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

Published
4 months agoon

The Psychedelic Access and Research Alliance (PAREA) has released a position statement calling on the EU to harness psychedelics in a bid to create innovation in the area of mental health treatments and make the Union a leader in biomedicines.
Data shows that in 2019, 7.2 % of the EU population aged 15 years and older were living with chronic depression. However, mental health treatment in Europe has seen little to no innovation in decades.
Highlighting that the right to innovation is enshrined in the European Charter of Patients’ Rights, the position statement is a response to the EU Pharmaceutical Package revision and extends its reach to cover the full lifecycle of medicines, underscoring the urgent need to incentivise the development of novel mental health treatments.
The revision package was put forward in April 2023, and is a bid to overhaul current pharmaceutical legislation to ensure the supply of medicines and their availability to patients in the EU in light of growing problems with medication shortages.
PAREA argues that psychedelics should be at the forefront of the EU’s mental health efforts, highlighting how psychedelic therapies have shown promising clinical results as potential treatments for several mental health conditions and substance use disorders.
The organisation, which campaigns for advancing psychedelic therapies and research in Europe, states: “PAREA calls for the review of EU pharmaceutical legislation to be leveraged as a critical tool to foster innovation and support the development and deployment of innovative mental health treatments. Psychedelic therapies, with their potential to revolutionise mental health care, should be at the forefront of this effort.
“This approach can position the EU as a global leader in this field and enhance the EU’s biomedical capabilities.”
Speaking at PSYCH Symposium, Tadeusz Hawrot, Founder and Executive Director of PAREA, described the EU Pharmaceutical Package revision as a “once-in-a-generation reform”.
“…It will have significant consequences both in Europe and also globally for decades for free trade agreements,” said Tadeusz on the Symposium panel ‘The Future of Psychedelic Medicine in the EU’.
“We have this kind of EU legislative superstructure and single market and we have this mechanism for regulatory approval of new drugs which is centralised. However, then there are all the diverging healthcare systems underneath and pricing reimbursement, and ultimately access decisions are done Member State by Member State…
“The pharma revision is there to change it. On the one hand, the ambition is to kind of normalise access across the EU and the second goal … is stimulating innovation in the area of high unmet needs.”
Deirdre Ryan, Pain Alliance Europe (PAE) President and Vice-Chair of PAREA, commented: “European medicines reform must prioritise meaningful, needs-driven innovation that places patient and public health at the forefront. Millions of Europeans with mental health conditions have been left in the dark with a lack of new developments in treatment, with many barriers and stigma to access psychological interventions.
“While not a cure-all, psychedelic-assisted therapies offer a long-term novel approach that doesn’t at present fit within the current structures of EU regulation or safety protocols. This needs to change.
“With many shortages and profound unmet need, the EU Pharmaceutical strategy needs to adapt and modernise. PAREA’s position statement outlines the full lifecycle of medicines, from research and development to patient access.”
PAREA’s position statement explores the unique challenges faced by psychedelic therapies which have seen 50 years of stigma, contributing to one of the largest censorships of scientific research in history.
Highlighting a recent European Commission (EC) discussion paper, ‘Scoping study on evidence to tackle high-burden under-researched medical conditions’, which found mental health disorders as number one on a list of “high-burden under-researched medical conditions”, PAREA underscores the “shockingly low” number of EU-approved therapies for mental health.
“For instance, last year, none of the 89 new medicines recommended for approval by the EMA were for mental health conditions,” writes PAREA, noting that the EU does provide positive examples for incentivising funding.
“The EU has demonstrated a successful approach to incentivising R&D in the realm of orphan medicines. Since 2000, over 200 orphan medicines have been authorised for the benefit of patients suffering from rare diseases.”
PAREA also states its support for another EC discussion paper which proposes the development of a “graded classification” of unmet needs based on standardised criteria which could be used to guide government allocation of funding and medicine reimbursement.
To date, a major barrier for psychedelic research has been a lack of funding – with the majority of research being taken on privately.
PAREA’s position statement calls for the “infusion of public funds to make psychedelic research more equitable and inclusive, and for a comprehensive package of incentives for smaller developers.”
While these incentives will help foster innovation in mental healthcare, psychedelic research will also be supporting the EU’s ambitions to become a global leader in biosciences, says PAREA, as per the 2022 Versailles Declaration.
Among other incentives, the orgainsation is also calling for EU regulators to explore how academia and non-profit organisations can best contribute to the development of psychedelic innovative medicines, and how EU policies can favour an academic-driven pathway for their development.
To read the full statement and set of calls please click here.
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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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