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Innovative Medicines Canada (IMC) updates its Code of Ethical Practices

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The Innovative Medicines Canada (IMC) was founded on April 23, 1914, by representatives of 10 pharmaceutical and toilet products companies under the name “Canadian Association of Manufacturers of Medicinal and Toilet Products”. In 1915, the association changed its name to “Canadian Pharmaceutical Manufacturers Association”, while in 1965, the association again changed its name to the “Pharmaceutical Manufacturers Association of Canada (PMAC)”.

In constant evolution, in 1999, PMAC changed its name to “Canada’s Research-Based Pharmaceutical Companies (Rx&D)” and in 2003, launched a joint Code of Ethics in partnership with the Quebec Board of Continuing Medical Education (CEMCQ). Finally, in 2016, the association changed its name to its current name, “Innovative Medicines Canada (IMC)”. Currently, IMC has 49 member companies, who undertake the development of new medicines and vaccines.

In 2022, IMC made another update to their Code of Ethical Practices. The main changes took place in the following sections of the Code of Ethical Practices from IMC:

1. Section 6 - Business Meetings and Discussions

2. Section 9 - Learning Programs for Health Care Professionals

3. Section 12 - Provision of Funding

1.4. 1.1.                    SECTION 6 - BUSINESS MEETINGS AND DISCUSSIONS

1.4.1.1. ITEM 6.1 - GENERAL PRINCIPLES

In item 6.1., it is clarified that venues for scientific education must be appropriate to the purpose of the meeting and meals or refreshments can be provided, always on an ancillary basis. If the events take place outside of Canada, the country's applicable laws must be respected.

Events are defined as learning programs, advisory boards, consultant meetings, etc.

In the same item, the code clarifies that employees are prohibited from joining in activities such as golf, hockey, theater, spa, etc., that is, entertainment with third parties involved.

As an amendment, the following paragraph is included in this item: “6.1.2 No stand-alone hospitality or entertainment is to be provided and the provision of tickets or vouchers, is not permitted, with the exception of hospitality related to a charity event as referred to in Section 12.3.2.2 of this Code.”

1.4.1.2. 6.2. LOCATIONS AND VENUES

Item 6.2 makes clear that the locations for holding business meetings and/or events must be an appropriate setting for learning or conducting a business discussions. Capital cities and other large metropolitan cities are considered appropriate locations for meetings and holding meetings in a location where none of the attendees work or reside is strongly discouraged.

Lavish, extravagant, otherwise perceived as luxurious, or entertainment, sports-related, leisure, or vacation venues – e.g., golf courses, ski resorts, health spas, beaches, rivers, lakes, or casinos – should be equally avoided, even if the cost is low and justifiable.

In this item, 3 new paragraphs were inserted:

6.2.4 As the interpretation of reasonable can clearly vary across the country depending on city or province, the onus is on Members to ensure that the venue is not extravagant nor reasonably perceived as such.”

6.2.5 Face-to-face in person business meetings and/or events must not be held in personal residences.”

6.2.6 Under no circumstances shall a Member pay a ‘clinic room rental fee,’ ‘clean-up fee’ or any other similar type ‘fee’ that can reasonably be construed as a direct or indirect payment to gain access to a Health Care Professional. Paying for a meeting room in a medical building is acceptable if required for a business discussion and provided the “fee” is within fair market value for a dedicated meeting room and is not paid directly to an individual Health Care Professional.”

1.4.1.3. 6.3 PROVISION OF MEALS AND REFRESHMENTS

The provision of reasonable meals and refreshments is allowed, provided that the purpose is to facilitate business discussions, and the participation of spouses/companions even if they pay for their own meals, is not permitted.

The following paragraphs are added in this item:

6.3.2.1 The number of Stakeholders attending a business discussion, excluding promotional or learning programs that are covered in Sections 5, 9 and 10 of this Code, must be reasonable and justifiable if subjected to scrutiny by Stakeholders. Honorarium must not be provided to Stakeholders attending a business discussion.”

6.3.2.1.1 Member employees may invite a maximum of five Stakeholders, per informal interaction, per Member Company. Although there may be more than one employee from a Member in attendance, the number of Stakeholders cannot be increased to result in larger groupings.”

6.3.2.1.2 Member employees other than sales representatives and their direct supervisors may invite more than five Stakeholders, per interaction, per Member Company when the legitimate purpose of such business discussion is documented through an agenda or through any other acceptable form of documentation.”

6.3.2.2 Attendance to a business discussion is limited to invited Stakeholders. Under no circumstances can meals and refreshments be extended to their spouses/companions or their administrative staff.”

1.5. 1.2.                  SECTION 9 - LEARNING PROGRAMS FOR HEALTH CARE PROFESSIONALS

1.5.1.1. 9.1 GENERAL PRINCIPLE

IMC members may support accredited and unaccredited programs, irrespective of format, designed by Health Care Professionals for Health Care Professionals, aimed at health research, health sciences, clinical practice, and professional development.

1.5.1.2. 9.2 STANDARDS

The code makes it clear that the agenda must not be promotional-oriented and presentations must give a balanced view of all relevant therapeutic options available. Scientific support provided by the member company should be disclosed employing transparent accounting practices.

Remuneration of the speaker or moderator must be calculated at fair market value, and may only be provided after the service has been rendered. Reasonable travel, accommodation and out-of-pocket expenses may be reimbursed. Any other type of payment is prohibited.

The member company must have full editorial control over the presentation content displayed. In this item 9.2.6, the following text was added: “If requested by presenting Health Care Professionals (HCP), medical/education personnel (i.e. non-sales personnel) can provide content to HCPs as appropriate to satisfy the unmet learning need. Sales representatives cannot provide any content or slide deck to HCPs to present at a learning program”.

Payment for any kind of entertainment in learning programs is not allowed.

Three new sub-items are included in item 9.2 Standards:

9.2.7 Member companies do not support product claims that are not consistent with the terms of market authorization and expect content and materials presented to be fair, balanced and reflect the prevailing body of scientific information and/or therapeutic options. If a speaker or a moderator chooses to make claims about unapproved uses of a product, they must be required by contract to inform the audience of this fact at the start of the presentation and to the extent possible, before making reference to the unapproved claim. A disclaimer should be written on the presentation”.

9.2.8 Learning programs supported by Members or through a third party are designed for Health Care Professionals and invitations are to be extended only to Health Care Professionals and other relevant collaborators. These programs must not be offered to non-HCP spouses/companions or family members of Health Care Professionals. It is recognized that Health Care Professionals may wish to travel with their spouses/companions or family members. Should they choose to do so, the planning and costs of travel, accommodation, meals and refreshments of the spouses/companions or family members are the responsibility of the Health Care Professionals. Members must not in any way offer support or facilitate the travel and accommodation arrangements of spouses/companions or family members of Health Care Professionals, or extend hospitality to them”.

9.2.11 Member sales representatives can only attend learning activities as observers; they cannot participate in the discussion. Member employees cannot detail products, provide samples or set up any booth at learning programs”.

1.5.1.3. 9.3 CONTINUING HEALTH EDUCATION (ACCREDITED PROGRAMS)

The term continuing health education includes programs for all Health Care Professionals, accredited by one of the following institutions: (i) The Royal College of Physicians and Surgeons of Canada, (ii) The College of Family Physicians of Canada, (iii) The Federation of General Practitioners of Québec (FMOQ), (iv) The Federation of Medical Specialists of Québec (FMSQ), (v) The Canadian Council on Continuing Education in Pharmacy (CCCEP) and (vi) Other Canadian organizations that provide credits that are recognized by accrediting bodies.

1.5.1.4. 9.4 OTHER LEARNING ACTIVITIES

Other Learning Activities are defined as unaccredited programs, events or activities, including self-directed learning programs that do not meet the accreditation criteria set out by the professional organizations listed above. They are considered to be non-promotional in nature.

In this item 9.4 Other Learning Activities, two new sub-items were included:

9.4.2.4 Member sales representatives can only be involved in logistical activities associated with learning programs such as: (i) Distribution of approved invitations; (ii) Execution of agreements; (iii) Propose a potential speaker or moderator; (iv) Making arrangements for venue, online platforms, incidental meals and refreshments in keeping with Section 6 of this Code; (v) Confirmation of attendees; (vi) Collection of evaluations; and (vii) Distribution of learning program material (acceptable to attendees only)”.

“9.4.2.5 While sales representatives can be involved in the distribution of an invitation and can propose a speaker or moderator, members must ensure there is appropriate oversight by non-sales personnel in the final approval of invitations, speakers and moderators. Final decisions on invitations, speakers and moderators, must be made by non-sales personnel”.

1.5.1.5. 9.5 PRECEPTORSHIPS

Health Care Professional's Preceptorships are unique programs that should facilitate learning and transfer of skills and knowledge from one Health Care Professional to another, as they allow a HCP to spend time with a trainer (the “Preceptor”) who is a recognized expert in their field, in order to gain better understanding and insight into a therapeutic area or disease state.

Members may support preceptorship, although the payment of honoraria calculated must always respect fair market value. Reasonable travel and accommodation expenses of the preceptor and Health Care Professionals invited to participate in the preceptorship can be reimbursed.

A maximum of five Health Care Professionals, per calendar year, per brand, and per specialty, may be sponsored to participate in preceptorship programs. Appropriate preceptorship locations are an appropriate teaching center, being a teaching hospital, teaching clinic or a university, in or outside Canada.

1.5.1.6. 9.6 SPEAKER TRAINING AND WORKSHOPS

An appropriate number of Health Care Professionals may be trained on legitimate learning programs, new products, new indications or disease states or significant label changes (i.e. patient safety) for the sole purpose of disseminating this information at subsequent events. These training meetings are referred to as Speaker Training.

Speaker Trainings, may not include more than twenty participants (trainers are excluded from this number) and must be held within Canada. Reasonable travel and related expenses may be paid, including the provision of appropriate meals and refreshments all through written agreement, however, entertainment is prohibited.

Speakers should be selected based on criteria such as general medical expertise and reputation, knowledge and experience regarding a particular therapeutic area, and communication skills.

Should the need arise to have an internationally recognized expert as trainer, members may invite the international expert to Canada or send up to five Canadian recognized experts per new product or new indication to an appropriate teaching center, a teaching hospital, a teaching clinic or a university in the country of the internationally recognized expert. Training by an internationally recognized expert can only occur after the new product is registered in Canada and before the expected date of launch of the new product.

1.6. 1.3.                   SECTION 12 - PROVISION OF FUNDING

1.6.1.1. 12.1 GENERAL PRINCIPLES

Scientific support should not serve as an incentive to prescribe, recommend, dispense, purchase, supply, approve, reimburse or administer a product.

Scientific support may also not be provided to an individual stakeholder or an entity that is controlled in fact by an individual stakeholder or its family member, legal representative or agent with the exception of: (i) Sponsorship of an individual Health Care Professional or other Stakeholder to attend an international conference or meeting event (in accordance with Section 10.2) or (ii) In the case of investigator-initiated studies, where the individual stakeholder is the investigator of the study.

1.6.1.2. 12.2 DONATIONS AND GRANTS

Donations, whether on your own initiative or at the request of others, are funding or in-kind contributions to support general health care, local communities or other charities and philanthropic activities. Members must not control or influence the support provided or acquire a tangible benefit. Donations may only be provided to non-profit organizations and registered charities involved in conducting artistic, charitable, cultural, community, educational, humanitarian, health, philanthropic and sporting activities.

Grants, upon third-party request only, are funding to support independent bona-fide scientific, medical or health-related activities (carried out for educational, informational or research purposes) where the member does not control, influence, or participate in the design or conduct of the activity or acquire a tangible benefit from the funding. Grants may be provided to groups or associations of Stakeholders to organize bona-fide activities, such as medical research, public policy research, continuing professional education, and training, or to support any project that will enhance patient outcomes or relates to, patient or community education or community projects that promote better health care. Grants must not be provided to hospitals, private medical practices/clinics or academic societies, or professional associations or organizations for routine operational costs.

1.6.1.3. 12.3 SPONSORSHIPS

Sponsorships are provisions of funding or in-kind contributions to organizations involded with education, health-related, scientific or medical activities, to support medical scientific activities or other bona-fide activities (undertaken for education, informational, research or related purposes) where the member company may control, influence or participate in the design or conduct the activity or acquire a tangible benefit. Sponsorships can be solicited or unsolicited and can include programs, projects or activities.

Members may provide financial or non-financial support to registered charities and/or non-profit organizations by sponsoring a fundraising activity, which may include the purchase of a table or tables at a dinner or other social event, the purchase of a foursome at a golf tournament, or other sporting or cultural activity. Individuals invited by members to attend such fundraising activities may be Stakeholders other than Health Ccare Professionals, their spouses and/or administrative staff.

1.6.1.4. 12.4 JOURNAL CLUBS AND ROUNDS

This item was included entirely after this change, with the addition of the following paragraphs:

“12.4.1.1 Journal clubs and rounds are activities during which HCPs exchange information on related scientific and clinical issues. These activities take place in a variety of formats including lectures, debates, panel discussions or simulations to achieve particular learning objectives and are non-promotional in nature”.

12.4.2.1 All support provided to journal clubs and rounds must be provided exclusively in the form of a grant. Members must ensure that support is provided in accordance with Sections 12.1 and 12.2”.

12.4.2.2 The recipient organization may use the grant to pay for expenses including speaker honoraria, meals and refreshments, or travel and accommodation in relation to a journal club or round. However, Members cannot pay these expenses separately from the funding provided”.

12.4.2.3 Members must only sponsor journal clubs and rounds that take place in an appropriate setting conducive to learning, such as a hospital, a clinic or an academic institution”.

12.4.2.4 Member employees may attend journal clubs and rounds, as long as they are permitted by the institution organizing the activity. Member sales representatives can attend these activities only as observers; they cannot participate in the discussion. Member employees cannot detail products, provide samples, or set up any booth at a journal club or round”.

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