Transparency

Although tracking of healthcare provider spending and transparency reporting remains an important area for compliance-minded pharmaceutical industry stakeholders, initial polling at the Canadian Pharmaceutical Compliance Congress in June 2019 found that it was no longer an immediate priority, with only 17% of respondents stating they were ready to begin reporting. This is a worrisome sign, as aggregate healthcare professional spend monitoring is a vital element of risk mitigation for manufacturers. With increasing government and public interest in this area, it is worth noting that, even if transparency reporting isn’t top of mind for manufacturers, it remains a key area of concern for regulators. The representatives from regulatory bodies who participated in the conference referenced transparency reporting efforts as a common thread in their presentations.

Representatives from Health Canada educated attendees on the increased monitoring efforts by the department, sharing that in late 2018, the Minister of Health announced it was dedicating $5 million in Health Canada funding to create a dedicated team to act as an operational resource for marketing compliance and enforcement monitoring across various activities. In total, Canadian federal investments in proactive monitoring initiatives equal nearly $9 million — a number that is certain to rise in the future. The department’s commitment to proactive monitoring and post-decision efforts to ensure transparency and awareness of improper promotional activities, was reiterated, not just among industry stakeholders, but among end users of health products and services, i.e. the general public.

The Pharmaceutical Advertising Advisory Board, introduced attendees to PAAB’s new initiatives. Representatives explained that its reoriented focus is centered on a structural change to the organization’s team of reviewers. These oversight professionals’ more proactive monitoring and enforcement activities sends a clear signal to the industry that it must more readily prepare for more targeted scrutiny and assessment. The PAAB will undertake comprehensive analysis of common risks across all complaints — it is expected that the regulatory body will follow in the footsteps of the U.S. FDA’s open publication of monitoring results in a bid for greater transparency.

The activities conducted on behalf of manufacturers by third party vendors was a topic of frequent discussion during the conference. The message was clear: The promotional activities and relationships these players have with manufacturers is expected to face greater regulatory scrutiny and more detailed examination in the future.

Once considered only tangentially related entities, even hospital systems are realizing the risk mitigation benefits that come with strengthening compliance governance through the appointment of compliance officers. As are regulators, they look to U.S. health systems for guidance on how to structure expanded HCP conflict of interest management to enhance transparency.

Patient Support Programs (PSPs)

Created to meet patient needs and address administrative and logistical obstacles in treatment adherence, PSPs play a valuable role in Canadian healthcare. A Health Canada research updated in June 2019 found that roughly one in five households had experienced being unable to obtain or complete a course of prescription medication because of the cost.

Polls on PSP involvement conducted during the recent Canadian Pharmaceutical Compliance Congress revealed that, in many cases, such programs were managed by a commercial business unit potentially exposing organizations to significant compliance risk. Attendees expressed interest in and had questions about the future state of regulations on PSPs and where opportunities for interpretation lie.

Attendees learned about updates to Innovative Medicines Canada Code expected to be published in 2020, which includes new rules regarding PSP—that will take effect in July of 2020. Of note: The new guidelines are anticipated to prohibit industry PSP services that may be perceived to duplicate or compete with resources or services provided and funded by the existing healthcare system. Payments and benefits to HCPs will face new restrictions, strictures around arm’s-length remuneration and limitations on product-specific activities.

The passage of Bill 92 in Quebec marks a significant provincial-level regulation on PSP activity. It prohibits manufacturers, wholesalers and other intermediaries from reimbursing medication costs to patients covered by the public and private sector beneficiary plan. Although it was amended last fall to allow financial assistance to patients for “humanitarian reasons;” it also includes restriction on manufacturer-wholesaler exclusivity or preferential distribution agreements. The disciplinary board of the Quebecois pharmacist governing body (Ordre des Pharmaciens) initiated hearings on improper engagements between pharmacists and manufacturers this summer.

This bill is viewed as the start of a regulatory trend in PSP oversight in which bodies focus more on industry interaction with external stakeholders and the inherent risks. Other provinces are expected to follow suit with increased focus on this area of stakeholder engagement in the future, as Bill 92 follows a 2017 decision from the Alberta Court of Appeal that banned pharmacies from offering loyalty programs or incentives in exchange for the provision of certain drugs or services, as well as a 2016 British Columbia Supreme Court ban on loyalty rewards programs for pharmacies.

As PCC participants learned, the “value” associated with PSP services can expose organizations to risk in spite of the specialized and important role they play as a patient resource. Organizations need to understand the inherent risks in these programs and the ramifications of their exposure to risk when interacting with patient advocacy groups, specialty pharmacies, nurse educators, and patients. In committing to a patient-centric paradigm, manufacturers must be mindful to engage in continual assessment and modification of PSPs to mitigate risk and provide compliance-centric patient support that emphasizes safety and efficacy.

Other Learning Activities (OLAs)

The PCC program included numerous sessions that discussed the role of OLAs, with Health Canada’s guidance stipulating that OLAs are intended to be non-promotional — an open interpretation that allows for risk considerations of several types: Message context and content, intended primary and secondary audience, delivery frequency and review process, and transfer-of-value protocols. This guidance overlaps with Health Canada’s initiative to proactively monitor the promotional activities mentioned above.

Health Canada encouraged industry stakeholders to focus on monitoring industry influence in the actual presentation or even itself. However, initial polling of PCC attendees revealed that although 100% of them participate in OLAs, many fall short in the scope of their compliance efforts regarding sales and commercial influences in their logistics and operational protocols. A few examples:

• 20% do not conduct regular monitoring audits
• 6% have no FMV guidelines for HCP engagement
• 79% of OLAs conducted have some commercial influence or participation

There are currently many questions and discussion about whether or not HCPs or industry stakeholders must submit material for approval, taking place across regulatory bodies — including Health Canada, PAAB, physician groups and associations. The question of just where the power of review and approval lies remains an open one. The resulting ambiguity around everything from editorial control of slides to best practices for executing the review process provides yet another justification for the necessity of targeted risk assessment.

Health Canada plans to release an updated distinction document that will focus on these questions surrounding promotional versus non-promotional activities, and the IMC Code 2020 update will include new rules on OLAs.

Until the publication of that guidance, the key advice relative to OLAs is that appropriate continuing health education management, fair market value assessment and standardization of HCP selection are areas for future consideration, and therefore merits proactivity among industry stakeholders. Although this is currently not monitored by Health Canada, its alignment with primary compliance guidance on transparency reporting is the writing on the wall for Canadian pharmaceutical firms.

The challenges of these key themes were reiterated at multiple workshops and echoed by the interactive panel discussions at this year’s Canadian Pharmaceutical Compliance Congress. They will continue to lead compliance challenges going forward.

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