In two letters seen by Psychedelic Health, a cross-party group of MEPs has expressed concern over the lack of progress with the medical use of psychedelics in the EU.
Stating that this stagnation is creating a disadvantage for millions of Europeans affected by mental health conditions and substance use disorders, the MEPs have called on regulators to move faster on psychedelic healthcare in Europe.
The authors of the letters are urging the EMA to play a more active role in the advancement of psychedelic research and to work more closely with the EMCDDA.
The letters follow recent developments in Australia, which has made moves to increase access to psychedelic therapies for patients. The country will reclassify psilocybin and MDMA to enable prescribing by authorised psychiatrists from July 1, 2023, and the substances will be rescheduled from Schedule 9 of the Poisons Standard, which is prohibited substances, to Schedule 8, which is controlled drugs.
Additionally, in recent years, the US has granted Breakthrough Therapy Designation for MDMA-assisted therapy for PTSD and has funded psychedelic research with a USD $35 million grant, Canada has included psilocybin and MDMA on its Special Access Programme, and Alberta has moved to begin regulating psychedelic therapies.
The MEPs that have signed the letter include Alex Agius Saliba, Robert Biedroń and Sara Cerdas of S&D, Jarosław Duda of the EPP, Tilly Metz of the Greens and European Free Alliance, and Frédérique Ries of Renew Europe.
The scheduling of psychedelics
The MEPs highlight that, despite substances such as LSD, psilocybin, and MDMA being classified in the most restrictive category in the UN scheduling – alongside highly addictive drugs like crack cocaine – recent scientific research has shown psychedelic-assisted psychotherapies can be highly effective treatments for mental health conditions.
In this regard, the MEPs suggest that the EMCDDA is well positioned to foster discussions about the EU’s potential role in re-examining the scientific evidence behind the current scheduling of psychedelic compounds in the UN conventions.
The authors write: “The most restrictive scheduling of psychedelic compounds reinforced misinformation and stigmatization, and directly contributed to a scientific stagnation by detracting scientists from conducting research on these substances.”
In Europe, more than 150 million people are affected by mental health conditions, however, there have been no new innovative treatments since the advent of SSRIs. This restrictive scheduling of psychedelic drugs means research into these compounds as innovative mental health treatments is challenging due to high licensing costs and lack of research funding.
MEP Alex Agius Saliba, commented: “Just recently, the European Medicines Agency released an annual report about medicines considered for approval in 2022. Leading the list are over 20 new cancer and nearly 15 novel treatments for neurology approved last year.
“While this is undoubtedly great news, at the same time I’m very worried that no single new treatment for mental health conditions obtained regulatory approval in 2022. We have high ambitions in Europe when it comes to health innovation and we must do better for people affected by mood disorders.
“In this regard, one particular area which promises to offer true innovation is psychedelic novel treatments but Europe is lagging behind which is why, together with my other fellow Members of the European Parliament, we decided to send this letter to EMA and EMCDDA.”
Raising the profile of psychedelics
The MEPs have told Psychedelic Health that they will be working alongside European non-profit, the Psychedelic Access and Research European Alliance (PAREA), this year to raise awareness of scientific developments in the field of psychedelics.
Throughout 2023, PAREA aims to ramp up its campaigning for psychedelic advancement in Europe through education and engagement with European health organisations.
Member of the European Parliament and Head of the Polish S&D delegation, Robert Biedroń, commented: “In Europe, over 100 million citizens are affected by mental health conditions and substance use disorders. Unfortunately, treatment options for these diseases are still often suboptimal.
“Many members of the European Parliament – including myself – recognise a tremendous potential of psychedelic-assisted therapies in addressing the huge unmet needs in those therapeutic areas.
“This year, we will work with PAREA to establish an alliance of supportive parliamentarians to raise awareness in the European Parliament about those novel treatments and call upon the European Commission and EU member states to already start preparing for their likely approval by the European Medicines Agency in the coming years.”
PAREA Vice Chair and Executive Director of the European Brain Council, Frederic Destrebecq, added: “We are very pleased with this initiative from a cross-party group of MEPs who appreciate the important role that psychedelic-assisted therapies will likely play in addressing the pandemic levels of mental health and substance use disorders that we witness in Europe.
“We share their sentiment that the EMA and EMCDDA should become more engaged in determining issues surrounding efficacy and safety of the medical use of psychedelic substances, the current regulatory frameworks applicable to using psychedelics in a medical context, and the potential implications psychedelic novel treatments will have for European healthcare systems.
“This initiative is also timely because in May PAREA is organising a meeting with interested MEPs to explore building an alliance in the European Parliament.”
