Evidence note F report V4.5

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

F.1Recommendation and boundary: remove the additional personal offence for patients smoking their own lawfully prescribed CBPMs, including a departure from instructions. Clinical advice against smoking can remain. Government’s own patient example defeats any claim that benefit was inconceivable. The general recommendation rests on the relationship between lawful supply, health risk and punishment, rather than requiring every patient to fit that example or prove necessity.

F.1aThe medicine has entered a regulated prescribing and supply pathway. Existing professional, product and supply controls address that pathway. They do not prevent every harmful use or patient departure. For that residual conduct, this report favours risk information, access to usable alternatives and continuing care. The 2018 rationale values a simple street-enforcement line, but making genuine patients offenders deliberately sacrifices the prescription distinction that the scheme otherwise recognises. Administrative convenience and the harms of smoke do not, in this report’s judgment, outweigh that additional burden. Government must produce any evidence of diversion or harm to others on which it relies to justify punishing the genuine patient.

F.2Why general protection: clearer warnings or a lower penalty leave the patient an offender. A narrow medical-necessity exception makes protection turn on disputed urgency, available devices and proof at an encounter. Protection limited to a smoking prescription would miss the very patient departure at issue. General protection within the lawful-prescription boundary is clearer and preserves care when clinical advice has not been followed. It leaves controls on illicit possession, supply, product quality and prescribing to be addressed in the amendment and does not authorise smoking in every place or circumstance. The full consequences for possession and premises require precise drafting.

F.2aRapid relief alone does not distinguish smoking from vaporisation: official route information describes rapid onset for both. The practical question is whether a patient can use the available device and obtain timely relief in their circumstances. Pete describes his own experience of obtaining relief. Government must assess practical access to usable treatment. Assessment should examine dexterity, help, equipment reliability and access to workable alternatives without making criminal protection depend on proving those problems.Health Canada, Using a cannabis product, Smoking and Vaping

F.3The available legislative route: Misuse of Drugs Act section 22(1)(a)(i) permits regulations excluding the application of provisions creating offences in prescribed cases. Section 31 provides for different cases and circumstances, statutory instruments and consultation with ACMD. SI 2018/1055 was itself made using sections 7, 10, 22, 30 and 31. Existing delegated powers therefore provide a route to remove the patient's additional criminal burden; a new Act is not a prerequisite to pursuing that correction. The Home Office should bring forward the necessary regulations, with consequential possession, premises, prescribing and product controls addressed in the drafting. Misuse of Drugs Act §§22/31; 2018 instrument preamble.

F.4The 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.5Health bodies already involved: Preet Kaur Gill's answer to Stuart Andrew, UIN 3221, answered 1 June 2026, identifies DHSC, NHS England and MHRA as observers on the ACMD CBPM working group, to support collaboration on health-system impacts. DHSC's reply to JBD, FOI-1652371, dated 13 November 2025, p2, separately confirms its observer role and says the relevant departments will consider the report before acting. Those health bodies are already inside the process; Government must turn that involvement into an accountable response while ACMD forms its independent advice. The Government response should identify their contributions, the action owners and the timetable for resolving the patient burden. Written answer UIN 3221; DHSC reply p2.

F.6The following open questions arise from the assembled evidence and define how Government's response should be assessed:

F.7What recorded patient and clinical evidence informed the assessment attributed to the health department, and the choice to impose an offence in the limited circumstances where benefit was recognised? The Home Office says it holds no requested information; the health department confirms relevant information is held but refuses disclosure. Evidence note D2; Evidence note D3.

F.8What additional risk justifies punishing the genuine patient’s smoking, beyond regulating prescribing and supply, providing usable alternatives and continuing care? Government should distinguish patient departures from irresponsible prescribing and compare general protection with a narrow exception, lower sanction and improved safeguards.

F.9How did Government meet its public sector equality duty when considering these patients and the criminal consequences? It should identify what it considered, rather than rely on calling the system proportionate. Evidence note D1; Evidence note D2.

F.10Why was the direct criminal effect on patients entering the lawful prescribing pathway presented as continuity? How does Government answer C.11’s distinction between policy continuity and the changed patient position? What preparation and approval records explain the published assurance that Nick Hurd and the named officials could confirm the Memorandum’s standard? What further parliamentary advice followed?

F.11What Justice Impact Test, consultation with criminal-law officials, approvals, handling arrangements and cost agreement supported the change? Government must produce the record from the responsible functions. Evidence note D4; Evidence note D5.

F.12Who ensures that patients receive a complete explanation and that prescription checks and care work together? How are patients and outcomes identified? The Crown Prosecution Service says it holds information relevant to question 3 and invites a fresh request; Government must use that route and the relevant records to account for affected patients. Evidence note E1; Evidence note E2; Evidence note E4.

F.13How will ACMD and Government apply the minister’s stated relevance test to the patient offence and the professional alternative JBD submitted? What will the health observers contribute, who will act on the results, and when? Evidence note E3; Evidence note F2.

F.14Ministers must translate the remedy into a precise legal amendment, addressing remaining possession, premises, prescribing and product controls and the instructions needed to put it into practice. That drafting and delivery work should start now.

F.15A sufficient response must put R1 interim protection and R3 patient information into effect now; correct the R2 parliamentary account; supply or precisely account for the R4–R5 records; and set proportionate R6 monitoring. The final corrective act is R7 legal reform with demonstrated implementation. Ministers should use ACMD’s independent advice to inform their own decisions, without treating its report as permission to delay protection or legislative work. Publish owners, dates and evidence of actual delivery; retain R1 until the reformed arrangements demonstrably protect patients.

F.16Parliamentary scrutiny does not immunise delegated legislation from legal review. In R (Public Law Project) v Lord Chancellor [2016] UKSC 39, §§22–23, the Supreme Court explains that courts can review statutory instruments, including instruments subject to affirmative approval, and invalidate an exercise outside the statutory power. Government cannot use parliamentary scrutiny as a shield against review of the powers it exercised. A court would examine the legal defect advanced; the documentary finding in C.11 separately requires Government to correct the account.

F.17Parliamentary privilege also matters. Wilson v First County Trust Ltd (No 2) [2003] UKHL 40, §§55–60 and 65–67, distinguishes Parliament’s proceedings from the courts’ task. It permits use of parliamentary material for recognised purposes, including background and review of executive conduct, while protecting proceedings from impeachment or questioning. A challenge must respect that boundary. The relevant distinction is between protected parliamentary proceedings and the executive’s exercise of legal power. Government remains answerable for its own explanation and decision.

F.18A validity issue can matter in criminal proceedings. Boddington v British Transport Police [1998] UKHL 13, Lord Irvine’s opinion, recognises that a defendant may challenge the lawfulness of a rule or administrative act underlying a charge, subject to the governing statutory context. Mr Boddington was entitled to raise the challenge but lost on its merits; the burden was on him. Its application to a charge under section 18 would turn on that statutory context and the legal grounds advanced.

F.19Timing and scope: in England and Wales CPR 54.5 ordinarily requires judicial review promptly and no later than three months after grounds first arose. A direct challenge based on grounds arising from the 2018 making is far outside that ordinary period. Any extension, later decision or different route requires specific legal analysis. The difficulty of a late legal challenge gives Government no reason to delay correction of the parliamentary account or removal of the additional patient offence. Evidence note C6; Evidence note F1.