Pennsylvania medical schools respond to suit aimed at derailing medical marijuana research program

On March 17, the Pennsylvania Department of Health published new temporary regulations that will expand patient access to pharmaceutical-grade medical cannabis and greatly enhance the commonwealth’s nascent medical marijuana program. Under the new regulations, the department will allow certain medical marijuana organizations to partner with Pennsylvania medical schools to conduct research regarding the use of medical marijuana to treat specific medical conditions.

The authority for the regulations comes from Chapter 20 of the Medical Marijuana Act. That chapter creates two types of new entities: academic clinical research centers, or ACRCs, and clinical registrants, or CRs. An ACRC is defined as an accredited medical school within the commonwealth that operates or partners with a licensed acute care hospital. Presently, there are nine Pennsylvania medical schools that fit this definition.

Through these collaborations, medical marijuana organizations will be able to work directly with the Commonwealth’s leading medical institutions to study specific cannabis formulations and develop products to treat Pennsylvania patients. The new program is unique to Pennsylvania and represents a significant step forward that could make the commonwealth a national research hub for medical cannabis.

Despite the clear authority in Chapter 20 to create the program, and the anticipated benefits of the research collaborations with the Pennsylvania medical schools, on April 11, 2018, six existing Pennsylvania medical marijuana growers and nine dispensary owners filed a legal challenge to the medical research program on the grounds that it would “flood the market with medical marijuana” and undercut their businesses. In short, the coalition of growers and dispensaries is asking a judge to nullify the state-authorized research program before it gets off the ground. 

To date, several of the Commonwealth’s medical schools have already contracted with cannabis companies seeking to conduct research into the safety and efficacy of medical cannabis as a treatment for specific conditions. On April 24 a group of Pennsylvania medical schools, including the University of Pennsylvania and Thomas Jefferson University, filed an amicus brief with the court arguing the potential harm to public health in delaying research far outweighs the individual commercial interests of marijuana growers and dispensaries who seek to block implementation of the research program.

Specifically, the medical schools note that regulations implementing Chapter 20 were intended to be released shortly after the regulations governing the commercial permitting process, which were published in late 2016. However, trade organizations that represent commercial growers and dispensaries – including the Pennsylvania Cannabis Coalition – have continued to raise roadblocks, substantially delaying the regulatory process. 

The medical schools conclude that “[a]ny delay – even what Petitioners insist is merely a ‘short wait’ – imposes substantial harm on those members of the public who suffer from serious medical conditions and on their families and loved ones. Petitioners’ pecuniary interests should not be permitted to take precedence over the public health needs of the Commonwealth and its citizens.”

A hearing on the commercial growers and dispensaries request to halt the implementation of Chapter 20 is scheduled for May 2 in Harrisburg, Pa.

The Regulated Substances Blog is intended to keep readers current on developments regarding medical cannabis legalization and regulation and is not intended to be legal advice. If you have any questions, please contact the author, Peter Murphy, at pmurphy@eckertseamans.com, or contact Dan Clearfield at dclearfield@eckertseamans.com or any other member of our Regulated Substances Group.

 

Share This Post

Author

Peter S. Murphy

Member - Wilmington