Dear Readers,

There's no more fitting way to begin this newsletter than by honouring the late Dr. Roland Griffiths, Ph.D., who passed away earlier this week. A distinguished psychopharmacologist at Johns Hopkins University, Dr. Griffiths is widely credited with revitalizing medical research on psilocybin. He notably led his first clinical trial on the substance back in 1999. While he may not be here to witness the full impact of his groundbreaking work, the significance of his contributions will undoubtedly continue to resonate long after his passing.

As we look forward to the European Parliament elections in June 2024, EU political parties are busy crafting their election manifestos. PAREA is joining this important conversation with the release of our own manifesto. Our aim is to shape priorities in health policy, with a specific focus on mental health. Alongside this, we're developing an implementation toolkit for engaging national MEP candidates. If you are active in national policies or organizations that focus on the therapeutic use of psychedelics within the EU, we encourage you to get in touch. Together, we can ensure that our future MEPs prioritize mental health and embrace innovative treatment approaches.

In another significant development, the European Medicines Agency (EMA) has published updated draft depression guidelines, now including a section on psychedelic therapies. This inclusion was mentioned as one of the motivating factors for the EMA's decision to revisit the guidelines, as we learned in a recent meeting with them. Another key discussion during the meeting concerned the upcoming EMA multi-stakeholder workshop on psychedelics, slated for April 2024, in Amsterdam. Additional details on our meeting with EMA can be found below. But first, consider registering for the upcoming event on psychedelic therapies taking place in the European Parliament.

With best wishes,
Tadeusz Hawrot
PAREA Founder & Executive Director

On behalf of the MEP Action Group for the Medical Use of Psychedelics, we warmly invite you to an event at the European Parliament, focusing on the potential of psychedelic therapies within the evolving EU pharma legislation context. This event marks the first meeting organized under the umbrella of the recently formed MEP Action Group. The key focus of the meeting will be on discussing the creation of a supportive regulatory environment to stimulate innovation in novel mental health treatments, particularly in the promising field of psychedelic therapies.

Event details:

• Date: 6th November 2023

• Time: 16:15 – 18:00

• Venue: European Parliament and online

PAREA RECENT ACTIVITIES

The recently released PAREA EU Elections 2024 Manifesto offers a fresh perspective on mental healthcare in Europe in preparation for the 2024 EU elections. It promotes the use of psychedelic therapies to help patients confront the root causes of their mental health issues, going beyond symptom management. The manifesto proposes the establishment of a multidisciplinary EU task force to help prepare Europe for the roll-out of psychedelic therapies through measures such as developing standards of care. This approach encourages collaboration among various stakeholders including healthcare professionals, patient advocacy groups, regulatory bodies, psychedelic organizations, and other relevant parties.

As the 2024 EU Parliament elections approach, this manifesto becomes a vital resource for those committed to advancing mental healthcare in Europe, providing an innovative roadmap for the future.

EU asks psychedelic drug developers: Where are you?

In October, PAREA held its fourth meeting with the EMA Chief Medical Officer. Among the topics discussed were:

• EMA regulatory workshop on psychedelics;

• Concerns about the lack of commercial interest in Europe;

• Inclusion of psychedelics in the EMA draft guidelines on depression.

The EMA is supportive of the field of psychedelic therapies and understands the challenges that developers, especially small pharmaceutical companies and academics, may face in meeting the rigorous scientific and regulatory expectations for obtaining marketing authorization in the EU. The agency has repeatedly stated its readiness to offer guidance and support, inviting interested parties to reach out. Additionally, the EMA is open to discussing how data from overseas trials could be used to apply for marketing authorization in the EU. However, the concern raised was the lack of commercial interest in Europe, which could result in Europeans missing out on access to psychedelic therapies in the coming years, even as other regions begin to integrate them into healthcare. To date, only one or two psychedelic companies have sought EMA advice, and that was before the COVID-19 pandemic. Without interest from developers, the EMA's hands are tied.

The full meeting report is available to Pro subscribers.

Breaking new ground: introducing psychedelic therapies to the European pain community

Securing the trust and active engagement of the scientific and clinical communities is a critical step in advancing the field of psychedelic science. It's also essential for the successful integration of psychedelic therapies into routine clinical practice in the future.

In line with this objective, PAREA played a pivotal role in introducing the topic of psychedelics at the European Pain Federation Congress in September. This achievement was made possible through the dedicated efforts of our Vice-Chair, Deirdre Ryan, who also serves as the President of Pain Alliance Europe.

During a key session at the congress, James Close from Imperial College London presented his team's studies on the potential of psychedelic therapies in pain management.

To the best of our knowledge, this marks the first time that the subject of psychedelics has been openly discussed within the scientific community focused on pain research and management.

The Latest From Europe

EMA's new depression guidelines includes a section on psychedelics

The European Medicines Agency has just issued a new draft "Guideline on clinical investigation of medicinal products for depression." This is the third revision, with previous versions released in 2002 and 2013.

What's noteworthy is that the draft guideline now includes a dedicated chapter on psychedelics. It acknowledges that "the development of new fast-acting antidepressants and the use of psychedelics require distinct approaches." The document addresses critical aspects of developing psychedelic treatments and the evolving landscape of psychedelic-assisted psychotherapy for major depressive disorder. These aspects encompass: Placebo and/or Comparator, Expectations and Unblinding, Dosage, Sustaining Effects, Safety, and Psychotherapy.

The guideline also acknowledges that "psychedelic-assisted psychotherapy faces various challenges, especially in terms of standardization, training, monitoring, and safety, which must be addressed in specific study designs."

A public consultation on the draft guideline is now underway and will remain open until March 31, 2024.

EU Parliament's first mental health report aims for broad action and monitoring

The European Parliament's subcommittee on public health is addressing the deteriorating mental health landscape across Europe with its first-ever report on the subject. Spearheaded by Rapporteur Sara Cerdas, who is also the Vice-Chair of the MEP Action Group for the Medical Use of Psychedelics, the report aims to provide a comprehensive approach to mental health issues affecting the EU's 27 member states and 450 million citizens.

The report is aligned with the European Commission's June communication on mental health, which promised 20 "flagship initiatives" and €1.23 billion in EU funding. Cerdas' report goes beyond the Commission's communication by calling for more direct funding in mental health and outlining key areas of focus such as prevention, early diagnosis, combating stigma, and improving accessibility to care.

PAREA has been advocating for the inclusion of psychedelic medicines in this report, and we are pleased to report a recent amendment that promotes a broader exploration of innovative treatment options, with a specific emphasis on psychedelic-assisted therapies for mental health conditions.

The report - seen as a crucial step in setting the stage for EU-wide action on mental health - is expected to be adopted later this year.

European pharma industry advocates for 'broader perspective' amid regulatory and budget pressures

As Europe's pharmaceutical sector faces mounting pressures, a new report commissioned by pharma lobby EFPIA offers a counter-narrative. Addressing challenges such as impending regulatory changes in Brussels and budget constraints in national governments, the report advocates for a more holistic view on healthcare spending. It outlines actionable changes that don't necessitate additional funding, including long-term horizon scanning for net pharmaceutical costs and innovation agreements to ease upfront investment costs. Moreover, it recommends adopting a "societal value perspective" in health technology assessment (HTA) decisions—a practice already in place in Sweden. Additionally, public debates should move beyond the unit price of drugs to consider their broader health and economic benefits. These insights could be particularly relevant for emerging psychedelic therapies, which, if approved, may also challenge payers due to their high upfront costs and resource demands.

Variability in European antidepressant usage: The economic and healthcare Implications

The Euronews analysis provides an eye-opening look at the rising consumption of antidepressants medications in European countries over the last 20 years. The study explicitly notes a significant surge in prescriptions since the onset of the COVID-19 pandemic. In some nations, the number of prescriptions for these medications has multiplied many times over, dramatically increasing the financial strain on healthcare systems. For example, Germany's annual spending on antidepressants alone has now reached an estimated €724 million.

The detailed analysis goes beyond antidepressants to include data on anti-anxiety medications, revealing similar trends in rising usage. These comprehensive data points serve as a pressing reminder that European countries are facing escalating costs and a growing dependence on pharmaceutical treatments for mental health issues. The report urges an in-depth evaluation and possible restructuring of current mental health policies to better manage the increasing demand and expenditure.

EMA set to boost transparency in clinical trials: implications for patients and science

The European Medicines Agency (EMA) is making a pivotal change in the transparency requirements for clinical trials. Presently, drug manufacturers are only mandated to release a summary of clinical trials through an EU portal within a year after completion, while crucial details in the study protocol can remain unpublished for up to seven years. The protocol provides critical insights into how trials are conducted, benefiting both researchers and patients.

Following a year-long push by transparency advocates, the EMA has initiated a consultation to publish the protocol along with the summary. This move simplifies the process for pharmaceutical companies and the EMA, who will no longer have to redact and approve sensitive content across multiple documents. The decision was lauded as a victory for patients and scientific advancement.

European Commission to launch biotech initiative in bid for industry modernization

The European Commission is planning to launch an EU biotech and biomanufacturing initiative in the first quarter of next year. The initiative aims to capitalize on the high growth potential and labour productivity of biotechnologies and biomanufacturing, which are seen as key to the modernization and competitiveness of EU industry. This comes in response to calls for a European strategy, especially after the U.S. took similar action last year. The effort will tackle issues such as regulatory fragmentation and varying interpretations of biotechnologies across member states. Industry leaders and Commission representatives are currently discussing the initiative's objectives.

MHRA webinar on International Recognition

The UK’s Medicines and Healthcare products Regulatory Agency has created a new international recognition route for medicines utilising pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States. This new framework will support patients in the UK with expedited access to safe and effective medicines that have been approved by trusted regulatory partners. From 1 January 2024, international recognition will sit alongside the MHRA’s current national procedures. A recent MHRA webinar on this topic provides potential applicants with the opportunity to increase their knowledge and understanding of the guidance on the International Recognition Procedure.

In addition, the Gov.UK just published New streamlined notification scheme for lowest-risk clinical trials marks start of MHRA overhaul of regulation as part of its ‘overhaul’ of clinical trials regulations.

Selected psychedelic medicines' global news

PAREA Promotes Psychedelic Access and Research Across Europe American Journal of Endocannabinoid Medicine

PAREA launches psychedelics manifesto for mental health in Europe Psychedelic Health

Opening Critical Periods with Psychedelics Psychedelics Today

Norrsken Foundation launches psychedelic science initiative for mental health Tech.eu

Study results suggest improved efficacy of DMT therapy with SSRIs Psychedelic Health

American Psychiatrists' Opinions About Classic Hallucinogens and Their Potential Therapeutic Applications: A 7-Year Follow-Up Survey Mary Ann Liebert, Inc., publishers

Opinion: Self-medicating with psychedelics drugs is a dangerous plan The Washington Post

What Psychedelics Can Teach Us About Play TIME

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