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Could UK patients access psychedelic therapies before Europe?

The UK Government has announced a new drug authorisation model that could see the introduction of psychedelic therapies ahead of the EU.

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UK MPs demand answers Drugs Minister dodges psilocybin debate

Psychedelic-assisted therapies could hit UK markets sooner than expected – and sooner than may happen in Europe – under a new government funding plan for innovative drugs.

The UK’s HM Treasury has announced £10 million in funding for the Medicines and Healthcare products Regulatory Agency (MHRA). 

The funding, which will be provided over the next two years, will be used to accelerate routes for bringing innovative medical products developed in the UK onto the market. 

Additionally, and what could be the most impactful development for psychedelic therapies in the UK, the funding will also accelerate drugs to the UK market that have been made and approved by other trusted regulatory partners globally. 

A trusted recognition framework

With the new funding supporting the establishment of an international recognition framework, the Government has stated that this will allow the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners and provide patients with fast-track access to best-in-class medical products that have been approved in other countries.

As recently highlighted by Brian Barnett from US-based Cleveland Clinic in his co-authored article “Psychedelic Medicine’s Future Depends on Proactive Development of a Robust Medical Billing and Coding Strategy”, which has been published in the inaugural issue of Psychedelic Medicine, investigational psychedelic therapies are likely to begin gaining regulatory approval as medical treatments in the US within the next two years.

This may mean that UK patients could see access to psychedelic therapies sooner than anticipated, as some of these therapies, such as MAPS’ MDMA-assisted therapy and COMPASS Pathways’ psilocybin-assisted therapy, which have both been granted FDA Breakthrough Therapy designation, may receive FDA approval in the United States in this projected time frame.

See also  Billing and coding system needed for US psychedelic therapies

Professor David Nutt, Chair of Psychedelic Access and Research European Alliance (PAREA), commented: “Myself and most UK experts think this represents an acceptance that the MHRA isn’t able to fulfill its traditional role since Brexit.

“I think it might be good news for MAPS and COMPASS Pathways in that if the FDA approves their products then likely the MHRA will accept rather than ask for more trials. However, we then have the issue of getting the price down to a level that NICE will approve.”

UK non-profit Drug Science commented: “Drug Science welcomes the recent government announcement. However, we hope that the regulators do not hold psychedelics to a different standard just because of their international scheduling.

“If MDMA receives market authorisation in the US in the coming years, it ought to be eligible for this accelerated pathway.”

The pressing need for drug policy review

Timmy Davis of the Conservative Drug Policy Reform Group (CDPRG) has welcomed the news as a positive development for patients but highlights that the issue of rescheduling psychedelic compounds remains.

Davis commented: “This is a really interesting development, that I am happy to see. 

“While I welcome the fact that what’s been announced will probably lead to expedited access to medicines from the psychedelics in the UK, it leaves the lack of an evidence base for their class and schedule unaddressed and perpetuates 50 years of differential prohibition. 

“There is no scientific rationale underpinning the drug laws in the UK. This is particularly stark in the case of psilocybin which has consistently been found to be one of the safest of the controlled drugs to users and society. 

“No review of the evidence has ever been conducted, so while this may be a positive step towards patients gaining access, the other uses of psychedelics will remain criminalised. With the exception of alcohol and tobacco, the only way to access drugs of any sort remains medical. 

“While this remains the case, those of us without a psychiatric diagnosis indicated for psychedelic-assisted therapy will not be able to access and benefit from the multiple uses of these substances. 

“It is exciting that these prohibited substances are being recognised as having medical potential but it’s important not to lose sight of the context – the harms of prohibitionist drug policies are serious and extend beyond the psychedelics.”

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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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Policy

Transform Drugs releases groundbreaking book: How to regulate psychedelics

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Transform Drugs releases book: How to regulate psychedelics

UK charity Transform Drug Policy Foundation has published a new book ‘How to Regulate Psychedelics: A Practical Guide’ that sets out how psychedelics can be legalised and regulated for non-medical adult use.

While an increasing amount of research is pointing to the potentially beneficial effects of psychedelic treatment on mental health conditions, many people across the globe are using psychedelics outside of the clinical setting.

The book includes a set of proposals for post-prohibition policies, covering psychedelics including psilocybin, LSD, DMT and Mescaline. 

Previously, Transform’s guides on regulating stimulants and cannabis have been used to advise governments around the world on drug policy. This book seeks to inform the debates on psychedelic drug reforms taking place across the world.

Co-author and Public Affairs and Policy Manager at Transform Drug Policy Foundation, Ester Kincová, stated: “Despite psychedelic drugs being illegal, their non-medical use within society has been steadily increasing. 

“Punitive enforcement has not decreased use or eliminated supply, but it has made use more unsafe. 

“Legalising and regulating psychedelics is a pragmatic move to reduce harm. This is no longer a theoretical debate, states in the US are already recognising the need and  making moves to regulate for non-medical adult use.”

Scientific Chair of Drug Science, Professor David Nutt, added: “Once again Transform have come up with a well thought out and practical plan for the regulation of another group of currently illegal drugs – in this case psychedelics. 

“Their ideas would be both easy to implement and to engage with and will, if adopted, radically enhance the safe use of these remarkable agents.”

Proposals for regulation

The book includes a four-tiered regulation model “that attempts to manage the variety of psychedelic preparations and the different ways in which they are used”.

These include:

  • Private use, home cultivation, foraging and not-for-profit sharing.
  • Membership-based non-for-profit associations for plant-based products.
  • Licensed production and retail adaptable to different products and environments
  • Regulated commercial guided or supervised use

Additionally, a decriminalisation model is proposed which suggests that possession for personal use should no longer be an offence of any kind or be subject to any sanctions; Drugs for personal use should not be confiscated; cultivation of small amounts of plant-based drugs for personal use should be decriminalised, among other suggestions.

The book also includes topics such as embedding social justice, equity and human rights into policy design, how to think about psychedelics regulation, why regulate psychedelics and why now, and psychedelics and the UN drug treaties.

To read the book, please visit transformdrugs.org/.

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Policy

Oakland ballot seeks to legalise medical psychedelics

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Oakland ballot seeks to legalise medical psychedelics

Activists in Oakland have filed a ballot that seeks to legalise safe and legal access to psychedelics for therapeutic uses. 

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.

See also  Australia reschedules psilocybin and MDMA

Additionally, it would create a statewide framework for regulating the possession, use, cultivation and production of substances for medical and therapeutic use.

The initiative has been introduced by proponent and founder of the Oakland-based Church of Ambrosia, Dave Hodges, to the California Attorney General’s office for the 2024 ballot, and will need 546,651 valid signatures to qualify.

See also  CDPRG discusses the UK's Reschedule Psilocybin campaign

The filing follows California Governor Gavin Newsom’s recent veto of Senate Bill 58, the bill that sought to decriminalise the use of certain psychedelic drugs. 

Hodges emphasised that SB58 would have been a step forward, but that it had major flaws concerning its lack of provisions to ensure access, public safety and quality control. That veto, Hodges said, compelled him to move quickly on the initiative filing.

When the California Attorney General certifies the initiative for circulation, backers will have about four and a half months to gather the required signatures for ballot placement. 

Signature collecting will begin in early December.

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