Dear First name / Readers,

 

We are back after the summer break with a wealth of news from Europe and beyond. While the field of psychedelic science experienced a significant setback in the US with the recent FDA decision not to accept the NDA for the MDMA-assisted therapy for PTSD, Europe continues to see tremendous policy momentum surrounding psychedelic therapies. Notable advancements include the launch of the European Citizens Initiative PsychedeliCare, the EU Drug Agency’s release of FAQs on psychedelics, recent two EMA publications following the April workshop on psychedelics, and a study exploring European psychiatrists' attitudes toward psychedelics. You can learn more about all of these updates in the sections below.

 

In September, PAREA engaged with key European institutions to build political support for mental health and psychedelic therapies. Following the recent EU elections, we see fresh opportunities to re-engage with the European Parliament, Commission, and Council.

At the Commission, discussions focused on potential EU-funded future projects for psychedelic science.

 

Re-establishing the MEP Action Group on Psychedelic Therapies in the European Parliament is a top priority, and our meetings with new MEPs have laid the groundwork for its relaunch in the coming months.

 

On the Council front, PAREA met with health attachés from four EU Permanent Representations, advocating for stronger mental health innovation within the revision of the EU pharmaceutical legislation. PAREA’s proposed legislative amendments aimed at better incentives for R&I efforts in mental health and psychedelic science.

 

You can read more about the pharmaceutical package and PAREA’s work in POLITICO health coverage from 13th September.

 

During our time in Brussels last week, PAREA had engaging meetings with policymakers from eight countries - Spain, Hungary, Poland, Germany, Cyprus, the Czech Republic, the Netherlands, and Romania, ensuring a broad level of engagement and support across Europe.

 

Special thanks to FTI Consulting for their generous pro bono support to PAREA, helping us effectively navigate the Brussels EU bubble.

 

 

 

PAREA NEWS

On August 17-18, PAREA participated in the Hopkins-Oxford Psychedelic Ethics (HOPE) Summit in Washington, D.C., where PAREA’s Founder spoke about our ongoing work and the newly funded EU project on psychedelic therapies, PsyPal.

 

PsyPal places ethics at the centre and emphasizes independent ethical oversight, with an independent ethics advisor and ethics-related deliverables embedded in the project. PAREA believes this form of independent ethical supervision should be a core component of any major psychedelic therapy project or commercial activity in the field.

 

The HOPE Summit provided a valuable platform for connecting with key thought leaders, focusing on addressing challenges in the psychedelic field with an emphasis on action. The discussions underscored the importance of ethics, responsibility, and transparency.

 

For more on the HOPE Summit and its outcomes, visit the links below:

 

PAREA regrets the U.S. FDA recent decision to reject the new drug application for MDMA-assisted therapy for PTSD. The therapy has shown promising clinical trial results, offering hope for individuals suffering from treatment-resistant PTSD.

 

To address the key concerns raised by the FDA and its advisory committee ahead of the FDA decision, PAREA co-authored an extensive position statement. This document addresses issues such as regulating a treatment that combines MDMA and psychotherapy, blinding and expectation, misuse risks of MDMA, training of therapists, risks of therapist misconduct and boundary violations, uncertain long-term benefits, and the negative benefit-risk ratio.

 

Despite positive outcomes from rigorous studies demonstrating MDMA's potential to significantly reduce PTSD symptoms, the FDA's decision will delay access to a potentially life-changing therapy for many individuals in need and the refusal of this innovative treatment option highlights the ongoing challenges in getting psychedelic-assisted therapies approved for wider use.

 

For more information on the FDA's decision, you can access the full PAREA statement here.

The scale of human suffering caused by the war in Ukraine and the degree of unmet mental health needs create a sense of urgency and call for increased collaboration.

 

PAREA’s Founder visited Kyiv in August and signed a Memorandum of Understanding with the  Ukrainian Psychedelic Research Association (UPRA) in order to work together towards opening up safe and equitable access to psychedelics for people in Ukraine who have developed treatment-resistant PTSD. .It is impressive and encouraging to see the incredible work that UPRA and many other groups and individuals are doing to make this a reality.

 

During his visit, PAREA’s Founder also visited the Forest Glade veterans mental health centre, where a pilot study on MDMA-assisted therapy is being prepared, and met with its Director, Kseniia Voznitsyna. The study has been approved by the Health Ministry and will likely start in about half a year.

 

Following the June workshop “Psychedelics for Healing War-Induced Trauma” with Ukrainian participants and international experts that PAREA organized in Warsaw, PAREA is now creating several expert groups to support the progress taking place in Ukraine.

 

THE LATEST FROM EUROPE

The PsychedeliCare European Citizens’ Initiative has been officially registered by the European Commission.

 

The European Citizens' Initiative is a mechanism that allows EU citizens to propose new legislation by gathering one million signatures from at least seven EU Member States, prompting the European Commission to consider and potentially act on the initiative.

 

The PsychedeliCare calls on the Commission to:

The European Commission noted that this initiative aligns with current EU public health objectives, particularly in addressing mental health challenges.

 

PAREA has been pleased to support this initiative since its early stages and we assisted its leaders with developing the key asks.

 

What’s next? The PsychedeliCare team is preparing for the launch event which needs to take place within the next six months. After the launch, we will have one year to gather 1 million signatures across the 27 EU Member States.

 

The European Medicines Agency released the extensive meeting report from EMA April's multi-stakeholder workshop on psychedelics. PAREA contributed to its development.

The EMA has significantly increased its focus on psychedelic therapies recently, resulting in several publications where EMA experts discuss the opportunities and challenges in the field. This report is the most comprehensive and wide-encompassing state of play so far. It is structured around several key themes: regulatory perspectives and developments; methodological challenges; safety considerations; considerations and challenges for implementation, including EU-specific issues like Health Technology Assessment, funding opportunities, and compassionate use programs in Europe.

 

PAREA’s input into the April discussions is mentioned throughout the document, and our reflections are extensively quoted in discussions on legal classification. We highlighted an asymmetry in the drug scheduling system, where minimal anecdotal evidence can classify a substance as Schedule I, but extensive phase III clinical trial data is required to reconsider its classification. The current scheduling adversely affects progress towards equitable access to psychedelic therapies. The report adds that PAREA believes there is enough evidence to initiate a discussion on the rescheduling of psychedelics, a process that falls under the purview of the UN Commission on Narcotic Drugs.

 

The report mentions PAREA's recommendation to create a pan-European multidisciplinary advisory body to offer a comprehensive framework for addressing mental health innovation in the EU. This body could recommend care models for psychedelics, training and licensing standards, ethical guidelines, and safety standards.

 

Following the workshop, the EMA also published a comment in Lancet Psychiatry: “Applying the EU regulatory framework for the clinical use of psychedelics”. 

 

The European Union Drugs Agency (EUDA) has officially begun its work in Lisbon, taking over from the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). This transition, resulting from newly applied legislation, revises the EMCDDA mandate and formally establishes the EUDA. With enhanced tools and competencies, the EUDA aims to strengthen the EU's response to the health and security challenges posed by illicit drugs.

Following an external evaluation of the EMCDDA, the European Commission called for a broader, more proactive remit in January 2022 to address new challenges from potent emerging substances. The legislative process concluded in June 2023, setting the EMCDDA on a one-year course to becoming the EUDA.

 

The EUDA's mission is organized around four service categories:

New mechanisms include a European Drug Alert System for serious risks and a European Threat Assessment System to boost preparedness and response to health and security threats. The European Network of Forensic and Toxicological Laboratories will also support information exchange and training.

 

The European Union Drugs Agency has just released a FAQ document on the therapeutic use of psychedelic substances to enhance understanding of key developments, address policymakers' concerns, and provide insights into ongoing research. The document covers the therapeutic use and clinical research of psychedelics, as well as the prevalence and patterns of their use in Europe and the presence of unlicensed and illegal practices.

 

The FAQ highlights the difficulty of generalizing in this area due to the variety of substances and conditions under review. It addresses the risks of using psychedelics, noting an ongoing EUDA project aimed at better understanding the risks related to unregulated practices, such as those at retreats.

 

In terms of medical research, the FAQ points out that defining adjunct psychological interventions has been limited, complicating the distinction between the effects of the psychedelic substance and the associated therapy. This echoes similar concerns from the EMA.

 

The answer to the final question, “Are psychedelics already available for treatment in Europe?” also highlights that future key issues will include funding reimbursement. As medication or treatment reimbursement procedures and costs are country-specific, this will significantly impact the availability of any authorized medicine.

 

A recent study published in Nature Scientific Reports offers insights into the attitudes of European psychiatrists toward “psychedelic-assisted psychotherapy”. The study surveyed psychiatrists across 33 European countries, revealing that while there is a general openness to the potential of psychedelics in treatment, concerns remain about their associated risks.

Key findings include:

The Federal Agency for Disruptive Innovation (Sprind), located in Leipzig, Germany, aims to invigorate the economy through pioneering funding methods for breakthrough technologies. Sprind's challenges invite teams to solve specific technological problems, offering rapid grants with minimal paperwork and continuous competition for further funding. Unlike traditional grant programs, Sprind emphasizes output over input monitoring and provides flexibility for project adjustments.

 

Sprind has cross-party support and a growing budget, currently around €250 million. Modelled partially on the US's DARPA, Sprind focuses on high-impact innovations, such as long-term energy storage and carbon-to-value projects, supporting them from concept to market readiness. The agency's funding process is notably swift, with some grants approved within weeks.

 

Despite its innovative approach, Sprind faces pressure to demonstrate its effectiveness in the upcoming five-year assessment. Successful projects include the world’s tallest wind turbine and algae-based carbon capture solutions, underscoring Sprind's potential to drive significant advancements.

 

 

Against this backdrop, the Dimension Study, led by PAREA's member, the MIND Foundation, in collaboration with Sprind, aims to commence in Europe in 2025. This phase III clinical trial would be the largest psychedelic trial, involving over 700 patients to assess psilocybin plus psychotherapy against traditional antidepressant treatments. Find out more on the MIND’s website. 

 

Europeans are the world's heaviest drinkers, consuming an average of 9.2 litres of pure alcohol per person annually, according to a new WHO report. Despite known health risks, drinking habits in the continent have not changed.

 

WHO’s Dr. Gauden Galea highlighted severe impacts, including domestic violence, accidents, and mental health issues, urging countries to implement effective policies to curb drinking.

Stark figures revealed men drink nearly four times more than women, with 470 million Europeans consuming alcohol. Two-thirds of adults drink, with one in ten having an alcohol use disorder and nearly six per cent living with alcohol dependence. Only 12 out of 53 countries have reduced consumption by 10 per cent since 2010.

 

Alcohol remains the leading cause of death in Europe, responsible for nearly 800,000 deaths annually. Most alcohol-related deaths result from noncommunicable diseases such as heart disease and cancer.

A new report led by Mario Draghi calls on the European Union to significantly increase its investments, comparable to the post-WWII recovery. The report emphasizes the need for greater spending in key areas such as health and innovation, advocating for enhanced R&D investment to maintain the EU’s global competitiveness.

 

Draghi highlights Europe’s long-standing issue: it struggles to turn innovation into commercial success, with many startups seeking venture capital and growth in the US due to EU regulatory challenges. The report recommends doubling the next Framework Programme’s budget to €200 billion over seven years, provided reforms are enacted. The future programme, likely named Framework Programme 10, should focus on fewer priorities and allocate a greater share to disruptive innovation.

 

The report stresses the need for investments in cutting-edge technologies and healthcare improvements to address societal challenges. However, Draghi’s push for more joint EU borrowing faces opposition from countries like Germany and the Netherlands, which resist additional debt-sharing measures.

 

Read a more in-depth analysis prepared for our Pro Subscribers

 

 

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