Psychedelic-assisted therapies could hit UK markets sooner than expected – and sooner than may happen in Europe – under a new government funding plan for innovative drugs.
The UK’s HM Treasury has announced £10 million in funding for the Medicines and Healthcare products Regulatory Agency (MHRA).
The funding, which will be provided over the next two years, will be used to accelerate routes for bringing innovative medical products developed in the UK onto the market.
Additionally, and what could be the most impactful development for psychedelic therapies in the UK, the funding will also accelerate drugs to the UK market that have been made and approved by other trusted regulatory partners globally.
A trusted recognition framework
With the new funding supporting the establishment of an international recognition framework, the Government has stated that this will allow the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners and provide patients with fast-track access to best-in-class medical products that have been approved in other countries.
As recently highlighted by Brian Barnett from US-based Cleveland Clinic in his co-authored article “Psychedelic Medicine’s Future Depends on Proactive Development of a Robust Medical Billing and Coding Strategy”, which has been published in the inaugural issue of Psychedelic Medicine, investigational psychedelic therapies are likely to begin gaining regulatory approval as medical treatments in the US within the next two years.
This may mean that UK patients could see access to psychedelic therapies sooner than anticipated, as some of these therapies, such as MAPS’ MDMA-assisted therapy and COMPASS Pathways’ psilocybin-assisted therapy, which have both been granted FDA Breakthrough Therapy designation, may receive FDA approval in the United States in this projected time frame.
Professor David Nutt, Chair of Psychedelic Access and Research European Alliance (PAREA), commented: “Myself and most UK experts think this represents an acceptance that the MHRA isn’t able to fulfill its traditional role since Brexit.
“I think it might be good news for MAPS and COMPASS Pathways in that if the FDA approves their products then likely the MHRA will accept rather than ask for more trials. However, we then have the issue of getting the price down to a level that NICE will approve.”
UK non-profit Drug Science commented: “Drug Science welcomes the recent government announcement. However, we hope that the regulators do not hold psychedelics to a different standard just because of their international scheduling.
“If MDMA receives market authorisation in the US in the coming years, it ought to be eligible for this accelerated pathway.”
The pressing need for drug policy review
Timmy Davis of the Conservative Drug Policy Reform Group (CDPRG) has welcomed the news as a positive development for patients but highlights that the issue of rescheduling psychedelic compounds remains.
Davis commented: “This is a really interesting development, that I am happy to see.
“While I welcome the fact that what’s been announced will probably lead to expedited access to medicines from the psychedelics in the UK, it leaves the lack of an evidence base for their class and schedule unaddressed and perpetuates 50 years of differential prohibition.
“There is no scientific rationale underpinning the drug laws in the UK. This is particularly stark in the case of psilocybin which has consistently been found to be one of the safest of the controlled drugs to users and society.
“No review of the evidence has ever been conducted, so while this may be a positive step towards patients gaining access, the other uses of psychedelics will remain criminalised. With the exception of alcohol and tobacco, the only way to access drugs of any sort remains medical.
“While this remains the case, those of us without a psychiatric diagnosis indicated for psychedelic-assisted therapy will not be able to access and benefit from the multiple uses of these substances.
“It is exciting that these prohibited substances are being recognised as having medical potential but it’s important not to lose sight of the context – the harms of prohibitionist drug policies are serious and extend beyond the psychedelics.”
