Authored By: William F. McDevitt, Esq.
Pennsylvania wants upcoming innovators in the medical marijuana and commercial hemp industries to locate in the Commonwealth. To that end, Pennsylvania is encouraging universities and medical schools to participate in product development associated with cannabis. Ten educational institutions in Pennsylvania have answered that call and are in the process of developing programs to advance marijuana research.
On May 14, 2018, eight Pennsylvania medical schools were recognized as “academic clinical research centers” (ACRCs) under Chapter 20 of the Medical Marijuana Act (MMA):
- Drexel University College of Medicine, Philadelphia
- Lake Erie College of Osteopathic Medicine, Erie
- Penn State College of Medicine, Hershey
- Philadelphia College of Osteopathic Medicine, Philadelphia
- Temple University, Lewis Katz School of Medicine, Philadelphia
- Thomas Jefferson University, Sidney Kimmel Medical College, Philadelphia
- University of Pennsylvania, Perelman School of Medicine, Philadelphia
- University of Pittsburgh School of Medicine, Pittsburgh.
ACRCs are permitted to contract with “clinical registrants” (CRs), entities that will possess grower/processor licenses, licenses to operate up to six dispensaries and other privileges (including distribution of plants and seeds between CRs and other licensed grower/processors and the ability to sell products from other grower/processors).
No CR licenses have been awarded; applications may be submitted through July 12, 2018. It is believed that the eight medical schools already have contracted with companies that are applying for licenses.
The anticipated distribution of CR licenses has been challenged by four of the five companies that received both grower/processor and dispensary licenses last year. Those companies, with other entities, have filed a lawsuit in Commonwealth Court seeking to overturn the regulations relating to CRs. The current dual-license holders argue that the Chapter 20 regulations afford CRs greater privileges than other licensees, while also allowing them to compete commercially. The companies also contend that they are able to provide medical schools with research support.
Several medical schools filed a joint amicus curie (friend of court) brief, arguing that they have to maintain rigorous standards to reliably produce quality research. The medical schools seek to contract with entities other than those currently producing and dispensing medical cannabis commercially.
The Commonwealth Court suit remains pending.
Separate from its anticipated work as an ACRC, Thomas Jefferson University is working with Lehigh University and the nonprofit Hemp Industry Council to establish a Center for Excellence (CFE) to conduct research on industrial hemp. Under the 2014 Farm Bill and Pennsylvania’s 2016 Hemp Research Act, growers can obtain permits to grow hemp, a variety of cannabis that under the law must contain less than 0.3 percent of the psychoactive chemical tetrahydrocannabinol (THC). Private growers can grow a limited amount of hemp – the 2018 limit is 100 acres each. Growers that contract with universities can grow larger amounts and the universities can aggregate their yield.
The proposed CFE seeks to establish a “research supply chain” to explore commercial-scale processing and product development. Hemp has not been commercially produced in the United States for 70 years. Harvesting hemp requires specialized machinery, most notably decorticators, which separate the outer “bast” (fibers) from the inner “hurd” (pulp). Similarly, processing hemp fibers and pulp is different from processing cotton or wood. Other countries that currently manufacture and export hemp products have modern machinery and operational experience that must now be developed here if the United States is to remain competitive in the industry.
The CFE seeks to grow, process and then convert hemp fiber and wood into usable, profitable forms. Charles Pollack, M.D., Director of the Thomas Jefferson University Institute for Emerging Professionals, says that hemp bandages may be more absorbent and possess antibacterial properties. Hemp fibers and pulp have potential uses in packaging, sneakers, furniture, automobile upholstery and a host of other products. In addition, hemp seed and oil have potential uses as a food source or for medicinal purposes.
The Commonwealth is actively encouraging its universities and medical schools to explore and innovate within the cannabis industry in hopes of creating jobs and commercial opportunities. Several universities are developing programs and facilities to help Pennsylvania become an industry leader.
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 firstname.lastname@example.org.