Discrimination by Design V3
A last resort medicine and an additional crime
Interim research report
26 October 2026
For the Home Office and Department of Health and Social Care
Copied to the Advisory Council on the Misuse of Drugs
Justice by Design
Pete Lindsay
Foreword
At 52 I was diagnosed with Functional Neurological Disorder (FND), a condition I had never heard of. It affects how my brain and body send and receive signals. My symptoms include severe vocal and physical tics, and loss of speech and movement. When I cannot move or communicate, I can still hear, feel and see what is happening around me. My life is divided between small windows of functionality and periods when I cannot walk, talk, feed or clean myself.
Even within the NHS, my care has been fragmented, with no coordinated follow-through. Intensive rehabilitation did not lead to continuing, joined-up support. I have had to fight for further care, where it is available at all, while many professionals I encounter have limited knowledge of FND. This is the baseline from which I have to manage my condition.
That baseline is already isolating. Shops, busy environments and group or social interactions can be intolerable. In five years I have been to a pub or out for a meal fewer than five times. Everyday life has become restricted in ways that are hard to convey through a list of symptoms or appointments.
My prescribed cannabis is a last-resort treatment. It relieves my symptoms and restores some independence. Sometimes symptoms escalate until I cannot look after myself. In my experience, smoked use has restored control most reliably at those moments. When I am most vulnerable, trying to regain that control can make me an offender.
The medicine that helps me participate in life brings another layer of isolation. Cannabis stigma affects how patients are seen and treated; the smoking prohibition adds criminal exposure. I also fear what disclosure of smoking could mean for my continuing prescription. My clinician needs to know how I actually use my medicine to care for me safely. The prohibition puts pressure on both sides of that conversation: I fear losing treatment, while my clinician must reconcile continuing care with professional duties and the criminal law. But if we stay silent, these problems stay hidden and cannot be put right. My condition and medical need have not changed. I recognise smoking’s health risks and do not think it should be medically prescribed. The question is why a patient using their own lawfully prescribed medicine should face an additional crime for how they take it.
My civil service background led me to investigate that question. This report is an interim update on an ongoing research programme. My early analysis went to ACMD’s October 2025 call for evidence; this update is intended to inform its forthcoming advice and Government’s response. It starts with the patient’s existing burden and asks Government to justify the additional one it has imposed.
Pete Lindsay
Justice by Design
Printed contents and figure list
Contents
1. A last-resort medicine, an exceptional patient offence 5
2. Government chose to make the patient’s act a crime 7
3. The new patient burden was presented as continuity 9
4. Government has not shown how it assessed the effect on patients 11
5. Who answers for the consequences for patients? 14
6. Conclusions and recommendations 17
Evidence note A The law and the prescribed patient 21
Evidence note B What ministers knew and chose 26
Evidence note C How the new offence was explained 30
Evidence note D How the effects on patients and justice were assessed 33
Evidence note E Policing patient care and the current review 38
Evidence note F The remedy and Government response 45
Selected original decision records 58
Table of figures
Figure 2 The choice to impose a personal prohibition 29
Figure 3 The review timeline and the current opportunity 40
Table of tables
Table 1 The six paragraphs of regulation 16A 22
Table 2 The statutory comparison governing prescribed medicines 23
Table 3 The disclosed smoking advice and its significance 26
Table 4 Home Office requests replies and internal review 33
Executive summary
Government should remove the extra offence for smoking lawfully prescribed cannabis medicine. Professional controls should govern prescribing. Advice, usable treatment and continuing care should address patients’ departures from instructions. Government must also disclose its assessment and correct Parliament’s record. Health and justice bodies must make prescription checks and care work together.
A patient receives cannabis medicine as a last resort. Why do the laws governing prescribed medicines uniquely make smoking it a crime?
Government told Parliament that these prescriptions ‘are only written when other licensed medicines have not been effective’. A patient can lawfully obtain the medicine yet commit a separate crime by smoking it. The maximum sentence is two years in prison, a fine, or both after conviction on indictment. This is the more serious trial procedure. Cannabis medicines sit in the same legal schedule as morphine, fentanyl and methadone. These medicines and drugs laws create no matching personal ban on the act of taking prescribed morphine by a different route. They expressly ban the patient’s smoking of prescribed cannabis.
NHSBSA’s September 2026 disclosure records 1,792,723 private prescription items for unlicensed cannabis medicines, dispensed in the community in England on prescriptions dated 2025. These are items, not patients or smoking episodes.
Government has not shown why this extra crime is needed or how it fairly balances the burden on patients. Officials’ September 2018 advice to ministers recognised rare cases where smoking could bring a medical benefit. One example was a terminally ill cancer patient needing relief from nausea. Ministers could have relied on professional controls. They chose a personal ban, partly to make police enforcement easier.
Having a genuine prescription does not protect a patient who smokes the medicine. A patient may face urgent symptoms or be unable to use the usual route. Those problems explain why protection matters; patients should not have to prove necessity to receive it. Doctors should advise on suitable treatment and provide continuing care.
A patient need not be prosecuted to face this burden. The author’s account and clinic no-smoking waivers expose a care dilemma: disclosing actual use may put prescribed treatment and medical oversight at risk. Clinicians must respond to that disclosure while meeting prescribing duties and managing the criminal prohibition. The 2018 advice expressly invoked professional discipline. Discouraging candour undermines the care and monitoring on which Government relies. Prosecution totals do not measure that problem.
Government materially misled Parliament about the new burden on prescribed patients. It disclosed the ban but presented its criminal effect within lawful treatment as continuity. Keeping a policy against smoking did not keep the patient’s legal position unchanged. The reform allowed lawful supply and possession while expressly making the patient’s smoking a crime. Intent is not the issue. Government’s own documents show the gap between its decision and its account to Parliament.
Government told Parliament the regime was ‘a proportionate one’. The decision papers and FOI replies examined here do not show why this patient offence was needed or fairly balanced. The Home Office accepts that its equality duty applied. It says it holds no information answering the targeted assessment requests. DHSC says it holds relevant information but refuses to disclose it on cost grounds. The justice and monitoring replies leave further gaps.
The 2019 review excluded associated criminal offences. The current review has broader terms. In September 2026, answering a question on cultivation, the minister said a relevant issue could be included even if the terms did not name it. This offence was part of the 2018 changes under review. It should be examined. Health bodies already attend the review’s working group.
About this report
This interim report examines the separate crime a patient commits by smoking lawfully prescribed cannabis medicine. It asks why Government chose that rule, how it explained it and assessed its effects, and who must address them. It calls for removal of the extra patient offence. Professional controls should govern clinical practice.
The report is for the Home Office and the Department of Health and Social Care. It is copied to the Advisory Council on the Misuse of Drugs (ACMD). Patients, parliamentarians, lawyers and policy professionals can use it to assess the current review and Government’s response.
The legal comparison covers Great Britain. Evidence note A explains the products and prescribing routes it covers. Northern Ireland has a separate regime. Most evidence about police and justice practice concerns England and Wales. Scotland’s health, police and prosecution bodies must apply the recommendations through their own systems.
Methodology and evidence
The report follows the offence through law, advice to ministers, Parliament’s record, FOI exchanges, guidance and review. It tests its case against the original sources. These include the disclosed ban, existing safeguards and the judgment against the applicants in Hristozov.
This report examines the 2018 changes that opened wider prescribing of cannabis medicines while making patients’ smoking an additional crime. It asks how Government made and justified those choices, and what they mean for patients nearly eight years later. The legal analysis also checks relevant later amendments. The report checks FOI replies against the questions asked. The relevant exchanges accompany the report.
The report distinguishes documentary findings, institutional statements, its own analysis and its recommendations. ‘Not held’ differs from information withheld on cost grounds or details a database cannot retrieve. Evidence note A explains how regulation 16A(3) and section 18(1) together create the offence.
Pete Lindsay writes as a prescribed patient. His foreword gives his own experience. Figure 1 illustrates the law; it does not depict a recorded prosecution. Sal Aziz’s case is a separate, consented account drawn from records he published. The report distinguishes his testimony, staff observations and its own conclusions.
Research and drafting were assisted by AI tools. Original-source checks covered the legal comparisons, decision papers, institutional replies, prescribing figures and equality authorities used for the findings. Links and internal references were checked separately. The author takes responsibility for the report.
Using the evidence
Citations give source pages or paragraphs. Public links open the publisher’s page. Word’s private-source links open files in the accompanying evidence folder; keep that folder beside the document. The PDF links open the appended records. Its index gives physical PDF pages for print readers. A searchable reading aid accompanies the scans. The supplied originals remain the authority.
Understanding the documents
Acts and regulations. Parliament passes Acts. Regulations are laws made under powers an Act gives, often to ministers.
The 1971 Act and the 2001 Regulations. The Misuse of Drugs Act 1971 makes breaking certain regulations a crime. The 2018 change added the personal smoking ban to the Misuse of Drugs Regulations 2001. Its legal address is regulation 16A(3): paragraph (3) of regulation 16A.
Original and consolidated law. The original 2018 regulations show the change made then. Consolidated law brings later amendments into the text.
Explanatory Note and Explanatory Memorandum. The Note is the short explanation printed with the regulations. It is not part of the law. The Memorandum (EM) is the department’s fuller explanation to Parliament of the change and its reasons.
Assessments of impact, equality and justice. An impact assessment (IA) examines likely effects, costs, benefits and options. An equality impact assessment (EIA) examines effects on groups protected by equality law, including disabled people. The equality duty requires real attention to those groups’ needs and disadvantages. There is no required document title or format. A Justice Impact Test (JIT) examines effects on courts, prosecutions, legal aid, prisons and probation. It helps services prepare and agree costs. Equality evidence: Evidence note D1
Parliament’s powers. Under either procedure, Parliament can accept or reject the regulations as a whole. It cannot change individual rules, as it can when considering a Bill for an Act of Parliament.
Negative procedure. Regulations can become law without a debate or approval. Either House can vote to cancel them within a set period, usually 40 days. The 2018 cannabis regulations used this procedure.
Affirmative procedure. Parliament must debate the regulations and expressly approve them. This requires greater parliamentary scrutiny than the negative procedure.
Duties and advice. A statutory duty is an obligation imposed by law. Government guidance can also require a process. Experts advise ministers. Ministers remain responsible for the law they make.
The bodies involved. The Home Office owns controlled-drugs policy. DHSC is the Department of Health and Social Care. ACMD gives expert advice on drugs. The General Medical Council (GMC) regulates doctors. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines.
Requests and references. A Freedom of Information (FOI) request asks a public body for recorded information. The source pages distinguish JBD’s filing reference from the body’s case reference. A case may cover a reply, internal review and attachments.
Annexes and evidence notes. ‘Disclosure attachment B’ means a document supplied with an authority’s reply. ‘Evidence note B’ means this report’s supporting analysis. An annex inside an original submission is identified as part of that submission.
Sources: Parliament’s legislation and procedure guide; Parliament’s explanation of Explanatory Memoranda; 2018 Justice Impact Test guidance; Parliament’s affirmative-procedure explanation
1. A last-resort medicine, an exceptional patient offence
Key Point: A lawful prescription does not protect the patient from the smoking offence.
1.1 Government treats unlicensed cannabis prescribing as a last resort. A doctor assesses unmet need after other treatment has failed. The 2018 impact assessment, CP171 and the June 2026 answer establish that premise. The smoking offence covers the statutory product category, including patients on this last-resort route. Evidence note A2 explains the legal routes to treatment.
Sources: 2018 impact assessment, Annex 1, p26; Government response CP171, paragraph 28; Written answer UIN 3221, 1 June 2026
1.1a NHSBSA recorded 1,792,723 privately prescribed items for unlicensed cannabis medicines dispensed in the community in England on prescriptions dated 2025. The September 2026 disclosure counts the date written, including items processed later. It counts items, not patients or smoked use. Reporting lags and manual recording mean totals can change. A separate September reply says reliable unique-patient totals cannot be produced: NHS numbers appear on only about 20–30% of private prescriptions. An October reply continues to withhold NHS unlicensed prescribing information because low numbers risk identifying patients.
Sources: NHSBSA FOI-04096, response and Part 1 (2025); monthly calculation and supplied data; FOI-04092, patient-identification limits; FOI-04114, NHS data. Data Warehouse, NHSBSA Copyright 2026.
1.2 The 2018 regulations created a category called ‘cannabis-based products for medicinal use in humans’, or CBPMs. They opened lawful routes to these medicines from 1 November 2018. One is an unlicensed ‘special’: medicine supplied for an individual patient’s clinical need. A doctor on the GMC’s Specialist Register must prescribe it or direct its use. ‘Unlicensed’ does not mean illicit. Clinical trials and authorised medicines have separate routes.
Sources: 2018 regulations, regulations 3–4
1.3 The same regulations banned smoking a product in this category, apart from a stated research exception. Section 18(1) of the 1971 Act makes breaking that rule a crime. This means subsection (1) of section 18. Schedule 4 of the Act sets the maximum penalty on indictment at two years in prison, a fine, or both. The ban applies to anyone smoking a qualifying product. A prescription gives no exception.
The operative rule
“A person shall not self-administer a cannabis-based product for medicinal use in humans by the smoking of the product (other than for research purposes in accordance with regulation 13);”
Sources: Misuse of Drugs Regulations, regulation 16A(3); Misuse of Drugs Act, section 18(1); Act, Schedule 4 penalty table
Figure 1 The split patient
Statutory illustration.
1.4 Medicines and drugs laws uniquely single out this medicine category for an express ban on the patient’s own route of use. General medicines law restricts who may give prescription-only medicines by injection. It expressly excludes people giving medicine to themselves. The cannabis rule expressly targets that personal act. Evidence note A3 compares the provisions and explains the separate prepared-opium offence.
Sources: Human Medicines Regulations, regulation 214(2)
1.5 Unauthorised possession can already be a crime under section 5 of the 1971 Act. The smoking rule also reaches a patient who obtains and possesses the medicine lawfully. Their prescription gives no exception. The extra criminal burden exists whether or not the patient is prosecuted.
Sources: Regulation 16A(3); Misuse of Drugs Act, section 5(1)–(2)
1.6 The proposed protection covers patients smoking their own lawfully prescribed CBPMs without requiring a smoking prescription. In 2005, Quayle rejected a broad medical-necessity defence for cannabis activity outside lawful prescribing. This report concerns patients who already have lawful prescriptions. They need clear legal protection, without having to prove necessity. Smoking and vaporisation can both act quickly. The practical issue is whether the patient can use the available method when needed (F.2a).
Sources: Regulation 16A(3), complete exception; R v Quayle, paragraphs 54–57 and 67
1.7 Health risks call for advice, support and product safeguards. Those risks alone do not justify making a patient’s use of their own lawful medicine a crime.
Justify the exceptional patient offence
The Home Office must justify this exceptional patient punishment. The remedy evidence note supports general patient protection. The recommendation requires removal of the extra patient offence in full.
2. Government chose to make the patient’s act a crime
Key Point: Ministers chose the personal ban after recognising rare cases of patient benefit and considering professional controls.
Which ministerial document is this?
The key advice on smoking is dated 13 September 2018. The Home Office disclosed its smoking extract on 13 March 2026. JBD asked for the full context. The 16 April reply supplied the fuller submission, supporting papers and decision email, with redactions. The 11 September submission is a separate, earlier paper. The report distinguishes the dates of the original advice from later disclosure dates.
Sources: Initial disclosure, 13 March 2026, attachment C; Follow-up request and fuller-disclosure reply, 16 April 2026
2.1 The 13 September advice said DHSC thought specialist prescriptions for smoking would be extremely unlikely. It still recognised rare cases where smoking could be a legitimate treatment. Its example was a terminally ill cancer patient needing relief from nausea. It then urged further controls because of a possible diversion risk. The enacted ban gives no prescription exception, even for that patient.
The patient recognised internally
The submission describes limited situations “where the harm of smoking is outweighed by the benefit to the patient”.
Sources: Home Office smoking-options submission, 13 September 2018, paragraphs 12/15
2.2 ACMD’s recommendation 6 addressed prescriptions and product instructions. It said products should not be administered by smoking. It did not propose a personal criminal offence. Asked under FOI to find such a recommendation, the Home Office searched and ‘did not find a result’. Government chose to criminalise the person taking the medicine.
Sources: ACMD advice, recommendation 6; Home Office reply and request, 13 March 2026, pp1–2
2.3 Ministers could have relied on professional guidance and regulation. Those controls address prescribing and irresponsible supply. A patient who departs from instructions needs clear advice, practical support and continuing care. Government must explain why it chose an extra criminal penalty for that patient instead.
The alternative ministers were offered
“As an alternative, it is open to you to rely on the professional guidance and regulation to mitigate risks of irresponsible prescribing.”
Sources: Smoking-options submission, paragraphs 13 and 17
2.4 Drug-driving law already allows prescription checks through a conditional medical defence. So police and prosecutors already check prescriptions. Government must explain why it needed a smoking offence to give officers the 'clear line' its officials wanted (§14). Sal Aziz’s successful appeal shows why protection must work at the first encounter. Recognising a prescription after lengthy proceedings cannot undo the disruption those proceedings caused (E.22a–E.22c).
Sources: 13 September advice, paragraph 14, p6; Road Traffic Act, section 5A(3)–(5); National police guidance, p5; CPS reply 14391, p2; Impact assessment, paragraph 76
The enforcement advantage
The smoking line would make clear to an officer encountering smoking that “an offence has likely been committed”.
Sources: Smoking-options submission, paragraph 14; Impact assessment, paragraph 76
2.5 A genuine prescription cannot make prohibited smoking lawful. Officers must still establish the facts and choose a lawful response. The patient depends on that response despite lawful supply and possession. Professional rules cannot remove this criminal burden. A change in the law can.
Sources: Regulation 16A(3)
Removing the extra patient offence leaves controls on unlawful possession and supply, prescribing, products, drug driving and smoking in shared smoke-free places. The detailed remedy also addresses possession and premises rules that could otherwise defeat patient protection.
2.6 ACMD’s 2020 assessment found little evidence of genuine prescribed medicines reaching illicit markets. It also reported illicit cannabis falsely labelled as medicinal. Those were different problems. Neither smoking nor using a vaporiser tells police whether the product is genuine or the person has a lawful prescription.
Sources: ACMD assessment covering letter, conclusion 12
2.7 The earlier Home Office submission put the patient issue under ‘Media handling advice and correspondence lines’. Paragraph 25 of that 11 September 2018 paper envisaged a decision that the rules ‘should not extend to allowing patients to smoke doctor-prescribed cannabis’. This was Home Office advice, separate from ACMD’s advice. Officials had identified prescribed patients and foreseen possible objections once the stance became public, before the final decision.
Sources: Earlier Home Office submission, 11 September 2018, paragraph 25
2.8 The 17 September 2018 decision email records the Home Secretary’s agreement to the smoking restriction. He rejected a fixed expiry date. The rule took effect on 1 November.
Sources: Decision email chain, decision recorded 17 September 2018
Explain the choice to punish patients
Government must explain why it imposed a personal criminal prohibition despite having prescribed patients and possible objections in view (2.7). It must provide current risk evidence and explain why product and prescription checks cannot address it (2.6). Easier enforcement must be weighed against recognised medical benefit and professional controls. The recommendations require disclosure of the evidence and removal of the extra patient offence.
3. The new patient burden was presented as continuity
Key Point: Government materially misled Parliament. The ban was disclosed. Its direct criminal effect on lawful prescribed use was presented as continuity.
3.1 Before 2018, drugs law in Great Britain imposed no general personal offence of smoking cannabis. Unlawful possession was a separate offence. So was an occupier or manager knowingly permitting cannabis smoking on premises. The reform opened general prescribing without individual Home Office licences. It also added an express personal smoking prohibition for CBPMs, enforced through section 18(1), even where possession was lawful. Internal advice said a new personal rule was needed because premises controls did not prevent public smoking. The Memorandum described a ban being kept in place. It disclosed the ban but did not explain the new crime within lawful treatment. Intent is not the issue. Government’s own documents show what it decided and what it told Parliament.
Sources: 13 September advice, paragraphs 11–13/17, pp5–6; 2018 regulations, regulations 3–4; Memorandum 6.2, p2; Memorandum 7.8, p4; Memorandum 7.17, p6; Misuse of Drugs Act, section 5 and section 8
The explanation Parliament received
Officials proposed ‘introducing a requirement’ against smoking. The Memorandum called the resulting rule one that ‘maintains the prohibition’ and ‘continues to prohibit smoking’.
Sources: 13 September advice, §13(a), p5; Memorandum §§6.2/7.8/7.17; 2018 regulations and Note
3.2 The published assurance identifies who must answer. Nick Hurd signed the regulations. His ministerial role was the first addressee of the 13 September advice. The Memorandum names him and the two senior officials identified on the submissions as people who ‘can confirm’ its required standard. The preparation and approval records should explain why the new patient burden was presented as continuity.
Sources: Memorandum 15.2–15.3, p7; Regulations, signature p4; 13 September submission, title page; GOV.UK, ministerial role; Commons written statement HCWS994, smoking passage
3.3 The Memorandum linked ACMD’s prescribing advice to keeping the ban. The Home Office later searched for an ACMD recommendation of criminal prohibition and found none. The Lords scrutiny report said the restriction followed medical advice. It did not identify the new personal offence. Government’s internal advice and enacted law show the new burden that its explanation presented as continuity.
Sources: Memorandum 7.17, p6; Home Office search result and request, pp1–2; Lords scrutiny report, paragraph 7
3.4 The Home Office circular also described a continuing smoking ban. It said penalties for unauthorised supply, possession and cultivation were unchanged. It did not identify the prescribed patient’s section 18 offence. On 31 October 2018, the Chief Medical Officer and NHS England sent guidance to NHS and private clinicians in England. It explained the new cannabis prescribing rules. The letter stated the smoking ban and health risks but did not identify the patient’s separate criminal offence. DHSC now expressly expects patients to be told about the criminal consequence.
Sources: Home Office Circular 018/2018; Clinician letter, 31 October 2018; DHSC reply, 17 April 2026
3.5 The regulations’ own Explanatory Note lists the smoking ban among ‘Additional controls’. Yet the Memorandum says the instrument ‘maintains the prohibition’. It presents that new patient offence as a restriction already in place.
Sources: Explanatory Note, p5; Memorandum 6.2, p2
3.6 The impact assessment named criminal justice agencies among those affected. It repeated the same continuity claim: smoking would ‘remain prohibited’. It suggested this could help police distinguish illicit cannabis from medicinal products and limit additional costs. But that passage did not assess the new patient offence or weigh its burden against the possible medical benefit officials had recognised. The new criminal burden also required MoJ engagement through its Justice Impact Test process (4.7–4.8).
Sources: Impact assessment, A.2 p4 and paragraphs 75–77 p15
3.7 Ministers made the regulations on 9 October and laid them on 11 October 2018. They took effect on 1 November. Section 31(2) required the negative procedure. Parliament could annul them; no advance approval vote was needed. Failure to annul does not show informed endorsement of the patient offence.
Sources: Explanatory Memorandum, paragraphs 3.3/5.1; Parliament’s negative-procedure explanation; Misuse of Drugs Act 1971, section 31(2)
3.8 The Home Office has already accepted an omission in this very Memorandum. It apologised to Parliament’s Joint Committee on Statutory Instruments for failing to name one of the legal powers it relied on. That concerned a different omission. It shows an established route to acknowledge and correct the account.
Source: JCSI 38th Report 2017–19, Appendix 2, Home Office memorandum 6 November 2018, paragraph 7
Correct Parliament’s account
The Home Office must explain and correct the contradiction between the Note’s additional control and the Memorandum’s continuity account (3.1 and 3.5). It must disclose how that account was prepared and approved, address the published ministerial and official assurances (3.2), and produce the further parliamentary advice officials promised. The earlier apology establishes a route for correction (3.8). The recommendation to correct Parliament’s record specifies the action required.
4. Government has not shown how it assessed the effect on patients
Key Point: Government has not produced the patient assessment or shown how it examined the effects on the justice system.
4.1 The Home Office accepts that its equality duty applied when it made the regulations. This was concrete: officials’ example was a cancer patient, disabled by statute. However wide the Home Office’s searches, finding nothing does not show how it met the duty.
Sources: Home Office reply, 20 March 2026, p1; Equality Act 2010, section 149; Equality Act 2010 Schedule 1 paragraph 6(1), at 11 October 2018; 13 September 2018 advice, paragraph 12, initial disclosure p4
4.2 Equality law required “due regard”: conscious, informed attention to discrimination, equal opportunity and good relations. Section 149(3)–(4) covers disabled people’s disadvantages and different needs. Meeting those needs can require more favourable treatment. Cancer was already a disability under Schedule 1 paragraph 6(1). Bracking requires that attention before and when the decision is made. The duty continues when ministers consider patient protection and respond to ACMD; it did not end in 2018.
Sources: Bracking [2013] EWCA Civ 1345, [26]
Sources: Equality Act 2010, section 149(1)–(6); Equality Act 2010 Schedule 1 paragraph 6(1), at 11 October 2018
4.3 JBD asked for the evidence behind the identified patient group and DHSC’s assessment. It also asked about expected behaviour, legal consequences and equality. The Home Office’s June and July replies said it held none of the requested information. Internal review upheld that answer after searches involving relevant teams, staff and former policy leads. Searches covered the rule, medicinal cannabis, patients, impact assessment and equality. The department has not produced the patient assessment.
Sources: Home Office reply, 9 June 2026, with the request; Home Office reply, 10 July 2026, with the request; Home Office internal review, 20 July 2026
4.4 DHSC gave a different answer. It said it held relevant information for both the 8 May request and the narrower 19 June request. It refused both on cost grounds. In July it repeated smoking harms and enforcement difficulty. It then accepted that this did not directly explain the basis of the assessment attributed to it. Those general reasons do not answer the request for the patient assessment.
DHSC’s own distinction
“DHSC holds information relevant to your request.” Its later explanation begins: “Whilst we recognise that this does not directly address your request”.
Sources: DHSC reply, 8 June 2026, pp1/3–5; DHSC reply, 20 July 2026, pp1–4
4.5 ACMD answered ‘No information held’ on criminal-law effects, emergency use, equality, vulnerable groups and consideration of the Memorandum or impact assessment. Government relies on ACMD’s advice about how patients should take the medicine. The patient offence Government chose still needs its own evidence and justification.
Sources: ACMD reply, questions 3–7; filed 20 April 2026
4.6 The impact assessment’s business checks do not answer the patient question. Its 46 pages contain no identified equality, human-rights or Justice Impact Test assessment. Evidence note D6 explains why business checks and the Law Commission’s categories do not provide that scrutiny.
Sources: Law Commission consultation paper 195, Part 1; Impact assessment, assessment cover sheet
4.7 The Home Office introduced a new personal prohibition enforced through section 18. Its own impact assessment named justice agencies and anticipated enforcement effects. MoJ’s July 2018 guidance required a Justice Impact Test for proposals that could affect any aspect of the justice system. Even expected minimal effects needed evidence and MoJ agreement. New or extended offences also needed discussion and justification with MoJ’s criminal-law policy team before JIT submission. Calling the ban an ‘additional control’, or enforcing it through an existing offence, did not remove those process requirements.
Sources: 2018 Justice Impact Test guidance, printed pp4–6; Impact assessment, A.2 p4 and paragraphs 75–77 p15
4.8 No justice-impact assessment or criminal-law engagement record has been identified in the material supplied to this research. MoJ’s 28 April 2026 reply came from the HMPPS Briefing and Correspondence Team. It said no information in scope was held because MoJ was not the appropriate authority and referred JBD to the Home Office. It did not identify searches by the Justice Impact Test or criminal-law policy teams. Their records and the Home Office’s are needed to establish what work took place.
Sources: JBD request to the Ministry of Justice, 12 January 2026; Ministry of Justice reply, 28 April 2026
4.9 Government has not shown the patient assessment or justice checks behind its choice. The remedy evidence note also gives the patient and policy reasons for removing the offence.
Different questions for policy law and clinical care
4.10 Five standards test Government’s choice. Was the public decision reasonable? Was the restriction needed and fairly balanced? Did services make reasonable adjustments for disabled people? Was clinical judgment sound? What could a careful person do in the patient’s actual circumstances? Each concerns a different responsibility. Evidence note D7 explains the legal standards and the practical fairness comparison.
Comparison | Question it asks | What this evidence shows |
|---|---|---|
Wednesbury reasonableness | Could a reasonable public authority reach this decision after considering the relevant matters? | The patient benefit and professional alternative require an evidence-based answer. |
Proportionality | Is the aim important? Does the measure help? Could a less restrictive option work? Is the overall balance fair? | Article 8 covers choices about medical treatment. Government must justify extra punishment within lawful prescribing. Hristozov allowed a wide margin and upheld a restriction on access to unauthorised products. D.19–D.20 explain why that does not answer this patient offence. |
Reasonable adjustments | What reasonable, lawful steps should services take to avoid seriously disadvantaging disabled people? | Covered services must consider care, information and handling. This services duty excludes making ministerial regulations. The separate public sector equality duty still applies. |
Bolam and Bolitho | Does a responsible body of medical opinion support the clinical judgment, and does that opinion withstand logical examination? | Clinical advice needs sound professional reasons. Advice against smoking does not establish why the patient should face a crime. |
Fairness in the patient’s actual circumstances | What could a careful person reasonably do with this patient’s condition, knowledge, urgent needs and workable alternatives? | Urgent symptoms and unusable alternatives strengthen the case for clear protection. Relying on an uncertain necessity defence leaves the patient exposed. |
Legal sources and detailed application: Evidence note D7
Produce the patient and justice assessments
The recommendations require the Home Office and DHSC to produce the patient assessment and explain how they met the equality duty and standards in 4.10. They also require the Home Office and MoJ’s JIT and criminal-law functions to produce their records of engagement, assessment, justification, approval, handling and cost agreement.
5. Who answers for the consequences for patients?
Key Point: Patients must be able to tell clinicians how they use their medicine without fearing loss of care. Prosecution totals do not measure that problem. Prescription checks, police handling and care must work from the first encounter.
5.1 The replies do not show a joined-up way to identify and review effects on prescribed patients. Responsibility is split between treatment advice, professional standards and criminal enforcement. The gap includes the CPS case management system and the administrative systems of MoJ and His Majesty’s Courts and Tribunals Service (HMCTS).
Sources: Home Office reply, 20 March 2026; DHSC reply, 17 April 2026
5.2 No reply identifies who ensures patients receive the full criminal warning. The Home Office holds no allocation record and points to DHSC. DHSC points to prescribers and pharmacies for communication, regulators for standards, and the Home Office and police for sanctions. GMC says this warning has not been a specific consideration. It holds no record assigning responsibility. Packaging, pharmacy labels and counselling must give consistent route instructions. Patients also need a plan if they cannot use that route. The patient-information recommendation and the health-and-justice evidence note address this duty in practice.
Sources: Home Office allocation answer; DHSC communication and responsibility answer; General Medical Council response email, 16 July 2026
5.2a The September 2018 advice put clinicians inside the enforcement framework. Prescribing contrary to guidance could be considered in disciplinary proceedings; serious or persistent failures could lead to restrictions, suspension or removal from the register. It separately linked recreational “rogue” prescribing to possible unlawful supply. Knowing that a patient smokes is not the same as prescribing for smoking or recreational use. Yet disclosure leaves the clinician to reconcile continuing care, prescribing duties and the patient’s criminal exposure. Government must explain how that clinical relationship is protected.
Sources: 13 September 2018 submission, paragraphs 12–17, pp5–6; GMC FOI response IR1-5469823870, 16 July 2026, answers 1/3/4; GMC prescribing guidance, paragraphs 35/48/51; regulation 16A(1)–(3)
5.3 CPS makes prosecution decisions in England and Wales. Its case management system does not centrally record whether a lawful CBPM prescription was asserted and has no keyword search facility. Identifying such cases would require manual file checks, which CPS said would exceed the FOI cost limit. MoJ and HMCTS say their administrative systems cannot retrieve prescription evidence presented in court. That would require access to the court case records themselves. Their central data therefore do not establish how many prescribed patients face the smoking offence.
Sources: CPS reply 14391, request and system limits; Ministry of Justice/HMCTS reply, 16 July 2026
5.4 General safeguards exist. CPS cites its Code and guidance. The College cites general learning and specialist advice. NPCC identifies national CBPM guidance. The replies do not show how prescription checks, smoking enforcement and continuing care work together. Listing safeguards does not demonstrate that connection.
Sources: CPS reply, 17 April 2026; College of Policing reply, 9 July 2026; National Police Chiefs’ Council reply, 31 March 2026
5.5 The problem starts before any charge. A prescription check can establish lawful possession. It cannot remove the smoking offence. That includes patients smoking from temporary necessity when smoking was not prescribed. A later decision not to prosecute cannot undo treatment already interrupted.
Sources: Regulation 16A(3); Arrest necessity safeguards, PACE Code G, paragraphs 1–2
5.6 Sal Aziz’s case shows why a medical defence must work promptly. Police stopped him on 31 March 2024. He was convicted and disqualified from driving for three years in October 2025. His appeal succeeded on 10 February 2026, 681 days after the stop. The prosecution’s hearing record says the court rejected prescription expiration as definitive and preferred his evidence. His prescribed use was not smoked. The successful defence did not prevent lengthy proceedings or the work needed to overturn the conviction.
His August 2023 hospital record concerns a separate event. It records his report that police took his prescribed cannabis while he used a vaporiser, leaving him without access. Staff observed distress; he attended hospital. These records show the consequences for one prescribed patient when recognition and access fail. The London Drugs Commission gives wider evidence on clinics and prescription recognition. E.22a–E.22c distinguish what each Aziz record establishes.
Sources: London Drugs Commission report, pp277–282; Aziz account; Hospital record, pp1–3; CPS appeal record, pp18–19.
5.7 Government promised monitoring in 2018 and again in 2019. The impact assessment also promised a review two years after the rules took effect. Yet the 2019 commission excluded ‘Any associated criminal offences for cannabis as summarised in Schedule 4’. That Schedule includes the offence enforcing the smoking ban. The commission invited advice on the rule while excluding its criminal consequence.
Sources: Commons written statement HCWS994, smoking passage; Government response CP171, paragraph 32; 2019 commission, pp1/3; Misuse of Drugs Act, Schedule 4; Impact assessment paragraph 115, p23
5.8 On 9 September 2026, Home Office minister for policing and crime Sarah Jones answered James Naish MP’s written parliamentary question about whether ACMD’s commission excluded cannabis cultivation. She said an unnamed issue would not be excluded if relevant to the review. The patient smoking ban was one of the very changes being reviewed. It meets that relevance test directly. Government cannot exclude a chosen consequence by reviewing only unforeseen ones.
Sources: Minister’s written answer, 9 September 2026; Current ACMD commission, 2 June 2025
5.9 JBD put the patient offence before ACMD on 16 October 2025. It sent the V1 briefing with Annexes D and E. ACMD’s September 2026 update says the working group is finishing its report, expected by year end.
Sources: JBD submission email as sent, 16 October 2025; ACMD work update, 21 September 2026, section 1
What review and outcome data must establish
5.10 DHSC, NHS England and MHRA already observe ACMD’s working group. They should help deliver a response covering health and justice. ACMD gives independent advice. Government remains responsible for the law, its explanation and its response. Protecting patients is the immediate priority. That protection must start now and continue until legal reform works in practice, while work to change the law proceeds and ACMD completes its advice.
Sources: Written answer on health observers, 1 June 2026; DHSC observer-role reply, 13 November 2025
5.11 Registry evidence must distinguish prescribed routes from actual use. Government’s 2022 response described NHS-only coverage and work on private data. The cited 2026 study takes route from prescriptions. The author describes fear of losing treatment. Clinic no-smoking waivers make the care dilemma concrete: how can patients disclose smoked use without fearing loss of prescribed treatment and medical oversight? Staying silent can obstruct care and monitoring. The number affected is not established by prescription or prosecution totals. Government must secure a route to candid disclosure and continuing care. Monitoring must count treatment interruptions and patients who leave treatment, with clear populations and totals. Patient research must be voluntary and confidential, minimise personal data and prevent identifiable disclosures feeding enforcement. Prosecution counts answer a different question.
Sources: Government response, 21 January 2022, recommendations 1–2; Clustering study, Methods: Data Collection; London Drugs Commission, pp277–278
Make protection and monitoring work
Government must name a lead and show how patients receive the full criminal warning, consistent route instructions and a workable care plan. It must demonstrate prompt prescription checks, lawful police handling and continuing treatment from the first encounter. It must identify affected patients and outcomes, state current registry coverage including private patients, and account for the promised two-year review and its treatment of criminal consequences. The recommendations call for immediate protection, clear patient information and monitoring of patient effects. Research must be voluntary and confidential, with protection against identifiable disclosures feeding enforcement.
6. Conclusions and recommendations
What the findings establish together
6.1 Government chose a personal smoking ban after recognising rare cases of benefit and considering professional controls. Those controls govern prescribing. Patients need advice and usable treatment. Care should address patients’ departures from instructions, alongside supply and product safeguards. In this report’s judgment, easier street enforcement does not outweigh the extra punishment of patients using their own lawful medicine. F1 develops that case.
6.2 Government materially misled Parliament about the new burden on prescribed patients. It disclosed the ban but presented the new crime within lawful treatment as continuity. Keeping the policy did not keep the patient’s legal position unchanged. Claims about what a minister intended cannot answer that documentary finding.
6.3 Government has not shown the patient justification, equality assessment or justice preparation behind this offence. Responsibility and monitoring also remain unresolved. The Home Office’s no-information answers and DHSC’s cost refusals leave different gaps. The replies do not demonstrate how health and justice arrangements work together for patients.
6.4 Removing the extra patient offence is the remedy. Government must also disclose its assessment, correct Parliament’s record, prepare justice services and secure reliable care.
Actions required
R1 Protect patients immediately while reform proceeds. Government should secure coordinated instructions from the relevant police and prosecution authorities. Apply NPCC/APCDLO’s patient-first approach from the first encounter.
Recognise and protect prescribed CBPM patients in the same way as patients prescribed other Schedule 2 medicines. Lawful possession and use should not themselves trigger arrest, seizure, detention, prosecution or other adverse action. Use lawful discretion to avoid criminalising patients. Check prescriptions and applicable defences promptly. Record any separate grounds for action and protect continuing treatment.
Name a lead, an escalation route and review arrangements across jurisdictions. These measures must start before ACMD reports. Keep them until comprehensive reform is in force and protection demonstrably works. R7 must remove the smoking-specific criminal burden.
Basis: Chapter 5 and conclusion 6.3
R2 Correct and complete Parliament’s record. The Home Office should explain the new crime within lawful treatment. It must name and resolve the contradiction between the Note’s additional control and the Memorandum’s claim of continuity (C.11). Disclose how the text was prepared and approved. Explain the published assurance naming the minister and senior officials. Produce the promised further parliamentary advice. The department has already apologised for another omission in this Memorandum (C.15). It must correct this account too.
Basis: Chapter 3 and conclusion 6.2
R3 Give patients clear instructions they can use now. DHSC and MHRA should work with manufacturers, prescribers, pharmacies and professional bodies. Align packaging, labels, written advice and counselling. State the intended route. Explain when inhalation means vaporisation and distinguish it from smoking. Explain clinical instructions and the legal ban separately. Give patients an accessible care plan and contact if they cannot use that route or their device fails. Test understanding with patients. Name who checks delivery and audit the instructions supplied. Warnings support care. They do not justify the offence or replace reform.
Basis: Chapter 5 and conclusion 6.3
R4 Produce the assessment and explain the choice. The Home Office and DHSC should disclose what they considered when deciding the rule. Include patient circumstances, health and diversion risks, alternatives and equality duties, wherever recorded. Distinguish controls on prescribers from the choice to punish patients.
Basis: Chapter 4 and conclusion 6.3
R5 Produce the justice record. The Home Office and MoJ’s Justice Impact Test and criminal-law policy functions should produce their engagement, assessment, justification and approval records. Show how they applied the July 2018 requirements to the new prohibited act and its potential justice effects. Include handling plans, expected costs and cost agreements. HMPPS’s reply did not identify searches by those functions. Government must obtain their records and the Home Office’s.
Basis: Chapter 4 and conclusion 6.3
R6 Monitor the effects on patients. Departments and delivery bodies should state registry coverage, patient populations, interruptions and stopped treatment. Address barriers to candid clinical disclosure and protect continuing medical oversight. Research on actual use should be voluntary and confidential. Minimise personal data and protect against identifiable disclosures feeding enforcement. Justice data should separately show what can be counted, including prescription assertions. General drugs totals are not smoking cases. Record time to resolution and disruption before correction, as well as final outcomes.
Basis: Chapter 5 and conclusion 6.3
R7 Remove the extra patient offence and show the reform works. Ministers must begin the legal amendment now. It must protect patients smoking their own lawfully prescribed CBPMs, including departures from the prescribed route. Protection must not require a smoking prescription or proof of necessity. Professional controls should govern prescribing. Patients need usable treatment, advice and care. ACMD’s independent advice should inform ministers. Responsibility for the law stays with them; advice need not delay action. Government should publish its decision and evidence, and reasons for any refusal. Name who will act and when. Show that the changed law, instructions and care work together. Keep R1 protection until that delivery is demonstrated.
Supporting evidence notes
These notes provide the legal comparison, decision history and replies behind the findings. The catalogue and evidence folder lead to the supplied sources. Selected decision pages are also reproduced at the end.
Follow an evidence link, then use its return link to resume the chapter. Evidence note B2 is one example. Labels such as B.4 identify individual paragraphs. Source pages count from the first PDF page unless a printed page is specified. Quotes retain the source wording. Analysis around them explains the finding. Original redactions remain.
Evidence note A: the law and the prescribed patient · Evidence note B: what ministers knew and chose · Evidence note C: how the offence was explained · Evidence note D: patient assessment and scrutiny · Evidence note E: policing, accountability and review · Evidence note F: the remedy and Government response.
Evidence note A The law and the prescribed patient
A1 Why Government describes prescribing as a last resort
Sources and pinpoints: CP171, Government response to the Health and Social Care Committee, September 2019, §28, PDF p10/printed p11, read with §§26–31; CMO/NHS England letter, 31 October 2018, p2 and prescribing context pp1–3; ACMD advice, 11 September 2018, pp3–5.
A.1 CP171 gives Government’s own account to Parliament of prescribing as a last resort. Its Dutch comparison starts at paragraph 26. Paragraph 28 begins ‘As in the UK’ and says prescriptions ‘are only written when other licensed medicines have not been effective’. The preceding bullet also specifies a named-patient basis.
A.2 The clinician letter expects an unmet need that licensed medicine cannot meet, after established treatments have been exhausted. It describes specialist prescribing of unlicensed specials and safeguards that can be audited. Its expectations cover NHS and private practice in England. Its account of authorised products dates from 2018.
A.3 ACMD says unlicensed products should be a last resort when no MHRA-authorised drug meets the clinical need (p4). It describes three access routes (pp3–4). Government and its advisers placed unlicensed prescribing in that last-resort setting. Evidence note A2 gives the legal conditions.
A.4 Finding: Government treats the relevant unlicensed prescribing route as a last resort. This report tests the extra criminal burden on those patients. Evidence note A2 identifies the product category and legal access routes.
A.4a Parliament raised the patient issue before 2018. A Lords committee in 1998 proposed prescription as the line between medical and recreational use. In 2001 it criticised reliance on prosecution discretion for genuine therapeutic users without a viable alternative. Those warnings sharpen the question about today’s lawful prescribing system.
Sources: Lords 1998 report, paragraphs 8.7/8.11–8.15; Lords 2001 report, paragraphs 15–18
A2 Which medicines the rule covers and how it creates an offence
A.5 SI 2018/1055 created the product category and personal ban together. It was made on 9 October, laid on 11 October and took effect on 1 November 2018. Regulation 3 introduced the CBPM definition (p2). Regulation 4 inserted regulation 16A and the ban (pp2–3). The instrument covers England, Wales and Scotland (1(3)). Related scheduling changes appear at pp3–4 and the Note at p5.
A.6 A product must meet three conditions to be a CBPM. It must be or contain cannabis, cannabis resin, cannabinol or a cannabinol derivative, with the stated dronabinol/stereoisomer exclusion. It must be produced for medicinal use in humans. It must also be a medicinal product, or a substance or preparation for use as an ingredient of one or in producing an ingredient. Products covered by paragraph 5 of Part 1 of Schedule 4 are excluded. Street cannabis does not qualify just because someone uses it as treatment. The definition does not require a prescription. The smoking ban therefore extends beyond prescribed users.
A.7 All six paragraphs of the inserted regulation do distinct work:
Table 1 The six paragraphs of regulation 16A
Provision | Operative content, accurately paraphrased except the full quotation below |
|---|---|
16A(1) | Subject to (4), prohibits ordering a CBPM for administration unless it is a special medicinal product that is not also investigational and is for use under a specialist medical practitioner's prescription/direction; an unauthorised investigational product for a clinical trial; or a medicinal product with a marketing authorisation. |
16A(2) | Subject to (4), prohibits supplying by way of or for administration unless the supply follows a compliant (1) order and satisfies the corresponding specialist-direction, trial or authorisation route. |
16A(3) | The personal smoking prohibition, quoted in full below. |
16A(4) | Excludes ordering/supply for administration to animals for research from this regulation. The patient’s own smoking remains governed by paragraph (3). |
16A(5) | Takes the meanings of investigational medicinal product, marketing authorisation and special medicinal product from HMR 2012. |
16A(6) | Defines specialist medical practitioner by the GMC Specialist Register under Medical Act 1983 s34D. |
A.8 A person shall not self-administer a cannabis-based product for medicinal use in humans by the smoking of the product (other than for research purposes in accordance with regulation 13);
A.9 The research exception is part of regulation 16A(3). Regulation 13 concerns premises approved by the Secretary of State for cannabis research and how section 8 of the Act applies. MDR regulation 13
A.10 Section 18(1) makes breach of regulations under the Act a crime. It excludes regulations under section 10(2)(h) and (i). Those deal with notifying addiction and licensed prescribing or supply to addicted people. They do not describe regulation 16A(3). Section 18 therefore enforces the smoking ban. MDA section 18(1)
A.11 The section 18(1) entry in the Act’s Schedule 4 sets out summary and indictment penalties. On indictment, the maximum is ‘2 years or a fine, or both’.
A.12 DHSC now expects patients to be told about this criminal consequence. Its reply of 17 April 2026 says communication should explain that smoking is illegal and a crime (p1). Pages 2–3 explain professional responsibilities and refer sanctions to the Home Office and police. DHSC FOI-1688183, 17 April 2026
A.13 The consolidated law keeps the smoking ban, section 18(1) offence and penalty. The original 2018 instrument shows how it was enacted. Evidence note A3 compares it with other medicines laws.
A3 How this rule differs from other medicines laws
A.14 The comparison asks a precise question. Do medicines and drugs laws in Great Britain expressly ban another category of prescribed medicine by the patient’s own route of use? Table 2 compares professional controls, premises liability and prepared opium with the cannabis rule.
A.15 The comparison covers three laws in consolidated form: the Human Medicines Regulations 2012, Misuse of Drugs Regulations 2001 and Misuse of Drugs Act 1971. It also uses the original SI 2018/1055. That instrument covers Great Britain. Northern Ireland’s separate regime is outside this comparison.
Table 2 The statutory comparison governing prescribed medicines
Source | What it regulates | Comparison with 16A(3) |
|---|---|---|
HMR 214(1)/(2), with 255 | Sale/supply of prescription-only medicines and parenteral administration; 255 makes specified breaches offences. | 214(2) expressly says “otherwise than to himself or herself”. The administration restriction excludes the person's own administration. |
HMR 215/255(3) | Supplementary prescribers' prescribing, administration and directions, subject to clinical-management-plan/record conditions. | A professional-role restriction, not a personal prohibition on the patient's own route of taking a lawfully supplied medicine. |
Other HMR offence subjects screened | Manufacturing/importing, authorisation, sale/supply, registration, pharmacovigilance, packaging, advertising, inspection/information and related obligations. | No equivalent express offence for a medicine category and the patient’s own route was identified. These provisions regulate the listed activities. The cannabis rule separately targets the patient’s own use. |
MDR 10/13/16A | Lawful possession; cannabis research premises; CBPM orders, supply and self-administration. | The express personal smoking prohibition is 16A(3); possession authority is separately governed. |
MDA 8 | Occupier/management knowingly permitting specified activities, including cannabis/resin/prepared-opium smoking. | This offence concerns knowing permission by someone responsible for premises. It is not a general personal offence by the smoker. A patient can also act as an occupier. |
MDA 9 and 37 | Personal smoking or other use of prepared opium and related conduct; prepared opium means opium prepared for smoking and includes residues. | A separate, older offence covers personal use of prepared opium. It is defined by the prepared substance. The cannabis rule expressly bans a route of use for a defined medicine category within lawful prescribing. |
MDR Schedules 1/2 | Raw opium in 1; medicinal opium in 2. | The law distinguishes prepared opium from the medicinal-opium entry. Section 9 applies if the substance is prepared opium. Calling its use medicinal gives no exemption. This distinct offence must be compared with the actual medicine and prescribing rules. The categories cannot be treated as interchangeable. |
A.16 HMR 214(2) restricts who may give a medicine parenterally (for example, by injection). It expressly excludes giving it to oneself. It allows appropriate practitioners and people acting on their directions, with the stated approved-country exclusion. Regulation 255(1)(b) makes breach an offence. It cannot criminalise what the rule expressly excludes. Regulation 215 governs supplementary prescribers in that role. The cannabis rule instead expressly targets the patient’s own use of the defined medicine.
A.17 The statutory search covered express restrictions on smoking, self-administration and administration in these three laws. It included medicines offences, professional and product controls, prepared opium and premises liability. Table 2 shows the distinctions. The finding concerns an express ban on a defined medicine category and the patient’s own route of use within this framework.
A.18 The consolidated law retains the 2018 ban and section 18 offence. SI 2025/1249 concerns hospital aseptic facilities, pharmacy technicians and supply or possession. It does not amend regulation 214(2), regulation 16A(3) or the relevant section 18 penalty row.
A.19 Finding: within these medicines and drugs laws, CBPMs alone are expressly singled out as a medicine category for a personal ban on a route of use. Table 2 distinguishes prepared opium, premises liability and professional controls. This is the legal comparison behind ‘uniquely’ in the headline question.
A.19a CBPMs are listed in Schedule 2 beside morphine, fentanyl and methadone. These laws impose no corresponding personal self-administration offence merely for taking prescribed morphine by a different route. Possession conditions and drug-driving rules are separate legal questions. That distinction prevents the comparison being read as permission to disregard every prescribing instruction.
Sources: MDR 2001, Schedule 2; regulation 10(2); HMR 2012, regulation 214(2); MDA 1971, sections 5/9
A.20 Drug-driving law already recognises prescribed THC. In England and Wales, SI 2014/2868 sets the blood limit at 2 microgrammes per litre. Road Traffic Act section 5A(3)–(5) gives a conditional medical defence. It covers medical supply or prescription, following directions and lawful possession. Once enough evidence raises it, the prosecution must disprove it beyond reasonable doubt. National police guidance applies that law to medicinal cannabis (p5). CPS points to its defences guidance (reply 14391, p2). These rules show that prescription checks are possible. Patients smoking contrary to directions need the separate change recommended here. Section 5A; Specified THC limit; Police guidance p5; CPS reply p2
A4 The patient's lawful medicine and prohibited act
Sources: MDR 10(2), 16A; MDA 5/18; SI 2018/1055 pp2–3; DHSC FOI-1688183 pp1–3.·Return to paragraph 1.5
A.21 Regulation 10(2) permits possession of certain controlled medicines for administration under specified practitioners’ directions. It covers Schedule 2, Schedule 3 and Part I of Schedule 4 drugs, subject to exclusions. Those exclusions concern undisclosed concurrent supply and false statements to obtain it. Regulation 16A(1)–(2) separately governs CBPM orders and supply. Lawful supply and possession are therefore real legal categories.
A.22 Regulation 16A(3) separately bans smoking; section 18(1) makes breach a crime. Neither says smoking automatically cancels a prescription or removes every right to possess the remaining medicine. Lawful possession depends on its own facts and conditions. This report concerns the direct smoking offence.
A.23 A patient can lawfully obtain medicine and commit a separate crime by how they take it.
A.24 The recommendation protects patients smoking their own lawfully prescribed medicine, including departures from instructions. A route they temporarily cannot use illustrates a serious case. It is not a test patients must pass for protection. The present rule gives only its research exception.
Evidence note B What ministers knew and chose
B1 What ACMD recommended and to whom
Original: 11 September 2018 ACMD advice, complete 9-page advice; route discussion and Recommendation 6 at p7; practitioner guidance pp4–5; communication Recommendation 9 p8; review Recommendation 11 p9.
B.1 ACMD recommendation 6 concerns prescription-route information and producers’ directions. It says products should not be administered by smoking. It proposes no personal criminal offence. The Home Office’s search for such a recommendation ‘did not find a result’ (13 March 2026). The reply and request are supplied together. Home Office reply/request pp1–2
B.2 Professional controls and product instructions govern practice. A rule binding the person taking medicine adds a separate legal burden. This finding compares ACMD’s actual advice, officials’ proposal and the enacted rule. It does not rely just on the word ‘should’. Evidence note B2 and Evidence note B5 show the decision and its patient effect.
B2 The 13 September briefing benefit, control and enforcement
Original: HO FOI2026/03841 disclosure attachment B, briefing dated 13 September 2018, “Cannabis: Options on Definition of Cannabis Based Medicinal Products”; PDF pp5–6, §§11–17. The disclosed document has 12 pages; its redactions are preserved. Paragraph 16 and other areas are redacted; withheld content is not read or inferred.
Table 3 The disclosed smoking advice and its significance
Pinpoint | Checked content | What it establishes |
|---|---|---|
§11, p5 | Ministers' prior smoking concerns; ACMD language quoted; existing landlord/occupier controls described as difficult to enforce and insufficient for public smoking. | Officials distinguished the premises problem from the proposed new control. |
§12, p5 | DHSC assessment of extremely low likelihood of specialist smoking prescriptions; narrow circumstances in which harm could be outweighed by benefit, for example a terminally ill cancer patient needing relief from nausea. | Government’s own recognition of possible benefit to the patient. |
§13(a), p5 | Proposed requirement for a person not to administer a CBPM by smoking. | Proposed personal rule, subsequently enacted as self-administration prohibition. |
§13(b)/(c), pp5–6 | NHS guidance and GMC disciplinary regulation; separately, potential unlawful-supply criminal sanctions for rogue recreational prescribing. | Professional safeguards and criminal regulation of illicit prescribing were expressly available. |
§14, p6 | Clear licit/illicit line; police seeing street smoking would infer an offence likely occurred. | An express enforcement purpose: a simple smoking line for police. |
§15, p6 | Restriction would not apply to vaping; an appropriate medical device envisaged. | Officials expressly distinguished smoking from vaping and envisaged legitimate medical-device use. |
§16, p6 | Redacted. | No claim about its contents. |
§17, p6 | After a redaction, recommendation to introduce paragraph 13 controls; explicit alternative to rely on professional guidance/regulation. | Government's own alternative, quoted in Evidence note B5. |
B.3 The visible advice gives a clear chain. It recognises possible patient benefit, offers professional controls and recommends a personal ban with an enforcement advantage. That chain supports the finding that Government added a patient offence to secure a simple smoking line for police. The redacted advice remains unknown.
B.4 The impact assessment records police and Border Force experience distinguishing medicinal from illegal use of other controlled drugs, including benzodiazepines (paragraph 76, p15). DHSC’s later reply cites difficulty telling prescribed from recreational cannabis as a reason for the ban (FOI-1712285, p2).
B.5 A genuine prescription can establish the prescribing route. It gives no exception to the smoking ban. Officers must assess the facts and choose a lawful response. The 2018 advice deliberately made smoking a signal of likely offending while recognising possible patient benefit. Evidence note E4 examines police response and care.
B3 The earlier Home Office submission of 11 September 2018
Original: Home Office submission “ACMD Advice on Cannabis — Proposals”, dated 11 September 2018; disclosed as attachment D to the Home Office’s 16 April 2026 reply, FOI2026/03841. Paragraph 25 spans PDF pp8–9; paragraph 27 is on p9. Its own title page identifies Home Office authorship. It is separate from both the 13 September smoking-options submission and the ACMD’s advice letter. The 16 April covering letter describes Annex D as an ACMD submission; the attachment’s own title page identifies the Home Office Drugs and Alcohol Unit.
B.6 Paragraph 25 appears under ‘Media handling advice and correspondence lines’. It envisages a decision that the new rules ‘should not extend to allowing patients to smoke doctor-prescribed cannabis’. It proposes smoking harms and police difficulty as the public explanation. It foresees that patient groups might object. The next passage is redacted. Officials identified prescribed patients and foresaw possible objections before the final rule.
B4 Recorded ministerial decision and time limit
Original: HO03841 disclosure attachment C, three-page email-chain disclosure, PDF pp1–3/printed 9–11. The decision page is reproduced among the selected original records. At the foot of PDF p1 is a 17 September 2018 14:48 header. Its body on p2 records that the Home Secretary agreed option 1, did not wish to time-limit the regulations, and agreed the smoking restriction. Lower on p2 is a different 13 September 17:36 header, whose submission message continues on p3. These dates are not interchangeable.
B.7 The 13 September briefing proposed an 18-month limit. The decision rejected that limit. The instrument took effect on 1 November 2018, rather than the 29 October timetable in the briefing. Evidence note E3 sets out monitoring and review promises. Sources: 13 September briefing, paragraph 4 p3; SI 2018/1055 p1; 13 September briefing, paragraph 10 p5; Evidence note E3.
B5 The professional-control alternative
Original: 13 September briefing §17 p6, visible text after the redaction:
B.8 As an alternative, it is open to you to rely on the professional guidance and regulation to mitigate risks of irresponsible prescribing.
B.9 Paragraph 13(b)–(c) identifies guidance and regulation of clinicians. The annex on p12 also lists safeguards for specials. These include patient-specific need, licensing, manufacturing and distribution standards, inspection, import notice and adverse-reaction reporting. These are the controls Government put before ministers in 2018.
B.10 Government offered ministers an express professional alternative for irresponsible prescribing. Patients departing from instructions raised a separate question. F1 explains the case for advice, usable treatment and care, and removal of the extra patient offence.
Date | Government record | ACMD advice |
|---|---|---|
11 September 2018 | Patients smoking doctor-prescribed cannabis identified; possible patient objections anticipated. Media handling advice, paragraph 25. | Prescription and product-route directions; no personal criminal offence recommended. |
13 September 2018 | Patient benefit recognised; professional guidance and regulation offered as an alternative. Smoking-options advice, paragraphs 11–17. | |
17 September 2018 | Smoking restriction agreed; proposed time limit declined. Ministerial decision email. | |
1 November 2018 | Personal smoking rule takes effect, enforced through section 18(1). |
Figure 2 The choice to impose a personal prohibition
Government recognised possible patient benefit, considered professional controls and chose a personal prohibition. Source chain and original pinpoints: Evidence note B1 to Evidence note B5.
B.11 ACMD separated diversion from false labels. Its November 2020 covering letter reported little evidence then of prescribed cannabis medicines entering illicit markets (conclusion 12, p4). It also reported illicit cannabis labelled as medicinal, with an unclear policing effect. A genuine patient’s smoking does not show whether a label is true.
Evidence note C How the new offence was explained
C1 The explanatory memorandum's two passages
Original: explanatory memorandum to SI 2018/1055, §3.1 p1; §§5.1/6.2 p2; §7.8 p4; §§7.11–7.17 pp5–6; §10 p6; §§11/14 p7. Instrument Explanatory Note p5. Source reference
C.1 The Note and Memorandum contradict each other about the smoking rule’s continuity. The September advice said existing premises controls were insufficient and proposed a new personal rule (§§11–13(a)). It described introducing controls again in §§17/30. Regulation 4 inserted that rule. The Note calls it additional. The Memorandum presents it as maintained or continued. That new criminal effect within lawful treatment needed explanation. Evidence note C6
C.2 The Memorandum identified a novel product definition as a matter of special interest to Parliament (§3.1). It did not identify the extra personal offence there. It said no human-rights statement was required because of the negative procedure and no amendment to an Act (§5.1). It recorded informal consultation with manufacturers and stakeholders (§10.2), but no full public consultation (§10.3). These descriptions leave the patient’s criminal burden unexplained. Explanatory memorandum §§3.1/5.1/10.2–10.3
C2 Ministerial statements and the scrutiny committee
Originals: Commons HCWS994, 11 October 2018, p2; Lords HLWS961, same date, pp2–3. The Lords text transmits the same Home Secretary statement. Commons source · Lords source
C.3 The ministerial statements linked misuse and enforcement concerns to a continuing ban, including medicinal products. They described lawful access and specialist prescribing of unlicensed specials. They did not explain the new personal offence, section 18(1) or its penalty. Both promised close monitoring and review after ACMD’s final advice.
C.4 The Lords scrutiny committee described the definition and prescribing rules. It said ‘on medical advice, such products may not be administered by smoking’ (HL Paper 205, paragraph 7, printed p4/PDF p6). It named no new personal offence or section 18 penalty. The instrument was not drawn to the House’s special attention (printed p6/PDF p8). Committee report pp4/6
C.5 The committee’s account omitted the direct patient offence and penalty. That omission adds force to the demand for correction. C.11 compares Government’s knowledge, enacted law and account to Parliament.
C3 Implementation accounts and the later explicit criminal warning
Originals: Home Office circular, issue 1 November 2018, pp1–4 (especially 2/4), guidance routes pp5–6; CMO/NHS England letter, 31 October 2018, p5 with prescribing context; DHSC1688183, 17 April 2026, p1.
C.6 The circular said penalties for unauthorised supply, possession and cultivation were unchanged (p1). It repeated the continuing smoking ban (pp2/4). Those explanations did not identify the prescribed patient’s section 18 offence.
C.7 The clinician letter stated the ban and health risks (p5). It did not call the ban continuing or name the personal offence. DHSC now expects patients to be told smoking is illegal and a crime (2026 reply, p1).
C4 The impact assessment's enforcement-cost lens
Original: impact assessment HO0323 to SI 2018/1055, pp1–2 and p4, §§8–12 and A.2; p15, §§75–77. The business-assessment status on p1 and checklist on p24 are examined separately in Evidence note D6.
C.8 The impact assessment named justice agencies in A.2. It said effects could not be robustly counted and used illustrative scenarios (§§8–12). It expected costs from distinguishing genuine CBPMs from illicit cannabis (§75). It suggested continued smoking prohibition might ease that distinction and mitigate some additional costs (§76). Costs might still be substantial (§77). Its example calculates identification time, not patient prosecutions.
C.9 Finding: this passage assesses police classification and costs. It does not assess the new patient offence or the clinical case recognised by ministers’ advisers.
C5 Parliamentary scrutiny expected and advice promised
Originals: 11 September briefing §27, p9; 13 September briefing §34, p10. Paragraph 27 anticipates Parliament scrutinising the measures once laid and a proposed “Dear colleague” letter setting proposals out in full. Paragraph 34 promises further advice on parliamentary considerations.
C.10 Officials promised further parliamentary advice. Government must produce it with the records of drafting and approval. It must identify the earlier personal ban it said was continuing and correct the account of the new patient burden. Evidence note C6; Evidence note F3.
C6 Government materially misled Parliament
C.11 Government disclosed the ban in the law, Memorandum and ministerial statement. The misleading account presented the new patient burden as continuity. Before reform, possession, supply and licensing controls chiefly restricted access, with separate premises liability. Exceptional licences allowed limited medical access. The reform opened general prescribing without those individual licences. It then expressly banned patients’ smoking even where supply and possession were lawful. Section 18 supplied the offence. The internal papers explain why officials wanted a new personal rule. Evidence note A2; Evidence note B2; Evidence note B3; Evidence note C1; Evidence note C2.
C.11a Keeping the policy against smoking did not keep the patient’s legal position unchanged. Disclosing the ban did not explain the new personal crime within lawful treatment. The Memorandum calls ordering and supply controls additional while saying the smoking ban is maintained. The Note lists smoking among additional controls. That contradiction requires an answer, not an appeal to publication of the ban.
C.11b The new burden mattered to Parliament’s scrutiny. Punishing patients within lawful treatment was a substantial choice. Ministers knew of rare cases of benefit and had a professional alternative. Presenting the burden as continuity obscured that choice. The documents support the finding that Government materially misled Parliament about the patient’s legal position.
C.11c Before reform, section 18(2) already made breach of a Home Office licence condition an offence. Exceptional medical access could therefore carry enforceable limits. The 2018 reform nevertheless created a general personal smoking offence across the wider prescribing route, without depending on breach of an individual licence. Keeping a licensing restriction or a policy against smoking does not explain away that new statutory burden within lawful treatment.
Sources: MDA 1971, section 18(2), in force before reform; Home Secretary statement, 19 June 2018
C.12 Section 31(2) required the negative procedure. Parliament could annul the regulations without an advance approval vote. Government cannot treat non-annulment as informed approval of a burden it failed to explain.
C.13 Intent is not the issue. The documentary finding requires correction. The Ministerial Code, paragraph 1.6(c), requires accurate and truthful information and prompt correction of inadvertent error. Government must correct its account or answer the legal and documentary comparison. Arguing about deliberate deception does neither.
C.14 The Memorandum names Nick Hurd and the two senior officials on the submissions as people who ‘can confirm’ its standard (§§15.2–15.3). Hurd signed the instrument; his role was an addressee of the advice. This published assurance identifies who must explain preparation and approval. Government should disclose those records and the further advice promised in §34. Evidence note C5; Evidence note F4; Memorandum 15.2–15.3, p7.
C.15 The Home Office already accepted an omission in the same Memorandum. On 6 November 2018 it told the Joint Committee on Statutory Instruments that paragraph 3.2 should have named section 7(1)(b) as a power relied on. It ‘apologises for not doing so’. This was a different defect, concerning legal powers. The acknowledgement establishes a parliamentary route for correction.
Source: JCSI 38th Report 2017–19, Appendix 2, Home Office memorandum 6 November 2018, paragraph 7
Evidence note D How the effects on patients and justice were assessed
D1 Proportionality assertion and equality duty
Originals: CP171 §31, PDF 10/printed 11; HO03126, 20 March 2026, pp1–2 with actual request p3; Equality Act 2010 s149, version at 11 October 2018.; Equality Act 2010 Schedule 1 paragraph 6(1), at 11 October 2018; 13 September 2018 advice, paragraph 12, initial disclosure p4
D.1 CP171 calls the regime proportionate and describes treatment for needs licensed medicines cannot meet. The Home Office accepts it had its own equality duty when making the law (HO03126). It holds no record assigning responsibility. It says each authority carries the duty for its own functions.
D.2 Section 149 required Government to consider equality when deciding the rule. Subsection (3) covers disadvantage and different needs. Subsection (4) says meeting disabled people’s different needs includes taking account of their disabilities. Subsection (6) permits more favourable treatment within the Act. This duty addressed a concrete patient: officials named cancer as their example. Schedule 1 paragraph 6(1) already made cancer a disability on 11 October 2018.
D.2a Bracking summarises what “due regard” requires. The decision maker must be informed and consider the equality implications before and at the decision, with rigour and an open mind. The duty is personal and continuing. Recording the steps taken is important evidence of compliance. These principles require Government to account for the patient effects it considered in 2018 and those it must now address. They do not prescribe a particular document title or transfer the balancing judgment from the decision maker to the court.
Sources: Bracking [2013] EWCA Civ 1345, [26](2)–(8)
D.3 ACMD’s reply answered ‘No information held’ to questions 3–7. These concerned criminal-law effects, advice and implementation, emergency use, equality, vulnerable groups and consideration of the Memorandum or impact assessment. It cited earlier advice on route. The reply is undated and filed as received on 20 April 2026. ACMD reply pp1–2.
D2 Matched Home Office requests, replies and review
Table 4 Home Office requests replies and internal review
Pair | Actual scope and response |
|---|---|
p2 reproduces the 12 May request for the patient-cohort assessment, foreseeable consequences and s149 consideration; p1 says a thorough systems search found no held requested information and refers to DHSC. | |
p2's19 June request asks for the source of DHSC's extremely-low/narrow-circumstances assessment, anticipated patient behaviour, legal consequences and equality consideration. p1 says relevant decision files were searched/reviewed and no requested information held. | |
p1 upholds 06253, describes relevant teams, individual staff, policy leads who moved teams and previous FOI teams, and lists searches for 16A/16A(3), cannabis/CBPM, smoking, patient cohort, impact assessment and equality terms. pp3–4 reproduce the 19 June review request. |
D.4 Earlier requests wrongly described loss of an exemption and liability for remaining stock. A4 identifies the direct offence: smoking is prohibited even when supply and possession are lawful. The 19 June internal-review request, IR2026/08630, expressly raised that lawful-possession case. It also asked about the basis of DHSC’s assessment and equality. It is reproduced in the review reply at pp3–4. The earlier mistake cannot dispose of this corrected question.
D.5 Finding: after the searches described, the Home Office reports no held information answering these targeted questions. They cover sources, assessment, patient behaviour, consequences and equality. The September briefing still records an assessment. Government has not shown the patient scrutiny underlying it.
D3 DHSC held-information refusals and the repeated 640-file estimate
D.6 DHSC’s July reply confirms relevant information is held but refuses disclosure under the FOI cost limit. The refined 19 June request asks what informed its specific low-likelihood and narrow-circumstances assessment, and for source categories and records. DHSC repeats health and enforcement reasons from the Memorandum. It accepts these do not directly answer the request. Its explanation gives a 13 September 2019 date once; the original briefing and later reference are 13 September 2018. DHSC FOI-1712285, 20 July 2026.
D.6a The 8 May request asked about DHSC’s role, recognised patient cases and consequences (JBD FoI_1C2a). The 8 June reply confirmed held information but refused on cost grounds (FOI-1704324). JBD narrowed the request on 19 June to the basis of the specific assessment (FoI_1C1d). DHSC again confirmed held information and refused on cost grounds on 20 July (FOI-1712285). The narrower question still produced no disclosure.
Sources: May request and June reply in full; June refinement and July reply in full
D.7 Two replies cite about 640 potentially relevant files. The April reply concerns development and communication and estimates £553.33 to review a sample (FOI-1688183, Q4 pp2–3). The June reply concerns patient assessment and gives an estimate of £553 (FOI-1704324, p1). Both say the full answer would exceed £600. The repeated figure does not prove identical file sets or separate corroboration. N03 complete reply; DHSC 8 June reply, p1.
D.8 DHSC says it holds relevant assessment information but refuses disclosure. The 640 figure counts potentially relevant files, not verified assessment records. It appears in two replies and must not be added or treated as independent evidence. The content remains undisclosed.
D4 What the justice process required in 2018
Original: Ministry of Justice Justice Impact Test guidance, July 2018, printed pp4–6/PDF pp6–8; checklist printed p8/PDF p10. The cover identifies July 2018; the copyright footer carries 2016.
D.9 The July 2018 guidance requires a JIT for new policy proposals with potential effects on any aspect of the justice system (printed p4). Even expected minimal effects need evidence and MoJ agreement through that process. It calls for early engagement and says JIT clearance should ideally precede Cabinet Committee clearance. New or extended offences need discussion and justification with MoJ’s criminal-law policy team before JIT submission (p5). The Criminal Offences Gateway had ended. Criminal-law policy scrutiny of new or significantly amended offences continued (p6). The checklist covers necessity, proportionality, penalties, investigations, prosecutions and service costs (pp8–9).
D.10 The cannabis rule added a prohibited act enforced by section 18(1). The impact assessment named criminal justice agencies (A.2, p4) and anticipated extra enforcement work (paragraphs 75–77, p15). Potential justice effects triggered the JIT process. Neither the ‘additional control’ label nor use of an existing offence removed that trigger or answered the guidance’s separate requirement for criminal-law discussion of new or extended offences.
D5 The MoJ question and the answer actually obtained
D.11 Pair: JBD FOI_1D to MoJ, 12 January 2026, three pages; MoJ260112115 response, 28 April 2026, two pages. Request p2 specifies 1 January 2018–31 December 2020 unless otherwise stated. MoJ1–7 cover awareness, prosecution likelihood, legislative model, proportionality/foreseeability, emergencies, equality and review; MoJ8 concerns cost-limit assistance.
D.12 MoJ said it held no information in scope because it was not the appropriate authority and referred JBD to the Home Office. The reply was signed by the HMPPS Briefing and Correspondence Team. It did not identify searches by the JIT or criminal-law policy teams. MoJ-1 and MoJ-3 described exemption withdrawal. Regulation 16A(3) instead directly prohibits smoking, enforced through section 18. The other substantive questions separately sought assessments of prosecution, proportionality, emergencies, equality and review.
D.13 No relevant justice-impact assessment, engagement or approval record has been identified in the material supplied to this research. The HMPPS-origin reply does not establish what searches the relevant JIT or criminal-law functions made. The missing record is therefore the Home Office’s and those functions’ engagement, assessment, justification, approvals and cost agreement under the July 2018 process.
D6 The patient between law reform and business assessment
Sources: Law Commission, Criminal Liability in Regulatory Contexts, Consultation Paper 195 (2010), §§1.9–1.14, printed pp3–4; §2.24, p26; Appendix D.38, p237. Impact assessment HO0323, pp1 and 24. The 2010 consultation proposed law reform. Its categories provide a comparison for the later prescribed-patient problem.
D.14 The Law Commission included offences regulating chemists because licensed trade identifies them in advance (§1.12). It excluded public illegal-drug offences: users and dealers generally become legally identifiable through the offence. Appendix D.38 assumed regulatory offences mainly affect businesses. Paragraph 2.24 still recognised that many issues mattered beyond the paper’s scope. This report uses that reasoning for comparison. It does not attribute a patient finding to the Commission.
D.15 The impact assessment says ‘RPC Opinion: Not applicable’ and ‘Not a regulatory provision’ (p1). Its checklist has one Business Impact Target row, marked ‘Not in scope of BIT’ (p24). That row concerns economic effects on business and civil society bodies. ‘Not a regulatory provision’ is a technical business-target label. It does not mean the measure has no criminal effect. The patient burden needs its own assessment.
D.16 A lawful prescription identifies the patient before the prohibited act. The Commission’s reason for excluding unidentified illegal-drug users does not describe that position. Business-target checks do not assess the personal criminal burden either. Neither supplies a patient justification. This is the report’s comparison of the categories.
D.17 Government cannot use these reviews to answer the patient question. The Commission’s scope, business checks and Lords scrutiny each addressed something different. Evidence note C2 records the committee’s account. Evidence note D4 and Evidence note D5 identify the records needed.
D7 Five standards for judging the decision and its effects
D.18 Wednesbury is a demanding test of whether a public decision was reasonable. Keyu lists irrationality and failure to consider relevant matters among review grounds (§127).
D.19 Article 8 covers how patients choose treatment with their doctors. Hristozov expressly brings a limit on that choice within private life (§116). Bank Mellat asks whether the aim is important, the measure helps, a less intrusive option could work and the balance is fair (§§20/74–76). Calling the whole regime proportionate does not answer them.
D.20 Hristozov upheld restricted access to unauthorised experimental products, including for seriously ill patients. The Court allowed a wide margin and found a fair balance. A general rule without individual exceptions was not automatically contrary to Article 8 (§§124–127). Here prescribing is already lawful. The measure adds a personal crime for how patients take that medicine. A judgment about access to unauthorised products does not justify adding that crime.
D.21 Reasonable adjustments concern a covered service, the serious disability-related disadvantage and lawful steps it can reasonably take. Equality Act sections 20–21 and 29 set that duty. Schedule 3 paragraph 2(3) excludes making ministerial regulations from section 29. The minister’s separate section 149 duty remains. The adjustment question therefore concerns care, information, equipment and handling.
D.22 Bolam and Bolitho test clinical judgment against responsible medical opinion and sound reasoning. McCulloch explains that test and the duty to discuss reasonable alternatives and material risks (§§1–2/56–66/83). A ban cannot replace an assessment of the patient’s treatment options. Clinical advice against smoking still leaves Government to justify punishing the patient.
D.23 Practical fairness asks what a careful person could do in the patient’s circumstances. Relevant facts include urgent symptoms, knowledge, relief, usable alternatives and support. Quayle rejected a broad medical-necessity defence overriding cannabis law (§§54–57/67). It left exceptional necessity cases open. Since 2018 prescribing has been lawful. Government should give patients clear protection. Temporary disruption shows why it matters; patients should not have to prove necessity to receive it.
D.24 The five standards test different responsibilities. Government must explain its decision, justify punishment, consider disabled patients, respect sound clinical judgment and address practical needs. A general smoking warning answers none of those questions on its own. F1 makes the case for removing punishment while keeping professional controls and patient care.
Original legal sources: Keyu, §§127–134; Bank Mellat (No 2), §§20/74–76; Bolitho (1997); McCulloch, §§1–2/56–66/83; Equality Act, Schedule 3 paragraph 2(3); Hristozov, §§116–127; R v Quayle, §§54–57/67–69
Evidence note E Policing patient care and the current review
E1 The communication/responsibility chain
Originals: HO03126 pp1–3; DHSC1688183 pp1–6; GMC IR1-5469823870 original email, 16 July 2026, response to 19 June request, answers 1/3/4 and full response context. The preserved original email contains the response and quoted request.
E.1 The Home Office holds no record of who gives the specified warning or ensures it is given. It points to DHSC and health services. DHSC expects prescribers and pharmacies to explain the crime. It puts professional assurance with regulators and sanctions with the Home Office and police. It cites published material for questions 1–2 under section 21, then refuses the development question on cost grounds under section 12.
E.2 GMC says communication about regulation 16A(3) has not been a specific consideration (answer 1). It explains its general standards on competence, consent, prescribing and patient decisions. It cannot identify another responsible body because it has not considered the issue (answer 3). It holds no record assigning this specific responsibility (answer 4).
E.3 The replies establish professional expectations. They do not show that a named lead secured the full criminal warning or checked delivery. The gap concerns responsibility for explaining this consequence.
E2 What the systems can and cannot supply
E.4 CPS does not centrally record whether a lawful CBPM prescription was asserted, and its case management system has no keyword search facility (14391, p2). Identifying those cases would require manual file review. CPS says this would exceed £600 or 24 hours. Its 4,328 charged offences are a broad drugs total used to estimate costs, not a count of CBPM patients or smoking prosecutions. CPS does hold information for question 3 and invites a fresh request. The reply is printed 10 July 2026 but says the request arrived on 20 July. That date conflict remains unresolved.
E.5 MoJ and HMCTS administrative systems cannot retrieve evidence presented in court about the prescription or product involved. Such evidence, if held, can only be obtained from the court case records themselves. Those records are held for court purposes, rather than by MoJ for FOI purposes. MoJ therefore says it holds no information in scope. It refers the policy questions about differentiation and monitoring to DHSC. 260619034, 16 July 2026.
E.6 The CPS case management system and MoJ/HMCTS administrative systems do not provide a centrally retrievable account of proceedings in which lawful prescribed possession was asserted. Their replies concern recognition of prescribed cannabis generally. They do not supply a count of patients facing the smoking offence.
E3 Earlier exclusion, broader current remit and JBD's actual submission
E.7 Government promised monitoring in the 2018 statements and again in CP171 §32. The impact assessment also promised review two years after commencement (§115, PDF p23): by November 2020. Yet the 2019 commission excluded ‘Any associated criminal offences for cannabis as summarised in Schedule 4’. It still invited advice on amending the regulations (p3). Schedule 4 includes the offence enforcing the smoking ban. HCWS994 p2; HLWS961 pp2–3; CP171 §32; The 2019 longer-term commission. Impact assessment paragraph 115, p23
E.8 The current commission, dated 2 June 2025, asks about intended effects, unintended consequences and lessons for research. It does not repeat the criminal-offences exclusion. Nor does ACMD’s call for evidence of 17 September 2025. Its questionnaire covers patient issues and improvements (16/18), legal challenges (19), impact (20) and public legal awareness (24). These questions accommodate the patient offence. The review should answer it.
E.9 On 9 September 2026, Home Office minister for policing and crime Sarah Jones answered James Naish MP’s written parliamentary question about whether the 2 June 2025 ACMD commission excluded cannabis cultivation. She said cultivation was not named but would not be excluded if relevant to the review. She described its scope as intended effects and unintended consequences of the 2018 changes, and affirmed ACMD’s independence. Written answer UIN 22265.
E.10 The 2018 instrument inserted the patient smoking ban. Its effect is directly relevant to the changes under review. It meets the minister’s relevance test even more directly than an unnamed topic. A chosen consequence belongs under intended impact; it need not be unforeseen. Evidence note A2; 2018 instrument regulation 4.
E.11 JBD sent ACMD an open letter, the early Discrimination by Design briefing of 18 September 2025, and Annexes D and E on 16 October 2025. The outgoing email identifies the documents and why they matter to the review. V1 is cited here as submission history. Its superseded legal wording is not this report’s analysis; Evidence note A gives that analysis. Submission email, 16 October 2025.
E.12 The 1 June 2026 answer to Stuart Andrew, UIN 3221, expected the ACMD report by summer 2026. The later published update of 21 September 2026, section 1, said the working group was concluding its report, expected by year end. Written answer UIN 3221; September update section 1
E.13 Government’s relevance test places the smoking offence within the review. JBD submitted the issue. ACMD’s advice and Government’s response should address the chosen patient burden and professional alternative. Health bodies already observe the review (F2). Ministers must address the issue in their response to ACMD’s independent advice.
Figure 3 The review timeline and the current opportunity
Dated review remits, ministerial scope explanation, submission identity and public timetable: Evidence note E3.
E4 How health services, police and justice should work together
Table 5 How health and justice responsibilities connect
Original and actual question | Answer and its proper use |
|---|---|
CPS14145, 17 April 2026, pp1–3; formally adopted charging, prescription-evidence, discontinuance and governance guidance. | No CBPM-specific adopted guidance for those matters. CPS relies on the Code, general drugs guidance and individual statutory/factual assessment. CPS must show how its general safeguards work for prescribed patients. |
College FOIA-2026-094, 9 July 2026, questions pp1–2; answers pp3–4. | Q1: dedicated CBPM learning products were not considered. Q3: no recorded reason held. Q4 cites general curriculum/drugs learning, NPCC/force guidance, supervisors/legal teams, drugs experts and CPS lawyers. The College identified no consideration of dedicated CBPM learning. It relies on general training and specialist advice. |
NPCC 2802/2026, 31 March 2026, full response pp1–5; operational, training, coordination and governance questions. | Identifies national CBPM guidance; no additional national training products or separate coordination material; ownership/review records were being established and timelines not formally set. National accountability for ownership and review remained unresolved in that reply. |
MoJ/HMPPS 260305036, 18 March 2026, actual 5 March questions p1, referral pp1–2. | No held in-scope custody/prison handling, care/continuation, verification, escalation or governance material; refers healthcare to NHS England/Public Health Wales. Government must explain how the custody and healthcare responsibilities connect and secure continuing treatment. |
E.14 Government must show that its cited safeguards work together for CBPM patients. Recognition, police handling and care need accountable delivery. The smoking offence adds a criminal burden to the problems those replies already show.
E.15 APCDLO’s guidance starts with the patient. It treats lawful prescribed possession like other controlled medicines (p3). Officers should approach the person as a patient, then check packaging, dispensing information, identity and, if needed, the clinic (p4). Further possession action needs justified grounds to reject the prescription. These checks can prevent avoidable arrest, seizure and interrupted treatment. Page 5 separately states the smoking ban. The guidance gives no exception to that offence or specific smoking-and-care pathway. It offers general CDLO referral. R1 seeks delivery across police and prosecution; R7 removes the remaining offence. The cover says February 2025; the closing page says November 2025. APCDLO guidance pp4–5.
E.16 NPCC identifies the APCDLO/Drugs Portfolio guidance published through the College in February 2025. It directs arrest, seizure and prescription checks there. Its March 2026 reply reports no extra national training or separate interagency coordination material. It holds no record of an NPCC owner or review mechanism. Those arrangements were being established after a leadership change, with no fixed review timetable (p4). NPCC response pp2–4.
E.17 Sussex policy says lawfully prescribed CBPM should not be confiscated (§5.3, p5). Its arrest-necessity factors include ‘Not smoking cannabis within public view’ (§§6.4–6.5, p6). That protects possession but gives no specific pathway for a prescribed patient who smokes. Sussex policy pp5–6.
E.18 A prescription gives no exception to smoking under regulation 16A(3). Officers must still assess the product, conduct and circumstances, then choose a lawful response. In England and Wales, PACE Code G requires grounds for the offence or suspicion and grounds that arrest is necessary. Those safeguards govern the response. They do not make smoking lawful. The burden remains even without prosecution. A later decision not to prosecute cannot undo treatment already interrupted. PACE Code G §§1.1–1.4/2.1–2.8; Evidence note A2; Evidence note A4.
E.18a The recommended standard is equal patient protection. Lawful prescribed possession and use should not themselves trigger adverse police or prosecution action or disrupt treatment. Check prescriptions and defences promptly. Record any separate grounds for action and secure continuing care. The competent authorities must issue coordinated instructions. These must respect operational independence, individual facts and national jurisdictions. Guidance cannot remove the smoking offence; R7 must change the law. Begin protection now and keep it until reform demonstrably works. Check actual encounters, care, escalation and patient experience. A policy document alone is not delivery.
E.18b Pete reports varied packaging, from inhalation-only wording to some no-smoking statements. Pharmacy labels may specify vaping. NHS guidance identifies route, instructions and warnings as key information (pp4–5). It recommends positive route instructions (p8) and user testing (p5). NHS SPS places responsibility for suitable information on prescribers and pharmacists. R3 applies those principles: consistent instructions, a clear distinction between vaporisation and burning, and a plan if the route cannot be used. Better warnings do not justify a crime. NHS labelling guidance pp4–5/8; NHS SPS: Choosing a suitable product.
E5 Why gaps in responsibility matter to patients
E.19 Evidence notes A and B establish the last-resort setting, recognised patient benefit and direct offence. The Commission’s published evidence adds clinic practice and problems with police recognition. The following paragraphs identify what that evidence shows. Evidence note A; Evidence note B.
E.20 The London Drugs Commission describes the private-clinic process (pp277–278). Patients sign a waiver saying they will not smoke dry-herb prescriptions or pass them on. Footnote 760 links the smoking offence to regulation 16A(3) and section 18(1). This shows how the criminal rule reaches clinic instructions. Commission pp277–278. The professional system depends on knowing what patients actually do. Current GMC prescribing guidance asks clinicians to encourage openness about departures from instructions, understand the reasons and seek an agreed treatment the patient can follow. Making the disclosed conduct a crime places an obstacle inside that relationship. The consequences extend to clinicians as well as patients.
E.20a The 11 September submission relied on clinical responsibility and regulatory safeguards (paragraphs 2, 8(a) and 12; Annex B). The 13 September submission explicitly added professional discipline to the smoking controls and offered reliance on professional guidance and regulation as the alternative (paragraphs 13(c) and 17). Its criminal warning concerned prescribing for recreational use. Those are distinct from learning that a patient has smoked, discussing the reasons or continuing bona fide treatment. The papers do not establish automatic discipline, criminal liability or a requirement to discharge a patient merely because the clinician knows. Continuing prescriptions must still meet the legal conditions for ordering and supply and the clinician’s duties to assess benefit and safety.
Sources: 11 September 2018 submission, pp2–6/12–13; 13 September 2018 submission, paragraphs 12–17, pp5–6; GMC FOI response IR1-5469823870, 16 July 2026, answers 1/3/4; GMC prescribing guidance, paragraphs 35/48/51; regulation 16A(1)–(3); GMC information for CBPM prescribers
E.20b The GMC’s July 2026 FOI reply connects this unresolved clinical position to the information gap. It had not specifically considered whether prescribers should explain the legal consequences of regulation 16A(3), and held no recorded information specific to responsibility for that warning. It stressed professional judgment, informed decisions and dialogue. That reply addresses communication, not a ruling on clinicians’ liability for knowledge of smoked use. Government and the professional system must now explain how to give the full legal warning, receive an honest account and sustain appropriate treatment without treating disclosure itself as misconduct. A patient’s admission must trigger a clinical response, not an assumption of recreational prescribing.
Sources: GMC FOI response IR1-5469823870, 16 July 2026, answers 1/3/4; GMC prescribing guidance, paragraphs 35/48/51
E.21 The Commission reports that even a matching legitimate prescription is not always understood or accepted (p281). It describes an overnight detention while officers checked with a clinic. It recommends routine police awareness (p282) and records challenges to patients using prescribed cannabis in public (p301). These are recognition and handling problems. Page references avoid the report’s repeated paragraph numbers. Commission pp281–282/301.
E.22 Government must explain the extra criminal burden when lawful possession already meets recognition problems. The waiver and custody accounts show the need for connected information, checks and care. The originals in Evidence note A and Evidence note B establish the offence and the recognised patient case.
E.22a Aziz’s hospital record concerns prescribed, non-smoked use. It records his report that police removed his cannabis while he used a vaporiser, leaving him without access (6 August 2023, pp1–3). It also records distress staff observed, hospital attendance and self-discharge before planned assessment and treatment were complete. A hospital record of his reported loss of access and the distress staff observed demands action before charging.
E.22b The driving case is separate. The HMCTS/DVLA notice records the 31 March 2024 offence date, conviction on 13 October 2025 and three-year driving ban (CPS SAR p1). The appeal record of 10 February 2026 records a successful appeal and costs to be assessed (pp18–19). The court rejected prescription expiration as definitive and preferred his evidence on product expiry. Published prescriptions direct vaporisation (appendix pp1–2). The 681 days measure proceedings, not loss of medicine. The defence ultimately succeeded. Protection must work before that eventual correction.
E.22c Aziz published the institutional records. They document his reported loss of access, observed distress and lengthy proceedings ending in a successful appeal. Eventual correction cannot replace prompt recognition and care. This report uses the account and relevant records. Raw medical and court files and unrelated personal details are excluded from the companion. Aziz account; Hospital pp1–3; CPS SAR p1 and pp18–19; Prescription appendix pp1–2.
E6 What registry evidence can establish
E.23 Government’s January 2022 response accepted further assessment in principle, subject to enough data. ACMD had found too little evidence to assess all effects. Government supported an official registry, then covering NHS patients only, and explored private-provider data. NHS England’s December 2022 letter identifies its registry host as Arden and Greater East Midlands CSU. That official collection differs from the UK Medical Cannabis Registry in the research papers.
Sources: 2022 response, recommendations 1–2; NHS England’s registry letter, background
E.24 The 2026 clustering study derives treatment route from active prescriptions. Its baseline table records smoking before treatment. It does not measure continued smoking of prescribed medicine. The 2023 evaluation also asks about route information. A prescription or route field does not show how the patient actually took the medicine. Government needs evidence of actual use.
Sources: Methods: Data Collection; Table 1 and its footnotes; Methods: survey question 5
E.25 Monitoring needs clear patient populations and totals, usable routes, interrupted treatment and discontinuation. Include patients who leave treatment. State current public and private coverage. The clinic no-smoking waiver raises a foreseeable barrier to candid reporting: patients may fear that admitting smoked use could cost them prescribed treatment and medical oversight. Government must secure a way to disclose actual use and obtain continuing care. Clinicians need clear guidance on responding to admissions, reviewing treatment and recording actual use without equating knowledge with endorsement. Research must examine clinicians’ responses and patients’ reasons for withholding information, including any treatment lost after disclosure. Studies should be voluntary and confidential, collect little personal data and prevent identifiable disclosures feeding enforcement. Prescriptions do not establish actual use. Case counts and confidential patient research serve different purposes; they should not be casually linked.
Source: London Drugs Commission, pp277–278
E.25a NHSBSA’s September 2026 response cannot provide reliable totals of distinct private patients. NHS numbers are captured on about 20–30% of private prescriptions; counting only identifiable records would materially understate patient numbers and skew averages. This is a prescribing-data gap, separate from the CPS and MoJ case-record gaps. Government must establish the patient population and actual-use information needed for safe monitoring.
Sources: NHSBSA FOI-04092, response
Evidence note F The remedy and Government response
F1 Why the remedy follows the evidence
Basis: 13 September briefing §§13/17, pp5–6, with ACMD Recommendation 6 ACMD advice of 11 September 2018 p7 and enacted/current 16A(3) SI 2018/1055/MDR current. Evidence note B establishes Government's recognised patient case and offered professional alternative. Evidence note A establishes the additional personal offence; Evidence note D; Evidence note E establish what supporting scrutiny and accountability have not been demonstrated.
F.1 Remove the extra offence for patients smoking their own lawfully prescribed CBPMs, including departures from instructions. Clinical advice against smoking can remain. Government’s own example shows that benefit was not inconceivable. General protection rests on the relationship between lawful supply, health risk and punishment. Patients should not have to fit that example or prove necessity.
F.1a The medicine has passed through regulated prescribing and supply. Professional, product and supply controls govern that route. They cannot prevent every harmful use or departure from advice. This report favours risk information, usable alternatives and care for that conduct. The 2018 rationale valued a simple police line. Making genuine patients offenders sacrifices the prescription distinction the system otherwise recognises. In this report’s judgment, that convenience and smoking harms do not outweigh the extra burden. Government must produce any evidence of diversion or harm to others it relies on to justify punishment.
F.1b Unauthorised possession and supply remain offences under sections 5 and 4 of the 1971 Act. Regulation 16A(1)–(2) continues to control CBPM orders and supply, with express clarification protecting otherwise lawful care when clinicians know about smoked use (F.3e). Prescribing, professional and product requirements remain. Drug-driving law remains, including the offence of driving while impaired and section 5A’s conditional medical defence. Changing the smoking offence would not give a patient who disregards medical directions an automatic drug-driving defence.
Sources: MDA sections 4–5; MDR regulation 16A(1)–(2); RTA 1988, sections 4/5A
F.1c Smoke-free law already covers cannabis. It continues to control smoking in the places it protects, including most enclosed public places and workplaces. For the smoker’s smoke-free offence, the maximum fine is £200 in England and Wales and £1,000 in Scotland. By contrast, the patient offence can bring up to two years on indictment even for smoking one’s own prescribed medicine at home. Shared-space smoking controls address harm to others; they do not create officials’ simple street-enforcement line.
Sources: Health Act 2006, sections 1/7; SI 2007/764, regulation 2(2); Public Health (Wales) Act 2017, sections 4/5; Scottish 2005 Act, sections 2/4; England/Wales standard scale; Scottish standard scale
F.1d The cannabis-specific premises offence in section 8(d) needs a corresponding exclusion for the protected patient’s smoking. Otherwise an occupier who knowingly permits that use can remain exposed. Regulation 10(2)’s possession conditions also need express protection so that smoking alone does not defeat lawful possession. Section 22(1)(a)(i) allows offence provisions to be excluded in prescribed cases. This can protect patient use while retaining the remaining premises, possession and supply controls.
Sources: MDA section 8(d); section 22(1)(a)(i); MDR regulation 10(2)
F.1e Professional safeguards must permit candid clinical care. Removing the patient offence must also resolve how clinicians and dispensers can continue otherwise lawful treatment when they know a patient has smoked or may smoke. Awareness alone must not be treated as prescribing smoking, recreational supply or professional misconduct. Clinical decisions still require an individual assessment, advice, records and review. The reform does not require clinicians to prescribe a treatment they judge inappropriate.
Sources: MDR regulation 16A(1)–(2); GMC prescribing guidance, paragraphs 35/48/51; GMC FOI response, 16 July 2026
F.2 Protection should cover patients using their own lawful prescription, including departures from instructions. It must not require a prescription for smoking or make patients prove necessity. Warnings do not remove the extra crime. General protection preserves care when advice has not been followed. It does not allow smoking in every place or circumstance. The amendment must address remaining possession, supply, product, prescribing and premises rules precisely.
F.2a Official information says smoking and vaporisation can both give rapid relief. Speed alone does not distinguish them. The practical question is whether the patient can use the device and get relief when needed. Pete gives his own experience. Government must assess dexterity, available help, device reliability and usable alternatives. Criminal protection should not depend on proving those problems. Health Canada, Using a cannabis product, Smoking and Vaping.
F.3 Existing powers offer a route to remove the patient offence. Section 22(1)(a)(i) allows regulations excluding offence provisions in specified cases. Section 31 allows different cases and circumstances, requires statutory instruments and provides for ACMD consultation. The 2018 regulations used sections 7, 10, 22, 30 and 31. A new Act is therefore not a prerequisite to pursuing reform. The Home Office should bring forward regulations and address related possession, premises, prescribing and product rules in the drafting. Misuse of Drugs Act §§22/31; 2018 instrument preamble.
F.3a Illustrative wording for Government’s drafters follows. It protects the patient to whom the medicine was lawfully supplied for treatment, including use contrary to route instructions. It requires neither a smoking prescription nor proof of necessity. The ordering, supply and research controls remain, with the clarification in F.3e to protect otherwise lawful care. Government must settle the instrument and the related provisions under the powers identified above.
F.3b For regulation 16A(3): “A person shall not self-administer a cannabis-based product for medicinal use in humans by smoking the product, except for research purposes in accordance with regulation 13 or where that product was lawfully supplied to that person for their own medical treatment.”
F.3c Corresponding possession provision: “For the purposes of regulation 10(2), a person shall not cease to be authorised to possess a cannabis-based product for medicinal use in humans lawfully supplied to that person for their own medical treatment merely because they self-administer it by smoking.”
F.3d Corresponding premises provision under section 22(1)(a)(i): “Section 8(d) of the Act does not apply to the smoking of a cannabis-based product for medicinal use in humans by the person to whom that product was lawfully supplied for their own medical treatment.” These clauses leave smoke-free law and other independently unlawful conduct to operate. Fraud, diversion and possession of medicine not lawfully supplied to the patient remain separate questions.
Sources: MDR regulation 16A; regulation 10(2); MDA sections 7/22/31
F.3e Corresponding clarification of regulation 16A(1)–(2): “An order or supply otherwise complying with paragraphs (1) and (2) does not cease to comply merely because the prescriber or supplier knows that the person to whom the product is supplied has self-administered or may self-administer that product by smoking.” Government must check this alongside the possession and premises provisions, medicines law and professional guidance. Its purpose is to protect candid disclosure and otherwise lawful continuing care, while retaining clinical judgment and controls on independently unlawful supply.
Sources: MDR regulation 16A(1)–(3); MDA section 18; GMC prescribing guidance, paragraphs 35/48/51
Return to conclusions and recommendations
F2 Who should answer and what they should provide
F.4 The response matrix identifies the accountable functions and the evidence needed to judge Government's answer. Recommended leads are distinguished from existing allocations of responsibility.
F.5 DHSC, NHS England and MHRA already observe the CBPM working group (UIN 3221, 1 June 2026). DHSC’s November 2025 reply also confirms its observer role. It says departments will consider ACMD’s report before acting. Those bodies must turn involvement into an accountable health response while ACMD gives independent advice. Government should name their contributions, action owners and dates. Written answer UIN 3221; DHSC reply p2.
Table 6 Responses required from responsible bodies
Function | Required response | Evidence by which its answer can be judged |
|---|---|---|
Home Office policy owner | Remove the additional personal offence for lawfully prescribed use; account for the decision and correct Parliament’s account. | Specific legal change; original option comparison; reasons for excluding recognised patient circumstances; patient/equality assessment and parliamentary explanation. Evidence note A; Evidence note B; Evidence note C; Evidence note D. |
DHSC/NHS bodies/MHRA and professional system | Use existing observer roles to deliver an accountable health response; make professional route decisions, patient information and care responsibilities usable. Align packaging, pharmacy labels and counselling, with patient testing and an accessible plan for route or device failure. | Observer contributions identified; produced held assessment sources; responsibilities for prescribers/dispensers and assurance; patient participation and a treatment-interruption pathway. Evidence note B5; Evidence note D3; Evidence note E1; Evidence note E4; Evidence note F2. |
Home Office/MoJ justice functions | Demonstrate criminal-law/JIT engagement and align clinical/justice handling. | Actual engagement, justification, necessity/proportionality, clearance, estimates and costs; clear route for resolving cross-system failures. Evidence note D4; Evidence note D5. |
Policing / prosecution / court administration functions | Issue and implement patient-first instructions from the first encounter: prompt prescription and defence checks; protection from adverse action merely for lawful possession or use; continuity of care, escalation and recorded reasons for separate action. | Usable verification/handling routes; evidence that the general safeguards cited operate together; a practicable prescribed-patient cohort/outcome method. Evidence note E2; Evidence note E4. |
ACMD current review; HMG policy response | ACMD independently advises on the 2018 impact inquiry. Ministers should decide and implement reform, informed by that advice, while immediate protection proceeds. | Explicit findings on the patient burden applying the stated scope; a reasoned HMG response with health-observer contributions, action owners and a timetable. Evidence note E3; Evidence note F2. |
Policy owners with health/justice delivery bodies | Sustain correction and review of the patient consequence. | An identified accountable lead, patient participation, reviewable outcomes and a correction process. Evidence note E1; Evidence note E2; Evidence note E3; Evidence note E4; Evidence note E5. |
Return to conclusions and recommendations
F3 Questions Government still needs to answer
F.6 The following open questions arise from the assembled evidence and define how Government's response should be assessed:
F.7 What patient and clinical evidence informed DHSC’s assessment and the offence imposed even where benefit was recognised? The Home Office says it holds no requested information. DHSC confirms relevant information but refuses disclosure. Evidence note D2; Evidence note D3.
F.8 What extra risk justifies punishing the genuine patient’s smoking? Why are prescribing and supply controls, usable treatment and continuing care insufficient? Government must distinguish patient departures from irresponsible prescribing and justify retaining the extra offence.
F.9 How did Government meet its equality duty for these patients and criminal consequences? Identify what it considered. Calling the system proportionate does not answer. Evidence note D1; Evidence note D2.
F.10 Why was the new crime within lawful prescribing presented as continuity? Answer the contradiction in C.11. Disclose how the Memorandum was prepared and approved, and what supports its named assurances. What further parliamentary advice followed? Why has this account not been corrected, when the department already apologised for another omission in the same Memorandum?
F.11 What justice-impact work, criminal-law consultation, approvals, handling plans and cost agreement supported the change? Government must produce the records from those functions. Evidence note D4; Evidence note D5.
F.12 Who ensures patients get the full warning, prompt prescription checks and continuing care? How are patients and outcomes identified? CPS holds relevant question 3 information and invites a fresh request. Government must use that route and the case records to account for affected patients. Evidence note E1; Evidence note E2; Evidence note E4.
F.13 Where is the review promised for two years after commencement in IA §115? What did it examine and find about the patient offence? How will ACMD and Government now apply the minister’s relevance test to that offence and the professional alternative JBD submitted? What will health observers contribute, who will act, and when? Evidence note E3; Evidence note F2.
F.14 Ministers must turn the remedy into precise regulations. Address remaining possession, premises, prescribing and product rules, and instructions for delivery. That work should begin now.
F.15 A sufficient response must put R1 protection and R3 information into effect now. Correct Parliament’s account under R2. Supply or precisely account for the R4–R5 records. Set R6 monitoring that identifies patient effects. Deliver R7 reform and show it works. Ministers must use independent ACMD advice to inform their decisions, without delaying protection or legislative work. Publish owners, dates and evidence of delivery. Keep R1 until reform demonstrably protects patients.
Return to conclusions and recommendations
F4 Legal implications and possible routes for review
F.16 Courts can review regulations even after Parliament approves them. Public Law Project explains that courts may invalidate regulations made outside the granted power (§§22–23). Parliamentary scrutiny cannot shield Government’s use of those powers from review. A court would examine the legal ground put before it. The documentary finding in C.11 separately requires correction. R (Public Law Project) v Lord Chancellor [2016] UKSC 39.
F.17 Parliamentary privilege protects proceedings from challenge in court. Wilson distinguishes those proceedings from review of executive conduct (§§55–60/65–67). Parliamentary material can be used for recognised purposes, including background, within that boundary. A legal challenge must respect it. Government still answers for its own decision and explanation. Wilson v First County Trust Ltd (No 2) [2003] UKHL 40.
F.18 A defendant may sometimes challenge the validity of a rule underlying a criminal charge. Boddington recognises that route, subject to the governing statute. Mr Boddington could raise the challenge but lost on the merits. He bore the burden. A section 18 case would depend on its statutory context and the legal grounds advanced. Boddington v British Transport Police [1998] UKHL 13.
F.19 In England and Wales, judicial review must normally be brought promptly and within three months of the grounds arising (CPR 54.5). A challenge to the 2018 making is far outside that period. An extension, later decision or other route needs specific legal analysis. That difficulty gives Government no reason to delay correcting its account or removing the patient offence. Evidence note C6; Evidence note F1.
Source catalogue
Citations give source pages or paragraphs. Public links open the publisher’s page. Word’s private-source links open the accompanying evidence folder; keep it beside the document. The PDF links open appended records. Its index gives physical pages for print readers. The searchable transcription is a reading aid for scanned papers. The supplied originals remain the authority.
Legislation and legal guidance
Equality Act 2010 Schedule 1 paragraph 6(1) at 11 October 2018 — Open original
Equality Act 2010 section 149 at 11 October 2018
Publisher route: https://www.legislation.gov.uk/ukpga/2010/15/section/149/2018-10-11 Open original
Human Medicines Regulations 2012 consolidated text
Publisher route: https://www.legislation.gov.uk/uksi/2012/1916/contents Open original
Human Medicines Regulations regulation 214 consolidated comparison
Publisher route: https://www.legislation.gov.uk/uksi/2012/1916/regulation/214 Open original
Human Medicines Regulations regulation 214 publisher text
Publisher route: https://www.legislation.gov.uk/uksi/2012/1916/regulation/214 Open original
Misuse of Drugs Act 1971 consolidated text
Publisher route: https://www.legislation.gov.uk/ukpga/1971/38/contents Open original
Misuse of Drugs Act Schedule 4 penalty table
Publisher route: https://www.legislation.gov.uk/ukpga/1971/38/schedule/4 Open original
Misuse of Drugs Act section 18 publisher text
Publisher route: https://www.legislation.gov.uk/ukpga/1971/38/section/18 Open original
Misuse of Drugs Regulations 2001 consolidated text
Publisher route: https://www.legislation.gov.uk/uksi/2001/3998/contents Open original
Misuse of Drugs Regulations regulation 16A publisher text
Publisher route: https://www.legislation.gov.uk/uksi/2001/3998/regulation/16A Open original
PACE Code G arrest guidance for England and Wales
Publisher route: https://www.gov.uk/government/publications/pace-code-g-2012/pace-code-g-2012-accessible Open original
Road Traffic Act 1988 section 5A
Publisher route: https://www.legislation.gov.uk/ukpga/1988/52/section/5A Open original
SI 2018/1055 made 9 October 2018
Publisher route: https://www.legislation.gov.uk/uksi/2018/1055/pdfs/uksi_20181055_en.pdf Open original
SI 2025/1249 statutory amendments
Publisher route: https://www.legislation.gov.uk/uksi/2025/1249/contents/made Open original
Patient case study: Sal Aziz, Rex v Saleem Aziz, 10 February 2026, published by PatientsCann UK; case chronology pp20–24. Supporting participant-published hospital record (6 August 2023), CPS SAR p1/pp18–19 and prescription appendix pp1–2. Narrative only; raw records are not appended. Public participant account
Policy advice and parliamentary records
NHS labelling and packaging of unlicensed medicines guidance December 2021 published February 2022
NHS Specialist Pharmacy Service Using unlicensed medicines updated 27 June 2024
Publisher route: https://sps.nhs.uk/articles/using-unlicensed-medicines/
ACMD advice 11 September 2018
Publisher route: https://assets.publishing.service.gov.uk/media/5b97a0deed915d665d860037/Consultation_on_Cannabis-derived_medicinal_products.pdf Open original
ACMD assessment covering letter 27 November 2020
Publisher route: https://www.gov.uk/government/publications/cannabis-based-products-for-medicinal-use-in-humans-cbpms Open original
ACMD call for evidence 17 September 2025
Publisher route: https://www.gov.uk/government/calls-for-evidence/cannabis-based-products-for-medicinal-use/cannabis-based-products-for-medicinal-use-call-for-evidence Open original
ACMD call for evidence questionnaire
Publisher route: https://www.gov.uk/government/calls-for-evidence/cannabis-based-products-for-medicinal-use Open original
ACMD work programme update 21 September 2026
Publisher route: https://www.gov.uk/government/publications/acmd-autumn-2026-work-programme-update/acmd-autumn-2026-work-program-update-accessible-version Open original
APCDLO Medicinal Cannabis and the Police guidance
Publisher route: https://www.cicouncil.org.uk/app/uploads/2026/01/APCDLO-Medicinal-Cannabis-Guidance-Version-1.pdf Open original
CMO and NHS England clinician letter 31 October 2018
Publisher route: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/753444/letter-with-guidance-on-cannabis-based-products-for-medicinal-use.pdf Open original
Commons written statement HCWS994 11 October 2018
Publisher route: https://questions-statements.parliament.uk/written-statements/detail/2018-10-11/HCWS994 Open original
JCSI 38th Report 2017–19 Appendix 2, Home Office memorandum 6 November 2018 — Open original
Explanatory memorandum to SI 2018/1055
Publisher route: https://www.legislation.gov.uk/uksi/2018/1055/pdfs/uksiem_20181055_en.pdf Open original
Government response CP171 September 2019
Publisher route: https://assets.publishing.service.gov.uk/media/5d711898e5274a0979d82e0f/government-response-to-the-health-and-social-care-committee-report-on-drugs-policy-medicinal-cannabis.pdf Open original
Home Office ACMD work programme commission 2 June 2025
Publisher route: https://www.gov.uk/government/publications/acmd-3-year-work-programme-2025-to-2028-commissioning-letter/acmd-3-year-work-programme-2025-to-2028-commissioning-letter Open original
Home Office Circular 018/2018
Publisher route: https://www.gov.uk/government/publications/circular-0182018-rescheduling-of-cannabis-based-products-for-medicinal-use-in-humans Open original
Home Secretary commission to ACMD 5 February 2019
Publisher route: https://www.gov.uk/government/publications/cannabis-based-products-for-medicinal-use-in-humans-commission-to-the-acmd/cannabis-based-products-for-medicinal-use-in-humans-commission-to-the-acmd-accessible-version Open original
Impact assessment to SI 2018/1055
Publisher route: https://www.legislation.gov.uk/ukia/2018/129/pdfs/ukia_20180129_en.pdf Open original
Law Commission Criminal Liability in Regulatory Contexts Consultation Paper 195 2010
Publisher route: https://web.archive.org/web/20220119115610/https://s3-eu-west-2.amazonaws.com/lawcom-prod-storage-11jsxou24uy7q/uploads/2015/06/cp195_Criminal_Liability_consultation.pdf Open original
London Drugs Commission The Cannabis Conundrum March 2025
Publisher route: https://www.london.gov.uk/sites/default/files/2025-05/FINAL%20LDC%20REPORT%20-%20The%20Cannabis%20Conundrum%2028-5-25.pdf Open original
Lords Secondary Legislation Scrutiny Committee Sub Committee B HL Paper 205 25 October 2018
Publisher route: https://publications.parliament.uk/pa/ld201719/ldselect/ldseclegb/205/205.pdf Open original
Lords written statement HLWS961 11 October 2018
Publisher route: https://questions-statements.parliament.uk/written-statements/detail/2018-10-11/HLWS961 Open original
Ministry of Justice Justice Impact Test guidance July 2018
Publisher route: https://assets.publishing.service.gov.uk/media/5b6daf8ee5274a1cfa14fb9c/justice-impact-test-guidance.pdf Open original
Sussex Police Drugs Policy 1147 2024 selected extracts
Open document and related exchange · Full evidence collection [Source ID SUSSEX1147]
Written answer UIN 22265 Sarah Jones to James Naish 9 September 2026
Publisher route: https://questions-statements.parliament.uk/written-questions/detail/2026-08-28/22265 Open original
Written answer UIN 3221 Preet Kaur Gill to Stuart Andrew 1 June 2026
Publisher route: https://questions-statements.parliament.uk/written-questions/detail/2026-05-20/3221 Open original
Parliamentary accountability and legal review
UK Parliament: Parliament’s role in secondary legislation —Open original
UK Parliament glossary Affirmative procedure — Open original
UK Parliament glossary Negative procedure
Publisher route: https://www.parliament.uk/site-information/glossary/negative-procedure/ Open original
Definition of the made negative procedure; read with this instrument and memorandum.
Cabinet Office Ministerial Code updated 29 June 2026
Publisher route: https://www.gov.uk/government/publications/ministerial-code/ministerial-code Open original
Sections 1.6(c) and 1.7; current correction and ministerial accountability standards.
R Public Law Project v Lord Chancellor 2016 UKSC 39
Publisher route: https://supremecourt.uk/uploads/uksc_2015_0255_judgment_6c55e80506.pdf Open original
Judgment of 13 July 2016, §§20–23; delegated legislation and review.
Wilson v First County Trust Ltd No 2 2003 UKHL 40
Publisher route: https://publications.parliament.uk/pa/ld200203/ldjudgmt/jd030710/will-2.htm Open original
Judgment of 10 July 2003, §§55–60 and 65–67; parliamentary material and privilege.
Boddington v British Transport Police 1998 UKHL 13
Publisher route: https://publications.parliament.uk/pa/ld199798/ldjudgmt/jd980402/bodd02.htm Open original
Judgment of 2 April 1998, Lord Irvine’s opinion: statutory context, collateral challenge and outcome.
Civil Procedure Rules Part 54 Judicial review
Publisher route: https://www.justice.gov.uk/courts/procedure-rules/civil/rules/part54 Open original
Rule 54.5; England and Wales judicial-review time limits.
Information requests and responses
ACMD reply IC-494733-Z9F5 filed 20 April 2026 letter undated
Open document and related exchange · Full evidence collection [Source ID ACMDFOI]
College of Policing FOIA-2026-094 response 9 July 2026
Open document and related exchange · Full evidence collection [Source ID S18]
CPS 14145 response 17 April 2026
Open document and related exchange · Full evidence collection [Source ID S16]
CPS 14391 response printed 10 July 2026
Open document and related exchange · Full evidence collection [Source ID S17]
DHSC FOI 1652371 reply 13 November 2025
Open document and related exchange · Full evidence collection [Source ID DHSC1652371]
DHSC FOI-1688183 response 17 April 2026
JBD request: 23 March 2026; JBD filing reference: FoI_1D1a. Authority case reference: FOI-1688183.
Open document and related exchange · Full evidence collection [Source ID N03]
DHSC FOI-1712285 response 20 July 2026
JBD request: 19 June 2026; JBD filing reference: FoI_1C1d. Authority case reference: FOI-1712285.
Open document and related exchange · Full evidence collection [Source ID S06]
GMC IR1-5469823870 response email 16 July 2026 with direct line redacted
Open document and related exchange · Full evidence collection [Source ID N06msg]
Home Office FOI2026/03126 response 20 March 2026
Open document and related exchange · Full evidence collection [Source ID S01]
Home Office smoking-options submission, 13 September 2018
Open document and related exchange · Full evidence collection [Source ID S05]
Home Secretary decision email chain, disclosed 16 April 2026
Open document and related exchange · Full evidence collection [Source ID S13]
Earlier Home Office submission about ACMD advice, 11 September 2018
Open document and related exchange · Full evidence collection [Source ID S14]
Home Office FOI2026/06253 response 9 June 2026
Open document and related exchange · Full evidence collection [Source ID S02]
Home Office FOI2026/08343 response 10 July 2026
JBD request: 19 June 2026; JBD filing reference: FoI_1C1c. Authority case reference: FOI2026/08343.
Open document and related exchange · Full evidence collection [Source ID S04]
Home Office IR2026/08630 internal review 20 July 2026
Open document and related exchange · Full evidence collection [Source ID S03]
JBD information request to MoJ 12 January 2026
Open document and related exchange · Full evidence collection [Source ID S15]
MoJ 260112115 response 28 April 2026
Open document and related exchange · Full evidence collection [Source ID S07]
MoJ and HMCTS 260619034 response 16 July 2026
Open document and related exchange · Full evidence collection [Source ID S20]
MoJ and HMPPS 260305036 response 18 March 2026
JBD request: 5 March 2026; JBD filing reference: FoI_2A_HMPPS. Authority case reference: 260305036.
Open document and related exchange · Full evidence collection [Source ID S19]
NPCC FOI 2802 2026 reply 31 March 2026
Open document and related exchange · Full evidence collection [Source ID NPCC2802]
JBD submission to the review
Historical submission: Discrimination by Design, 18 September 2025, submitted 16 October 2025
Submission history: cited by title and date in the 16 October 2025 email. V1 and its attachments are held in JBD’s records and excluded from this travelling package. Read the redacted email body [Source ID M06]. Sources: Read the submission email.
JBD submission email body to ACMD 16 October 2025 with personal email redacted
Open document and related exchange · Full evidence collection [Source ID M06]
Home Office reply and initial smoking extract, 13 March 2026
JBD request: 24 February 2026; JBD filing reference: FOI_1C1. Authority case reference: FOI2026/02862.
Open complete source and context [Source ID HO02862]
Home Office fuller disclosure reply, 16 April 2026
JBD request: 16 March 2026; JBD filing reference: FoI_1C1a. Authority case reference: FOI2026/03841.
Open complete source and context [Source ID HO03841]
DHSC reply to the May patient-assessment request, 8 June 2026
JBD request: 8 May 2026; JBD filing reference: FoI_1C2a. Authority case reference: FOI-1704324.
Open complete source and context
DHSC reply to the original design and implementation request, 25 February 2026
JBD request: 12 January 2026; JBD filing reference: FOI_1D. Authority case reference: FOI-1680704.
Open complete source and context
Government response to ACMD, 21 January 2022
Open complete source and context
NHS England patient registry letter, 12 December 2022
Open complete source and context
Erridge and colleagues, UK Medical Cannabis Registry clustering study, 2026
Open complete source and context
Tait and colleagues, UK Medical Cannabis Registry patient evaluation, 2023
Open complete source and context
Keyu v Secretary of State [2015] UKSC 69, paragraphs 127–134
Bank Mellat (No 2) [2013] UKSC 39, paragraphs 20/74–76
Bolitho v City and Hackney Health Authority, judgment 13 November 1997
McCulloch [2023] UKSC 26, paragraphs 1–2/56–66/83
Equality Act sections 20–21/29 and Schedule 3 paragraph 2(3)
Hristozov v Bulgaria, paragraphs 116–127
NHSBSA private unlicensed cannabis prescribing, FOI-04096, September 2026
Response and original data; supplied data and monthly calculation
NHSBSA private patient-identification limits, FOI-04092, September 2026
NHSBSA NHS unlicensed prescribing information, FOI-04114, October 2026
Bracking v Secretary of State for Work and Pensions [2013] EWCA Civ 1345
Original judgment, paragraph 26
Smoke-free law and penalties in Great Britain
England: Health Act 2006; SI 2007/764; Wales: Public Health (Wales) Act 2017; Scotland: Smoking, Health and Social Care (Scotland) Act 2005
Pre-reform medical licensing and criminal licence conditions
Home Secretary statement, 19 June 2018; MDA section 18(2), 31 October 2018
GMC prescribing guidance on dialogue, adherence and treatment decisions
Current guidance, paragraphs 35, 48 and 51; Current information for CBPM prescribers
Selected original decision records
13 September 2018 smoking-options submission — disclosure attachment B
Original source page 5 of 12
13 September 2018 smoking-options submission continued
Original source page 6 of 12
Home Secretary decision email — disclosure attachment C
Original source page 2 of 3
11 September 2018 Home Office submission — disclosure attachment D
Original source page 8 of 14
11 September 2018 Home Office submission continued
Original source page 9 of 14