Psychedelic medicine is coming for Europe. Are we ready?

Prescriptions for psychedelic drugs are closer than ever for European patients grappling with complex mental health problems – but there are still a few thorny hurdles to contend with.

For decades, psychedelics like LSD, magic mushrooms, and MDMA (ecstasy or molly) have been known primarily as party drugs that elicit hallucinogenic states, after studies on their therapeutic potential ground to a halt in the 1970s in both Europe and North America.

Today psychedelics are once again entering the mainstream. Research has picked back up, many European psychiatrists are generally open to psychedelics in medical practice, and countries like Switzerland and Australia are making them available to patients on a limited basis.

While no traditional psychedelic therapies have yet been approved in the European Union, 20 studies are complete or under way to test psilocybin – the hallucinogenic compound in magic mushrooms – and four focus on MDMA.

It’s thought that psychedelic experiences can help patients revisit their trauma or pain in a controlled setting, and most treatments pair the drugs with therapy to help patients work through their trip-induced insights later on.

“This is such a different way to treat psychiatric disorders,” Ulf Bremberg, a chemist who founded the psychedelic research hub HumanKindLabs and also a visiting researcher at Uppsala University in Sweden, told Euronews Health.

These treatments are not without controversy. Proponents bill psychedelics as the biggest advancement in mental health treatment since selective serotonin reuptake inhibitors (SSRIs), a common type of antidepressant, emerged in the 1970s.

They say psychedelics have the potential to treat conditions as wide-ranging as depression, obsessive-compulsive disorder (OCD), anorexia, addiction, and maybe even physical ailments like chronic pain.

But sceptics warn that small studies have been sensationalised, that they are hard to replicate, and that the fanfare around psychedelics makes it difficult to analyse them objectively.

Now, with larger-scale studies under way, advances in brain scan technology, the emergence of personalised medicine, and shifting public beliefs around psychedelics, a clearer picture is beginning to emerge, scientists at the forefront of the movement say.

“We are post-hype,” said Henrik Jungaberle, who leads the Berlin-based MIND Foundation, a psychedelic research nonprofit, and its clinical partner OVID Health Systems.

“Now we’re in a situation that is a little bit more sobering,” Jungaberle told Euronews Health. “It comes down to better studies with more diverse populations that tell us more about how psychedelics will work outside of the psychedelic bubble”.

Psilocybin on the horizon

In the United Kingdom, neuropsychopharmacologist Rayyan Zafar is laser-focused on how psychedelics actually affect the brain.

He is leading a study at Imperial College London’s Centre for Psychedelic Research to test psilocybin as a treatment for gambling addiction, which became a diagnosable behavioural health disorder in 2013.

In studying the brain’s reward system, Zafar discovered differences in the ways that intense gamblers’ and other people’s brains are activated, which could help explain their unhealthy behaviours. Zafar believes psilocybin may be able to override these “maladaptive networks” with new brain pathways.

Research three to four weeks after a psychedelic therapy session seems promising. But Zafar is testing whether those changes are sustained over time – that is, whether a single dose of psilocybin could curb or even eliminate the addiction.

“It’s the first time in a clinical population that we’ve done longer-term brain imaging to see whether it correlates with clinical outcomes,” Zafar, who is also senior research officer for the advisory group Drug Science, told Euronews Health. But “we just don’t know that yet”.

The first psychedelic to hit the European market will likely come from UK-based Compass Pathways, which is testing psilocybin for treatment-resistant major depression in 10 European countries (the Czech Republic, Denmark, Germany, Ireland, the Netherlands, Portugal, Spain, and the UK) as well as Canada and the United States.

In one of Compass’ most recently published studies, many of the 233 participants had been suicidal or engaging in self-harm for years, and other depression treatments hadn’t worked for them. Very few had ever tried psilocybin before.

So in a cosy room designed to counter the sterile coldness of a medical office, patients took their doses, donned eye covers, and listened to a special playlist to guide their inward-facing journeys. Therapists hovered nearby in case of problems.

Over the next six hours – or until the drug wore off – they tripped. Then they talked about it with a therapist.

Twelve weeks later, patients who had received a high dose of psilocybin saw a far greater improvement in depression than those who had the placebo alone, the researchers concluded, prompting them to pursue a phase 3 trial – the last stage before applying for regulatory approval to sell the treatment.

That study is in progress, and a Compass spokesperson said the company will ask for US approval soon after it is completed, followed by the EU and UK.

“This needs to be seen from a business perspective,” Bremberg said, calling Compass the “most advanced programme” whose work should be expanded upon for conditions other than treatment-resistant depression.

Bremberg is doing just that, helping to lead the first EU-funded clinical trial on psychedelic medicines, which launched earlier this year.

That study will test whether psilocybin can alleviate anxiety and depression among patients with progressive diseases like multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). Researchers hope to begin dosing about 100 patients across Europe in January and expect to have results two years later.

“People are facing death,” Bremberg said, and the experience of tripping on psilocybin could be viewed as “transcending the here and now, and this life … But you come back, and you can talk about it with someone who is a good therapist. That is the intention”.

US setbacks could delay access in Europe

The psychedelic movement has also hit some roadblocks recently.

In August, US regulators rejectedLykos Therapeutics’ application to market MDMA-assisted therapy for post-traumatic stress disorder (PTSD), which had been designated as a breakthrough treatment with strong potential.

That decision, and the ensuing chaos within the company, effectively popped the bubble around psychedelic medicine – for now.

“That in general, I would say, put the whole field a few years back,” Bremberg said. “Instead of being a shiny beacon … it becomes a lesson, homework for everyone in the field”.

One of the US Food and Drug Administration’s (FDA) reasons for the rejection is also a chief concern around psychedelics in the EU: it’s difficult to run a double-blind study, meaning patients do not know whether they received the actual drug or a placebo, for a medicine that induces a hallucinogenic trip.

Coupled with the fact that psychedelic studies tend to attract people who already have positive views of the drugs, the “breaking blind” problem can make it harder to interpret study results.

“Blinding is effectively impossible with psychedelics because of the psychoactive effects,” Michiel van Elk, an associate professor at Leiden University in the Netherlands whose research team focuses on psychedelic and other spiritual experiences, told Euronews Health.

While van Elk is a “bit more sceptical towards therapeutic applications” for psychedelics in general, he said the blinding problem could be addressed by giving people a low dose of the drug, rather than a dummy treatment.

An alternative control group – those who don’t get the drug – would be to have them undergo another form of “experiential” therapy induced through breathwork or meditation.

European psychedelic scientists and advocates watched the Lykos saga in the US closely. Bremberg said his team may make some tweaks to their study design as a result of its failure, but there will not be many changes because the study is already in the works.

Notably, a Dutch scientific advisory group said in June that MDMA-assisted therapy should be approved to treat PTSD, underscoring that “different scientific committees, based on the same evidence, can come to radically opposed conclusions,” van Elk said.

Even so, with Lykos focused on the US fallout, it’s not likely to hit the Dutch market anytime soon, he said.

Meanwhile, the European Medicines Agency (EMA) said the US decision on Lykos will not affect its own assessment of psychedelic therapies.

“While EMA and the US FDA have a longstanding collaboration and do regularly exchange information on a range of regulatory topics, they conduct their assessments independently, according to the mandates and guidelines in place in their respective jurisdictions,” an EMA spokesperson said.

In April, the EMA convened researchers, advocates, pharmaceutical representatives, and foreign regulators to offer input on how the EU should approach psychedelic medicine going forward.

Tadeusz Hawrot, who heads the Psychedelic Access and Research European Alliance (PAREA) and spoke at the EMA meeting, told Euronews Health that EU decision-makers are lagging behind other countries and should do more to “incentivise innovation in this area”.

“Big companies are prioritising the US in terms of launching their new therapies, and it’s certainly the case with psychedelics,” Hawrot said.

“We wouldn’t want to have patients in Europe waiting a few more years” if psychedelics become broadly available elsewhere, he added.

Van Elk believes the most “pragmatic” strategy is to make certain psychedelic treatments available on a compassionate use basis, meaning people with serious conditions and no other treatment options could try them as a last resort while researchers collect data on the outcomes and any adverse effects.

At the same time, he wants scientists to move forward with more rigorous clinical trials.

From regulatory approval to patient access

Even if – or, as advocates believe, when – psychedelic therapies are approved, companies will face another hurdle: getting doctors, health insurers, and patients on board.

That issue is top of mind for Jungaberle in Berlin.

After a promising smaller-scale study testing psilocybin among depressed patients, MIND is raising €30 million (on top of €25 million already committed by German innovation agency SPRIN-D) to fund a late-stage clinical trial with about 700 patients. If it launches on time in late 2025, it would be the largest psychedelic study to date.

Notably, it would also measure psilocybin against antidepressants.

While drug companies only need to show that their medications work better than a placebo to get regulatory approval, Jungaberle said that showing they work better than the standard of care – in this case, antidepressant medications – could entice pharmaceutical companies to make the drug, doctors to prescribe it, and health insurers to pay up.

Without that, “it’s not attractive for the pharma company, but it’s also not attractive for any mental health professional,” Jungaberle said.

Meanwhile, in the UK, Zafar’s study involves therapists at the National Health Service’s (NHS) gambling clinic, which he hopes will ensure a “smoother transition” for psychedelic medicine into doctors’ offices if the treatment is approved.

With psychedelic research at an inflection point, that kind of acceptance will likely determine how widespread these medicines become in the coming years.

“We need to translate science into patient access,” Hawrot said.