Last month, the UK House of Commons debated the current state of regulatory and legal hurdles negatively affecting the development of psilocybin-based (the psychedelic compound most commonly found in ‘magic mushrooms’) therapies for mental and physical health disorders in the UK. The debate resulted from an e-petition, which garnered 11,824 votes in February this year.
The debate saw a consensus among Members of Parliament across party lines, collectively supporting the proposal for rescheduling psilocybin from the currently held Schedule 1 classification for spurring research benefitting patients and the UK healthcare & life sciences sector.
While this debate marks progress, the UK still substantially lags behind the US in harnessing the potential of psychedelics-based therapies, where the US FDA has recently released draft guidance for researchers trialling psychedelic therapies.
Currently in the UK, psilocybin is classified as a Schedule 1 substance under the Misuse of Drugs Regulation 2001, which means that psilocybin is considered to have no therapeutic use and therefore cannot be lawfully prescribed or possessed. As a result of this classification, any research into psilocybin requires a license from the Home Office, bureaucracy which is a significant barrier to any research on its therapeutic effects.
In a detailed discussion lasting nearly 1.5 hours, the House of Commons members discussed the need for rethinking the current legal status of psilocybin. Here are the three key takeaways from the debate:
- The untapped potential of psychedelic substances: The House recognised that there is a new wave of research highlighting the promise of psychedelic substances in assisting patients with neuropsychiatric disorders like treatment-resistant depression, post-traumatic stress disorder (PTSD), and anorexia nervosa. For example, psilocybin has garnered special interest in the USA, where it was granted a ‘breakthrough therapy’ status to treat treatment-resistant depression by the US Food and Drug Administration (FDA) as far back as 2018 to accelerate research and related clinical approvals in this area. The current cost of depression alone to the UK economy is estimated to be about £110 billion or 5% of the UK’s GDP. There was some consensus in the House of Commons debate that easing research hurdles in the UK could benefit the economy, patients, and life sciences research alike.
- Current scheduling and missed opportunities: Some MPs expressed disappointment at the UK’s sluggish progress in the area of psychedelics-based therapies and at psilocybin’s classification as a Schedule 1 drug despite, they argued, there being no evidence of the drug creating dependency or addiction Recounting experiences of UK researchers, it was highlighted that obtaining these licences is extremely costly and cumbersome, and can cause researchers in this area to abandon their plans altogether. It was further explained in the debate that, as a result of the current scheduling, charities such as Heroic Hearts have to take UK veterans abroad enable them to access psilocybin-based therapy for treating PTSD, whereas with a more conducive environment for research, these therapies could be developed and administered within the UK. In light of these missed opportunities, The Royal College of Psychiatrists and various mental health charities have urged the UK Government to revise their scheduling policy. Notably, the Advisory Council on Misuse of Drugs (ACMD) had been tasked with reviewing the current law on psilocybin in 2017, however it has not yet released its report.
- The government’s response: Representing the government, Robert Jenrick, MP and Minister for Immigration, assured the House that the government has commissioned the ACMD to consider how to facilitate the research with respect to all Schedule 1 substances and not just psilocybin. The government also apprised the House of a recent meeting between the Home Office Chief Scientific adviser and her counterpart in the Department of Health and Social Care to discuss the rescheduling of Schedule 1 drugs to spur research on psychedelic medicines in the UK.
And in contrast… hot off the press in the US: FDA guidance on researching psychedelics
The recent debate has set the ball rolling for a more conducive and supportive ecosystem for research on psychedelic-based therapies in the UK, which is a welcome change for many. However, the UK has a lot of ground to cover if it is to catch up and compete with the research ecosystem in the US.
The US FDA has demonstrated a more proactive approach to facilitate research in this area by granting ‘breakthrough therapy’ status to psilocybin-based therapies as far back as 2018. Moreover, recently, the FDA released a draft guidance document for clinical researchers trialling psychedelic drugs, including specific guidance on trial conduct, data collection, study participant safety, and new drug application requirements. FDA recognizes that designing clinical studies to evaluate the safety and effectiveness of these compounds can present unique challenges, and the draft guidance is meant to support the ethical conduct of clinical trials as well as to ensure the integrity of the trial and the reliability of the results. FDA also encourages clinical trial sponsors to request meetings with the agency for advice on any specific drug development program. This development is a further sign of the US’s continuing progress in this novel field.
But fundamental differences in approach remain…
In the US, many psychedelic drugs are Schedule I substances under the Controlled Substances Act, which is mainly administered by the Drug Enforcement Administration (DEA). The FDA guidance also notes that “Should a psychedelic drug that is a Schedule I controlled substance receive FDA approval as a drug product, the abuse potential assessment would assist in determining an appropriate rescheduling action under the Controlled Substances Act”. The US approach is thus fundamentally different from the one proposed in the UK. While the UK government wants to reconsider its scheduling policy to facilitate research, the US proposes to form its scheduling policy based on clinical research and trials, representing a more participative approach to policy change.
Recent small steps in the UK and Europe
While the UK and Europe trail the US in psychedelics research, there have been two exciting developments:
The EMA’s multi-stakeholder psychedelics workshop: In March, the European Medicines Agency (EMA) revealed its plan of organising a multi-stakeholder workshop for promoting the development of psychedelic-based therapies in Q3/Q4 2023. This plan was revealed by the Executive Director of the EMA in a reply to an earlier open letter by six Members of European Parliament (MEPs), who had expressed concerns about the lack of research progress within this field.
UK psilocin human trial: While the hurdles for conducting psychedelic research in the UK remain, it is clear that obtaining regulatory approval is not impossible. Recently, the UK Medicines and Healthcare products regulatory Agency (MHRA) approved a first-of-its-kind human trial to test the efficacy of MSP-1014 (a novel psilocin drug and pharmacologically active form of psilocybin) in treating major depressive disorder (MDD). Despite this development, a more holistic scientific and regulatory framework for psychedelic research remains a work in progress.