Psychedelics: new frontier for mental health conditions? – Commentary

Introduction
What are psychedelics?
Trip down memory lane
Legal hurdles
Funding challenges
Moral issues
Patenting questions
Comment

Introduction

Psychedelics are a group of medicines that alter mood and sensory perceptions, and – despite traditionally having mystical connotations – are now known to offer much-needed hope for many debilitating mental health conditions.

This article provides a brief history of these medicines and discusses the prospect of them becoming a mainstream treatment for a range of psychiatric disorders in the United Kingdom.

What are psychedelics?

“Psychedelics” are a class of psychoactive substances that produce temporary changes in perception, mood and cognitive processes, which affect all the senses. Some psychedelics are found in nature, while others are made in the laboratory, including those known in popular culture as “magic mushrooms”. Psilocybin is the naturally occurring molecule found in almost 150 species of mushrooms and, once ingested, turns into psilocin, causing psychedelic effects.

Psychedelics offer a new frontier because they look to be useful in the treatment of depression and anxiety, which is reported to be at a global all-time high following the covid-19 pandemic. Indeed, in the United Kingdom, the prime minister, Boris Johnson, has indicated that he will consider calls to legalise psilocybin in response to the potential for treatment of mental health conditions. Psychedelics are therefore expected to be an area of interest for pharmaceutical investors in the near future.

Trip down memory lane

The traditional use of psilocybin-containing fungi is thought to date back hundreds, if not thousands, of years. Psilocybin-containing “magic” mushrooms appear to have been used ubiquitously; it is reported they were used at Eleusian ceremonies of ancient Greece, and by pre-Mayan cultures, for example. However, the archetypal psychedelic in modern Western society, lysergic acid diethylamide (LSD), was first synthesised in 1938 by Albert Hofmann at a laboratory in Switzerland. At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest, with some key features noted.

However, as psychedelics diffused into wider society and recreational use increased, some individuals reported a variety of ongoing symptoms including visual distortions, flashbacks and other symptoms that occurred long after the drugs had left the body. Eventually, the unethical and covert use of psychedelics, along with a general hardening of socio-political attitudes towards drug use, contributed to the decision to place psychedelics in Schedule I of the 1971 United Nations (UN) Convention on Psychotropic Drugs (the Convention), which was designed to control the use and availability of such drugs. The Convention contains four schedules, Schedule I being the most restrictive. It includes drugs claimed to create a serious risk to public health, the therapeutic value of which is not currently acknowledged by the Commission on Narcotic Drugs.

In the United Kingdom, the Misuse of Drugs Act 1971 was introduced to reflect the United Kingdom’s commitments under the Convention (as well as the UN Single Convention on Narcotic Drugs and the UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances).

As a result of the Convention and related national legislation, medical use ceased and research dwindled across the globe until the turn of the millennium. Since then, there has been a steady renaissance of clinical and academic interest in psychedelic drugs.

Today, although access to psilocybin remains so restricted, it is being investigated as a novel therapy for treatment-resistant depression and other difficult-to-manage mental health conditions, including obsessive-compulsive disorder, substance misuse disorders and end-of-life anxiety. It could be the next breakthrough drug in these treatments; however, the legal, commercial, moral, and IP hurdles are formidable.

Legal hurdles

Psilocybin therapy may be a novel and paradigm-shifting development in the treatment of mental health conditions. It works in a different way to traditional antidepressants and psychological therapies by directly decreasing activity and changing patterns of connectivity in brain regions strongly associated with ongoing depression and anxiety. Clinical trial evidence suggests that psilocybin may be effective in groups where traditional treatments have failed. This is where the clinical and health-economic problem lies, where new treatments are most needed and where commercial potential exists.

In the United Kingdom, supplementary to the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001 determine the circumstances in which it is lawful to possess, supply, produce, export and import controlled drugs. The authorised scope of activity will depend on which of the five schedules the controlled drug is assigned. Schedule 1 contains those drugs that are considered to have little or no therapeutic value and are subject to the most restrictive control, such as LSD and MDMA (ecstasy), whereas Schedule 5 contains drugs that are considered to have therapeutic value and are commonly available as over-the-counter medicines. Although Schedule 1 drugs may be used for the purposes of research, a UK government Home Office licence is required.

The Misuse of Drugs Regulations 2001 deems psilocybin, along with many other potentially revolutionary medicines, harmful and lacking medical potential – and it is classed as a Schedule 1 drug. This has meant that psilocybin, along with many other substances vested with therapeutic potentials, has (erroneously) been perceived as harmful, which has led to a scientific blackout lasting about 50 years, precluding new treatments being developed.

In November 2018, a precedent was set for moving controlled drugs (cannabis-based products for medicinal use) from Schedule 1 to Schedule 2 prior to market authorisation as a medicine. This provided a legal route for cannabis-based products for medicinal use to be prescribed by doctors in strictly controlled circumstances without the requirement for a Home Office licence.

If psilocybin followed suit and was re-categorised, with restrictions strictly limiting its availability for registered clinical trials and experimental research studies, it has the potential not only to deliver new treatments for patients, but also to establish the United Kingdom as a world leader in psychedelic research, grow the UK drug development industry and advance public health. Psilocybin therapies are among the very few recent advances in mental health drug development with substantial commercial potential.

A policy change would immediately reduce the obstacles to scientific research and commercial development, shortening the time required to bring new drugs to market and reducing the end cost of therapies, which will no doubt translate into significant savings for the National Health Service later on.

Increasing pressure is being placed on the government to consider re-classifying psilocybin, with surveys of the general public demonstrating support for such a change, which would remove some of the administrative barriers to using psilocybin in medical research. To an extent, this may be as a result of the increasing prevalence and awareness of mental health conditions among the population, perhaps in part as a result of the prevailing covid-19 pandemic.

Funding challenges

If bureaucratic burdens are reduced, there are nevertheless still challenges to be overcome in using psychedelics in medical research. Researchers suggest that psychedelics are misunderstood, and they remain heavily stigmatised, which means funding is not readily available for research. As a result, many researchers may be deterred from entering the field, and for similar reasons, universities are often hesitant to support this type of work.

Funding is therefore an issue: nearly all research is funded by private donors through corporate-sponsored research centres. This naturally leads to pharmaceutical companies, venture capitalists and patent holders benefitting most from the commercialisation of psilocybin.

Moral issues

Although obtaining funding for research involving psychedelics may prove challenging, there is perhaps a wider, moral issue: what happens to indigenous communities who have used psychedelics for hundreds of years?

Indigenous communities may view patents and the commercialisation of psychedelics as forms of exploitation and theft of their sacred knowledge and technologies. The 1992 UN Convention for Biological Diversity (CBD) directs the signatory states (including the United Kingdom), through national legislation, to:

respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices.

This was followed by subsequent agreements, including the 2010 Nagoya Protocol on Access to Genetic Resources, to which a number of countries (including the United Kingdom) have contracted in recognition of the importance and value of biodiversity to human society. The Nagoya Protocol provides a framework for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilisation of genetic resources. It recognises that benefits derived by users of genetic resources should be shared with those who provide them, with the ultimate objective being the conservation and sustainable use of biodiversity.

Such developments also led to the establishment of the 2003 UNESCO Convention for the Safeguarding of the Intangible Cultural Heritage, which recognised that:

in particular indigenous communities, groups and, in some cases, individuals, play an important role in the production, safeguarding, maintenance and re-creation of the intangible cultural heritage, thus helping to enrich cultural diversity and human creativity.

Furthermore, in 2007, the United Nations Declaration on the Rights of Indigenous Peoples stated that:

States shall provide redress through effective mechanisms, which may include restitution, developed in conjunction with indigenous peoples, with respect to their cultural, intellectual, religious and spiritual property taken without their free, prior and informed consent or in violation of their laws, traditions and customs.

In building up a pharmaceutical company’s IP estate around psilocybin compounds, questions may arise as to whether indigenous people should be compensated in some way. At the time of writing, there has been no indication that any such compensation has been paid. This is perhaps not surprising – the use of psychedelics as medical treatments has not yet become mainstream, and therefore substantial investment returns may not have yet been realised. However, this is certainly a consideration that pharmaceutical manufacturers may have to face in the future.

Patenting questions

However, use by indigenous populations and the related moral considerations do not take away the fact that it is the pharmaceutical companies that are the ones investing in the refinement of psychedelic substances for medicinal application and commercialisation. As is the case with the development of any other medication – and perhaps more so given the administrative hurdles, such as obtaining Home Office permission in the United Kingdom, that currently need to be overcome with respect to the use of psychedelics – pharmaceutical companies and investors will rightly expect a return on their investment in the development of such products.

The patentability of chemical substances is assessed in the same way as any other alleged invention under the UK Patents Act 1977. As mentioned already, psilocybin is a naturally occurring substance that is widely available and has been used by some communities for centuries, and therefore cannot be patented due to lack of novelty.

Further, a discovery of, for example, a natural substance cannot be patented,(1) but “you can patent a useful artefact or process that you were able to devise once you had made your discovery”.(2)

It is therefore likely that patents will be most likely sought for subtle variations of these naturally occurring substances. However, the process of refining such naturally occurring substances for medicinal use with subtle variations, and seeking patent protection for such variations, is controversial. It may limit access to therapies that are not actually new and could otherwise be inexpensive and widely available.

While there are also some patents protecting a formulation of psilocybin, there are fewer (if any) protecting the methods of synthesising and administering it. This is therefore an area where further patent filings are expected in the future.

However, particular challenges may arise in respect of the patentability of psilocybin derivatives – namely, whether the alleged invention is excluded from patentability on the basis that it may not be considered patentable because it is “contrary to public policy or morality”.(3) Reclassifying psychedelics such as psilocybin as Schedule 2 drugs in the United Kingdom would show a clear departure from this traditional perception. The use of such substances for the treatment of mental health conditions is clearly for the public good, thereby potentially weakening any arguments that such products and patents would be contrary to public policy or morality – indeed, quite the opposite.

Comment

The potential of psychedelics as treatments for debilitating mental health conditions offers a new hope to patients and potentially significant windfalls for pharmaceutical companies that successfully circumvent the challenges to bring these products to market.

More evidence as to the applicability and safety of these medicines is clearly required, but with the UK government now considering their potential use, the future for new, revolutionary treatments for mental health patients looks brighter.

The UK Life Sciences Vision, published in July 2021, sets out as one of the government’s priorities the need to address the significant unmet need for innovative new treatments and technologies, through deepening the understanding of mental ill health, and using this knowledge to advance the development of new therapies and products (for further information about the Life Sciences Vision report, click here). Psychedelics may offer one such innovative new treatment.

For further information on this topic please contact Carissa Kendall-Windless or Sarah Taylor at Pinsent Masons by telephone (+44 20 7418 8250) or email ([email protected] or [email protected]). The Pinsent Masons website can be accessed at www.pinsentmasons.com.

Endnotes

(1) Section 1(2)(a) of the Patents Act 1977.

(2) Peter Prescott QC (sitting as a Deputy Judge) in paragraph 34 of CFPH LLC [2005] EWHC 1589 (Pat).

(3) Section 1(3) of the Patents Act 1977.

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