Innovating Mental Health in the EU Pharma Legislation: Regulatory Pathways for Psychedelic Therapies

The European Parliament’s commitment to exploring the therapeutic potential of psychedelics has taken a significant step forward. With the recent expert roundtable event titled “Innovating Mental Health in the EU Pharma Legislation: Regulatory Pathways for Psychedelic Therapies,” key policymakers, researchers, and industry leaders convened to pave the way for integrating psychedelic therapies into European healthcare.

The event, co-hosted by MEPs Mikuláš Peksa and Alex Agius Saliba, was instrumental in advancing discussions on the regulatory integration of psychedelics into mental health treatments. The presence of Prof. David Nutt as the moderator added substantial weight to the proceedings, considering his prominent role in drug policy and psychiatric research.

A diverse panel of speakers, including Josh Hardman, Tadeusz Hawrot, Maryam Jabir, Tomáš Pálenícek, Damian Kettlewell, and Deirdre Ryan, provided a broad spectrum of perspectives on the innovative use of psychedelic compounds. They deliberated on creating a regulatory environment that could foster and incentivize such novel therapies.

In a powerful testament to the current climate surrounding psychedelic research, Viktor Chvátal, Secretary-General of PsychedelicsEUROPE, argued, “The momentum that can be felt in Brussels must be catalysed at the Member State level.” He highlighted the progressive measures already adopted by countries like the Czech Republic and the Netherlands, emphasizing the need for a collaborative approach between public and private sectors to integrate psychedelic-assisted therapies into the mainstream.

The agenda of the event was meticulously structured, starting with opening remarks from the hosting MEPs, followed by an emotionally compelling testimonial from Maryam Jabir, a participant in a psychedelic-assisted therapy trial. Each subsequent speaker built upon the narrative that addressing high unmet needs in mental health care is critical, and psychedelics may offer an unprecedented opportunity to do so.

The event concluded with the launch of a position paper and closing remarks from Deirdre Ryan, indicating a strong commitment to actionable outcomes. This position paper outlines the practical steps and recommendations discussed throughout the roundtable, aiming to bridge the gap between current legislative frameworks and the incorporation of psychedelic therapies.

This roundtable marks a significant moment in the legislative engagement with psychedelic research and could herald the dawn of a new era in mental health treatment within the European Union.

Below, you can find a summary of the meeting.

Summary of the EU Pharma Legislation Psychedelic Therapies Event

Josh Hardman, founder of Psychedelic Alpha, presented on the EU drug development efforts concerning psychedelics.

• In the post-Brexit world, the UK wanted to incentivize drug developers similarly to the US. The UK’s innovation passport system granted 5-10% of passes to psychedelic drug developers, which was significant compared to zero psychedelic candidates being prioritized in the US’s prime program.
• The EU’s prime program has only enabled two psychiatric drug candidates, both of which failed. This highlights the lack of incentives and enablement for psychiatric drug candidates in the prime program.
• Psychedelic research and clinical trials are happening mainly outside of Europe, with Europeans often being the first to test the drugs. This risks Europeans becoming “psychedelic guinea pigs” by proving the treatments work but then not having access once approved, as later-stage trials happen elsewhere.
• Hardman suggests the EU could incentivize trials that compare psychedelics to the standard of care to provide cost-effectiveness data to EU member states.
• The EU could also support earlier research through scientific advice, logistical advice on scaling up therapies across the EU, and developing standardized protocols.
• Hardman argues the EU should bring pivotal approval-enabling studies back to Europe and support the rollout of psychedelic therapies across member states.

And from the Q&A:

• Hardman discussed the potential to gather real-world data on approved medical psychedelics like ketamine to compare effectiveness and safety to off-label or generic versions.
• Hardman noted psychedelic Phase III trials involve large participant numbers (e.g. 1000 for psilocybin), so substantial real-world data is being collected. He said collecting data during trials could reveal new indications for psychedelics beyond the trial focus.
• Hardman would like to see a large registry for psychedelics but noted challenges around gathering data on illegal recreational use.
• In the Q&A, there was also a discussion about the FDA and EMA considering historical/indigenous psychedelic use data for safety insights. Hardman expressed frustration at re-testing psychedelic safety given historical use but noted some rationale around strategic division from the counterculture.

Tadeusz Hawrot, the founder of PAREA, was next to present on the mental health burden and unmet needs in Europe.

• Hawrot spoke on behalf of PAREA, representing patient groups, scientific communities, and EU psychedelic foundations.
• He discussed the high burden and unmet needs of mental health conditions in Europe based on prevalence data.
• He noted the lack of new mental health treatments approved despite the high disease burden in Europe.
• He suggested the EU pharmaceutical legislation review should provide incentives and priorities for mental health and psychedelic drug innovation.
• He spoke about the potential for psychedelics to help make people “agents of their own healing” with professional therapist support.
• He stated the majority of psychedelic R&D and later-stage trials are happening outside Europe.
• He called for a comprehensive EU incentive package for psychedelic startups and pharma companies.
• He proposed an EU hub for mental health R&D to coordinate efforts and set priorities across Europe.
• He emphasized the need to address mental health as a pillar of sustainable development in Europe.
• He highlighted mounting evidence that psychedelic therapies could help those suffering, including treatment-resistant cases.
• He argued the EU legislation review should stimulate innovation in mental health and psychedelics.

Maryam Jabir, one of the participants in the COMPASS Phase II trial, spoke about her (challenging) experience in the trial.

• Maryam described lifelong struggles with mental health issues and feeling incompatible with life despite privileges.
• She learned about psilocybin therapy and was drawn to the concept of it “resetting” the brain.
• Maryam entered the trial hoping psilocybin could provide a “raft” to get to shore, not expecting a “miracle cure”.
• She had a very challenging psychedelic experience that shattered her coping mechanisms and masks. Maryam felt she failed the trial team, the drug, her mother – she believed the experience made things worse.
• In her speech, Maryam emphasized she doesn’t believe the dose itself made things worse, rather it forced reckoning with inner pain.
• She highlighted the difficulty of integrating such an intense experience back into everyday life afterwards. She stressed importance of professional support before, during and after psychedelic experiences.
• She argued while clinical trials are important, natural psychedelic therapies have centuries of evidence. She suggests focus on practical/ethical frameworks, training, community integration alongside legislation.

Tomáš Pálenícek, a psychedelic researcher from the Czech Republic, discussed his experience studying these compounds.

• Pálenícek stated he would discuss pitfalls scientists and clinicians face when working with psychedelics, using depression research as an example of psychedelic effectiveness.
• He explained that treatment-resistant depression often involves months or years of unsuccessful treatment, leading to disability and societal costs.
• Tomáš showed research indicating the fast-acting antidepressant effects of ketamine and the longer-lasting effects of psilocybin.
• He highlighted a psilocybin study showing comparable efficacy to an antidepressant, with more psilocybin subjects in remission without medication.
• He noted the surge in registered psychedelic trials, with his institute conducting studies and facing bureaucratic hurdles.
• He listed issues like psychedelics’ Schedule I status, accessing pharmaceutical-grade drugs, and developing proper protocols and therapist training.
• Tomáš described difficulty providing compassionate access to trial responders due to needing drug manufacturer approval.
• He pointed out the high cost of one-on-one psychedelic therapy models and the need to explore options like group therapy.

Damian Kettlewell, CEO of Clairvoyant Therapeutics, finally discussed his company’s forays into Europe, including a short presentation on their preliminary data.

• Damian explained Clairvoyant Therapeutics aims to be the first company to bring psilocybin therapy to market for alcohol use disorder in Europe, the UK, and Canada by 2026.
• He shared they are launching a European office in Portugal in partnership with a startup incubator to execute their Phase III trial.
• He noted 3.4 million alcohol use disorder patients in their target markets, with only 1% seeking treatment and poor standard of care options currently.
• He referenced previous research showing psilocybin significantly reduced heavy drinking days versus placebo.
• He said their similar Phase II trial has screened 115 participants already, with strong EU patient recruitment.
• He explained their commercial incentive is being first to earn regulatory data exclusivity, treating thousands of patients by 2030.
• He mentioned the need to train many therapists in their protocol and the lack of classic IP protections for psilocybin.
• He shared they will release interim Phase II results in 2024, are fundraising towards an IPO, and aim to partner with pharma.
• He cited challenges like reluctance towards psychedelic research in Eastern Europe and uncertainty around EU pharmaceutical changes.