On 11 September 2018, the ACMD published its Advice to the Home Secretary and to the Secretary of State for Health and Social Care. 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  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”.
By Rudi Fortson QC