Commitment of the Industry
The international pharmaceutical industry is committed to the improvement of the health of mankind through research and development of new medicines and the production and marketing of pharmaceutical products of reliable quality, in accordance with internationally defined standards of good practice.

As part of its commitment to health, the industry has an obligation and responsibility to provide accurate information and education about its products to health care providers in order to establish a clear understanding of the appropriate use of prescription medicines.

Promotional activities must be consistent with high ethical standards and information should be designed to help health care providers improve services to patients. Information must be provided with objectivity, truthfulness and in good taste and must conform to all relevant laws and regulations. Claims for therapeutic indications and conditions of use must be based on valid scientific evidence and include clear statements with respect to side effects, contra-indications, and precautions.

High standards of ethical behaviour shall apply equally to marketing of pharmaceutical products in all countries, regardless of the level of development of their economic and health care systems

Standards of Promotion
Promotional material for pharmaceutical products should be accurate, fair and objective and presented in such a way as to conform not only to legal requirements but also to high ethical standards and to be in good taste. Claims should not be stronger than scientific evidence warrants, and every effort should be made to avoid ambiguity.

Scientific Evidence
Information in promotional material should be based on an up-to-date evaluation of evidence that is scientifically valid and should not give an incorrect or misleading impression. Prescribing information should be supported by this information and be in accordance with the local product authorisation or, where this is not applicable, should be in accordance with an authorisation issued by a regulatory authority in an industrialised country. Scientific data to support the claims and recommendations for use should be made available, on request, to healthcare providers.

With regard to product information on labelling, packaging, leaflets, data sheets and in advertisements, it is understood that national laws and regulations dictate the format and content of the information communicated. Companies should, however, attempt to provide uniform information on indications, contraindication, warnings, precautions, side effects and dosage wherever possible, within the context of national requirements. Health professionals in developing countries should have access to similar data to those being communicated in industrialised countries.

Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the enquiry.

Data from in vitro and animal tests should be clearly marked as such and not be cited in such a way that it could give an incorrect or misleading impression.

Safety Data
Particular care should be taken that essential information as to pharmaceutical products' safety, for example, contra-indications, precautions and side effects, is appropriately and consistently communicated, subject to the legal, regulatory and medical practices of each nation. The word "safe" should not be used without qualification. Substantiated information on serious and unexpected adverse reactions associated with pharmaceutical products should be reported to the appropriate national health authority as a priority.

Disguised and Misleading Promotion
Promotional material, such as mailings and medical journal advertisements, must not be such as to disguise its real nature. Post-marketing and surveillance studies should be conducted on a scientific or educational basis. These studies should not be conducted simply as a means to promote a product and influence physicians, with little or no scientific or educational basis.

Pre-Registration Communications
No pharmaceutical product shall be promoted for use in a specific country until the requisite approval for marketing for such use has been given in that country. However, this provision is not intended to abridge the right of the scientific community and the public to be fully informed concerning scientific and medical progress. It is not intended to restrict a full and proper exchange of scientific information concerning a pharmaceutical product, including appropriate dissemination of investigational findings in scientific or lay communications media and at scientific conferences. Nor should it restrict public disclosure to stockholders and others concentrating any pharmaceutical product as may be required or desirable under law, rule or regulation.

Communications to the Public
Where it is permitted by law to communicate directly with patients regarding their prescription medicines, all such information should be accurate, fair and not misleading. Where companies assist in the conduct of public/patient disease awareness programmes to meet growing demands of society for more information and enhance public understanding of disease prevention, signs and symptoms of medical conditions, illnesses, and available treatments, such activities should adhere to the highest standards of accuracy and support the role of the health care provider.