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EU bodies provide perspective on regulation of psychedelics

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EU bodies provide perspective on regulation of psychedelics
Photo by Waldemar on Unsplash

In what marks an important development for Europe, a number of EU bodies have published a joint commentary in the world-leading medical journal, The Lancet, acknowledging the therapeutic potential of psychedelics. 

The European Medicines Agency (EMA), experts from the EU regulatory network and representatives from the European College of Neuropsychopharmacology (ECNP) have jointly issued the commentary.

Entitled ‘The Therapeutic Potential of Psychedelics: The European Regulatory Perspective’, the commentary explores classic psychedelics specifically – mescaline, DMT, LSD and psilocybin – as potential treatments for mental health conditions. 

See also  PAREA 2023: campaigning for psychedelic therapy in Europe 

The authors highlight that, with mental health problems affecting more than one in six people, this brings considerable economic costs that exceed 4% of gross domestic product across the EU. In this regard, they emphasise the need for effective and safe new treatments for mental disorders.

Exploring a number of challenges that will need to be addressed, the authors raise issues informed by work for the EMA, the EMA’s Central Nervous System Working Party and the ECNP.

See also  Discussing Alberta’s move to regulate psychedelic therapy

The Psychedelic Access and Research European Alliance (PAREA) has welcomed the development, which it describes as an “opportunity to open up an institutional debate about moving towards safe, effective and accessible adoption of psychedelic-assisted therapies in Europe.”

Research and clinical trials

Some of the key issues addressed by the authors include challenges with research methodology to enable valid efficacy estimations in clinical trials. 

The authors cover double blinding, the roles of positive and negative expectancy, and the use of independent, blinded external raters (including psychedelic naive patients).

Additionally, the need for investigation to establish optimum doses of psychedelics and individualised dosing, along with the relation between characteristics of the acute psychedelic experience and clinical improvement, are highlighted.

Regarding psychedelic-assisted psychotherapies, the authors note the need for trials to establish the added value of psychedelics compared with psychotherapy or psychological support alone, and that preparatory psychotherapy sessions should be investigated.

Barriers to research in Europe

Classic psychedelics all sit in Schedule 1 of the UN’s Convention on Psychotropic Substances of 1971, meaning it is currently extremely difficult to carry out research into the substances due to the costs associated with licensing.

The authors highlight this as another issue that needs to be addressed, suggesting that the UN’s classification of the substances may need to change due to their potential as a therapeutic, along with the fact that they do not show potential for addiction – one of the criteria a substance must meet to be classified in Schedule 1 of the Convention.

The authors state: “Classic psychedelics do not show potential for addiction and the justification for the UN schedule 1 classification (ie, drugs with “no currently accepted medical use and a high potential for abuse”), as adopted in the 1971 Convention on Psychotropic Substances, should be questioned by evidence of the therapeutic potential of psychedelics.”

Tadeusz Hawrot, Founder and Executive Director of PAREA, told Psychedelic Health: “The most restrictive scheduling of psychedelic compounds directly contributed to and reinforced a long scientific stagnation by detracting scientists from conducting research in this area. 

“Likewise, European governments and EU bodies have been discouraged from supporting psychedelics research. This lack of public funding has been further undermining the ability to pursue psychedelics research, especially for those scientists who are less resourced and are not affiliated with the industry. 

“Consequently, companies and private donors typically fund psychedelic trials and the regulatory constraints and patent incentives create a pharmaceutical landscape that privileges high-cost synthetic variants over existing substances.

“Relying predominantly on industry-supported research to achieve the regulatory approval is not an equitable solution to rescheduling psychedelics with medicinal properties and yet, currently approval of scheduled medicines (by regulators such as EMA) and rescheduling are effectively synonymous. 

“Psychedelics should have their classifications reviewed based on the recent scientific and medical progress, independent of their possible regulatory approval as medicines. The support from The Lancet commentary authors in this regard is much welcome.”

Regulating psychedelic therapy

As symbolised by recent developments – such as Australia’s rescheduling of MDMA and psilocybin for depression and PTSD, Canada’s inclusion of the latter on its Special Access Programme (SAP) and Colorado and Alberta’s moves to decriminalise psychedelics – the need to address regulation around psychedelics is becoming increasingly important. 

Under Australia’s new approach, any psychiatrist looking to prescribe psychedelic therapies will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.

In their Lancet commentary, the authors stipulate that given approval, regulation around psychedelics in Europe should see conditions and restrictions related to safe and effective use defined at the time of approval, and monitoring requirements in place before, during, and after administration of the substances.

Regulatory tools that could facilitate this include product characteristics, risk management plans and pharmacovigilance studies, along with educational materials, appropriate training and controlled access programmes.

The authors conclude: “The therapeutic potential of psychedelics has triggered new hopes and high expectations, but larger clinical trials are needed to further evaluate efficacy and safety. 

“A thorough scientific assessment of the benefit–risk balance will be required, as for any other medicines. 

“Developers are encouraged to engage early with the EMA through all available scientific and regulatory platforms in their efforts to overcome the challenges associated with the development of psychedelic treatments.”

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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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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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