You are currently viewing PsychedeliCare Launches First European Citizens’ Initiative Demanding Political Action on Psychedelic-Assisted Therapies

PsychedeliCare Launches First European Citizens’ Initiative Demanding Political Action on Psychedelic-Assisted Therapies

  • Post category:Analysis / News

Words by Charles Bliss for Psychedelic Alpha.

From 14 January 2025, the PsychedeliCare European Citizens’ Initiative (ECI) has 12 months to gather one million signatures in support of its request that the European Commission take meaningful action to fund, standardise and reschedule psychedelics for medical use.

PsychedeliCare is utilising an instrument of participatory democracy which it hopes will unlock the potential of psychedelic-assisted therapies to address the mental health crisis in Europe.

The ECI is an official petitioning framework that allows EU citizens to mobilise around areas of common concern, encourage debate and instigate reform by proposing legislative changes.

By securing one million signatures over the course of 2025, the PsychedeliCare initiative aims to formally request that the European Commission commits to “foster equitable, timely, affordable, safe and legal access to innovative psychedelic-assisted therapies”.

It is the first time a movement of this scale has called on the European Commission to address drug policy reform regarding psychedelic treatments.

PsychedeliCare Founder and Project Co-ordinator Théo Giubilei told Psychedelic Alpha: “The PsychedeliCare initiative aims to enable the implementation of psychedelic-assisted therapies in the EU to ensure that we have safe and affordable psychedelic-assisted therapies for European citizens.”

Théo first learned about the ECI tool while studying for his master’s degree in political science at Sciences Po Strasbourg. He has also worked in Brussels at the Council of European Municipalities and Regions (CEMR) and at the European Parliament within the Committee on Transport and Tourism (TRAN)—experience which he hopes will ensure that the PsychedeliCare initiative meets the requirements for success. “I know the tool and I know how the EU works,” he said.

What is a European Citizens’ Initiative and how does it work?

First introduced by the Treaty of Lisbon, a European Citizens’ Initiative is a way for people in the European Union to suggest changes to EU laws on topics that matter to them. The tool, which has been in effect since 2012, empowers citizens to influence policies in areas such as healthcare, climate, energy, mobility, agriculture, consumer protection and digital rights. In the 12 years since ECIs were officially introduced 10 have been successful, generating a total of 12,975,370 signatures.

Article 11 of the Treaty of Lisbon defines the legal basis for the ECI: “Not less than one million citizens who are nationals of a significant number of Member States may take the initiative of inviting the European Commission, within the framework of its powers, to submit any appropriate proposal on matters where citizens consider that a legal act of the Union is required for the purpose of implementing the Treaties.”

Any group of at least seven citizens from seven different EU countries can come together to launch an initiative. They must form a citizens’ committee to lead the effort. Before collecting signatures, the proposal for the initiative must be registered with the European Commission to meet regulatory approval.

Once approved, the committee must collect at least one million signatures from citizens across the EU within one year. Signatures must come from at least seven EU countries, and there are minimum thresholds for each country to ensure fair representation across the bloc.

The estimated total population of the European Union is 449 million, of which approximately 358 million are eligible to vote and therefore sign a citizens’ initiative. That means each initiative requires around 0.28% of the total eligible population to sign. With 525,600 minutes in a year, just less than two signatures are needed every minute to meet the deadline.

If the ECI satisfies all these requirements and one million signatures have been verified, the European Commission is legally bound to review and respond to the initiative with an official communication. A successful ECI does not guarantee a new law, but it does force the EU to seriously consider the initiative and its requests. It may also request a debate in the European Parliament and seek to implement new legislation.

Now that we understand how the tool works, let’s look at what the PsychedeliCare ECI has set out to achieve.

PsychedeliCare has published three requests that—if the one million signatures are gathered in time—the European Commission must address within six months:

  1. The Commission should support the establishment of an expert consensus on standards of psychedelic care, with psychological support, therapist training, ethical guidelines and safety measures, to ensure the safe and effective rollout of psychedelic therapies. The Commission should back capacity building efforts for multidisciplinary training programs on mental health, specifically designed for psychedelic therapy training for healthcare providers.
  2. The Commission should boost EU-funded research into the therapeutic applications of psychedelics to strengthen the evidence of their safety and efficacy. It should support the development of research networks focusing on innovative therapies.
  3. The Commission should adopt common positions within UN fora to advocate for pragmatic, progressive transnational regulations concerning psychedelic compounds, and make appropriate recommendations for the rescheduling of psychedelic compounds in the 1971 UN Convention on Psychotropic Substances.

Théo said that the first request, regarding the standardisation of psychedelic-assisted therapies, would involve everything from professional certification and treatment protocols (such as how many therapists should be in the room during therapy, for example) to agreements on which medicines are recommended to treat certain conditions.

It would also be necessary to establish common standards to “avoid having different practice protocols” across the EU. He suggests that one way of moving towards this would be to bring patients, public health organisations, universities, clinicians and researchers together to exchange best practices.

Psychedelic Industry UK, a trade association which launched in September 2024, is one of 31 organisations that have partnered with the PsychedeliCare initiative. PsyIndUK’s CEO and Co-Founder James Bunn told Psychedelic Alpha that one of his main concerns with the psychedelic space is its lack of standardised professional accreditation and modes of practice.

While working as a legal and regulatory consultant in the psychedelic sector in locations such as Oregon, Colorado, Canada, Australia and New Zealand, James was alarmed at the different models of training, patient care, safety and ethics in each culture. “It is radically different jurisdiction to jurisdiction,” he said.

James Bunn Image
James Bunn, CEO and Co-founder at Psychedelic Industry UK.

But the establishment of an expert consensus of standards in psychedelic care would “add legitimacy to the practice”.

“Standardisation—of things like training protocols, patient safety, what to do in certain circumstances—is going to be really vital,” Bunn said. “Especially when we’re at the stage of potentially developing properly accredited courses from therapeutic bodies or universities.”

“We are starting to see that in the medical cannabis world,” he continued. “Now that there’s more of an understanding about how this is to be prescribed and used in practice, and clinicians are more comfortable with using the medicine itself, then it means that those standardised practices can then be translated into educational resources for future generations of prescribers.”

PsyIndUK is currently focused on creating guidelines for psychedelic-assisted therapy trials, covering preparation, integration and psychological support. It is also exploring how these therapies could be incorporated into NHS care in the future. The group plans to provide guidance for NHS commissioners and collaborate with mental health charities like Mind, Calm, Papyrus and the Mental Health Foundation to gather patient support for psychedelic-assisted therapies.

Bunn is aware that the PsychedeliCare ECI may not directly benefit the UK, which is no longer a member of the EU, but he hopes that the “ripple effects” of the initiative will travel across the English Channel.

“The fact that it’s happening in Europe doesn’t mean that we can’t be supportive of this, to try and promote it as much as possible, send things in the right direction, and even be part of the debate,” he said. “The European initiative is using known pathways to get change to happen, which is exactly what we want to do as well in the UK—when the time is right.”

Another aim of the ECI is to reduce the stigma associated with investigational medicines like psilocybin and MDMA, which will be necessary to achieve the initiative’s third request regarding the rescheduling of psychedelic compounds under the 1971 UN Convention on Psychotropic Substances.

“The problem with psychedelic substances and policy implementation today is there’s so many obstacles—and that comes mainly from stigma,” Théo said.  

He feels that providing “rational, scientific, sound information” to the public and to policymakers regarding the medical potential of these substances will help to “erase the stigma and delete the obstacles” that plague the possibility of psychedelic-assisted therapy in Europe.

Nätverket för Psykedelisk Vetenskap (NPV) is a Swedish NGO which aims to advance the scientific exploration of psychedelic substances while enhancing opportunities for researchers to study their risks, mechanisms of action and potential clinical applications. It has partnered with PsychedeliCare for the launch of the ECI.

Måns Bergkvist Image
Måns Bergkvist, Vice President at Nätverket för Psykedelisk Vetenskap.

“Public perceptions of psychedelics are still influenced by the historical stigma associated with these compounds,” said NPV Vice President Måns Bergkvist. “Therefore, we are optimistic that this ECI initiative will raise even greater awareness about this field of science.”

“While psychotherapy and medication can benefit many individuals, these standard treatment methods, which have been in place for the last 30 years, do not always effectively address treatment-resistant depression and anxiety disorders,” Måns added. “Thus, there is a pressing need for innovative treatments for mental illness.”

The annex to the PsychedeliCare proposal pointed out that, in the past three years, the EU has approved just one new psychiatric treatment. During the same period there have been 68 approvals in oncology.

But Måns emphasised that psychedelic interventions must first be carefully studied to better understand their efficacy and safety. “The potential benefits and risks associated with psychedelic compounds warrant thorough evaluation,” he said.

The initiative’s second request to increase investment for research into the therapeutic applications of psychedelic compounds would address this concern, its proponents hope.

Last year, the EU announced it would fund its first ever multi-site clinical study into psychedelic-assisted therapy. The PsyPal trial, led by the University Medical Centre Groningen with HumanKindLabs and a consortium of 19 European organisations, will invest €6.5 million to explore whether psilocybin therapy can help reduce psychological and existential distress in patients with progressive incurable diseases, including chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS/MND) and atypical Parkinson’s disease (APD). (See European Union Grants €6.5M for Multi-Site Psilocybin Study in Palliative Patients.)

Though the PsyPal trial marks a positive step towards exploring the therapeutic potential of psychedelics, the PsychedeliCare initiative demands that the EU significantly increase investment in broader research and clinical trials involving psychedelics such as LSD, psilocybin and MDMA. Théo said that meaningful policy change, however, will only happen if people across the EU raise their voices and push for reform.

“Policy makers—specifically on this subject—will not move if they don’t see support from the public,” said Théo. “We need everybody on board, because this is a grassroots movement.”

Théo Giubilei, Founder and Project Co-ordinator at PsychedeliCare.

To gather the one million signatures necessary to demand a response to its three requests, PsychedeliCare is reliant on an army of activists across the continent to spread the word. Its team is made up of scientists, doctors, therapists, researchers, creatives, marketers, artists, policy experts, activists, spiritual practitioners and educators. The project is managed by teams overseeing co-ordination, communication, coalition building, fundraising, scientific research and IT support. There are also 16 national teams across the continent, with more currently in the process of self-organising.

Merle Kelder is a national team co-ordinator for the PsychedeliCare team in Estonia. “The mental health crisis is evident to everyone,” she said. “Organising and mobilising is essential to advocate for innovative solutions that can alleviate suffering and reduce healthcare costs. This initiative raises awareness about the potential of psychedelics and promotes informed discussions.”

Merle Kelder, National Team Co-ordinator at PsychedeliCare Estonia/

In support of the initiative, the Estonian team has produced a talk show series on psychedelics featuring guests such as journalist Neeme Raud, Dr. Viljar Veede, founder of a clinic offering ketamine-assisted psychotherapy, and Dr. Anne Kleinberg, chairperson of the Estonian Psychiatric Association.

Magdalena Kaspryszyn, CEO and Co-Founder at HoloMind Instytut Terapii Psychodelicznej in Poland, said mobilising around the ECI is important to raise awareness, challenge misconceptions and advocate for evidence-based policies.

Magdalena Kaspryszyn, CEO at Holomind Instytut Terapii Psychodelicznej.

“Grassroots efforts strengthen democracy by showing that systemic change begins with collective action,” she said. “For the psychedelic movement, this means creating a future where these substances can be safely and legally integrated into therapeutic and medical contexts. This initiative also reinforces the principles of unity, solidarity and co-operation among EU member states, while celebrating the richness of cultural diversity.”

This sense of solidarity is particularly felt in Poland, which has welcomed more than a million refugees fleeing war in Ukraine. Magdalena feels that psychedelics could help to heal the trauma caused by the war, with the World Health Organization estimating that 25% of the Ukrainian population are suffering from post-traumatic stress disorder (PTSD).

“These are individuals in desperate need of psychological support, not to mention the veterans and soldiers fighting on the frontlines,” Magdalena said. “The need for innovative and rapid methods to assist people in crisis is both evident and urgent.

“If legalised in Europe, psychedelic therapy has the potential to help not only millions suffering from treatment-resistant depression but also the growing number of victims of wars and conflicts happening both within Europe and in its immediate neighbourhood.”

An official launch event for the ECI will take place at the European Parliament in Brussels on 6 February 2025 from 10am to 12pm CET. Théo hopes that being invited to parliament will help to “build political credibility” for the project.

The event will be hosted by MEP Tilly Metz, a Luxembourgish politician and member of the Greens/European Free Alliance. She is also Vice Chair of the Subcommittee on Public Health and Co-Chair of the MEP Action Group on Psychedelics in Healthcare, which promotes the clinical use of psychedelics in the EU.

The event will seek to “unite policymakers, civil society, clinicians, researchers and patient representatives” in building awareness, momentum and engagement for psychedelic therapies in Europe.

It will also feature patient testimonials and presentations on the current state of research from experts such as Tadeusz Hawrot, Founder and Executive Director of the Psychedelic Access and Research European Alliance (PAREA).

The launch event will also be live-streamed online. You can register to attend here.