The National Health Service (General Medical Services) Regulations 1992 (amendment)
Covers spate of provisions including responsibility of doctors with regards to their patients’ smoking.
- Made 10 March 1992; came into force 1 April 1992; covers England and Wales.
- Requires doctors to advise patients about significance of use of tobacco, diet, consumption of alcohol, and the misuse of drugs, and to advise against smoking as part of service to patients.
The National Health Service (General Medical Services) Amendment (No. 2) Regulations 2001
Makes nicotine patches and gum available on prescription on the NHS to treat smoking dependency.
- Made 26 March 2001; England and Wales; came into force 17 April 2001 in England and 1 May 2001 in Wales.
The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 2001
Concerns the sales status of many nicotine replacement therapies (NRTs).
- Made 10 May 2001, UK wide; came into force 31 May 2001.
- Amends Medicines General Sales List to alter status of many NRTs from being a controlled drug available under the supervision of a pharmacist to one available on general sale.
The Value Added Tax (Reduced Rate) (Smoking Cessation Products) Order 2008
Reduced rate of 5% VAT set out in the Value Added Tax Act 1994 applied to pharmaceutical products designed to help people to stop smoking tobacco sold over the counter. Consumer e-cigarettes are taxed at the standard 20% VAT rate, any licensed as medicines would attract 5% VAT.
Health and Social Care Act 2012
Wide-ranging Act introducing major structural changes affecting NHS, public health, and adult social care; only changes relevant to the provision of stop smoking services and wider tobacco control in the NHS and between the NHS and local authorities included below. See Explanatory Memorandum for more information and background.
- Made 27 March 2012, came into force 1 April 2013.
- Gave responsibility for NHS commissioning, including of NHS stop smoking services, to NHS England at a national level and clinical commissioning groups (CCGs) at a local level.
- Gave responsibility for health improvement functions, including commissioning and delivery of local stop smoking services, to local authorities.
- Established health and wellbeing boards to facilitate joint working across local authorities and NHS including, but by no means limited to, strategy for addressing smoking.
- Established Public Health England (PHE) as an executive agency of the Department of Health to oversee health improvement and protection, independent but with ministerial oversight – since abolished in 2020 and replaced by Office for Health Improvement and Disparities (OHID).
- Established NHS England as a body to oversee operation of CCGs and allocate funding to them.
- Established the National Institute for Clinical Excellence (NICE) as a non-executive agency of the Department of Health responsible for guidance and quality standards for social care; later extended to all health and public health care, including guidance for the NHS on smoking.
NHS Long Term Plan 2019
Sets out a 10-year strategy for improving and reforming the NHS in England including for treating tobacco dependency; only tobacco dependency component outlined here (Chapter 2). Commits to providing:
- all people admitted to hospital who smoke NHS-funded tobacco treatment services including bespoke treatment for expectant mothers and their partners.
- a universal smoking cessation offer within specialist mental health services for long-term users of specialist mental health services and those in learning disability services.
Medicines and Healthcare Regulatory Agency (MHRA)
The MHRA is an executive agency of the Department of Health and Social Care which regulates medicines, medical devices and blood components for transfusion in the UK. It is also the Competent Authority for the regulation of consumer e-cigarettes in the UK.
MHRA Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines
- Updated 29 October 2021; UK wide.
- The MHRA seeks to encourage the licensing of electronic cigarettes (e-cigarettes) and other inhaled NCPs as medicines and aims to support companies to submit marketing authorisation applications for these products.
- Products should meet the standards of quality, safety and efficacy as defined under medicines regulations.
- In addition to the medicine’s authorisation, where the E-cigarette is refillable and re-useable it will need to meet the UK Medical Device Regulations 2002 (as amended)
MHRA guidance on E-cigarettes: regulations for consumer products
The MHRA is also the Competent Authority for the notification scheme for e-cigarettes and refill containers in Great Britain and Northern Ireland, and is responsible for implementing the majority of provisions under Part 6 of the Tobacco and related Products Regulations (TRPR) and the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020, which
- restrict e-cigarette tanks to a capacity of no more than 2ml
- restrict the maximum volume of nicotine-containing e-liquid for sale in one refill container to 10mlrestrict e-liquids to a nicotine strength of no more than 20mg/ml
- require nicotine-containing products or their packaging to be child-resistant and tamper evident
- ban certain ingredients including colourings, caffeine and taurine
- include new labelling requirements and warnings
- require all e-cigarettes and e-liquids be notified to the MHRA before they can be sold
National Institute for Health and Care Excellence (NICE) Guidance – Tobacco: preventing uptake, promoting quitting, and treating dependence (update)
NICE is an executive non-departmental public body, sponsored by the Department of Health and Social Care. It provides guidance on smoking cessation treatment, advice to smokers, and some wider tobacco control measures in the NHS in England and Wales.
- Published 30 November 2021 following consultation; England and Wales.
- Recommends that health practitioners talk to smokers about e-cigarettes as a quitting aid and offers guidance on how to talk to patients about e-cigarettes.
- Recommends that e-cigarettes are made available for sale in secondary care settings.
- Recommends that incentive schemes are used to support pregnant women to quit smoking.
- Recommendations on mental health services reiterate importance of supporting smokers with a mental health condition to quit as well as their carers, and others in their household.
Devolved nations
- Stop smoking guidance for health services in Scotland.
- Regulations on provision of NRT in Scotland.
- Responsibility of doctors in Scotland with regards to their patients' smoking.