The Future of Psychedelic Medicine in Europe: A Conversation With the Founder of PAREA

As psychedelic medicine gains momentum in North America, Europe is charting its own psychedelic path.

Yet the road to legal access to psychedelic therapies is long and winding, with many bureaucratic barriers along the way. Helping to navigate and hopefully accelerate the path is PAREA — the Psychedelic Access and Research European Alliance — a nonprofit working to ensure that psychedelic medicines reach the people who need them most. Founded by EU policy advisor Tadeusz Hawrot, PAREA is working to bridge science, policy, and access.

This wide-ranging conversation looks at the regulatory realities in Europe and how psychedelic therapies can — and must — be integrated into public health systems across the continent.

A Missing Voice for Psychedelics in Europe

When Tadeusz Hawrot first began speaking with European policymakers about psychedelic medicines, he was struck by how little visibility the topic had in the EU institutions.

“When I first engaged with European policymakers, it was clear there wasn’t a single, responsible voice representing the psychedelic field.”

That gap inspired him to launch PAREA — an alliance that brings together patient groups, medical societies, and psychedelic foundations to change perceptions about psychedelic-assisted therapies, raise awareness, and ultimately, bring better health options to European citizens.

“EU policymakers simply weren’t aware of psychedelics as a serious therapeutic option. To effectively put psychedelics onto the EU agenda, I chose a multi-stakeholder partnership approach — uniting reputable organisations already trusted by policymakers. This includes patient groups like Pain Alliance Europe, professional bodies such as the European Psychiatric Association, and leading psychedelic foundations.”

But this isn’t your everyday usual advocacy. This is introducing compounds that are still illegal in most countries and convincing medical and political institutions that these “drugs” are actually viable therapeutic options for the mainstream medical community.

So, unlike many advocacy groups that focus on a single issue or policy goal, PAREA is playing the long game, aiming to build a trustworthy community and platform from the ground up.

“Rather than tackling isolated issues, our focus is on creating an ecosystem and building trust with communities. My own nearly two-decade professional background working at the intersection of brain health, advocacy, and policy with the EU institutions and WHO convinced me I had the experience to responsibly drive this forward.”

Europe’s Psychedelic Bottleneck

From a medical care perspective, it is particularly difficult to accept that people continue to suffer because of no or inadequate availability, or the lack of affordability of internationally controlled substances for medical purposes in reliable pharmaceutical quality.  — European Union statement, Meeting of the UN CND, Vienna, 2020

Despite increasing evidence that psychedelics can treat mental health conditions like PTSD and depression, most European health systems are nowhere near ready to implement them.

Hawrot points out that this isn’t unusual. New therapies typically take years, even decades, to move from research into clinical practice.

“I prefer to see barriers as natural stages of progression rather than obstacles. However, one significant concern is the implementation gap — it takes on average 17 years for therapeutic innovations to reach routine clinical practice after their effectiveness has been established. We must work proactively to shorten this timeframe, building healthcare system readiness and care infrastructure as early as possible.”

Stigma remains a major hurdle, but it’s not just about public opinion, it’s about professional readiness. Doctors, therapists, and nurses need to trust the treatments before they can integrate them into care alternatives for their patients.

“Globally, we still face considerable stigma. Cultivating broad cultural acceptance is essential, as psychedelics must be recognised as legitimate, evidence-based healthcare interventions. 

Ultimately, we aim for equitable access across as many European nations as possible.

“Real-world implementation will heavily depend on healthcare providers’ willingness and ability to integrate these therapies into their practice. Providers’ attitudes, training, and confidence in these interventions will largely determine how quickly and effectively they become mainstream.”

Hawrot argues that research alone isn’t enough. Implementation needs to be tested in community-based settings, not just clinical trials.

“We need to engage trusted medical institutions — professional societies, major academic centres — early and meaningfully. Formal training for therapists should be expanded, practice standards established, and rigorous monitoring implemented. To accelerate this process, it’s important to begin testing real-world implementation even while clinical research is ongoing. For example, clinical studies often provide settings that do not match resource-constrained community mental health environments. 

“Understanding the impacts of varied ‘set and setting’ contexts must become part of the standard clinical research protocols.”

The Challenge of a Fragmented Continent

Unlike in the U.S., where the FDA serves as a central gatekeeper, Europe’s healthcare and drug policy decisions are largely national — and vary widely from one country to the next.

“Navigating EU bureaucracy requires extensive experience and nuanced understanding, as there isn’t a single centre of power. Instead, progress demands carefully targeted engagement across multiple EU institutions simultaneously, something I’ve been doing for nearly two decades.”

This fragmentation creates deep inequalities in access. In some countries, new medicines are reimbursed within months; in others, patients wait years.

“One particular complexity unique to Europe is the significant disparity in patient access timelines for new medicines across EU countries. 

“In Romania, the wait for reimbursement averages two-and-a-half years, compared to just four months in Germany. Likewise, while patients in Italy access seven out of ten new EU-approved medicines, Romanian patients get fewer than two in ten. 

“This enormous inequity, tied to national economic conditions, presents a central challenge for introducing psychedelics into healthcare systems. Addressing this fundamental inequity will be crucial if we’re serious about fair and widespread patient access to psychedelic therapies.”

Working Towards Europe’s Psychedelic Future

Despite the challenges, Hawrot remains optimistic. He envisions a phased rollout of psychedelic therapies, starting with controlled access programs and evolving toward full-scale integration into public health systems.

“I prefer thinking in five-to-ten-year timeframes, which helps manage expectations and acknowledges the realities of systemic change. Positive developments are already visible: the Czech Republic recently moved toward medical access to psilocybin, and Germany has officially announced compassionate-use pathways for psilocybin treatments.”

For these therapies to truly benefit society, we must ensure fairness … Otherwise, psychedelics risk becoming another privilege for the wealthy, further deepening existing inequalities.

By 2026, PAREA plans to pilot regulatory programs for early use of psychedelics in specific indications.

“In 2026, PAREA intends to develop detailed models for regulatory sandboxes, such as ketamine for depression and psilocybin for end-of-life care, allowing early access and building healthcare system readiness ahead of full regulatory approval. We hope for EMA (European Medicines Agency) approvals of some psychedelic therapies within this decade, advocating for a staged, controlled rollout, balancing widespread access with patient safety.”

He also envisions a pan-European training platform to ensure quality, safety, and consistency of care.

“In the mid to longer term, we envision EU financing support for a pan-European platform to train healthcare providers, creating EU-wide standards of care involving professional societies. This infrastructure is essential for consistent, high-quality therapy delivery and for reducing access inequalities between EU countries. 

“Ultimately, we aim for equitable access across as many European nations as possible.”

Integrating Into the System

So, imagine all this work is successful. We’ve navigated the European bureaucracy and medical access is getting legalized. What will it look like when psychedelic therapy is just another tool in the mental health toolkit?

“I envision psychedelic therapies integrated into Europe’s healthcare systems in a staged and structured manner, leveraging strong collaboration between policymakers, healthcare providers, researchers, and patient advocates.

“In practice, patients would receive psychedelic therapies prescribed within clearly defined and carefully monitored clinical settings. Clinicians would have undergone formal, standardized training programs supported by professional societies, ensuring consistent quality of care and ethical practice standards.”

Step by step, moving from science to regulatory acceptance to a gradual and structured implementation.

“National health services would embed psychedelic therapies into their existing mental health care frameworks, including robust infrastructure and reimbursement systems, removing financial barriers for patients. To achieve this, substantial investments in healthcare infrastructure and professional training are necessary, alongside ongoing dialogues with the EMA, EU institutions, and national health authorities.

“Ultimately, mainstream integration means that psychedelic therapies become routine, equitable, evidence-based treatments available to all patients who stand to benefit, regardless of their socio-economic status or geographic location.”

Following the U.S. Lead — Carefully

The FDA will likely approve psychedelic therapies in the next few years, a milestone event that will send ripples across the Atlantic. PAREA is ready to use that momentum.

“U.S. FDA approvals will be extremely significant. Right now, many European stakeholders still view psychedelics as investigational drugs, essentially saying, ‘show us the evidence’ — meaning large Phase 3 clinical trials demonstrating safety and efficacy. Until approvals happen, psychedelics won’t fully appear on their regulatory radar”

“After FDA approval, PAREA will have additional leverage to highlight that these therapies are accessible in the U.S. and other jurisdictions, while Europeans are left waiting. We’re actively engaging with EU policymakers to create a more supportive environment for mental health innovation in Europe. 

“To this end, recently we published a policy paper: Leading, not Lagging: Putting Mental Health at the Core of Europe’s Innovation and Competitiveness Agenda, which argues for the need to elevate mental health innovation as an EU strategic priority.”

Increased Access as Mission Statement

While public debate often centers on decriminalization, PAREA remains focused on the medical system.

“PAREA acknowledges the significance of drug reform efforts and how these initiatives indirectly advance psychedelics as medicines. However, our primary focus isn’t drug reform per se, but rather ensuring psychedelic therapies become prescription treatments integrated into formal healthcare systems. To achieve this, psychedelic therapies must follow standard drug approval pathways, particularly large, pivotal clinical trials.”

Still, the current scheduling of psychedelics in Europe does pose serious challenges for researchers.

“That said, scheduling is indeed an issue — it complicates research significantly. Here’s where we’d welcome stronger EU leadership, similar to the proactive stance Europe took on cannabis rescheduling at the UN. Though drug reform isn’t our central mission, we’ve spoken extensively about the negative impact current scheduling has on psychedelic research. For instance, at last year’s European Medicines Agency workshop, I addressed this specifically.”

So as PAREA continues to grow its influence, the stakes are clear. Without coordinated action, psychedelics in Europe could remain confined to research papers and private clinics. But with strategic investment, policy alignment, and a commitment to equity, these therapies could transform mental health care across the continent. Tadeusz Hawrot is betting on (and working on) the latter.

“Equitable access sits at the core of our mission. Mental health issues disproportionately affect low-income and underserved populations, who also face the highest barriers to care. For these therapies to truly benefit society, we must ensure fairness — that anyone who could benefit can access quality care without financial or geographic barriers. Otherwise, psychedelics risk becoming another privilege for the wealthy, further deepening existing inequalities. 

“If there’s one crucial thing I aim to achieve through PAREA, it’s to ensure psychedelics are accessible solutions reaching communities who need them most.”

Learn more about PAREA’s work www.parea.eu