Ophthalmologists could face ban on gifts from industry

OPHTHALMOLOGISTS may soon be banned from accepting any significant gifts from industry under a new proposal before the world medical association
In addition to banning most gifts, the proposal would severely regulate industry sponsorship of medical conferences and clinical research.
The proposal, which could become an official part of World Medical Association policy by September, represents the latest development in curtailing potential conflicts of interest between physicians and industry.

Already, the World Health Organisation, a number of national medical associations and pharmaceutical manufacturing associations have issued similar guidelines. The WMA proposal, however, would represent the first worldwide decision on such an issue from a physician group.
Given the ethical weight of such guidelines, they could soon form the basis for new national or even European laws to regulate the relationship between physicians and the pharmaceutical, medical device, medicals supply and medical technology industries.

No gifts of ‘considerable value’
Under the proposed guidelines, physicians cannot accept any "gift of considerable value for his or her personal use".
The guidelines, however, allow physicians to accept "gifts of nominal value which are closely tied to the physician's work, and which are routinely given as promotional items, such as: pens, diaries, patient care items such as drug samples, inexpensive medical supplies and patient-teaching aids appropriate to their area of practice provided these aids carry only the logo of the donor company and do not refer to specific therapeutic agents, services or other products.

"No gift, even one of nominal value, shall be accepted if it involves a stipulation that the physician prescribe a certain medication or refer patients to a certain facility."
The guidelines also make no allowance for accepting cash gifts. "Under no circumstances may a physician accept gifts of cash," the guidelines read.
The guidelines also ban physicians from making deals with industry about possible medical malpractice lawsuits. "No physician shall agree to be indemnified for lawsuits in exchange for prescribing specific medications or making referrals to specific facilities," the guidelines read.

Limits on clinical trial involvement
The guidelines also severely limit the participation of manufacturers in clinical trials of their products:

• The physician shall not allow himself or herself to be subject to external pressure regarding the results of his or her research or their publication.

• Research involving human subjects shall be performed in accordance with the Declaration of Helsinki and all relevant local law and must be approved in advance by the researcher's local institutional review board or ethics committee.

• If possible, a physician or institution that wishes to undertake research shall approach more than one company to request funding for the research.

• Any physician conducting research shall keep detailed records of such research, including names of participants, in order that such participants may be contacted later for further research or treatment, if the need arises. If necessary to ensure confidentiality, identifying details may be encrypted or separated from research findings but should be accessible if needed. Identifiable information about research participants should not be passed to the sponsoring company without the consent of the individuals concerned.

• A physician may receive compensation for his research on the condition that such compensation be based on his or her time and effort and shall in no way be connected to the results of the research.

• If the physician works for an institution that funds research through a central fund, the physician shall be compensated through that fund. Such a restriction, however, does not exclude payment for intellectual property rights.

• The results of research funded by a commercial entity shall be publicised with the name of the sponsoring entity disclosed, along with a statement disclosing who requested the research. This shall apply whether the sponsorship is direct or indirect, full or partial.

• In cases where results of research are linked to the names of products, only the generic names of such products, and not the brand names, shall be published.

• Where a physician or his or her family has a significant financial interest in a commercial entity, and there is reason to suspect that such physician might be subject to a conflict of interest, he or she should not participate in research funded by the company in question unless an ethics committee first reviews and authorises the case. The financial interest must be disclosed when publishing the results of the research.

Strict guidelines of medical conference sponsorship
The proposal also establishes strict guidelines for industry sponsorship of medical conferences. According to the proposal, the guidelines are based on the principle that commercially sponsored conferences must be a continuing medical education event that is rooted in the exchange of professional and scientific information.
Against such a background, the proposal specifies that:

• While conference sponsors may request that a certain topic be included in the conference programme, care must be taken to ensure that they have no influence on the content, presentation, choice of lecturers, or publication of results.

• To avoid any perception of one company's undue influence over a conference, it is preferable that several companies be invited to contribute.

• Funding for a conference shall be accepted as a contribution to the general costs of the meeting and not as payment for a specific lecturer or participant. No individual physician shall receive payment directly from a commercial entity to cover traveling expenses, room and board at the conference or compensation for his or her time.

• A lecturer or consultant who supplies actual services may be reasonably compensated for travelling expenses and room and board at the conference. Such payments shall not be made for token services.

• Organisers of the conference shall receive appropriate funding for meals, entertainment and social events comprising part of the conference. The level of hospitality shall not exceed that which is acceptable for similar conferences not funded by commercial enterprises.

• Neither conference organisers, conference faculty nor physicians attending a conference shall receive additional benefits such as payment for family members or for extended stays.

• Medical students, interns and residents may receive special grants to attend conferences if they are selected by their professional associations or academic institutions according to criteria established and publicised in advance.

• The name of a commercial entity sponsoring a conference shall be publicly disclosed to allow the medical community and the public to assess the information presented in light of the source of funding. In addition, conference organisers and lecturers shall disclose to conference participants any financial affiliations they may have with manufacturers of products mentioned at the event or with manufacturers of competing products.

• In all cases, presentation of material by a physician must be scientifically accurate and give a balanced review of possible treatment options. It should not be influenced by the sponsoring organisation.

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