The Psychedelic Access and Research European Alliance (PAREA) has launched a policy paper in line with a recent meeting on medical psychedelics in the European Parliament.
In a significant step for Europe, the MEP Action Group for the Medical Use of Psychedelics meeting took place to dicuss medical psychedelics within the EU pharmaceutical legislation framework.
PAREA launched its policy paper “Unmet Medical Needs: Aligning Medical Innovation with Societal Health Needs” in line with the event, and as a follow up to the orgainsation’s recent position statement, “Leveraging the EU Pharmaceutical Package: A Life Cycle Approach to Address High Unmet Needs and Foster Mental Health Innovation by Incentivizing Psychedelic Novel Medicines”.
Challenging the current paradigm that narrowly defines unmet and high unmet medical needs, PAREA argues in the policy paper that “the existing focus on life-threatening or severely debilitating conditions fails to consider the broader health and societal context.”
The paper outlines the burden created by prevalent mental health conditions including on the individual as well as healthcare systems, society and the economy, arguing that “the current criteria for unmet medical needs do not adequately account for the potential to significantly improve quality of life, especially for chronic conditions.”
As this criteria dictates what receives funding, the paper argues, “a recalibration is essential for ensuring that medicine development aligns more closely with public health priorities and needs.”
The policy paper also calls for:
- The urgent expansion of criteria used to define high unmet medical needs to include the prevalence of conditions and their societal impact.
- The establishment of a European Hub for Mental Health Research and Development that would unite EU institutions, member states, healthcare funders, and philanthropic organizations.
- For mental health to be addressed as a central pillar of sustainable development.
On the European Parliament meeting, PAREA stated: “The event, which coincided with the ongoing discussions on the revision of the EU pharma package, focused on creating a supportive regulatory environment to foster innovation in novel mental health treatments, particularly psychedelic therapies.
“The gathering underscored the urgency of addressing unmet medical needs in the EU and the potential of psychedelic therapies to offer rapid, durable improvements for conditions such as depression and PTSD.”
The organisation continued: “As the EU revises its pharmaceutical legislation, PAREA’s policy paper serves as a critical voice, advocating for a recalibrated approach that aligns medicine development with public health priorities and societal needs. It is a call to action for policymakers, healthcare professionals, and stakeholders across Europe to recognise and address the unmet needs in mental health care.”
To read the full policy paper please click here.
