October, 2024

Dear First name / Readers,

 

We are pleased to welcome Francisca Silva to the PAREA team starting today. Francisca brings a strong background in neuroscience and mental health policy, including recent experience with the European Medicines Agency. Her passion and expertise will be invaluable as we push forward in our mission to transform mental health care across Europe. If you'd like to connect with Francisca or congratulate her on joining, feel free to reach out to her here.

 

Last month, we observed World Mental Health Day, during which I attended the WHO Mental Health Forum in Geneva. There, WHO Director-General Tedros Ghebreyesus emphasized a stark reality: mental health remains one of the most overlooked areas in healthcare. Until we start treating mental health with the same urgency as cancer, diabetes, or pandemics, it will remain on the sidelines of policy discussions. We need a deeper commitment from policymakers if we are to see real change.

 

In light of these challenges, PAREA has issued a commentary calling for stronger mental health initiatives within the EU. It reflects our position on the necessity of placing mental health as a core priority within European policy, advocating for resources, research, and practical frameworks that can drive genuine progress.

 

Our work in the EU space continues, with a focus on building political support for mental health and psychedelic therapies across EU institutions. Over the past weeks, I have met with eight additional Members of the European Parliament from various countries in Strasbourg. These meetings are part of our ongoing effort to re-establish a supportive network within the European Parliament, especially with new MEPs following the recent elections.

 

Thank you for following our journey as we strive to bring innovation in mental health to the forefront of EU priorities.

 

 

 

PAREA NEWS

We’re thrilled to welcome Francisca Silva to the PAREA team, joining us as a Project Officer! A neuroscientist by training, Francisca brings a wealth of knowledge and a genuine passion for brain health and mental well-being. Her interdisciplinary academic background includes a dual MSc in Brain and Mind Sciences from University College London (UCL) and Sorbonne Université, along with a BSc from the Maastricht Science Programme.

 

Francisca's journey into psychedelics-related work began during her recent traineeship at the European Medicines Agency, where she was involved in initiatives like the EMA Multi-Stakeholder Workshop on Psychedelics held in April 2024. Her experiences at the EMA have fueled her commitment to bridging the gap between scientific research and real-world applications, particularly in the area of mental health.

 

As Francisca puts it: "Mental health has always been a driving cause for me, as it touches each and every one of us. There is a massive need to improve how we understand this topic and our approaches to support those who are struggling. Psychedelics hold significant potential both as therapeutic interventions and to reshape the way we approach mental health care and understand brain health as a whole."

 

We are excited to have Francisca on board, knowing that her expertise and dedication will be invaluable as we work towards advancing mental health and psychedelic research across Europe.

 

PAREA has issued a commentary in response to a recent high-level expert report commissioned by the European Commission, which outlines strategic recommendations for the future of the EU’s R&I Framework Programme. The report underscores the need for increased funding and prioritization of critical societal challenges like mental health, which is increasingly affecting Europeans but remains underfunded and under-researched.

 

Among the report's key recommendations is the establishment of a Societal Challenges Council, aimed at tackling issues with limited commercial appeal, such as mental health. This Council would focus on addressing urgent societal needs, fostering innovation in areas like mental health that the pharmaceutical industry often overlooks due to lower market potential.

The report highlights a stark disparity in funding: despite mental health costing Europe €461 billion annually, only 0.68% of Horizon 2020's budget was allocated to mental health research. In line with the outcomes of the Conference on the Future of Europe, the report urges the EU to prioritize investments to “improve understanding of mental health issues and ways of addressing them.”

 

PAREA supports the report’s recommendations, calling for a dedicated EU mission on mental health, akin to the existing Cancer Mission, within Horizon Europe. Such an initiative would bolster R&I efforts in mental health and create a more supportive environment for innovation and care. Additionally, PAREA advocates for specific incentives within the EU pharmaceutical package to stimulate investment in developing novel treatments for mental health.

 

In September, PAREA's Founder attended two landmark events in New York, as part of the Science Summit during the 79th UN General Assembly, contributing to conversations about brain health and its central role in shaping the future of global health architecture.

 

First event: Neuroscience and Society: A Life Course Approach to Brain Health was co-hosted by the PAREA’s Founding Member European Brain Council and other key partners including the Brain Capital Alliance, Davos Alzheimer’s Collaborative, and UNICEF. The discussions highlighted the profound impact of brain health across various sectors: from policy and business to education and even the justice system, brain health is increasingly being recognized as a critical issue that affects every aspect of society. The second event, The Brain Economy Summit, focused on the growing global momentum for investments in Brain Capital as a means to drive both economic and social progress.

 

PAREA looks forward to building on the momentum generated by these global events.

 

As a member of the EU4Health Civil Society Alliance, PAREA co-signed an open letter addressed to European Commission President Ursula von der Leyen, raising concerns about the priority given to health within the EU’s agenda. The letter follows the announcement of Commissioners-designate and emphasizes the importance of having a Commissioner with relevant expertise to address health policy adequately.

 

The letter also stresses the role of civil society organisations in shaping healthcare policies and calls for sustainable funding opportunities under the EU4Health programme. It highlights concerns over the lack of acknowledgment of these aspects in the Mission Letter to the proposed Commissioner for Health and Animal Welfare.

 

The EU4Health CSA has requested a meeting with President von der Leyen to discuss these concerns and advocate for health to remain a priority in the Commission’s agenda.

 

A recent Euronews article explores the growing momentum behind psychedelic therapies in Europe and the hurdles that still need to be overcome before these treatments become widely accessible to patients. The piece highlights ongoing research, regulatory complexities, and the increasing interest from medical professionals and lawmakers in integrating psychedelics into healthcare. PAREA’s Founder was featured in the article, providing insights into the regulatory and political landscape that will shape the future of these promising treatments. With more EU-funded projects, like PsyPal, and broader public discussions underway, Europe could soon see significant advancements in mental health treatments — but only if existing barriers are addressed.

 

NEWS FROM OUR PARTNERS

PAREA member PsyPAN launched a new Impact Report aimed at amplifying the voices of participants in psychedelic clinical trials and improving future treatment experiences. Titled "In the Participants’ Words: Patient Insights from Psychedelic Clinical Trials," the report was unveiled at the Interdisciplinary Conference on Psychedelic Research in the Netherlands.

The report gathers insights from a series of workshops held by the Participant Collaboration Council, which included former clinical trial participants and experts. Together, they reviewed key aspects of the clinical trial process — from recruitment and preparation to dosing and post-treatment integration — and co-developed recommendations to make the participant experience more cantered and effective.

 

This initiative marks the beginning of what PsyPAN hopes will become a standard practice across the entire psychedelic-assisted therapy sector. By working closely with former trial participants, the sector can develop better safeguards and best practices, improving outcomes for future patients. A peer-reviewed whitepaper will be published later this year to further explore these findings.

 

 

THE LATEST FROM EUROPE

France’s newly appointed Prime Minister Michel Barnier has announced that mental health will be a primary focus of the government’s agenda for 2025. Recognizing the increasing impact of mental health issues across the country, the Prime Minister emphasized the need for a comprehensive strategy that addresses both prevention and care.

 

The initiative will aim to expand access to mental health services, with a particular focus on underserved communities. The government also plans to tackle the stigma surrounding mental illness, while providing additional support for healthcare workers involved in mental health care.

 

The Minister stressed: "I want to say it clearly: mental health is everybody's business: The state, local authorities, businesses, associations. We will, therefore, make mental health the major national cause of 2025".

 

Spain has launched a public consultation on a draft decree that aims to regulate the use of medical cannabis for a range of conditions, including multiple sclerosis, epilepsy, chronic pain, and chemotherapy-induced nausea. Under the proposed regulation, only specialist doctors will be authorized to prescribe medical cannabis, and hospital pharmacists will be responsible for preparing strictly regulated doses.

 

The draft decree is designed to ensure safe access to medical cannabis, emphasizing tight control measures around its use and distribution. The consultation, which provides stakeholders the opportunity to provide input, will remain open until October 21.

 

The proposed regulation marks a significant step forward for Spain in the medical cannabis sector, as it seeks to address patient needs while maintaining stringent safety standards.

 

The Commission published a guidance document on the validity of clinical studies for joint clinical assessments under the EU Health Technology Assessment Regulation, adopted by the Member State Coordination Group.

 

This guidance helps to define, classify, and assess the certainty of clinical study results in an objective, reproducible and transparent way. It covers the analysis of data from different types of single clinical studies.

 

This guidance complements the guidance documents previously adopted by the Member State Coordination Group on outcomes for joint clinical assessments, on quantitative evidence synthesis for direct and indirect comparisons and on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments.

 

The Innovative Health Initiative (IHI) has recently published a comprehensive spotlight focusing on the Impact of Mental Health Disorders, which highlights the importance of addressing mental health as a critical component of health R&I. This publication emphasizes the far-reaching consequences of mental health conditions on individuals, healthcare systems, and societies, while showcasing how innovation in the field can help mitigate these impacts.

 

IHI emphasizes the need for cross-sector collaboration, innovative therapies, and improved access to care to combat the growing mental health crisis. Their ongoing projects focus on providing new solutions for mental health disorders through partnerships between public and private sectors. These initiatives aim to accelerate the development of diagnostics, treatments, and care pathways that can significantly improve outcomes for those affected by mental health conditions.

 

The Commission is planning to combine all its R&I funding into a single "Competitiveness Fund"  that would be launched under the new multiannual budget due to start in 2028. This new fund would consolidate resources, simplify the application process, and focus on improving Europe's competitiveness in key sectors such as health, digital technology, and climate.

 

The proposal reflects growing concerns about the need to boost Europe’s research capabilities to keep up with global competition, particularly from the U.S. and China. While details are still being finalized, the idea is to better align R&I efforts with the EU’s industrial strategy. Find out more from Science|Business.

 

This development would have a significant impact on the distribution of EU research funding in the coming years. Stay tuned as PAREA continues to monitor how this might affect health innovation, particularly in mental health and psychedelic research.

 

WHAT WE ARE READING