CONFLICTS OF INTEREST AND INDUSTRY RELATIONSHIPS

Approved by the Board: March 2024

Companion Resource: Advice to the Profession

Definitions

Conflict of interest: A conflict of interest is created any time a reasonable person could perceive that a physician’s judgments or decisions about a primary interest (e.g., the patient’s best interests, unbiased medical research) are compromised by a secondary interest (e.g., direct financial gain, professional advancement). A conflict of interest can exist even if the physician is confident that their professional judgment is not actually being influenced by the conflicting interest or relationship.

For the purposes of this policy, conflicts of interest also include those circumstances defined in Part IV (ss. 15-17) of Ontario Regulation 114/94 (“the General regulation”) under the Medicine Act, 1991.

Industry: The full range of commercial enterprises associated with health care. These include, but are not limited to, the pharmaceutical industry, the biotechnology industry, the medical device industry, and commercial providers of services related to clinical practice, research, and/or education.

Policy

General

Interactions between physicians and industry have the potential to benefit both physicians and patients by advancing medical knowledge, supporting professional development, and improving patient care. While industry has a valuable and legitimate role to play in the practice of medicine, sometimes the goals and interests of industry may be at odds with a physician’s professional and legal obligations. This policy sets out expectations to help physicians navigate their interactions with industry and manage conflicts of interest which impact patient and public trust in physicians and the medical profession.

1. Physicians must maintain their clinical objectivity and professional independence in all interactions with industry and when making decisions regarding patient care.
2. Physicians must identify situations or circumstances that are, may reasonably be perceived to be, or may lead to, a conflict of interest.
   1. Physicians must avoid these situations or circumstances where possible
3. Where avoidance is not possible, physicians must:
4. 1. proactively disclose the details of their interactions with industry to the relevant parties (e.g., patients, research participants, institutions, attendees at educational events); and
   2. resolve conflicts of interest in the patient’s best interests.¹

Conflicts of Interest under the Medicine Act, 1991

4. Physicians must meet their obligations regarding conflicts of interest as described in Part IV (ss. 15-17) of the General regulation.²

5. In addition, when physicians are ordering a diagnostic or therapeutic service to be performed by a facility in which the physician or a member of their family³ has a proprietary interest, they must communicate to the patient that:
   1. the patient has the option to obtain the diagnostic or therapeutic service elsewhere; and
   2. the patient’s choice will not affect the physician-patient relationship or the quality of health services provided by the physician.
6. Physicians must not actively direct a patient to a supplier or facility in which they or a family member has a proprietary interest, or from which they receive a benefit, unless the patient has specifically requested it.

Industry Relationships in Clinical Practice

7. Physicians must not request or accept fees or equivalent compensation, personal gifts, or inducements of any value from industry in exchange for seeing industry representatives in a promotional or similar capacity.
8. Physicians must only distribute patient teaching aids provided by industry that:
   1. primarily entail a benefit to patients (i.e., have more educational than promotional value);⁴,⁵
   2. they are satisfied are accurate, balanced, complete, and adequately disclose any potential safety concerns; and
   3. do not have value to the physician outside of their professional responsibilities.

Samples

9. Physicians who distribute samples of drugs or devices from industry must comply with the expectations set out in relevant CPSO policies.⁶
10. Physicians must:
    1. consider the potential influence of samples on their prescribing choices, including the short- and long-term costs of the medication; and
    2. use clinical evidence to determine the appropriate choice of drug or device in alignment with the patient’s best interests, including whether the medication or device has an advantage over first line therapy with respect to benefit and safety.
11. Physicians must not obtain any form of material gain for themselves or for the practice with which they are associated (including from selling or trading) when distributing samples.

Continuing medical education/Continuing professional development (CME/CPD)

Accredited CME/CPD

12. Physicians involved⁷ in industry-sponsored accredited CME/CPD activities and events must comply with guidelines outlined by relevant accrediting bodies, including the National standard for support of accredited CPD activities.

Unaccredited CME/CPD

13. Physicians who organize and/or present at industry-sponsored unaccredited CPD/CME activities and events must only accept reasonable honoraria and reimbursement for hospitality (i.e., travel, lodging, and/or meal expenses).
14. Physicians who attend industry-sponsored unaccredited CPD/CME activities and events must not accept reimbursement or subsidies for hospitality expenses, outside of meals or social events that are held as part of the activity or event.

Consultation/advisory boards and industry-sponsored research

15. Physicians who sit on advisory or consultation boards or who serve as individual advisors or consultants to industry organizations must:
    1. enter into a written agreement setting out the details of the arrangement;
    2. only agree to impart specialized medical knowledge that could not otherwise be acquired by the organization;
    3. not engage in promotional activities on behalf of the organization while in this position; and
    4. present information that is accurate, balanced, and complete where relevant to their practice, research, or teaching, and when providing educational activities on behalf of the company.
16. Physicians must only participate in industry-sponsored research that is ethically defensible, scientifically valid, and that complies with relevant national guidelines, including the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS-2), regardless of the source of funding.
17. Physicians must only be included as an author of a published article reporting the results of industry-sponsored research if they meet the authorship criteria set out by the International Committee of Medical Journal Editors (ICMJE).⁸

Compensation

18. Physicians who sit on advisory or consultation boards, serve as individual advisors or consultants to industry organizations, or participate in industry-sponsored research (including attending Investigator Meetings) must only accept compensation that is reasonable and commensurate with services provided.⁹
19. Physicians must only accept compensation for recruiting patients into a research study if the physician was required to undertake activities beyond their normal practice (e.g., meeting with patients, discussing the study, and obtaining knowledgeable consent for the disclosure of personal health information).¹⁰
20. 1. Physicians must not accept finder’s fees (i.e., payments for identifying or recruiting a patient into a trial, whereby the sole activity performed by the physician is to disclose the names of potential research participants).

Endnotes

^1.The physician-patient relationship is a fiduciary relationship from which fiduciary duties arise, such as the duty to act in the patient’s best interests and in good faith. In this relationship, the balance of knowledge and information favours the physician, so that patients are reliant on their physicians and may be vulnerable. Patients rely on and must be confident that the physician has put the needs of the patient first.

^2.O. Reg. 114/94: GENERAL under the Medicine Act, 1991, S.O. 1991, c. 30. The General regulation sets out when it is a conflict of interest for physicians to receive benefits from a supplier for patient referrals or of medical goods or services to patients; to rent premises; to sell or otherwise supply drugs, medical appliances, medical products, or biological preparations to patients at a profit; and to order a diagnostic or therapeutic service to be performed by a facility in which the physician or a member of their family has a proprietary interest. A physician is required to disclose the details of the proprietary interest to CPSO. CPSO's Conflict of Interest Declaration Form is available online.

 ^3.A "member of his or her family” is defined under s. 15 of the General regulation.

^4.It is preferable that patient teaching aids include at most the logo of the donor company and not refer to specific therapeutic agents, services, or other products.

^5.Section 33 of the Personal Health Information Protection Act, 2004 (PHIPA) prohibits the collection, use, or disclosure of personal health information (PHI) for the purpose of marketing or market research unless the patient expressly consents. For example, physicians would not be permitted to use the PHI of their patients to determine which patients would benefit from receiving marketing information in respect of particular goods, service, products, equipment and devices without their express consent.

^6.Including the Prescribing Drugs and Physician Treatment of Self, Family Members, or Others Close to Them policies.

^7.This includes physicians who organize, speak at, moderate, facilitate, attend, or author materials for CME/CPD activities.

^8.Specifically, the criteria found in the ICMJE Recommendation Defining the Role of Authors and Contributors.

^9.Reasonable compensation can be at fair market value. Parameters such as time, expenditure, and complexity of the work required may be relevant considerations in determining compensation amount.

^10.Consent is considered knowledgeable if it is reasonable to believe that the individual knows the purpose of the disclosure and knows that they can give or withhold consent.