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Media Report: EU bodies provide perspective on regulation of psychedelics



Psychedelic Health UK report

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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Lykos In Patent Mode On MDMA




We don’t believe in taking out IP on MDMA

We don’t believe in taking out IP on MDMA

We don’t believe in taking out IP on MDMA

We don’t believe in taking out IP on MDMA

oh actually we do



Double Blind

In a shocking move that contradicts its previous stance on intellectual property, Lykos Therapeutics (formerly known as MAPS PBC) — the organization leading the movement to legalize MDMAassisted therapy — has filed multiple patent applications for specific forms and formulations of MDMA. Prior to this revelation, which was first reported on by Psychedelic Alpha, Lykos had long been praised in the psychedelic community and media for its “altruistic stance” in not seeking patent protections as part of its strategy, instead choosing to publish its research findings in scientific literature.

MAPS’s anti-patent stance, which intended to prevent MDMA from being monopolized, stood in stark contrast to the aggressive patent strategies of competitors like Compass Pathways and Atai Life Sciences. Rick Doblins, the founder of MAPS, had been analyzing the non-patentable status of MDMA since the late ‘80s, and in an article titled “MDMA Patentability and Orphan Drug Designation,” published in 1992, he wrote:

“It could be a major setback if MAPS funded MDMA research and secured approval for its medical use only to have someone else control it through an inexpensively obtained use patent.”

Read more

Lykos Therapeutics Quietly Moves to Patent MDMA


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Press Release: PsychedelicNewsWire Named Official Media Sponsor of the 4th Annual Psychedelic Therapeutics and Drug Development Conference




LOS ANGELES, May 17, 2024 (GLOBE NEWSWIRE) — PsychedelicNewsWire (“PNW”), a specialized communications platform for the psychedelics sector and one of the 60+ brands powered by IBN (“InvestorBrandNetwork”), is pleased to announce that it will be the Official Media Sponsor for the 4th Annual Psychedelic Therapeutics and Drug Development Conference (“the conference”), an industry flagship event dedicated to research and development of psychedelics in the healthcare space hosted by Arrowhead SciTech Conferences & Events (“Arrowhead”). The event will be held at the iconic Revere Hotel Boston Common, 200 Stuart Street, Boston, MA 02116 on 23-24 May 2024

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individualized treatment

Risks of Psychedelics for People with Personality Disorders




While psychedelics have shown promise in treating certain mental health conditions, a recent study suggests they may pose risks for individuals with personality disorders. The findings underscore the importance of careful screening and personalized approaches in psychedelic-assisted therapy.

Navigating the Psychedelic Landscape: Potential Risks for Individuals with Personality Disorders

Psychedelics, including substances like psilocybin and LSD, have gained significant traction in recent years for their potential therapeutic benefits in treating mental health conditions such as depression, anxiety, and PTSD. However, a recent publication in the Journal of Psychopharmacology has raised concerns about the suitability of these substances for individuals with personality disorders.

The study surveyed individuals who had used psychedelics and who were also diagnosed with personality disorders. A considerable number of respondents reported negative and persistent psychological impacts following their psychedelic experiences. Notably, these included heightened anxiety, paranoia, mood instability, and an exacerbation of existing personality disorder symptoms.

Researchers suggest that the vulnerability of individuals with personality disorders to the adverse effects of psychedelics may stem from pre-existing challenges in emotional regulation, self-identity, and interpersonal relationships. The profound and introspective nature of psychedelic experiences can intensify these issues, potentially leading to psychological distress and symptom aggravation.

This research highlights the critical need for thorough screening and assessment in the context of psychedelic-assisted therapy. It suggests that individuals with personality disorders might require tailored therapeutic approaches and robust support systems to navigate potential risks and to secure safe and positive outcomes.

Why It Matters

The burgeoning interest in psychedelic therapy underscores the necessity to discern both the potential benefits and risks across different demographic groups. This study contributes valuable insights, particularly for clinicians and researchers, stressing the importance of personalized treatment plans and the cautious consideration of individual vulnerabilities when administering psychedelic-assisted therapy.

Potential Implications

The findings from this study emphasize the need for ethical and responsible practices within the field of psychedelic-assisted therapy. There is a pressing requirement for the development of detailed screening protocols that can identify individuals who may be more susceptible to the adverse effects of psychedelics. Furthermore, crafting specialized therapeutic strategies that cater specifically to the needs of individuals with personality disorders is essential for ensuring their safety and overall well-being during and after undergoing psychedelic experiences.

The Bigger Picture

The debate surrounding the therapeutic use of psychedelics is complex, with various factors influencing the suitability of these treatments for different individuals. While there are promising results in general populations, the nuanced needs and potential vulnerabilities of those with personality disorders require careful consideration to prevent harm and maximize therapeutic outcomes. This necessitates ongoing research, improved clinical protocols, and a commitment to patient-centered care in the burgeoning field of psychedelic medicine.

Source: Science Alert

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