Organisational statutory responsibilities related to SI2018/1055

So, what is SI2018/1055?

SI 2018/1055 refers to The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018.

This was a significant piece of legislation in the United Kingdom, because it changed the legal status of cannabis-based products when used for medicinal purposes.

The regulations moved cannabis-based products for medicinal use in humans from ‘Schedule 1’ to ‘Schedule 2’ of the Misuse of Drugs Regulations 2001, allowing specialist doctors to prescribe them. The SI (Statutory Instrument) also established a legal definition for cannabis-based products for medicinal use in humans.

Drug ‘Schedules’

In the context of the Misuse of Drugs Regulations 2001 (UK legislation), drugs are placed in one of five schedules, primarily based on an assessment of their medicinal or therapeutic usefulness and their potential for harm when misused. The schedules dictate the level of control and the circumstances under which the drugs can be lawfully possessed, supplied, or administered.

Schedule 1 drugs

Drugs in Schedule 1 are considered to have no known legitimate medicinal or therapeutic value in the UK and are subject to the greatest restrictions.

Production, possession and supply of Schedule 1 drugs are generally unlawful except under a specific, individual Home Office licence, typically granted only for research or other very limited special purposes.

Schedule 2 drugs

Drugs in Schedule 2 are considered to have therapeutic or medicinal value and can be prescribed by doctors. They are subject to strict controls due to their potential for misuse and potential for addiction.

They can be lawfully prescribed by registered medical practitioners and possessed and used by individuals with a valid prescription. They are subject to specific requirements relating to prescriptions, safe custody/storage and the need to keep formal records/registers of stock and transactions.

The significance of SI 2018/1055 was moving qualifying cannabis-based products for medicinal use in humans from Schedule 1 to Schedule 2, acknowledging their medicinal value and allowing for their legal prescription and use in appropriate clinical circumstances.

So, who decides?

Several Government departments are involved in the deciding on which drugs can be prescribed by which doctors and to which patients. They can also decide on the ‘best’ method of administration of these drugs – seemingly without regard to medical efficacy/outcomes; speed, simplicity and efficiency of administration of the drug; patient safety – and the risk of potential criminalisation. The departments include:

HOME OFFICE

The Home Office is responsible for determining the following (under the Misuse of Drugs Act 1971):

– drug Classes (A, B, C)

– seriousness of an offence (possession, supply, production)

– maximum penalties

– Police powers

The Home Office also determines under the Misuse of Drugs Regulations 2001 (and amendments):

– medical and scientific use

– medical prescribing rights

– medical product licensing

– storage, record-keeping, destruction

Department of Health and Social Care (DHSC)

The DHSC oversees the clinical, therapeutic, and public-health implications of policies affecting medicines and patient care. Their responsibilities include:

– ensuring clinical safety and therapeutic appropriateness

– overseeing prescribing frameworks and specialist access rules

– assessing impacts on patient safety and treatment effectiveness

– aligning policy with MHRA medicines regulation

– discharging the Public Sector Equality Duty for health-related decisions

– evaluating impacts on disabled and clinically vulnerable patients

Advisory Council on the Misuse of Drugs (ACMD)

The ACMD provides independent scientific, medical, and social-harm advice to the Home Secretary on drug control. Their responsibilities include:

– assessing physiological, psychological and social harms

– evaluating therapeutic or medical value

– advising on Class (A/B/C) placement

– advising on Schedule (1–5) suitability and medical legitimacy

– reviewing evidence for policy changes

– advising on risks of criminalisation and misuse patterns

– advising on unintended consequences, misuse patterns and proportionality of proposed controls

Ministry of Justice (MoJ)

The MoJ regulates and oversees the criminal justice consequences of any change to offences, penalties, or criminalised conduct. Their responsibilities include:

– assessing new or amended criminal offences

– evaluating sentencing impacts

– modelling prison, probation, and court workload

– assessing prosecution and legal aid implications

– ensuring proportionality of criminalisation

– ensuring compliance with human rights laws (ECHR)

– identifying discriminatory or unequal justice impacts

Cabinet Office (CO)

The Cabinet Office (including the Equality Hub and Better Regulation Unit) ensures constitutional, regulatory, and cross-government compliance in policy-making. Their responsibilities include:

– enforcing the Better Regulation Framework

– ensuring impact assessments are completed where required

– ensuring Public Sector Equality Duty compliance

– coordinating cross-departmental policy alignment

– reviewing whether policy choices are proportionate and evidence-based

– preventing departments from bypassing scrutiny

Department for Education (DfE)

DfE upholds statutory duties relating to education, safeguarding, and equality, including responsibilities that extend beyond the school system. These include:

– discharging the Public Sector Equality Duty across all protected groups assessing disability, health, and inclusion impacts of government policy safeguarding children and young people affected by cross-government decisions

– ensuring non-discrimination in access to services and public functions providing guidance on public health messaging in educational settings contributing to cross-government equality analysis where health, disability, or children’s welfare are affected.

Note: DfE’s Public Sector Equality Duty responsibilities apply even when DfE is not the lead department.

Regulatory options for the Home Office for the making of SI2018/1055 – consequences and impacts

Government had several options when considering amendments to the Misuse of Drugs Act. These included:

Option 1: categorise medicinal use cannabis as a Schedule 2 drug

This could perhaps be seen as the ‘normal’ UK practice.

– It would aligns with existing medicines’ regulation

– It would remove contradiction between ‘no medical use’ and prescribing

– It would enable plant-based prescribing without discrimination

– It is used by most countries with medical regimes

Benefits of Option 1

Regulatory coherence restored: Cannabis plant and cannabis medicines sit within the same therapeutic framework. There would be no contradiction between “medical use” and Schedule placement

Access pathway stabilised: Clinicians and pharmacists operate within familiar Schedule 2 Controlled Drugs processes – therefore prescribing becomes straightforward.

Equality Act exposure reduced: Disabled patients are not singled out for criminal sanctions because of their preferred method of administrating their medication. Therefore discrimination risks fall to negligible levels.

Research and product development unlocked: Schedule 2 licensing removes major barriers to clinical trials, manufacturing and academic work.

International alignment: Option 1 would bring the UK into line with EU, US and many other countries who treat medical cannabis as a beneficial, effective, controlled medicine rather than a prohibited substance.

Option 2: create a new drugs Schedule sub-category for medicinal-use cannabis (eg, 2A)

Option 2 provides a coherent, bespoke framework

– Allows tight, bespoke controls without misclassifying medical cannabis

– Offers legal clarity without inventing narrow product-based definitions

– Supports consistent clinical guidance and predictable prescribing rules

– Maintains political caution while avoiding structural contradictions

Regulatory coherence restored: A bespoke Schedule 2A creates a clear, internally consistent framework for cannabis-based medicines without misclassifying the plant or creating artificial product categories.

Access pathway stabilised: Clinicians and pharmacists operate within predictable, rule-based prescribing and dispensing processes; guidance is consistent and not dependent on narrow CBPM definitions.

Equality Act exposure minimised: No route-specific criminalisation is required; disabled patients are not singled out for differential treatment, and discrimination risks remain low.

Research and product development unlocked: A dedicated sub-schedule provides a stable legal basis for trials, manufacturing, and academic work without the full barriers of Schedule 1 licensing.

International alignment achieved: Brings the UK closer to jurisdictions using bespoke but coherent medical cannabis schedules, offering tight control without the contradictions of the current framework.

Option 3: keep cannabis in Schedule 1 + create ‘CBPM’ Category and add Regulation 16A(3)

This is the Home Office’s choice

– Leaves cannabis incorrectly classified as “no medical use”

– Creates internal contradiction once prescriptions are allowed

– Imposes criminal liability for a route of administration

– Restricts access through narrow, artificial product definitions

– Generates Equality Act, PSED, and Better Regulation vulnerabilities

Regulatory coherence lost: Cannabis remains “no medical use” in Schedule 1 while cannabis medicines are permitted in Schedule 2, creating a structural contradiction at the heart of the framework.

Access pathway destabilised: Clinicians face inconsistent rules, narrow product definitions, and route-based restrictions; prescribing depends on artificial legal categories rather than clinical judgement.

Equality Act exposure increased: Reg. 16A(3) uniquely criminalises a lawful route of administration, disproportionately affecting disabled patients who rely on inhaled forms for therapeutic effect.

Research and product development constrained: Schedule 1 status maintains significant barriers to clinical trials, licensing, and innovation, preventing the UK from developing or evaluating plant-based products.

International alignment abandoned: No other jurisdiction splits plant and product in this way or criminalises a medical route of administration; the UK becomes a clear outlier.

Why did the Home Office chose Option 3?

Easiest parliamentary route

Option 3 could be delivered entirely by negative resolution, avoiding debate and scrutiny required for Options 1 and 2.

Avoided cross-government involvement

No need for agreement from DHSC, MoJ, Cabinet Office, MHRA by rescheduling or creating new controlled-drug categories.

Enabled fastest implementation

The negative SI allowed the Home Office to move from announcement to law in weeks, not months – crucial (expedient?) during political pressure in 2018.

Preserved maximum departmental control

The Home Office retained full authority over cannabis by keeping the plant in Schedule 1, avoiding any shift of regulatory power toward DHSC/MHRA.

Created the appearance of medical legalisation without substantive reform

Inventing CBPMs allowed the Home Office to claim “medical cannabis is now legal” while avoiding broader rescheduling, market expansion, or patient-led access.

Could the Home Office have made SI 2018/1055 amendment to the Misuse of Drugs Act without 16a3 and how would that affect prescribed patients?

No new criminal offence created

Removing 16A(3) would have avoided creating a unique offence for using a lawful medicine, keeping SI 2018/1055 as a technical amendment rather than criminal reform.

Reduced Equality Act exposure

Without route-based criminalisation, disabled patients are not singled out for differential treatment; discrimination risk falls to baseline.

Prescribing becomes clinically coherent

Clinicians could recommend inhaled administration when clinically appropriate without patients facing criminal liability for following medical advice.

Patient safety improves

Patients could use the most effective and fastest-acting route of administration for symptom control without fear of enforcement or legal ambiguity.

Framework becomes legally defensible

Omitting 16A(3) would preserve the HO’s political caution while avoiding the structural contradiction, PSED breaches, and procedural defects generated by the offence.

A workable but tightly controlled medical regime

SI 2018/1055 would still restrict access – but without creating the incoherent, discriminatory trap that now affects prescribed patients.