The European Citizens’ Initiative for Psychedelic-Assisted Therapies – launching at the start of 2025 – is aiming to collect one million signatures to urge the European Commission (EC) to take action on psychedelic-assisted therapies.

There are 150 million people in Europe living with a mental health condition, according to the World Health Organization (WHO). While there are treatments available, there has been no innovation in this area for over 50 years, and the treatments do not work for everyone.

For example, 10 to 30% of patients with major depressive disorder are resistant to currently available treatments, highlighting an urgent need for new therapies.

Adding to this, data from the Organisation for Economic Co-operation and Development (OECD) shows that mental health conditions cost the European economy up to €600 billion a year.

However, in recent years, increasing scientific research has shown psychedelic-assisted psychotherapy as an innovative and effective treatment for conditions such as depression, anxiety, addiction, and post-traumatic stress disorder (PTSD).

This mounting evidence has led to changes in policy and psychedelic access in countries such as Australia and Canada, where authorised patients are now able to access safe, legal psychedelic therapies.

Against this backdrop, the European Citizens’ Initiative for Psychedelic-Assisted Therapies has launched to urge the EC to support the future roll-out of psychedelic-assisted therapies in European healthcare systems.

The initiative is backed by 24 organisations, associations, researchers, therapists, patients, and citizens from 17 European countries, that are supporting the right of EU citizens to access affordable psychedelic-assisted therapies.

From 14 January 2025, the campaign will have one year to collect one million signatures from at least seven EU Member States in order to formally call for action from the EC. If the campaign collects the signatures successfully, the EC will have six months to respond to the initiative.

“With the launch in January begins a year-long campaign that can bring hope to millions of European citizens suffering from mental health problems,” commented Théo Giubilei, Founder of the PsychedeliCare Initiative.

Dr Rayyan Zafar, Chair of the recently launched Psychedelic Industry UK, which is also backing the initiative, commented: “On behalf of Psychedelic Industry UK, we welcome the launch of the First European Citizens’ Initiative for Psychedelic-Assisted Therapies, a pivotal step in addressing the growing mental health crisis in Europe.

“With the mental health burden rising across the continent and an increasing body of scientific research supporting the efficacy of psychedelic-assisted therapies (PAT), public support for this initiative is essential.

“Psychedelics, when used in a controlled, therapeutic setting, have shown remarkable potential in treating conditions such as depression, PTSD, addiction, anxiety, and other neuropsychiatric disorders which have reached epidemic proportions globally. However, regulatory barriers continue to limit their integration into modern healthcare.

“Public engagement can be a powerful catalyst for change, as we’ve seen in the UK with cannabis regulations. A groundswell of public support was instrumental in shifting political conceptions, leading to regulatory reform.

“A similar trajectory is possible for psychedelic therapies, but it requires broad public endorsement to pressure policymakers into action.

“This initiative presents an unparalleled opportunity for regulatory authorities to engage with the growing evidence base supporting psychedelic-assisted therapies. By doing so, we can develop a comprehensive regulatory framework that not only facilitates access to these treatments under medical supervision but also ensures the highest standards of safety and efficacy.

“We have witnessed the strides made in North America and Australia where medical and regulated access models for psychedelics are being developed and are in fruition. Europe must not be left behind.

“The time has come for our regulatory systems to reflect the scientific advancements in the field, many of which were discovered here, to improve patient access to life-changing therapies, and help tackle the escalating mental health crisis in Europe.

“This initiative is not just about signatures. It is about creating a movement that encourages policymakers to embrace innovation and evidence-based solutions in mental health care.

“I urge the public, professionals, and advocates across Europe to support this campaign.”

Organisations from across France, Croatia, the Netherlands, the Czech Republic, Italy, Portugal, Sweden, Greece, the United Kingdom, Ireland, Spain, Switzerland, Belgium, Estonia, and Poland are backing the campaign.

To find out more and to join the network, visit the official initiative website psychedelicare.eu.

On August 9 the U.S Food and Drug Administration rejected Lykos Therapeutics’ New Drug Application (NDA) for MDMA-assisted psychotherapy. However, the journey to approval is not over yet, and Lykos is now working to address the issues that led to the rejection.

While the news is a devastating blow to the 13 million in the U.S. living with PTSD, it comes as no surprise as the decision follows the recommendation of an independent advisory committee not to approve the therapy in June.

Rejecting the NDA, the FDA issued a complete response letter (CRL) citing concerns over blinding, expectancy bias, and insufficient data to demonstrate durability. The authority has now requested a further Phase 3 trial which will take years and cost millions to complete.

Lykos Therapeutics (Formerly MAPS PBC) has requested a meeting with the FDA to discuss its resubmission.

Since the decision, three studies from Lykos have been retracted from the academic journal Psychopharmacology due to “protocol violations amounting to unethical conduct”, the organisation has laid off 75% of its staff, and Founder and President of MAPS Rick Doblin has stepped down from the board of directors. 

Doblin responded to the FDA decision stating: “MAPS and our supporters have been advocating for the development and supporting the FDA-approved research of MDMA-assisted therapy for more than 38 years; MAPS will continue working towards safe, legal access to this therapy for the more than 350 million people living with PTSD worldwide.

“Our collective commitment to MDMA-assisted therapy remains unwavering. MAPS remains fully focused on supporting culturally appropriate research, rigorous science, and drug policy reform that empowers citizen advocacy in all areas of the world including those with high incidences of trauma and limited resources.”

The road to approval

While the contents of the CRL letter are not available to the public, it might be assumed that the issues laid out in the letter lay the groundwork for a successful second Phase 3 trial.

Chief Executive Officer of Lykos Therapeutics, Amy Emerson, has shared disappointment at the request for this second trial, stating that: “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades.

“While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature.”

CRL’s are not unusual following Phase 3 trials, and Pink Sheet has highlighted how the use of CRL’s by the FDA hit an all time high in 2022, with 31% of decisions on novel agents resulting in a CRL and almost half of those needing further clinical trials. 

Pink Sheet further details that CRLs with clinical concerns generally had negative outcomes, with nine needing new trials and three programmes discontinuing following receipt of a CRL.

Dr Ingmar Gorman, co-founder and CEO of Fluence, however, believes the current circumstances are promising, highlighting that: “This perspective helps us frame the current situation not as a setback, but as a natural step in the rigorous process of bringing new treatments to those who need them.

“The extensive feedback typically offered in a CRL provides a clear roadmap for approval — something that would have been unimaginable four decades ago when MDMA was first banned. 

“This marks important progress in the field of psychedelic research and mental health treatment. We’ve come a long way, and that’s worth celebrating.”

Some of the main concerns from the FDA were expectancy bias and functional unblinding in the trials, as 90% of participants in the MDMA group guessed that they had received the medicine and not a placebo. Equally, 40% of participants had tried MDMA before participating in the trial. 

Bliding is a core issue for psychedelic research as the effectiveness of current methods is limited when using compounds that have a very noticeable effect. Research suggests the need for new methods for improving psychedelic trials in order to maintain their scientific integrity if these therapies are to make it to approval, such as utilising biomarkers or real-world data.

Additionally, combining a drug with psychotherapy as a protocol is novel, and the FDA does not regulate psychotherapy, making the approval process all the more complicated. 

However, concerning MAPS’ MDMA trials, the FDA agreed to the protocols early on, and Doblin has said the authority is “moving the goalposts” now the trials are completed.

PAREA, Drug Science and Mind Medicine Australia recently published a position statement addressing the issue of blinding and expectation, as well as the issues of combining a drug with psychotherapy, the misuse risks of MDMA, training of therapists, risks of therapist misconduct and boundary violations, uncertain long-term benefits, and the negative benefit-risk ratio.

The statement suggests potential routes forward for the therapy such as basing its advancement on a model created for cannabis by the US Department of Health and Human Services (DHHS).

The statement reads: “We have previous experience with similar challenges with new medicines. The most famous is that of the first drugs for HIV, the access to which was too slow for patients who were dying, prompting the creation of the accelerated approvals process by lobbying the FDA for faster regulatory process and the NIH for more research.  

 “If MDMA does not get marketing authorisation, a model might be based on the August 2023 decision of the US Department of Health and Human Services (DHHS) to move cannabis down from Schedule I to Schedule III alongside ketamine and buprenorphine. The decision was based on an eight-factor analysis of abuse related harms and an overview of clinical use. 

“This review was led by DHHS with input from various agencies including the FDA who agreed that cannabis met the criteria of commonly accepted medical use (CAMU) so was de-facto a medicine hence could not stay in Schedule I.  

“Schedule III was seen as commensurate with its low abuse potential. Current research data for MDMA in PTSD are almost certainly stronger than any medical cannabis product so the same decision could be reached, as was done by the TGA in Australia.”

It’s not over

While the decision marks a major setback for Lykos, MDMA therapy may still one day reach the millions of PTSD patients in need of innovative treatments if Lykos can address the issues raised in the CRL in the new Phase 3 trial. Additionally, it may be that emerging New Chemical Entities with improved profiles to MDMA may pip MDMA to the approval post elsewhere.

Political pressure is also on to get access to MDMA therapy for patients, with over 80 US lawmakers urging Biden to allow approval of the therapy for US veterans and advocacy organisations supporting the advancement of MDMA therapy for this patient population. 

Non-profit organisation, VETS: Veterans Exploring Treatment Solutions, commented on the development to say: “Roughly 20 veterans die by suicide every day. A recent study estimates the number could be as high as 44. This is unacceptable. 

“The potential of MDMA-assisted therapy to help veterans heal from post-traumatic stress disorder (PTSD) remains paramount. We will not allow bureaucratic processes to deter us from advocating for approval of this transformative treatment.

“While we understand and respect the FDA’s commitment to safety, we urge careful consideration of the cost of inaction. 

“The fight for safe, legal access to MDMA-assisted therapy may have hit a roadblock, but VETS stands resolute. We wholeheartedly believe that every veteran deserves access to the most effective forms of healthcare available. We are never out of the fight.”

Heroic Hearts, a non-profit organisation supporting veterans into legal psychedelic therapies, stated: “As leading federal advocates for Veterans’ access to MDMA-AT, Healing Breakthrough & Heroic Hearts are deeply concerned by the FDA’s denial of Lykos’ NDA for MDMA-AT. This is the epitome of bureaucratic red tape – and the result is people will keep dying. MDMA-AT is the most effective treatment ever developed for PTSD, a condition at the core of the Veteran suicide crisis that claims over 17 lives each day.

“The FDA’s decision is a missed opportunity to embrace groundbreaking science, save countless Veteran lives, and honor the sacrifices made by those who served our country. If this critical treatment remains inaccessible, we face losing an additional 6,000 Veterans to suicide this year alone—and every year thereafter.

“Healing Breakthrough and Heroic Hearts Project will not relent. Our commitment to advocating for this life-saving treatment is unequivocal. We will continue to push for progress, collaborate with stakeholders, and fight persistently until MDMA-AT is available to every Veteran who desperately needs and deserves it.”

Elsewhere in the world, Canada and Australia have already begun allowing access to MDMA-assisted therapy in specific circumstances for select, authorised patients, and the Dutch State Commission on MDMA recently released its report advising the Government to allow access to MDMA therapy for people living with PTSD. Equally, other companies are developing treatments with psychedelics such as psilocybin for mental health conditions including anxiety and depression, some of which are now in Phase 3 trials. 

Rivki Stern Youdkevich, Co-Founder and CEO of Shortwave Life Sciences, which is developing psychedelic treatments for anorexia nervosa, commented: “PTSD is associated with an increased risk of mortality due to comorbid conditions such as substance abuse, depression, physical health issues, as well as a higher risk of suicide.

“Risk of a new medicine or treatment versus the risk to the lives of the patient population existing without that treatment is a key consideration in the regulator’s assessment of new drugs. In the case of PTSD, the equation is very clearly positive, and even more so in the case of anorexia nervosa, which is the deadliest mental health disorder of all, with no currently approved FDA medication, and a 50% chronicity rate.

“We believe that this underlying high and positive benefit-to-risk ratio will ultimately guide the regulator to approve innovative and inherently safe psychedelic components in the treatment of life-threatening disorders. At Shortwave we are already proving the safety of our psilocybin-based combination drug and will be able to demonstrate its efficacy according to FDA regulations as we progress in our clinical trials.”

PAREA, a European advocacy organisation for access to psychedelic therapies stated: “People living with PTSD and other mental health conditions, as well as their families, had high hopes and expectations for the introduction of this new treatment option. 

“Although this decision pertains to the US and there is no current market application for this treatment in Europe, we are concerned that the regulatory expectations could set a precedent that might slow down progress in mental health innovation worldwide.”

Last month, the Dutch State Commission on MDMA released its report advising the Government to allow access to MDMA-Assisted Therapy (MDMA-AT) for people living with PTSD. The report has now been translated into English. 

The Netherlands’ history with MDMA stretches back decades, with over 550,000 people in the country having taken MDMA recreationally at least once in 2022. 

Its extensive use in raves and clubs has led to criminal gang operations and industrial-scale production of the compound in the country, igniting calls for its regulation to stop this criminal activity. 

However, outside of this recreational use, recent years have seen increasing research demonstrating MDMA’s potential as a treatment for PTSD in combination with psychotherapy. 

In light of these developments, the independent State Commission was established by the Dutch Parliament in 2023 to research the legal status of MDMA and provide advice on its medical use.

Highlighting that Dutch drug policy dates from 1995 and has not been reviewed since 2009, the report emphasises that there is an urgent need for a thorough review and update on the basis of scientific evidence and not “emotions”.

While the MDMA: Beyond Ecstasy report does not review the entire Dutch drug policy, it maps out the historical, legal, policy-related, public health science and therapeutic aspects of MDMA, includes recommendations for policy and the use of MDMA in medical settings, and concludes there is sufficient evidence for MDMA’s medical application.

Speaking to Psychedelic Health, Sergio Pérez Rosal, MD, Associate at the Faculty of Psychedelic Studies at University of Ottawa, commented: “The recent publication of the “MDMA: Beyond Ecstasy” report by the Dutch State Commission on MDMA marks a significant step forward in the evolving understanding of MDMA’s role in both recreational and therapeutic contexts. 

“This detailed report provides a balanced view of MDMA, exploring its historical use, current policy challenges, and future possibilities, particularly in the realm of mental health treatment.”

Recommendations on MDMA

Advising on the pros and cons of the medicinal use of MDMA for the treatment of PTSD, the committee recommends in the report that the Netherlands develops a regulatory framework for the medical use of MDMA as quickly as possible.

Notably, the report found that the health effects of MDMA appear to justify its transfer from a Schedule I substance to a Schedule II substance, and that evidence exists that demonstrates MDMA-assisted therapy for PTSD offered in a clinical, controlled setting is “not only effective, but also relatively safe”.

The report reads: “A possible move to another schedule to the UN Convention may, however, be considered in the international context. The Netherlands could, for this purpose, ask the WHO to reassess its inclusion of MDMA in Schedule I to the 1971 UN Convention. This would promote the taking of steps in the international context and the Netherlands could play a guiding role in this connection.”

The report also explores alternative routes for access in the country, however, highlights that many of them are not financially viable. 

Recommendations for the government include: 

• For the medical use of MDMA to treat PTSD be developed in the Netherlands as soon as possible and that its implementation be facilitated.
• Lay down clear frameworks and preconditions to prevent the risky or harmful use of MDMA-AT.
• Set up naturalist research to make MDMA-AT available as soon as possible.
• Explore whether existing psychedelic substances require a different registration approach than ‘normal’ medication does. New legal frameworks may have to be set up for unregistered substances with a known medical use that are already available on the illegal market.

Recommendations to professional associations include:

• The professional associations must draw up guidelines for the treatment

of PTSD using MDMA-AT.

• Develop special training courses for providing MDMA-AT. 

Recommendations to treating physicians and/or organisations:

• Raise realistic expectations in communications with patients.
• Use MDMA of pharmaceutical quality in order to guarantee the correct dosage and purity of the MDMA.

The suggested multi-year, large-scale naturalist study would MDMA-AT available to specially selected patients and investigate aspects such as the feasibility and cost-effectiveness of MDMA-AT in the Netherlands.

“One of the key takeaways from the report is the Commission’s strong endorsement of MDMA-assisted therapy (MDMA-AT) for PTSD. The report highlights compelling evidence from recent studies indicating that MDMA-AT can be exceptionally effective for PTSD patients, especially those who have not found relief through traditional therapies,” said Perez Rosal. 

“The Commission’s recommendation to initiate a large-scale naturalistic study in the Netherlands to facilitate the use of MDMA-AT underscores a proactive approach to addressing mental health challenges.”

Uncertainty for MDMA in the US

The report and its recommendations were published just days following the U.S. Food and Drug Administration’s (FDA) advice on Lykos Therapeutics MDMA-assisted therapy New Drug Application (NDA), which voted that there was not enough data to confirm its therapeutic efficacy and safety.

While the final decision on the matter is not expected until 11 August 2024, the advice has been a major blow to the advancement of psychedelic therapy in the US.

Perez Rosal added: “This decision has generated significant debate among researchers and mental health professionals, many of whom argue that the therapeutic potential of MDMA should not be overlooked despite the committee’s concerns about study design and data integrity.

“The Dutch State Commission’s report calls for an updated and evidence-based drug policy that reflects the current scientific understanding of MDMA. By focusing on both the recreational and therapeutic aspects of MDMA, the report advocates for a nuanced approach that prioritises public health while also recognising the potential benefits of MDMA in treating severe mental health conditions.

“As discussions continue globally, the Dutch report sets a thoughtful and forward-looking example of how to navigate the complexities surrounding MDMA. It highlights the importance of grounding policy decisions in scientific evidence and balancing the potential risks and benefits of MDMA use.

“The “MDMA: Beyond Ecstasy” report by the Dutch State Commission is a landmark document that could pave the way for innovative mental health treatments and more informed drug policies. It invites a necessary dialogue on how best to harness the potential of MDMA in a safe and effective manner, offering hope for improved therapeutic options for those suffering from PTSD and other mental health disorders.”

To read the report in full and see the complete recommendations, please visit: https://www.government.nl/documents/reports/2024/05/31/mdma-beyond-ecstasy