Recent studies have shown promising results for the use of psychedelics to treat a whole array of mental health issues, including post-traumatic stress disorder (PTSD), depression, and anxiety. Momentum is also growing behind the decriminalization of psychedelics, with several jurisdictions now recognizing that certain psychedelics as the next controlled plants to become legal for medical purposes and making proactive changes to their criminal laws and policies.
We posed the question, “Will psychedelics be regulated like cannabis?” to cannabis and psychedelics expert Elliott Rolfe, Senior Associate and head of the Psychoactive Medicines Law Team at Mackrell.Solicitors in London.
Elliott is well-known for his expertise in the U.K. cannabis and psychedelics industry. He is establishing even greater recognition for the cannabis specialist firm, through the development and growth of Mackrell’s Psychoactive Medicines Team, a legal department dedicated to supporting this exciting new industry.
Here’s Elliott’s response to this important question:
Comparing general regulation for cannabis and psychedelics cannot be accomplished simply. Due to the uniquely complex nature of each sector, answering this question requires a look back at the history of legalized cannabis and the current state of psychedelics.
A New Era in Medicine
Medical cannabis has received a great deal of attention in the last few years. However, as those in the know will tell you, it is only one of a whole collection of psychoactive plant medicines that are set to revolutionize healthcare.
Other psychoactive (or often “psychedelic”) compounds that are undergoing clinical trials worldwide include those derived from mushrooms, truffles, cacti, and naturally derived compounds, such as LSD.
These different psychedelic plants and chemicals have shown a remarkable potential to treat an array of mental health conditions, brain injuries, and inflammatory conditions in an unrivaled way in modern medicine.
An Industry of Many Branches
The initial popularity of “cannabis” in the U.K. was an explosion of non-controlled cannabis extract products, known as CBD products. The CBD industry in the U.K. is eclectic in and of itself, firmly occupying the ‘wellness’ space, which helps relieve daily aches, pains, and stressors, as opposed to treating intractable medical conditions.
Therefore, the CBD industry requires a significantly lesser level of regulation than licensed medicines. This means the barriers to market CBD products are not as expensive, time-consuming, or convoluted (although regulation has increased in recent years). So as long as CBD wellness products like these do not make any ‘medical claims,’ i.e., claiming to treat or cure specific conditions, nor contain any controlled substances, they may continue to enjoy this lighter regulatory oversight and faster path to market.
On the other side of the cannabis sector are the currently rarer cannabis medicines. This complete form of medical cannabis, which can include high-THC cannabis flowers, now comprises products for treating life-altering conditions, such as childhood epilepsy, chemotherapy side effects, and symptoms of multiple sclerosis. Compared to their CBD-product cousins, cannabis medicines are tightly regulated and fall squarely under controlled drugs and pharmaceutical legislation.
Now turning to psychedelics, we will likely see the same wellness versus medical market split. Psychedelics for wellness are available in a small handful of jurisdictions, most notably the Netherlands where psilocybin retreats are intended for personal development (such as creativity, mood, and spiritual growth).
In the main though, psychedelics are being developed as medicines to treat intractable mental health issues and will be marketed as such. Therefore, this side of the industry will be treated in law as fully regulated medicines, subject to the same rigorous controlled drugs and pharmaceutical regime governing medical cannabis.
Medical psychedelics and medical cannabis are unlikely to enjoy the same high-street product availability as the CBD industry, although dispensary and clinic models are being implemented rapidly across the globe. The medical side will however boast far higher safety, quality, and efficacy standards, thanks to the stringent controls on their production, storage, transport, dosing, marketing, and general product development imposed by the national medicines’ regulators.
With psychedelics, however, the regulation might not stop there.
Another Layer to the Puzzle
Curiously, and somewhat unique to psychedelic medicine, and the psychedelic-assisted psychotherapy (“PAP”) world, is the amalgamation of therapy concurrently with ingestion of the medication. The predominant model associated with psychedelic treatment is one where the patient ingests the psychedelic medicine while a psychotherapist is present to guide them through the experience. Then following, the patient attends a series of ‘integration’ sessions with the psychotherapist, where the patient can talk through and make sense of their experience.
One question that arises is whether any additional regulation will be required to safeguard patients in this novel and dynamic context of treatment? Bringing such treatments into the mainstream and combining them in this way may invite commercial participants with less benevolent motivations, add complexity and give rise to additional wellbeing considerations (the likes of which have already been reported during clinical trials).
On the other hand, further regulation may be an extra step in an industry that initially struggled to get off the ground for all the legislative controls. At present, the psychotherapy industry is self-regulated, and there is already a substantial regulatory regime covering the medicines themselves, as discussed above.
Any regulation that benefits both sectors needs to consider the unique setting within which both cannabis and psychedelics operate for their current and potential patients. Unprecedented in the pharmaceutical industry is the presence of these potential medicines that have been used privately, unsupervised, and unlicensed within the national population (for recreation and wellness healing) and have tremendous untapped potential in the medical sphere as well.
Policymakers will need to find a proportionate way of regulating this intricate play between the recreational, wellness, medical, and psychotherapeutic contexts; an approach that protects patient health and awareness while encouraging a less convoluted route for academic research; and one that maintains the potential to legislate for an adult-use market if the evidence and economics support it.
From the outset, it is clear that that regulation will require responsibility distributed across several competent authorities, great discernment in the end products being delivered to patients, and careful, multidisciplinary input from those working closely with these compounds for many years.
About Mackrell.Solicitors
Mackrell.Solicitors is an award-winning, full-service law firm with a truly global reach. Headquartered in Central London, with offices in the heart of Birmingham, the firm has been providing high-quality legal advice and services since 1845.
Mackrell.Solicitors set up the U.K.’s first dedicated cannabis legal department three years ago and are now at the cutting edge of the current cannabis and psychedelics regulatory regimes. The firm provides regulatory, corporate, and commercial advice and services to the CBD wellness, medical cannabis, and psychedelic medicines industries in the U.K., Europe, and beyond. The firm also provides the full suite of legal support through its other departments, including its employment, property, litigation, private client, and corporate and commercial teams.
