Health Action International	European Public Health Alliance

HEALTH ACTION INTERNATIONAL (HAI) EUROPE
and the
EUROPEAN PUBLIC HEALTH ALLIANCE (EPHA)

JOINT STATEMENT ON THE

Background: On January 10, 2002, researchers, consumer, patient, WHO and pharmaceutical industry representatives, drug regulators, health professionals, insurers and others met to discuss the question: Providing Prescription Medicine Information to Consumers: Is there a role for Direct-to-Consumer Advertising (DTCA)? This meeting was held to discuss the European Commission's proposed amendment to Article 88 of the Directive on the Community Code relating to Medicinal Products for Human Use. This proposal will, for a five-year trial period, permit pharmaceutical companies to provide consumers with promotional information on prescription only medicines (POMs) authorised to treat HIV/AIDS, asthma and diabetes. The concern is that this proposal will likely invite full-scale DTCA in the EU. DTCA of prescription medicines is currently banned in every industrialised country in the world, with the exception of the United States and New Zealand.

This meeting clarified a number of points:

1. PEOPLE WANT OBJECTIVE INFORMATION ON PRESCRIPTION MEDICINES. Everyone emphatically agreed that the public needs access to balanced, comparative, relevant, up-to-date, accurate and unbiased information on pharmaceuticals and non-pharmaceutical treatments but only DG Enterprise defended their proposal.

2. NO ONE CLAIMS RESPONSIBILITY FOR THE COMMISSION'S PROPOSAL. No one could say who exactly is driving this proposal. Specifically at this symposium:

• DG Enterprise said that this proposal was based on expectations expressed by patient groups but it could not name a single patient group supporting this proposal. Patient groups attending said that they had not been consulted, did not support this proposal and promotional information provided by the drug industry would not meet their information needs.
  
  
• The director of the European Federation of Pharmaceutical Industries and Associations (EFPIA) claimed that they have no position on DTCA and representatives from AstraZeneca, Novartis and Merck Sharp & Dohme who attended offered no comment.
  
  
• It became clear that some national health policy makers (such as the Dutch Ministry of Health) reject DTCA but want to improve the quality and accessibility of information about medicines (which does not require any change in legislation).

3. THERE IS NO EVIDENCE THAT THE COMMISSION'S PROPOSAL ON ARTICLE 88 WILL BENEFIT PUBLIC HEALTH. Consumer advocates and public health officials all spoke strongly that they believe that the proposal to allow promotional information will not result in the provision of quality information to consumers. It was emphasised that the likely outcome of this proposal will encourage unsafe or unnecessary use of medicines and lead to a US-style spiral of unsustainable health care spending. This proposal does not adhere to the EU's precautionary principle of first "doing no harm".

4. THERE IS EVIDENCE THAT DIRECT TO CONSUMER ADVERTISING OF PRESCRIPTION MEDICINES THREATENS PUBLIC HEALTH. Based on the experience of DTCA in the US and New Zealand, advertising of prescription medicines is a grave threat to public health and puts the profits of the pharmaceutical industry ahead of public health. Considering nearly 20 years experience of DTCA in the US, it clearly places undue stress on public health budgets, increases the amount of misleading and unhelpful health information and increases the inappropriate and unnecessary use of medicines. Experience in the US has shown that enforcement of regulations controlling DTCA of pharmaceuticals is difficult and costly, and that violations are common mostly due to advertisers minimising risk information and exaggerating benefits.

1. Reject this proposal in its current form, as it does not uphold the Community's Treaty obligation to ensure a high level of public health in all of its activities as set out in article 152 of the EU Treaty. Neither does it conform to the WHO's Ethical Criteria for Medicinal Drug Promotion as agreed on by all WHO member states in 1988. It is not necessary to change Article 88 to ensure that people get quality information on medicines. The changes proposed to this article will likely invite full-scale DTCA for prescription medicines in Europe with potentially devastating public health consequences. This will have a global impact that threatens to strain health systems and budgets in Eastern and Central Europe, and developing countries.

2. Vigorously enforce the present legislation with review, sanctions, and thorough monitoring of promotion to health professionals and the general public. Better enforcement mechanisms including strong inter-jurisdictional co-operation on the monitoring of all means of promotion of medicines will prevent abuses and improve the overall quality of medicine information for consumers and prescribers.

3. Develop a robust consumer information and education strategy to ensure that people receive and can use quality, objective information on medicines. Specifically,

• Improve the quality of patient information leaflets to make them more reader-friendly, comprehensive, and understandable.
  
  
• Encourage the provision of independent and comparative information about medicines for health professionals and the public. Furthermore, promote regular independent testing of the effectiveness of medicine information in educating and informing professionals and the public.
  
  
• In the long term develop ways of teaching people the basic principles underlying rational therapies, and critical appraisal skills

Europe
Health Action International - Europe
European Public Health Alliance [this statement is made on behalf of EPHA but doesn't necessarily reflect the position of all members]
Act Up Paris
Act Up Toulouse, France
AIDES, association de lutte contre le SIDA, Pantin, France
AGIHAS (PLWHA Support Group), Latvia
Association Mieux Prescrire, France
Boletin Terapéutico Andaluz, Spain
BUKO Pharma-Kampagne, Germany
Consumers' Association, United Kingdom
Der Arnzeimittelbrief, Germany
Drug Information Centre, State Medicines Control Agency, Ministry of Health, Lithuania
European Federation of Asthma and Allergy (Patient) Associations
Farmacologiche "Mario Negri", Milan, Italy
Farmakoterapeutice informace bulletin, Czech Republic
Fundacis Institut Catala de Farmacologia, Spain
Groupe de Recherche et d'Action pour la Santé, Roux, Belgium
The Insulin Dependent Diabetes Trust (IDDT) United Kingdom
International Society of Drug Bulletins
KILEN - Consumer Institute for Medicines and Health, Sweden
National Phobics Society, United Kingdom
Projekt Farmaka, Belgium
La revue Prescrire, France
Sida Info Service, France
Social Audit Ltd, United Kingdom
Standing Committee of European Doctors
TRT-5 (collective of 8 AIDS organizations), France
Professor Björn Beermann, MDPhDMPA, Sweden
Professsor Albano Del Favero, Italy
Dr Markus Fritz, Head, Swiss Drug Information Centre,SDIC/SMI, Switzerland
Professor Dr. Anita Hardon, University of Amsterdam,The Netherlands
Dr Andrew Herxheimer, DIPEx (Database of Individual Patients' Experiences of Illness), United Kingdom
Dr Gianni Tognoni, Dept. of Cardiovascular Research, Istituto di Ricerche, Italy
Professor Giampaolo Velo, Istituto Di Farmacologia, Italy
Corinne Zara, Spain

Other Regions
Breast Cancer Action, USA
National Women's Health Network, USA
Prevention First Coalition, USA
Public Citizen's Health Research Group, Washington, USA
The Center for Medical Consumers, New York, USA
Warren Bell, BA MD CM CCFP, British Columbia, Canada
Breast Cancer Action Montreal, Canada
Alan Cassels, co-Chair, PharmaWatch, Canada
Centre of Excellence in Women's Health, Dalhousie University, Halifax, Canada
Consumers Association, Canada
Assoc. Professor Joel Lexchin MD, School of Health Policy and Management, York University, Toronto, Canada
Barbara Mintzes, Centre for Health Services and Policy Research, University of British Columbia, Canada
Working Group on Women and Health Protection, Montreal, Canada
Sharon Batt, Elizabeth May Chair in Women's Health and the Environment, Maritime, Canada
Accion Internacional para la Salud, America Latina y el Caribe
Health Action International - Asia/Pacific
Healthy Skepticism, Australia
Linda Curling, QA Manager (Pharmacist),Triomed (Pty) Ltd, Pinelands, South Africa
Andy Gray, Senior Lecturer, Dept. of Experimental & Clinical Pharmacology. Nelson Mandela School of Medicine, Natal, South Africa
P. Randles, Link Hills Pharmacy, Waterfall, South Africa