart of the confusion and questioned whether the proposal refers to 'public advertising or 'information to the public'.

"Whether the Commission uses the word 'information' or 'advertising' is beside the point," says Margaret Ewen, co-director of HAI Europe in Amsterdam. "The real question is whether this legislative change will allow US-style prescription drug advertising. We believe it will."

While the pharmaceutical industry consistently claims that drug advertising leads to improved patient health Ms. Mintzes is not convinced.

"In nearly 20 years of US drug advertising to consumers, there's no evidence that exposure to drug advertising improves health or prevents hospitalizations or deaths. We know that advertising can lead to increases in use of new drugs - and that this happened even for drugs that were later withdrawn from the US market". In the last five years Rezulin (troglitazone), Propulsid (cisapride) and Baycol (cerivastatin) were pulled from the market because of unacceptable risks, including patient deaths.

Numerous public interest groups in Europe and other regions have signed the HAI Europe/ EPHA joint statement today calling on the EU to take a stronger role in providing consumers with quality prescription drug information and vigorously enforce the present legislation with better monitoring of drug promotion to health professionals.

The concerns of consumer groups were echoed by Mr. Léon Wever, Director of Pharmaceutical Affairs with the Dutch Health Ministry who questioned the proposed change: "If it is about information, not advertising, then there is no need to change the law." He noted that the Dutch government would vote against this proposed change.

HAI Europe's Margaret Ewen said "there is a vital need for consumers to access quality, comparative drug information. This information must be unbiased and not provided by drug companies in order to promote a product."

HAI Europe, a network consumer, health, and development groups working towards the rational use of drugs, calls on the European Commission to leave the current advertising regulations intact, and ensure that patients get access to quality, objective and understandable drug information.

For more information please contact Margaret Ewen, Health Action International Europe; phone 0031 20 683 3684, email info@haiweb.org