Asked by: Sammy Wilson (Democratic Unionist Party - East Antrim)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he has had recent discussions with his EU counterparts on the legality of the proposed generational smoking ban in Northern Ireland.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
In preparation of the Tobacco and Vapes Bill, the Government has considered all its domestic and international obligations. The Government engages with the European Union and member states on a wide variety of issues, including matters relating to Northern Ireland. This engagement is confidential.
Asked by: Sammy Wilson (Democratic Unionist Party - East Antrim)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department (a) sought and (b) received legal advice on the compatibility of the generational smoking ban proposed in the Tobacco and Vapes Bill with the Windsor Framework, particularly in relation to Northern Ireland's regulatory alignment obligations.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
In preparation of the Tobacco and Vapes Bill, the Government has considered all its domestic and international obligations. The Government does not disclose whether it has sought or received legal advice.
Asked by: Sammy Wilson (Democratic Unionist Party - East Antrim)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential enforcement challenges associated with implementing the proposed generational smoking ban in Northern Ireland.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
Measures in the Tobacco and Vapes Bill will strengthen enforcement and will help to ensure the successful implementation of the smoke-free generation policy. Age of sale restrictions for tobacco products are already in place in Northern Ireland, with enforcement led by district councils. The Department of Health in Northern Ireland, through the Public Health Agency, funds tobacco control officers to conduct test purchases and support retailer compliance. These arrangements are expected to continue under the new legislative framework and will include additional products. The Department of Health in Northern Ireland is working closely with councils in preparation for implementation of the smoke-free generation policy on 1 January 2027.
The bill also gives ministers in Northern Ireland the ability to introduce a licensing scheme for the retail sale of tobacco, vaping, and nicotine products. This will strengthen enforcement, support legitimate businesses, and crack down on rogue retailers who breach the law. Once implemented, this will replace the existing retailer register for tobacco products in Northern Ireland.
The Northern Ireland Assembly provided its legislative consent for the Tobacco and Vapes Bill on 10 February 2025.
Asked by: Sammy Wilson (Democratic Unionist Party - East Antrim)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential impact of family hubs on (a) neighbourhood health and (b) the delivery of integrated community-based health services.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
The 10-Year Health Plan outlined proposals for a new Neighbourhood Health Service, which embodies our preventative principle, that care should happen as locally as it can. Neighbourhood health services will build on, and will coordinate with Best Start Family Hubs and Start for Life services to continue to integrate children’s services, National Health Services, and public health.
The Neighbourhood Health Service will mean that millions of patients are treated and cared for closer to their home by new teams of health professionals, providing easier, more convenient access to a full range of healthcare services on people’s doorsteps.
The impact of Family Hubs and Start for Life services will take time to be realised. The current Family Hubs and Start for Life programme is subject to two national, independent evaluations to understand its implementation and impact.
Asked by: Sammy Wilson (Democratic Unionist Party - East Antrim)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many (a) serious but non-fatal and (b) fatal adverse reactions associated with the use of mifepristone have been reported to the Medicines and Healthcare products Regulatory Agency in each of the last 10 years.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses available data, including from the Yellow Card scheme, and seeks advice from their independent advisory committee, the Commission on Human Medicines, where appropriate, to inform regulatory decisions.
It is important to note that a reaction reported to the Yellow Card scheme does not necessarily mean it has been caused by the medicine, only that the reporter had a suspicion it may have. Underlying or concurrent illnesses may be responsible, or the events could be coincidental.
The following table shows the number of Yellow Card reports classified as serious, excluding fatal outcomes, and those with a fatal outcome, received for mifepristone from the initial licensing of the medicine, up to 13 May 2025:
Year | Serious reports | Reports with a fatal outcome |
2015 | 3 | 0 |
2016 | 9 | 1 |
2017 | 25 | 1 |
2018 | 9 | 0 |
2019 | 6 | 1 |
2020 | 8 | 0 |
2021 | 5 | 0 |
2022 | 5 | 0 |
2023 | 2 | 2 |
2024 | 10 | 0 |
2025 | 6 | 0 |
Reports received via the Yellow Card scheme can contain more than one suspect medicine. It should be noted that mifepristone is used in combination with misoprostol, and as such 60 of the serious reports and five reports with a fatal outcome include both products as the suspect drug.
Misoprostol is licenced for a variety of indications, including gastroprotection in duodenal and gastric ulcers, termination of pregnancy, and induction of labour. Mifepristone is licenced for termination of pregnancy and induction of labour.
A list of the possible side effects of mifepristone and misoprostol are provided in the product information document for healthcare professionals, the Summary of Product Characteristics, and in the UK Patient Information Leaflet.
A Yellow Card report is considered serious according to two criteria. Firstly, a reported reaction can be considered serious according to our medical dictionary. Secondly, if the original reporter considers the report to be serious, they can select from the six serious criteria available, which are: patient died due to reaction; life threatening; resulted in hospitalisation or prolonged inpatient hospitalisation; congenital abnormality; involved persistent or significant disability or incapacity; or if the reaction was deemed medically significant.
Asked by: Sammy Wilson (Democratic Unionist Party - East Antrim)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many serious, non-fatal, adverse reactions associated with the use of misoprostol have been reported to the Medicines and Healthcare Products Regulatory Agency in each of the last ten years; and how many fatal adverse reactions associated with the use of misoprostol have been reported to the Medicines and Healthcare Products Regulatory Agency in that period.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses the available data, including from the Yellow Card scheme, and seeks advice from their independent advisory committee, the Commission on Human Medicines, where appropriate, to inform regulatory decisions.
It is important to note that a reaction reported to the Yellow Card scheme does not necessarily mean it has been caused by the medicine, only that the reporter had a suspicion it may have. Underlying or concurrent illnesses may be responsible, or the events could be coincidental.
The following table shows the number of Yellow Card reports classified as serious, excluding fatal outcomes, and those with a fatal outcome, received for misoprostol from initial licensing of the medicine up to 13 May 2025:
Year | Serious reports | Reports with a fatal outcome |
2015 | 10 | 0 |
2016 | 11 | 1 |
2017 | 28 | 2 |
2018 | 4 | 0 |
2019 | 7 | 1 |
2020 | 13 | 0 |
2021 | 19 | 1 |
2022 | 19 | 1 |
2023 | 9 | 2 |
2024 | 21 | 0 |
2025 | 8 | 0 |
Reports received via the Yellow Card scheme can contain more than one suspect medicine. It should be noted that misoprostol is used in combination with mifepristone, as such 60 of the serious reports and five reports with a fatal outcome include both products as the suspect drug.
Misoprostol is licenced for a variety of indications, including gastroprotection in duodenal and gastric ulcers, termination of pregnancy, and induction of labour. Mifepristone is licenced for termination of pregnancy and induction of labour.
A list of the possible side effects of mifepristone and misoprostol are provided in the product information document for healthcare professionals, the Summary of Product Characteristics, and in the UK Patient Information Leaflet.
A Yellow Card report is considered serious according to two criteria. Firstly, a reported reaction can be considered serious according to our medical dictionary. Secondly, if the original reporter considers the report to be serious, they can select from the six serious criteria available, which are: patient died due to reaction; life threatening; resulted in hospitalisation or prolonged inpatient hospitalisation; congenital abnormality; involved persistent or significant disability or incapacity; or if the reaction was deemed medically significant.
Asked by: Sammy Wilson (Democratic Unionist Party - East Antrim)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department plans to make Omaveloxolone available through the NHS.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing evidence-based recommendations for the National Health Service on whether new, licensed medicines represent a clinically and cost-effective use of NHS resources.
The NICE is unable to make a recommendation about the use of omaveloxolone for treating Friedreich's ataxia in people aged 16 years old and over, in the NHS. This is because the company, Biogen, withdrew its evidence submission. The NICE will review its decision if the company decides to make a new submission. Further information is available at the following link:
www.nice.org.uk/guidance/indevelopment/gid-ta11431
NHS England does not fund medicines where the company has not engaged with the NICE. This is to avoid a potential pathway for circumventing the NICE’s appraisal process.
Asked by: Sammy Wilson (Democratic Unionist Party - East Antrim)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the impact assessment for the Tobacco and Vapes Bill, published on 5 November 2024, whether the specified cost of retailer staff training (a) is a one-off cost and (b) reflects ongoing costs in relation to planned secondary legislation relating to that Bill.
Answered by Andrew Gwynne
The estimated familiarisation and staff training costs included in the Tobacco and Vapes Bill impact assessment are assumed to be one-off costs, and individual estimates are provided for each specific policy.
The bill will gradually end the sale of tobacco products across the country, so an individual born on or after 1 January 2009 will never be legally sold these products, including through proxy purchasing. Although it will mean the legal age of sale effectively increases by one year each year, the regulations will not change every year. This means it will be a one-off cost for retailers in terms of training staff.
Some indicative estimates for staff training are included for secondary legislation. This, however, will be subject to consultation and, where proportionate, further work will be completed to assess the costs and benefits of these measures.
We will continue to work closely with retailers to support them in implementing the smoke-free generation policy in the future.
Asked by: Sammy Wilson (Democratic Unionist Party - East Antrim)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will make a comparative estimate of the costs of (a) implementing a one-time increase in the legal purchase age of tobacco and (b) introducing an age escalator, in the context of the Tobacco and Vapes Bill.
Answered by Andrew Gwynne
Smoking is the number one preventable cause of death, disability, and ill health. It causes approximately 80,000 deaths a year in the United Kingdom, one in four of all cancer deaths, and kills up to two-thirds of its users.
Smoking also substantially increases the risk of many major health conditions throughout people’s lives, such as strokes, diabetes, heart disease, stillbirth, dementia, and asthma. Three quarters of smokers wish they had never started smoking but are unable to stop due to the addictive nature of tobacco.
It is estimated that smoking costs the country £21.8 billion a year in England. This includes an annual £18.3 billion loss to productivity, through smoking related lost earnings, unemployment, and early death, as well as costs to the National Health Service and social care of over £2 billion.
On 5 November 2024, the Department published an impact assessment on the Tobacco and Vapes Bill. This found that the introduction of the smoke-free generation policy, the progressive increase in the age of sale, will get smoking rates in England for 14 to 30 year olds to 0% as early as 2050. Over the next 50 years it will save tens of thousands of lives, and avoid up to 130,000 cases of cases of lung cancer, strokes, and heart disease.
The impact assessment explored a one-time age increase, but this has been discounted as it does not achieve the policy objective to prevent future generations from ever taking up smoking and getting smoking prevalence to 0% to achieve a smoke-free United Kingdom. Simply raising the age of sale to one set year will only raise the age that people start smoking, and would not break the cycle of addiction and disadvantage.
Asked by: Sammy Wilson (Democratic Unionist Party - East Antrim)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he plans to include steps to (a) grow and (b) upskill the Parkinson's specialist workforce in the (i) ten year and (ii) long-term workforce plan.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
The 10-Year Health Plan will set out how we will deliver a National Health Service that is fit for the future, with a better service for everyone, regardless of condition or service area. We expect that the long-term workforce plan will need to be updated to reflect that plan, so that we train the staff we need to ensure that all patients are cared for by the right professional, when and where they need it.