Pangaea Express: PSPs Regulations in the updated IMC Code
Patient Support Programs and Medical Practices Activities (MPAs) within Section 15 of the updated Innovative Medicines Canada Code of Ethical Practices incorporates some new, stricter regulations regarding direct and indirect payments to HCPs as the code will be:
- Prohibiting Members’ direct and indirect payments or other benefits to a patient’s prescribing HCP or a person who is not at arm’s length from the patient’s prescribing HCP;
- Prohibiting third-party service providers from providing payments or other benefits to a patient’s prescribing HCP or a person who is not at arm’s length from the patient’s prescribing HCP; and
- Prohibiting payments or other benefits to an HCP for services reimbursable by the healthcare system.
The key is keeping any payment at arm’s length from the patient’s prescribing HCP. This is to help “mitigate against real or perceived conflicts of interest between the pharmaceutical industry and Health Care Professionals”. If the prescribing HCP provides patient support services, they could only be compensated for their service through the publicly funded healthcare system.
Beyond the regulations surrounding PSPs, there are additional changes to the IMC code including (but not limited to) Section 6 and 10 regarding the appropriateness of venue locations for business meetings, events and third-party conferences and congresses. As well, Section 12 and the new Section 13 provide more in-depth definitions and clarity to distinguish among donations, grants, sponsorships and collaborations and partnerships as well as providing specific standards for each type of funding.
While the amendments to the Code will come into effect on January 1, 2020, Section 15, related to PSPs/MPAs will become effective on July 1, 2020 to ensure smooth transition of existing PSPs/MPAs. As well, the new guidelines that relate to sponsoring conferences and congresses will come into effect January 1, 2021 to respect any pre-existing sponsorship commitments by member companies.
While the changes to the PSP funding may not be a surprise to some given the growing lens of transparency within the industry, this revision could have significant implications. Will prescribing HCPs continue to administer infused or injectable medicines within their clinics? Will companies that are not IMC members abide by the spirit of the code, nonetheless, or will they continue to fund HCPs for their PSP services? It may be helpful to have an educational component for HCPs that offer PSP services to understand why and when their payments will stop.
For more information, please contact Marla Weingarten.