March 2021 saw the opening of the UK’s first high street clinic offering psychedelic-assisted therapies. Awakn Life Sciences opened a groundbreaking clinic in Bristol, offering therapies to treat addiction and other mental health conditions, exploring the use of ketamine and MDMA as a therapeutic tool in trials.

MDMA and ketamine are just two of a number of psychedelics that have recently generated significant research and commercial interest. In addition, LSD, Psilocybin, Mescaline and DMT have been the subject of studies with notable results, prompting much discussion around the capacity of the existing regulatory framework in the UK to accommodate psychedelic therapy.

These developments pose challenges under the current regulatory framework in the UK. The drugs listed above are all categorised as ‘class A’ drugs under the Misuse of Drugs Act 1971 (MDA) and are covered under Schedule 1 of the Misuse of Drugs Regulations 2001 (MDR). Ketamine, currently ‘class B’ under the MDA, and covered under Schedule 2 of the MDR, has also been of interest for its therapeutic potential.

Companies possessing, manufacturing, producing or supplying controlled drugs in England, Wales or Scotland need to hold a domestic licence. Equally, university research departments need a licence to produce, possess or supply controlled drugs listed in Schedule 1 of the MDR, though do not usually need a licence to possess and supply controlled drugs in Schedules two to five of the MDR.

This is a market which is starting to develop and is worth watching in view of the way the market for medical cannabis has developed in the last few years. We are working with clients in the sector and will be providing a further update in our next edition.