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Appeal launched for psychedelic therapies in Europe

PAREA has launched an appeal to the EU to help with the safe roll-out of psychedelic treatments in Europe.

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Appeal launched to EU for psychedelic therapies in Europe
Image provided by PAREA.

The Psychedelic Access and European Alliance (PAREA) has launched an appeal to European Union institutions and Member States for psychedelic-assisted therapies in Europe.

The appeal was launched at a meeting in the European Parliament on 6 December, entitled “Psychedelic-assisted therapies in the treatment of brain disorders”.

Over 400 people registered for the event including EU and government officials, which PAREA says is a clear sign that Europeans have started looking for “evidence-based education on psychedelic medicines”.

The meeting explored psychedelic-assisted therapies for the treatment of mental health conditions, substance use disorders and neurological conditions.

Expert members of PAREA in the field of psychedelic science made presentations on the current state of psychedelic research, including Tadeusz Hawrot, Founder and Policy Lead at PAREA; David Nutt, Professor of Neuropsychopharmacology Imperial College London; Anton Gomez-Escolar, MPH, MIR, MSc; and, Professor Dr Jan Ramaekers, Faculty of Psychology and Neuroscience, Maastricht University, The Netherlands.

PAREA has stated the launch of its appeal aims to further shape discussions on the responsible and safe roll-out of psychedelic treatments in the future.

Hawrot, told Psychedelic Health: “PAREA has been working hard in 2022 to raise awareness among the EU policymakers about the recent scientific and regulatory progress in the area of psychedelic science. This has now culminated in our first meeting organised in the European Parliament. 

“We feel we are now ready to start moving from education to proposing concrete actions. To this end, at the event, we launched our appeal to European policymakers presenting our policy recommendations that can facilitate safe, responsible and equitable rollout of psychedelic-assisted therapies.”

See also  Europe to establish regulatory guidance on psychedelics in 2024 

Innovating mental healthcare in Europe

There are currently around 100 million people living in Europe with a mental health condition, including addictions such as alcohol use disorder (AUD). 

With psychedelic therapies showing promise as potentially efficacious treatments for such conditions, more research will be needed into these compounds, along with discussions on how psychedelic-assisted therapies could be rolled out across European healthcare systems.

In its appeal, PAREA stated: “By and large, no new pharmaceutical treatments have emerged out of the pharmaceutical industry. We urgently need more innovation in these areas and psychedelic-assisted therapies (PATs) are emerging as a potent new class of treatments for mental, neurological and substance use disorders, as indicated by the rapidly growing, rigorous, and compelling body of research. 

“In conjunction with proper psychosocial support, they hold the potential to provide safe, rapid-acting, and robust clinical improvements with durable effects.”

PAREA highlights that the US expects psychedelic therapies with MDMA and psilocybin to be approved by the FDA by 2025 and that the EU may follow these developments.

To do this, PAREA recommends the development of infrastructure that could facilitate high quality, safe, affordable, and equitable access to psychedelic-assisted therapies, including the establishment of standards of practice, training of specialised therapists, credentialing and licensing, safe and ethical use monitoring and more.

However, PAREA states that EU regulators are not currently equipped to evaluate the combination of a drug and therapy: “…traditionally they have been assessing the safety and efficacy of medications alone. Therefore, a close collaboration with the regulatory agencies is needed to overcome this barrier.”

See also  Alberta to regulate psychedelic-assisted psychotherapy

Hawrot commented: “We believe that the best way forward is by establishing a European expert forum led by EU institutions and engaging a wide range of stakeholders spanning European governments, payers and health technology assessment bodies, patient organizations, scientists, doctors, psychedelic organizations active in research and education, relevant community-based services as well as industry voices. 

“Together, we can start establishing European guidelines that the governments could choose to follow as they put in place frameworks and structures to accommodate the medical use of psychedelics.”

To find out more about the meeting please visit the PAREA website at: parea.eu

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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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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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