The Psychedelic Access and Research Alliance (PAREA) has released a position statement calling on the EU to harness psychedelics in a bid to create innovation in the area of mental health treatments and make the Union a leader in biomedicines.
Data shows that in 2019, 7.2 % of the EU population aged 15 years and older were living with chronic depression. However, mental health treatment in Europe has seen little to no innovation in decades.
Highlighting that the right to innovation is enshrined in the European Charter of Patients’ Rights, the position statement is a response to the EU Pharmaceutical Package revision and extends its reach to cover the full lifecycle of medicines, underscoring the urgent need to incentivise the development of novel mental health treatments.
The revision package was put forward in April 2023, and is a bid to overhaul current pharmaceutical legislation to ensure the supply of medicines and their availability to patients in the EU in light of growing problems with medication shortages.
PAREA argues that psychedelics should be at the forefront of the EU’s mental health efforts, highlighting how psychedelic therapies have shown promising clinical results as potential treatments for several mental health conditions and substance use disorders.
The organisation, which campaigns for advancing psychedelic therapies and research in Europe, states: “PAREA calls for the review of EU pharmaceutical legislation to be leveraged as a critical tool to foster innovation and support the development and deployment of innovative mental health treatments. Psychedelic therapies, with their potential to revolutionise mental health care, should be at the forefront of this effort.
“This approach can position the EU as a global leader in this field and enhance the EU’s biomedical capabilities.”
Speaking at PSYCH Symposium, Tadeusz Hawrot, Founder and Executive Director of PAREA, described the EU Pharmaceutical Package revision as a “once-in-a-generation reform”.
“…It will have significant consequences both in Europe and also globally for decades for free trade agreements,” said Tadeusz on the Symposium panel ‘The Future of Psychedelic Medicine in the EU’.
“We have this kind of EU legislative superstructure and single market and we have this mechanism for regulatory approval of new drugs which is centralised. However, then there are all the diverging healthcare systems underneath and pricing reimbursement, and ultimately access decisions are done Member State by Member State…
“The pharma revision is there to change it. On the one hand, the ambition is to kind of normalise access across the EU and the second goal … is stimulating innovation in the area of high unmet needs.”
Deirdre Ryan, Pain Alliance Europe (PAE) President and Vice-Chair of PAREA, commented: “European medicines reform must prioritise meaningful, needs-driven innovation that places patient and public health at the forefront. Millions of Europeans with mental health conditions have been left in the dark with a lack of new developments in treatment, with many barriers and stigma to access psychological interventions.
“While not a cure-all, psychedelic-assisted therapies offer a long-term novel approach that doesn’t at present fit within the current structures of EU regulation or safety protocols. This needs to change.
“With many shortages and profound unmet need, the EU Pharmaceutical strategy needs to adapt and modernise. PAREA’s position statement outlines the full lifecycle of medicines, from research and development to patient access.”
PAREA’s position statement explores the unique challenges faced by psychedelic therapies which have seen 50 years of stigma, contributing to one of the largest censorships of scientific research in history.
Highlighting a recent European Commission (EC) discussion paper, ‘Scoping study on evidence to tackle high-burden under-researched medical conditions’, which found mental health disorders as number one on a list of “high-burden under-researched medical conditions”, PAREA underscores the “shockingly low” number of EU-approved therapies for mental health.
“For instance, last year, none of the 89 new medicines recommended for approval by the EMA were for mental health conditions,” writes PAREA, noting that the EU does provide positive examples for incentivising funding.
“The EU has demonstrated a successful approach to incentivising R&D in the realm of orphan medicines. Since 2000, over 200 orphan medicines have been authorised for the benefit of patients suffering from rare diseases.”
PAREA also states its support for another EC discussion paper which proposes the development of a “graded classification” of unmet needs based on standardised criteria which could be used to guide government allocation of funding and medicine reimbursement.
To date, a major barrier for psychedelic research has been a lack of funding – with the majority of research being taken on privately.
PAREA’s position statement calls for the “infusion of public funds to make psychedelic research more equitable and inclusive, and for a comprehensive package of incentives for smaller developers.”
While these incentives will help foster innovation in mental healthcare, psychedelic research will also be supporting the EU’s ambitions to become a global leader in biosciences, says PAREA, as per the 2022 Versailles Declaration.
Among other incentives, the orgainsation is also calling for EU regulators to explore how academia and non-profit organisations can best contribute to the development of psychedelic innovative medicines, and how EU policies can favour an academic-driven pathway for their development.
To read the full statement and set of calls please click here.
