Correspondence

Circular 001/2020: Epidyolex scheduling, (SI) 2020 No. 559

Published 24 June 2020

Introduction

This circular draws attention to the content of the Statutory Instrument (SI) 2020 No. 559. The new provisions, The Misuse of Drugs (Amendment) (England, Wales and Scotland) Regulations 2020 amend the Misuse of Drugs Regulations 2001 and come into force today (24 June 2020).

Links to the SI, together with the accompanying explanatory memorandum and impact assessment can be found beneath the Annex to this document.

Summary

This SI places the cannabis-based medicine, ‘Epidyolex’, in Schedule 5 to the Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’), with the effect that it is excepted from the prohibition on importation, exportation and possession under the Misuse of Drugs Act 1971 (‘the 1971 Act’).

Epidyolex is licensed for use as an adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome (two rare forms of epilepsy), in conjunction with clobazam, for patients two years of age and older. It mostly consists of the active ingredient cannabidiol (‘CBD’) and a small amount of delta-9-tetrahydrocannabinol (‘THC’), which is controlled as a Class B drug under the 1971 Act.

Background

The 2001 Regulations provide access to controlled drugs for legitimate medicinal or exceptionally for industrial purposes. Drugs which are controlled under the 1971 Act are listed in one of five Schedules to the 2001 Regulations, based on an assessment of their medicinal or therapeutic usefulness, the need for legitimate access and their potential harms when misused. Scheduling imposes requirements around prescribing, supplying, record-keeping, labelling, destruction and safe custody. Schedule 1 controlled drugs are subject to the greatest restrictions and Schedule 5 to the lowest.

On 1 November 2018, cannabis-based products for medicinal use in humans (‘CBPMs’) were placed in Schedule 2 to the 2001 Regulations and removed from Part 1 of the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015, meaning that CBPMs could be prescribed for medicinal use in the UK where clinically appropriate[footnote 1]. Epidyolex met the definition of a CBPM under the 2001 Regulations and was supplied as an unlicensed medicine.

On 19 September 2019, the European Commission issued a marketing authorisation in relation to Epidyolex which meant that it became a licensed CBPM in the UK. Following this authorisation, the Advisory Council on the Misuse of Drugs recommended that Epidyolex be placed in Schedule 5 to the 2001 Regulations because THC is present only as an impurity and it has a low risk of abuse potential, low risk of dependency and low risk of diversion.[footnote 2]

In December 2019, the National Institute for Health and Care Excellence (NICE) also assessed the clinical and cost effectiveness of Epidyolex, recommending its use, in combination with clobazam, for treating seizures associated with Lennox–Gastaut syndrome and Dravet syndrome in people aged two years and older[footnote 3], meaning that it may be prescribed on the NHS for these conditions.

Impact of the Scheduling of Epidyolex

Scheduling a cannabis-based medicine which has received marketing authorisation under the 2001 Regulations distinguishes it from those licensed and unlicensed CBPMs.

By placing Epidyolex in Schedule 5 to the 2001 Regulations, it is no longer subject to the prohibition on importation, exportation and possession under the 1971 Act. This will reduce administrative processes for companies wanting to supply Epidyolex to patients with severe epilepsy.

The amendment will also remove restrictions around prescribing Epidyolex for patients with severe epilepsy by extending the length of time the prescription can be valid for. In addition, Epidyolex will no longer be subject to the Department of Health and Social Care’s (‘DHSC’) recommendation of a maximum 30-days’ supply. This may help reduce the number of appointments needed for patients, with prescribers, saving time and reducing costs for both patients and healthcare professionals.

Annex A

Emma Nichols, Drugs Legislation Team, Drugs Misuse and Firearms Unit at the Home Office can be contacted with any queries regarding this circular. Email: emma.nichols5@homeoffice.gov.uk

Annex B

For more information and further guidance please go to:

SI reference for the Scheduling of Epidyolex:

The Misuse of Drugs (Amendment) (England, Wales and Scotland) Regulations 2020