Evidence note E report V4.5

Justice by Design report analysis; not an independent source. Originals preserved separately.

E.1Home Office says it holds no record of when/by whom the specified information is given or of an allocated ensuring authority, and points to DHSC/the healthcare system. DHSC says information is held; prescriber/pharmacy communication is expected to include illegality/criminal offence; regulators provide professional assurance; sanctions belong with Home Office/police. It invokes s21 published material for questions 1/2, including clinic information and regulator/legal routes, and s12 for the development/implementation question.

E.2GMC answer 1 says the 16A(3) communication issue has not been a specific consideration. Its substantial general-standards explanation addresses competence, consent, prescribing and patient decisions. Answer 3 cannot identify another responsible body because GMC has not considered the matter; answer 4 holds no situation-specific allocation information.

E.3Finding: the replies establish professional expectations but do not demonstrate that an identified lead secured the whole communication pathway for this criminal risk and checked its delivery. Evidence note A4 corrects the historical exemption-loss account used in the request and reply. The finding concerns responsibility for this consequence.

E.4CPS 14391, printed 10 July 2026, pp1–3: the questions concern systems for identifying lawful-prescription assertions and relevant decision-making and Road Traffic Act information. Page 2 reports no requested central recording or case-system keyword facility; manual review would exceed £600/24 hours. Its 4,328 charged offences are a broad drugs-offence category used in a cost example, not a count of CBPM patients or regulation 16A(3) prosecutions. CPS expressly holds relevant question 3 information and invites a fresh request. The letter says the request was received 20 July 2026, after its printed 10 July date; that internal date conflict remains unresolved.

E.5MoJ 260619034, 16 July 2026, pp1–2: actual 19 June questions concern identifying proceedings with lawful-prescription assertions and policy material about differentiation/monitoring. Administrative HMCTS/MoJ systems cannot supply the requested evidential detail. If held, it is in court case records held for court purposes, outside MoJ's FOI holding position. Policy questions are referred to DHSC. Government must identify a workable way to use the underlying case records to account for affected patients.

E.6Finding: these replies fail to supply a retrievable patient-outcome account through the requested systems. Government must show how monitoring identifies the affected cohort and evaluates the criminal consequence. The replies concern recognition of prescribed cannabis generally. Government still owes an account identifying the patients affected by this offence.

E.7HCWS994 p2/HLWS961 pp2–3 promise monitoring; CP171 paragraph 32 renews it. The 2019 commission, p1, excludes ‘Any associated criminal offences for cannabis as summarised in Schedule 4’, while p3 invites advice on amending the regulations. The section 18(1) offence and penalty appear in Schedule 4. These are concurrent features of that historical commission; the exclusion is not attributed to the current review. HCWS994 p2; HLWS961 pp2–3; CP171 §32; The 2019 longer-term commission

E.8Current commission: the Home Office letter of 2 June 2025 seeks assessment of the legislation's desired impact and unintended consequences, with lessons for research. It does not repeat the 2019 criminal-offences exclusion. ACMD's call of 17 September 2025 seeks evidence on the 2018 changes, intended impact and unintended consequences; it likewise does not repeat the exclusion. Questionnaire questions 16 and 18 address patient issues and improvements; 19 legislative challenges; 20 impact and unintended consequences; and 24 public legal awareness. Those subjects expressly accommodate the patient issue and require an answer in the current review.

E.9The minister's explanation of scope: Sarah Jones's written answer to James Naish, UIN 22265, answered 9 September 2026, concerned cultivation under Misuse of Drugs Act section 6. She explained that the 2 June 2025 commission did not mention cultivation and that it would therefore not be excluded if relevant to the review's scope. She described that scope as the impact of the 2018 changes, intended impact and unintended consequences. She also affirmed ACMD's independence in conducting its work and formulating advice. Written answer UIN 22265.

E.10Application to the patient offence: regulation 16A(3) was inserted by the 2018 instrument being reviewed. The effect of that prohibition on a patient using a prescribed medicine is directly relevant to the impact inquiry. Applying the minister's stated relevance test, that question is within scope. The minister’s relevance test applies even more directly to a rule introduced by the very legislation under review. A deliberately imposed consequence belongs under intended impact without being labelled unforeseen. Evidence note A2; 2018 instrument regulation 4.

E.11On 16 October 2025 JBD sent ACMD an open letter, its early Discrimination by Design briefing dated 18 September 2025 and supplementary Annexes D and E. The preserved outgoing email identifies the submitted documents and explains their relevance to the review. The report’s legal analysis is set out in Evidence note A. Submission email, 16 October 2025

E.12The 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.13Finding: Government's stated relevance test puts the personal smoking prohibition within the 2018 impact inquiry. JBD submitted that issue to the process. ACMD's advice and the Government response should therefore address the chosen criminal burden and the professional-control alternative explicitly. The health bodies' existing observer roles are set out in Evidence note F2. Government must address the issue in its response to the independent advice.

E.14Finding: Government must demonstrate that the cited safeguards connect and work for prescribed CBPMs, with accountable recognition, handling and care. The smoking offence adds criminal exposure to the recognition and care problems shown by these replies.

E.15Patient-first recognition at the first encounter: APCDLO’s guidance p3 treats lawful prescribed possession like possession of other controlled medicines. Page 4 tells officers to approach people with medicinal cannabis as patients and pursue prescription checks through packaging, dispensing information, identification and, where needed, the prescriber or clinic. It advises against further possession-related action without justified grounds to reject lawful prescription. These are practical safeguards against avoidable arrest, seizure and treatment interruption. Page 5 separately states that smoking is prohibited. The guidance supplies a patient-first starting point, rather than an exception to the smoking offence; it offers general CDLO referral but no smoking-specific enforcement-and-care pathway. R1 seeks implementation across enforcement and prosecution; R7 addresses the remaining legal exposure. The cover says February 2025 and the closing page November 2025. APCDLO guidance pp4–5

E.16National guidance and its governance: NPCC's reply 2802/2026, dated 31 March 2026, identifies the APCDLO/NPCC Drugs Portfolio guidance published through the College of Policing in February 2025, and directs arrest, seizure and verification questions to it. It reports no additional national training products, no separate written interagency coordination material beyond that guidance, and no recorded ownership or review mechanism within NPCC, which it says was being established. Page 4 says review arrangements and timelines had not yet been formally set following a change of portfolio leadership. Government must demonstrate how that national ownership and review gap has been resolved. NPCC response pp2–4.

E.17Sussex Police Drugs Policy 1147/2024, section 5.3, p5, states that lawfully prescribed CBPM should not be confiscated. Sections 6.4–6.5, p6, address arrest necessity and include ‘Not smoking cannabis within public view’ among factors that may make arrest unnecessary. The policy supplies a possession safeguard, but no smoking-specific pathway for a lawfully prescribed patient. Government must show how the patient safeguard works at actual encounters. Sussex policy pp5–6

E.18Where discretion stops: regulation 16A(3) determines that a prescription does not make prohibited smoking lawful. The officer still has to assess the product, conduct and relevant circumstances and choose a lawful, proportionate response. In England and Wales, PACE Code G requires both the offence or suspicion element and reasonable grounds that arrest is necessary. Those safeguards govern response; they do not create a prescription exception to the act. This is the immediate burden that remains even if no prosecution follows. Any interruption of treatment already caused cannot be reversed by a later decision not to prosecute. PACE Code G §§1.1–1.4/2.1–2.8; Evidence note A2; Evidence note A4.

E.18aEquivalent patient protection is the recommended operational standard: lawful prescribed possession and use should not themselves trigger arrest, seizure, detention, prosecution or treatment disruption. Prescription evidence and applicable defences should be considered promptly, before avoidable escalation. Any separate grounds for action should be recorded and treatment continuity secured. Coordinated instructions must be issued through the competent enforcement and prosecution authorities, respecting operational independence, individual case assessment and the different national jurisdictions. While the smoking prohibition remains, guidance cannot remove its criminal exposure; the R7 amendment is needed for that protection. Interim protection should begin immediately and remain until comprehensive reform and its practical delivery are demonstrated. This requires checks of actual handling, treatment continuity, escalation and patient experience; a new policy document alone is insufficient.

E.18bClarity at the point of use: Pete reports varying product instructions, including inhalation-only wording and some no-smoking statements, alongside pharmacy labels specifying vaping. This is his account of instructions encountered, not a market-wide audit. NHS best-practice guidance for unlicensed medicines identifies route, directions and warnings as key information (pp4–5), recommends specific positive route directions (p8), and supports user testing (p5). NHS Specialist Pharmacy Service places responsibility on the prescriber and pharmacist for appropriate patient information. R3 applies those principles to aligned instructions, an explanation of vaporisation and combustion, and a care plan when the route cannot be used. Clearer warnings do not resolve the justification for criminal punishment. NHS labelling guidance pp4–5/8; NHS SPS: Choosing a suitable product

E.19Evidence selected: the last-resort prescribing premise, the recognised patient-benefit example and the direct personal offence are established in Evidence note A and Evidence note B. Published Commission evidence adds reported clinic practice and police-recognition consequences; the following passages identify what those reports establish.

E.20The clinic pathway: the London Drugs Commission's The Cannabis Conundrum, dated March 2025, describes the standard private-clinic process at pp277–278. It says patients sign a waiver confirming they will not smoke a dry-herb prescription or pass it to anyone else; footnote 760 links the smoking offence to regulation 16A(3) and section 18(1). The Commission’s account shows how the criminal rule reaches the clinic’s instructions to its patients. Commission pp277–278.

E.21Prescription recognition and custody: at p281 the Commission reports evidence that even a matching legitimate prescription is not always understood or accepted, and that a patient has on occasion been held overnight while officers follow up with the clinic. Page 282 recommends routine officer awareness of the law and prescriptions; p301 records police challenge to prescribed patients consuming in public. These passages show problems recognising lawful prescriptions and handling patients. The report repeats paragraph numbers 11.71–11.76, so these passages are cited by page. Commission pp281–282/301.

E.22Patient consequence: Government must explain why a prescribed patient bears an additional criminal burden when the published record already describes difficulty securing recognition of lawful prescribed possession. The waiver and custody accounts support a connected information, recognition and care pathway. The statutory burden and the recognised patient circumstances stand on the originals in Evidence note A and Evidence note B.

E.22aAziz: broader patient impact despite prescribed, non-smoked use. The participant-published hospital record of 6 August 2023, pp1–3, records his report of vaporiser use, police removal of his cannabis and subsequent lack of access. It also records clinical distress, hospital attendance and self-discharge before the planned assessment/treatment was completed. A hospital record documenting lost treatment access and observed distress demands attention before a patient reaches the charging stage.

E.22bThe separate driving proceedings: the HMCTS/DVLA notice in the participant-published CPS SAR p1 records the 31 March 2024 offence date, conviction on 13 October 2025 and a three-year disqualification imposed. The complete appeal-hearing record, pp18–19, dated 10 February 2026, records the successful appeal, costs order to be assessed, rejection of prescription expiration as definitive and preference for his evidence on product expiry. Signed prescriptions in the published appendix pp1–2 give vaporisation directions. The 681-day interval describes the proceedings, not medicine deprivation. The appeal ultimately recognised his defence. The prolonged proceedings show why effective protection must operate before that eventual correction.

E.22cSource and significance: the participant published copies of the institutional records. They document his reported loss of treatment access, observed distress and the lengthy proceedings ending in a successful appeal. They show why eventual correction cannot substitute for prompt recognition, care and protection. The report uses the individual account and relevant records; raw medical and court files and unrelated personal details are excluded from the companion archive. Participant account; Hospital pp1–3; CPS SAR p1 and pp18–19; Prescription appendix pp1–2;

E.23The January 2022 response agreed in principle, subject to sufficient data, with ACMD’s recommendation for further assessment: ACMD had identified insufficient evidence to assess all consequences. The response accepted the importance of an official registry, stated NHS-only coverage at that time and described exploration of private-provider data. NHS England’s December 2022 letter identifies its registry as hosted by Arden and Greater East Midlands Commissioning Support Unit on its behalf. That is distinct from the UK Medical Cannabis Registry in the research papers. Government must identify present coverage of the official collection, including private prescribing.

E.24The 2026 clustering study’s Methods derive treatment route from active prescriptions. Its baseline table records smoking among current cannabis consumers before treatment; it is not a measure of continued smoking of prescribed medicine. The 2023 patient evaluation also includes a route-information question. A route field or prescription entry is not an observation of how a patient actually took the medicine. Government needs actual-use evidence to answer that question.

E.25Monitoring should identify relevant populations and denominators, usable routes, interruptions and discontinuation, including people outside successful continuing treatment. Government should state current public and private coverage. Actual-use studies need voluntary participation, confidentiality, data minimisation and safeguards against identifiable disclosures feeding enforcement while the act is criminal. Prescription records are not observations of use; administrative case counts and confidential patient research serve different purposes and should not be casually linked.