Medical Marijuana Program Lessons Learned: Compliance Program Design (Part Four)

Transformation

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August 1, 2019

Medical Marijuana is legal in 34 states and the District of Columbia, with legalization being considered in at least a half dozen other states. Despite the uptick in legalization, expertise within this nascent field remains scarce. Harnessing our experience leading five state medical marijuana programs, we’ve unpacked the actionable insights that other states can apply to their respective program journeys. In this article, we’ll share best practices in the design of compliance programs.

Legalization, program standup, and permitting tend to draw the most attention from the public. As a result, in the early days of most medical marijuana programs, the focus is on ensuring permits are awarded in short order, and that the medication is made available to the public. However, states cannot afford to overlook the establishment of the compliance function. A robust focus on compliance ensures the oversight of medical marijuana organizations for the purpose of enforcing adherence to the state’s rules and regulations to protect patient safety, and to create a fair and equitable environment for businesses to operate. In our experience, states cannot expect non-specialized staff to simply stretch to take on compliance roles as this will only lead to burnout and underperformance.

As a starting point, states should allocate budget for resources who are singularly focused on compliance with ongoing opportunities for learning and development. Beyond appropriate resourcing, we’ve identified other critical best practices for program compliance. All are grounded in providing uniform and consistent expectations for medical marijuana organizations and are enforced through standardized tools and processes by all those involved in enforcement, such as inspectors:

  • Tools and guidelines: Holding medical marijuana organizations to the same expectations, by ensuring they are hearing the same messages, is critical to a compliance program. Tools, including checklists and interpretive guidelines, will limit the amount of user variation to maintain consistent results. A failure to establish uniform tools and processes proactively have led medical marijuana organizations to receive varying messages about compliance.
  • Build a strong line of communication with medical marijuana organizations: Particularly in the first operational year of a state’s medical marijuana program, interpretations of the law produce norms that can have lasting impacts. Decisions and updates should be swiftly communicated to medical marijuana licensees, to ensure they’re aware and in compliance with regulatory changes. Open, clear, and timely communication will help to ensure uniform understanding of compliance expectations among the key players involved.
  • Adopt an external point of view: A robust compliance program looks externally to other states and internally to other departments for best practices. Navigating a relatively new industry, states can draw upon transferable skills and functions present in other agencies with compliance programs. For example, organizations can find relevant expertise in state departments of agriculture or pharmacy oversight boards, such as inspection, growing, and processing. Siloed programs are deemed to repeat the mistakes made by their peers in other departments and early adopting states. As the number of states implementing medical marijuana programs continues to grow, there will be further opportunities for inter-state collaboration on best practices, ranging from nuanced logistical questions to long-term strategic concerns.

Rounding out a successful medical marijuana program is a focus on compliance. Building upon a strong foundation of communications, systems, and permitting, compliance requires proactive resourcing, uniform tools, and a shared understanding of expectations and insights – both internally and externally.

Click here to read parts one, two, and three of our series.


This blog was co-authored by Jeff Smith

Jeff has over 20 years of experience across multiple industries including, public sector, medical device, healthcare, retail, financial services and manufacturing, assisting companies with the execution of program development, business process design, and system design and implementation. Specific areas of his expertise include program/project management, business architecture/analysis, business process design, cross-functional team leadership and facilitation, FDA compliance, and strategic planning.

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