14 Nov 2009
In its recently concluded General Assembly meeting held at Delhi, the World Medical Association has issued guidelines for physicians’ behaviour on issues of conflict of interest and their relationship with commercial enterprises. "These identify areas where a conflict of interest might occur during a physician’s day-to-day practice of medicine, and seek to assist physicians in resolving such conflicts in the best interests of their patients." Provision was also made to the aspect of "physicians receiving sponsorship or gifts when attending conferences or conducting research".
The Guidelines on 'Conflict of Interest' cater to five specific instances wherein conflict of interest could arise. These relate to (i) research - as "the interests of the clinician and the researcher may not be the same. If the same individual is assuming both roles, as is often the case, the potential conflict should be addressed by ensuring that appropriate steps are put in place to protect the patient, including disclosure of the potential conflict to the patient." In this regard the WMA inter alia prescribed that "Research should be conducted primarily for the advancement of medical science. A physician should never place his or her financial interests above the welfare of his or her patient. Patient interests and scientific integrity must be paramount. All relevant and material physician-researcher relationships and interests must be disclosed to potential research participants, research ethics boards, appropriate regulatory oversight bodies, medical journals, conference participants and the medical centre where the research is conducted."
On the aspect of (ii) education, the WMA prescribes that "The educational needs of students and the quality of their training experience must be balanced with the best interests of patients. Where these are in conflict, the interests of patients will take precedence" where "while recognizing that medical trainees require experience with real patients, physician-educators must ensure that these trainees receive supervision commensurate with their level of training." As regards (iii) Self-referrals and fee-splitting - WMA describing its broad ambit denounced this practice in as much as it stated, "Referral by physicians to health care facilities (such as laboratories) where they do not engage in professional activities but in which they have a financial interest is called self-referral. This practice has the potential to significantly influence clinical decision-making and is not generally considered acceptable unless there is a need in that particular community for the facility and other ownership is not a possibility (for example, in small rural communities). The physician in this situation should receive no more financial interest than would an ordinary investor."
Dealing with (iv) Physician offices, WMA was of the view that "The physician should not receive any financial compensation or other consideration either for referring a patient to these services, or for being located in close geographical proximity to them. Physician-owned buildings should not charge above-market or below-market rates to tenants." As regards (v) Organizational/institutional conflicts it was acknowledged that "Health care institutions in particular are increasingly subject to a number of pressures that threaten several of their roles, and many academic medical centres have begun to identify alternate sources of revenue." Therefore it was proposed that "policies should be in place to ensure that these new sources are not in conflict with the values and mission of the institution (for example, tobacco funding in medical schools)."
To remove all doubts (and perhaps to disallow lawyers to read the document like a statute) the guidelines also stated that "Each doctor has a moral duty to scrutinise his or her own behaviour for potential conflicts of interest, even if the conflicts fall outside the kinds of examples or situations addressed in this document. If unacknowledged, conflicts of interest can seriously undermine patient trust in the medical profession as well as in the individual practitioner."
As regard the "Relationship between Physicians and Commercial Enterprises" the WMA acknowledged that "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" and in this regard prescribed various detailed guidelines in regard to (i) attendance in 'Medical Conferences', (ii) receiving 'Gifts' from medicine manufacturers, (iii) conducting 'Research', and (iv) 'Affiliation with Commercial entities'. Have a look.