Government Increases Oversight for Non-Accredited Educational Activities
Is Canadian Pharma prepared?
Non-Accredited Educational Activities, also known as Other Learning Activities (OLA), play an important role in a health care professional’s continuous learning. However, the lines between education and promotion are sometimes blurred, leading to concerns about how these activities are influencing prescriber behaviour and resulting in increased scrutiny from Canadian regulatory bodies. The pharmaceutical industry could potentially face large process changes and now is the time to prepare.
As per Innovative Medicine Canada’s (IMC) Code of Ethical Practices , OLAs are non-promotional and unaccredited programs, events or activities, including self-directed learning programs, that do not meet the accreditation criteria set out by a health profession organization. Due to their non-promotional nature, the content is required to present a balanced viewpoint and aspire to high ethical standards.
Health Canada, advertising preclearance agencies, and medical associations have all recently taken steps to review and better define a wide body of activities and relationships between content providers (e.g., pharmaceutical companies, third-party education organizations) and content recipients (HCP community, medical colleges and patients). These actions are creating urgency for content providers to implement compliance and risk mitigation strategies around OLAs.
Marketing and Sales Involvement Scrutinized
What factors have led to the increase in scrutiny on the part of the public and regulatory bodies?
While the legitimate need to educate HCPs on under-managed disease states has served as the foundational rationale for OLA programs, extensive marketing and sales involvement in the planning and execution of these activities have been observed. This contravenes IMC’s Code of Ethical Practices which clearly defines these programs as non-promotional. Messages that promote a drug are considered advertising while messages that are intended to provide information are generally not.
The volume of OLA activities has exploded in recent years, which is also a reason behind increased public scrutiny. In contrast, prior to the increase in OLAs, there was an observed decline in industry support of accredited independent medical education. This led to concerns that the industry was replacing accredited programs with more focused programming that is tightly connected to innovative therapies, and presumably, has a greater ROI. These are likely contributing factors to the recent statement by Health Canada that they will be clarifying their 1996 guidance on the distinction between advertising and promotional activities versus “other” categories of activities.
Monitoring and Enforcement
It is anticipated that Health Canada will begin observing this refreshed guidance document in Spring 2019. These updates follow Health Canada’s December 2018 launch of proactive monitoring of health product advertising. A dedicated compliance and enforcement team was created within the agency to evaluate multiple media and communication formats pertaining to Canadian health product advertising. This includes television, newspapers, digital and online media (including social), medical journals, Continuing Medical Education (CME) materials, HCP survey data and the U.S. Bad Ad Program. Similar regulatory monitoring and enforcement teams for OLAs are anticipated.
With this increased scrutiny, the threshold to demonstrate compliance around OLAs has risen sharply. It is expected that tighter regulatory constraints will arise as government agencies seek to crack down on bad actors; their initial focus being on the opioid epidemic. However, it is reasonable to anticipate a broader scope given the increasing volume and reliance by manufacturers on these activities.
With the potential for some OLA activities to be classified as promotional, manufacturers of drugs and pharmaceutical devices need to consider how to improve compliance controls. This requires more than a simple technological patch to keep ahead of the new rules. Organizations need to shift their approach, so compliance is integrated throughout the process (around a company’s entire organizational structure) rather than being treated as an add-on or peripheral component (or siloed).
Managing this will require a comprehensive plan, deep understanding of the end goal, and the dedication of knowledgeable resources. The complexity, frequency and recurrent nature of OLAs makes the risks to be mitigated numerous and far-reaching in scope. Canadian pharma compliance professionals need to be confident that their current systems cover areas such as:
- Transparency of speaker payments for eventual reporting
- Restrictions on excessive value of company-provided meals and extravagant venues
- Annual needs assessment and program planning
- Speaker nomination and contracting
- Confirmation honoraria for cancelled programs
- On-label specialization of speakers and attendees
- Monitoring of speaker frequency, training, and presentation decks
Requirements apply both to prior and aftermarket authorization (which includes information communicated to the general public). Canadian pharma must simultaneously evaluate and integrate into its compliance infrastructure elements such as:
- Context of message
- Primary and secondary audiences
- Who delivers the message (provider)
- Who sponsors the message and how
- Influence of manufacturer on message content
- Content of the message
- Frequency of message delivery
For compliance to be successful, a “matrix of considerations” must be taken into account.
A rigorous analysis of your organization’s current situation and a clear roadmap to a fully connected and compliant system will allow you to continue delivering OLAs that will hold up under the scrutiny of the new guidelines.”
1Code of Ethical Practices, 2018. Innovative Medicines Canada. http://innovativemedicines.ca/wp-content/uploads/2018/06/Code-Formatted_Regular_EN-2.pdf
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