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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”.

The Legal Status of “Poppers”

The Legal Status of “Poppers”

In R v Rochester [2018] EWCA Crim 1936, decided on 17th August 2018, the Court of Appeal (Criminal Division) concluded that the Psychoactive Substances Act 2016 does not require a “psychoactive substance” to be capable of producing its “psychoactive effect” by directly stimulating or depressing the central nervous system. Indirect effect is sufficient.  The substance in that case was nitrous oxide, commonly known as “laughing gas”.

The appellant’s contention was that the effect must be direct.  The argument was largely fuelled by events after the Act appeared on the statute book (28 January 2016) but before it came into force (26 May 2016).  Concern had been raised in Parliament that alkyl nitrites (“poppers”) – when used as a sexual aid – would be caught by the PSA.  The Home Office commissioned the Advisory Council on the Misuse of Drugs (AMCD) to provide an assessment of the harms and psychoactivity of alkyl nitrites when used in that way.

On 16 March 2016, the ACMD provided a report stating that poppers dilate blood vessels and relax muscles, including the bladder, digestive tract, vagina and anal sphincter. The Council remarked that “The brain receives a transient ‘rush’ or ‘high’ as an indirect effect caused by increased blood flow caused by the dilation of blood vessels in the brain and periphery.” [Link]  Importantly, the ACMD said:

“The [Council’s] consensus view is that a psychoactive substance has a direct action on the brain and that substances having peripheral effects, such as those caused by alkyl nitrites, do not directly stimulate or depress the central nervous system.”

It was therefore unnecessary to add alkyl nitrites to the list of exempted substances and products in schedule 1 to the Act.  By letter dated 22 March 2016, the Minister for Preventing Abuse, Exploitation and Crime wrote to the ACMD “…Having given due consideration, the Government agrees with your advice and interpretation of the definitionWe do so in the understanding that ‘poppers’ have these unique indirect effects.” [Emphasis added]  See, to similar effect, a letter from the Minister to Mike Freer MP [Link].

The issue raised on appeal was foreshadowed in an article written by this commentator in Criminal Law Review ([2018] Crim. L.R. 229, Issue 3).

The question now is: “where does this case leave the legal status of poppers when produced, supplied, imported or exported for recreational use?”  The answer may be that unless Parliament makes an exemption in the PSA, poppers may fall within the Act as a ‘psychoactive substance’”.

This commentator has previously warned that statements made in correspondence between the ACMD and the Minister do not have the force of law.  The Court of Appeal cannot be criticised for noting and placing reliance on the fact that the PSA does not expressly require a “psychoactive effect” to be direct.  The ACMD had also noted that the definition of a ‘psychoactive substance’ in the PSA “is not explicit with respect to direct or indirect effects on the central nervous system” (para.2.5).

As for the ACMD’s view on the meaning of a “psychoactive substance”, the Court remarked that this was “not an admissible aid to construction; neither is the minister’s acceptance of that view”.   Limits are placed on the use of out-of-court statements as an aid to statutory interpretation.  The Courts tend to analyse the language and structure of the statute under consideration.  In any event, despite the Minister’s reassuring statement, there was a time when the Government was minded to bring “poppers” within the terms of the PSA (see Hansard, House of Commons, 27th Oct 2015, e.g., col.38).

The Court said that the “precise boundaries between direct and indirect effect” had not been explored in the materials before it and “may not be free from difficulty”.  It added, “Were a distinction to be drawn between direct and indirect effects, we see considerable scope for expert disagreement about where those boundaries lie.”

The problem with the PSA is that it sets no clear boundaries and is laced with conceptual and forensic difficulties.

Drug Related Deaths – 2017

Drug Related Deaths – 2017

The Office for National Statistics has published data (principally for England and Wales) concerning deaths relating to drug poisoning – two thirds of which are attributed to drug misuse [Link].
Although the number of deaths for 2017 (3,756) is similar to levels seen in 2016, the marked increase in fentanyl deaths from 58 in 2016 to 75 in 2017 is disturbing (noting that fentanyl and its analogues have been found mixed with heroin “causing accidental overdose in users”).  Other findings include:

  • Males’ mortality rate decreased from 91.4 deaths per 1 million population in 2016 to 89.6 in 2017, while the female rate increased for the eighth consecutive year to 42.9 deaths per 1 million population; neither changes were significant.
  • The North East had a significantly higher rate of deaths relating to drug-misuse than all other English regions; London had a significantly lower rate.
  • Deaths involving cocaine continued to rise while deaths related to new psychoactive substances halved in 2017.

There is an evident need for investment (financial and skills) in prevention, rehabilitation and treatment (see, for example, the piece by Prof Alex Stevens in “The Conversation” [Link], and the Report of the ACMD “Commissioning impact on drug treatment” (see, in particular, the conclusions at para.3.10) [Link].

The case for at least piloting in the UK medically supervised drug consumption facilities has been made elsewhere in these pages (see, for example, Fortson and McCulloch, “Evidence and Issues Concerning Drug Consumption Rooms” [Link].

Defining “Medicinal Cannabis”

Defining “Medicinal Cannabis”

The ACMD has published its advice to the Home Secretary regarding the scheduling of cannabis-derived medicinal products [link].  As stated in my earlier blog, in order to make certain cannabis related products available on prescription, it is not enough merely to move cannabis from schedule 1 to the Misuse of Drugs Regulations 2001 to another schedule.  The complex provisions of the UK/EU medicines legislation must also be considered.  It is therefore significant that the ACMD has stated:

Defining Cannabis-derived medicinal products
The CMO’s report states that “using other forms, such as grown or street Cannabis, as a medicine for therapeutic benefit is potentially dangerous”.  The ACMD agrees that raw Cannabis (including Cannabis-based preparations) of unknown composition should not be given the status of medication.
Prescribers, patients, regulators and policy-makers must have confidence in the effectiveness, composition and consistency of Cannabis-derived medicinal products to ensure patient safety. Cannabis-derived medicinal products should meet defined safety and quality assurance standards to ensure that they do not put patients at risk of harm. Risks to patients may arise from impurities and adulterants, and variability in the composition of active constituents.
One of the complexities of this area is the lack of clarity of what Cannabis-derived medicinal products are. The ACMD has identified this as a problem that needs addressing with clear definitions. The Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA) should agree on appropriate definitions and medicinal standards following appropriate consultation. The ACMD requests the development of appropriate definitions to be completed in a timely manner, so that it does not introduce unnecessary delays to the ACMD’s ‘longer term’ review, or prevents doctors prescribing Cannabis-derived medicinal products to patients where there is an identified need and likelihood of benefit.

Quite apart from the fact that (controversially) raw herbal cannabis would remain in schedule 1, the statement that “Cannabis-derived medicinal products should meet defined safety and quality assurance standards to ensure that they do not put patients at risk of harm” is an oblique reference to the rules relating to medicinal products.  Which cannabis-related products – and how many – would meet those standards?  How many of those products would be available on prescription either on a named-patient basis (restrictive) or because they receive a UK MHRA “marketing authorisation” and are designated “Prescription Only Medicines”?
Reality may not match much of the anticipation and hype that has surrounded this topic.

Billy Caldwell and Medicinal Cannabis

Billy Caldwell and Medicinal Cannabis

Every few years, the plight of persons who have used ‘cannabis’ to alleviate pain and suffering due to a medical condition, has captured the attention of the public.  If there is to be a review of the laws relating to the medicinal use of cannabis then this is to be welcomed and long overdue.  The matter might have been addressed in 2005 after the Court of Appeal felt constrained to dismiss a number of conjoined appeals in R v Quayle and others  [2005] 1 WLR 3642.  Each of the appellants had possessed, or cultivated or imported cannabis to alleviate pain.  On the 16th June 2018, the  Home Secretary tweeted that “This morning, I’ve used an exceptional power as Home Secretary to urgently issue a licence to allow Billy Caldwell to be treated with cannabis oil“.

However, in order to make progress in this area, certain issues need to be clarified and carefully understood.  First, the expression “cannabis oil” is misleading.  It is now used loosely to refer to a number of cannabis related substances and products.  Forensic analysts will say that some oils containing THC are “controlled drugs” while other cannabis-related oils (e.g. CBD oils that do not contain any THC) will not be.  Secondly, there needs to be clarity as to the forms of cannabis that have medicinal value.  Merely moving “cannabis” from one schedule to another within the Misuse of Drugs Regulations 2001 does not answer that question.  Thirdly, it is not just the Misuse of Drugs Act 1971 that needs to be considered.  The UK, in common with many other countries, operates a statutory regulatory regime in respect of the production, distribution and licensing of “medicinal products”.  Substances and products that are presented as having medicinal properties or which function as medicines, can fall within that complex regime (see the Human Medicines Regulations 2012 and the Medicines Act 1968).  A breach of the statutory provisions can lead to civil proceedings or criminal prosecution.   The sooner these issues are resolved, the better.