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Physician/Industry Relationships Guidelines

PHYSICIAN/INDUSTRY RELATIONSHIPS GUIDELINES

The following guidelines have been developed by CARO to assist physicians in determining when a relationship with industry is appropriate. Although directed primarily to individual physicians, including residents as well as medical students, the guidelines also govern the relationships between industry and medical associations. These guidelines focus on the pharmaceutical companies; however, the CMA and CARO consider that the same principles apply to the relationship between physicians and all commercial organizations, including manufacturers of medical devices, infant formulas, health care products, and service suppliers. These guidelines reflect a national consensus and are meant to serve as an educational resource for physicians throughout Canada. Individuals are also referred to The Code of Pharmaceutical Advertising Advisory Board (PAAB) to which CARO subscribes.

General Principles

1. The primary objective of professional interactions between physicians and industry should be the advancement of the health of Canadians rather than the primary good of either physicians or industry.

2. The relationship between physicians and industry must always be in keeping with the fundamental ethical principles that govern social interactions in general.

3. The relationships between physicians and industry is guided further by the CARO Code of Ethics.

4. The practising physician’s primary obligation is toward the patient. Relationships with industry are appropriate only insofar as they do not affect the fiduciary nature of the patient/physician relationship.

5. In any relationship between a physician who is not an employee of the pharmaceutical industry and the industry itself, the physician should always maintain professional autonomy, independence and commitment to the scientific method. The physician should be prepared to disclose the nature of such relationships to his or her patients, to the organizers and audience of a continuing medical education (CME) event at which he or she is a speaker, and in comparable situations.

Research

6. A prerequisite for physician participation in industry-sponsored research activities is evidence that these activities are ethically defensible, socially responsible and scientifically valid.

7. The participation of physicians in industry-sponsored research activities should always be preceded by formal approval of the project by an appropriate ethics review body. Such research should be conducted according to the standards and procedures of the particular ethics review body.

Continuing Medical Education

8. The CMA and CARO distinguishes between education, training (eg, in the use of a medical device) and product promotion. Although these guidelines apply to each of these activities this section focuses on CME. Above all, CME activities should address the educational needs of the targeted medical audience.

9. The ultimate decision on the organization, content and choice of CME activities shall lie in the hands of the physician-organizers.

10. CME organizers and their delegates must not be in a position of conflict of interest by virtue of any relationship with the company or companies that fund CME activities.

11. The ultimate decision on funding arrangements for CME activities should be the responsibility of the physician-organizers. Although the CME program may acknowledge the financial or other aid received it should not identify the products of the company that fund the activities.

12. All funds from a commercial source should be in the form of an educational grant payable to the institution or organization sponsoring the CME activity. Upon conclusion of the activity, the physician-organizers should be prepared to present a statement of account for the activity to the funding organizations and other relevant parities.

13. Whenever possible, generic names should be used rather than trade names in the course of CME activities. In, particular, physicians should not engage in peer selling^{^[1]}.If specific products or services are mentioned, there should be a balanced presentation of the prevailing body of scientific information on the product or service and of reasonable, alternative treatment options. If unapproved uses of a product or service are discussed, presenters must inform the audience of the fact.

14. Travel and accommodation arrangements, social events and venues for industry-sponsored CME activities should be in keeping with the arrangements that would normally be made without industry sponsorship. For example, the industry sponsor should not pay for travel or lodging costs or for other personal expenses of physicians attending a CME event. Subsidies for hospitality should not be accepted outside of modest meals or social events that are held as part of a conference or meeting. However, faculty at CME events may accept reasonable honoraria and reimbursement for travel, lodging and meal expenses. Scholarships or other special funds to permit medical students, residents and fellows to attend educational events are permissible as long as the selection of participants for these funds is made by their academic institution.

Other Considerations

15. These guidelines apply to the relationship between physicians and all commercial organization, including manufacturers of medical devices, and health care products as well as service suppliers, to no less a degree than to the relationship between physicians and pharmaceutical manufacturers.

16. Physicians should not invest in pharmaceutical manufacturing companies or related undertakings if knowledge about the success of the company or undertaking might inappropriately affect the manner of their practice or their prescribing behaviour.

17. Practising physicians affiliated with pharmaceutical companies should not allow their affiliation to influence their medical practice inappropriately.

18. Practising physicians should not accept a fee or equivalent consideration from pharmaceutical manufacturers of distributors in exchange for seeing them in a promotional or similar capacity.

19. Practising physicians should not accept personal gifts from the pharmaceutical industry or similar bodies.

20. Practising physicians may accept 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 (e.g., baby formula).

Medical Students and Residents

21. These guidelines apply to physicians-in-training as well as to practising physicians. Medical curricula should deal explicitly with the guidelines.

[1] Peer selling occurs when a pharmaceutical manufacturer directly sponsors a seminar or similar event that focuses on its own products and is designed to enhance the sale of those products. The manufacturer directly engages a physician to conduct the session this form of participation would reasonably be seen as being in contravention of the CARO's Code of Ethics, which prohibits endorsement of a specific product. Peer selling, as understood in this sense, differs from the sort of situation in which a pharmaceutical manufacturer provides funds to CME organizers to sponsor a bona fide educational event on a specific condition or on specific products. In the latter event the control and structure of the CME event lies in the hands of the CME organizers. Even though the products may be the focus of such a bona fide event the arms-length nature of the sponsorship by the manufacturer and the fact that the control and structure of the event lie in the hands of the CME organizers remove it from the realm of advertising and do not constitute an endorsement of the product in question.