State issues new medical marijuana research regs
State regulators issued new rules for medical marijuana research after a court blocked earlier guidelines that would have allowed entities to sell cannabis without obtaining the same permits as other companies in the state.
Prepared by the Department of Health, the rules codify how academic medical schools can work with commercial partners to research medical marijuana.
The original guidelines were upended in May after a group of 11 plaintiffs holding permits to grow and sell medical marijuana commercially filed a lawsuit arguing that the original research regulations gave special privileges to the commercial partners of the medical schools, known as clinical registrants.
But the revised regulations, which were rolled out on Aug. 17, seemed just as bad to at least one person involved in the original lawsuit.
"We saw these regulations as just solidifying the errors we thought existed in the first one," said Judith Cassel who works at Harrisburg law firm Hawke McKeon & Sniscak LLP. She represented plaintiffs in the original lawsuit.
Officials from the Department of Health insisted that the research part of the medical marijuana program will help make Pennsylvania a national leader in studying ways to use medical marijuana.
In a statement, Secretary of Health Dr. Rachel Levine said: "By establishing this part of the program, we will be able to help shape future treatment for patients, not only in Pennsylvania, but nationwide."
Cassel's objections center on the process for approving clinical registrants and the potential for conflicts of interest.
Under the revised rules, Cassel said, clinical registrants still do not have to go through the same permitting process as other companies approved to sell and grow medical marijuana in Pennsylvania.
"You don’t have to go through a competitive process. In fact, if you went through it and failed, you can still get a permit," she said. All a clinical registrant needs, she added, is a contract with a medical school approved to conduct research.
"And God knows how you got that contract with the teaching university because that’s not made public," Cassel said.
Cassel also was concerned that firms acting as research partners would have a commercial incentive, potentially tarnishing the research in which they take part.
"You’ll be trying to see what adverse effects medical marijuana might have or what conditions medical marijuana fails to treat. Are you going to be a proponent of those results if your bottom line is based on sales?” Cassel said, noting the rules do not specify how conflicts can be avoided.
The clinical registrants, known as CRs, will partner with eight state-approved academic clinical research centers including Penn State Milton S. Hershey Medical Center and College of Medicine, to grow and sell marijuana commercially while also researching it.
She also criticized how the revised rules treat potential donations made by CRs to the nonprofit research centers. CRs are barred from making donations unless they have a history of giving to a particular entity.
"What does that mean?" Cassel said.
The regulations say the history of a CR giving to a certified teaching hospital must have been established at least one year before June 22, 2018 - the effective date of Act 43, a law passed to resolve concerns raised in the lawsuit.
Officials from the Department of Health said they strongly disagreed with Cassel's take.
"The department is committed to ensuring that the permitting process is fair and transparent, and any suggestion of pay-to-play is an offense to this medical program aimed at helping people suffering from serious medical conditions," department officials said.
Cassel said she and her clients are looking at all legal options including determining whether the revised regulations comply with Act 43, as well as other ways the regulations or the legislation may violate constitutional provisions.
More than 60,000 patients in Pennsylvania have registered to participate in the medical marijuana program, nearly 38,000 of whom have received their identification cards and are able to purchase medical marijuana at a dispensary. Approximately 1,200 physicians have registered for the program, nearly 750 of whom have been approved as practitioners.
The medical marijuana program was signed into law by Gov. Tom Wolf in April 2016. Wolf announced in May of this year the eight universities certified as academic clinical research centers.