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Lawsuit questions supply

Med. marijuana research at heart of issue

Medical marijuana companies from across the state are once again taking up the fight against the state's method of handling cannabis supply for research purposes.

A court injunction over a lawsuit earlier this year paused the state's medical marijuana research program, but progress continued after the legislature amended a bill and passed new regulations over the summer. Now, a group of dispensaries have filed a similar suit against the state, citing their concern that there's still a lack of focus on medical marijuana research.

In May, 12 medical marijuana companies in the state — including Cresco Yeltrah, which has a dispensary in Butler County and a grower-processor facility in Jefferson County — filed a suit against the state, arguing that chapter 20 of the state's Medical Marijuana Act regulating academic clinical research centers and its suppliers would be undermined by commercial interests, with suppliers pursuing profit over research. A commonwealth court judge agreed and issued the injunction. In response, the state passed medical marijuana laws that limit the commercial incentive, allowing the health department to resume reviewing permits for medical marijuana growers and dispensaries to supply the eight medical schools that were approved in May to operate as academic clinical research centers. Included in the list of certified universities were the University of Pittsburgh School of Medicine and Lake Erie College of Osteopathic Medicine.

But Judith Cassel, a Harrisburg-based attorney representing the group of phase I and Phase II permittee winners bringing the suit, said that the state's amendments and temporary regulations have done nothing to address what she said are the two biggest issues raised in the original lawsuit.

“I like to say it's a wolf in sheep's clothing,” said Cassel, who was also involved in the original suit. “It gives lip service to research and it allows the CRs to sell in the commercial market. We think the process should be open and transparent. The best of the best should be chosen and research should be the focal point of chapter 20.

She continued, “Research helps everybody in the area ... It's going to help my clients, patients and health care professionals. We don't want the opportunity for real research to pass by a lot of the CRs.”

The group has dubbed itself the Medical Marijuana Advocates for Research and the companies behind the suit haven't identified themselves in this latest filing, citing a fear of retribution from the state's health department, according to Cassel.

Originally, the plan, which administration officials announced in March, called for the certification of medical marijuana research centers throughout the state. Officials outlined a process by which medical schools could seek approval to conduct research, and on May 14 Gov. Tom Wolf announced the certification of eight Medical Marijuana Academic Clinical Research Centers. But these research centers need a supply of marijuana and the state's plan addressed this by creating designated suppliers, known as “clinical registrants.”

That's the aspect of the plan to which members of the state's marijuana industry objected in court in May, arguing that officials effectively rewrote regulations governing how licenses for growing and dispensing medical marijuana were awarded, months after the firms sunk “tens of millions of dollars” into securing licenses for themselves through a competitive application process that drew hundreds of applicants. The refiling attempts to address the same issues.

Current rules still allow an approved medical marijuana supplier, or “clinical registrant,” to sell to a state-registered patient “regardless of whether the patient is a participant in a research study.”

In October, the state announced that it would accept applications until Nov. 8 for “entities” to register as clinical registrants from current or hopeful commercial growers and dispensaries.

In the announcement, the department instructs that all applicants seeking the clinical registrant status include a “research contract” with one of the research centers and that the applicant must be a current commercial permit holder or applying for a commercial grower or dispensary permit.

The statement also boasted of the state's mission to push research.

“The clinical registrants will work hand-in-hand with the eight certified medical schools to conduct groundbreaking medical marijuana research,” Secretary of Health Dr. Rachel Levine wrote in the statement. “Together, these entities will come together to research the effect medical marijuana use may have on some of the most severe medical issues of our time. These studies have the potential to help cancer patients, veterans and individuals who are struggling with opioid use disorder.”

A spokesman for the state's health department said the applications are currently being reviewed and that there will be an announcement later this month with the department's selections.

In an email, spokesman Nate Wardle wrote that the department wouldn't comment on ongoing litigation, adding, “However, the governor and bipartisan members of the general assembly are united in their support for chapter 20 of the medical marijuana program. Pennsylvanians should rest assured that, one way or another, our efforts to allow for research into epilepsy, cancer, autism and a whole host of other serious conditions suffered by children throughout the commonwealth will prevail.”

The announcement for applications was the first big step taken by the state in choosing clinical registrants after the group Cassel represented brought forward the original lawsuit in May.

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