By Rudi Fortson Q.C.*
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, “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 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.
*We thank Rudi Fortson Q.C for this guest post on the Release blog. Rudi Fortson has been an independent practising Barrister since 1976, and is a Visiting Professor of Law at Queen Mary, University of London. He took silk in 2010.
Rudi Fortson is noted for his work in relation to serious crime, including fraud, confiscation, asset-recovery, money-laundering, drug trafficking and drug law. He has chambers at 25 Bedford Row, London.