Innovative Medicines Canada ("IMC") has published the 2022 Annotated Version of the Code of Ethical Practices (the "Code"), which will take effect April 1, 2022. The 2022 Code includes significant revisions to the guidelines on learning programs that aim to minimize the promotional aspects of these activities. Changes also include a new section on journal clubs and rounds, and a clarification on virtual meetings with Health Care Professionals ("HCPs").
Learning Programs for HCPs
A Documented Need
The Code now requires that learning programs "serve to enhance or fill an unmet documented need" among HCPs. According to the IMC notice summarizing the changes in the 2022 Code, this means that, "[b]efore supporting learning activities, members must conduct a needs assessment to ensure there is a legitimate unmet learning need." With respect to Other Learning Activities ("OLAs"), the Code specifies that the documented needs assessment must be reviewed and approved by the Member personnel responsible for learning activities, which would typically exclude sales personnel.
Limited Role for Sales Reps
Other revisions seek to limit the role of sales representatives in planning and administering learning programs. Sales representatives are no longer permitted to provide material to HCP speakers for their presentations, including material that is approved by the Pharmaceutical Advertising Advisory Board (PAAB) or is exempt from such review. Medical/educational personnel are, however, still permitted to provide material upon request by presenting HCPs, as appropriate to satisfy the unmet learning need. The IMC notice summarizing the changes provides that such material must be fair, balanced and objective.
In addition, sales representatives can only attend learning activities as observers and must not participate in any discussion. With respect to OLAs, while sales representatives can be involved in the distribution of an invitation and can propose a potential speaker or moderator, the final decisions on invitations, speakers and moderators must be made by non-sales personnel.
Further, no Member employees can detail products, provide samples, or set up booths at learning programs.
Increased Clarity on Off-Label Content
While full editorial control remains with the HCP speaker or moderator, the 2022 Code requires Members to implement additional safeguards regarding off-label information presented during learning programs. Under the 2020 version of the Code, contracts with OLA speakers or moderators were to include a requirement that the speaker or moderator inform the audience at the start of the presentation if any unapproved uses of a product would be discussed. Under the 2022 Code, this contractual requirement will extend to speakers and moderators in all learning programs, and they must also be required to inform the audience, to the extent possible, before making reference to an unapproved use during the presentation.
Moreover, the Code now advises that Members should consider providing a "note to audience" that speakers can add to their presentations which would inform the audience that:
- funding was provided by the Member company;
- the speaker has full editorial control over their presentation;
- any conflicts of interest that need to be disclosed; and
- the Member company does not support claims that are not consistent with the terms of market authorization.
Journal Clubs and Rounds
The 2022 Code introduces a new section on journal clubs and rounds. Journal clubs and rounds are defined as non-promotional activities during which HCPs exchange information on related scientific and clinical issues to achieve particular learning objectives. Members may only provide support to journal clubs and rounds in the form of a grant, which can be used by the recipient organization to pay for expenses including speaker honoraria, meals and refreshments, or travel and accommodation related to a journal club or round.
Member employees may attend journal clubs and rounds if permitted by the organizing institution. As with learning programs, sales representatives can only attend as observers and must not participate in the discussion, and Member employees cannot detail products, provide samples or set up booths.
Virtual Meetings with HCPs from Home
Finally, the 2022 Code clarifies that the prohibition on Members holding meetings with HCPs in a personal residence only applies to face-to-face, in person meetings, and therefore does not apply to virtual meetings.
This is in line with the IMC's statement on Compliance with the IMC Code of Ethical Practices during COVID-19, in which the IMC provided additional guidance on virtual learning programs and recommended that Members follow the spirit of the Code and its guiding principles to resolve any issues which may not be strictly addressed by the main provisions of the Code.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
