We checked in with Elliott Rolfe and Harry Lancaster, of the Psychoactive Medicines Law and Regulatory team at Mackrell Solicitors [1] in London.
"What always amazes me is the breadth of the practice" said Chris Lane, Director of Business Development and Client Relations at Mackrell. "From cannabinoids to CBPMs, functional mushrooms to full blown psilocybes, charitable start-ups to listed conglomerates: there's never a corner they haven't recently covered. This is a roundup of the latest developments in each area".
Cannabis
On cannabinoid wellness products
"We continue to see an array of inventive cannabinoid wellness products, often testing legal grey areas. The "novel" nature of these products makes understanding the route to market an interesting challenge for many of these companies. The FSA's Novel Foods regime is tricky to avoid for a new product and entails the usual strict safety testing before products can be sold. To take one example, "hydrogenated" cannabinoids have made an appearance of late, with compounds such as H4-CBD, HHC, and HHC-O (cannabinoids with hydrogen and other atoms present in their chemical structure, that do not appear in conventional CBD or THC) the subject of much legal debate. As with functional mushroom products, the risk of placing these types of products on shelves comes down to a whole range of factors. We encourage companies to consider evidence around their safety, psychoactivity and Novel Foods status, together with relevant legislative definitions and enforcement practice. Unfortunately for companies wishing to market them, most of the creative cannabinoids are clearly controlled. Even where that's not true, it's essential to have a disciplined and precise strategy for ensuring regulatory compliance; or to put it another way - companies need to know the rules very well to ensure they stay on the right side of them.
Authorities can be quick to respond to developments, and several countries have now introduced legislation expressly banning HHC. This move has been criticised by many, who point out that prohibition does little, if anything, to reduce rates of use and merely invites poor quality production from the legacy market.
On CBD cannabis flower for wellness
"There is still demand for CBD cannabis flower in 2023, and we're getting plenty of requests for advice from companies wishing to sell. Unbeknownst to many, it has never been legal to sell CBD flower, as UK law does not differentiate between different types of flower regardless of their THC content. On the plus side, the UK Court of Appeal recently ruled in the case of R v Mariotta that hemp flower was an agricultural product that, prior to Brexit, could not lawfully be subject to UK import or sale restrictions (although that's only of use in historic cases). More usefully post-Brexit, the court made it clear that it did not view hemp flower (with a THC content of up to 0.2%) as a narcotic drug.
Senior courts have now concluded that CBD is not psychoactive (in the case of Kanavape), and that hemp flower is not a narcotic drug (in the case of Mariotta). This doesn't legalise the sale of CBD flower in the UK, but it will be interesting to see how the CPS would justify it being in the public interest to prosecute in connection with something that the courts have ruled is neither psychoactive nor a narcotic. However, at present the law remains clear: it is not lawful for companies to sell CBD hemp flowers, but we will be keeping any eye out to see how this is enforced in future.
On medical cannabis
The range of medical cannabis products on the UK market is growing rapidly, with high quality flowers, oils, cartridges and capsules available through private clinics for those with a prescription. Prescription numbers are hard to conclusively confirm - of the estimated 2 million British residents who are purchasing from the street to treat their medical condition, only 2-4% of these are currently believed to have a prescription, so there is a major market opportunity if the other 96-98% can be accessed. While there is clear industry growth, the truth is that the current rules - both on prescribing and on distribution - prevent the industry growing very quickly. The rules that apply to medical cannabis are generic rules that apply to all unlicensed medicines. There is a serious bottleneck for clinics around accessing prescribers, as only specialist doctors can prescribe and many GPs are uneducated on the subject. Industry participants also note that the rules around importation and distribution are not sufficiently bespoke to cater for the current needs of patients. As a result of these issues, products are constantly going out of stock and expiring before reaching patients, and there are other continuity of care issues. The real opportunity and need here is for both effective lobbying for reform of the rules and education of doctors and the public on the benefits, safety and availability of medicinal cannabis.
Psychedelics
On psychedelic medicine
For many years now, researchers have been studying the effect of psychedelic substances, such as psilocybin mushrooms, LSD and DMT. These compounds have shown ground-breaking promise for actually curing (rather than simply managing) some of society's most intractable mental health issues, including depression, anxiety and PTSD, and this is beginning to cut through into the mainstream. However, the current restrictions applying to these compounds (which are largely Schedule 1, Class A drugs) make the development of any kind of industry very challenging, and most of the movement is in the research and clinical trials which should support the reform that's required here. Hot legal topics in this space at present include the apportionment of risk within research agreements, patient understanding and consent issues, and post-treatment care in relation to participants in clinical trials. To take an example from this week, PsyPAN are a non-profit organisation created to support psychedelic clinical trial and therapy participants who we are advising in relation to the risks of working in these areas. Anyone looking to be involved in the industry as it develops in the UK needs to be focusing on the regulatory reform aspect- despite its world-leading life sciences industry, the UK risks falling behind other jurisdictions if medicines and treatment models can't be developed here.
On psychedelic wellness
Outside of the clinical trial setting, psychedelic treatments are not yet lawful in the UK. However to meet the demand, non-profit organisations have emerged and they are coming to us for help arranging for UK citizens to receive therapy outside the UK. One example is Heroic Hearts UK, which carries out research into the potential of psychedelic treatments alongside the retreats that it organises for veterans, and we're working with groups looking at doing similar things for other benevolent causes.
A similar service which has recently emerged is the "concierge" wellness service. The concept: a knowledgeable intermediary with connections to safe, vetted and legal psychedelic experiences in places like the Netherlands and Jamaica. We have been advising these services in relation to implementing gold-standard internal governance frameworks, reducing regulatory risks, and many issues also seen on clinical trials, such as consent and liability issues.
On legal changes
These are still fairly regular and changes close to home are hoped to have a positive influence domestically - for example Germany's cabinet this week approved a landmark bill to legalise cannabis for adult use and cultivation. Not so long ago, the MHRA announced that from 2024 it will implement a new regime to enable rapid approval for medicines already approved by trusted regulators such as the US Food and Drug Administration (FDA). This would open up the possibility of psychedelic assisted therapy with MDMA (once known as ‘ecstasy'), a compound expected to be approved as a licensed medicine by the FDA in late 2024 to early 2025 - and a compound that would therefore become a licensed medicine in the UK shortly afterwards. How that will work in practice is currently unclear.
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 UK's first dedicated cannabis legal department five years ago and work at the cutting edge of the current medical cannabis and psychedelics regulatory regimes.
The firm provides regulatory, corporate and commercial advice and services to the CBD, medical cannabis and psychedelic medicines industries both in the UK, 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.
For further information please contact Elliott Rolfe [2], Head of Psychoactive Medicines Law and Regulatory at Mackrell Solicitors [3]
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