What is happening in Europe?: 5 Questions for Psychedelic Access and Research European Alliance founder Tadeusz Hawrot

Hawrot discusses the state of psychedelic research in the EU and what challenges lay ahead for psychedelic reform in the region.

The European Union has been relatively slow to fund psychedelic research. But in the last few months, the EU has made several moves that suggest that may be changing. In April, the European Medicines Agency, the EU agency in charge of the evaluation and supervision of pharmaceutical products, will hold a meeting at their Amsterdam headquarters to discuss development of psychedelics that address unmet medical needs. Meanwhile, the EU’s Horizon Europe program awarded €6.5 million (about $7 million USD), for a four-site clinical trial studying psilocybin’s efficacy in treating psychological distress in people with progressive diseases including multiple sclerosis and chronic obstructive pulmonary disease, or COPD. 

To better understand the outlook for EU psychedelics research, The Microdose spoke with Polish-born EU science policy expert Tadeusz Hawrot, founder of the Psychedelic Access and Research European Alliance (PAREA). Hawrot formerly worked for the European Brain Council managing advocacy efforts for brain research, and as he learned more about psychedelic research, he was excited by the area’s potential to treat mental health conditions. Hawrot still works in brain research advocacy, serving as an advisor to two neurology associations, but in 2022, he founded the Psychedelic Access and Research European Alliance. The group has been a key coalition-builder in Europe, connecting patient groups, psychedelic non-profits, researchers, and members of the EU parliament. (For example, PAREA coordinated a group of members of EU parliament to sign a letter urging the European Medicines Agency to hold a psychedelics conference, which led to the agency planning its April meeting.) Hawrot discusses the state of psychedelic research in the EU and what challenges lay ahead for psychedelic reform in the region.

How would you characterize the state of European psychedelics research, and how has that landscape changed over the last decade or so?

A lot of people in the psychedelics world assume everyone is up to speed on the topic – and I know that in the U.S., some media has been picking up the story – but the vast majority of people here in Europe don’t know anything about the scientific progress made in studying psychedelics. I was at a regional health meeting in Kazakhstan in October 2023 where leaders from all European health ministries and international organizations were attending. These are people who are making public health decisions and managing agencies, and no one was aware of the existing clinical trials. But that’s changing. 

Here in the U.S., there are states like Oregon and Colorado that are moving ahead on developing psychedelics programs and legislation despite these substances remaining illegal at the federal level. Are there EU member countries that are similarly out ahead of the pack on psychedelics issues?

There are efforts in a couple of member states that stand out. In the Netherlands, they have an MDMA state commission, where the government is looking at recreational use. They’re looking at advancements in clinical trials and trying to understand what that means for their country, and whether a possible outcome might be special access programs for compassionate use. And in Portugal, there is a group that started last year to advocate for expanded or special access for people to use psychedelic therapies that have gone through phase 3 clinical trials — specifically, that’s psilocybin and MDMA. 

Does the structure of the EU affect access to psychedelics?

To have therapeutic access in the EU, we’ll need regulators to approve the drugs as medicines. That would be either through the European Medicines Agency or national authorities would need to approve these drugs as medicines for some indications, like depression; every country still has their own rules. And that’s part of why it’s such a headache: we have 27 countries and 27 healthcare systems. It’s likely that drug developers will want to have a program through the EMA rather than individual countries because that way, they have access to all the countries. One big problem with Europe is that so far, we are not that attractive for smaller drug developers; everyone prioritizes the U.S. MAPS, unfortunately, paused their clinical work in Europe. So we don’t know when we will have any approvals - it’s years ahead. [Reporter’s note: While it is theoretically possible that drug developers could use U.S. clinical trial data to apply for EMA approval, that data might not satisfy regulators, who want to see data representative of the EU’s population and medical settings.]

What other hurdles do you see for psychedelics in the EU? 

It's not just about the clinical and scientific assessment of these drugs, but taking into account financial and economic constraints. When the decisions are made about what's included in the basket of covered services and for what price? There are potentially huge access inequities. Drug companies usually choose to target the four or five biggest economies within the EU, and additionally, there are complicated mechanisms for assessment and who will pay for them. We have been changing the paradigm from whether the drugs will be approved by regulators to whether they will be paid for by national payers. Just as an example: say there is a drug approved in the EU. For the German patient, on average, it takes about four months to see this drug in the pharmacy or wherever. In other EU countries with smaller economies, you need to wait for two years to see this drug. Many new treatments are not reaching smaller countries at all, or with a significant delay. 

What will PAREA be working on in the coming months?

We’re really building familiarity with people and engaging with different groups across the EU. Since day one, by design, we have wanted to bring in patients and patient organizations first and foremost, because they are why we are doing this: to address huge unmet medical needs that people with medical conditions are experiencing. With elections for Members of EU Parliament, or MEP, coming up in June, we want to build an even stronger MEP group for medical psychedelics. 

We are also thinking about the long-term sustainability of PAREA’s work. For better or worse, the organization is mostly just me, for now. I have a policy intern helping me with our newsletter updates and organizing European Parliament events. We have a fantastic graphic designer and executive advisory committee. But the vast majority of work is me, and the challenge is that we are still not yet financially sustainable; I have to do another job. In the first year, psychedelic companies were still doing okay, so we had five industry partners, which was a great start, and more than half of our funds were coming from nonprofits. We had small contributions from European philanthropists, but we don't have this tradition of philanthropy in Europe. We don’t enjoy the level of support that you might see in the U.S. But overall we are doing okay — PAREA is still a young organization and things take time. 

This interview has been edited and condensed for clarity and length.