Pennsylvania is moving forward with its intent to bring medical schools and university health systems into its burgeoning medical marijuana industry. The state had included a research partnership component in its initial 2016 law legalizing medical cannabis, but only on March 16 did the Department of Health release the actual legal language behind this idea (known as “Chapter 20”).
Pennsylvania was the first state to include medical research partnership provisions in its medical marijuana program. Other states, like Colorado, have provided grant funding for research through certain public agencies (like the Colorado Department of Health and Environment).
“It was a very interesting solution to the problem, which was that they wanted to have evidence-based, science-based clinic research being done by the best research facilities, but at the time … the research facilities were concerned about triggering federal regulatory review,” Daniel Clearfield, regulatory attorney at Eckert Seamans, tells Cannabis Business Times.
Up to eight medical schools in the state will partner with growers/processors in Pennsylvania that must earn “clinical registrant” licensure from the state’s Department of Health (DOH). (In Pennsylvania, cultivation and processing licenses are issued in tandem.)
Per the regulations, medical staff from partner schools will lend expertise and resources to ensure that those registrants are performing the highest-quality research into medical marijuana. In legal parlance, those schools are known as Academic Clinical Research Centers (ACRCs); they include, for instance, the University of Pennsylvania, the University of Pittsburgh Medical Center and Lake Erie College of Osteopathic Medicine.
(Cannabis Business Times has left a message seeking comment from Laurel Harvest Labs, which has signed a partnership with Temple University.)
Because the ACRC will be merely looking over the shoulder of clinical registrants performing the actual research and are not directly involved with the studies, formal DEA approval is not needed.
Both the school