In a new policy briefing for the European Medicines Agency (EMA), Psychedelic Access and Research European Alliance (PAREA) has called for an advisory body on psychedelics to be established in Europe.
Following an announcement earlier this year that the EMA would be holding a workshop on psychedelics in 2023, PAREA has prepared a policy brief outlining its recommendations and insights.
The brief, sent to the EMA this week, aims to guide preparations and discussions for the workshop. Tadeusz Hawrot, Founder and Director of PAREA, explains that it focuses on the importance of strategic planning, professional cohesion and the role of advisory bodies.
Marking an important step for psychedelics in Europe, the workshop will be held as a response to a letter from a group of cross-party MEPs calling for the EU to act fast on psychedelics.
Signatories of the letter included MEPs 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 letter followed news from countries such as Australia and the US which have begun making changes to drug policy to allow access to psychedelic therapies for patients in select circumstances.
PAREA’s policy brief, as seen by POLITICO, suggests that experienced psychedelic users should be included on the advisory panel. Additionally, the brief emphasises the importance of centralised co-ordination as opposed to individual EU countries establishing their own working group.
In a public comment, Hawrot stated: “We advocate for the creation of a multidisciplinary advisory body to guide regulators and professionals on best practices and care standardisation.
“We believe this body would benefit from the collective knowledge of various stakeholders, including the EMA, EMCDDA, national competent authorities, professional organizations, healthcare professionals and managers, psychedelic organizations, patients’ organizations, drug developers, and the wider community.
“Centralised co-ordination would offer an efficient mechanism to propel the field forward, rather than individual EU countries initiating their own work groups.”
Hawrot highlighted the importance of this centralised co-ordination approach at the PSYCH Symposium in July.
“I think a non-psychedelic specific regulatory challenge is the fragmentation and health technology assessment processes where country by country, they have their own methodologies,” stated Hawrot.
“Luckily, the European Union is now working on harmonising this through the central HTA [Health Technology Assessment] process, which is a long journey – but there is a light at the end of the tunnel.”
Speaking from PAREA’s perspective, Hawrot also explained that Europe needs to look at the prescription use of psychedelics within the clinical context.
“The one challenge I see is combination therapy because, as we know, the EMA and the FDA don’t regulate clinical protocols […] so what we will need is an expert consensus on standards of care. Things like the treatment protocols, standards for the training of the therapist, ethical guidelines, and also data collection protocols,” said Hawrot.
“What we need here is this expert consensus bringing together professional organisations that already have well-established safeguards like psychologists and psychiatrists. Then also drug developers who have their own protocols, bringing in patients organisations and the whole community, and coming up with the standards that would make it much easier for the regulators to approve these treatments.”
Watch the full PSYCH Symposium panel on Psychedelics in Europe – featuring Psychedelic Health – here.
