Medicinal Cannabis Prescribing: A Study of Boundary Work and Medico‐Legal Risk
| Published date | 01 November 2021 |
| Author | Paula Case |
| Date | 01 November 2021 |
| DOI | http://doi.org/10.1111/1468-2230.12669 |
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Modern Law Review
DOI:10.1111/1468-2230.12669
THE
MODERN LAW REVIEW
Volume84November 2021No. 6
Medicinal Cannabis Prescribing: A Study of Boundary
Work and Medico-Legal Risk
Paula Case∗
The prescription of ‘unlicensed’ cannabis-based medicines was legalised in 2018.A ‘boundary
work’analysis of the post reform guidance issued for doctors reveals a discourse which frames
the prescription of medicinal cannabis as a matter for clinical judgement, but also as fraught
with medico-legal hazard. The article highlights a triad of rhetorical devices comprising the
‘last resort’ pr inciple,‘per sonal responsibility’ andthe randomisedcontrolled tr ial asan exclusive
measure of ‘safety and ecacy’. Having identied a pronounced signalling of medico-legal risk
which is likely to have a chilling eect on prescribing,this article explores how the Bolam-
Bolitho formulation of the legal standard of care in negligence litigation might respond to this
new domain of prescribing. This article concludes with observations about the compatibility of
innovativeprescr ibing of unlicensed cannabis medicines with the standardof care in negligence
law, notwithstanding the extreme caution inherent in the interim prescribing guidance.
INTRODUCTION
In 2018, the prescription of unlicensed medicinal cannabis products was le-
galised in the United Kingdom, largely as a result of activism by those caring
for children with rare and intractable epilepsies.1These conditions can cause up
to one hundred seizures per day2and have a signicant mortality rate.3Cannabis
∗Senior Lecturer, SchoolofLaw andSocialJustice, University ofLiverpool. Iwouldliketothank
the two anonymous reviewers and colleagues at Liverpool for their extremely helpful comments
which have undoubtedly strengthened this paper.This article is connected with another project with
University of Liverpool ethics approval to interview and survey medical practitioners on their expe-
rience and understandings of the legal requirements around medicinal cannabis prescribing (approval
no 7495). Unless otherwise stated,all URLs were last accessed on 16 April 2021.
1A. Schlag etal, ‘Medicalcannabis intheUK: From pr inciple topractice’ (2020) Journal of Psy-
chopharmacology (online r st), 1.
2 Billy Caldwell, who went from up to 100 seizures in a day to more than 300 days of being
seizure free when using cannabis oil – ‘Boy who suered morethan one hundred seizures a day
has none in 300 days after being prescribed cannabis oil’ The Independent 6 September 2017.
3For example Sudden Unexpected Death in Epilepsy (SUDEP). All epilepsies carry an increased
risk of death. Dravets Syndrome, a rare intractable form of epilepsy,carries a 10-15 per cent
chance of SUDEP before the age of 10, see www.dravet.org.uk.
© 2021 The Author.The ModernLaw Review © 2021 The Modern Law Review Limited.(2021) 84(6) MLR 1189–1226
Medicinal Cannabis Prescribing
had substantially improved the quality of life of a number of these children (and
their families), including by dramatically decreasing the number and severity
of seizures,reducing the frequency of hospitalisation and even enabling some
children to start school.4The reformswere eectedby ‘rescheduling’ cannabis-
based medicinal products (CBMPs) under the Misuse of Drugs Regulations
2001,5a move accompanied by a requirement that use of the unlicensed prod-
uct must be in accordance with the prescription or direction of a specialist
medical practitioner.6The explanatory memorandum to the 2018 regulations
states that reforms aimed to ensure that access is provided where medically ap-
propriate,whilst ‘minimising the risk of harm, misuse and diversion’.7
This new domain of prescribing was not conned to cases of intractable
childhood epilepsies,8but could also be used to potentially transform the lives
of many adults with chronic health conditions.9Over 18 months after the re-
forms however, patients (including the same desperate families whose cases had
triggered the government’s review of cannabis as a medicine) had resorted to
crowd funding,10 petitioning Westminster11 andcour t action to push for funded
prescriptions for medicinal cannabis.12 In March 2020,when Teagan Appleby’s
family could no longer aord her private prescription for medicinal cannabis,
she was admitted to hospital in a critical condition13 during‘lockdown’, a
4n 2above,andseeV. Twomey, For Ava (Cork:MercierPress, 2019).
5ie moving them from Schedule 1 (controlled drugs considered to have no medicinal value) to
Schedule 2 (controlled drugs acknowledged to havemedicinal benets): Misuse of Drugs (Amend-
ments) (Cannabis and Licence Fees) (E.W.&S) Regulations 2018 (SI 2018 No 1055) inserting a new
Regulation 16A into the Misuse of Drugs Regulations 2001 (SI 2001/3998). Ashealth isa devolved
matter,separate legislation was required in Northern Ireland: TheMisuseofDrugs(No2)Regu-
lations (Northern Ireland) 2018 (2018/173).
6ibid, reg 4.
7Explanatory Memorandum to the Misuse of Drugs (Amendments) (Cannabis and Licence Fees)
(England, Wales and Scotland) Regulations 2018, para 3.2.
8The regulations make no reference to specic conditions.
9See for example the case of Lara Smith, discussed in parliamentary debates at
https://hansard.parliament.uk/commons/2019-05-20/debates/8231D857-B2DF-47EA-
86F4-E7CF7068A6CE/MedicalCannabisUnderPrescription. Infact, twenty yearsearlier, a
1998 Select Committee had strongly recommended precisely the same reforms, having heard
evidence of the relative safety and ecacy of cannabis as a treatment – in particular,but not
exclusively, for patients suering with pain and spasticity caused by multiple sclerosis (MS):
House ofLordsScience andTechnologySelectCommittee, 9th Report Cannabis (1997-98).
For an insight into a range of adult patient experiences with medicinal cannabis in the patients’
own words, see thepodcastsand blogson pleacommunity.org.uk) andM. Biles, Cannabis Voices
at https://www.marybiles.com/podcast.
10 https://www.crowdfunder.co.uk/united-patients-alliance.
11‘Families protest over NHS medical cannabis rules’BBC News 5 February 202 at https://www.
bbc.co.uk/news/uk-england-51385994.
12Charlotte Caldwell took the Health Board in Northern Ireland to court to provide a prescrip-
tion for her son Billy whose epilepsy is substantially mitigated by medicinal cannabis: https://
www.belfastlive.co.uk/news/health/billy-caldwell-medicinal-cannabis-battle-17749677.Atthe
time of writing, the family of Charlie Hughes are bringing action against NICE and their local
NHS Trust for refusing to prescribe for their 2-year-old son who suers from West Syndrome
– ‘Parents’NHS cannabis ght for toddler who suers 100 epilepsy seizures a day’ The Mir-
ror 20 March 2020 at https://www.mirror.co.uk/news/uk-news/parents-nhs-cannabis-ght-
toddler-21851951.
13 https://www.kentonline.co.uk/canterbury/news/cannabis-plea-for-girl-in-intensive-care-
227836/.
1190 © 2021 The Author.The ModernLaw Review © 2021 The Modern Law Review Limited.
(2021) 84(6) MLR 1189–1226
Paula Case
situation which undoubtedly risked prejudicing her health even further.Is-
sues of access for adults are also ongoing and similarly revolve around nd-
ing apractitioner willingtoprescribe, and aordability.14 Although the cost of
private prescriptions for most adults (as opposed to the quantities needed for
intractable epilepsies) are usually lower,15 they are still higher than many can
aord and patients often resort to the black market or ‘medical exile’to access
this medicine.16
When the 2018 reforms were followed by an absence of NHS prescriptions,17
the Secretary of State for Health and Social Care appeared to blame doctors
for their unwillingness to prescribe.18 In parliamentary debates on the issue of
access,19 the medical profession’s ‘interim guidance’ to doctors was identied
as a key barrier to prescribing.20 A House of Commons Select Committee
explained the reluctance to prescribe in terms of ‘evidence’ and spectres of
medico-legal risk:
[D]octors must be satised that there is a sucient evidence base for prescribing the
unlicensed product.If there is an insucient evidence base, doctors are reluctant
to prescribe knowing that they are taking personal responsibility for doing so and that
there could be serious professional and legal consequences if there are adverse outcomes
for their patient.21
As explored later in this article,the National Institute for Health and Care
Excellence (NICE) guideline published late in 2019 did little to improve mat-
ters for those seeking increased access. While the reforms had been concerned
with unlicensed products,the NICE guideline on ‘Cannabis Based Medicinal
14 ‘No new NHS patients prescribed cannabis oil since legalisation’ The Guardian 1 July 2020;
‘Medicinal cannabis: why are doctors still not prescr ibing?’The Guardian 3 November 2019.
15MCCS FAQs,section 7 at https://www.ukmccs.org/medical-cannabis/faqs/.As of June 2020
the estimated average costs for most conditions was around £500 per month,but families of
children with epilepsy were facing costs of £1,000+per month.
16D.Nutt et al, ‘So Near and Yet So Far’ (2020) 10 BMJ Open 1, 1.
17 There were around 30 NHS prescriptions for unlicensed medicinal cannabis products in the
rst year: CrossParty ParliamentaryGroup forDrugPolicy Reform, TheUKReviewofMedical
Cannabis: the needs of a nation – Part A (2020) 5-6. Presumably, anumberofthese wererepeat
prescriptions.
18‘It is a source of deep frustration to me that … because a clinical decision is needed for a pre-
scription … many parents who entirely understandably think that their child would benet
from medicinal cannabis now nd that they cannot get a clinician to sign it o’HC Deb vol
658 col 37 8 April 2019 (emphasis added).
19Experiences of the legalisation of medicinal cannabis, followed by a longer-term struggle for
patient access, isastorysharedelsewhere. See forexampleD. Nutt, ‘Why medicalcannabisis
still outofpatients’ reach’ (2019) 365BMJ1903 andN. Ries, ‘PrescribewithCaution: The
Response of Canada’s Medical Regulatory Authorities to the Therapeutic Use of Cannabis’
(2015-2016) 9 McGill JL & Health 215. Recent research suggests that fewer than 10 per cent
of Canadian medical cannabis users obtain the drug solely from legal sources’, ibid,241.
20NHS England,Barr iers to accessing cannabis-based products for medicinal use on NHS prescription (2019)
34.
21Health andSocialCareCommittee, DrugPolicy: MedicinalCannabis(2019) para 21 (emphasis
added).
© 2021 The Author.The ModernLaw Review © 2021 The Modern Law Review Limited.
(2021) 84(6) MLR 1189–12261191
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