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CDPRG discusses the UK’s Reschedule Psilocybin campaign

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CDPRG discusses the UK's Reschedule Psilocybin campaign
Image: provided by PAR Global. The UK's first ever psychedelics advert launched as part of the Reschedule Psilocybin campaign.

Timmy Davis of the Conservative Drug Policy Reform Group (CDPRG) tells Psychedelic Health about the organisation’s campaign to reschedule psilocybin in a bid to increase psychedelic research.

Currently in the UK psilocybin is categorised as a Schedule 1 drug under the Misuse of Drugs Act 2001 – the highest schedule alongside drugs such as raw opium and LSD. 

This status makes research into the substance incredibly challenging as financial costs for licensing and laboratory retrofitting can be costly. 

Although costly – some are successful in carrying out such research – and now, an increasing amount of studies are showing psychedelic compounds such as psilocybin, LSD, DMT and others as promising treatments for mental health conditions.

A recent debate in UK Parliament saw MP for Warrington North, Charlotte Nichols, lead calls for the rescheduling of psilocybin after describing her own experience living with PTSD as a “living hell”.

See also  UK MPs demand answers as Drugs Minister dodges psilocybin debate

The debate was the result of three years of campaigning from CDPRG and Psychedelic Access Rights (PAR Global), which has taken the form of parliamentary meetings and the launch of a petition that reached over 10,000. the campaign also saw the launch of The UK’s first-ever psychedelics advert that featured on a digital billboard in London.

Ahead of the debate, CDPRG and leading mental health charities – including Heroic Hearts, SANE, The Campaign Against Living Miserably – and organisations Drug Science and the Royal College of Psychiatrists, called on the ACMD to review psilocybin status as a Schedule 1 drug for research purposes. 

How did we get here?

Speaking to Psychedelic Health, Timmy Davis, Psychedelics Lead at CDPRG and Policy Director at PAR, explains that in 2019, due to a lack of action on psychedelic research, the Reschedule Psilocybin project was launched at Europe’s leading psychedelic conference, Breaking Convention.

See also  Breaking Convention: bringing together leading minds in psychedelics

Following this, in 2020 Davis, along with Manchester University Professor Jo Neill, Dr James Rucker and others in the CDPRG, collaborated with the Adam Smith Institute to compile the report ‘Medicinal Use of Psilocybin: Reducing restrictions on research and treatment’.  

The report highlights that in 2017 the Home Office commissioned the ACMD to review what could be done to facilitate research involving Schedule 1 controlled drugs. 

It states: “In December 2017, the ACMD proposed the creation of a temporary ‘research schedule’ with reduced regulatory requirements. Their recommendation was that Schedule 1 drugs proceeding into clinical trials could be moved to this novel schedule, provided that the drug sponsor issues a detailed investigator’s brochure and ethical committee approval to the Home Office, showing evidence of safety and tolerability. 

“Under this model, drugs that are not successfully brought to market would revert to Schedule 1 status.”

The authors go on to highlight that, in 2019 “a Home Office Minister of State, Nick Hurd, wrote to the Chair of the ACMD to reject the notion of a novel research schedule on the basis of a “heavy burden on legislative amendment time,” since Ministers would be required to consult with the ACMD every time a drug was moved into or out of the proposed schedule.”

Davis continues: “The Misuse of Drugs Regulations 2001, based upon the 1971 Misuse of Drugs Act stipulates the Schedules of controlled drugs and so who can prescribe them and how easy they are to research. At the time of the 1971 Act, psilocybin hadn’t had any application made to the MHRA requesting it be considered a medicine, so fell automatically within Class A and Schedule 1.”

Davis highlights that this decision was counter to the evidence which “hadn’t even been collected and considered”, leading to huge barriers to research for over 50 years. Other drugs such as heroin and cocaine fell under Schedule 2 as they were considered to have medical utility.” 

To add to these barriers, psilocybin and psychedelics across the board have carried a heavy stigma after years of media reports painting the compounds as dangerous – meaning many scientists have shied away from such research. 

“This is very frustrating for UK life sciences and bioscience research,” says Davis. “Also for the development of mental health treatments, and so, essentially, for patients.”

Championing patient access

In October 2022, the British Medical Association warned that the UK is facing a mental health crisis “that is spiralling out of control” and the UK government was failing patients due to a “system that is struggling to keep up with rising demand.”

The UK’s Office of National Statistics stated that between July 2019 and March 2020 prevalence of mental health conditions in the UK population was 10%, rising to 21% by January to March 2021 and dropping to 16% by June 2022.

Against this backdrop, the CDPRGUK is campaigning for patient access to psilocybin-assisted psychotherapy. 

“The government has commissioned the Advisory Council on the Misuse of Drugs (ACMD) to look into barriers to research, and this is really good because it means that if the recommendations are acted upon then research will be facilitated,” says Davis.

“That said, the evidence is there that psilocybin is in the wrong schedule, so hopefully the recommendations will reflect that rather than just changing the restrictions on Schedule 1 substances. 

“For the Home Office to reschedule psilocybin they will first have to review the evidence for its harms and medical utility.

“If the Home Office does review the evidence, regardless of the outcome, it shows that they have a commitment to evidence-based drug policy – but most importantly psilocybin’s current schedule is unjustified and should be modified to reflect the evidence, allowing the patients who are demanding access to have it prescribed to them by their psychiatrists.”

This sentiment is echoed by the UK public, with results from a YouGov survey revealing that 55% of respondents support relaxing restrictions on the medical use of psilocybin for mental health conditions if it didn’t affect how it was classified in criminal law. 

A total of 68% supported access to patients in palliative care when they learned patients in Canada were able to receive access under its Special Access Programme (SAP). 

Additionally, a recent CDPRG report – ‘Making UK Drug Policy A Success: Reforming The Policy Making Process’ – shows that the majority of MPs from all parties want evidence-based reform in the UK.

“We feel confident and are really excited to see how everything plays out – it is hard to find anyone who is against increasing access to those who need it,” Davis concludes.

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Policy

EMA workshop: One small step for Europe, one giant leap for psychedelics

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EMA workshop: One small step for Europe, one giant leap for psychedelics

In a watershed moment for psychedelics in Europe, the European Medicines Agency (EMA) held a workshop from 16 to 17 April to discuss regulatory guidelines for the development and therapeutic use of psychedelic medicines.

2024 is set to be an important year for psychedelics and the EMA multi-stakeholder workshop is just one of the key events kicking it into action.

The two-day workshop – Towards an EU Regulatory Framework – brought together patients, healthcare professionals, academia, regulators and industry.

As Europe risks lagging behind countries such as Australia and America in seizing the potential of psychedelics for mental health innovation, the meeting was held in response to a letter from a group of cross-party MEPs calling for the EU to act fast on these therapies.

See also  EMA adds psychedelics to major depression guidelines

The MEPs wrote to the EMA and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) to say the organizations need to play a more active role in the advancement of psychedelic medicines in Europe.

Highlighting that the recent shift in perspective towards psychedelics has garnered interest in Europe, the EMA has stated that concerns remain over challenges developers may face in meeting the scientific and regulatory expectations for receiving marketing authorisation for the medicines – holding the workshop as a starting point in working through these issues.

While the meeting marks one small, initial step for the EMA, the organisation’s interest in this developing field of research marks a giant leap for the advancement of the therapies in Europe.

Towards an EU regulatory framework for psychedelics

The meeting heard regulatory perspectives on psychedelic drugs in psychiatry from across Europe, Australia and America, as well as insights on the legal status of psychedelics and their impact on research.

Non-profit organisation PAREA highlighted how Europe is currently facing a mental health crisis with a desperate need for innovation in care, with not a single new medicine out of the 89 approved in 2022 targeting mental health.

The organisation emphasised the obstacles posed by regulation for scientific research and proposed a number of recommendations for a more supportive regulatory framework to help move psychedelic therapies forward, including:

  • Incentives such as regulatory protection: rescheduling psychedelic drugs to enable scientific research.
  • Enhanced EMA support: Utilising Europe’s PRIME scheme which focuses on medicines under development that are not yet authorised in the EU.
  • The establishment of an EU Commission on Novel Mental Health Therapies.
  • Accelerated assessments: Utilising Conditional Marketing Authorisation (CMA) and the EMA’s Adaptive Pathways programme for early patient access.
  • A more predictable reimbursement environment.

Speaking to Psychedelic Health, Tadeusz Hawrot, Founder and Director of PAREA, stated: “An importance of collaboration among different stakeholders felt central to the discussions, highlighting a need for joint effort to address the intricate issues surrounding psychedelic therapies.”

Building on the momentum created at the workshop, Hawrot said that PAREA will be exploring opportunities for a multistakeholder collaborative project as part of the Horizon Europe funding.

“The project would involve professional societies, patient groups, EMA and national competent authorities, addressing a number of most pressing topics related to psychedelic therapies at an intersection of regulation, science, and areas needed for implementing these therapies such as standards of care,” Hawrot explained.

“An upcoming EU Partnership on Brain Health will be an important opportunity to explore in this regard.”

Research and clinical trials

Further discussions focussed on methodological issues related to research and trials.

These surrounded issues with blinding and expectations, the importance of proper dosage justification and documenting dose-response relationships, as well as the need to investigate sub-psychedelic doses and their associations with psychoactive effects and neuroplasticity.

Hawrot commented: “In terms of some key areas addressed yesterday and today, discussion revolved around designing effective trials, the importance and type of therapeutic support, difficulties with using placebos, managing expectations, and how strict drug control policies are slowing down research.

“Exploring what can be standardised in trials, the crucial role of patient input and preferences, and the need for thorough aftercare provisions were further key points.”

The importance of Real World Evidence was also highlighted as a key path for advancing psychedelic therapies in Europe

Some implied next steps discussed were continuing dialogue between developers and regulators, seeking early feedback, and collaborating to address challenges in psychedelic drug development.

Patient representation and care

Ensuring the safe and effective use of psychedelic substances in clinical trials and real-world settings was also a main point of discussion, with patient representatives providing insight on their experience, as well as suggestions for patient care.

In particular, stakeholders including representatives of the Psychedelic Participant Advocacy Network (PsyPAN) highlighted the need for aftercare such as post-integrative therapy and peer support or professional guidance, however, it was also emphasised that these types of support are difficult to regulate.

The importance of patient involvement in research was also discussed, highlighting that patient involvement goes beyond study participation and includes a more active role in research design and decision-making.

Advancing innovation

Providing an environment where innovation can flourish will be vital for advancing psychedelics, and with companies already carrying out trails but hindered by strict regulations and expensive costs changes are needed sooner rather than later.

George McBride, Co-Founder of UK CMO Clerkenwell Health explained that the company is considering a significant investment into the EU to build out centres for the conduct of psychedelic research, querying the competitiveness of the EMA versus other jurisdictions such as the U.S FDA, Australia’s TGA, Health Canada and the UK’s MHRA.

EMA representatives provided assurance that the organisation is ready to be part of a collaborative and supportive effort to establish standards of care and standards for data gathering.

Speaking to Psychedelic Health, Stephen Murphy, CEO of PSYCH, commented: “This workshop is a key moment for the advancement of psychedelic medicines in Europe.

“The interest of the European Medicines Agency and the discussions in this week’s meeting highlights the organisation’s desire for innovation in mental healthcare and willingness to support psychedelic medicines through collaborative efforts.

“Taking action on psychedelic therapies now is a positive move towards preventative care in the area of mental health.

“We are pleased to see these developments at the start of 2024, which is set to be an important year for psychedelics across the globe.”

Harwot concluded: “The workshop made it clear that continuing conversations with regulators and developers and taking a measured approach to regulations are vital.

“It is very encouraging to see the degree of interest from EMA to explore the therapeutic potential of psychedelics and support developers in this field.”

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Policy

UK advisory body issues rapid response on psychedelics for anxiety

POST has confirmed it intends to publish a major briefing on psychedelic drugs to treat mental health conditions in 2024.

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Photo by Shreyas Sane on Unsplash

The UK’s independent Parliamentary Office of Science and Technology (POST) has issued a rapid response on psychedelic-assisted therapy for anxiety disorders.

The response is intended to inform policymakers on the topic as increasing research around psychedelics shows the compounds may hold promise as innovative treatments in the area of mental health.

The rapid response is the second response on psychedelics to come from POST – one of the first independent bodies of its kind in the world that sources independent analysis of public policy issues relating to science and tech for government.

See also  UK advisory body issues rapid response on psychedelic research

The response reads: “The social and economic costs of anxiety disorders in the UK are substantial, both for individuals and society. The Office for National Statistics reported that between 2019 and 2023, ‘depression, bad nerves and anxiety’ was the most prevalent health condition amongst those economically inactive because of long-term sickness.

“Beyond personal impacts, people with anxiety disorders account for a large amount of demand on healthcare. Consultations for GAD increased significantly between 1998 to 2018, and levels of anxiety were reported to increase during the COVID-19 pandemic.”

Responding to research and policy developments

Both rapid responses have been issued following a parliamentary debate discussing psilocybin access in May 2023.

The debate saw a group of crossparty MPs call for the rescheduling of psilocybin to remove barriers to research and demand an urgent review of the evidence for psilocybin’s current status as a Schedule 1 drug under the Misuse of Drugs Regulations 2001, “with a view to rescheduling”.

The Royal College of Psychiatrists, psychedelic access non-profit Heroic Hearts UK, and other leading mental health charities, also wrote letters to the Veterans Minister and the Minister of State for Crime, Policing and Fire, urging them to champion access for patients in the UK.

See also  UK MPs welcome psychedelic research, call for scheduling review

The rapid response covers psychedelics for anxiety including Treatment options for anxiety disorders, Lifestyle factors, Psychological treatments (psychotherapy), Pharmacological treatments, Psychedelic drugs for anxiety, Challenges in undertaking research involving psychedelics, Research examples and Ongoing research.

Joanna Neill, Professor of Psychopharmacology at the University of Manchester, acted as an external peer reviewer.

At the time of the first rapid response publication, speaking to Psychedelic Health, Neill commented: “It is very encouraging that Parliament is starting to engage with the enormous clinical potential of psychedelic medicine, particularly at a time when mental health disorders are at an all-time high.

“New therapies are urgently needed and psychedelics could provide just that. Given the weight of evidence presented in this new POST note, enabling safe patient access on the NHS must be a key priority for Parliament.”

POST has confirmed it intends to publish a major briefing on psychedelic drugs to treat mental health conditions in 2024.

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Policy

Now is the time for psychedelic access, says campaigner

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Now is the time for psychedelic access, says campaigner

Activists in Oakland recently filed a ballot put forward by Dave Hodges seeking to legalise safe and legal access to psychedelics for therapeutic uses. 

In the face of critics, Hodges has said now is the time for safe access to psychedelics.

The Psychedelic Wellness & Healing Initiative would enable the sale, possession and use of psychedelics for therapeutic purposes if passed. Psychedelics that would be allowed under the ballot include Psilocybin, MDMA, DMT, and Mescaline.

If passed, the initiative would give doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of problems, including obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), depression, anxiety, addiction, suicidality and traumatic brain injury (TBI), among others.

Hodges has said: “Now is the time for safe, controlled medical access for patients in need. The way to solve the problem is not by continuing to ignore it.” 

Hodges’ solution is to create a structure for use that includes proper dosages and access to experts who can help users benefit from appropriate treatment.

The updated initiative language emphasises safety, and gives doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of conditions.

Research by the University of Michigan and Columbia University shows non-LSD hallucinogenic use on the rise and Hodges has stated that increase means that the initiative providing guidelines for use is needed more than ever. 

Hodges said he hopes Californians will read the initiative, share their thoughts about it over the holiday week and offer feedback via the initiative website, PW4CA.com, by 27 November, 2023, the deadline for modifications.

“Now is the time to provide medical and therapeutic access to psychedelics,” Hodges said. “The way to do this is through the initiative.”

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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