On December 2, 2019 Innovative Medicines Canada (IMC) published a revised version of its Code of Ethical Practices (IMC Code)(PDF).
These changes are intended to ensure that relationships between the innovative pharmaceutical industry and various stakeholders, including notably, healthcare professionals (HCPs), follow the highest ethical standards. Among other things, we note additional, more stringent restrictions regarding compensation of prescribing HCPs.
There are five major updates to the Code:
1. Guiding Principles
To begin, it is now explicit that the guiding principles apply throughout the IMC Code and should be read into all sections. The guiding principles are intended to provide interpretations of the IMC Code and assist members in respecting the spirit of the IMC Code where no specific provisions apply.
2. Meeting Locations and Venues
The updated IMC Code provides additional clarity and guidance regarding the appropriateness of locations and venues for business meetings and discussions initiated or sponsored by member companies.
Meeting locations should not be the main attraction of the event. Venues must not be extravagant, luxurious or perceived as such. They must not be known for their entertainment, sports, leisure or vacation facilities.
For additional information, see the Note For Guidance On Events And Meetings Organized Or Sponsored By Companies (PDF) published by IMC in October 2019.
3. Sponsored Conferences and Congresses
There is also new precision regarding the sponsorship of third-party conferences and congresses.
When deciding whether to provide sponsorship, members should ensure that: (1) there is medical or scientific value by reviewing the detailed agenda; and (2) the venue is appropriate and not extravagant.
4. Compensation for Services Provided by Stakeholders
The new IMC Code has more clearly defined the various categories of funding which may be provided to stakeholders, including, grants, donations, sponsorships, collaborations and partnerships. It has also clarified the standards that apply in each category of funding.
Furthermore, these standards apply to both direct and indirect compensation of stakeholders, (i.e. they apply equally to a third party service provider hired by a member).
For additional information, see the Note For Guidance On Retaining The Services Of Stakeholders (PDF) published by IMC in October 2019.
5. Patient Support Programs (PSPs)
Last but certainly not least, many important changes were made to the chapter governing PSPs and medical practice activities (MPAs).
The IMC Code now prohibits members from providing payments or other benefits, directly or indirectly to a patient's prescribing HCP for services provided in the context of PSPs and MPAs. Any support provided through a PSP/MPA should exclusively benefit the patient and not the patient's prescribing HCP or a person who is not at arm's length from the patient's prescribing HCP (e.g. clinic owned by the prescriber, staff member, etc.).
The only proposed exception to the this prohibition is if a patient resides in a remote community and would not be able to reasonably obtain the service from another HCP.
Third party service providers are likewise prohibited from providing such payments or benefits. IMC members are even required to ensure that such third party service providers so comply. This could be done, for instance, by way of adaptation to the company's master service or other agreements with service providers. This is especially important in a context where specialty service providers are not subject to the rules of the IMC Code. It is the IMC member who bears the risk of non-compliance and should therefore incentivize compliance by contract or otherwise.
Moreover, the IMC Code now clarifies that manufacturers cannot pay for any services that are reimbursable by the publicly-funded healthcare system.
For additional information, see the Note For Guidance On Patient Support Programs And Medical Practice Activities (PDF) published by IMC in October 2019.
Coming Into Force
The updated IMC Code will come into effect on January 1, 2020.
Nonetheless, the changes related to PSPs and MPAs will only come into effect on July 1, 2020, while those related to sponsoring third-party conferences and congresses will come into effect on January 1, 2021. Pharmaceutical companies should make good use of this transition period by re-evaluating their support programs and adjusting their compliance policies before the more stringent ethical rules become effective. Fasken is available to assist with these reviews in order to ensure optimal compliance with the new provisions of the IMC 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.
