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Month: September 2018

Medicinal Cannabis – acting with “pace”.

Medicinal Cannabis – acting with “pace”.

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… 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).


ACMD Advice on Cannabis-derived medicinal products

ACMD Advice on Cannabis-derived medicinal products

On 11 September 2018, the ACMD published its Advice to the Home Secretary and to the Secretary of State for Health and Social Care [Link].  It is a constructive document that highlights a number of issues and problems that this commentator has raised for some time.  In some respects the document is nuanced.  Doubtless in the interests of readability and brevity it does not discuss a number of complexities concerning the legal definition of a “medicinal product”, the ‘marketing authorisation’ regimes, or the ‘specials regime’ (supply to fulfil special patient needs) in respect of medicinal products that do not have a UK or an EU marketing authorisation.

The ACMD advice demonstrates that a UK legislative regime for the provision of “Cannabis-derived medicinal products” (CDMPs) will not occur in a matter of days or weeks.  Any contrary expectation was perhaps fuelled by the statement (often made) that moving cannabis from schedule 1 to the Misuse of Drugs Regulations 2001 to Schedule 2 would enable doctors to prescribe “medicinal cannabis”.  This was an over simplification: it is only one step.

The ACMD document makes four telling statements:

1)  “CDMPs should meet defined safety and quality assurance standards to ensure that they do not put patients at risk of harm. As an interim measure, only products meeting these standards were recommended to be rescheduled to Schedule 2 of the Misuse of Drugs Regulations 2001.” [p.1]

2) ” Any definition of CDMPs should be underpinned by existing regulations [The Misuse of Drugs Regulations 2001, The Human Medicines Regulations 2012, and The Controlled Drugs (Supervision and Management and Use) Regulations 2013] and clinical guidance specific to CDMP prescribing.” [p.3]

3) ” …the responsibility for prescribing an unlicensed CDMP falls within the existing framework for the prescription of unlicensed medications. The ACMD agrees that unlicensed CDMPs should be considered as a product of last resort and used only when no other drug with MHRA marketing authorisation meets the clinical need.” [p.4]

4) “To expedite the transition from the use of ‘specials’ to the use of licensed medicinal products, the Government should encourage pharmaceutical companies developing CDMPs to apply for MHRA marketing authorisation.” [p.9]

Medical efficacy and product safety are key considerations in the regulated provision of a CDMP.  Given the existing UK/EU legal framework, a CDMP that has a UK “marketing authorisation” would (it is submitted) provide the most flexible ‘access route’ for its prescription.  But securing such authorisation is not a light touch.  The “specials” regime is largely set out in the Human Medicines Regulations 2012.  It is a restrictive regime because it applies to medicinal products that lack a UK or an EU “marketing authorisation”.  Current legal restrictions include: (a) that the medicinal product is supplied in response to an unsolicited order – in other words, the initiative to supply rests with the practitioner; and (b) that there is no “special need” if there exists an authorised approved equivalent drug (consider Case C-185/10 Commission v Poland [2012] ECR, para. 36).  The importation and distribution of “specials” would seem to require someone to have legal authorisation to do so.

There are also ethical issues for medical practitioners to consider when prescribing or administering any drug – especially one that has no “marketing authorisation”.