Earlier posts by this commentator have cautioned against an expectation that “Cannabis-Derived Medicinal Products” (CDMP) would – in a matter of weeks or a few months – be made available on prescription by local GPs.  The latest correspondence from the Home Office to the Advisory Council on the Misuse of Drugs (21 September 2018) [Link] is a further indication that the caution was not misplaced.  The letter states that “the Government decided to act with pace and reschedule cannabis based products for medicinal use, within the current legal framework, as quickly as it could”.   It adds “we think it is critical that we do not hinder the use of cannabis-based products for medicinal use for the relief of pain and suffering where medically appropriate and there is evidence…..it is important to reiterate that we are still at an early stage. We will continue to review and evolve our approach in the light of experience” [emphasis added].  The Government awaits the receipt of the ACMD’s “full report on cannabis-derived medicinal products in July 2019”.

As previously stated, the provision of CDMPs is not simply a matter of moving such products (or ‘cannabis’) from Schedule 1 of the Misuse of Drugs Regulations 2001 to another schedule.  Any product (whether a controlled drug or not) that is presented as having medicinal properties or which has a medicinal function will attract the complex UK/EU medicines legislation.  It is therefore unsurprising that the Government’s latest response (21 Sept) states that CDMPs “like any other medicine….need to comply with the requirements of the Human Medicines Regulations 2012” (Response to ACMD Recommendation 1).  Even this is an over-simplification.  The recent decision of the High Court concerning the use of Avastin for wet Age-related Macular Degeneration shows how complex the medicines legislation can be: Bayer Plc and Novartis Pharmaceuticals UK Ltd v NHS Darlington CCG and Oths [2018] EWHC 2465 (Admin).  That decision may be the subject of an appeal, but whatever the final outcome, the case may have some relevance in the context of CDMPs were a CDMP to be supplied “off-label” or to fulfil a special need (‘specials’).  The Bayer case shows the extent to which – in relation to medicinal products – UK law and EU law form a package of measures.

On 21 September the Government also announced its “definition” of “Cannabis based products for medicinal use” [Link].  The “definition” is not as clearly identified on its webpage as being such, but it appears to be: “There are 3 broad requirements for products before they can be prescribed: • the product is or contains cannabis, cannabis resin, cannabinol or cannabinol derivatives; • the product must be produced for medicinal use in humans; • it must be a product that is regulated as a medicinal product or an ingredient of a medicinal product.”  The third condition is of particular interest because it is arguably clearer than the Government’s interim definition as it makes plain that the product is one that is “regulated” as a “medicinal product” (a term defined by the Human Medicines Regulations 2012).