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Initiated March 2002
Approved by the WMA General Assembly, Tokyo 2004
- 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 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.
- MEDICAL CONFERENCES
- Physicians may attend medical conferences sponsored in whole
or in part by a commercial entity if these conform to the
following principles:
- 5.1 The main purpose of the conference is the exchange
of professional or scientific information.
- 5.2 Hospitality during the conference is secondary to
the professional exchange of information and does not
exceed what is locally customary and generally acceptable.
- 5.3 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.
- 5.4 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.
- 5.5 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.
- 5.6 A conference can be recognised for purposes of continuing
medical education/ continuing professional development
(CME/CPD) only if it conforms to the following principles:
- 5.6.1 The commercial entities acting as sponsors,
such as pharmaceutical companies, have no influence
on the content, presentation, choice of lecturers,
or publication of results.
- 5.6.2 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
following conditions:
- 6.1 The gift is only of nominal value.
- 6.2 The gift is not in cash.
- 6.3 The gift, even one of nominal value, 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.
- 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:
- 7.1 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.
- 7.2 If possible, a physician or institution wishing
to undertake research approaches more than one company
to request funding for the research.
- 7.3 Identifiable information about research patients
or voluntary participants is not passed to the sponsoring
company without the consent of the individuals concerned.
- 7.4 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.
- 7.5 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.
- 7.6 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 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:
- 8.1 The affiliation does not compromise the physician's
integrity.
- 8.2 The affiliation does not conflict with the physician's
obligations to his or her patients.
8.3 Affiliations and/or other relationships with commercial
entities are fully disclosed in all relevant situations
such as lectures, articles and reports.
9.10.2004
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