Prescribing Cannabis-based Medicinal Products: Moving Forward from the Landmark

Prescribing Cannabis-based Medicinal Products: Moving Forward from the Landmark

Today is undoubtedly a landmark moment but – as foreshadowed in earlier posts – the regime will be more restrictive than many persons in the media, and certain commentators, had claimed a few months ago.   The reason is that the medicines legislation (and not just the Misuse of Drugs Act 1971) was/is bound to set the ‘pace’ in relation to Cannabis-based medicinal products (CBMPs).

The relevant legislation is The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (E.W.&S) Regulations 2018 (SI 2018 No.1055), which came into force today.

A useful and comprehensive statement of the current position has been published by the MHRA [link] “The supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans ‘specials’
A letter dated 31st Oct 2018 from the DHSC and NHS England is informative [link] but there are two statements within it that need to be treated with discretion:

Moving cannabis based products for medicinal use to schedule 2 will mean those [products] can be prescribed medicinally where there is an unmet clinical need” [p.1]
and that –
the Government has chosen to restrict the decision to prescribe cannabis-based products for medicinal use to only those clinicians listed on the Specialist Register of the General Medical Council. This restriction has been set out in regulations.” [p.2]

The latter statement is true if the CBMP is unlicensed: in which event, the product must be treated as a “special”.  However, IF a CBMP has a “marketing authorisation”, the MHRA state that this prescribing restriction “will no longer apply” [p.6]:

The Misuse of Drugs Regulations 2001, as amended by [SI 2018 No.1055], provide that the prescriber must be a Specialist doctor registered on the General Medical Council (GMC) Specialist Register to be able to issue prescriptions for unlicensed CBPMs.  Once a substance receives Marketing Authorisation this prescribing restriction will no longer apply, and the product is available for patient use as other Schedule 2 drugs. See Regulation 16A of the 2001 Regulations.

Regardless of whether the CBMP is unlicensed or has a “marketing authorisation”, professional and regulatory guidelines, and ethical considerations, will be relevant.  But, how long will it take for a CBMP to acquire a full “marketing authorisation”?

Note that a CBMP (as defined in the Regulations) can be “cannabis” or “cannabis resin” – but, it must be “produced for medicinal use in humans” (and meet the remaining parts of the definition).  The MHRA document makes clear that a CBMP that is unlicensed must meet the specifications of a Specialist Medical Practitioner.  A CBMP will only acquire a “marketing authorisation” if it satisfies the stringent requirements for doing so.  It remains to be seen which products are considered by the regulatory bodies to be eligible for prescribing.

A CBMP remains a “controlled drug” for the purposes of the MDA 1971.

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