The Erice Statement on drug advertising to consumers
A group of clinical pharmacologists, physicians, pharmaceutical industry representatives, medical and general journalists, communications professionals, and consumer advocates met in Erice, Italy, on May 9-13, 2002 to discuss drug advertising to consumers.
The meeting was triggered by proposed changes to European Union legislation on the advertising of prescription medicines to the public. Its purpose was to consider the wider implications of direct-to-consumer prescription medicine advertising and its relationship to the information needs of the public and of patients, throughout the world.
Everyone agreed on the fundamental need for high quality medicines information, but participants differed in their view on advertising of prescription medicines to consumers. Some wanted to maintain the present prohibition of direct-to-consumer advertising; others would allow advertising subject to strict control by an independent, non-commercial, multi-representative statutory body, affiliated to the Regulatory Authority or the Ministry of Health. The arguments supporting each of these views are summarized below.
The relationship between promotion, advertising and information
The World Health Organization defines drug promotion as all informational and persuasive activities by manufacturers and their agents, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. 
Advertising is one form of promotion, partial in its selection of information, usually with commercial benefit to the promoter as its sole or principal intent.
It is important to distinguish these forms of communication from information that aims to educate and/or inform.
The need for good quality information
Personal health care involves choices among many possible treatments. Although the use of a prescription medicine is mediated by a health professional, patients need relevant information of good quality on benefits and harms related to the available options, presented in a way that enables them to choose appropriate treatment together with the doctor, and to manage their treatment subsequently.
The information must be scientifically valid, up-to-date and balanced. It should allow comparisons between drug and non-drug treatments, and the option of no treatment. Facts, hypotheses and conclusions should be distinguished, uncertainty acknowledged. Sources of information, and their particular bias should be identified, including all potential conflicts of interest. 
Education on the appropriate use of drugs, including the interpretation of safety information, is essential for the public as well as for patients. Such education requires commitment and targeted resources.
Drug information directed to the public, in whatever form, should be balanced in its account of benefits and harms. Trustworthy sources should be mandated to provide balanced information about all healthcare options in a readily accessible and understandable form. Such information should aim to support good doctor-patient interactions.
All the evidence needed to understand benefits and harms, including comparative information, must be openly available to the public. Vested interests and any other constraints on communicating parties that hinder their ability to meet this goal must be identified and understood.
Information of any kind must never damage, distort or subvert the true interest of public health, or the essential needs of individual welfare.
Should direct-to-consumer prescription drug advertising be allowed?
Arguments against legislative changes to allow such advertising
Medicines sold directly to the public are used for self-diagnosed conditions and can be self-prescribed, but prescription medicines require professional knowledge and understanding for safe and appropriate use.
1) Advertising and other forms of drug promotion aim to increase sales and cannot meet the criteria of quality information as described above, even when they are disease-oriented. Promotional information distorts the interaction between doctor and patient by focusing on the advertised treatment rather than on the necessary diagnostic and therapeutic decisions.
2) Experience in the United States and New Zealand has shown that direct-to-consumer advertising of prescription medicines has repeatedly misinformed the public. It has increased prescribing of the advertised drugs, leading to unnecessary increases in drug expenditure. 
3) Prohibitions on prescription drug advertising to the public are consistent with the WHO Ethical Criteria for Medicinal Drug Promotion and the EU Precautionary Principle. The latter supports action, â?owhere preliminary objective scientific evaluation indicates that there are reasonable grounds for concern about potentially dangerous effects on the environment, human, animal or plant healthâ?¦â? .
4) These considerations lead to rejection of changes to EU pharmaceutical advertising regulations, as well as similar proposed changes in other countries. Liberalisation is likely to have a profound negative impact, not only in Europe but throughout the world, in reducing the appropriateness and safety of medicine use.
Arguments in favour of cautious, controlled approaches to the introduction of prescription medicine advertising:
1) The aims of commercial and non-commercial promotion can coincide. When this is the case, commercial promotion may be in the interest of public health. However, each case must be considered individually, and the motivation and biases need to be transparently described.
2) A recent review of some experience on direct to consumer advertising in the United States drew the conclusion that there was little impact on the doctor-patient relationship (7). Data from another survey were also interpreted as suggesting a positive association between advertising and compliance with the use of a medicine, which may in turn lead to health benefits and reduced wastage (8).
These references are however preliminary and not peer reviewed.
3) Research into the impact of general ethical promotion of prescription medicines should be permitted under the following experimental conditions:
Â· The evaluation of positive and negative effects under strict experimental protocols
Â· The promotion of medicines only after sufficient patient exposure to ensure reliable knowledge of their effectiveness-harm profile.
Â· The promotion of appropriate use
Â· The provision of information about the medicine which is factual, balanced and fair
Â· The inclusion of appropriate warnings and cautions and encouragement to patients to consult their doctor
Â· Before it is used all such promotional material should be reviewed by an independent, statutory body, affiliated to the Regulatory Authority or the Ministry of Health
Â· Clear ethical and practical guidelines should be developed by this body and strict adherence to them ensured by regular monitoring and evaluation of promotional materials
(7) Aikin K. J., Division of Drug Marketing and Communication, FDA. 2002 DTC Advertising of Prescription Drugs: Preliminary Survey Results.
(8) Slaughter E., Schumacher M. Preventionâ?Ts International Survey on Wellness and Consumer Reactions to DTC Advertising of Rx Drugs. Prevention Magazine, Rodale Press, 2000/2001.