December, 2024

Dear First name / Readers,

 

As we near the end of 2024, it's a good time to reflect on a year filled with significant developments in the field of psychedelics in Europe.

 

The year began with the announcement of PsyPal, an EU-funded clinical trial studying psilocybin in the context of palliative care to explore whether it can help individuals cope with the psychological distress of their conditions. This marks the first time the EU has fully funded a study of a psychedelic, awarding more than €6.5 million through the EU’s Horizon Europe programme.

 

Soon after, the EMA held a multi-stakeholder workshop on psychedelics, focusing on creating a regulatory framework for psychedelic treatments in the EU. This was an important step in aligning stakeholders and laying the groundwork for future clinical applications.

 

Later in the year, the Dutch State Commission released its report on MDMA, concluding that MDMA-assisted therapy appears to be an effective and safe treatment for patients with chronic and treatment-resistant PTSD. The report recommended that the Dutch government facilitate the introduction and use of MDMA-assisted therapy as soon as possible.

 

We are also delighted to share that PAREA was invited by the WHO to review the draft WHO guideline on controlled medicines, reflecting the growing global importance of our work.

 

Finally, we are excited to announce that after several years of successful work, PAREA is starting a new chapter by becoming a legally registered organisation with a strong and multidisciplinary Board. This is a significant moment for us, and we look forward to the continued growth of our initiatives in the coming years.

 

It has been an exciting year, and we are grateful for the ongoing support as we continue to advocate for positive change in the landscape of mental health and psychedelic therapies. Thank you for being part of this journey.

 

Wishing you all a peaceful end to the year and a happy, productive 2025,

 

 

 

PAREA NEWS

 

December 12 marked an important milestone for PAREA as we elected our new Board of Directors and Office Bearers, and officially established our organisation as a legal non-profit entity, incorporated in Estonia.

 

At our General Assembly, we elected our nine Board members, representing a wide range of expertise, including patient organisations, scientific and clinical societies, and psychedelic foundations. We are excited to have an exceptional team on board, which will play a vital role in shaping PAREA’s vision and future endeavours. For more information, visit our Meet the Board page and check out our social media channels (LinkedIn, BlueSky), as we profile a different Board member each day.

 

Transparency is a core value for us, and we are committed to openness and accountability. On our website, you can also now find our founding articles of association and procedures, our Strategic and Work Plans for upcoming years, and detailed information about our funding sources.

 

With three years of impactful work already behind us, this signified a new step for PAREA, advancing our mission of advancing safe, effective, and accessible psychedelic therapies across Europe with renewed focus and autonomy.

 

We are excited to announce an upcoming event at the European Parliament in partnership with the PsychedeliCare European Citizens’ Initiative.

 

The event will mark the official launch of PsychedeliCare’s campaign to gather the one million signatures needed to bring a call for advancing psychedelic-assisted therapies to the European Commission. It will also serve as the re-launch of the MEP Action Group on Psychedelics in Healthcare, re-restablished by PAREA to drive forward policy change for mental health and psychedelic therapies in Europe.

 

Hosted by MEP Tilly Metz (Greens/EFA), the event will unite policymakers, civil society, clinicians, researchers, and patient representatives and showcase a call to action for European innovation in promising psychedelic therapies in response to limited treatment options and unmet needs. The aim will be to build awareness, momentum and engagement for psychedelic therapies in Europe. Presentations will address the current state of scientific research and emphasise real-world lived experiences and patient voices.

 

The event will take place in person on 6 February 2025 from 10AM to 12PM CET, at the European Parliament, in Brussels. It will also be live streamed. You can register to attend here.

 

PAREA was invited by WHO to be part of the External Review Group, formed to review the draft working document on “WHO guideline on balanced national controlled medicines policies to ensure medical access and safety”.

 

This new guideline follows the discontinuation of two earlier WHO guidelines on controlled medicines and pain management, from 2011 and 2012, in light of new scientific evidence on global disparities in access and safe use of controlled medicines, and the introduction of new WHO policies for managing conflicts of interest. PAREA was invited by the WHO to be a part of the external review group for this new guideline.

 

Our submission was developed collaboratively with a focus group of experts from legal, clinical, and research fields. We aimed to incorporate input on important considerations for medicines containing controlled psychedelic substances. These included: the public health harms caused by overly restrictive access to investigational controlled medicines with potential to tackle unmet medical needs; the barriers and inequities created by scheduling in research and medicinal product development; and the importance of ensuring access to controlled medicines for scientific research and through early access frameworks, prior to approval.

 

Our participation in this external review group reflects a growing recognition of the need to integrate safe access to innovative psychedelic therapies into national health policies.

 

Two new organisations have officially joined the PAREA Community Supporters network - the Italian Society for Psychedelic Medicine (SIMEPSI) and the Ukrainian Psychedelic Research Association (UPRA).

 

SIMEPSI is a multidisciplinary, non-profit organisation dedicated to promoting scientific research, raising cultural awareness, and developing safe regulatory frameworks for psychedelic therapies in Italy. They also focus on knowledge exchange and public education, paving the way for responsible and informed integration of these treatments. SIMEPSI joins PAREA after strengthening ties at the recent psychedelic science conference in Rovereto, Italy.

 

UPRA is a hub where academics, clinicians, patients, and activists come together to advance the legal therapeutic use and scientific research of psychedelics in Ukraine. With the ongoing conflict driving increased psychological suffering, the dire need for better mental health interventions makes UPRA’s work more crucial than ever. Their official membership follows the signing of a Memorandum of Association in Kyiv earlier this year, reflecting a shared commitment to collaboration and progress.

 

Both organisations are driving meaningful progress nationally and beyond, addressing the needs of their countries while fostering connections with the broader international community. Their work to enhance education, policy, and research on evidence-based psychedelic therapies is invaluable in contributing to a wider ecosystem that supports the safe, ethical, and evidence-based use of these treatments.

 

PAREA joined over 55 European organisations in co-signing Mental Health Europe’s joint statement calling for decisive action to deliver on promises made for mental health care.

 

Building on commitments by several EU institutions to prioritise mental health, the statement, released on World Mental Health Day 2024, stresses the need for tangible follow-through to address the growing mental health challenges across Europe. It urges the European Commission, Member States, and the European Parliament to take concrete steps, including adopting comprehensive European strategy on mental health with clear timelines, budgets, and measurable indicators of progress; developing cross-sectorial national strategies coordinated with EU-level actions and aligned with a community-oriented approach; and creating an intergroup on mental health to foster exchanges between political groups and civil society.

November was a month of rewarding engagement with national psychedelic societies and communities across Europe.

 

On consecutive days, we participated in two events: the Emerging Therapies in Psychedelic Science Conference in Rovereto, Italy, and the Annual Symposium of Psychedelic Society Belgium, in Brussels. PAREA Founder, Tadeusz Hawrot, presented at both events, sharing insights on the future of psychedelic therapies, including ethical and legal challenges and access to these treatments.

 

National initiatives are vital to advancing the collective European conversation on psychedelic science and better mental health care. We are dedicated to continuing connecting with national psychedelic societies, exchanging knowledge, building community, and collectively contributing to the development of psychedelic treatments in Europe.

 

PAREA Founder and Executive Director, Tadeusz Hawrot, joined the Brain Health Matters podcast, hosted by the European Federation of Neurological Associations (EFNA), to discuss the topic of psychedelic therapies with the neurology community. Listen to the episode here (the psychedelics discussion starts at 23:05).

 

Focusing on the episode’s theme of patient involvement in neuroscience research, a central topic of the conversation was the PsyPal project. The EU-funded project, in which both PAREA and EFNA are involved, will explore the potential of psilocybin therapy to treat psychological distress in chronic, incurable conditions, including three neurological conditions. PsyPal embraces the principles of public and patient involvement (PPI) and meaningful patient engagement to ensure that the research reflects the needs and preferences of the people who may benefit from these treatments. By directly involving medical and patient communities, the project is committed to maintaining a patient-centred approach and the highest ethical standards at every stage.

NEWS FROM OUR PARTNERS

 

PsyPal, the Horizon Europe-funded project exploring the safety and efficacy of psilocybin therapy for psychological distress in palliative care patients, has made an incremental step toward launching its clinical trial, expected to begin patient recruitment in 2025. The clinical trial has received authorisation under the EU Clinical Trials Regulation (CTR) in participating member states, with conditions.

 

This authorisation is the result of over a year of dedicated collaboration across the PsyPal consortium, a group of 19 partners from nine European countries. The consortium is supported by industry partner Avextra, which is supplying the study drug and assisting with the regulatory process.

 

The PsyPal consortium is now working on finalising the process to ensure full compliance and collaborating with the funding agency in the context of an ongoing independent Ethics Review procedure. These efforts reflect PsyPal’s commitment to upholding the highest EU ethical standards by working closely with regulators and ethics committees.

 

Read more about PsyPal on their website, and stay updated on the project’s progress by signing up to the PsyPal newsletter.

THE LATEST FROM EUROPE

An agreement has been reached among key political groups in the European Parliament, paving the way for a standalone Health Committee (SANT). The biggest political groups have agreed to split the competencies between the upgraded Health Committee and the existing Environment, Public Health and Food Safety Committee (ENVI).

 

Under the new arrangement, SANT will take responsibility for health policy areas, including pharmaceuticals and medical devices, public health, health crisis preparedness and response, mental health, patient rights, and health aspects related to bioterrorism. This move is a response to the growing need for a dedicated focus on health matters within the EU.

 

Meanwhile, ENVI will concentrate on environmental and climate policies, food safety, and pollution control, as it transitions to its new title, the Committee on the Environment, Climate, and Food Safety.

 

The Medical Research Agency of Poland has announced plans to allocate nearly €4 million for a clinical trial using psilocybin to treat treatment-resistant depression (TRD). Pending regulatory approval, this innovative trial to be conducted by the Medical University of Warsaw, will be one of the first globally to explore how selective serotonin reuptake inhibitors (SSRIs) impact the effectiveness and tolerability of psilocybin treatment for depression.

 

The study will consist of two parts: the first will explore whether adding psilocybin, combined with targeted psychotherapy, can improve outcomes for patients continuing SSRIs; the second will investigate the effects of discontinuing SSRIs on the safety and efficacy of psilocybin therapy. Participants will be randomly assigned to one of two arms in each part, either receiving standard of care (e.g. SSRIs, regular psychotherapy) or two psilocybin doses, preceded by preparation sessions and each followed by integration sessions.

 

If approvals, namely from the European Medicines Agency (EMA), proceed as planned, patient recruitment for the trial is expected to begin in approximately one year.

This study represents an important step forward for Poland in contributing to global advancements in psychedelic research and mental health care.

 

A new report by IQVIA for the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Vaccines Europe, demonstrated that Europe’s share of commercial trials has reduced from 22% in 2013, to 18% in 2018 to 12% in 2023. As such, Europe’s clinical trial participation has fallen by 60,000 places since 2017, despite a global surge in research projects. At the same time, China has doubled its number of commercial trials since 2018, and now accounts for an 18% share of global commercial clinical trials.

 

To reverse this trend, EFPIA recommends prioritizing measures that make Europe a more attractive location for clinical trials. These include:

When examining the distribution of commercial clinical trials across various therapeutic areas, the report finds that psychiatric conditions account for only 2% of the total, placing them at the very end of the list.

 

As the EU debates pharmaceutical reforms, Poland is stepping up its advocacy for equitable access to medicines—a critical issue as the country prepares for its EU Presidency in the second half of 2025. The divide between wealthier nations prioritizing innovation and countries like Poland demanding affordability highlights key tensions shaping the future of EU health policy. With Poland’s Presidency on the horizon, these discussions take on even greater importance. 

 

Pro subscribers can access our in-depth analysis on what this means for the EU’s health agenda and the potential implications for pharmaceutical access and innovation.

The OECD recently released its Health at a Glance: Europe 2024 report, providing a comprehensive overview of the health landscape across the EU. Among the wealth of information, several key findings related to mental health and depression stand out.

 

The “gender paradox of suicide”:
Suicide remains a significant cause of death across Europe, with nearly 50,000 people dying by suicide in 2021. Suicide rates among men are nearly four times higher than among women. However, the gender gap in suicidal intent and behaviour is much smaller, or even reversed in some cases. This is attributed to men using more lethal means during suicide attempts, a pattern referred to as the “gender paradox of suicide.”

 

Depression statistics among older adults:
Data from 2021–2022 reveals that, on average, 26% of adults over 50 in the EU reported multiple symptoms of depression. Women in this age group were more likely to report such symptoms (32%) than men (19%). The data comes from the Survey of Health, Ageing and Retirement in Europe (SHARE), which uses the EURO-D scale to assess symptoms such as mood, pessimism, suicidality, and sleep quality.

 

Positive trends in suicide prevention:
There’s some good news: Between 2004 and 2021, suicide rates across the EU decreased by 25%, reflecting progress in suicide prevention and mental health awareness efforts.

The report also provides data on drug use, noting that 2.2% of young adults in EU countries reported using MDMA/ecstasy in the past year. Classical psychedelics like psilocybin and LSD were not mentioned in this edition.

The European Commission is developing a comprehensive life sciences strategy to ensure that innovation effectively addresses societal needs and benefits patients. Commissioner for Startups, Research, and Innovation, Ekaterina Zaharieva, is leading this initiative, aiming to support research, foster innovation, and expedite the transformation of scientific breakthroughs into tangible products.

 

While specific details of the strategy are still under development, the approach emphasizes collaboration among various sectors, including academia, industry, and government.

This strategy will hold particular relevance for areas like mental health, where there is a significant societal burden and a pressing need for innovative treatments. Psychedelic therapies, for example, have shown promise but face challenges in funding and integration into mainstream healthcare. A robust life sciences strategy could address these issues by promoting research and facilitating the development of new therapeutic options.

 

The forthcoming strategy represents a pivotal opportunity for the EU to enhance its competitiveness in the global life sciences sector. By fostering collaboration and streamlining the path from research to market, the EU aims to ensure that scientific advancements translate into real-world health solutions for its citizens.

 

WHO/Europe’s newly released Alcohol Policy Playbook exposes the immense health, social and economic toll of alcohol use in the European Region, which has the highest levels of alcohol consumption globally.

 

On average, adults in Europe consume 9.2 liters of pure alcohol annually, contributing to nearly 800,000 deaths each year, primarily from cardiovascular disease (40%) and cancer (15%), while also contributing to falls, burns, sexual assault, and intimate partner violence. Among young people aged 15 to 19, alcohol is responsible for 25% of injury-related deaths. In 2019, alcohol was a major factor in 35% of road fatalities, 37% of suicides, and 42% of homicides.

 

The economic costs of alcohol exceed any financial benefits to the alcohol industry. High-income countries lose an estimated 2.6% of GDP annually to alcohol-related harm. In the EU alone, alcohol-attributable cancer deaths cost nearly €5 billion in 2018, accounting for 10% of the total cost of cancer deaths in the Region.

 

The Playbook challenges the narrative that health issues related to alcohol only affect a minority of individuals with harmful drinking patterns and underscores the disparity between public health priorities and commercial interests in this area. Evidence shows that any level of alcohol consumption can cause harm, with even moderate drinking increasing the risk of developing cardiovascular disease and cancer. Yet, less than 50% of Europeans are aware of the links between alcohol and cancer, a gap perpetuated by profit-oriented narratives. WHO/Europe calls on governments to accelerate the implementation of comprehensive alcohol policies that prioritize public health.

The Netherlands is piloting a regulated cannabis market, aiming to assess its impact on public health, crime, and safety. Starting April 7, the experiment transitions from allowing both “tolerated” and regulated cannabis sales to exclusively regulated products in designated shops.

 

Since 1976, cannabis has been sold openly in coffee shops, with possession of small amounts decriminalised. However, the production and bulk distribution of cannabis remain illegal, leading to challenges like untested products and unclear dosing.

 

The pilot seeks to address these gaps by legalising and regulating the production, sale, and distribution of cannabis while enabling quality control. A dedicated team of researchers, guided by an independent committee, is evaluating its effects on public health and social outcomes.

 

The four-year pilot is limited to ten of the country’s 342 municipalities, with results expected to inform future cannabis policy in the Netherlands.

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