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Physicians’ Relationships with Industry: Practice, Education and Research

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Approved by Council: September 2014

Companion Resource: Advice to the Profession

Other References: Results from the most recent consultation

 

Policies of the College of Physicians and Surgeons of Ontario (the “College”) set out expectations for the professional conduct of physicians practising in Ontario. Together with the Practice Guide and relevant legislation and case law, they will be used by the College and its Committees when considering physician practice or conduct.

Within policies, the terms ‘must’ and ‘advised’ are used to articulate the College’s expectations. When ‘advised’ is used, it indicates that physicians can use reasonable discretion when applying this expectation to practice.

 

Definitions

Industry: In this policy, industry refers to the full range of commercial enterprises associated with health care. These include, but are not restricted to, the pharmaceutical industry, the biotechnology industry, the medical device industry, and commercial providers of services related to clinical practice, research, and education.

Conflict of interest: A conflict of interest is created any time a reasonable person could perceive that a physician’s personal interest or relationship with industry is at odds with their professional responsibilities.1 In this policy, the term “conflict of interest” is defined broadly and in accordance with the definition above. While sections 15-17 of Ontario Regulation 114/94 under the Medicine Act, 1991 describe some specific situations that constitute conflicts of interest, this policy is not limited in its scope to those specific situations.

 

Policy

  1. Physicians must safeguard their clinical objectivity and professional independence when interacting with industry.2
  2. Physicians must avoid or recognize and appropriately manage conflicts of interest arising from their professional duties.

Industry gifts

Research demonstrates that accepting gifts or inducements from industry influences and likely undermines a physician’s independent clinical judgment, even where the physician believes otherwise.3

  1. Physicians must not request or accept a fee or equivalent compensation from industry in exchange for seeing industry representatives in a promotional or similar capacity.
  2. Physicians must not accept personal gifts of any value from industry or industry representatives.
  3. If accepting items from industry that advance disease/treatment education (e.g. patient teaching aids), physicians must only accept items that:
    1. primarily entail a benefit to patients, and
    2. do not have value to the physician outside of their professional responsibilities.

Product detailing

  1. Where industry representatives are providing information about products or services, physicians are permitted to accept meals for themselves and appropriate staff, however, physicians must only accept meals that are of a modest value.4
    1. Physicians are advised to consider the reasonable expectations of their patients in assessing whether a meal is “modest”.
  2. Physicians must critically evaluate any information provided by industry representatives and not solely rely on this information when making clinical decisions regarding patient care.
  3. Physicians must ensure that industry-produced patient-education materials (e.g. pamphlets) are accurate, balanced, and complete, before providing them to patients.

 Drugs samples

  1. Physicians who accept drug samples from industry must comply with the expectations for drug samples that are set out in the Prescribing Drugs
    1. Physicians must not take samples for personal use or the use of their family members.5

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

Physician organizers of CME/CPD events

  1. Physicians who organize CME/CPD events must ensure that:
    1. final decisions regarding the content, faculty, educational methods, and materials are made without influence from industry sponsors;
    2. CME/CPD activities are scientifically valid, objective, and contain balanced information relevant to the topic or focus of the event;
    3. all funds from industry are in the form of an independent educational grant payable to the institution or organization sponsoring the CME/CPD activity;
    4. educational materials and presentations refer to generic names in addition to trade names where a generic name exists;
    5. physician presenters are paid an amount that is at fair market value and commensurate with the services provided6;
    6. physician presenters are paid through the meeting organizers and not the industry sponsor;
    7. negotiations for space or for types of promotional displays at CME/CPD functions are not influenced by industry sponsorship;
    8. promotional displays from industry are not in the same room as the educational event;
    9. presenters, attendees, and their personal guests pay for the full cost of any pre or post meeting social events;
    10. there is a mechanism to manage all identified conflicts of interest; and
    11. industry sponsorship of the event is fully disclosed (this includes making the disclosure publicly accessible prior to the meeting).
  2. Physicians who organize CME/CPD events must only accept payments that are at fair market value and commensurate with the services provided.7
  3. Where a CME/CPD activity does not have a formal organizing committee, and where a physician is directly engaged by industry to organize the event,8 physician organizers must continue to comply with the expectations set out above with the following exception:
    1. funding for the event, including payments to presenters, may be provided directly by industry and need not be in the form of an independent educational grant.

Physician presenters, session chairs, and/or panel members

  1. Physicians who prepare and present a substantive educational session at a CME/CPD event (or who act as Session Chairs and/or Panel Members) must:
    1. ensure the scientific validity, objectivity, and completeness of the information they present;
    2. provide a balanced presentation of the prevailing body of scientific information when mentioning specific products or services, and if reasonable, alternative products or services;
    3. disclose where any presentation materials, including presentation slides, have been developed by industry;
    4. refer to generic names in addition to trade names (where a generic name exists);
    5. only accept payments that are at fair market value and commensurate with the services provided; and
    6. only accept payments that are made through the meeting organizers and not the industry sponsor.9
  2. Where a CME/CPD activity does not have a formal organizing committee, physicians who present at a CME/CPD event must continue to comply with the expectations set out above with the following exception:
    1. payment may be accepted directly from the industry sponsor provided it is at fair market value and commensurate with the services provided.10

Disclosure of industry relationships at CME/CPD events

  1. Physicians who organize and/or present at CME/CPD events must disclose to attendees at the event all conflicts of interest arising from their relationships with industry, including (but not limited to):
    1. current or past relationships with manufacturers of products mentioned at the event or with manufacturers of competing products;
    2. any direct financial payments from industry;
    3. investments in industry (excluding mutual funds);
    4. membership on advisory boards;
    5. grants or clinical trials funded by industry; and
    6. any other significant (paid or unpaid) relationships with industry.

Physicians who attend CME/CPD events

  1. Physicians who attend CME/CPD events must not accept payment or reimbursement for travel, lodging, or meal expenses from industry; however, physicians may accept meals provided at a CME/CPD event where the meal is of modest value.11
    1. Physicians are advised to consider the reasonable expectations of their patients in assessing whether a meal is “modest”.
  2. Physicians must only dispense scholarships or other funds from industry to undergraduate medical students or postgraduate trainees (including fellows) to attend CME/CPD events where the selection of recipients is made by their academic institutions.
  3. Physicians who attend a CME/CPD event must model ethical behaviour by acting in accordance with this policy.

Consultation or advisory board/investigator meetings

  1. Physicians who are asked by industry to sit on advisory or consultation boards, or to serve as individual advisors or consultants, 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 hiring company;
    3. not engage in promotional activities on behalf of the company while in this position;
    4. disclose their relationship with industry when providing educational activities on behalf of the company, and ensure that all information presented is accurate, complete, and balanced;
    5. only accept remuneration at fair market value and commensurate with the services provided; and
    6. only attend meetings that are held in the physician’s geographic locale or which form part of a meeting that the physician would normally attend (when these arrangements are not feasible, reasonable travel and accommodation expenses may be reimbursed).
  2. Physician researchers who attend Investigator Meetings (where researchers meet for the purpose of developing research protocols or discussing research results) must:
    1. only accept remuneration at fair market value and commensurate with the services provided; and
    2. only attend meetings in the physician’s geographic locale or as part of a meeting that the physician would normally attend (when these arrangements are not feasible, reasonable travel and accommodation expenses may be reimbursed).

Industry-sponsored research

  1. 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).12,13
  2. Physicians must only participate in research involving human participants, including post-marketing surveillance studies (phase IV clinical research), that has the approval of a research ethics board (REB). This applies equally to research that only involves the use of personal health information [PHI].14
  3. Physicians must only participate in clinical trials that have been registered prior to the enrolment of the first participant in a web-accessible research registry.

Patient consent for the use or disclosure of personal health information

  1. Physicians must comply with their legal obligations under the Personal Health Information Protection Act, 2004 (PHIPA)when collecting, using, or disclosing personal health information in relation to all research initiatives, including those sponsored by industry.15
  2. Physicians must only use or disclose patient information if they have the patient’s consent, or if the provisions under Personal Health Information Protection Act (PHIPA)16 which permit the use or disclosure of information for research purposes without consent have been satisfied.17
  3. Physicians must not use PHI for research purposes if other information will serve the purpose, and physicians must not use more PHI than is reasonably necessary for the purpose.18
  4. Physicians must comply with any requirements of the research ethics board with respect to the documentation of consent for the use or disclosure of PHI.

What information must be disclosed to patients participating in industry-sponsored research?

  1. Whenever engaging in research involving human participants, physicians must inform the potential participant about the relative probability of harms and benefits of participating as a research participant and must disclose all risks, even those which are rare or remote, especially if they entail serious consequences.19
  2. Physicians must advise prospective participants that they have the right to decline to participate or to withdraw from the study at any time, without prejudice to their ongoing care.
  3. Physicians must inform their patients of the nature of the benefit the physician will receive for recruiting the patient for participation in the research study.20 Physicians must also disclose any affiliations (e.g., with the pharmaceutical company or researcher) that may impact on the patient’s decision to provide consent.

Compensation

  1. Physicians must only accept compensation for participation in industry research at fair market value, commensurate with services provided.
  2. Physicians must only accept compensation for recruiting patients into a research study (including post-marketing surveillance studies) if:
    1. recruiting patients requires the physician to undertake activities beyond their normal practice, including, but not limited to, meeting with patients, discussing the study, and obtaining informed consent for the disclosure of patient information; and
    2. compensation is at fair market value and commensurate with the services provided.
  3. Physicians must not accept “finder’s fees”, whereby the sole activity performed by the physician is to disclose the names of potential research participants.

Publication of research findings

  1. Physicians must only be included as an author of a published article reporting the results of industry-sponsored research if they have contributed substantively to the study or the composition of the article.21
  2. Physicians must not agree to publish as author any article written in whole or part by the employees or agents of industry (“ghostwriting”) unless contributions are clearly disclosed by authorship or acknowledgment.
  3. When submitting industry-sponsored research to medical journals or for public consumption, physicians must fully comply with the disclosure requirements of the receiving publication.
  4. Physicians must clearly disclose any relationship they have to industry where it has provided funding or other support for the studies or where it makes­ the products that are the subject of the study, whether or not the publications require such disclosure.
  5. Physicians must seek to publish negative as well as positive results in the spirit of good science, and in the interest of contributing to the existing body of knowledge.
  6. Physicians must not enter into agreements that would limit their right to submit research results for publication, disclose the results of a study, or report adverse events.
  7. Physicians must not knowingly be involved in concealing research results or presenting them in a misleading fashion.
 

Endnotes

1. 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.

2. For more information, please see the College’s accompanying Advice to the Profession: Physicians’ Relationships with Industry: Practice, Education and Research.

3. Key evidence from the literature can be found in the following articles:

  • Katz, Dana, Caplan, Arthur, & Merz, Jon. (2003, June 1). All Gifts Large and Small: Toward an Understanding of Pharmaceutical Gift Giving. University of Pennsylvania Scholarly Commons – Center for Bioethics Papers.
  • Fugh-Berman, A, & Ahari, S. Following the Script: How Drug Reps Make Friends and Influence Doctors. (2007). PLoS Med. 4(4), e150.
  • Spurling, GK, et al. Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians’ Prescribing: A Systematic Review. (2010). PLoS Med. 7(10), e1000352.

4. Physicians are reminded that it is an act of professional misconduct to receive a benefit from a supplier contrary to s. 16(a) of O. Reg. 114/94 under the Medicine Act, 1991.

5. Limited exceptions are set out in the Physician Treatment of Self, Family Members, or Others Close to Them policy.

6. Payments may include reimbursements for reasonable travel, lodging, and meal expenses.

7. Payments may include reimbursements for reasonable travel, lodging, and meal expenses.

8. Example of such an event: “industry dinner”.

9. Payments may also include reimbursements for reasonable travel, lodging, and meal expenses.

10. Payments may include reimbursements for reasonable travel, lodging, and meal expenses.

11. Physicians are reminded that it is an act of professional misconduct to receive a benefit from a supplier contrary to s. 16(a) of O. Reg. 114/94 under the Medicine Act, 1991.

12. View the statement here: http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf.

13. Physician must adhere to the Tri-Council Policy Statement: Ethic Conduct for Research Involving Humans (TCPS-2) regardless of whether they are receiving funding from one of Canada’s three federal research agencies: the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), or the Social Sciences and Humanities Research Council of Canada (SSHRC).

14. For the definition of “personal health information”, see s. 4 of the Personal Health Information Protection Act, 2004, S.O. 2004, c.3, Sched. A (PHIPA).

15. Grant-funded research would be subject to the same privacy and consent requirements as set out in this section, as would marketing and market research. Physicians should be aware that funding agencies may also stipulate requirements with respect to consent and privacy.

16. PHIPA, 2004.

17. S. 37(1)(j) and 37(3) of PHIPA provide that physicians who do not have patient express consent may use their patients’ personal health information only if they comply with the provisions of PHIPA at s. 44(2) – (4) and 44(6)(a) –(f), which require the submission of a research plan for research ethics board approval. Additional requirements for research plans are set out in s. 16 of the Ontario Regulation 329/04 under PHIPA. Similar obligations apply to the collection of patient personal health information for research purposes, as set out in s. 29(a) and s. 36(1) (a) and (d) of PHIPA.

18. S. 30 (1) and (2) of PHIPA.

19. Halushka v. University of Saskatchewan (1965), 53 D.L.R. (2d) 436 (Sask. C.A.) Weiss v. Solomon (1998), 48 C.C.L.T. 280 (Qc. Sup. Ct.).

20. Informing patients of the “nature” of the benefit involves disclosing the type of benefit that may be received. It also includes disclosing the amount of any compensation the physician will receive.

21. The criteria for authorship that must be met are those set out by the International Committee of Medical Journal Editors (http://www.icmje.org/).