Evidence note D report V4.5
Justice by Design report analysis; not an independent source. Originals preserved separately.
D.1CP171 calls the regulatory regime proportionate and links patient access to unmet licensed-medicine need. HO03126 acknowledges that the Home Office had its own s149 duty when making the legislation; it holds no responsibility-allocation record and explains that each authority bears the duty for its own functions.
D.2Section 149(1) sets the three due-regard aims. Subsection (3) addresses disadvantage and different needs; subsection (4) expressly requires steps to take account of disabled persons' disabilities in meeting their different needs. Subsection (6) recognises that compliance may involve more favourable treatment, without permitting conduct otherwise prohibited by that Act. Government must demonstrate its patient-specific consideration. The duty concerns what decision-makers actually considered. Government must produce that consideration and its supporting evidence, whatever title or form the records take.
D.3The adviser's information response: ACMD's reply to the 12 January 2026 request, case IC-494733-Z9F5, answered ‘No information held’ to questions 3–7 covering criminal-law awareness, advice versus implementation, emergency self-administration, equality and vulnerable cohorts, and engagement with the explanatory memorandum or impact assessment. It referred to earlier advice for the route question. The response identifies a gap in the held record answering those questions; Government must supply the assessment supporting the criminal consequence it chose. The letter is undated and is filed as received on 20 April 2026. ACMD reply pp1–2.
D.4Earlier requests used an incorrect account of exemption withdrawal and remaining-stock liability. Evidence note A4 identifies the direct offence: smoking itself is prohibited even where supply and possession are lawful. The 19 June request expressly asked about a patient lawfully possessing prescribed medicine who then smoked it, alongside the source of DHSC’s assessment and equality consideration. That request is reproduced with the July reply. The earlier wording cannot dispose of this corrected question.
D.5Finding: after the stated searches, the Home Office reports no held information answering these targeted source, assessment, behaviour, consequence and equality questions. The 13 September briefing remains evidence of the assessment recorded there. Government has not demonstrated the underlying patient-specific scrutiny sought by these requests.
D.6Assessment inquiry: DHSC FOI-1712285, 20 July 2026, response pp1–2; actual 19 June refined request pp3–4. Questions ask for what informed the low-likelihood/narrow-circumstances assessments, source categories and source records. DHSC says relevant information is held but invokes s12 cost grounds. Its discretionary account quotes EM7.17's health/enforcement reasons and expressly acknowledges that this does not directly answer the assessment-source request. It contains a 13 September 2019 date in that explanation; the attached/requested briefing and its later reference are 13 September 2018. The original submission is dated 13 September 2018.DHSC FOI-1712285, 20 July 2026
D.6aThe refusal sequence: the 8 May request (JBD FoI_1C2a) asked about DHSC’s role, the recognised patient circumstances and consequences. DHSC replied on 8 June (FOI-1704324), confirming relevant information was held but refusing on cost grounds. The 19 June refinement (JBD FoI_1C1d) narrowed the question to the recorded basis of the specific assessment. DHSC’s 20 July reply (FOI-1712285) again confirmed relevant held information and refused on cost grounds. The second request narrowed the first; DHSC still confirmed relevant held information and refused disclosure.
D.7The approximately 640-file sample appears in two replies. FOI-1688183 of 17 April, Q4 pp2–3, addresses development and communication and estimates £553.33 to review a sample. FOI-1704324 of 8 June, p1, also reports about 640 potentially relevant files and an estimated £553 for its patient-assessment request. Both say a full response would exceed the £600 limit. The April request carries the old exemption-loss premise. The repeated estimate does not establish that the underlying sets are identical or independent. N03 complete reply DHSC 8 June reply, p1
D.8DHSC’s assessment responses confirm relevant held information but refuse disclosure. The 640-file figure counts potentially relevant files, leaving their assessment and warning content undisclosed. It occurs in both the April communication answer and June assessment answer; the estimates must neither be added nor treated as independent corroboration. What has actually been assessed remains a disclosure question.
D.9Printed p4 requires a JIT for all new proposals potentially affecting justice, with evidence and MoJ agreement even for expected minimal impacts. Page 5 calls for early engagement, ideally clearance before Cabinet write-round and justification/discussion of new or amended/extended criminal offences before JIT submission. Page 6 says the old Criminal Offences Gateway is discontinued, while the Criminal Courts and Criminal Law Policy Unit continues scrutiny of new/significantly amended offences, including those owned by other departments. Checklist p8 addresses necessity/proportionality, penalties and effects on investigations/prosecutions; pp8–9 cover courts, legal aid, prisons and volumes.
D.10Application: regulation 16A(3) added a prohibited act using section 18(1); impact assessment A.2 expressly identifies justice agencies. Both the potential-impact limb and criminal-law engagement are material questions. Calling section 18(1) pre-existing does not explain how the newly prohibited act and its justice impacts were handled.
D.11Pair: 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.12The response says no information is held in scope because MoJ is not the appropriate authority and refers to Home Office. It does not describe a JIT-specific search. The request carries the obsolete exemption-withdrawal premise and described its documentary chronology as complete; neither premise describes the legal mechanism or complete record established here. The criminal-consequence/proportionality questions remain relevant to the direct offence now correctly identified.
D.13The request and reply did not produce the justice assessment or engagement record. The reply identified no search by the relevant Justice Impact Test or criminal-law functions. Government must obtain the record from those functions and the Home Office, and show how it followed the July 2018 process.
D.14The law-reform distinction: paragraph 1.12 includes offences regulating chemists because they are linked in advance by licensed trade. It excludes public illegal-drug offences on the basis that users or dealers generally become identifiable in legal terms through the offence. Appendix D.38 assumes that regulatory offences mainly affect businesses. Paragraph 2.24 nevertheless recognises that many of the paper's issues also matter beyond its scope. That leaves its reasoning available for comparison without attributing a patient finding to the Commission.
D.15The 2018 business checks: the impact assessment's first page records ‘RPC Opinion: Not applicable’ and ‘Not a regulatory provision’. Its p24 checklist contains a single Business Impact Target row, marked ‘Not in scope of BIT’, and describes assessment of economic effects on business and civil society organisations. ‘Not a regulatory provision’ is a technical business-target classification, not a finding that the measure has no regulatory or criminal effect. The patient’s criminal burden therefore needs assessment in its own right.
D.16The patient gap: a person lawfully prescribed a CBPM is identifiable through prescribing and dispensing before the prohibited smoking act. The rationale for setting unidentified illegal-drug users outside the regulatory review does not describe that patient's position. The business-target entries do not assess the personal criminal burden either. This is the report's analysis of the categories: neither supplies a patient-specific justification for the additional offence. Government must identify where that justification was tested.
D.17Government cannot point to the Law Commission’s exclusion of public illegal-drug offences, business-target checks or the Lords committee’s consideration as an answer to the patient assessment. Each addressed a different question. Evidence note C2 records the committee’s account. Government must identify the actual patient and justice scrutiny supporting this offence. Evidence note D4 and Evidence note D5 identify the records required.
D.18Wednesbury rationality is a demanding public-law standard. Keyu, paragraph 127, identifies irrationality and relevant considerations among review grounds. Government must explain how it considered the recognised patient benefit and professional alternative before choosing personal criminal liability.
D.19Article 8 protects private life, including autonomy in medical treatment. Hristozov §§116–127 recognises that interest but accords a wide regulatory margin and finds no violation. Bank Mellat (No 2) §§20/74–76 identifies proportionality questions: important aim, rational connection, a less intrusive workable measure and fair balance. Government must answer those questions for the additional patient offence, rather than simply describe the overall regime as proportionate.
D.20Hristozov upheld refusal of access to unauthorised experimental products, including for seriously ill applicants. The majority considered the fair balance maintained and held that a general rule without individual exceptions was not automatically contrary to Article 8 (§§124–127). Here lawful prescribing already exists and the measure adds personal criminal liability for a route of use. Government cannot rely on a judgment about access to unauthorised products to answer why patients face extra punishment within treatment already lawfully prescribed. It must justify that distinct burden.
D.21Reasonable adjustments concern the actual covered provider or authority, the disability-related substantial disadvantage and reasonable lawful steps within its powers. Equality Act sections 20–21 and 29 govern that analysis. Schedule 3 paragraph 2(3) excludes the preparation and making of a ministerial statutory instrument from section 29. The Minister’s separate section 149 public sector equality duty remains. The report therefore tests lawful care, communication, equipment and handling arrangements under the adjustment lens, while requiring the Home Office to demonstrate legislative equality scrutiny separately.
D.22Bolam and Bolitho concern professional clinical judgment, supported by responsible medical opinion and capable of logical analysis. McCulloch [2023] UKSC 26, paragraphs 1–2, 56–66 and 83, explains both that practice test and its relationship with the duty to discuss reasonable alternatives and material risks. A prohibition cannot substitute for patient-specific assessment of available treatment options. A clinical judgment against smoking still leaves Government to justify the separate decision to punish the patient.
D.23The practical fairness test asks what a careful person could reasonably do given their urgent symptoms, knowledge, experienced relief, usable alternatives and support. In R v Quayle [2005] EWCA Crim 1415, paragraphs 54–57 and 67, the Court rejected a medical-necessity defence overriding the then policy against medicinal cannabis, while leaving exceptional necessity cases open. The 2018 scheme now permits lawful prescribing. Government should provide clear statutory protection. Temporary disruption illustrates why that protection matters; patients should not have to prove necessity before receiving it.
D.24The five standards expose different parts of the same decision: whether Government acted reasonably, justified the extra punishment, considered disabled patients properly, respected sound clinical reasoning and faced the patient’s practical circumstances. Government must answer each relevant test with evidence. A general warning about smoking cannot discharge them all. F1 brings those questions into the case for removing punishment while retaining professional controls and patient care.