There is growing pressure on EU policymakers to play a role in promoting the development of psychedelics as medicines. The pharmaceutical regulations reform is an opportunity to incentivise research say MEPs
Psychedelic therapies have the potential to significantly improve treatment of mental health disorders and Europe will fall behind if it does not offer greater support to researchers and set out pathways for their regulatory approval, a group of MEPs has warned.
“The ongoing revision of the pharmaceutical package in the European Parliament presents a unique opportunity for the realm of psychedelics,” Czech MEP Mikuláš Peksa said during a meeting organised by the action group for the Medical Use of Psychedelics, set up in May this year by seven MEPs to persuade fellow MEPs of the potential of psychedelics in mental healthcare and to advocate for their safe, regulated use.
Parliament’s public health committee is currently mulling the contested proposal for the largest reform to the EU’s pharmaceutical legislation in over 20 years. MEPs have until 13 November to submit amendments, and could push for regulatory pathways for psychedelic therapies.
The cross-party action group was launched with the support of Psychedelic Access Research and European Alliance (PAREA) and the PsychedelicsEUROPE association.
Use of psychedelic drugs is for the most part illegal across Europe and the United Nations classifies them as schedule 1 drugs that have no accepted medical use. But a growing body of research suggests they have significant potential for managing mental health disorders such as post-traumatic stress disorder, depression, alcoholism and anorexia, when used in a prescribed setting in combination with psychotherapy.
In July, Australia authorised psychiatrists to prescribe MDMA and psilocybin, the active component in magic mushrooms, to treat PTSD and treatment-resistant depression. MDMA-assisted therapy for PTSD is expected to be approved in the US by the end of 2024.
It is now essential to ensure late stage trials are taking place in Europe, said Josh Hardman, who set up the Psychedelic Alpha newsletter and community. “We have incredible psychedelics researchers in Europe – probably the best in the world – and have amazing practitioners and lots of clinical trial participants.
But said Hardman, most of those trials are early and mid-stage trials. “We risk Europeans becoming psychedelic guinea pigs, where we give them the drugs first and let them try them out, but when comes to funding pivotal studies, it gets offshored to North America.”
Drug developers, researchers and investors would also benefit from earlier logistical advice, “giving them the confidence that if they invest and fund these trials through to completion, they will be supported in scaling up and rolling out psychedelics across all 27 member states,” Hardman said.
The Commission’s proposed pharmaceutical reform is intended to incentivise rolling treatments out across all member states by offering an extension to the regulatory data protection period which prevents competitors from referring to another company’s clinical trial data when applying for market authorisation, if a product is put on the market in all member states within two years of getting approval from the European Medicines Agency.
The two year deadline, “is difficult for any treatment, but with psychedelics I think it is going to be even more challenging, because of the higher logistical and resource burden,” Hardman said.
With start-ups and small companies undertaking the majority of research and development in the field, “We need a comprehensive package of incentives for smaller developers,” said PAREA founder Tadeusz Hawrot. “We’ve seen stagnated innovation for many decades” when it comes to mental health treatments, he said. Studies suggest psychedelics can offer rapid and durable therapies. “The revision of the EU pharma legislation must provide a more supportive regulatory environment,” Hawrot said.
PAREA used the event to launch its policy paper, calling for Europe to rethink its approach to incentivising innovation, including redefining what constitutes ‘high unmet medical needs’ and therefore receives priority and funding.
This should include mental health and substance abuse disorders which, though not always life-threatening, “impose a massive chronic burden on individuals, healthcare systems, societies and economies”.
This is an area where many people do not receive adequate treatment, and where innovation has traditionally been lacking. Not a single one of the 89 new drugs recommended for approval by the European Medicines Agency last year targeted mental health conditions. “EU prioritisation and concrete initiatives are crucial to spur R&D in this field,” the report says.
Recommendations include creating a ‘European Hub for Mental Health R&D’, formed of EU institutions, member states, healthcare funding bodies and philanthropic organisations, to provide support for evidence-based decision-making in mental health and to set priorities for research and development.
The MEP action group has joined with others in lobbying the European Medicines Agency, which as a result is planning to host a workshop on promoting the development of psychedelics by the end of this year.
In the US, the Food and Drug Administration published guidelines on how to conduct clinical trials of psychedelics in June, but EMA is yet to issue any similar advice.
However, EMA staff, including the chief medical officer Steffen Thirstrup, co-authored a paper in The Lancet in March 2023, on the European perspective on regulating psychedelics.
Also in June, the European Commission adopted a comprehensive approach to mental health, which includes integrating mental health across policy areas such as education, employment and environment.