Relationships between the Department of Internal Medicine and Health Related Industries
|Policy:||Relationships between the Department of Internal Medicine and Health Related Industries|
|Policy Nr:||Sec 09 - 01|
|Target Review Date:||31 December 2017|
|Main Stakeholder:||Department Head|
Appropriate and transparent interactions between the pharmaceutical industry (hereafter, Industry) and the medical profession can be beneficial in promoting advances in research and evaluation of new therapies and in developing and supporting educational programs that benefit both physicians and their patients. Many postgraduate training and clinical programs have become increasingly dependent on direct Industry contributions or contract research for discretionary funding, which is unlikely to be replaced from governments, the universities or teaching hospitals.
If we accept that interactions between physicians and Industry can ultimately benefit patients, and that Industry support for training and clinical programs have become essential, it is evident that there must exist rules and processes to ensure that these interactions do not violate the fundamental ethical principles underlying medical practice. In particular, the fiduciary relationship between physicians and their patients must not be compromised by gain accruing to physicians through their involvement with Industry. A Guidelines for Physicians in Interactions with Industry] has been provided in a Canadian Medical Association (CMA) policy document. However, the CMA guidelines do not define in detail the processes needed to ensure that an institution is able to demonstrate the compliance of its members with the policy. Defining these processes and procedures is the purpose of this Departmental Policy document.
General Policies for Department of Internal Medicine Members’ Relations with Industry
- All department members are required to maintain detailed records of all financial transactions with pharmaceutical or other companies, private contributors and agencies. Records must include details of service arrangements, fees and other contributions and reimbursement of expenses.
- Full disclosure of these health-related relationships to the department member’s direct supervisor (in most cases the Section Head) and to the Department Head is required. In any case of use of investigational drugs or other products in patients, any financial relationship with Industry related to the agent in question must also be fully disclosed to the Research Ethics Board of the University of Manitoba and to the patients involved.
- Accepting gifts or privileges directly or indirectly from Industry is contrary to the Department of Internal Medicine and Max Rady College of Medicine policies.
- Department members are required to notify the Department Head of any observed or reported attempt by companies to directly contact and influence patients to lobby on their behalf in order to procure or influence sales.
Consulting Agreements with Industry
- Provision of paid consultation services to Industry by Department members is permissible. However, members must satisfy themselves and make clear to Industry that the obligations of physicians must be strictly limited to deliverables defined within the terms of the service agreement. Payment received from Industry must be proportional to the defined service (see #Appendix I), and the terms of the agreement must be disclosed in writing to the member’s Section Head and the Department Head.
- Consulting arrangements must be formalized; describing expectations, services and benefits to both parties. Potential consultants must possess highly specific qualifications derived either from senior participation in a relevant research program, or be recognized as highly specialized in clinical or academic skills.
- These agreements must be approved by both the member’s Section Head and Department Head in advance.
- Physicians who have had a prior or ongoing relationship with Industry, because of their unique knowledge or expertise, will often be approached to provide advice on matters that will influence the use or purchase of proprietary products. Providing advice or information to institutions or agencies is acceptable so long as full disclosure of the relationship is made at the outset. Physicians in such circumstances must ensure that they do not retain final responsibility and authority to effect decisions that relate to the final use or purchase of such products, nor participate directly in committee deliberations where such decisions are being made.
Industry Sponsorship of Research Within the Department of Medicine
- Participation by department members in industry-sponsored research meeting the standards detailed in the CMA guidelines is encouraged.
- All industry-sponsored projects and the funding agreements relating to them will be disclosed to and approved by the member’s Section Head in writing.
- All industry-sponsored projects involving department members or being carried out within the facilities of the University of Manitoba, its affiliated teaching hospitals or the WRHA/Shared Health, must be approved by the Research Ethics Board of the University of Manitoba.
Guidelines for Management of Funds from Industry Sources
- All research funding from Industry to department members will be administered through Specific Purpose Account at the or at the affiliated teaching hospitals.
Private bank accounts for Industry research funding are not permissible.
- Surplus Research Account funds unexpended at the completion of the project will be transferred to one or more General Purpose accounts, which may be used for research, education or academic enrichment, which may include educational travel, work-related equipment and staff-appreciation functions and resources; not permitted are non-work-related purchases directly benefiting the department member or a family member.
Disbursements of Funds
- Residual grant funds after disbursement of the physician fee component will be deposited in a single specific purpose account for the use of all section members. The priorities for the use of moneys in this account will be decided by the full membership of the section, and disbursements from this fund will be approved by the Section Head in accordance with the priorities set by the section as previously described.
- Disbursements from all General Purpose surplus-fund accounts will require signed approval by the Department Head or delegate, and by both the faculty member responsible for the account and the Section Head or site designate. Non-resolvable disagreements between the co-signatories will be adjudicated by the Department Head.
- At the completion of a study the principal investigator (and co-investigators where appropriate) can elect to receive a portion or all of the physician fees as personal income in accordance with the Guidelines for Personal Financial Relationships between Department of Internal Medicine members at the University of Manitoba and the Pharmaceutical Industry Policy as outlined in Section 4, Appendix 1 part 3 of the Department of Internal Medicine Specific Purpose Accounts handbook.
- If the principal investigator elects not to receive the physician fees as personal income he/she can choose to deposit the equivalent amount in a specific purpose account under the name of the investigator for personal research and educational projects as outlined in Appendix I. However, once deposited into the specific fund account, removal of funds for physician fees will not be permitted, and all expenditures, transfers and transactions will be fully disclosed to and approved by the member’s Section Head as stated in Section 4a)&4b).
- Payments received by individual department members for administration or research-related tasks are permissible. However, such payments must be within reasonable limits for such work (see Appendix I), disclosed to and approved by the Section Head and reported as clinical income under the provisions of the Geographical Full-Time Agreement. Payments to department member’s family members may be permissible but require that i) the rate of pay be appropriate to the work performed; ii) the family member possess qualifications appropriate to the task; iii) the appointment be approved by the department member’s immediate supervisor; iv) one family member not have a direct supervisory relationship with another, in accordance with University and Hospital policies on nepotism in the workplace.
- A statement disclosing all expenditures, transfers and transactions of both individual and section specific purpose accounts will be tabled at the section meeting on a three-month basis.
Industry-Sponsored Continuing Medical Education and Continuing Professional Development
Industry support for legitimate CME/CPD activities meeting the standards detailed in the CMA guidelines and Max Rady Faculty of Medicine policies is encouraged. In particular, support for such activities must be in the form of an unrestricted educational grant with complete responsibility for program content remaining with the physician organizers of the event.
- Reasonable honoraria and reimbursement (see Appendix I) for travel expenses and lodging for faculty members of CME events meeting CMA guidelines may be provided through Industry sponsorship and appropriately acknowledged.
- Reimbursement directly or indirectly (eg. through a sponsoring society) from Industry sponsors for travel, lodging and personal expenses for attendees of CME events is contrary to the published CMA guidelines and is not allowed.
Industry Sponsorship of Fellowship and Faculty Positions
- Industry support of Fellowship training positions within the department or of Faculty Professorships is acceptable, but must be in the form of an unrestricted grant administered by the department, and must not be tied to any particular individual department member or any expectation of service or obligation of the funded physician to the funding company.
- Industry-sponsored Clinics Industry sponsorship of special-purpose clinics are acceptable, but must be:
- a. approved by the Section Head and Department Head
- b. funded for a pre-specified term for implementation of a specific purpose or project
- c. free of obligation on the part of department members or their patients to use, prescribe or purchase any particular proprietary pharmaceuticals or other products.
Industry Relations with Department of Internal Medicine Resident Trainees
- Industry sponsorship of Department of Internal Medicine Resident educational events is encouraged.
- Funds for Resident educational events must be solicited and administered by the relevant residency Program Director as an unrestricted educational grant from industry; negotiations and correspondence directly between residents and Industry representatives is not acceptable.
- The agenda/program of such events will be determined exclusively by the physician organizers of the event.
- Industry support for the event will be publicly acknowledged at the event, and representatives of sponsoring companies are welcome to attend when such
attendance would be appropriate; however, product detailing at the event is not acceptable. The “Department of Internal Medicine Policy Governing Relationships between the Department of Internal Medicine and Health Related Industries” was modified in November 2016 to reflect the “Interactions between the Max Rady College of Medicine and Health-Related Industries” Policy which is effective January 1, 2017.
- CMA Policy: Physicians and the Pharmaceutical Industry(Update 2001)www.cma.ca
- Canada’s Research Based Pharmaceutical Companies(Rx & D) Code of Marketing (Revised November 1999).
|Could not find document on successor organization's page, http://innovativemedicines.ca/ethics/ Ttenbergen (talk) 23:18, 18 May 2017 (CDT)|
- Guidelines for Continuing Medical Education Events, External Support of Educational Programs and Working Relationships with Commercial Companies. Department of Continuing Medical Education, Faculty of Medicine, University of Manitoba, April 1997.
|Could not find document on U of M's site; that department doesn't even show up any longer Ttenbergen (talk) 23:18, 18 May 2017 (CDT)|
- Coyle SL. Physician-Industry Relations. Parts I and II. Position paper of the Ethics and Human Rights Committee, American College of Physicians-American Society of Internal Medicine. Annals of Int Med 133: pp 396-406, 2001.
- Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research. A Report of the AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subjects Research. Association of American Medical Colleges. February, 2008.
- WRHA policy #30.40.10 Trust and Specific Purpose Accounts: http://home.wrha.mb.ca/corp/policy/files/30.40.010.pdf
- St. Boniface Hospital Specific Purpose Accounts Policies.
- University of Manitoba Policies. "Interactions between the Max Rady College of Medicine and Health-Related Industries." Policy effective January 1, 2017.
Guidelines for Personal Financial Relationships Between Department of Internal Medicine Members at the University of Manitoba and the Pharmaceutical Industry
Reimbursement for services as a speaker at a CME function
- For speaking engagements that require overnight travel, the provided honoraria shall not exceed $3,000 per day plus reimbursement for reasonable out-of-pocket expenses documented with receipts.
- For speaking engagements that do not require overnight travel, the provided honoraria shall not exceed $1,500 per day plus reimbursement of reasonable out-of-pocket expenses documented with receipts.
- For the development of enduring materials, the provided honoraria shall not exceed $1,500 per day plus reimbursement of reasonable out-of-pocket expenses documented with receipts.
- For the review of enduring materials, the provided honoraria shall not exceed $1,000 per day plus reimbursement of reasonable out-of-pocket expenses documented with receipts.
Reimbursement for acting as a Consultant to a Pharmaceutical company
- Reimbursement for consulting shall not exceed $3,000 per day. Consulting fees exceeding the above guideline may only be accepted if approved in advance by the Section Head and/or Department Head.
- Payment to an investigator for administrative activities required to initiate a research study including budgeting, ethics submission, impact committee documents and the like) shall not exceed $1,500 in total. An additional $1,500 may be paid if study initiation requires travel to an out-of-town investigator’s meeting.
- Payments to an investigator for study-related procedures, examinations, follow-up visits required by protocol may not exceed the Manitoba Health tariff for these services and may not be double billed.
- Payments to an investigator for research-related services required for the conduct of a study not covered by Manitoba Health tariffs (administrative work, letters, reports etc.) may not exceed $750 per patient enrolled in the study.
- There will be no other payments to investigators for activities related to the conduct of industry-sponsored research studies other than those listed above.
- All payments received, or expected to be received, will be disclosed to the Department Head and to the Research Ethics Board of the University of Manitoba, and will be disclosed to patients as part of the Informed Consent document.
- The payment limits outlined above are not intended to restrict the line budget payment negotiated for these services with the study sponsor, but only apply to actual disbursements to faculty members.
- Fees exceeding or in addition to the above guideline must be approved in advance by the Department Head.
Department members engaging in clinical investigations who are also acting as paid consultants to the sponsoring company will disclose all consultation reimbursement to the Department Head and to the Research Ethics Board of the University of Manitoba.
Ownership of equity in Pharmaceutical companies by Department Members
- Department members may not hold more than a 5% equity position in a pharmaceutical company for which they are conducting research.
- All equity positions in companies for which the department member is conducting research will be disclosed to the Department Head and to the Research Ethics Board.
Please also refer to relevant Industry Relationships Policies.