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MEPs urge European regulators to move faster on psychedelics

The European Medicines Agency (EMA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) need to play a more active role in psychedelics, say MEPs.

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MEPs urge European regulators to move faster on psychedelics
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In two letters seen by Psychedelic Health, a cross-party group of MEPs has expressed concern over the lack of progress with the medical use of psychedelics in the EU.

Stating that this stagnation is creating a disadvantage for millions of Europeans affected by mental health conditions and substance use disorders, the MEPs have called on regulators to move faster on psychedelic healthcare in Europe.

The authors of the letters are urging the EMA to play a more active role in the advancement of psychedelic research and to work more closely with the EMCDDA.

The letters follow recent developments in Australia, which has made moves to increase access to psychedelic therapies for patients. The country will reclassify psilocybin and MDMA to enable prescribing by authorised psychiatrists from July 1, 2023, and the substances will be rescheduled from Schedule 9 of the Poisons Standard, which is prohibited substances, to Schedule 8, which is controlled drugs.

See also  EU bodies provide perspective on regulation of psychedelics

Additionally, in recent years, the US has granted Breakthrough Therapy Designation for MDMA-assisted therapy for PTSD and has funded psychedelic research with a USD $35 million grant, Canada has included psilocybin and MDMA on its Special Access Programme, and Alberta has moved to begin regulating psychedelic therapies.

The MEPs that have signed the letter include 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 scheduling of psychedelics

The MEPs highlight that, despite substances such as LSD, psilocybin, and MDMA being classified in the most restrictive category in the UN scheduling – alongside highly addictive drugs like crack cocaine – recent scientific research has shown psychedelic-assisted psychotherapies can be highly effective treatments for mental health conditions.

In this regard, the MEPs suggest that the EMCDDA is well positioned to foster discussions about the EU’s potential role in re-examining the scientific evidence behind the current scheduling of psychedelic compounds in the UN conventions.

See also  Global coalition launches to push for psilocybin rescheduling 

The authors write: “The most restrictive scheduling of psychedelic compounds reinforced misinformation and stigmatization, and directly contributed to a scientific stagnation by detracting scientists from conducting research on these substances.”

In Europe, more than 150 million people are affected by mental health conditions, however, there have been no new innovative treatments since the advent of SSRIs. This restrictive scheduling of psychedelic drugs means research into these compounds as innovative mental health treatments is challenging due to high licensing costs and lack of research funding. 

MEP Alex Agius Saliba, commented: “Just recently, the European Medicines Agency released an annual report about medicines considered for approval in 2022. Leading the list are over 20 new cancer and nearly 15 novel treatments for neurology approved last year. 

“While this is undoubtedly great news, at the same time I’m very worried that no single new treatment for mental health conditions obtained regulatory approval in 2022. We have high ambitions in Europe when it comes to health innovation and we must do better for people affected by mood disorders. 

“In this regard, one particular area which promises to offer true innovation is psychedelic novel treatments but Europe is lagging behind which is why, together with my other fellow Members of the European Parliament, we decided to send this letter to EMA and EMCDDA.”

Raising the profile of psychedelics

The MEPs have told Psychedelic Health that they will be working alongside European non-profit, the Psychedelic Access and Research European Alliance (PAREA), this year to raise awareness of scientific developments in the field of psychedelics.

Throughout 2023, PAREA aims to ramp up its campaigning for psychedelic advancement in Europe through education and engagement with European health organisations.

Member of the European Parliament and Head of the Polish S&D delegation, Robert Biedroń, commented: “In Europe, over 100 million citizens are affected by mental health conditions and substance use disorders. Unfortunately, treatment options for these diseases are still often suboptimal. 

See also  PAREA 2023: campaigning for psychedelic therapy in Europe 

“Many members of the European Parliament – including myself – recognise a tremendous potential of psychedelic-assisted therapies in addressing the huge unmet needs in those therapeutic areas. 

“This year, we will work with PAREA to establish an alliance of supportive parliamentarians to raise awareness in the European Parliament about those novel treatments and call upon the European Commission and EU member states to already start preparing for their likely approval by the European Medicines Agency in the coming years.”

PAREA Vice Chair and Executive Director of the European Brain Council, Frederic Destrebecq, added: “We are very pleased with this initiative from a cross-party group of MEPs who appreciate the important role that psychedelic-assisted therapies will likely play in addressing the pandemic levels of mental health and substance use disorders that we witness in Europe. 

“We share their sentiment that the EMA and EMCDDA should become more engaged in determining issues surrounding efficacy and safety of the medical use of psychedelic substances, the current regulatory frameworks applicable to using psychedelics in a medical context, and the potential implications psychedelic novel treatments will have for European healthcare systems. 

“This initiative is also timely because in May PAREA is organising a meeting with interested MEPs to explore building an alliance in the European Parliament.”

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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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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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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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