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Dear Readers,
Welcome to this edition of our newsletter, which is brimming with updates and opportunities for our community.
Firstly, our EU Elections Campaign 2024 is in full swing, and you can join us in advocating for mental health innovation and the potential of psychedelic therapies. Your voice is important and together, we can make a significant impact.
The EU-funded project PsyPal continues to gain momentum, and, If you haven't already, there's still an opportunity to register for the upcoming launch event at the European Parliament (the event will be also streamed).
We're also reminding everyone that the EMA workshop on psychedelics is approaching fast. This event promises to be a pivotal moment for the advancement of psychedelic therapies within the EU regulatory framework.
Lastly, we're proud to announce the release of PAREA's Annual Report for 2023. This document highlights our achievements, challenges, and the strides we've made in the past year. It's a testament to the hard work and dedication of our community, and we hope it inspires you as much as it does us.
With best wishes,
Tadeusz Hawrot
PAREA Founder & Executive Director
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PAREA News
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Our annual report 2023 is out!
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In 2023, PAREA marked its first full calendar year with successful stakeholder
engagements, several policy papers, being featured in numerous conferences in Europe
and beyond, and the co-creation of the Members of the European Parliament Action
Group on the Medical Use of Psychedelics. The year culminated in a significant EU Parliament event, marking the launch of PAREA third policy paper that year, centred on the critical topic of unmet medical needs. The momentum continued with our 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.
You can read the full annual report here.
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PAREA EU elections campaign
With the EU elections just around the corner (June 6-9), we're stepping into a crucial time that will shape the EU's direction for the next few years. It's a chance to influence the future leaders of the EU to prioritize mental health and explore innovative treatments like psychedelic therapies.
PAREA is diving into the election buzz with a clear goal: to make mental health and the potential of psychedelic therapies a priority for the next set of EU policymakers.
We need your voice in this. By getting involved, you're helping push for a future where mental health care embraces new, effective treatments.
Whether you live inside or outside the EU, sign the public call to action: show your support for integrating innovative mental health treatments, including psychedelic therapies, into EU healthcare.
MEP Mental Health Innovation Pledge: Engage MEP candidates, urge them to support the Mental Health Innovation Pledge 2024.
Spread the word: share our message with friends, family, and on social media. See campaign’s resources.
Your action matters. Support our campaign today and be part of the change!
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Discover the future of palliative care at the PsyPal project launch event
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We're excited to extend an invitation to the launch event of the PsyPal project, an initiative funded by the European Union to investigate the use of psilocybin in palliative care. This event is scheduled for 9th April, from 12:15 to 13:45 CEST, at the European Parliament in Brussels (and online). It's organized under the auspices of the MEP Interest Group on Brain Health and Neurological Conditions, run by the European Federation of Neurological Associations, and the MEP Action Group for the Medical Use of Psychedelics, coordinated by PAREA.
The PsyPal project represents a groundbreaking effort to fill crucial gaps in palliative care, focusing on how psilocybin therapy could alleviate the psychological distress experienced by individuals with terminal conditions, through a multi-site clinical trial.
The event promises a thorough examination of the project’s goals and its anticipated influence on future mental health treatments, covering everything from the scientific basis and patient experiences to the legal and regulatory framework surrounding psychedelic research.
To express your interest in joining us in person or to register for virtual attendance, please sign up here.
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PAREA Founder discusses the future of psychedelics in the EU with “The Microdose”
PAREA is pleased to announce that its founder, Tadeusz Hawrot, was featured in the UC Berkeley Center for the Science of Psychedelics' "The Microdose 5 Questions." In this interview, he discusses the evolving landscape of psychedelic research within the EU and the hurdles that lie ahead for psychedelic reform in the region. He highlights the recent initiatives by the European Medicines Agency and the EU’s Horizon Europe program, which signal a shift towards embracing psychedelic research for addressing unmet medical needs. He also discusses the challenges posed by the EU's diverse regulatory environment and the importance of EU-wide approval for psychedelic therapies.
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Pathways to Access Summit & ICPR 2024: Events you won't want to miss
PAREA is proud to co-organize the inaugural Pathways to Access Summit (Paths) on June 5th, the day preceding ICPR. This one-day event that we coorganize with OPEN Foundation, Psychedelic Alpha, Blossom, and Norrsken Mind, aims to dissect the paths to developing, approving, and incorporating psychedelic medicines into the European healthcare system. An indispensable event for those interested in European regulatory and healthcare access issues.
And speaking of ICPR, the Interdisciplinary Conference on Psychedelic Research 2024 is set to return for its sixth edition on June 6-8 in Haarlem, the Netherlands. Organized by the OPEN Foundation since 2010, ICPR remains the pioneering and leading conference on psychedelic research and therapies in Europe.
ICPR 2024 promises a comprehensive experience with nearly 100 interdisciplinary speakers, panel discussions, workshops, symposia, and film screenings.
The OPEN Foundation is offering us a special €100 discount code for our community! Use the code “PAREA100” when purchasing your tickets at:
https://icpr-conference.com/tickets
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The latest from Europe
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EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework
This is a reminder that the EMA workshop on psychedelics is scheduled for 16 - 17 April 2024 at the EMA headquarters in Amsterdam, and it will also be live-streamed. This workshop aims to bring together a diverse group of stakeholders, including patients, healthcare providers, academics, regulatory bodies, and the pharmaceutical industry. The focus will be on exploring the advancement and therapeutic application of psychedelics for unmet medical needs in mental health.
PAREA, along with several of its member organizations, will be participating and featured on the agenda.
For more details, click here .
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The psychedelic landscape in Europe: Insights from the EMA Chief
In a recent interview published by the European College of Neuropsychopharmacology (ECNP), the Chief Medical Officer of the European Medicines Agency, Dr. Steffen Thirstrup, shared insights on the evolving perspective towards psychedelics in medical treatment.
He highlighted the historical context of psychedelic restrictions, attributing them more to political factors than scientific evidence, and mentioned the relatively low addiction potential of these substances compared to opioids and central nervous stimulants.
Dr. Thirstrup pointed out the scarcity of innovation in treatments for mental disorders and suggested that psychedelics could offer new possibilities for conditions like treatment-resistant depression and PTSD.
He stressed the critical need for drug developers, encompassing both the pharmaceutical industry and academic researchers, to engage with the EMA at the onset of their developmental processes. He detailed the frequent oversight of considering European regulatory expectations, which differ significantly from those in the U.S. By initiating dialogue with the EMA early, developers can navigate the unique regulatory landscape of Europe, ensuring that any potential challenges or requirements specific to the European context are identified and integrated into the trial designs from the start.
The interview also covered the EMA's recent update of depression guidelines, which now consider psychedelics, and Dr. Thirstrup's participation in the 2023 ECNP New Frontiers Meeting in Nice, where he valued learning from diverse perspectives, including those of patients who have experienced psychedelics.
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PAREA's partners Cybin and MindMed lead with FDA breakthroughs in psychedelic therapy
We are very pleased that our two industry partners, Cybin Inc and MindMed, have recently received FDA Breakthrough Therapy Designation (BTD) for their pioneering treatments. Cybin's psilocybin analog, aimed as an adjunctive treatment for major depressive disorder (MDD), allows for dual-therapy with existing antidepressants, showing significant improvement in symptoms, with 75% of participants achieving remission in their Phase 2 trial. They are gearing up for a Phase 3 study across the U.S. and Europe in mid-2024. On the other hand, MindMed's MM120 program for Generalized Anxiety Disorder (GAD) not only received BTD but also showcased positive 12-week durability data from their Phase 2b study, demonstrating a clinically significant reduction in anxiety symptoms. This marks a critical advancement in addressing the unmet needs of individuals living with GAD, with MindMed preparing for future Phase 3 trials to bring MM120 closer to patients. These milestones underscore the therapeutic potential of psychedelics in mental health, marking significant progress in the field.
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EU Parliament reaches compromise on pharma rules: a closer look at new drug protections
The European Parliament has agreed on updates to the pharmaceutical package, affecting how new drugs, including potential psychedelic therapies, will be brought to market. Following extensive negotiations, a compromise sets regulatory data protection at seven-and-a-half years, with an option to extend this for medications meeting unmet medical needs, potentially pushing total protection to eight-and-a-half years.
Crucially, the updated agreement modifies the strategy for introducing new medicines across the EU. Moving away from the original Commission proposal, it now allows member states to request that pharmaceutical companies submit for pricing and reimbursement within one year post-approval. This adjustment aims to expedite access to new treatments. Notably, there's a tailored provision for small and medium-sized enterprises, non-profits, and entities with a portfolio of five or fewer approved drugs, granting them a two-year window to apply, thereby easing the process for smaller players in the pharmaceutical landscape.
Additionally, drugs approved with comparative clinical trials are eligible for six months of data protection, aligning with the Commission's initial proposal. The Parliament's directive proposal further introduces new incentives not previously outlined by the Commission: an additional six months of data protection for medicines developed significantly within the EU or in collaboration with university hospitals, centres of excellence, or bioclusters.
PRO subscribers can access our full analysis of the proposed changes.
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From taboo to tolerance: Germany approves cannabis decriminalization
Germany has officially decriminalized cannabis possession and home cultivation starting April 1, following the Bundesrat's approval. Adults can now possess up to 25 grams of cannabis and cultivate up to three plants. From July 1, "cannabis clubs" will supply members with cannabis, capping at 50 grams monthly per member. Health Minister Karl Lauterbach hailed the move as a significant step towards dismantling the black market, urging responsible use. Despite concerns over potential court overloads due to amnesty provisions and debates over possession limits and proximity restrictions to schools, the law passed. Amendments to ease state burdens and enhance addiction prevention are planned before July. This legislation marks the initial phase towards fully legalizing cannabis, with future plans for state-controlled sales through pilot programs.
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“The most important health legislation” in this mandate adopted: European Health Data Space
EU institutions have reached a provisional agreement on the European Health Data Space (EHDS), hailed as a significant advancement in health legislation.
MEP Tomislav Sokol who was leading this file in the Parliament remarked, “This is the most important health legislation adopted in this mandate... The consequences of this will be long term and profound in terms of better health care, in terms of digitalization of health care systems, harmonisation of standards, and also having much more research done within the EU.” MEP Sara Cerdas also praised the agreement, saying, “When it comes to research and innovation, I still don’t think we can imagine the potential in regards to how much it will benefit citizens, not only in the EU but also worldwide.”
The new agreement allows EU citizens to electronically access their health data and lets healthcare professionals use this data for treatment. It also means patients can collect their prescriptions in any EU country, regardless of where they were originally prescribed.
The deal also addresses the complex issue of using health data for other purposes, like research or policy-making. Now, health data that's either anonymous or has personal details hidden can be shared for these public interest activities.
However, there was a lot of debate about whether people should be able to refuse to have their data used this way. In the end, it was decided that everyone has the right to say no to their data being used for these secondary purposes. Exceptions are made for specific public interest cases, policy-making, statistics, and protecting intellectual property and trade secrets.
The EHDS, introduced by the Commission in May 2022, is now awaiting formal adoption.
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EU gears up for HTA amid industry and agency concerns
As the EU prepares for the implementation of health technology assessments (HTA) in January 2025, aimed at evaluating the added value of new therapies, starting with cancer drugs and advanced therapies, both the pharmaceutical industry and HTA bodies express reservations. Industry voices call for clearer guidelines and more proactive stakeholder engagement, while HTA agencies hesitate due to uncertainties about funding and the scale of assessments.
The Commission has initiated public consultations for the first draft of implementing rules for clinical assessments. However, the HTA Coordination Group (HTACG) member reveals a lack of eagerness among HTA bodies to undertake EU-wide assessments without confirmed financing, highlighting a potential bottleneck for evaluating a significant number of therapies.
Pharma industry advocates for greater industry involvement in the HTA process, particularly in defining critical assessment measurements (PICO). Despite these calls, an HTACG member emphasizes the distinction between industry assessments and HTA evaluations, suggesting limited industry input in the process.
With the HTA set to commence in January, stakeholders work towards ensuring readiness, though challenges in alignment and execution remain. The EU-wide HTA aims to streamline therapy evaluations across member states, yet the path forward requires balancing industry insights with the integrity of the assessment process.
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Belgium's Prime Minister calls for unified European stock exchange to boost biotech’s funding
Belgian Prime Minister Alexander De Croo, in a recent interview with POLITICO, emphasized the need for Europe to establish its own version of the Nasdaq to help European companies raise funds more efficiently. Highlighting the challenge of European biotech firms often turning to the U.S. for investment, De Croo and EU competition chief Margrethe Vestager visited Argenx, a biotech firm in Ghent, to discuss fostering a more robust financing environment within the EU. The duo advocated for a unified European stock exchange to facilitate easier capital raising for startups, contrasting the fragmented nature of current European markets. Despite efforts to create a Capital Markets Union, progress has been slow due to national divisions. De Croo's "Industrial Deal" aims to invigorate European industry by improving regulation and integrating the single market further, aspiring to create a conducive ecosystem for financing innovation and technology scale-ups in Europe.
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EU Parliament approves cost-saving patent extension tool for drugmakers
The European Parliament has endorsed a novel mechanism proposed by the European Commission to prolong pharmaceutical patents, aiming to reduce costs for drug manufacturers and streamline the protection of their innovations. The proposal for a unitary supplementary protection certificate (SPC) received substantial support, with 518 votes in favor, enhancing patent protection by up to an additional five years. This unitary SPC, applicable in 17 countries adopting the unitary patent system, simplifies the process, requiring a single application for extended patent protection across these nations, potentially saving patent owners €137,000. The European Union Intellectual Property Office (EUIPO) is designated to oversee this new system, emphasizing the need for examiners with specific expertise in assessing SPC applications.
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MSD releases a comprehensive publication on European pharmaceutical R&D
MSD has introduced the "Pharmaceutical Policy Passport ," a detailed guide designed to enhance understanding of the pharmaceutical innovation process and help improve access to new treatments. Released in conjunction with current EU discussions on pharmaceutical legislation, the well-researched and accessible document aims to offer policymakers a clear view of the factors and policies that are crucial for supporting pharmaceutical innovation. It covers important topics in pharmaceutical R&D, including issues related to affordability and access to medicines. The guide emphasizes the importance of government policies in supporting pharmaceutical R&D efforts and ensuring that patients can access new medicines. This publication is intended to inform and assist in shaping policy decisions that will impact the future of pharmaceutical innovation and patient care.
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