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Rescheduling of cannabis-based products for medicinal use

17th October 2018

The government in England, Wales and Scotland has announced that cannabis-based products for medicinal use will be rescheduled as from the 1 November 2018 from Schedule 1 to Schedule 2. Northern Ireland is expected to mirror these changes shortly.

This change follows the government review (see our previous news item) and is the legislative step needed to enable cannabis-based medicinal products to be prescribed and supplied for human use.

The new regulations define a cannabis-based medicinal product as satisfying all the following criteria:

  • a preparation or product which contains cannabis, cannabis resin, cannabinol or a cannabinol derivative and
  • it is produced for medicinal use in humans and
  • it is a medicinal product, or a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product.

Any product which does not satisfy this definition will remain a Schedule 1 drug and only be available under a Home Office licence.

The existing medicines framework allows three access routes for the order, supply and use of these products by patients:

  • a medicinal product with a marketing authorisation or
  • an investigational medicinal product without marketing authorisation for use in a clinical trial or
  • an unauthorized (unlicensed) “special” for a specific patient, which can only be manufactured in, or imported into, the UK by a manufacturer or wholesale dealer that has a licence from the MHRA to do so and meets standards of good manufacturing practice (GMP).

In the case of cannabis-based medicinal products, a further restriction on specials has been included and the prescribing doctor (or direction from a doctor who has made the decision to prescribe) must be on the Specialist Register of the General Medical Council.

The 2018 Regulations continue to prohibit smoking of cannabis, including of cannabis-based products for medicinal use in humans.

Editor’s notes

This announcement is unlikely to affect palliative care specialists initiating cannabinoids for symptom management. Because trials examining cannabinoids for symptom relief generally use Δ9-THC, or a synthetic analogue, clinicians are likely to continue to prescribe either Sativex® or nabilone (see the recently updated PCF Cannabinoids monograph).

Specials manufacturers could now produce other cannabis-based medicinal products for human use, e.g. cannabidiol alone. However, to date, no RCT has confirmed a role for cannabidiol alone in palliating the symptoms of advanced life limiting illness. Thus, neither cannabidiol ‘specials’, nor Epidiolex® (a cannabidiol oral solution, marketing authorization pending; see our previous news item) are likely to be used by palliative care specialists at present.

We believe that the cannabidiol oils that patients have previously obtained via on-line suppliers (which generally retain traces of cannabis-based products) will not meet the criteria above for prescribing as a special unless they are produced and obtained within the existing framework for unlicensed specials (see above) and prescribed by a doctor on the specialist register of the GMC.

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