Dear First name / Readers,

 

June has been a particularly significant month in the field of psychedelic medicines. In the US, in an unexpected turn of events, the FDA Psychopharmacologic Drugs Advisory Committee (AdCom) voted against the efficacy and positive risk-benefit ratio of MDMA-assisted therapy for PTSD, despite phase 3 clinical data showing that sixty-seven percent of participants with severe PTSD who received MDMA combined with therapy no longer met the diagnostic criteria for the disorder. Together with Drug Science and Mind Medicine Australia, PAREA has published a post expressing our concerns over certain aspects of AdCom discussions. A more comprehensive article will be released shortly.

 

A couple of days after the AdCom meeting, the Dutch government MDMA-State Commission, established over a year ago and comprising leading experts in addiction, psychiatry, international law, and more, released a comprehensive report. The report concluded that “there appears to be sufficient scientific evidence for the effectiveness and safety of this form of therapy” and that “the government must act expeditiously to enable the therapeutic use of MDMA.” Until MDMA-assisted therapy is formally registered in the Netherlands, the Commission recommends providing state-of-the-art treatment through a large naturalistic study, for which the Dutch government has already allocated a few million euros.

 

As one of the report’s authors, Prof. Wim van den Brink, stated, "We shouldn't leave patients with very serious problems on their own because a study is not perfect."

 

The FDA decision regarding the approval of MDMA-assisted therapy for PTSD is expected in August.

 

In other news, EMA has now released all the presentations and a recording from the EMA multi-stakeholder workshop on psychedelics – towards an EU regulatory framework. A comprehensive meeting report will be published soon.

 

 

 

PAREA NEWS

In June, PAREA organized a 2-day closed strategic workshop, "Psychedelics for Healing War-Induced Trauma," in collaboration with the Open Society Foundations, Helsinki Foundation for Human Rights, and International Renaissance Foundation. The event, closely aligned with the Ukrainian Psychedelic Research Association (UPRA) and other Ukrainian groups, brought together key organizations and international experts to explore the therapeutic potential of psychedelics in the context of the ongoing war in Ukraine.

 

Participants ranged from veterans to members of the Ukrainian Parliament and groups such as Forest Glade, Azov Movement, Phoenix Ukraine, Heal Ukraine Trauma, Tokarev Foundation, Fenix Project, and others. International experts like Rick Doblin, David Nutt, David Esselman, Jonathan Lubecky, Eric Vermetten, and Paul Liknaitzky, contributed their insights on legal, clinical, and advocacy pathways.

 

PAREA's efforts to foster collaboration between Ukrainian and international groups will continue through dedicated working groups and ongoing support.

In the last few weeks, PAREA has been actively participating in several significant events. In May, at the World Health Assembly in Geneva, PAREA took part in a side event focused on closing the mental health financing gap, co-organized by the McKinsey Health Institute, the Clinton Health Access Initiative, Wellcome, and Kokoro. This event marked the beginning of the Coalition for Mental Health Investment.

 

PAREA also attended the 14th International Sakharov Conference “Hidden Wounds of War. Trauma, Healing and Recovery among Ukrainian Veterans” in Lithuania, where discussions centred on trauma, healing, and recovery among Ukrainian veterans. This conference paved the way for a strategic workshop in Warsaw, organized by PAREA in June for Ukrainians, to explore the role of psychedelics in treating war-induced trauma and how the international community can help.

 

On June 5th, we co-organized the Pathways to Access Summit, followed by the Interdisciplinary Conference on Psychedelic Research (ICPR) from June 6th to 8th. PAREA Founder Tadeusz Hawrot delivered the opening talk at Paths and moderated a panel on "Pathways to Access in Europe" during the ICPR.

 

Later in June, PAREA’s Founder spoke about the road to access in the EU at the Polish Psychedelic Society's "Psychedelic Science" conference in Warsaw. The event also featured discussions on psychedelic-assisted therapies for first responders and military veterans, especially in the context of the ongoing conflicts in Ukraine.

In May, PAREA submitted feedback to two important European consultations relevant to mental health: the Horizon Europe work programme Cluster 1, addressing diseases and reducing disease burden, and the EU survey "Transforming Health and Care Systems."

 

The EU Survey aims to identify challenges and issues in health and care systems and their broader economic impact. Meanwhile, the Horizon consultation seeks to provide policymakers with a better understanding of the requirements for innovative health technologies and personalised medicine.

 

In its response to the Horizon consultation, PAREA emphasised the need for more therapeutic options for mental health and highlighted psychedelic treatments as a promising new class of treatment for conditions like addiction and depression.

Through its feedback on the EU Survey, PAREA pointed out the significant differences in the EU regulatory framework regarding psychedelic clinical trials. It noted that the EU lags behind countries like the US, despite the OECD acknowledging the increasing economic burden of mental health disorders in Europe.

 

Additionally, the EU4Health Civil Society Alliance, including PAREA as a member, has raised concerns regarding the reduction in the total budget allocated for the EU4Health Programme. We called on the EU institutions to uphold the objective of meaningful engagement and sustainable funding to fulfil their public health mission within the EU4Health Programme.

The full statement endorsed by PAREA can be read here.

Exciting news for those involved in psychedelic research! Norrsken Mind, a non-profit organisation and member of PAREA, is offering grants for psychedelic research, educational initiatives and high-impact non-profit projects aimed at integrating psychedelic-assisted therapies into European healthcare systems. 

 

Eligible applicants include researchers, non-profit organisations, and private individuals in Europe. The application process, detailed on Norrsken’s website, outlines the types of projects funded, eligibility criteria and funding disbursement procedures. 

 

Applications are accepted on a rolling basis, with research grant proposals evaluated by a network of Scientific Advisors. The submission process is web-based and additional information can be found in the FAQ section. 

 

If you have a project that contributes to the safe and effective integration of psychedelic treatments in Europe, consider applying for funding from Norrsken Mind.

 

THE LATEST FROM EUROPE

The Dutch State Committee on MDMA, on June 6, 2024, delivered its comprehensive findings in the report titled "MDMA: Beyond Ecstasy" to the Dutch Minister of Medical Care. This 233-page report (for now, available only in Dutch), crafted by a six-member committee with diverse expertise spanning international law, addiction, psychiatry, criminal law, emergency medicine, and prevention, draws from extensive literature reviews, stakeholder discussions, and internal deliberations.

 

A primary task of the committee was to advise the Dutch government on the medical use of MDMA, particularly focusing on MDMA-assisted therapy for PTSD. The committee's findings underscore the therapy's effectiveness and safety for chronic, treatment-resistant PTSD patients. Given the high prevalence of PTSD, the committee urges the Dutch government to expedite the introduction of MDMA-assisted therapy.

 

However, the pathway to formal authorization and integration into healthcare systems faces significant hurdles. The report notes that it is improbable that a registration dossier for MDMA-assisted therapy will soon be submitted to the EMA or the Netherlands Medicines Evaluation Board for marketing authorization in the EU or the Netherlands. Given the non-feasibility of alternatives such as off-label use, compassionate use, and extended access schemes, the committee advocates for initiating a large, naturalistic study to monitor PTSD patients undergoing MDMA-assisted therapy.

 

The committee also emphasizes that MDMA-assisted therapy should only be administered by qualified therapists in specialized treatment settings. It calls on professional psychiatric and psychological organizations to provide clear ethical and judicial guidance to their members. Additionally, a hotline or helpline is recommended to support individuals who experience adverse effects outside regular treatment frameworks.

In June, the Council of the EU adopted conclusions on the future of the European Health Union, urging the new European Commission to keep health as a priority. In the document, member states acknowledged progress in health policy coordination at the EU level, outlined ongoing challenges, and identified key focus areas for strengthening the European Health Union.

 

Addressing healthcare priorities, the Council emphasized the need for an independent, evidence-based database to identify unmet patient and societal health needs. Is invites the EU to set up a voluntary Member State driven mechanism for the appraisal and prioritisation of the highest disease-specific, disease-overarching, and systems-level, health related unmet patient and societal needs, based on the scientific evidence about the disease specific needs and using transparent assessment criteria. It also encourages the EU to consider the identified most pressing unmet health-related patient and societal needs when deciding on national research funding and incentives.

 

Mental health featured prominently in the conclusions, recognized as a crucial aspect of wellbeing with wide-ranging social and financial impacts. The Council called for strengthened EU policies on health promotion, including mental health initiatives.

 

The conclusions also call for the creation of an “EU Health Investment Hub” to provide “on-demand” support to countries for national health projects.

Big changes are afoot for drug pricing in Germany. Health Minister Karl Lauterbach’s Medical Research Act (MFG) proposes that pharmaceutical companies negotiate confidential reimbursement prices with public health insurers. This proposal faces massive resistance from the governing coalition, as Germany is the only country with transparent reimbursement prices for patented drugs. Transparent pricing makes Germany a top reference market for drug prices globally.

 

The switch to secret prices could still be removed from the law, with a decision expected in the Bundestag before the summer recess. Interestingly, some pharmaceutical companies might prefer to maintain transparent pricing in Germany, Europe's richest country, as it often sets high price thresholds for other nations.

 

The proposed pricing rule is part of a broader pharma strategy law aimed at easing healthcare research using AI and data. The draft has had its first reading, and coalition parties can still make adjustments before it passes.

Belgium and the Netherlands are advocating for a need-driven research model to address unmet medical needs, focusing on societal requirements. A conference held during Belgium’s EU Council Presidency in April 2024 highlighted this initiative. The Netherlands presented a study identifying 33 conditions with the highest disease burden, showcasing gaps in drug development. Anxiety is topping the list and in the broader context of mood disorders, the report says: “Drug repurposing of psychedelics is mentioned as the most promising option.”

 

What constitutes unmet needs might have far ranging consequences, becoming a prerequisite for accessing incentives like PRIME, accelerated assessment, conditional marketing authorisation, and additional data protection. It could also inform reimbursement decisions. Recognising this, PAREA released a position paper on unmet needs last year and attended the Belgian conference this year.

 

Belgium and the Netherlands are pushing for a collaborative approach, with Belgium setting the stage for future presidencies and the Netherlands developing a flexible definition of 'unmet medical need' to accommodate different stages of drug development and various incentives. You can read more on this topic in the EURACTIVE article.

 

During the European Mental Health Week in May, the European Commission unveiled a "tracking framework" to showcase its advancements on the mental health communication launched in June 2023. Highlights include committing €11 million from the EU4Health program for a new initiative to identify mental health gaps and build capacity in partnership with WHO. Additionally, a €9 million EU-PROMENS project was launched, featuring a multidisciplinary training program for healthcare and other professionals. To combat stigma and promote knowledge sharing, the Commission also introduced a repository of mental health best and promising practices.

 

The next update is scheduled for World Mental Health Day on October 10, 2024.

The European Medicines Agency has expanded its scientific advice offerings to “transform how clinical trials are initiated, designed, and run,” according to a recent announcement. This initiative includes two new pilot programs under the Accelerating Clinical Trials in the EU (ACT EU) program, a collaboration between EMA, the Heads of Medicines Agencies (HMA), and the European Commission.

 

Pilot 1 provides scientific advice on clinical trials and requirements for marketing authorization.

 

Pilot 2 offers technical and regulatory support on the dossier of clinical trial applications before submission through the Clinical Trials Information System.

 

This move aims to address challenges with the Clinical Trials Regulation, especially concerning the IT system, and to revive Europe’s competitiveness in clinical research. Data indicates a growing trend of clinical trials being conducted in the U.S. and China, making this a crucial step for the EU to retain its appeal to the pharmaceutical industry.

 

In a joint statement, 18 industry associations and organizations called on the next European Commission to ensure legislative and financial commitments for EU Commission’s initiative on boosting biotechnology and biomanufacturing in the EU.

 

Overall, the Commission's new initiative has been positively received by industry. This initiative is seen as a strategic move to enhance the EU’s competitive edge globally and bolster a resilient economy through industrial innovation. Biotechnology and biomanufacturing are deemed essential for the EU to meet future industrial and research needs and contribute to sustainable transitions, health security, and economic growth. However, the initiative also highlights several challenges, such as the need for equitable market entry conditions, protection for innovation, and incentives for industry players.

 

The statement calls for immediate actions to address these challenges, including streamlining regulatory pathways, ensuring resource access for biomanufacturing, and enhancing public understanding of biotechnology. It urges the Commission to commit legislatively and financially to ensure effective implementation of the initiative, with support from EU Member States and alignment with European Parliament legislation.

 

Encouragingly, a recently released EU Council’s strategic agenda for 2024-2029  sets out that the EU will “build up” its own capacity “in sensitive sectors and key technologies of the future,” including health and biotechnologies. The agenda also mentions a commitment to bolster competitiveness and promote innovation.

Formerly known as FINOSE, the group has rebranded to Joint Nordic HTA Bodies (JNHB) to reflect the inclusion of Denmark and Iceland alongside Finland, Norway, and Sweden. The new website is www.jnhtabodies.org.

 

Members include the Danish Medicines Council (DMC), the Safety and Development Centre for the Pharmaceutical Area (Fimea), Landspitali—the National University Hospital of Iceland, the Norwegian Medicines Agency (NOMA), and the Dental and Pharmaceutical Benefits Agency (TLV) in Sweden. The collaboration aims to support timely and equal access to medicinal products, reduce divergence in HTA methodologies, and share resources and knowledge. The Memorandum of Understanding will continue until 30th June 2026.

 

Joint assessments will focus on relative effectiveness and health economics, and while they will meet legal requirements for access decision making in all five countries, they will not aim for joint decisions on recommendations or reimbursement. Practical submission guidelines are provided, including the option to supplement reports with country-specific information.

 

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