By David Landau
On Friday June 22nd, Pennsylvania Governor Tom Wolf signed into law a bill allowing Pennsylvania’s Medical Marijuana clinical research program to proceed. A Pennsylvania court a short while ago enjoined the program.
Chapter 20 of Pennsylvania Medical Marijuana Law provided for a first-in-the-nation, state sanctioned clinical research program. Under the law as originally enacted, Academic Clinical Research Centers (ACRC)— medical schools that are partnered with acute care hospitals – would affiliate with a potential grower/processor and dispensary operator to conduct clinical research. After certification from the State as an ACRC, The ACRC would select a partner and the affiliated grower and dispensary operator would separately apply for licenses. The State would not regulate the selection by the ACRC of a grower and dispensary operator, but the grower and dispensary operator would otherwise have to be qualified to obtain a Pennsylvania license to operate. Unlike the initial round of licenses awarded in Pennsylvania, these clinical research licenses would not be awarded by a competitive process. The choice of the operator would be solely in the discretion of the ACRC and if otherwise qualified to operate, it would be awarded a license and have the ability to open six dispensaries. Current licenses are only allowed three dispensaries. Each dispensary under Chapter 20 however must have an ongoing clinical research study to remain open.
Existing licensees sued the State claiming, among other things, that the Department of Health improperly delegated the State’s authority to regulate the medical marijuana industry to the ACRCs because the potential operators with would not be subject to a competitive award process. They obtained a preliminary injunction from a Pennsylvania court and the medical marijuana research program grounded to a halt.
With surprising speed, the State Legislature moved to address the issues raised by the lawsuit and swiftly passed a bill clarifying that the State could proceed as it had been doing. New regulations will have to be issued, but can be issued under an expedited process under the new law. The clinical research license process in PA should be underway shortly.