Authored By: William F. McDevitt, Esq.
On March 17, 2018, the Pennsylvania Department of Health (DOH) issued temporary regulations for clinical registrants and academic research centers, referred to as “Chapter 20 Temporary Regulations.”
Chapter 20 of Pennsylvania’s 2016 Medical Marijuana Act (MMA) allows up to eight “clinical registrants” to hold “integrated” licenses, meaning the entities can act as both grower/processors and dispensaries. Clinical registrants also must have a contract with an “academic research center,” defined as “an accredited medical school within the Commonwealth that operates or partners with an acute care hospital licensed within the Commonwealth.” Clinical registrants may operate up to six dispensaries and participate in Commonwealth-approved research studies in conjunction with other licensed clinical registrants.
The inclusion of Chapter 20 in the MMA advances the Commonwealth’s goal of clinically studying the uses of cannabis as a medical treatment. While the MMA requires the DOH to study the efficacy of medical marijuana, Chapter 20 allows the private sector to identify and develop effective cannabinoid treatments.
The Chapter 20 Temporary Regulations clarify clinical registrant operations under the MMA:
- Grower/processors and dispensaries may apply to surrender their current licenses to convert their organizations into integrated clinical registrants. If approved for conversion, the surrendered licenses will become publicly available. Presently, two companies, Chesco Yeltrah and Illera Healthcare, LLC, are known to hold both grower/processor and dispensary permits. This means that up to 4 additional permits (2 grower/processors and 2 dispensaries) may be available in the future. At this time, however, the DOH has not issued surrender/conversion application forms and no companies have indicated their intention to seek integrated licenses (either separately or as co-venturers). DOH has not indicated whether it would make surrendered licenses immediately available or hold them as part of a separate process.
- The Temporary Regulations appear to allow clinical registrants to dispense cannabis outside of clinical research studies. Regulation 1210.33 requires clinical registrants to operate the same electronic data system tracking as non-clinical entities, but they also must identify patients that are enrolled in approved research projects. Arguably, this implies that clinical registrants also may dispense to approved patients who are not part of a research study.
- Regulation 1210.36 permits clinical registrants to sell or exchange marijuana products, seeds and plants to other licensed grower/processors to advance research studies or for any other purpose.
- Regulation 1210.36 also permits clinical registrants to apply to the DOH for leave to distribute marijuana products to other licensed dispensaries. Cross-dispensary application forms have not been published and the criteria for allowing cross-dispensing are not known.
- While clinical registrants are able to operate twice the number of dispensaries as non-clinical entities (6 instead of 3), they may not operate more than 3 dispensaries in the same MMA region and not more than 3 in the same county. All dispensary locations must be approved by the DOH.
On March 22, 2018, the DOH announced that applications for the remaining statutory licenses (13 grower/processors and 23 dispensaries) will be accepted between April 5 and May 17, 2018. It is anticipated that clinical registrant, grower/processor and dispensary applications will be distributed. It remains to be seen whether any licensed entities will seek complementary licenses that would allow them to apply for clinical registrant status.
The release of the Chapter 20 Temporary Regulations provides an exciting opportunity to advance medical marijuana treatment in the Commonwealth. It will be up to the Commonwealth’s medical schools, acute care treatment centers and licensed marijuana entities to take advantage of clinical registrant status.
About the Author
William F. McDevitt is a partner in the Philadelphia office of national law firm Wilson Elser, where he is a member of the firm’s Cannabis Law practice. He can be reached at email@example.com.