Dear Reader,

As we enter a crucial year marked by EU elections, PAREA is ready to amplify its impact. Our primary focus is to rekindle support from Members of the European Parliament and collaborate closely with national psychedelic societies to optimize the impact of the elections. A cornerstone of our agenda is the continued advocacy for establishing an EU multidisciplinary body or project dedicated to standardizing care and training in psychedelic therapies. We are also excited about our participation in an upcoming EU-funded project on psilocybin therapy in palliative care, which will be launched very soon. 

Our 2024 commitment extends to educating policymakers and healthcare professionals, and we continue to be deeply engaged in key EU policy areas. These include mental health policies and the revision of EU pharma legislation, particularly focusing on negotiations around what constitutes unmet medical needs.

A major highlight for this year is the much-anticipated EMA multistakeholder workshop on psychedelics. PAREA has played an important role in bringing this workshop to fruition. We are thankful to the EMA for its dedication to advancing evidence-based psychedelic therapies in the EU and eagerly look forward to making a contribution to the workshop. See below for more details about the workshop.

With best wishes,
Tadeusz Hawrot, PAREA Founder & Executive Director

PAREA Recent Achievements

EMA sets stage for psychedelic therapy advancements with upcoming multi-stakeholder workshop

The European Medicines Agency announced the “EMA Multi-Stakeholder Workshop on Psychedelics – Towards an EU Regulatory Framework.” Scheduled for 16-17 April 2024 in Amsterdam, this workshop will unite patients, healthcare professionals, academics, regulators, and industry experts. The agenda focuses on exploring the development and application of psychedelic substances for mental health treatments, addressing regulatory challenges, and considering the need for further guidance.

PAREA applauds the EMA for this initiative, reflecting our ongoing advocacy for evidence-based psychedelic therapies in the EU. We have been advocating for the necessity of such a meeting since PAREA inception. Our efforts include contributing to a letter from a cross-party group of MEPs, which successfully prompted the EMA to schedule this workshop. Last October, we released a policy brief to inform the workshop's preparations and advocate for a multidisciplinary advisory body to guide best practices and care standardization.

You can read our relevant news release with more details here and register to the workshop here. The event will be live-streamed and recorded.

The Latest From Europe

Advancing psychedelic medicine in Europe: clinical and regulatory perspectives explored in a paper

PAREA's Chair, Prof. David Nutt, along with other authors, including from the European College of Neuropsychopharmacology (ECNP – PAREA member) and the EMA’s Chief Medical Officer, have co-authored a pre-proof paper titled “Knowledge gaps in psychedelic medicalisation: Clinical studies and regulatory aspects.”

The article delves into several essential themes, including the pharmacokinetic and pharmacodynamic characterization of psychedelics, comparative studies between different psychedelics, and the correlation between the duration of subjective effects and therapeutic outcomes. It also explores the complexities of polypharmacology and the crucial role of psychological support. A major focus is on the need to differentiate and evaluate basic psychological support models against more structured psychotherapy models, a question of high priority for the field.

The paper also discusses the implications for Health Technology Assessment (HTA) and payers, emphasizing the necessity for clinical trials to demonstrate relative effectiveness compared to existing treatments. An important aspect highlighted is the consideration of costs beyond the medicinal product, as such advocating for a societal perspective in pricing and reimbursement decisions.

Finally, the paper includes insights from the EMA, indicating that regulators are ready to actively support R&D in this field through various scientific and regulatory platforms.

€1.5 million boost: Netherlands leads Europe in psychedelic research with political endorsement

In another positive development from the Netherlands, the Dutch government is allocating €1.5 million for psychedelic research. This initiative not only provides funding but is also part of a broader strategy to build a sustainable infrastructure for the future of psychedelic research in treating mental health conditions like PTSD, depression, and anxiety.

The initiative has sparked active dialogue among Dutch political groups, showcasing widespread support across party lines for researching psychedelic treatments in mental health.

This funding is not just a financial boost but also a step towards creating a framework for future psychedelic research. It aims to enable concrete scientific studies that explore the effectiveness and safety of psychedelic substances in treating mental health conditions, potentially leading to accelerating the adoption of new therapeutic options in the Netherlands’ healthcare system.

Looking ahead, the next steps include the development of detailed research protocols, the establishment of collaborative networks among scientists and healthcare professionals, and the integration of these findings into clinical practices.

This proactive stance by the Netherlands not only contributes to a global shift in mental health treatment paradigms but also positions the country as a leader in psychedelic research within Europe.

PAREA member, the OPEN Foundation, has played an instrumental role in these advancements, actively contributing to both advocacy and strategic planning for this psychedelic research initiative. For a comprehensive overview of these efforts and the significant progress made, visit the OPEN Foundation's website.

Exploring psychedelic therapy’s role in healing Ukraine's war-induced trauma

An event “The Potential of Psychedelic-Assisted Therapy (PAT) in Mitigating War-Induced Trauma: The Case of Ukraine,” organized by PsychedelicsEUROPE  brought critical insights into using psychedelics for PTSD. Eric Vermetten, PhD, spoke about PTSD and MDMA, and presented preliminary reflections from the Dutch MDMA State Commission, while Jiří Horáček, PhD, explored ketamine's potential, presenting a model for Ukraine. Significantly, Ukrainian speakers, including Olga Chernoloz, PhD, emphasized the EU's role in establishing training centers and the need for specialized training. Ukrainian Parliament member Dmytro Gurin highlighted psychedelic medicines potential in addressing the mental health crisis post-war, advocating for Ukraine as a hub for psychedelic research and international collaboration. The session underscored the long-term impacts of war on mental health and the importance of global support in healing these wounds.

You can access the meeting recording here.

EU health programme 2024: advancing national collaboration in pricing and reimbursement

The 2024 workplan of the EU4Health Programme offers a detailed look into the European Commission's strategy for the National Competent Authorities on Pricing and Reimbursement and Public Healthcare Payers (NCAPR). With a grant allocation of €2 million, the plan aims to enhance national efforts and foster collaboration in these areas.

The Commission has restructured the NCAPR to address challenges in pricing, payment, and procurement policies more effectively. A key aspect of the 2024 joint action is to facilitate information exchange among national authorities and bolster national capabilities in these domains. The overarching goal is to develop technical tools and implement actions that enhance voluntary cooperation among pricing and reimbursement authorities and public healthcare payers, thereby strengthening their capacity to tackle common challenges.

The workplan prioritizes areas such as evidence generation, cooperative negotiations, demand-driven systems, budget sustainability, adapting to legal changes, cross-sector collaboration, and data sharing.

For the psychedelic sector, these developments are crucial. Companies in this field need a good understanding and engagement with these evolving policies and frameworks to effectively navigate the European access market.

EMA 2023 medicine approvals:progress in many areas, but none in psychiatry

EMA has just published its annual report on medicines recommended for approval in 2023, highlighting key developments in the pharmaceutical sector. Last year, a total of 77 medicines were recommended for marketing authorization. Oncology led the therapeutic areas with 25 new treatments, followed by neurology with 11, and cardiovascular diseases with 6. However, when it comes to addressing unmet medical needs in mental health conditions, which the OECD reports affect one in two people in their lifetime, there remains a significant gap. In line with the previous year's trend, the EMA did not approve any new therapies in psychiatry in 2023.

Record high mental health-related sick days in Germany amidst multiple crises

Mental health problems are becoming the leading cause of disability-related early retirement in many countries. 2022 witnessed a record high in the number of sick days taken due to mental health issues in Germany, reaching an unprecedented 132 million days, a significant increase from 126 million in the previous year. This surge, as reported by the Federal Ministry of Labour and Social Affairs, is attributed to the compounded stress of the pandemic, war, inflation, and increased work intensity. Workers in healthcare, childcare, and education are particularly affected. Over the last decade, these numbers have more than doubled from about 65 million days in 2012, with over 40% of early retirements due to reduced work capacity linked to mental health strains.

AI in European medicine: EMA sets the course for future innovation

The European Medicines Agency is making significant strides in integrating AI into the lifecycle of medicine development. After releasing a draft reflection paper in July, the EMA has now, in collaboration with the Heads of Medicines Agencies, officially published an AI work plan, set to guide AI use and assessment within the agency until 2028. Key elements of this plan include establishing an "AI Observatory" for ongoing technology monitoring, experimenting with AI in medicines agencies, and offering staff opportunities to enhance their skills through events like hackathons. Adopted at the EMA’s December Management Board meeting, this work plan aims to keep the European medicines regulatory network at the forefront of AI in medicines regulation. This move is part of a larger shift to harness AI's potential in drug development and healthcare, balancing its benefits against potential risks.

What we are reading

The new European Medicines Agency guideline on antidepressants: a guide for researchers and drug developers European Psychiatry

Letters (six) to the editor on the Goodwin et al.’s July 2023 Commentary, ‘Must Psilocybin Always “Assist Psychotherapy”?’ The American Journal of Psychiatry and author’s reply to the letters.

Psychoactive drug ibogaine effectively treats traumatic brain injury in special ops military vets Stanford Medicine  

Call for evidence-based psychedelic integration American Psychological Association PsycNet

MAPS PBC Closes $100m Series A, Rebrands to Lykos Therapeutics Psychedelic Alpha

Maybe, just maybe, psychedelics are the “master key” for unlocking everything from blindness to stroke to anorexia Vox

MindMed Announces Positive Topline Results from Phase 2b Trial of

MM-120 in Generalized Anxiety Disorder Business Wire

Compass Pathways announces investigational COMP360 psilocybin treatment was well-tolerated in phase 2 study of post-traumatic stress disorder Compass

Do psychedelic treatments always require psychotherapy? Ecstatic Integration

Will Psychedelics Replace Antidepressants? Nautilus

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