The European Parliament has begun to consider proposals from the Commission to allow industry to disseminate information on prescription drugs directly to the consumer. This move could risk leading to Direct-to-Consumer Advertising in Europe. In response, Health Action international-Europe (HAI Europe) and EPHA organised a seminar in Brussels on January 10 to discuss the question of: "Providing Prescription Medicine Information to Consumers: Is there a role for Direct-to-Consumer Advertising (DTCA)?"
As part of the European Commission’s Pharmaceutical Review process, which began last year, the Commission adopted a proposal for the amendment of Directive 2001/83/EC on the Community code relating to medicinal products for human use . This Directive prohibits the advertising of prescription only medicines to the general public. DG Enterprise proposes to allow pharmaceutical companies to provide information direct to the public on prescription drugs (Article 88) for three disease categories (1). This may open the door to Direct-To-Consumer Advertising (DTCA) in Europe.
The proposed change would allow industry to disseminate information on prescription medicines for the treatment of AIDS, asthma and chronic broncopulmonary disorder and diabetes. The proposal is justified by the Commission as "in the interests of patients in order to respond to their legitimate needs."
Lack of evidence to support proposal
The Commission says that the proposal was put forward "in view of the growing consumer demand for information". However, patient groups attending the HAI/ EPHA conference said that they had not been consulted, nor did they support this proposal. The Commission has provided no evidence of demand from patients.
No evidence has been provided of the health benefit or lack of harm of the Commission’s proposal.
Information or advertising?
Although there is a clear need for better information on prescription medicines to patients, central to the debate is whether this new provision is necessary or whether it simply provides a new promotional opportunity for pharmaceutical companies.
The Commission insists that the new provision concerns information and not advertising. However, it includes its proposed changes under the Title VIII on Advertising of Directive 2001/83/EC. Moreover, in the Explanatory Memorandum on the proposal, the Commission states: "It is proposed that there should be public advertising of three classes of medicinal products."
Mr Leon Wever, Director of Pharmaceutical Affairs at the Ministry of Health, Welfare and Sport in the Netherlands is against the proposal. He told the HAI/EPHA meeting that improving information to patients does not require a change in the law. Indeed, the current ban on DTCA for prescription only medicines does not affect the ability to provide information.
What are the arguments in favour of DTCA?
People want and need information on medicines
Advertisements will help people to get needed medical care at an earlier stage
Advertisements will lead to better compliance
A doctor’s prescription is needed, so the patient is protected.
Why is there resistance?
Prescription drugs are not like other consumer goods. Even when used properly, they can cause serious harm
Kees de Joncheere, WHO Regional Adviser for Pharmaceuticals and Technology, WHO, referred participants to the WHO Ethical Criteria which state that "advertisements to the general public … should not generally be permitted for prescription drugs or to promote drugs for certain serious conditions..."
People are vulnerable when they are ill
Sick and worried patients are less likely to exercise critical judgment of varied information sources.
Advertisements aim to stimulate sales. They cannot provide impartial, objective information.
The pharmaceutical industry has an interest in the sale of the product and is unlikely to provide complete and balanced information.
Advertising increases pressure from patients to their doctors for reasons unrelated to medical evidence
Since DTCA was authorised in the US in 1997, companies have massively increased television and radio advertising. Pharmaceutical sales are increasing at 12-15% per year. In a recent study by the Kaiser Family Foundation, 30% of a representative sample of 1,872 people interviewed said they had spoken to a doctor about a medicine that they had seen advertised on the television or in the press. (3)
Advertising promotes the consumption of medicines
Demand is stimulated for the most advertised medicines, which are not necessarily the most appropriate or cost-effective.
The cost of an increased consumption of prescription medicines puts further pressure on the sustainability of national health care systems
The introduction of DTCA in the US has "blown the lid off" the national drugs bill, according to Charles Medawar of Social Audit Ltd. "The 50 most advertised drugs (as opposed to the other 9,850) now produce half the annual increase in the US national drugs bill," according to Mr Medawar, who in December 2001 submitted a scathing report on DTC advertising to the European Parliament (4).
What happens elsewhere?
Only two countries - the US and New Zealand - allow DTCA at the present time. However, in Canada, the pharmaceutical industry is lobbying to allow advertisements that discuss both the drug and medical condition in advertisements similar to the TV and radio spots allowed in the US. Groups opposed to DTCA include the Canadian Medical Association, the Consumers Association of Canada and drug insurance plans, who warn that DTC ads will only boost demand for drugs and push up health care costs but do little to improve the health of consumers.
Global implications?
Experts say that the consequences of Europe following the US will inevitably mean that DTCA spreads to developing countries, where it will become even more difficult to control national spending on non-essential drugs.
What do patients want?
Conference presentations by Dr Angela Coulter, Chief Executive of the Picker Institute, and Clara MacKay, Principal Policy Advisor at the Consumers’ Association, UK, specifically addressed patient information needs on the basis of research findings.
Clara MacKay said that both consumers and patients needed more information. In particular, mothers purchasing medicines for their small children were interested in information about the side effects.
Overall, she concluded that consumers want information that "puts the medicine in context and that is accessible, practical and relevant." Consumers want to know why one patient is taking a different drug for what might appear to be the same condition, for example. They want information about their options, and the true benefits of different treatment, rather than promotion. They want to know about alternative therapies, the possibilities for relieving symptoms, and whether treatment is essential.
Alternative sources
Two examples of alternative sources of information were proposed as better and more independent responses to patients’ information needs. One was the expansion of information provided by community pharmacies proposed by Flora Giorgio of the Pharmaceutical Group of the European Union. A second option was to offer more patient to patient information, developed with the support of medical professionals.
The DIPEx internet-based multimedia resource (www.dipex.org) provides access to patients’ own experiences of being diagnosed with a serious illness. The information is produced with support from professionals and provides updates on available treatments, links to support groups and other reliable sources of information.
What if it is accepted?
If the proposals allowing dissemination of information about prescription drugs were adopted, the pharmaceutical companies would have to operate under certain restrictions. The Commission’s proposal establishes the following conditions for information dissemination:
The pharmaceutical industry should set up self regulatory procedures at the Member State level;
The information and its dissemination should follow the principles of good practice developed after consultation with interested parties at the EU level;
Any additional information to be made available should be notified to the European Agency for the Evaluation of Medicinal Products (EMEA), which then has thirty days to object. If it does not react, the information is deemed to be accepted.
The Commission leaves implementation to self-regulation by industry and principles of good practice still to be established. It requires that EMEA be notified - but allows only 30 days period for review and reaction, and after that period the notified information is deemed to be authorised.
Five years after the Directive has taken effect, it is proposed that there will be an evaluation and report.
To read more about the direct-to-consumer promotion issue, see HAI Europe’s website at: http://haiweb.org/campaign/DTCA/index.html
The Pharmaceutical Group of the European Union (PGEU) has responded to the Commission’s proposal amending the Directive on medicinal products for human use. It is available at PGEU’s website: http://www.pgeu.org/02.html Contact: Flora Giorgio, e-mail: pharmacy@pgeu.org
European AIDS Treatment Group has produced a position paper on Direct to Consumer Information in Europe (EATG-DTC in Europe, 12/12/01) Contact: office@eatg.org
EPHA has undertaken a survey on "Information to Patients on Prescription Only Medicines" and will be publishing the results shortly.
References:
(1) The new provisions regarding information of prescription-only medicines relate to Directive 2001/83/EC, Article 88, para 2 (published 26 November 2001). Para 1 maintains the existing general EU ban that prohibits advertising of prescription drugs to the general public.
(2) Paper presented by Ms Barbara Mintzes, Centre for Health Services and Policy Research, University of British Columbia, Canada.
(3) Understanding the effects of Direct-to-Consumer Prescription Drug Advertising, November 2001, The Henry J. Kaiser Family Foundation.
(4) "Health, Pharma and the EU, A briefing for Members of the European Parliament on Direct-to-consumer drug promotion," Charles Medawar, Social Audit, January 2002.
