United States: The New York Medical Psilocybin Legislation And Beyond

Intro

At the end of 2021, New York Assemblyman Pat Burke introduced Assembly Bill A08569 which related to the medical use of psilocybin. The legislation would establish psilocybin service centers to "provide innovative treatment options for ailments such as PTSD, depression, alcohol dependency, anxiety, among others," (New York State Assembly, 2021). The bill follows Oregon's recent psilocybin legalization, which is discussed in greater detail below. The bill's approach is similar to New York's Marijuana Regulation and Taxation Act, featuring varied license types and social equity provisions. While this bill is currently only proposed legislation, it serves as an example of what medical psilocybin may look like in the future for the Empire State.  

Psilocybin Background  

Psilocybin is the naturally-occurring psychoactive and hallucinogenic compound found within mushrooms of the genus Psilocybe, sometimes referred to as "magic mushrooms," (Hartney, 2021). Despite recorded human use of psilocybin dating back centuries, scientific studies on the substance's safety and potentially positive effects have only been conducted within the last two decades (Griffiths, Richards, McCann, & Jesse, 2006). Researchers at the Johns Hopkins Center for Psychedelic and Consciousness Research found that psilocybin was an effective treatment for depression and managing life-threatening cancer diagnoses. Studies have also found potential uses for psilocybin as a treatment for addiction and PTSD. Johns Hopkins is also further studying the effects of psilocybin in relation to general brain activity,  Alzheimer's Disease, and Anorexia. 

Assembly Bill A08569 License Types 

The proposed bill would establish a formal psilocybin program in New York, with the following license types: 

Psilocybin Service Center: a facility that registers with the department to assist one or more certified patients with the purchase, acquisition, possession, use or administration of medical psilocybin. 

Registered Organizations: a for-profit business entity or not-for-profit corporation organized for the purpose of acquiring, possessing, manufacturing, selling, delivering, transporting, distributing or dispensing psilocybin to psilocybin service centers for certified medical use. 

Psilocybin Research License: permits a licensee to produce, process, purchase and/or possess psilocybin for the following limited research purposes. 

• To test chemical potency and composition levels; 
• To conduct clinical investigations of psilocybin-derived drug products; 
• To conduct research on the efficacy and safety of administering psilocybin medically; and 
• To conduct genomic or agricultural research. 

Psilocybin Service Facilitator License: permits individuals to facilitate psilocybin administration sessions under the following requirements. 

• Have a high school diploma or equivalent education; 
• Any additional education or training requirements established by the department; 
• Any examination requirements established by the department; 
• Any other training, education, skill or fitness requirements adopted by the departments, such as: 

Certified Practitioner License: prior to issuing a certification a qualifying medical practitioner must complete, at a minimum, a two-hour course as determined by the department in regulation.  

Qualifying Medical Conditions 

If enacted, as with medical marijuana, psilocybin treatment would only be available to individuals with a qualifying medical condition. These are defined by Bill A08569 as one of the following: cancer, positive status for human immunodeficiency virus or acquired immune deficiency syndrome, amyotrophic lateral sclerosis, Parkinson's disease, multiple sclerosis, damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, epilepsy, inflammatory bowel disease, neuropathies, Huntington's disease, post-traumatic stress disorder, pain that degrades health and functional capability where the use of medical cannabis is an alternative to opioid use, substance use disorder, Alzheimer's, muscular dystrophy, dystonia, rheumatoid arthritis, autism or any other condition certified by the practitioner. 

Social Equity 

One of the factors to be considered by the state when determining whether to issue a license under the bill is "whether the psilocybin service center is a minority and/or women-owned business enterprise, a service-disabled veteran-owned business, or from communities disproportionally impacted by the enforcement of psilocybin prohibition." This seems to take after the MRTA's equity-focused approach, notably including women-owned businesses similar to the MRTA. 

The bill would also establish the Psilocybin Services Grant Program, a grant program to be established under section thirty-three hundred sixty-nine-qq of the public health law (as seen on page 23 of Bill A08569) for veterans and first responders to receive monetary assistance for psilocybin services pursuant to this title. The sum of two million dollars would be appropriated to the NYS Department of Health for the Psilocybin Services Grant Program. 

Stated Justification 

The bill provides the following as a "Justification" for its existence: 

"Struggles with diseases like PTSD, depression, anxiety, and alcoholism can be major disruptors to a person's livelihood as well as their family's. These mental health detriments can deteriorate physical health, result in performance deficits on tasks, and increase rates of suicide. Psilocybin therapy is a breakthrough avenue for providing people with treatment for these ailments. 

Certain occupations, particularly those that serve society by running into danger, have increased the prevalence of these health disruptors. Data from the RAND Corporation show that 8,000 New York veterans from the wars in Iraq and Afghanistan suffer from PTSD. Firefighters, police officers, and EMS workers have a higher prevalence of depression, PTSD, and substance abuse than the general population. 

The FDA recognizes psilocybin therapy as substantially better than present treatment options. Establishing a widespread route to provide New Yorkers with this medical treatment would be a monumental step in providing mental health care to improve lives. Oregon, Texas, and several cities have taken similar steps to increase access to psilocybin treatment. 

These therapy centers would offer a safe physical environment supervised by trained monitors to negate the minimal risk involved with psilocybin. Researchers at Johns Hopkins Medicine report that psilocybin shows low potential for abuse and can be classified as 'least harm to users and society.' 

Beyond enabling the creation of treatment centers, this legislation would also create a $2 million fund for veterans, firefighters, police officers, and EMS workers, who can apply for financial support towards treatment. Our first responders expose themselves to potential trauma on a daily basis to keep us safe and well. Ensuring their access to this treatment demonstrates our reciprocity to keep them safe and well." (New York State Assembly, 2021) 

Psilocybin Across the U.S.  

Psilocybin is currently illegal under U.S. federal law. It is classified as a Schedule I substance under the Controlled Substances Act, defined as having "a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision." However, as with cannabis (another federally illegal, Schedule I substance), states are free to enact their own legislation with regard to the manufacture, distribution, sale, and use of these substances. Federal enforcement of laws such as the Controlled Substances Act remains an unlikely prospect in jurisdictions that have enacted their own legalization or decriminalization laws.  

Oregon was the first state in the nation to legalize the use of psilocybin for therapeutic purposes via a ballot initiative in late 2020. The program isn't due to be operational until 2023, but Oregon's Psilocybin Advisory Board has held a number of meetings to better inform the program and develop proper safety measures. Under Oregon law, licensed therapists will be able to administer psilocybin as a mental health treatment. Similar to the proposed NY bill, professionals must be specially licensed to grow the mushrooms, extract the psilocybin, synthetically produce the drug, and/or provide therapy with psilocybin (Sweet, 2021). The treatment will be broken up into three sessions for preparation, administration, and integration (which is a reflection session with a licensed therapist).  

Last month, Washington State legislators filed SB 5660, also known as the Washington Psilocybin Wellness and Opportunity Act. Unlike the two aforementioned legalization efforts, this Act would legalize the supported adult use of psilocybin in Washington without specific medical conditions. The bill would establish licenses for manufacturing facilities, testing labs, service centers, facilitators, and implement the Washington Psilocybin Advisory Board to advise on the Act's implementation. The bill also includes a Social Opportunity Program, a provision to support small businesses, and accommodations for people with certain medical conditions to receive the psychedelic substance at home (Marks, 2022). 

Lawmakers in several states have filed bills regarding the decriminalization of psilocybin since the start of 2022. Del. Dawn Adams and Sen. Ghazala Hashmi sponsored nearly identical psychedelic decriminalization measures in the Virginia House of Delegates and Senate, respectively. Similarly, two Oklahoma lawmakers recently filed bills for the furtherance of psilocybin research and decriminalization. A Kansas lawmaker also filed HB 2465, for the legalization of both psilocybin possession and cultivation.

Denver, Colorado was the first city to decriminalize psilocybin mushrooms in 2019, with the Psilocybin Mushroom Policy Review Panel stating that no significant public health or safety issue took place in the two years following (Metzger, 2021). A number of other cities have followed suit, including Oakland, Santa Cruz, Detroit, Ann Arbor, Washington D.C., and others.  

Other jurisdictions where psilocybin is currently illegal are considering legalization and/or decriminalization measures. For example, Connecticut passed a law requiring the state to study the therapeutic potential of psychedelics, and Texas adopted a law requiring the study of psychedelic benefits for military veterans. 

There have even been recent advancements for psilocybin on a global scale, with the International Therapeutic Psilocybin Rescheduling Initiative announcing a campaign to revisit the strict scheduling under the United Nations' 1971 Convention on Psychotropic Substances.  

Certain countries are also looking at psilocybin reform, the most notable currently being Italy. After turning in over half a million signatures for the cannabis and psilocybin referendum in October, Italian officials have certified activists' collection of enough signatures to place the referendum on the country's ballot in the spring. The government will set date for the vote depending on the Italian Constitutional Court's determination of the legality of the proposal's provisions on February 15th. This ballot initiative is unique in that it would not only legalize personal cultivation of psilocybin and cannabis but would maintain a decriminalized fine for possession. 

Conclusion 

Many people are exploring psilocybin as a treatment for conditions with little to no relief available otherwise. New York legalized medical cannabis in 2014, only after almost half of all states had done so (ProCon.org, 2021). Similarly, New York only legalized adult-use cannabis this past year, after a third of states had already done so and almost a decade after the first states legalized it. Perhaps having learned its lesson, New York is far earlier than most other states in proposing a legal framework for the federally prohibited substance. In fact, New York has a chance to pave the way in providing a new therapeutic treatment for its residents on a large scale. Through thoughtful research and diligent policy-making, New York could potentially craft a program capable of serving as a benchmark for other jurisdictions.  

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