On June 22, 2018 Governor Wolf signed HB 2477 (“Amendment”) into law breathing new life into Chapter 20 of the Medical Marijuana Act (“Act”), the country’s first-of-its-kind law for cannabis research. This follows Commonwealth Court Judge Patricia McCullough’s May 22, 2018 issuance of a preliminary injunction halting the Department of Health’s (“DOH”) implementation of the Act’s Chapter 20 regulations. Chapter 20 of the Act governs the registration and operation of clinical registrants, the certification of academic clinical research centers (“ACRC”), and partnerships between clinical registrants and ACRCs for research purposes. A clinical registrant is a grower/processor and dispensary that will have a contractual relationship with an ACRC. An ACRC is an accredited medical school in the Commonwealth of Pennsylvania that “operates or partners with an acute care hospital licensed within this Commonwealth.” As of May this year, DOH had already certified eight medical schools as ACRCs under the Act. Continue reading…
DOH
Yesterday the Department of Health (DOH) released the much anticipated proposed temporary regulations for physicians that among other items, set forth requirements regarding: the physician registry, the completion by physicians of a four-hour training course, and issuing patient certifications, as well as prohibitions, including for example, a prohibition against advertising a physician’s ability to prescribe cannabis under the Pennsylvania Medical Marijuana Act (Act 16). As the proposed regulations are not yet effective, DOH will accept comments on them until April 20, 2017. More information about these draft regulations appears on the DOH website, and they are available here.
On August 18, 2016, the Secretary of Pennsylvania’s Department of Health (“DOH”), Dr. Karen Murphy, announced that the DOH has posted draft temporary regulations (“Regulations”) focusing on the 25 medical marijuana grower/processor permits that will become available under Pennsylvania’s Medical Marijuana Act (“Act”) that was passed last April.
The Regulations state the general application requirements for medical marijuana organizations, which requirements include detailed information about principals and financial backers of such organizations. Medical marijuana organizations include not just grower/processors, but also clinical registrants and dispensaries. The application requirements also contain a clear commitment to foster diversity. The Regulations establish procedures for promoting and ensuring that medical organizations foster diversity through participation of diverse groups in all aspects of the medical organization’s operations. This includes but is not limited to requiring each organization to have a diversity plan. Diverse groups are defined under the Regulations as “disadvantaged business[es], minority-owned business[es], women-owned business[es], service-disabled veteran-owned small business[es] or veteran-owned small business[es] that ha[ve] been certified by a third-party certifying organization.”
The Regulations also contain specific requirements for grower/processor permits. Application forms for permits will be posted on the DOH website in the future. Among the requirements is that a grower/processor notify DOH within six months of being issued an initial permit that it is ready, willing and able to begin production.
The Regulations prohibit executive level employees of the Commonwealth and their immediate family members from being employed by or holding an interest in medical marijuana organizations while employed by the Commonwealth and for one year thereafter.
The Regulations are not final and are open for public comment until August 26, 2016.
Although Pennsylvania joins 23 other states and the District of Columbia to legalize medical marijuana, marijuana is still classified as a Schedule I controlled substance by the U.S. Drug Enforcement Agency, and as such it remains a crime under federal law to grow, sell and/or use marijuana. Any content contained herein is not intended to provide legal advice in connection with the violation of any state or federal law. Although the Act provides for the legalization of medical marijuana in the Commonwealth of Pennsylvania, one should obtain legal advice with respect to any such compliance issues.
Stay tuned for details regarding an upcoming Cozen O’Connor webinar on these Regulations.
For more information about the Regulations or the Act, contact Chris Raphaely, J. Nicole Martin or another member of Cozen O’Connor’s Cannabis Industry Team.
On April 17, 2016, Governor Wolf signed Act 16 of 2016, making Pennsylvania the 24th state (plus the District of Columbia) to legalize marijuana for medical use. The full text of the act is available here.
Physicians, not surprisingly, will play a vital role in making medical marijuana available to Pennsylvanians, while ensuring patient safety in the process. This is what they should know about Act 16: Continue reading…