Evidence note A report V4.5

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

A.1CP171 introduces its Dutch comparison in §26. Paragraph 28 begins “As in the UK” and states that prescriptions “are only written when other licensed medicines have not been effective”. Its preceding bullet also specifies a named-patient basis. This is Government's own account to Parliament of the UK prescribing premise, expressed through the comparison.

A.2The clinician letter p2 expects an unmet need that cannot be met by a licensed medicine and exhausted established treatment options. It identifies the unlicensed/specials context, specialist prescribing and auditable safeguards. The letter's scope is expectations for NHS and private practice in England. Its account of authorised products describes the position in 2018.

A.3ACMD p4 says unlicensed products should be considered a last resort, used only when no drug with MHRA marketing authorisation meets the clinical need. Pages 3–4 set out three proposed access routes. Government’s own policy and clinical advisers therefore placed unlicensed prescribing in a last-resort setting. Evidence note A2 gives the statutory conditions for each access route.

A.4Finding: Government placed the relevant unlicensed prescribing pathway in a last-resort setting. The report tests the additional personal criminal burden imposed on that pathway. Evidence note A2 identifies the statutory product category and access conditions.

A.4aThe patient question predates 2018. A Lords committee in 1998 proposed prescription as the medical/recreational dividing line; in 2001 it criticised reliance on prosecution discretion for genuine therapeutic users without a viable alternative. Those earlier warnings sharpen the question Government must answer about the present lawful prescribing system.

A.5SI 2018/1055 was made on 9 October, laid on 11 October and took effect on 1 November 2018. Regulation 3, p2, introduced the CBPM definition; regulation 4, pp2–3, inserted regulation 16A and its smoking ban. The category and personal ban were introduced together. It covers England, Wales and Scotland (1(3)); related scheduling changes are at pp3–4, and the Explanatory Note at p5. SI 2018/1055

A.6The definition requires a product that: (a) is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative, with the stated dronabinol/stereoisomer exclusion; (b) is produced for medicinal use in humans; and (c) is a medicinal product, or a substance or preparation used as, or to produce, an ingredient of one. Products covered by paragraph 5 of Part 1 of Schedule 4 are excluded. Street cannabis does not qualify merely because someone uses it therapeutically. A prescription is not a condition of the definition, so the smoking ban is not confined to prescribed users.

A.7All six paragraphs of the inserted regulation do distinct work:

A.8A 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.9The research exception forms part of regulation 16A(3). Regulation 13 concerns Secretary-of-State-approved premises for cannabis research and the operation of section 8 of the 1971 Act. MDR regulation 13

A.10Offence: MDA section 18(1) makes contravention of regulations under the Act an offence, excluding regulations made under s10(2)(h)/(i). Those provisions concern doctor notification of addiction and licensed prescribing/supply to addicted persons; they do not describe 16A(3). Section 18 is the direct offence machinery.

A.11The 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.12Government's description: DHSC FOI-1688183, 17 April 2026, p1, expects communication that smoking is illegal and a criminal offence. Pages 2–3 set out professional responsibilities and refer sanctions to the Home Office/police. DHSC now expressly expects patients to be told about the criminal consequence created by the provisions above.

A.13The consolidated law retains regulation 16A(3), the section 18(1) offence and its penalty mechanism. Evidence note A3 explains the statutory comparison; the original 2018 instrument establishes the enactment. Evidence note A3

A.14The statutory comparison asks whether the medicines and controlled-drugs laws governing prescribed medicines in Great Britain single out another medicinal-product category for an equivalent personal ban on how a patient takes it. Table 2 addresses the professional, premises and prepared-opium provisions alongside the cannabis rule.

A.15Statutory sources and scope: the comparison uses the Human Medicines Regulations 2012, Misuse of Drugs Regulations 2001 and Misuse of Drugs Act 1971 in consolidated form, alongside the original SI 2018/1055. It concerns Great Britain, the extent of that instrument. Northern Ireland’s separate medicinal-cannabis regime is outside this comparison.

A.16Exact comparison: HMR 214(2) prohibits parenteral administration otherwise than to oneself unless the administrator is an appropriate practitioner (with the stated approved-country exclusion) or acts on that practitioner's directions. 255(1)(b) supplies the offence for breach. It cannot criminalise what 214(2) expressly excludes. 215 addresses a supplementary prescriber in that capacity. By contrast, 16A(3) expressly addresses self-administration of the defined medicinal product. This textual contrast supports the finding within the statutory comparison described above.

A.17Scope of the statutory comparison: the Human Medicines Regulations, Misuse of Drugs Regulations and Misuse of Drugs Act were examined for express restrictions on smoking, self-administration and administration. The comparison included the operative medicines offences, the professional and product controls, the prepared-opium rule and the premises offence. The statutory distinctions are shown in Table 2. The finding concerns an express personal prohibition on a defined medicinal-product category and route within this framework.

A.18Versions and amendments: the consolidated legislation retains the 2018 prohibition and direct section 18 offence. The provisions in SI 2025/1249 concern hospital aseptic facilities, pharmacy technicians and supply or possession arrangements; they do not amend regulation 214(2), regulation 16A(3) or the relevant section 18 penalty row.

A.19Finding: within the framework compared, CBPMs alone are expressly singled out as a medicinal-product category for this personal prohibition on a route of self-administration. The statutory comparison distinguishes the separate prepared-opium offence, premises liability and professional controls.

A.20Drug-driving checks already recognise prescribed THC. In England and Wales, regulation 2 of SI 2014/2868 sets the delta-9-THC blood limit at 2 microgrammes per litre. Road Traffic Act section 5A(3)–(5) provides a conditional medical defence, including prescribed or supplied medical use, compliance with directions and lawful possession. Once sufficient evidence raises the defence, the prosecution must disprove it beyond reasonable doubt. National police guidance, p5, applies the drug-driving law to medicinal cannabis; CPS reply 14391, p2, points to its defences guidance. Those provisions show that the system can check prescribed use. Protecting patients who smoke contrary to directions requires the separate amendment recommended here. Section 5A; Specified THC limit; Police guidance p5; CPS reply p2

A.21Regulation 10(2) authorises possession of Schedule 2/3/PartI-of 4 drugs for medical, dental or veterinary administration under specified practitioners' directions, subject to its actual exclusions. Those exclusions address undisclosed concurrent controlled-drug supply and false declarations/statements to obtain supply. Regulation 16A(1)/(2) separately governs CBPM orders and supply. A lawful clinical supply and possession scenario is therefore a real statutory category.

A.22The patient's smoking is independently prohibited by 16A(3), and section 18(1) supplies the offence. Neither provision says that smoking automatically cancels a prescription, withdraws all possession authority or makes every remaining dispensed quantity unlawful. Whether particular possession remains authorised depends on its own facts and statutory conditions. The direct act offence is the basis of this report's analysis.

A.23Patient consequence: a patient can lawfully obtain medicine and commit a separate offence through the way they take it. Government must justify the burden on the last-resort prescribing system it describes.

A.24The recommendation protects patients using their own lawfully prescribed medicine whether or not the departure from the instructed route was urgent. Temporary unavailability or unusability illustrates a serious case; it is not the legal threshold proposed. The current rule contains only its research exception.