In the UK, psychedelic medicine refers to a wide range of medicines that have a number of  common elements – they are controlled substances in law, they have particularly psychoactive effects, they usually (but not always) rely on activation of the 5HT2A receptor as the primary mechanism of therapeutic action, and they commonly (but not always) have a botanical origin. The most studied psychedelic medicines include:

• psilocybin – the most active compound in so-called magic mushrooms;
• dimethyltryptamine (DMT) – the most active compound in the Amazonian ayahuasca brew);
• 3,4-Methyl​enedioxy​methamphetamine (MDMA) – historically referred to as “Ecstasy”;
• lysergic acid diethylamide (LSD) – originally derived from ergot, a fungus that grows on rye and other grains; and
• ketamine – a licensed anaesthetic.

Mescaline, 5-MeO-DMT and ibogaine have also been the subject of studies.

Medicines Framework

The majority of psychedelic compounds are still in advanced research phases, which means none of them yet has a “marketing authorisation” – a product licence issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) allowing doctors to prescribe medicines for the indications for which they have been researched. Unlike cannabis, there have not yet been any exceptions made in UK law that permit psychedelic medicines to be prescribed in compassionate or special (or “unlicensed”) circumstances. As such, psychedelic medicines are only available for lawful administration through clinical trials at present. Therefore, the law that applies to this area of industry at the time of writing is the MHRA framework that governs investigational medicinal products for use in clinical trials, in addition to the Home Office regime that governs controlled drugs.

Looking to the future, it may be that – as an intermediary step ahead of any licensed psychedelic medicines – there is a rescheduling such as that seen with medical cannabis in England and Wales or with psilocybin and MDMA in Australia. This would mean the legal framework that applies would be the MHRA’s unlicensed medicines framework, relying on the discretion of specialist doctors to prescribe to meet unmet clinical need, and special licensing and oversight measures within the supply chain.

In terms of the laws that govern the area, for completeness it is therefore important to mention the end-goal state – that of psychedelics as licensed medicines in the UK. Many stakeholders intend psychedelics to be subject to the same laws that govern regular medicines. There may be special stipulations attached to the marketing authorisations – for example, that they must be administered in appropriate settings and supervised by psychotherapy or psychiatry clinicians – but the hope is that recognition as treatments with a similar risk/benefit ratio to conventional treatments will facilitate access to those with the most intractable conditions.

Ketamine is a useful illustrative example of the legal framework application to psychedelic medicine. Ketamine is a controlled drug of class B and – when prescribed medicinally in pharmaceutical form – schedule II. It has a marketing authorisation so it is classed as a licensed medicine in the UK; however, it is licensed for use as an anaesthetic and not for the psychedelic properties that have been shown to relieve symptoms of depression. Therefore, ketamine as a psychedelic treatment is prescribed on an “off label”-only basis in England and Wales as a last-resort option.

Controlled Drugs Licensing and Criminal Law Frameworks

The controlled drugs framework is relevant to the practice area, primarily for researchers and drug developers at the outset of the drug development process when new compounds are explored and traditional compounds are further investigated. The framework primarily comprises the Misuse of Drugs Act (MDA) 1971, the Misuse of Drugs Regulations (MDR) 2001 and – to a lesser extent – the Psychoactive Substances Act (PSA) 2016.

The MDA 1971 is the primary piece of legislation criminalising activities involving psychedelic substances without lawful authority and captures substances under its application by expressly listing them by name (or broad chemical description). Such compounds are organised into “classes” that essentially relate to the severity of penalties for unlawful use. The MDR 2001, by contrast, establishes the framework for lawful use. Psychedelics thought to have no medicinal value in the late 1960s when the MDA 1971 was drafted sit in the most restrictive schedule known as “Schedule I”.

The PSA 2016 is a piece of legislation designed to curb the rapid rise in novel psychedelic and other substances with the introduction of a blanket ban on sales of any substances that are not expressly listed in the MDA 1971 but have a psychoactive effect. It contains exemptions for researchers undertaking work under an ethics approval and other sanctioned scenarios.

The Proceeds of Crime Act (POCA) 2002 is relevant to UK entities considering investments in psychedelic medicine ventures abroad, particularly in jurisdictions with more permissive regulations than those in England and Wales. Under POCA 2002, “criminal conduct” encompasses activities that would constitute an offence if committed in the UK, regardless of their legality elsewhere. This principle is crucial for UK companies investing in international psychedelic wellness retreats, clinics and related enterprises, as revenues generated from such activity could be classified as “criminal property” under POCA 2002 – thereby potentially exposing individuals and companies to money laundering offences.

Charities Law

Owing to the benevolent nature of the industry, as well as the long-term difficulties around accessing these medicines, many charities operate in the sector. It is important for prospective charities to consider rules around providing public benefit, safeguarding and monitoring of beneficiaries, vetting of internal and external partners with regard to a broad range of risks, and rules prohibiting the promotion of treatments that are not yet licensed.

Medicines and Healthcare Products Regulatory Agency

The MHRA is responsible for regulating medicines, medical devices and clinical trials in the UK. The regulator approves clinical trials of psychedelic medicines to ensure safety, efficacy, and ethical compliance. The MHRA also approves the marketing authorisations for medicines once they have demonstrated quality, safety and efficacy in clinical trials and it licenses and oversees the manufacturing and distribution of medicines. The regulator also monitors adverse events and enforces pharmacovigilance requirements.

Home Office

As set out in 1.1 Primary Laws and Regulations, the Home Office oversees the control and licensing of substances under the MDA 1971 and the MDR 2001. It issues licences for research, possession, production and supply of controlled drugs – including psychedelics classified under Schedule I (eg, psilocybin, LSD and DMT) – by exercising the powers conferred on the Secretary of State in the MDA 1971.

Care Quality Commission

The Care Quality Commission (CQC) regulates health and social care providers, including private clinics offering ketamine-assisted treatments. As the field of psychedelic medicine evolves, future private clinics offering therapies involving substances such as psilocybin (if legalised for therapeutic use) would also likely fall under the CQC’s regulatory remit. This oversight ensures that such clinics comply with safety, quality and ethical standards.

Charities Commission

The Charities Commission regulates charitable organisations in England and Wales. It authorises and oversees charities supporting psychedelic research or patient access to psychedelic treatments, ensuring they operate lawfully, transparently, and in line with their stated objectives.

National Institute for Health Research and Ethical Approval Bodies

Although not a regulatory body, the National Institute for Health Research (NIHR) is pivotal in supporting research infrastructure and funding. It provides funding and guidance for research and facilitates the development of networks and collaborations between researchers, healthcare providers, and industry.

Ethical review is also a critical component of research involving psychedelic medicines. Research Ethics Committees (RECs) operate under frameworks established by the Health Research Authority (HRA) and assess clinical trial protocols to ensure the protection of participants’ rights, safety, and well-being. RECs approve studies involving psychedelics, focusing on informed consent, risk mitigation, and scientific validity.

National Crime Agency

The National Crime Agency (NCA) was set up to tackle organised crime. However, it is relevant to the psychedelics industry, as it is the agency responsible for enforcing POCA 2002 and investigating cases where UK entities profit from activities abroad that would be illegal domestically.

At present there are no self-regulatory industry bodies.

The legal market for psychedelic medicine in England and Wales is restricted to ketamine prescribed off-label, predominantly privately. There is limited access to ketamine through the National Health Service (NHS) – some of which is self-pay.

The private ketamine market consists of a small number of clinics, primarily in London, where ketamine is prescribed off-label for conditions such as treatment-resistant depression and anxiety. The exact size of the market is unknown. The flagship UK ketamine clinic, Awakn, opened in 2020 and closed in 2024, citing a lack of demand for its courses of treatment – some of which cost GBP6,000. Other clinics (and self-pay NHS clinics where the drug is a generic) price single infusions in the low hundreds of pounds; however, given that multiple infusions are often part of a course of treatment, the cost can still be considerable. It is unclear how the market will continue to develop at this stage.

There is also an illicit market for psychedelic medicines, with those seeking to benefit from medicines such as psilocybin seeking out underground practitioners who offer a range of supported experiences with various psychedelic compounds. There is no reliable data on the number of people seeking healing outside the traditional healthcare system in England and Wales via the use of psychedelic compounds, but the practice appears to be growing in popularity and signals the demand for such alternative therapies.

The psychedelic medicine market currently consists of companies devoted to bringing (often novel, patentable) psychedelic compounds to market as medicines, rather than those primarily engaged in distribution and supply through clinics and other settings. This is because, at the present moment, there is no legal route to providing the classic psychedelic compounds as medicines – with the exception of ketamine.

Although the UK has been a hub for psychedelic scientific research, and a number of prominent psychedelic companies are connected with or based in the UK, the short- to medium-term outlook for psychedelic medicine in the UK is mixed. The UK has not shown the regulatory enthusiasm for reform shown by countries such as Australia and the USA, has only granted limited government funding for research, and risks falling behind in the journey of bringing psychedelic medicines to market.

The UK is a somewhat unpredictable market for any future licensed medicine, as the main point of access to patients is the NHS and there is no guarantee that any given treatment will be included in the clinical guidelines or care pathways for a particular condition. So far, the successful licensed ketamine medicine Spravato has been rejected a number of times for recommendation by the National Institute for Health and Care Excellence (NICE), which is the gateway for general prescription on the NHS (see 3.1 Access to Psychedelic Medicines Today).

Patent challenges are a key legal risk area, where psychedelic compounds – particularly naturally occurring ones – may face difficulties in meeting UK patent criteria (eg, around novelty and inventive step). UK-specific patents or global IP protections may also give rise to freedom to operate (FTO) issues that restrict the commercialisation of certain treatments without appropriate licensing. Other legal risks include technical money laundering offence issues (as mentioned in 1.1 Primary Laws and Regulations and 2.1 Common Cross-Jurisdictional Issues) and – in rarer cases – a range of patient-orientated legal risks, such as clinical negligence, professional misconduct, and issues around informed consent to treatment.

Despite the difficult legal climate for the development of psychedelic medicines commercially in England and Wales, there is a relatively active community of individuals wishing to develop or invest in psychedelic businesses – often in other jurisdictions where circumstances are more favourable. Unfortunately, this is hampered by POCA 2002. As AML legislation, POCA 2002 makes it an offence in England and Wales to deal in the proceeds of crime; however, in this case, the proceeds of crime include the proceeds of activities carried out abroad that would constitute a crime if they were carried out in England and Wales. This means that investing in, for example, a Jamaican psilocybin retreat would put an investor at risk of being in breach of POCA 2002. Even though there is a defence where the conduct was not criminal conduct under the law of the relevant other jurisdiction, this does not apply where the conduct would constitute an offence punishable by more than 12 months’ imprisonment in England and Wales, which is almost invariably the case with conduct involving dealing with controlled drugs.

Mitigating or avoiding the consequences of POCA 2002 is complicated for UK nationals. This has created significant issues for investors and businesspeople in the UK who wish to be involved in projects involving psychedelic medicines in other jurisdictions.

The import or export of active psychedelic substances, or precursors to them, is tightly controlled under UK and international law and is actually prohibited in many contexts. Companies must navigate Home Office and MHRA requirements domestically, as well as foreign laws that present a high degree of jurisdictional variability. Operating in multiple countries while headquartered in the UK creates complex compliance challenges due to the differing legal frameworks.

Access to psychedelic medicines in England and Wales, unsurprisingly, is generically affected by the “mood music” from other influential global jurisdictions – although the general liberalisation of the rules in, for example, Australia and the USA does not currently seem to have any observable knock-on effect.

There are also specific provisions of the medicines licensing framework in England and Wales that mean that developments in other countries will have a direct impact on availability. The MHRA’s International Recognition Procedure (IRP) was introduced in 2024 as part of the UK’s regulatory framework following Brexit, replacing the EC Decision Reliance Procedure. It allows the MHRA to rely on decisions made by trusted regulatory authorities in other countries in order to expedite the approval process for medicines and medical devices in the UK.

The relevant reference regulators are as follows:

• Australia – Therapeutic Goods Administration (TGA);
• Canada – Health Canada;
• Switzerland – SwissMedic;
• Singapore – Health Science Authority Singapore (HSA);
• Japan – Pharmaceuticals and Medical Devices Agency (PMDA)
• USA – the US Food and Drug Administration (FDA)
• EU/European Economic Area (EEA) – European Medicines Agency (EMA) and the competent authorities of EU member states, Norway, Iceland and Liechtenstein.

The expedited approval process can be significantly faster than the standard review process. The MHRA can rely on the assessment reports from the recognised regulatory authorities, thereby reducing duplication of effort as well as speeding up the review process. However, the MHRA still maintains the right to request additional information or conduct its own assessment if deemed necessary.

For patients to benefit from the IRP, psychedelic medicines must be licensed in those other jurisdictions and subsequently an application needs to be made in the UK by the medicine’s developer. There was some excitement around the potential of the Lykos Therapeutics application for a marketing authorisation for midomafetamine (MDMA) in the USA for exactly that reason. However, even if the application had succeeded, there is no strong indication that Lykos Therapeutics would have attempted to use the US marketing authorisation to apply for an authorisation in the UK using the IRP. The IRP has significant potential to expedite access to psychedelic medicines for the UK public, but so far that potential has been unexplored.

Access to medical psychedelics is limited by the fact that no psychedelic is a licensed medicine in England and Wales. Given that they are Schedule I substances (apart from ketamine, if this is being included within the definition of “psychedelic”), they cannot be prescribed as “unlicensed” medicines by doctors.

The lack of licensed medicines is down to the same factors as other jurisdictions – ie, full clinical trials have largely yet to be completed. However, in England and Wales, it is also possible for doctors to prescribe “unlicensed” medicines – this is how the private medicinal cannabis market in England and Wales has been able to develop. In order for cannabis to become a medicine it first had to be taken out of Schedule I of the MDR 2001, which happened (partially) in 2018. If the compounds used in psychedelic medicine were removed from Schedule I, then a similar situation could arise with doctors prescribing them as “unlicensed” medicines – although, given the general requirement for supervision of patients using psychedelic medicine, this would be a far more complicated proposition than the current unlicensed cannabis medicine ecosystem.

The Home Office has received calls to look into the rescheduling of psilocybin into Schedule II under the MDR 2001. However, so far, the UK government’s line has been that there are pathways in place to develop medicines containing Schedule 1 substances and that rescheduling is therefore unnecessary.

Even once licensed psychedelic medicines are available in England and Wales, this will not necessarily guarantee widespread access to them. This is because the vast majority of people in England and Wales receive medical treatment through the NHS and, in order to be prescribed by NHS doctors, a medicine must generally first be assessed and then recommended by NICE. The experience of Spravato with NICE is informative – despite being available in 20 other countries across Europe (including Ireland and Scotland), it has been assessed by NICE multiple times and not recommended for NHS funding. Given the complex and likely expensive delivery mechanisms for future psychedelic medicines, there is every chance that they will encounter the same difficulties.

There are two primary likely routes to market access in England and Wales, as follows.

• A psychedelic medicine completes clinical trials and becomes available as a licensed medicine on the NHS and/or privately.
• Psychedelic compounds are rescheduled and an ecosystem for prescribing them as “unlicensed” medicines – along with an infrastructure for patients to safely use them – emerges, as has been the case with cannabis.

It is unclear how close England and Wales is to an adult-use market. This is because the approach of the new Labour government to the topic of drug reform in its recent election campaign was to not mention it at all, either positively or negatively. This was part of a strategy of avoiding saying anything that might put off swing voters or traditional Conservative party voters who might be discouraged from voting Labour if they made positive noises about drug reform. However, it means that there is little to go on when trying to predict whether Labour – a left-of-centre party – will be open to following the increasing number of jurisdictions that have begun to explore loosening controls around psychedelics.

Simply from the perspective of progressing from less controversial to more controversial substances, it seems highly unlikely that there will significant deregulation around psychedelics prior to this happening with cannabis. Hence, for those monitoring England and Wales, then progress in the creation of an adult-use market for cannabis will be the first indicator to look for.