The UK government has allocated £10 million to the Medicines and Healthcare products Regulatory Agency (MHRA) to accelerate the routes for bringing innovative medical products developed in the UK to the market. This fund will also fast-track access to best-in-class medical products that have already been approved in other countries, through the establishment of an international recognition framework. This could mean that psychedelic-assisted therapies could be available to patients in the UK sooner than expected, and possibly earlier than in Europe.
Psychedelic-assisted therapies, such as MDMA and psilocybin, have shown promising results in clinical trials, treating a range of mental health conditions, including PTSD, depression, anxiety, and addiction. The treatment involves administering a psychedelic substance under the supervision of a trained therapist.
According to a recent article co-authored by Brian Barnett from the US-based Cleveland Clinic, psychedelic therapies are likely to gain regulatory approval as medical treatments in the US within the next two years. This means that UK patients could have access to these treatments much earlier 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 timeframe.
Professor David Nutt, Chair of Psychedelic Access and Research European Alliance (PAREA), believes that the MHRA's decision to fast-track access to these treatments represents an acceptance that the MHRA is no longer able to fulfil its traditional role since Brexit. He says, "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."
However, the lack of an evidence base for the class and schedule of psychedelics remains a concern for some. Timmy Davis of the Conservative Drug Policy Reform Group (CDPRG) welcomes the recent development, but highlights that the issue of rescheduling psychedelic compounds remains. He says, "while this may be a positive step towards patients gaining access, the other uses of psychedelics will remain criminalized."
In conclusion, the UK's move to fast-track access to innovative medical products could mean that psychedelic-assisted therapies could become available to patients in the UK sooner than expected. However, the lack of evidence to support the class and schedule of these treatments remains a concern. With the UK's recent decision to allocate funding to the MHRA, and the US's likely approval of these treatments in the next two years, the future of psychedelic medicine looks promising.