Authored By: David Kotler, Esq.
Will Hospitals and Teaching Institutions Take the Plunge Into Medical Cannabis?
In 2011 the California Medical Association, which represents over 40,000 doctors in that state, became the first doctors’ group to call for the full legalization of cannabis, endorsing treating with medical cannabis and regulating it for appropriate use by patients with qualifying health conditions.
Certainly, there are those that would question whether any health condition legitimately deserves the use of a Schedule I controlled substance such as medical cannabis, however much has moved forward in 6 years.
Recently, a group of more than 50 physicians, including Jocelyn Elders M.D., a former Surgeon General of the United States, formed Doctors for Cannabis Regulation, a group which supports the legalization of cannabis.
While the American Medical Association has not endorsed state based medical cannabis programs or the legalization of cannabis, there has been a softening in regard to the belief that cannabis research be expedited and the status of cannabis (“marijuana”) as a Federal Schedule I controlled substance be reviewed. DEA decision on re-scheduling of marijuana is slated for this summer.
The tide continues to swell. A survey recently released by NORC Center for Public Affairs Research, found that a record high percentage of Americans – 61% – support cannabis legalization. Other polls have shown even higher numbers when addressing medical cannabis. A June 6, 2016 Quinnipiac poll showed 89.9 percent of voters polled approve medical cannabis recommended by a doctor.
Of all of the states which have now in some form or another legalized cannabis for medical or recreational use, Pennsylvania has taken the most aggressive approach to the involvement of hospitals and teaching institutions. If the walls in the Capitol Building in Harrisburg had ears, they would tell you that Jefferson University Medical School lobbied particularly hard for what ended up being codified in their new law establishing a medical marijuana program for patients affected by qualifying conditions.
Pennsylvania’s medical marijuana law provides for two separate research programs, the first to be conducted by the Pennsylvania Department of Health in partnerships with established and approved vertically integrated health care systems, and the second conducted by accredited medical schools which have established contractual partnerships with vertically integrated Medical Marijuana Organizations.
The Department of Health’s research program is required to study the impact of medical marijuana in the treatment and symptom management of serious medical conditions and conduct a study with a vertically integrated health system.
A vertically integrated health system is one which is licensed under Pennsylvania’s Health Care Facilities Act and one in which the complete spectrum of care, including primary and specialty care, hospitalization and pharmaceutical care, is provided within a single organization.
Under the law, the Department would review all serious medical conditions which are cited by a practitioner upon a practitioner’s certification that the patient be granted an identification card and, in turn, create a database of all serious medical conditions, including comorbidities, which are cited by practitioners in the certification of patients.
Once the database contains over 25 patients with the same serious medical condition, the law specifies that the Department petition the United States Food and Drug Administration and the United States Drug Enforcement Administration for approval under the program, The purpose, as petitioned to the Federal agencies is to study the effectiveness of treatment of specific serious medical conditions with patients who have agreed to participate in the research project. Those patients would be entitled to obtain their medical marijuana at no cost.
At the current time, this particular provision presents a bit of a problem based on the current policy positions taken by the FDA and DEA, but the framework is certainly set up in anticipation of potential future changes in federal policy to allow it.
The second research program established under the law is believed to be a first of its kind, and actually sets up a separate licensing scheme for what are termed “Academic Clinical Research Centers”. Under the law, an Academic Clinical Research Center is an accredited medical school within the State of Pennsylvania that operates or partners with an acute care hospital licensed within the state.
The process is then set forth by which an Academic Clinical Research Center partners with an entity that holds a permit as both a grower/processor and a dispensary to conduct research studies and, most importantly, the research is to be funded by the Department. The framework of this section allows for 8 separate licenses to be awarded with up to 6 dispensing sites per license, notwithstanding the caps on other licenses under the act. This process has the potential to create the largest state funded investigational research program of its kind in regard to medical cannabis.
Utilizing the framework set up by Pennsylvania’s medical marijuana law, Jefferson University very recently formed what some are calling the first center of its kind: “The Center for Medical Cannabis Educational Research”, which is part of the Institute for Emerging Health Professions. Its stated goal is to provide guidance to clinicians and patients about cannabinoid focused therapies. It is anticipated that the CMCR will offer courses to medical professionals who wish to become legally certified to recommend cannabis to patients, as well as to facilitate the research component allowed by the law.
With Pennsylvania’s aggressive approach as a backdrop, we can look at the baby steps that Florida has taken in implementation of the Compassionate Medical Cannabis Act of 2014. It may be found in Florida Statute Section 1004.441 which was created to address research of refractory and intractable epilepsy.
In particular, Subsection 2 reads “Notwithstanding Chapter 893, state universities with both medical and agricultural research programs, including those that have satellite campuses or research agreements with other similar institutions, may conduct research on cannabidiol and low THC cannabis. This research may include, but is not limited to, the agricultural development, production, clinical research, the use of medical derivatives of cannabidiol and low THC cannabis for the treatment of refractory or intractable epilepsy.” Section 7 of the Compassionate Medical Cannabis act of 2014 set aside $1 million non-recurring general revenue to the Department of Health to be deposited into the bio-medical research trust fund and reserved for research of cannabidiol and its effect on intractable childhood epilepsy. In awarding funding, a research university within the state that has obtained approval from the FDA for exploratory investigational new drug studies relating to cannabidiol and its effect on intractable childhood epilepsy may submit application.
As Florida moves toward November and the potential passage of Amendment 2 and its implementation, physicians, hospitals and medical teaching facilities may want to consider whether to lobby for Florida to follow the progressive approach to clinical research taken by states such as Pennsylvania rather than maintain the approach taken in the past 80 years in the United States and potentially allow others who are not similarly situated to drive the dialogue, research, and patient treatment with respect to the future use of medical cannabis in the treatment of various medical conditions.
David Kotler, Esq., a former Miami Dade County Assistant State Attorney, is a partner in Cohen Kotler P.A., located in southeast Florida. In 2014, Mr. Kotler formed a practice area in Cannabis-related law which allows him to draw from all of his practice areas to benefit his clients.