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June 23, 2005 Thursday Jumadi-ul-Awwal 15, 1426


KARACHI:s PMA offers guidelines for pharma industry


KARACHI, June 22: Expressing extreme concern about the unethical practices of pharmaceutical industry in bribing doctors, the Pakistan Medical Association Central Council has proposed some guidelines for the pharmaceutical industry.

The PMA has expressed hope that the industry will follow the guidelines in the interest of patients and people.

According to the PMA, different methods are used by the industry for promotion of their drugs. “Unfortunately, some doctors from all ranks and files have joined them while majority of doctors are opposing unethical methods for promotion of drugs,” Dr Shershah Syed, Secretary-General PMA Centre, said in a statement issued on Wednesday.

He said the PMA was also proposing to the PMDC and federal health ministry for legislation of these guidelines and strict action against pharmaceutical industry and individuals involved in unethical practices.

These guidelines are presented in a summarized form for the preparation of final draft for which suggestion are needed.

Guideline 1: Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals and other gifts are appropriate if they serve a genuine educational function.

Cash payments should not be accepted. The use of drug samples for personal or family use is permissible as long as these practices do not interfere with patient access to drug samples. It would not be acceptable for non-retired physicians to request free pharmaceuticals for personal use or for use by family members.

Diagnostic equipment primarily benefits the patient. Hence, such gifts are permissible as long as they are not of substantial value.

Guideline 2: Individual gifts of minimal value are permissible as long as the gifts are related to the physician’s work (e.g. pens and notepads). Although guidelines recognize that gifts related to a physician’s practice may be appropriate, they also make it clear that these gifts must remain of minimal value. It is not appropriate for physicians to accept expensive hardware or software equipment even though one purpose only may pertain to industry-related activities of a modest value.

Guideline 3: The legitimate “conference” or “meeting” is defined as an activity held at an appropriate location, where (a) the gathering is primarily dedicated in both time and effort to promote objective scientific and educational activities and discourse (one or more educational presentations should be the highlight of the gathering), and (b) the main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented. An appropriate disclosure of financial support or conflict of interest should be made.

Guideline 4: Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company’s sales representative may create a relationship which could influence the use of the company’s sponsor who in turn can use the money to reduce the conference’s registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the physicians attending the conference.

Guideline 5: Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians’ time. Subsidies for hospitality should not be accepted outside of modest meals or social events held as a part of a conference or meeting. It is appropriate for faculty at conferences or meeting to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging and meal expenses. It is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging and meal expenses. Token consulting or advisory arrangements cannot be used to justify the compensation of physicians for their time or their travel, lodging and other out-of-pocket expenses.

Guideline 6: Scholarship or other special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents, or fellows who will receive the funds is made by the academic or training institution. Carefully selected educational conferences are generally defined as the major educational, scientific or policy-making meetings of national, regional or specialty medical associations.

Guideline 7: No gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physician’s prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods, and materials should belong to the organizers of the conferences or lectures. —PPI



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