Navigating a Complex Regulatory Landscape


North Highland helped a state Department of Health efficiently design and deploy a comprehensive medical marijuana program. Given the sensitivity of the initiative, the project team’s ongoing emphasis on transparency around key program initiatives, dates, and milestones helped to minimize program noise, as well as ensure efficient implementation and stakeholder alignment.

A Public Sector Case Study

Client Situation

The client, a state Department of Health (DOH), was preparing to implement a medical marijuana program following the passage of state legislation that permitted the use of medical marijuana by patients being treated for serious medical conditions. The new legislation posed several challenges. First, a new statute mandated that the program be fully functional on an accelerated, oneyear timeline. In addition, the state also had one of the most restrictive and demanding medical marijuana laws in the country.

The client engaged North Highland to help design, lead, and execute a medical marijuana program, as well as align internal and external stakeholders around key initiatives. Having expertise in regulatory engagements, North Highland was positioned to deliver a program both anchored in national best practices, and tailored to the state’s unique circumstances. Most importantly, the team had the expertise to deliver a program that would satisfy state regulations and navigate the complex federal issues associated with marijuana.

Our Approach

North Highland first focused on standing up the fundamental program framework, anchored in several key activities:

  • Rules development: The project team led the development of rules that detailed program execution across manufacturers, patients, and healthcare practitioners.
  • Manufacturer selection: North Highland drove the development and execution of the selection process in four phases, including application completeness, detailed application assessment, applicant presentations, and semi-finalist site visits. The process enabled an efficient, comprehensive evaluation and selection process for medical marijuana growers, manufacturers, and dispensers.
  • Patient and practitioner registration: The project team designed and implemented the processes, tools, and communications around patient and healthcare practitioner registration.
  • IT functionality: North Highland led the program through the requirements gathering and design of the IT solution, which both collected data from manufacturers (point of sale data) and registered patients, healthcare practitioners, and caregivers in a single system.

The project team then designed the program's downstream components. These areas are often overlooked in state medical marijuana implementations, but are key to sustainable capabilities.

First, North Highland developed a selection and approval process for laboratories testing medical marijuana products, and set potency, purity, and stability testing standards. In addition, the team developed a multi-channel communications plan to educate public safety officials, physicians, and the public about the program; a compliance program to audit growers and dispensaries; as well as a customer service operation for patients and physicians.

North Highland’s project strategy incorporated best practices and critical learnings from prior regulatory engagements, in addition to those within private industry.

Value Delivered

Because of North Highland's approach and partnership with the state team, the program enjoyed a protest-free selection process. In addition, those observing the implementation applauded its rigor and efficiency. With sound, strategic registration processes in place, the state registered manufacturers (growers, processors and dispensers) in one-third the time of any previous state, while also adhering to the law's application and selection standards.

In totality, the program launched on-time, and today has over 10,000 patients, doctors, and caregivers registered. In addition, the program website has generated an average of 18,000-20,000 views per month. Throughout the initiative, North Highland’s focus on human engagement helped to embed sustainable program capabilities. The project team trained and developed the client’s employees on registry functions, program policies, regulatory oversight, and communication methods to ensure program success through ongoing stakeholder alignment.

Most importantly, by being clear and transparent about key milestones and meeting deadlines, the program established credibility with public safety, physicians, and the public. North Highland has since emerged as a national leader in medical marijuana program implementation, and several other states have engaged the firm for similar initiatives. The team continues to bring project management, best practice research, and subject matter expertise to help clients navigate a largely uncharted regulatory landscape.


Download

Need an Expert to speak at your next event?