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.
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 steps he is taking to reduce the time taken for patients diagnosed with a neurological condition to begin consultant-led treatment.
Answered by Andrew Gwynne
Tackling waiting lists, including for neurology, is a key part of our Health Mission. We are committed to getting back to the NHS Constitutional standard that at least 92% of patient wait no longer than 18 weeks from Referral to Treatment, within our first term.
To reduce waiting times for neurological services, NHS England is working hard to improve the delivery of services for admitted patients with neurological disorders, including at a trust level, whilst also enhancing the use of advice and guidance to optimise referrals, and improving productivity in outpatient services through reducing the number of missed appointments and by optimising follow up systems.
NHS England’s Neurology Transformation Programme is also working to develop guidance for health systems on all aspects of neurology pathway improvement in integrated care systems, including specialised services, secondary care, and community services. This work is focused on improving equity of access to, and timeliness of, care.
Diagnostics, and in some cases surgical procedures, are key parts of the neurological pathways. At the 2024 Autumn Budget, my Rt. Hon. Friend, the Chancellor of the Exchequer announced £1.5 billion of capital funding for new surgical hubs and diagnostic scanners. This will build capacity for over 30,000 additional procedures and over 1.25 million diagnostic tests, as well as new beds, which will create more treatment space in emergency departments, reduce waiting times, and help shift more care into the community.
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 steps she is taking to increase girls' access to mental health services.
Answered by Maria Caulfield
Health policy is devolved to the Northern Ireland Executive. In England, through the NHS Long Term Plan, the Government is providing record levels of investment and increasing the mental health workforce, to expand and transform National Health Service mental health services in England. Almost £16 billion was invested in mental health in 2022/23, enabling 3.6 million people to be in contact with mental health services, a 10% increase on the previous year. Of these, nearly 560,000 were females under the age of 18 years old, a 12% increase on the previous year.
We are rolling out mental health support teams to schools and colleges in England. There are now around 400 mental health support teams in place, covering 3.4 million children, or approximately 35% of pupils. We estimate that this will increase to 44% by April 2024, and we are working to increase this coverage to 50% of pupils by March 2025.
In addition, we announced in October 2023 that £4.92 million would be available for 10 early support hubs in England. We are now providing an additional £3 million to expand the number of hubs to 24 across the country. This £8 million overall package will improve access for children and young people to vital mental health support, offering early interventions to improve wellbeing before their condition escalates further.
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 steps she is taking to improve girls' health.
Answered by Maria Caulfield
Health policy is devolved to the Northern Ireland Executive. The Women’s Health Strategy for England sets out our plans for boosting the health and wellbeing of women and girls. It takes a life course approach, focused on understanding the changing health and care needs of women and girls across their lives, from adolescents and young adults to later life. We recently set out our priorities for 2024, which include actions to improve girls’ health, such as improving care for menstrual problems like endometriosis, continuing to roll out women’s health hubs, and boosting research.
In addition, the Department and the National Health Service have a number of universal public health interventions to improve the health and wellbeing of all children, and respond to further needs and safeguarding concerns. This includes investing approximately £300 million over three years to improve support for families though the Family Hubs and Start for Life programme, the Family Nurse Partnership to support vulnerable young mothers, the Healthy Start scheme to encourage a healthy diet for pregnant women, babies, and young children under four years old from low-income households, and Mental Health Support Teams in schools.
To support our ambition to eliminate cervical cancer, all children aged 12 to 13 years old are offered the human papillomavirus (HPV) vaccine. Due to the success of the adolescent HPV programme, there has been an 87% reduction in cervical cancers for those vaccinated when compared to previous generations.
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 she plans to introduce similar restrictions on nitrites in processed meat products to those set out in European Commission Regulation No 231/2012 on food additives nitrites (E 249-250) and nitrates (E 251-252), published on 1 June 2023.
Answered by Andrea Leadsom
The Food Standards Agency (FSA) considers that existing levels of nitrites and nitrates in the United Kingdom are sufficiently protective for consumers, and they remain important preservatives in a range of foods that control a range of harmful micro-organisms. However, as with all additives, this remains under review.
Given the European Union (EU) changes to levels, the FSA wishes to ensure there are no unintended food safety consequences. The FSA is engaging with stakeholders across the UK to understand the implications of the EU changes on nitrates in processed meat, cheese and fish products and any impacts they may have on industry. It is necessary to understand the ability of industry to reformulate to meet the various transition periods, whilst ensuring foods remain safe. This will support formulation of a UK position on the use of nitrates/nitrites as a food additive in these commodities.