Global Conversation On Psychedelic Therapy: Perspectives From Europe And The UK

On an international level, psychedelics remain in the most restrictive category of the 1971 UN Convention on Psychotropic Drugs.

The convention has allowed for the establishment of different drug policies among European countries, with more permissive ones found in places like the Netherlands and Portugal.

Members of the European Parliament have stated concern about the lack of European progress as a whole compared to the U.S., Canada and Australia and have asked the European Medicines Agency (EMA) to play a “more active role” and work with the European drugs agency, EMCDDA.

MEP and one of the letter’s signatories, Sara Cerdas told POLITICO that while there's "clearly a momentum" for psychedelics, the biggest challenge in both research and treatment is that the EMA regulates substances but not therapy.

In fact, the agency does not approve medicines but rather makes recommendations. The final call rests with the EU’s executive branch, the European Commission, which sets proposals for the 700 European Parliament members to vote on. If favored, each EU member state must make national laws compliant with the new regulations.

A further revision should also be made to the regulations on the 1961 Single Convention on Narcotic Drugs, as the international treaty considers psychedelics within the list of banned substances. That task would correspond to the UN agency International Narcotics Control Board (INCB.)

EMA’s reply to Parliament members was somewhat promising, setting out an initial approach to the development of psychedelic therapies by calling developers to engage with regulators and announcing plans for a stakeholder workshop later this year.

Meanwhile, the European Commission would publish a promised EU mental health strategy on June 7.

British neuropsychopharmacologist professor David Nutt and Polish advocate Tadeusz Hawrot founded the Psychedelic Access and Research European Alliance (PAREA) in 2022, which has already held its first meetings with MEPs and regulators.

Despite once leading this field Europe, says the professor, it now lags “behind the Americas and Australia.” He added that he views the illegal status of psychedelics as a “political act.”

See also: British Prof. David Nutt Talks About Need For Psychedelic-Assisted Therapy During Australia Visit

The EU, as the second largest medicines market in the world, spends €200 billion annually on innovative drugs and attracts 31% of total R&D investment in pharmaceuticals. It is also a leading global regulator, with upcoming changes in legislation impacting the rest of the world through expected free trade agreements, Hawrot told Psychedelic Alpha.

Major events taking place this year in Europe include the sixth edition of the Breaking Convention, the European College of Neuropsychopharmacology’s (ECNP) New Frontiers psychedelics-exclusive gathering (see psychedelics journalist Josh Hardman’s insights) and the upcoming PSYCH Symposium.

The UK Case

Following the approval of Brexit in early 2020, it is up to the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) to advance psychedelic therapies.

The agency confirmed that it would update its guidance on using real-world data in research toward achieving faster regulatory approval, an issue also discussed in the House of Commons this past March. 

Also in March, the British Treasury approved a £10 million fund for the MHRA to accelerate the development of innovative medical treatments. Although this could potentially make psychedelic-assisted therapy available one or two years earlier than expected, it remains to be seen what the rollout will permit.

Meanwhile, the UK Parliament is expected to debate psilocybin therapy this month, possibly on May 18, as announced by Parliament conservative member Crispin Blunt, with the backing of organizations such as the Conservative Drug Policy Reform Group (CDPRG UK.)

Photo: Benzinga edit with photo by Dana Creative Studio, PanuShot and Arif_Vector on Shutterstock.