S-2004-02-2009_OVE

PDF Upload


Handbook of WMA Policies
World Medical Association  S-2004-02-2009
WMA STATEMENT
CONCERNING THE RELATIONSHIP
BETWEEN PHYSICIANS AND COMMERCIAL ENTERPRISES
Adopted by the 55th
WMA General Assembly, Tokyo, Japan, October 2004
and amended by the 60th
WMA General Assembly, New Delhi, India, October 2009
PREAMBLE
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 enter-
prises 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.
MEDICAL CONFERENCES
Physicians may attend medical conferences sponsored in whole or in part by a commercial
entity if these conform to the following principles:
GENERAL PRINCIPLES
1. The main purpose of the conference is the exchange of professional or scientific
information.
S-2004-02-2009 New Delhi
Physicians and Commercial Enterprises
2. Hospitality during the conference is secondary to the professional exchange of
information and does not exceed what is locally customary and generally acceptable.
3. Physicians do not receive payment directly from a commercial entity to cover travel-
ling 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.
4. Physicians may not accept unjustified hospitality and may not receive payment from a
commercial entity to cover room and board for accompanying persons.
5. 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.
6. 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.
7. 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.
GIFTS
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 fol-lowing
conditions:
1. Physicians may not receive payments in cash or cash equivalents from a commercial
entity.
2. Physicians may not receive gifts for their personal benefit.
3. 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.
4. 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.
Handbook of WMA Policies
World Medical Association  S-2004-02-2009
RESEARCH
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:
1. 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.
2. If possible, a physician or institution wishing to undertake research approaches more
than one company to request funding for the research.
3. Identifiable information about research patients or voluntary participants is not passed
to the sponsoring company without the consent of the individuals concerned.
4. 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.
5. 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.
6. 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 re-
peated 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:
1. The affiliation does not compromise the physician’s integrity.
2. The affiliation does not conflict with the physician’s obligations to his or her patients.
3. Affiliations and/or other relationships with commercial entities are fully disclosed in
all relevant situations such as lectures, articles and reports.