In late 2019, Innovative Medicines Canada (IMC) updated its Code of Ethical Practices. Amongst the changes to the Code was new guidance on the operation of Patient Support Programs (PSPs) and Medical Practice Activities (MPAs). The changes seek to explicitly prohibit direct or indirect payments to a patient’s prescribing HCP or a person who is not at arm’s length from the patient’s prescribing HCP.
In this article, I’ll look specifically at these changes in Section 15 of the IMC Code, why they were needed, and what organizations should consider as next steps. Although the Code is binding for IMC members, non-member companies and other industry organizations can look to the Code as a gold standard of practice.
Why new guidelines on PSPs and MPAs?
PSPs and MPAs provide support to patients and medical practices to improve patient adherence to treatment and health outcomes or to support a patient’s understanding of their disease and its treatment. Programs can range from making patient support calls to the administration of drug products by a nurse.
The changes around the PSP and MPA guidance are in response to growing concerns about the levels of interaction between pharmaceutical companies and healthcare professionals or medical practices that happen through these programs. The updated guidance is intended to provide clarity and reduce the risk of perceived conflicts of interest in how PSPs and MPAs operate. These changes benefit both the industry and the healthcare system as it brings a better understanding to all parties on the intent of these programs and their operation.
As the body representing innovative pharma in Canada, IMC is attuned to changes in the industry, the evolving role of manufacturers, and the demands of other healthcare stakeholders. With an increasing drive to improve transparency in manufacturers’ activities, proactive changes like improvements to the PSP and MPA guidelines help mitigate perceived ethical transgressions and ensure that all players work together effectively for the betterment of patients.
Why these changes are important for the industry
Activities undertaken by PSP and MPAs have raised concerns in the past around equity and transparency in the levels of services that are provided. Left unaddressed, these activities -- particularly the delivery of payments or other benefits to an HCP or medical practice -- could call the validity of these programs into question and lead to greater scrutiny in the future.
By acting to eliminate the exchange of fees or benefits, it ensures these programs can continue to operate for their intended purpose – the benefit of patients. While not intended as marketing activities, the perception of these programs as such could lead to wholesale changes at a regulatory level.
Prohibiting payments to prescribing HCPs and those not at arms-length
For pharma companies, the new guidance prohibits payments or other benefits going to HCPs or those not at arms-length from the prescribing HCP. Any support provided through a PSP or MPA should exclusively benefit the patient. The prescribing HCP, or a person not at arm’s length from the patient’s prescribing HCP, should not receive any benefit – monetary or otherwise. This limitation applies whether the payment would come from an IMC Member or a third-party service provider acting on behalf of a Member.
To comply with the new Code, Members should specifically adhere to the following:
- Prohibit direct or 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. A prohibited benefit would include a nurse who is hired to provide services for the PSP at a medical practice and who does additional work for the practice or the patient’s prescribing HCP.
- Prohibit 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. This means that no payment or other benefit should be transferred to an HCP for services provided to the patient under the PSP, even if it takes place through a third-party provider.
- Prohibit payments or other benefits to an HCP for services reimbursable by the healthcare system. A Member or a third-party acting on behalf of a member may not compensate an HCP where it may result in the duplication of compensation.
Next steps for innovative pharma manufacturers
While IMC has taken a positive direction here, it requires Member companies to have a strong understanding of the broad scope of activities that fall under PSPs and MPAs and an awareness of the rare cases where there are exceptions to the general prohibitions.
Assessing your own PSPs and MPAs in relation to the new guidance is an important first step prior to it coming into effect in July 2020. Companies need to endeavour to proactively align their programs to the new guidance.
With vast industry experience, IQVIA can work with you to assess your existing programs and provide expert guidance on how to comply with the new guidance. Contact our Compliance experts for more information.