Government confirms that Epidyolex has been reclassified as a Schedule 5 drug in the UK

The Home Office on 24 June 2020 confirmed that Epidyolex (a cannabis-based medicine) has been reclassified, and will now appear under Schedule 5 of the Misuse of Drugs Regulations 2001 (MDR 2001), effective from that date.

The change is effective in England, Wales and Scotland and will see the medicine move away from Schedule 2 under the MDR 2001.

Elliott Rolfe, an Associate Solicitor at leading cannabis law firm Mackrell. Solicitors said “This reclassification is another step in the right direction. Schedule 5 medicines are not subject to the import, export, handling and storage restrictions imposed on Schedule 2 medicines, so hopefully, this change will make access to this CBD based medicine a little easier, as well as improving safety perceptions more generally”

Epidyolex is approved in the European Union (EU), in conjunction with Clobazam, for use as an adjunctive therapy of seizures associated with Lennox Gastaut syndrome or Dravet syndrome (two rare forms of epilepsy), for patients two years of age and older.

The UK Advisory Council on the Misuse of Drugs (ACMD) and its Technical Committee recommended the change to the Minister of State for Crime and Policing, Kit Malthouse MP, in January 2020.

This recommendation was made based on a written dossier and presentation from the UK Medicines and Healthcare products Regulatory Agency (MHRA), while the medicine was reviewed and approved by the regulatory authorities in September 2019.

The ACMD stated that the “low risk of abuse potential, low risk of dependency and low risk of diversion” was one of the key reasons for reclassifying the drug to a schedule 5 controlled drug.

However, they went on to state that the GW Pharmaceuticals medicine is “distinct from other commercially available CBD (cannabidiol) containing supplements that have not sought marketing authorisation as a medicine”, and as such, this reclassification only applies to Epidyolex.

Another positive move like this, by authorities in the United Kingdom, demonstrates the progression, albeit a slow one, of cannabis-based medicines being widely accepted as a safe form of treatment officially. It should help defeat the hesitation of introducing or developing other medicines synthesised from the plant, and serve to help educate the general population on the efficacy of cannabis-based medicines in treating chronic ailments.

Hopefully, this will boost confidence in the regulators that are all too tentative to make any considerable advances or decisions with regards to medicines in this industry.

For help and advice on matters relating to cannabis law, contact our expert team at Mackrell.Solicitors today.

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Ricardo Geada
Ricardo joined the firm in 2020 as part of fast-growing Cannabis Law team as a Senior Associate.