Adopted by the 55th WMA General Assembly, Tokyo, Japan, October 2004
and amended by the 60th WMA General Assembly, New Delhi, India, October 2009
In the treatment of their patients, physicians use drugs, instruments, diagnostic tools, equipment and materials developed and produced by commercial enterprises. Industry possesses resources to finance expensive research and development programmes, for which the knowledge and experience of physicians are essential. Moreover, industry support enables the furtherance of medical research, scientific conferences and continuing medical education that can be of benefit to patients and the entire health care system. The combination of financial resources and product knowledge contributed by industry and the medical knowledge possessed by physicians enables the development of new diagnostic procedures, drugs, therapies, and treatments and can lead to great advances in medicine.
However, conflicts of interest between commercial enterprises and physicians occur that can affect the care of patients and the reputation of the medical profession. The duty of the physician is to objectively evaluate what is best for the patient, while commercial enterprises are expected to bring profit to owners by selling their own products and competing for customers. Commercial considerations can affect the physician’s objectivity, especially if the physician is in any way dependent on the enterprise.
Rather than forbidding any relationships between physicians and industry, it is preferable to establish guidelines for such relationships. These guidelines must incorporate the key principles of disclosure, avoidance of obvious conflicts of interest and the physician’s clinical autonomy to act in the best interests of patients.
These guidelines should serve as the basis for the review of existing guidelines and the development of any future guidelines.
Physicians may attend medical conferences sponsored in whole or in part by a commercial entity if these conform to the following principles:
- The main purpose of the conference is the exchange of professional or scientific information.
- Hospitality during the conference is secondary to the professional exchange of information and does not exceed what is locally customary and generally acceptable
- Physicians do not receive payment directly from a commercial entity to cover travelling expenses, room and board at the conference or compensation for their time unless provided for by law and/or the policy of their National Medical Association.
- Physicians may not accept unjustified hospitality and may not receive payment from a commercial entity to cover room and board for accompanying persons.
- The name of a commercial entity providing financial support is publicly disclosed in order to allow the medical community and the public to assess the information presented in light of the source of funding. In addition, conference organizers and lecturers disclose to conference participants any financial affiliations they may have with manufacturers of products mentioned at the event or with manufacturers of competing products.
- Presentation of material by a physician is scientifically accurate, gives a balanced review of possible treatment options, and is not influenced by the sponsoring organization.
- A conference can be recognised for purposes of continuing medical education/ continuing professional development (CME/CPD) only if it conforms to the following principles:
7.1 The commercial entities acting as sponsors, such as pharmaceutical companies, have no influence on the content, presentation, choice of lecturers, or publication of results.
7.2 Funding for the conference is accepted only as a contribution to the general costs of the meeting.
Physicians may not receive a gift from a commercial entity unless this is permitted by law and/or by the policy of their National Medical Association and it conforms to the following conditions:
- Physicians may not receive payments in cash or cash equivalents from a commercial entity.
- Physicians may not receive gifts for their personal benefit.
- Gifts designed to influence clinical practice are always unacceptable. Promotional aids may be accepted provided that the gift is of minimal value and is not connected to any stipulation that the physician prescribes a certain medication, uses certain instruments or materials or refers patients to a certain facility.
- Cultural courtesy gifts may be received on an infrequent basis according to local standards if the gift is inexpensive and not related to the practice of medicine.
A physician may carry out research funded by a commercial entity, whether individually or in an institutional setting, if it conforms to the following principles:
- The physician is subject only to the law, the ethical principles and guidelines of the Declaration of Helsinki, and clinical judgment in performing research and does not allow himself or herself to be subject to external pressure regarding the results of his or her research or their publication.
- If possible, a physician or institution wishing to undertake research approaches more than one company to request funding for the research.
- Identifiable information about research patients or voluntary participants is not passed to the sponsoring company without the consent of the individuals concerned.
- A physician’s compensation for research is based on his or her time and effort and such compensation is in no way connected to the results of the research.
- The results of research are made public with the name of the sponsoring entity disclosed, along with a statement disclosing who requested the research. This applies whether the sponsorship is direct or indirect, full or partial.
- Commercial entities do not suppress the publication of research results. If results of research are not made public, especially if they are negative, the research may be repeated unnecessarily and thereby expose future participants to potential harm.
AFFILIATIONS WITH COMMERCIAL ENTITIES
A physician may not enter into an affiliation with a commercial entity such as consulting or membership on an advisory board unless the affiliation conforms to the following principles:
- The affiliation does not compromise the physician’s integrity.
- The affiliation does not conflict with the physician’s obligations to his or her patients.
- Affiliations and/or other relationships with commercial entities are fully disclosed in all relevant situations such as lectures, articles and reports.