EU Insights

Welcome to the latest edition of EU Insights. In this issue, we spotlight two important policy developments that are shaping the future of psychedelic therapies in Europe. First, we delve into our position statement on the EU pharmaceutical package revision. From addressing hurdles to suggesting early access pilot programs for psychedelic medicines, our statement covers the full medicinal lifecycle.

Secondly, in a significant development, we have submitted a policy brief to the European Medicines Agency (EMA) calling for the establishment of a multidisciplinary advisory body. Prepared in anticipation of the EMA's upcoming multistakeholder workshop on psychedelic therapies, the brief underscores the critical need for the active involvement of psychedelic organizations in shaping the future of these transformative treatments. We are pleased to inform our readers that PAREA has already received a response from the EMA regarding our policy brief. The EMA is committed to seriously considering the content of our brief and to dedicating the necessary time and resources to ensure that the workshop is both broad and comprehensive. This includes covering a wide range of topics and engaging various stakeholders. As a result, the workshop has been rescheduled for Q1/Q2 of 2024.

Elsewhere, in a historic move, the European Economic and Social Committee (EESC) has officially recognized the potential of psychedelic therapies in its "Measures to Improve Mental Health" opinion, requested by the Spanish EU Presidency. PAREA, having advocated for this inclusion, is heartened by the EESC's recognition of the promise of psychedelic novel medicines.

With best wishes,

Tadeusz Hawrot PAREA Founder & Executive Director

During the European Mental Health Week, Members of the European Parliament (MEPs) launched the MEP Action Group for the Medical Use of Psychedelics, aiming to set the course for the advancement of psychedelic therapies in the EU.

Recently, PAREA launched a statement “Leveraging the EU Pharmaceutical Package. A Life Cycle Approach to Address High Unmet Needs and Foster Mental Health Innovation by Incentivizing Psychedelic Novel Medicines.” It encompasses the complete medicinal lifecycle and the importance of novel mental health treatments. Specifically, we emphasize the potential of psychedelic therapies, despite the unique challenges they face including stigma, legal restrictions, and lack of extensive evidence. Our call for a clear identification of unmet needs prioritizes mental health conditions that haven't seen much innovation. Additionally, we propose implementing early access pilot programs and compassionate use of psychedelic medicines, especially for palliative care.

Psychedelics advisory body needed in Europe, says PAREA

In a significant move for the European psychedelic community, PAREA called for the establishment of a dedicated multidisciplinary advisory body on psychedelics in Europe. This proposal coincides with the European Medicines Agency's (EMA) announcement of an upcoming workshop on psychedelics. PAREA's policy brief, submitted to the EMA, aims to guide discussions and preparations for this event, emphasizing strategic planning, professional collaboration, and the importance of centralization. PAREA's vision involves a multidisciplinary advisory panel, including experienced psychedelic users, to shape best practices and standards of care, ultimately streamlining the path for responsible psychedelic therapies in Europe.

Read a coverage of our policy brief by POLITICO Europe: Experienced trippers should advise on Europe’s use of psychedelics, says lobby

EU Committee Recognizes Psychedelic Therapies and Calls for Mental Health Improvements

The European Economic and Social Committee (EESC) has adopted an opinion on "Measures to Improve Mental Health," recognizing the potential of psychedelic therapies for conditions like severe depression, PTSD, and alcohol use disorder. This is the first official EU recognition of their potential. The EESC also recommends developing person-centered mental health systems, swiftly implementing the EU Comprehensive Plan on Mental Health, considering socio-economic factors in mental health policies, and declaring 2024 as the European Year of Mental Health.

Psychedelic Progress: Exploring European Research and Therapeutic Frontiers with Frédéric Destrebecq and Tadeusz Hawrot

In the latest Drug Science podcast, Frédéric Destrebecq and Tadeusz Hawrot delve into the latest advancements in psychedelic research and clinical development across Europe. Frédéric Destrebecq, the Executive Director of the European Brain Council (EBC) and PAREA Vice-chair, leads efforts to elevate brain research awareness and shape policies for brain-related matters in Europe. Tadeusz Hawrot, a key figure in the European federation of neurological associations and Founder/Executive Director of PAREA Science, spearheads PAREA, Psychedelic Access and Research European Alliance). Professor Dr. David Nutt leads the interview covering education, research and policy.

Listen here to their vision on collaborative efforts towards uniting diverse stakeholders to advocate for safe and accessible psychedelic-assisted therapies throughout Europe.

Australia's Groundbreaking Decision to Legalize Medical Psychedelics: A TV Interview with PAREA Founder

In a historic move, Australia has become the first country to legalize medical psychedelics. The Founder of PAREA recently discussed this significant development in an interview with a Polish TV station (conducted in English). The conversation delved into the specifics of this decision, which has authorized the use of MDMA-assisted therapy for Post-Traumatic Stress Disorder (PTSD) and psilocybin-assisted therapy for treatment-resistant major depression.

However, this decision has not been without controversy. The interview also addressed the criticism and concerns that have arisen in the wake of this decision. Key among these is the potential risks associated with the use of psychedelic drugs and the need for a thorough risk-benefit analysis. The discussion highlighted the importance of caution and honesty when discussing the potential benefits of these drugs, as well as the need for more innovation in the field of mental health.

Norrsken Mind launches, a continuation of the Osmond Foundation

PAREA member Osmond Foundation will continue under a new name: Norrsken Mind: Psychedelic Science Initiative. The Swedish foundation will focus on supporting research on psychedelic substances and their potential to treat mental health disorders, both in Sweden and other European countries. It will also engage with healthcare professionals and mental health stakeholders to provide information and education on psychedelic research. PAREA is pleased to be one of the foundation's collaborators. Read more about Norrsken Mind's efforts here.

PAREA NEWS RELEASES

In our latest news release, we present summaries of three recent studies published in high-impact medical journals that explore the therapeutic potential of psychedelics. The first study, a Phase 2b trial published in the Journal of the American Medical Association (JAMA), enrolled 104 adults and shows promising results for psilocybin as a treatment for major depressive disorder. The second study, from Nature Medicine, investigates the safety and potential efficacy of psilocybin therapy for females with Anorexia Nervosa. Lastly, a study in the New England Journal of Medicine compares the effectiveness of ketamine and Electroconvulsive Therapy (ECT) for treatment-resistant major depression, suggesting ketamine as a viable alternative.

The Latest From Europe

Ernst Kuipers, Dutch Health Minister, on the Future Landscape of Psychedelic-Assisted Therapy: Navigating Challenges and Opportunities in the Netherlands

The chronicles of the psychedelic resurgence continue as Ernst Kuipers responds to a recent report on the therapeutic potential of psychedelics. A recap of the past year reveals Kuipers' unexpected enthusiasm for psychedelic-assisted therapy (PAT), recognizing its promise for treatment-resistant psychiatric disorders while acknowledging lingering barriers.

A significant milestone unfolded on October 13th, 2022, as the Dutch parliament explored the therapeutic use of psychedelics during a comprehensive discussion. This marked a pivotal moment, echoing parliament's excitement for PAT advancements. Kuipers' subsequent response, released on June 26th, 2023, expresses gratitude for a report shedding light on the prospects and challenges of psychedelic-assisted therapy. He aligns with the authors, supporting PAT's evolution as a treatment for severe psychiatric disorders, while emphasizing adherence to guidelines for rigorous clinical trials. Collaborative efforts between medical centers and healthcare facilities are encouraged, along with the pursuit of financing options. Kuipers acknowledges legal barriers in psychedelic research and underscores the importance of controlled settings due to the potential for harm. Additionally, he outlines the concept of compassionate psychedelic use for patients in dire situations, calling for monitoring and prevention measures. Kuipers emphasizes engagement with entities such as the European Medicines Agency and the establishment of educational structures through the Dutch Society for Psychiatry. However, he tempers the growing media hype around psychedelics by stressing the need for balanced expectations and responsible usage.

Read the full article here.

EU Commission's unveiling of Brain Health Partnership: A unique opportunity for psychedelic science

The European Commission recently revealed ten new partnerships, integral to the strategic plan for Horizon Europe 2025-2027, the final segment of the current €95.5 billion R&I program. The partnerships, co-financed by the EU, industry and governments, include a unique focus on brain health. This partnership's primary objective is to discover cures for brain disorders, translating research results into innovative treatments. With an estimated annual budget of €100 million, it aims to create an extensive European and global collaboration. This partnership offers unprecedented opportunities for the growth of psychedelic medicines. The priorities for this partnership will be determined by an EU-funded project, starting in Q4 2023, developing a strategic R&I agenda for the brain partnership. The project consortium is now confirmed and includes several PAREA members.

NIRO: A New Tool to Navigate EU Research Grants

Researchers seeking to navigate the EU's multiple (and admittedly, not always user-friendly) research grant websites now have a new tool at their disposal: NIRO (Navigating Innovation & Research Opportunities). Developed by EFPIA, GlaxoSmithKline, and FTI Consulting, NIRO is designed to aid single entities, teams from the private and public sector, not-for-profit organisations, and academia in identifying suitable R&I initiatives and programme opportunities. In addition to initiatives and programmes sponsored by the European Commission, the tracker also lists research funding opportunities from national ministries, agencies, and NGOs both within and outside the EU.

Big Pharma's Transatlantic Dilemma: Navigating Regulatory Reforms in the EU and US

The pharmaceutical industry is facing a complex predicament. Sweeping regulatory reforms in both the EU and the US are challenging the strategic considerations of global drugmakers. In the EU, proposed changes to medicine rules have led many to assert that companies may shift their focus to the US. However, with the US undergoing its own radical clampdown on drug pricing, the situation is far from simple. How will these simultaneous policy shifts impact the industry's future? Find out from our in-depth analysis available for pro-subscribers.

Therapeutic value: patients should have better treatments, not just more of the same

Drug development is costly and complex and has huge financial ramifications for both the pharmaceutical industry and healthcare systems. And yet, neither FDA nor EMA requires data on the magnitude of a drug’s effectiveness compared with other treatments for the same condition. Consequently, some EU countries perform a health technology assessment (HTA). HTA ratings assist in identifying drugs with high additional therapeutic value for fast availability, guide clinicians and patients in treatment selection, and help with price negotiations. These ratings also play a key role in government-level decisions on reimbursement and price negotiations.

A new study on the added therapeutic value of first versus supplemental indications of drugs in the US and Europe reports the disappointing results of current drug development efforts. Less than half of approved first indications of new drugs add value over existing treatments. Supplemental indications add even less added value (another approach to enhance outcomes is the multifaceted use of a drug: not just for the initial approved disease- primary indication - but also, when feasible, for other conditions - secondary indications).

The authors recommend that the therapeutic value of all indications for new drugs should be communicated clearly to patients and physicians to help them make informed and optimal decisions about the treatment, particularly as these drugs are often highly expensive.

Ukraine's Bumpy Road to Medical Cannabis Legalization

Ukraine is currently considering a law that could open doors to medical cannabis use while paradoxically maintaining its status as a prohibited substance. The law would create a licensing system for cannabis cultivation and permit health facilities to dispense cannabis-based medicines. Niya Nikel, head of Epiprosvita, an NGO supporting individuals with epilepsy, has been a vocal advocate for such a move, highlighting its significant impact on managing her daughter's seizures. Nevertheless, the law is under scrutiny and may undergo changes before its second reading this fall. Among the main issues is a ban on importing raw cannabis materials until 2028 and its ambiguous status as a "prohibited substance," which can potentially hinder research and medical production. Despite these criticisms, the proposed law has broad backing from key figures in Ukrainian government and healthcare, marking a significant shift towards potential cannabis legalization in the country.

Transforming Cannabis Policies: Germany's Strides in Medical Use and Research

Germany's anticipated cannabis legislation is set to transform the medical marijuana landscape. Most recently, Germany's cabinet has approved plans to legalize cannabis possession and establish community cultivation clubs, according to Health Minister Karl Lauterbach. The law, set to be passed by the Bundestag after the summer break, is expected to take effect in early 2024 with minor parliamentary adjustments anticipated. Lauterbach aims to diminish the black market and related crime while emphasizing the need for responsible use through an accompanying educational campaign.

The new bill, if passed, will remove cannabis's classification as a narcotic, significantly lessening restrictions on medical cannabis companies. This change is expected to reduce the costs associated with production, distribution, storage, and documentation processes. As a result, more patients could have access to cannabis treatments under the German health insurance scheme.

The other integral part of this legislative plan involves the initiation of research pilot programs. These programs, inspired by the Swiss model, are intended to explore the impact of regulated cannabis usage on consumption habits. The research aims to find out if regulated access to cannabis can shift user preferences towards healthier consumption methods, such as vaping or edibles. This commitment to research emphasizes Germany's data-driven approach to understanding the broader implications of regulated cannabis use.

The ministry is still preparing a second law to allow for commercial supplies in some regional test areas for five years with ongoing evaluation. However, this is likely to depend on the approval of the EU Commission, since such far-reaching legalization has to be in line with EU law.

PRO users can access a more detailed analysis of the German legislation.