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Psychedelics advisory body needed in Europe, says PAREA

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Psychedelics advisory body needed in Europe, says PAREA
Photo by ALEXANDRE LALLEMAND on Unsplash

In a new policy briefing for the European Medicines Agency (EMA), Psychedelic Access and Research European Alliance (PAREA) has called for an advisory body on psychedelics to be established in Europe. 

Following an announcement earlier this year that the EMA would be holding a workshop on psychedelics in 2023, PAREA has prepared a policy brief outlining its recommendations and insights.

The brief, sent to the EMA this week, aims to guide preparations and discussions for the workshop. Tadeusz Hawrot, Founder and Director of PAREA, explains that it focuses on the importance of strategic planning, professional cohesion and the role of advisory bodies.

See also  Psychedelics should be at forefront of EU mental health efforts, urge PAREA

Marking an important step for psychedelics in Europe, the workshop will be held as a response to a letter from a group of cross-party MEPs calling for the EU to act fast on psychedelics.

Signatories of the letter included MEPs Alex Agius Saliba, Robert Biedroń and Sara Cerdas of S&D, Jarosław Duda of the EPP, Tilly Metz of the Greens and European Free Alliance, and Frédérique Ries of Renew Europe.

The letter followed news from countries such as Australia and the US which have begun making changes to drug policy to allow access to psychedelic therapies for patients in select circumstances. 

PAREA’s policy brief, as seen by POLITICO, suggests that experienced psychedelic users should be included on the advisory panel. Additionally, the brief emphasises the importance of centralised co-ordination as opposed to individual EU countries establishing their own working group.

In a public comment, Hawrot stated: “We advocate for the creation of a multidisciplinary advisory body to guide regulators and professionals on best practices and care standardisation. 

“We believe this body would benefit from the collective knowledge of various stakeholders, including the EMA, EMCDDA, national competent authorities, professional organizations, healthcare professionals and managers, psychedelic organizations, patients’ organizations, drug developers, and the wider community. 

“Centralised co-ordination would offer an efficient mechanism to propel the field forward, rather than individual EU countries initiating their own work groups.”

Hawrot highlighted the importance of this centralised co-ordination approach at the PSYCH Symposium in July.

“I think a non-psychedelic specific regulatory challenge is the fragmentation and health technology assessment processes where country by country, they have their own methodologies,” stated Hawrot.

“Luckily, the European Union is now working on harmonising this through the central HTA [Health Technology Assessment] process, which is a long journey – but there is a light at the end of the tunnel.”

Speaking from PAREA’s perspective, Hawrot also explained that Europe needs to look at the prescription use of psychedelics within the clinical context.

“The one challenge I see is combination therapy because, as we know, the EMA and the FDA don’t regulate clinical protocols [] so what we will need is an expert consensus on standards of care. Things like the treatment protocols, standards for the training of the therapist, ethical guidelines, and also data collection protocols,” said Hawrot.

“What we need here is this expert consensus bringing together professional organisations that already have well-established safeguards like psychologists and psychiatrists. Then also drug developers who have their own protocols, bringing in patients organisations and the whole community, and coming up with the standards that would make it much easier for the regulators to approve these treatments.” 

Watch the full PSYCH Symposium panel on Psychedelics in Europe – featuring Psychedelic Healthhere.

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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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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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