Europe needs faster action on magic mushroom, MDMA therapies, urge MEPs

Europe is trailing behind when it comes to examining psychedelics’ potential to treat mental health disorders — and it’s time for the European Medicines Agency (EMA) to step it up.

That’s the call from a cross-party group of lawmakers at the European Parliament in a letter sent Thursday to the head of the EMA, Emer Cooke, and seen by POLITICO.

Medical interest in psychedelic-assisted therapy is undergoing a renaissance, with researchers looking at using drugs like MDMA to treat post-traumatic stress disorder (PTSD) and psilocybin — aka magic mushrooms — for treatment-resistant depression and alcohol use disorder, among other conditions.

But it’s in countries like the U.S. and Australia — rather than Europe — where there have been significant regulatory advances, note the MEPs.

Earlier this month, the Australian government announced that, starting July 1, authorized psychiatrists will be able to prescribe MDMA — and psilocybin-based therapies for the treatment of PTSD and treatment-resistant depression respectively.

“We’d like to express our concern about the lack of similar progress happening in the EU which is creating a disadvantage for millions of Europeans affected by mental health conditions and substance use disorders,” reads the letter to Cooke, which is signed by MEPs Alex Agius Saliba (S&D group), Frédérique Ries (Renew Europe group), Jarosław Duda (EPP group), Robert Biedroń (S&D group), Sara Cerdas (S&D group) and Tilly Metz (Greens/European Free Alliance group).

The MEPs want the EU’s medicines regulator to "play a more active role" in the matter, listing a number of challenges and questions that need to be addressed before psychedelic therapies can be adopted in Europe, such as better understanding their risks as compared with other medicines for similar conditions. They also suggest the EMA prepare a report, organize a workshop with relevant parties, and work more closely with Europe’s drugs agency, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).

There’s "clearly a momentum" for psychedelics among fellow lawmakers, MEP Cerdas told POLITICO. "The outcomes that we have been receiving from the research part are very encouraging," she said.

For Cerdas, the biggest challenge when it comes to researching and using psychedelic-assisted therapies is the fact that the EMA regulates substances, not therapy.

It’s a point that the EMA’s chief medical officer Steffen Thirstrup has also previously highlighted to POLITICO.

Just last week, a group of experts, including Thirstrup, laid out their view of the challenges to overcome for psychedelics to be a safe and effective treatment option in Europe, in a comment published in The Lancet medical journal. The authors of the comment note that the EMA regularly updates its guidelines, and is revising the one on the clinical investigation of medicinal products for depression.

In November, the EMA’s scientific senior specialist for psychiatry and mental health, Florence Butlen-Ducuing, also said that "psychedelics is one of the topics that we wish to now uptake in the guidelines."

Changing classes

But, for the lawmakers, there’s another key hurdle: psychedelics like MDMA, psilocybin and LSD are classified by the United Nations as so-called "Schedule 1" drugs. It’s a designation reserved for substances presenting a high risk of abuse, posing a serious threat to public health and which are "of very little or no therapeutic value," according to the EMCDDA. They are listed as requiring very strict control, and use is prohibited except for scientific or limited medical purposes.

It’s time for that to change, write the same MEPs in a separate letter to the EMCDDA’s director, Alexis Goosdeel, also sent on Thursday and seen by POLITICO.

"We believe that the international drug-scheduling system needs to be reformed to ensure that psychedelics with strong medicinal potential are more accessible to scientists and patients before they are approved by regulators like EMA and FDA," the letter reads.

For the lawmakers, the time is right for both EU agencies to act — and to do so together.

"The EMA and EMCDDA have a major opportunity to furnish EU policymakers, including European Parliament Members, with the vital information and direction they need in order to make informed decisions that impact the health of the European population and serve as a model for policymakers globally," state both letters.

Mental health in the EU has been moving up the political agenda and the European Commission is expected to publish an EU mental health strategy — promised by Commission President Ursula von der Leyen in her yearly State of the Union speech — on June 7.