Dear Reader, 

As we navigate the bustling period between summer's end and the year's close, PAREA has been immersed in a whirlwind of activity, culminating in a significant European Parliament event that we co-organized with our partners PsychedelicsEUROPE. It was a key milestone for us, marking the launch of PAREA third policy paper this year, centred on the critical topic of unmet medical needs. This issue is pivotal in the ongoing pharma revision negotiations, as the definitions set here will shape which treatments receive incentives and support from public authorities (for our Pro-subscribers, below we provide an update on the latest developments in the pharma file). The momentum continued with our PAREA partnership annual meeting in Brussels. These two meetings reinforced our dual role as both a policy influencer and a vibrant community of like-minded organizations and individuals.

Overall, 2023 has marked an exceptional year for mental health in the EU, with notable reports from the European Parliament, European Commission, Council of the EU, and the European Economic and Social Committee (EESC). The Commission's “comprehensive approach on mental health” set the tone earlier in the year, recently followed by influential mental health reports from both the Council of the EU and the European Parliament. Additionally, the July EESC's formal recognition of psychedelic therapies underlines the increasing focus on novel mental health treatments such as psychedelics at the highest levels of EU governance.

Finally, we are thrilled with the latest news about the MAPS NDA for the MDMA-assisted therapy for PTSD. Read here PAREA news release that was sent out to the EU policymakers.

As December unfolds and we approach the holiday season, I want to extend my early wishes for a peaceful holiday season and a joyous New Year to all our readers around the globe.

Tadeusz Hawrot
PAREA Founder & Executive Director

In a landmark event this November, the European Parliament was the venue for the inaugural meeting of the MEP Action Group for the Medical Use of Psychedelics titled "Innovating Mental Health in the EU Pharma Legislation: Regulatory Pathways for Psychedelic Therapies." Amid the ongoing revisions of the EU pharma package, the meeting concentrated on establishing a regulatory framework conducive to innovative mental health solutions, particularly psychedelic therapies. 

During the event, PAREA introduced its policy paper titled “Unmet Medical Needs: Aligning Medical Innovation with Societal Health Needs”. This document presents a compelling argument to redefine the current understanding of unmet and high unmet medical needs. It critically examines the prevalent narrow focus on life-threatening or severely debilitating conditions and proposes a broader perspective that takes into account overall health and societal impacts. As such, the policy paper calls for an urgent expansion of the criteria used to define unmet medical needs to include the prevalence of conditions and their societal impact. This broader perspective is crucial for prioritizing R&D in areas like mental health, where the potential for positive impact is immense.

To address the critical issues outlined in the paper, we called for the establishment of a European Hub for Mental Health R&D. This hub would unite EU institutions, member states, healthcare funders, and philanthropic organizations to foster evidence-based decision-making in mental health. It aims to set effective incentives and prioritize resources, driving innovation and addressing the substantial unmet medical needs in mental health care across Europe.

MEP Action Group queries European Commission on mental health priorities

Members of the MEP Action Group for the Medical Use of Psychedelics submitted a priority written question to the European Commission, which emphasizes the urgent need for prioritizing mental health within the EU pharmaceutical legislation revision. PAREA is proud to have contributed to the formulation of this important question.

The question begins by acknowledging the Commission's efforts in improving medicine access and highlights the staggering statistics of mental health issues in Europe, including chronic depression and high suicide rates. It brings to light the lack of adequate treatment for a majority of major depression cases and the concerning data on treatment-resistant patients.

Three critical questions were raised to the Commission:

1. The possibility of prioritizing mental health conditions with targeted research and innovation incentives.

2. The consideration of prevalence and societal impact as criteria for defining high unmet medical needs.

3. Inquiry into the Commission's actions and future plans for encouraging new mental health treatments in the context of the pharmaceuticals legislation review.

The full question can be accessed here, and we eagerly anticipate the Commission's response in January 2024.

POLITICO discusses with PAREA country-level progress in psychedelic therapies

POLITICO Europe's Morning Health Care recently spotlighted the evolving country-level landscape of psychedelic therapy in the EU, featuring a discussion with PAREA's Founder, Tadeusz Hawrot. Highlighted were the pioneering efforts of Portugal, the Netherlands, and the Czech Republic in integrating psychedelics into medical treatments for mental health disorders. In Portugal, campaigners are in talks with the government to expand the existing early access programs by allowing treatment with psychedelics in Phase III trials, the Netherlands is evaluating MDMA's medical applications, and the Czech Republic is contemplating a new law to regulate psycho-modulatory substances. This shift in EU member states’ attitude toward psychedelic medicines is vital. The collective movement of supportive countries can drive significant policy changes at the EU level, potentially leading to structured EU support and funding.

Access the POLITICO piece here.

ALPS Awareness Lectures on Psychedelic Science in Geneva

At ALPS conference in Geneva, PAREA’s Founder delved into the multifaceted challenges of bringing psychedelic therapies from clinical innovation to routine care. He discussed the hurdles of market incentives, regulatory approvals, health technology assessments, and the unique distribution and supply challenges, highlighting the intricate path from development to accessible treatment. Watch the full talk here.

MAPS Psychedelic Science Denver videos now online

The videos from the MAPS Psychedelic Science Denver conference are now online. PAREA Chair Prof. David Nutt presented on “Psychedelics therapeutics: What we know, what we think, and what we need to research” (see here) and PAREA Founder, Tadeusz Hawrot, spoke about the state of EU relevant policies (Tadeusz’s presentation starts at the 14-minute mark here).

Psychedelics Today interviews PAREA Founder Tadeusz Hawrot

PAREA founder Tadeusz Hawrot was interviewed by Psychedelics Today, on the evolving landscape of psychedelic research and mental health policies in Europe. Watch here the full interview.

Challenging, unresolved psychedelic experience: testimonial from a trial participant, Maryam Jabir

Maryam took part in a Compass Pathways phase 2b study of COMP360 psilocybin therapy for treatment-resistant depression. The testimonial was made during the MEP Action Group for the Medical Use of Psychedelics meeting "Innovating Mental Health in the EU Pharma Legislation: Regulatory Pathways for Psychedelic Therapies". Catch the full testimonial here. And subscribe to PAREA’s YouTube channel for more videos.

Esketamine recognized as an essential medicine for public health

The EU has just issued its first list of (over 200) medicines deemed essential for public health, a move to combat drug shortages. Crucially, the list, created by the European Commission, EMA, and EU countries, includes ketamine, categorized as both an anaesthetic and antidepressant (esketamine).

The list will support the EU’s efforts in ensuring supply security and preventing shortages of critical medicines. Inclusion in the list means that the prevention of shortages is particularly important as a shortage could cause significant harm to patients and pose important challenges to health systems. A medicine is considered critical if it is used in serious diseases and cannot be easily replaced by other medicines, for example in case of a shortage.

This development is a compelling indication that mental health conditions like depression are finally becoming recognized as critical health issues. It also suggests a growing openness towards psychedelic treatments, opening the door for potential future inclusion of more psychedelic therapies in essential medicine lists.

EU pharma legislation reform: facing delays amidst crucial debates

The EU's landmark pharmaceutical legislation reform is facing delays, unlikely to be adopted before the June 2024 European elections. Key disagreements among MEPs, particularly between EPP’s Pernille Weiss and S&D’s Tiemo Wölken, focus on clinical trial data protection and regulatory sandboxes for new therapies. The European Parliament is racing against time to agree on a text, with negotiations expected to be complex due to these differing viewpoints. The outcome of this reform is crucial, as it will significantly influence the pharmaceutical industry for the next two decades, impacting everything from innovation to patient access across the EU. PAREA has contributed to this discussion with a position paper on the pharmaceutical package revision and a policy paper on unmet needs.

Meanwhile, earlier this week, the German government published a policy document outlining measures to strengthen its pharmaceutical industry and simplify its regulatory process. Crucially, the country is opposed to any reduction in data protection.

For our pro-subscribers, we offer an in-depth analysis of the current progress with the pharma revision. This detailed report provides comprehensive insights and expert commentary on the evolving negotiations and their implications for the pharmaceutical industry and healthcare policy across the EU. You can read it here.

“Improving mental health is an individual, a social and economic imperative” – Council of the EU recommendations

Led by the Spanish EU Presidency, the Council of the EU, representing 27 member states, adopted Council conclusions on mental health. The conclusions underscore that “Improving mental health is an individual, a social and economic imperative”. The document asks the European Commission to attach concrete budget and timelines to the EU comprehensive approach to mental health. It encourages member states to develop cross-sectoral action plans, and to ensure access to timely, effective, and safe mental health care. It advocates for creating an interdisciplinary mental health workforce for a comprehensive approach to mental health promotion, prevention, treatment, and care. It also includes a call for multidisciplinary training and exchange programs for health and social care professionals. Furthermore, the Conclusions propose that a European year of mental health should occur no later than 2029.

European Parliament's report spotlights mental health

Soon after the Council of the EU's conclusions on mental health, the European Parliament has passed its own report on the subject. This report aligns with the several key Council's conclusions, advocating for dedicated mental health funding and the development of a detailed EU mental health strategy, complete with specific targets, goals, and measurable indicators. Additionally, the Parliament is urging the Commission to declare the upcoming year as the 'European Year of Mental Health', laying the groundwork for an overarching EU strategy in this area.

While our journey at PAREA has its challenges, notably our efforts to include references to psychedelic therapies in the report, we remain steadfast in our commitment. Despite an amendment mentioning psychedelics not being included in the final version, we continue to advocate for a supportive policy and regulatory framework for psychedelic therapies. The silver lining of 2023 has been the unanimous prioritization of mental health across all major EU institutions, signalling a collective effort to elevate mental health care standards and awareness.

Key Insights for Europe's HTA Body: Standardizing Assessments Across EU Nations

Europe's emerging health technology assessment (HTA) body, currently known as the HTA coordination group, is set to receive key insights on the major challenges of standardizing assessments across EU nations. These insights follow an October workshop by the European Commission with 44 organizations to address pressing issues.

The group is presenting its findings on how to uniformly assess new therapies in the EU. Key challenges include agreeing on essential clinical data, standard treatments for comparison, and additional supportive information.

Notably, defining standard comparators for cancer drugs, where treatments vary significantly across EU countries, emerged as a major hurdle. The consensus is to define standards as the best available treatment rather than the lowest common denominator. Additionally, the HTA body is advised to integrate various data sources, like single-arm trials and real-world data, especially for rare diseases, a move likely favoured by the industry.

This development is significant as, from January 2025, all new cancer drugs and advanced therapies will undergo these EU-wide added-value assessments. This will be followed by orphan drugs in 2028 and all other drugs in 2030.

EU pharma legislation: EMA weighs in on regulatory flexibility

EMA Executive Director Emer Cooke recently shared her views on the EU's ongoing pharmaceutical legislative reforms, including the concept of regulatory sandboxes, during a meeting with the European Parliament. The sandboxes would permit controlled experimentation under close regulatory watch, aiming to spur innovation in areas like new medications. Despite some opposition to the idea, Cooke supported the concept, suggesting that it could solve the issue of regulating unforeseen medical innovations. PAREA has shown interest in these developments, particularly because such regulatory sandboxes could be relevant for psychedelic therapies. A relevant recommendation has been included in PAREA's position paper on the pharma package. 

What we’re reading

PAREA’s psychedelic push: improving policy for mental health innovation in Europe Psychedelic Health 09.11.2023

MEPs call for EU to support research into the use of psychedelic drugs in treating mental health disorders Science|Business

Ukrainian MP tells MEPs country should be test bed for psychedelics POLITICO 

Innovating Mental Health In The EU Pharma Legislation Blossom Analysis

Psychedelic-assisted psychotherapy: Where is the psychotherapy research? PsyArXiv

European psychedelic initiative aims to impact education and regulation Psychedelic Health 

Rethinking Treatments for GAD: Progress in Sight for Patients in Need ENDPOINTS NEWS 

The Israelis and Palestinians Doing Ayahuasca Together VICE

Cybin Announces Unprecedented Positive Phase 2 Interim Data for CYB003 in Major Depressive Disorder Meeting Primary Efficacy Endpoint with Rapid and Significant Improvements in Depression Symptoms After Single Dose Business Wire 

Compass Pathways launches Phase 3 psilocybin trial in UK Psychedelic Health

Why psychedelics produce some of the most meaningful experiences in people’s lives  Vox