A joint declaration by HAI Europe, ISDB, AIM, BEUC and the Medicines in Europe Forum

3 October 2006

Executive summary

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Health information is a fundamental and necessary part of healthcare. However, the development of direct to consumer advertising, of disease awareness (or “disease mongering”) campaigns, “compliance programs”, and direct and indirect pharmaceutical industry support of patient’s organizations have blurred the boundaries between drug promotion and health information. If patients are to be able to make informed choices about their health, there needs to be a clear distinction between information and advertising that is disguised as “information”.

Relevant health information should be:

• reliable: evidence based (listing data sources), unbiased, and up-to-date, with full transparency on authorship and financing (enabling rejection of information influenced by conflicts of interests);
   
• comparative: presenting benefits and harms of the full range of available treatment options (including, where appropriate, the option not to treat), together with an explanation of the natural history of the disease,or condition; and
   
• adapted to users: understandable, accessible, and culturally sensitive. Currently, there are many sources of relevant health information for the public both in Europe and internationally. There is room for improvement but to state that a “patient information deprivation syndrome”exists in Europe is not true.Specific tools have been developed to assess and rate the quality of health information. The aim of these tools is to help both information providers and users to ensure accuracy, quality and relevance to health care choices. This declaration includes many examples of quality assessment tools and information sources provided by health authorities, medical product agencies, healthcare assessment agencies, health care providers, health professionals, consumers’ organizations and independent patient groups.

The role of pharmaceutical companies is strictly limited because of their inherent conflicts of interest. Recommendations on treatment choice must be independent both of individual companies that have a product for sale, and the industry as a whole.The statement by industry lobbyists that “Consumers and patients are effectively excluded from receiving information about their medicine and its comparative effects because of the] ban for] drug developers from informing patients …] even on the developers own web sites”, makes no sense. Pharmaceutical companies, and all “partners” financed by pharmaceutical companies, cannot provide unbiased comparative information on available drug and non-drug treatment alternatives.

Pharmaceutical companies do have a specific role to play: by law, they must provide well labelled drugs, including patient information leaflets. Directive 2004/27/CE requires package leaflet evaluation by patients.This is an important and much-needed step. Informative packaging and patient information leaflets are likely to contribute to better medication use and prevention of errors.

Proposals for improvement of European citizens access to relevant information include:

• ensuring transparency of medical products agencies to guarantee full public access to pre-market studies of drug safety and effectiveness, and pharmacovigilance data;

• requiring pharmaceutical companies to fulfil their obligations concerning packaging;

• developing and reinforcing sources of comparative, unbiased information on treatment choices;

• optimising communication between patients and health professionals;

• directly including patients in reporting of side effects of drugs;

• putting an end to the confusion of roles between pharmaceutical companies and other actors;

• full implementation and enforcement of the European regulation on drug promotion

© Medicines in Europe Forum, December 2006

Contents of the full text Declaration

1- IDENTIFYING THE FUNDAMENTAL NEED OF CITIZENS FOR HEALTH INFORMATION
1.1. Information as part of health education
1.2. Information as part of health care
1.3. Information in case of illness
1.4. Comparative information for informed decisions
2- TOOLS THAT AID ASSESSMENT AND USE OF RELEVANT HEALTH INFORMATION
3- OBSTACLES TO ACCESSING RELEVANT HEALTH INFORMATION
3.1. Quantity outweighs quality
3.2. Drug promotion presented as “information”
3.3. Lack of time for communication and tradition of secrecy
3.4. Diversity of individual needs
4- POSITIVE ACTION IN EUROPE AND ACROSS THE GLOBE
4.1. Health authorities
4.2. Medical products agencies
4.3. Healthcare assessment agencies
4.4. Healthcare providers
4.5. Healthcare professionals
4.6. Consumer organizations
4.7. Patients’ associations
4.8. Pharmaceutical companies obligations
5- PROPOSALS FOR IMPROVEMENT: PUTTING AN END TO CONFUSION OF ROLES
5.1. Ensuring transparency of medical products agencies
5.2. Making pharmaceutical companies fulfil their obligations concerning packaging
5.3. Developing and reinforcing the sources of relevant information
5.4. Optimising communication between patients and health professionals
5.5. Including patients as actors in the pharmacovigilance system
5.6. Considering individual patient needs
5.7. Putting an end to confusion of roles
5.8. Maintaining and enforcing the European regulations on drug promotion
CONCLUSION

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