Recently, there has been an surge of advocacy surrounding psychedelic therapies as potential breakthroughs for treating mental health disorders. This movement has now spread into European Parliament where Members of European Parliament (MEPs) are lobbying for increased support and regulatory pathways for psychedelic research. As the European Union considers revising pharmaceutical regulations, MEPs view this momentous opportunity to further incorporate psychedelics into mainstream medical treatments.
Recently, seven MEPs organized the Action Group for the Medical Use of Psychedelics as an advocacy effort. Their objective is clear: persuading fellow MEPs of psychedelics’ potential use in mental healthcare while advocating for their safe and regulated use. Czech MEP Mikulas Peksa highlighted pharmaceutical package revision as an opportunity for conducting psychedelic research.
At the center of this debate lies recognition that psychedelic drugs – though illegal throughout Europe – possessing potential to transform how mental health disorders are treated. Although classified by the UN as Schedule I drugs without accepted medical use, evidence shows otherwise; when used responsibly alongside psychotherapy sessions such as MDMA and Psilocybin found in magic mushrooms may prove highly successful at managing conditions like Post Traumatic Stress Disorder (PTSD), Depression, Alcoholism or Anorexia.
Australia has taken an important step by authorizing psychiatrists to prescribe MDMA and psilocybin for treating posttraumatic stress disorder and treatment-resistant depression. The United States is anticipated to approve MDMA-assisted therapy for PTSD by 2024; thus Europe needs to remain current by conducting late stage trials within its borders.
Josh Hardman, founder of Psychedelic Alpha newsletter and community, stressed the significance of conducting trials in Europe. According to Hardman, Europe boasts some of the best psychedelics researchers – possibly worldwide! – as well as amazing practitioners and participants for clinical trial participation. Unfortunately, most ongoing trials are still in their early and mid stages, leaving participants vulnerable if late stage research moves away from Europe towards North America.
At an early stage, one key factor should be considered carefully: offering logistical advice to drug developers, researchers and investors. Such assistance builds trust among stakeholders by encouraging investments in trials and research that could eventually lead to the widespread use of psychedelics across all 27 EU member states.
The European Commission’s proposed pharmaceutical reform aims to ease treatment across member states by expanding the regulatory data protection period. This measure prevents competitors from using another company’s clinical trial data when applying for market authorization within two years of receiving approval from the European Medicines Agency; however, this timeline could create logistical and resource burdens specific to psychoactive substances.
Tadeusz Hawrot, founder of Psychedelic Access Research and European Alliance (PAREA), advocated for comprehensive incentives to be provided for smaller developers in this sector. According to him, mental health treatments have experienced stagnated innovation for decades; therefore psychedelic therapies offer hope of rapid and durable therapies. EU pharmaceutical legislation should create more supportive regulatory conditions which foster innovation within this crucial sector.
PAREA took this occasion to present its policy paper calling for a revision of Europe’s approach to incentivizing innovation, by broadening what counts as “high unmet medical needs” so as to encompass mental and substance use disorders that place significant burdens on individuals, healthcare systems, societies and economies despite not necessarily being life-threatening conditions.
As part of its recommendations, EU institutions, member states, healthcare funding bodies and philanthropic organizations proposed creating a European Hub for Mental Health R&D that would support evidence-based decision making regarding mental health as well as prioritizing research and development activities.
MEP action group members have taken additional steps, engaging with the European Medicines Agency and planning for a workshop promoting the development of psychedelics by late 2017. While U.S. Food and Drug Administration guidelines exist for conducting clinical trials involving these substances, European Medicines Agency has yet to do so.
Additionally, the European Commission’s multidisciplinary approach to mental health – which encompasses its incorporation across policy areas like education, employment and environment – demonstrates a widespread acknowledgement of its significance within European society.
MEPs’ demands to fund research into the use of psychedelic drugs as treatments for mental health disorders demonstrates their increasing recognition of their potential benefits in treatment. With evidence proving their efficacy mounting, Europe should seize this chance and create regulatory pathways and foster innovation within mental healthcare services. As Europe undergoes reform of pharmaceutical regulations reform, Europe has an invaluable chance to set the path towards safe and effective psychedelic therapies that improve lives across its continent.