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Majority of UK MPs support drug policy reform

A new report has revealed the majority of MP’s support evidence-based drug reform.

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Majority of UK MPs support drug policy reform

A new report from the Conservative Drug Policy Reform Group (CDPRG) has shown the majority of MPs in the UK support drug policy reform, and highlights how current policy is a barrier to psychedelic research – restricting the development of new medicines.

As the rest of the world moves towards more progressive approaches to drug policy, the UK announced a ten-year crackdown on drugs. Dubbed the ‘overdose capital of Europe’, the UK’s new policy would see a record amount of funding funneled into reducing addiction and drug-related crime.

The new report from the CDPRG, ‘Making UK Drug Policy A Success: Reforming The Policy Making Process’, shows that the majority of MP’s from all parties want evidence-based reform in the UK – something the new government strategy is lacking. It also emphasises that the UK needs to rewrite its policymaking process for drugs.

The report says that the strategy, informed by the independent Dame Carol Black review, is confused between its approaches to problematic and non-problematic drug users, and “potentially places yet more burden on a criminal justice system that is already swamped by drugs-related work, serving to drive drug users even closer to their criminal supply chain and away from the treatment and security the state should offer.”

Time for evidence-based reform

The CDPRG polled MPs in June 2021, revealing that 72 per cent of Conservative MPs agree the process of making drug policy should make more use of evidence and research. 

It also showed that 85 per cent of Conservative MPs, and 90 per cent of all MPs, agree that improved cross-departmental coordination would better in helping to tackle the health crime and social problems associated with controlled drugs.

The recommendations in the report are informed by two round tables – one in collaboration with the Institute for Government and one co-chaired by Drug Science – as well as the most comprehensive analysis of UK drug policy to date. This analysis was carried out by the UK Drug Policy Commission almost ten years ago in 2012 and still remains relevant today.

CDPRG director of research, Dr Toby Webster, commented: “We’ve taken [from the analysis] the already established lessons of how drug policy should be made if it is to have a chance of achieving its stated objectives.

“The drug strategy is more complete in some areas than others – there will be a considerable amount of ongoing development, particularly in those areas for which they didn’t carry out a decent, formal, independent consultation, which is essentially everything except for treatment for addiction.

“Carol Black’s review of drugs part 2 covered the treatment of addiction very thoroughly, and it was clearly a useful resource for the team drawing up this strategy, as is reflected in the quality and detail of the recommendations they make in this area. There remains the opportunity for more formal consultation to improve the plans that are still being drawn up, and this is something we will be advocating for.

“As we engage with the ongoing development of the drug strategy, we hope to emphasise the principles of good governance that we present in our report, and we hope that this can be of some use – good policymaking processes lead to better policies, and this is what we hope to see.

“We are overall optimistic that there is an understanding that evaluating these policies properly, and having proper accountability, is key to making sure that we don’t continue the failings of the past, and we hope that this is maintained.

“We hope that the government’s commitment to evaluation and developing more sensible outcome measures leads to a willingness to admit and learn from mistakes, and change course if efforts are not working”.

The Government’s aim in its new strategy to help people reduce their reliance on addictive substances has generally been welcomed, but evidence-based drug reform groups said the new measures did not go far enough.

Drug Science urged the Government “to change its approach completely, and to adopt a rational, evidence-based approach of drug control”.

Responses also raised concerns that many of the initiatives listed are against evidence and will cause further harm.

See also  Reform organisations respond to new UK drug strategy

This sentiment from MPs and reform groups is an echo of the UK public’s views, with public polling from 2019 showing that only one in four adults believe current UK drug policy is effective at preventing harm to health and wellbeing, and three in four believe that criminal sanctions do not deter either drug use or supply. 

Additionally, a public survey carried out by YouGov earlier this year showed majority support for the rescheduling of psilocybin for research and medical purposes.

“The UK has made insufficient efforts to keep regulations up to date with the evidence base, and has been slow to respond to emerging information,” states the report.

See also  Majority in favour of changing law to boost psilocybin research in UK

Reforming the policymaking process

The report underlines the need for the UK to rewrite the policymaking process itself, saying that a methodologically flawed process sits behind the UK’s drug crisis.

Chair of the CDPRG MP Crispin Blunt says reforming this process is a “crucial foundation for producing better drug policy in years to come”.

Highlighting the inadequate capacity to carry out research that can inform policy creation as the principal problem, the report puts forward recommendations on how this can be changed.

“This is compounded by there being no specification on the extent to which policymaking must make use of evidence,” it states.

“COVID-19 has irrevocably increased awareness that the political and collective response to public health crises is best when guided by good science.”

However, the Government currently does not extend this to its drugs policy.

The 23 recommendations include suggestions to: 

  • Develop a National Drug Research Strategy
  • Establish a National Institute for Drug Science to coordinate research into substance misuse
  • Pilot schemes of new and innovative approaches such as harm reduction initiatives

They also include recommendations to ensure the Ten Year Drug Strategy is effective, suggesting that:

  • It should define specific, measurable and achievable goals, so that it can be clearly evaluated and held to account
  • It should include a robust outcome framework with evidence-based logic models informed by an open consultation 
  • It should clearly and simply outline the responsibilities of every involved department for achieving each specific commitment, and
  • It should outline the total projected expenditure including budgetary commitments of each spending department, and any funding which is to be ring-fenced for specific purposes

MP Crispin Blunt commented: “UK drug policy frequently misses its mark and our outcomes are among the worst in Europe for good reason.

“It has been apparent for some time that the way we make drug policy is not fit for purpose – indeed it is often chaotic and contradictory, barely evaluated, and with a distinct lack of senior accountability for the failures it has produced. This leads to an endless repetition of the same worn-out approaches, and outright denial from the top as they persist with strategies and legislation that has barely changed in 60 years.

“I am pleased to present our new report that shows in detail how poor policymaking has led to poor policies and poor outcomes, and recommends some steps towards improving this process.

“We are glad to see some acknowledgements of past failures in the government’s new drug strategy, and some more emphasis on data and evidence in taking the next few steps, but it remains to be seen if this will translate into concrete action.”

See also  Calls for UK Government to pilot Overdose Prevention Centres

Hindering scientific research

The new report highlights the current renaissance in psychedelic research – much of which, after 50 years of scientific censorship, is gleaning new insights into addiction and resistant mental health conditions. 

It notes the current barriers around the research of psychedelics such as psilocybin and MDMA in the UK – pointing out the multibillion market that is developing in this area across the globe.

“With over 50 psychedelics companies publicly listed across a number of exchanges, including the NYSE and NASDAQ, their combined market caps exceed $6bn,” states the report. 

“One of the largest of these companies is the UK-based Compass Pathways, but despite this and due to the harsh regulatory environment, there are currently no psychedelic companies at all listed on the London stock exchange.”

The CDPRG’s report, ‘Medicinal Use of Psilocybin’ shows there is little evidence of a social benefit to the current controls, and that there is now clear evidence these controls have actually slowed the development of new medicines.

The organisation, which has been campaigning for 24 months to reschedule psilocybin from Schedule 1 to Schedule 2, stated: “Returning to the ‘moral purpose’ and the spirit in which they were written, our drug laws should not inhibit the development of medicines.”

It continues: “The Home Office has been resistant to consulting the ACMD on the aforementioned scheduling of psilocybin for the purposes of facilitating medical research in the substance in the UK, despite the Home Office confirming that the substance (and a number of other controlled drugs) have not been subject to analysis or recent analysis of harm.

“The issue of the relationship between the Home Office, ACMD and use of evidence, in general, is contentious, with concerns that short term political priorities are taking precedence over evidence.”

To read the full report please visit: www.cdprg.co.uk

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Markets & Industry

FDA Grants Breakthrough Therapy Designation to Beckley and Atai’s 5-MeO-DMT Program

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Last week, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to 5-MeO-DMT, also known as toad venom, in a significant advancement for psychedelic medicine.

The designation was given to BPL-003, a novel intranasal formulation of 5-MeO-DMT developed by Atai Life Sciences and Beckley Psytech. 

The decision by the regulatory body aims to expedite the development of BPL-003 as a treatment for adults with treatment-resistant depression (TRD), a condition affecting up to 30% of the 280 million individuals worldwide living with depression.

The FDA’s decision follows promising results from a Phase 2b clinical trial, which demonstrated that a single dose of BPL-003 led to rapid and sustained reductions in depressive symptoms within 24 hours, with effects lasting up to eight weeks. Notably, the majority of participants were ready for discharge just 90 minutes post-treatment, highlighting the potential for a scalable, in-clinic treatment model.

5-MeO-DMT is a naturally occurring psychedelic compound found in several species. It is most famously present in the venom of the Incilius alvarius (Sonoran Desert toad), as well as in other Bufo toads. It also occurs in certain plants, including Virola species and Anadenanthera peregrina.

The companies state that BPL-003 is designed to deliver rapid and durable antidepressant effects from a single dose with a short therapeutic experience. The Breakthrough Therapy Designation facilitates intensive FDA guidance to support the advancement of BPL-003, with Phase 3 trials expected to initiate in the second quarter of 2026, subject to alignment with the FDA.

Other Breakthrough Therapy Designations in Psychedelic Compounds

The FDA has previously granted Breakthrough Therapy Designations to other psychedelic compounds, underscoring the growing recognition of psychedelics in mental health treatment:

  • Psilocybin: In 2018, the FDA granted Breakthrough Therapy Designation to psilocybin for the treatment of treatment-resistant depression. A second designation followed in 2019 for major depressive disorder. 
  • MDMA: In 2017, the FDA designated MDMA as a Breakthrough Therapy for the treatment of post-traumatic stress disorder (PTSD). 
  • LSD: In March 2024, the FDA granted Breakthrough Therapy Designation to an LSD compound for the treatment of generalized anxiety disorder (GAD), based on Phase 2b trial data showing rapid and sustained improvements in anxiety symptoms.

Global 5-MeO-DMT Research Landscape

Beyond BPL-003, several organizations are exploring 5-MeO-DMT’s therapeutic potential:

  • The Usona Institute has completed a phase 1 study of 5-MeO-DMT and is currently analyzing the results.
  • GH Research is currently studying a 5-MeO-DMT compound for treatment-resistant depression and is in phase 2 trials.

These initiatives reflect a global interest in harnessing the therapeutic potential of 5-MeO-DMT for various mental health conditions.

The FDA’s Breakthrough Therapy Designation for BPL-003 marks a pivotal moment in the development of psychedelic-based treatments for mental health disorders. With ongoing clinical trials and increasing regulatory support, 5-MeO-DMT is emerging as a promising candidate in the evolving landscape of psychiatric medicine.

Original picture by Alan Schmierer on Wikimedia Commons. Edited using AI tools.

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Insight

Is Ketamine Therapy Only Reaching The Wealthy? Dr. Celia Morgan On Expanding Equitable Access

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Dr. Celia Morgan is one of the UK’s leading figures in ketamine and psychedelic research, especially in the domain of addiction and mental health.

Based at the University of Exeter, she holds the Chair of Psychopharmacology and leads trials exploring how ketamine, paired with psychotherapy, can break cycles of relapse in substance misuse.

Morgan has led some of the largest clinical trials on ketamine-assisted therapy for alcohol use disorder and will be speaking at the upcoming PSYCH Symposium: London 2025, to be held at Conway Hall on December 4.

“I think that the most promising findings from our work with ketamine are of the sense of agency and autonomy in their recovery that the people we are working with experience,” she told Psychedelic Health in a written interview.

Still, she thinks several key challenges need to be tackled for these treatments to be able to reach more people. One of the biggest of such challenges is ensuring equitable access to these treatments.

“We see a relatively homogenous and privileged group in most studies, our work has tried to address this,” she said.

Building the infrastructure to safely deliver these treatments in public healthcare systems is another big challenge for the industry, she said.

Yet the healthcare sector can also take advantage of Ketamine’s regulated status to allow for a faster roll-out, when compared to other psychedelics like MDMA or psilocybin.

“Some of the recent recommendations by the Royal College fo Psychiatrists are steps on the way towards more widespread use,” she said.

What distinguishes Morgan in the psychedelics field is her dual commitment. She studies the risks and harms of recreational ketamine use while simultaneously designing controlled, clinical applications for it.

One of her flagship projects is Exeter’s KARE trial (Ketamine for Reduction of Alcohol Relapse), which blends ketamine infusions with psychotherapy for patients with alcohol use disorder. Early published data show dramatic improvements in abstinence rates during six-month follow-ups, far exceeding baseline relapse rates. Morgan has also worked on trials for gambling disorder and other behavioral addictions, expanding the frontier of what ketamine-assisted therapy might treat.

Morgan also plays a role in academia’s response to the psychedelic renaissance, she’s a co-lead on Exeter’s postgraduate certificate in psychedelic studies, a program designed to train clinicians, researchers, and therapists in the science and ethics of psychedelic medicine.

“I think its important to keep on with our efforts to study, regulate and roll out these treatments principally for the patients who might benefit from psychedelics as I have seen first hand in my work,” she said.

Picture is extracted from an interview with Dr. Morgan at PSYCH Symposium’s 2022 edition.

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News

Germany Pioneers Compassionate Psilocybin Access for Treatment-Resistant Depression in EU First

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By Jody Chu and James Bunn.

Germany has recently taken a landmark step by introducing compassionate access to psilocybin for patients with treatment-resistant depression (TRD), marking the first such programme in the European Union. This initiative allows eligible patients to receive psilocybin treatment outside of clinical trials under a legal framework designed for compassionate use.

Founder of Drug Science – Prof David Nutt says “It is pleasing to see such a rational development in the provision of proven therapy to people who have failed conventional treatments. I see no reason why the UK should not follow suit.

Compassionate access is a programme that permits patients with severe or life-threatening conditions—for whom standard treatments have failed and clinical trial participation is not feasible—to receive unapproved substances still in development.

In Germany, authorised by the Federal Institute for Drugs and Medical Devices (BfArM), the Central Institute of Mental Health (CIMH) in Mannheim and the OVID Clinic in Berlin are now licensed to offer psilocybin therapy to eligible patients. Led by Gerhard Gründer in collaboration with Filament Health, which will supply its psilocybin candidate, these two clinics are currently the only sites approved to provide psilocybin under this framework.

How the Programme Works

The programme emerged from years of clinical research demonstrating psilocybin’s potential for TRD, following Germany’s participation in major Phase 2 and Phase 3 studies, including the EPIsoDE trial. Approximately 20-30% of people diagnosed with depression are affected by TRD. Recognising that some patients could not access ongoing trials but faced urgent unmet medical needs, clinicians sought a pathway for legal treatment outside the traditional drug approval system. While similar psilocybin compassionate access programmes exist in Canada, Israel, and Switzerland, Germany sets itself apart by granting licensed psychiatrists the discretion to offer psilocybin on a case-by-case basis, as well as exempting approval for repeat treatments.

Eligibility & Treatment Protocol

Under the German model, patients must:

  • Have failed at least two standard antidepressant therapies.
  • Be ineligible for relevant clinical trials.

Psychiatrists at CIMH or OVID assess eligibility, oversee preparation, and supervise each dosing session. Psilocybin is administered in a controlled setting with two trained healthcare professionals, including a physician, followed by integration therapy to support psychological processing and minimise risks.

The Psilocybin-based medical product being provided is specifically Filament Health’s botanical formulation PEX010.

Crucially, the compassionate use framework operates outside the formal drug approval process and does not grant psilocybin market authorisation. Instead, it allows temporary, exceptional access under medical supervision. To improve accessibility for patients, the psilocybin itself is supplied free of charge by Filament Health, while overall treatment costs are typically covered by the patient’s health insurance. Early estimates suggest the programme can accommodate roughly 50 patients in its first year due to resource and staffing constraints, though demand is expected to be significantly higher.

 

Key Considerations

  • The compassionate use framework operates outside formal drug approval and does not grant psilocybin market authorisation.
  • Filament Health supplies psilocybin free of charge, while treatment costs are typically covered by health insurance.
  • Due to staffing constraints, the programme may only accommodate around 50 patients in its first year, though demand is expected to be far higher.

Implications for Psychiatry & Drug Policy

  1. Immediate Relief for TRD Patients – Provides an option for those with no alternatives while awaiting potential European Medicines Agency approval in coming years.
  2. Real-World Data Collection – Offers insights into psilocybin’s safety and efficacy in clinical settings.
  3. Foundation for Future Integration – Establishes clinical protocols, training pathways, and ethical guidelines for psychedelic therapies beyond trials.

By balancing compassionate access with strict oversight, Germany has created a model that offers hope while maintaining scientific rigour—a cautious yet significant step toward broader medical acceptance of psilocybin.

 

This article was written by Jody Chu and James Bunn and originally published at Drug Science UK.

Photo by Maheshkumar Painam on Unsplash.

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