Policy
New MHRA guidance will help with access to psychedelic medicines
Albert Labs has said it embraces the UK’s new guidance on Real-World data in clinical trials.

Published
2 years agoon

Albert Labs has highlighted that the UK’s new guidance on Real-World data will accelerate access to psychedelic treatments.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently confirmed that it would be updating its guidance on the use of Real-World data. It stated that the use of this data from clinical trials would help toward regulatory approval for new medicines at a faster pace.
Albert Labs, which is accelerating access to psychedelic-based medicines for patients with urgent and unmet needs, has said that this new guidance is consistent with its strategy. The company is one of the first psychedelic drug development companies to use a Real World Evidence (RWE) approach for regulatory approval.
Dr Malcolm Barratt-Johnson, Albert Labs CMO, commented: “We embrace this regulatory guidance particularly in the investigation of psilocybin-assisted psychotherapy.
“Albert Labs consider that carefully designed pragmatic trials that implement a progressive use of Real-World evidence, will greatly advance the understanding of the safety, effectiveness, impact, and optimal clinical use of this new therapy.”
Albert Labs is pursuing the Real-World Data pathway in the licensing of their natural psilocybin medicine, which has been endorsed by leading hospital centres in the UK.
This expedited pathway offered by the UK regulatory system will accelerate access to treatment, benefiting patients, not only in the UK but the rest of Europe, Canada and the US.
The guidance emphasises that a study or studies considered under this guidance need to be of the same standard as would be expected from a traditional Randomised Control Trial (RCT), and further states that well-designed and conducted prospective RCTs provide a high level of evidence irrespective of the categorisation of the data source.
“Our approach, in the investigation of psilocybin-assisted therapy, has been designed to reduce risk, improve outcomes, and importantly to speed up access to those patients who will benefit from this therapy,” added Barratt-Johnson.
“We believe Real World Evidence will play a vital role in helping safeguard the development of this promising mental health treatment.”
Albert Labs says is following the MHRA’s guidance and taking the necessary regulatory and scientific steps required for authorisation of a new treatment using an RWE approach.
The trials are focused on early access to treatment and the company expects to treat patients suffering from cancer-related distress in the first half of 2022.
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Policy
Now is the time for psychedelic access, says campaigner

Published
2 weeks agoon
21st November 2023By
News Editor
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.”
Policy
Transform Drugs releases groundbreaking book: How to regulate psychedelics

Published
3 weeks agoon
15th November 2023
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/.
Policy
Oakland ballot seeks to legalise medical psychedelics

Published
1 month agoon
30th October 2023By
News Editor
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.
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.
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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