By: William F. McDevitt, Esq.
Wilson Elser
Pennsylvania’s medical marijuana program contains a unique focus on research and monitoring. Chapter 19 of the Medical Marijuana Act (MMA) requires the establishment of a research program “to study the impact of medical marijuana on the treatment and symptom management of serious medical conditions.” The Department of Health (DOH) must establish a database of serious conditions, identify groups of patients with the same diagnosed conditions, apply to the United States Food and Drug Administration (FDA) for approval to study the application of marijuana to identified medical conditions, publish notice of any FDA-approved studies to be conducted and select a “vertically integrated health system” to conduct these studies.
The MMA also provides for up to eight “clinical registrants,” defined as an entity that has a contractual relationship with an accredited medical school (which must be associated with an acute care hospital) that holds separate licenses to grow/process and dispense medical marijuana. Unlike standard dispensaries, which are permitted to operate three locations per license, a clinical registrant can distribute medical marijuana at up to eight locations. Clinical registrants are required to conform to all of the requirements and obligations of both growers and processors, while maintaining a greater amount of capital − $15 million for clinical registrants, compared with $2 million for a grower/processor and $.15 million for a dispensary.
As of November 29, 2017, DOH has not issued regulations for clinical registrants. Draft regulations have been circulated but are not yet published in the Pennsylvania Bulletin. As presently conceived, the proposed regulations reference a clinical registrant’s ability to dispense medical marijuana generally, but also contain contradictory provisions limiting distribution to the participants of DOH-approved research studies. It is unlikely that the draft regulations will be submitted for public review until it is determined whether clinical registrants will be allowed to dispense products outside of established research studies.
If clinical registrants are limited to operating solely as research bodies, then they must effectively “publish or perish” to maintain their grower/processor and dispensary licenses. Under that model, clinical registrants will be required to maintain a steady stream of research projects.
Interestingly, MMA’s Chapter 19 research program specifically excludes participation by clinical registrants so they cannot depend on the mandatory research studies awarded by the DOH.
Despite the federal government’s limitation on clinical studies of marijuana, DOH is statutorily required to conduct research studies on the “impact” of medical marijuana and is poised to mandate, by regulation, continuing research activities by any clinical registrant that wishes to maintain dual grow/process and dispensary licenses. This commitment to research generally will benefit medical marijuana research and provide a continuing source of funding to Pennsylvania’s medical research facilities.
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 protected].
