Asked by: Justin Madders (Labour - Ellesmere Port and Neston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what her planned timetable is for publishing a response to the Hughes Report on compensation for patients damaged by sodium valproate, published 7 February 2024.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Government commissioned the Patient Safety Commissioner (PSC) to produce a report on redress for those affected by sodium valproate and pelvic mesh. We are grateful to the PSC and her team for completing this report, and our sympathies remain with those affected by sodium valproate and pelvic mesh. The Government is now carefully considering the PSC’s recommendations, and will respond substantively in due course.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she has made an assessment of the potential implications for her policies of the article in the British Medical Journal entitled Pfizer-BioNTech vaccine is “likely” responsible for deaths of some elderly patients, Norwegian review finds, published on 27 May 2021; and if she will have discussions with the Medicines and Healthcare products Regulatory Agency on the contents of the report.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Following the initial roll out of the COVID-19 vaccination programme in December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) had a comprehensive surveillance strategy in place, enabling continual close monitoring of emerging safety evidence including studies, published literature, and data arising from the widespread use in the United Kingdom and globally. This included the article and Norwegian reports highlighted. The MHRA communicates safety advice based upon consideration of the totality of evidence from all relevant information sources, rather than the strengths and limitations of individual data sources.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if the Medicines and Healthcare products Regulatory Agency will establish an expert review panel to investigate the cause of death for reports of suspected (i) fatal outcomes and (ii) adverse reactions in patients who have received a covid-19 vaccine.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Medicines and Healthcare products Regulatory Agency’s (MHRA) role is to ensure that the benefits associated with a medicinal product outweigh the known risks, at the time of first authorisation and thereafter. Whilst the MHRA seeks expert advice from the Commission on Human Medicines and its expert advisory groups on the likelihood of an association between a COVID-19 vaccine and a safety concern, this is based on the totality of evidence from Yellow Card data, and relevant information from other sources. Should a new link between a medicine and a safety concern be confirmed, the MHRA will take necessary regulatory action, such as updating product information to include a warning for patients and healthcare professionals.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what processes the Medicines and Healthcare products Regulatory Agency uses to determine whether a covid-19 vaccine may have caused (a) fatal outcomes and (b) adverse reactions in patients.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Medicines and Healthcare products Regulatory Agency (MHRA) does not assign causality at the level of individual reports, as this is not the responsibility of the MHRA, and as such a process is not held. The MHRA holds processes for cumulative analysis of Yellow Card data, as well as assessment of data from other sources, for patterns or evidence which might suggest a causal link between the vaccination and the reported reaction, alongside other relevant data. In relation to fatal reports, it is the role of a Coroner to determine the likely cause of death for an individual. The MHRA’s approach to post authorisation surveillance of COVID-19 vaccines is outlined in the published Report of the Commission on Human Medicines Expert Working Group on COVID-19 vaccine safety surveillance.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she has had recent discussions with the (a) Chair and (b) Chief Executive of the Medicines and Healthcare products Regulatory Agency on its statutory function to operate a system of post marketing surveillance in the UK for (i) fatal outcomes and (ii) adverse reactions in patients who have received a covid-19 vaccine.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Medicines and Healthcare products Regulatory Agency (MHRA) fulfils the requirements set out in the Human Medicines Regulation Part 11, in respect of obligations on the licensing authority to conduct surveillance of all medicinal products, including COVID-19 vaccines.
For COVID-19 vaccines, the MHRA implemented a proactive strategy, which included prospective safety data collection, and use of a range of domestic and international data sources and methodologies. For all products, events and outcomes, each data source is assessed based on its strengths and limitations, using appropriate methodologies and, where appropriate, statistical thresholds for those data. The MHRA also work closely with public health partners in reviewing the effectiveness and impact of the vaccines, to ensure the benefits continue to outweigh any possible side effects.
The MHRA keep all available evidence under review including studies, published literature, and data arising from the widespread use of COVID-19 vaccines in the United Kingdom and globally. Ministers routinely engage with officials from the MHRA on a number of issues.
Asked by: Daisy Cooper (Liberal Democrat - St Albans)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she has received representations of concern from (a) patient safety groups and (b) medical equipment suppliers on the interim methods and processes statement for late-stage assessments published by NICE.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The National Institute for Health and Care Excellence’s (NICE) interim methods and processes for late-stage assessment have been subject to a public consultation between 29 February and 28 March 2024. The consultation allowed stakeholders from across the sector, including medical equipment suppliers, patients, and caregivers, to comment on these interim methods and processes. This included the proposed use of predetermined price ranges for categories of technologies. The Department and the NICE are unable to comment on the results of the consultation at this stage, as the NICE is currently considering the responses. Further information will be made available upon the completion of this process.
Asked by: John Hayes (Conservative - South Holland and The Deepings)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many people are employed by NHS England in roles relating to equality, diversity and inclusivity as of 26 March 2024.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
There are 51 staff with equality, diversity, or inclusion in their job title at NHS England, as of 26 February 2024. This covers a wide range of roles both supporting NHS England as an employer, and facing the wider National Health Service system, with some of these roles also covering other areas of NHS policy. NHS England has reduced the number of roles focused on equality, diversity and inclusion as part of its merger with NHS Digital and Health Education England. The roles that remain are essential to helping the NHS meet its legal duties in the Equality Act 2010 and the principles that guide the NHS Constitution. This includes overseeing statutory programmes that are focused on tackling discrimination by some staff which includes disabled staff, as well as roles dealing with the sexual safety of staff and patients in the NHS.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare products Regulatory Agency has (a) requested and (b) reviewed data from the expert review panel set up by the Norwegian government into the cause of death in relation to patients who have received a Covid 19 vaccine.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Following the initial roll out of the COVID-19 vaccination programme in December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) had a comprehensive surveillance strategy in place, enabling continual close monitoring of emerging safety evidence, including relevant safety information from international regulators. This included engagement with the European Medicines Agency to discuss data emerging from European Member States and countries in the European Economic Area, such as Norway. The MHRA communicates safety advice based upon consideration of the totality of evidence from all relevant information sources, rather than the strengths and limitations of individual data sources.
Asked by: Baroness Bennett of Manor Castle (Green Party - Life peer)
Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government what assessment they have made of the case for incorporating into pharmaceutical, pesticide and other chemical regulation consideration of impacts on human, animal, plant and soil microbiomes.
Answered by Lord Douglas-Miller - Parliamentary Under-Secretary (Department for Environment, Food and Rural Affairs)
The Medicines and Healthcare products Regulatory Agency (MHRA) operates a robust programme of regulating and monitoring medicines to ensure patients have access to safe and effective medicines. While the microbiome is still an evolving field, the MHRA is working to further our understanding on the impact of pharmaceuticals on the microbiome. Experts in MHRA are leading on international efforts to improve understanding of this area, for example through the development of World Health Organisation reference reagents for the microbiome.
The potential impact of a chemical on plant health, including soil microbiomes is already considered, as appropriate, as part of the Health and Safety Executive (HSE)’s robust risk assessment process for pesticides and for biocides.
The legislation around veterinary medicines makes it clear that when considering the authorisation of antimicrobial substances for use in animals, there should be consideration of the impacts on the human, target animal, and environmental microbiomes, including plants and soils.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many prescriptions for mirtazapine were issued in each year since 2014; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA received for mirtazapine in each year since 2014; and what consideration NHS England has given to adding sexual dysfunction as a side effect on the patient information leaflets for mirtazapine.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The following table shows the total number of items issued for mirtazapine, each year since 2014 to 2023:
Time Period | Total items issued |
2014 | 6,056,918 |
2015 | 6,783,906 |
2016 | 7,526,200 |
2017 | 8,198,345 |
2018 | 8,938,362 |
2019 | 9,702,599 |
2020 | 10,532,577 |
2021 | 11,249,963 |
2022 | 11,776,025 |
2023 | 12,401,593 |
Source: Data was provided by the NHS Business Services Authority, using the British National Formulary chemical substance mirtazapine
Note: Items have been dispensed, but not necessarily prescribed, in England.
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.
The MHRA has received a total of 46 Yellow Card reports of sexual dysfunction related reactions suspected to be associated with mirtazapine, four of which include information that suggest the suspected adverse reactions persisted after mirtazapine was withdrawn. The following table shows the number of Yellow Card reports of suspected mirtazapine related sexual dysfunction, and reports of sexual dysfunction that persisted after the drug was withdrawn, each year from 2014 to 2024:
Year | Reports of sexual dysfunction | Reports of sexual dysfunction that continued after mirtazapine was withdrawn |
2014 | 3 | 0 |
2015 | 1 | 0 |
2016 | 2 | 0 |
2017 | 3 | 0 |
2018 | 1 | 0 |
2019 | 5 | 1 |
2020 | 3 | 0 |
2021 | 5 | 1 |
2022 | 10 | 1 |
2023 | 9 | 0 |
2024 | 4 | 1 |
Source: data provided by the MHRA.
It is important to note that the inclusion of a particular report on the MHRA’s system does not necessarily mean that the adverse reactions reported have been caused by the suspect drug. Additionally, the number of reports received should not be used as a basis for determining the incidence of a reaction, as neither the total number of reactions occurring, nor the number of patients using the drug, is known.
The MHRA continuously monitors the safety of medicines on the United Kingdom’s market, including mirtazapine. Reports of suspected adverse reactions are reviewed weekly by a multidisciplinary team as part of the MHRA’s signal detection process. The term signal is used to define any suspected adverse reaction or potential safety concern that requires further evaluation.
Responsibility for adding a side effect to the product information leaflet sits with the MHRA. The product information for mirtazapine reflects the data currently available, and does not include sexual dysfunction as a possible side effect. However, data from Yellow Card reports and other sources such as published studies and periodic safety assessments are kept under continuous review by the MHRA. The marketing authorisation holder has recently submitted the latest periodic safety update report to the MHRA, and this will be carefully assessed. If there is sufficient evidence and associated data about the potential to experience sexual dysfunction as a side effect, the patient information for mirtazapine can be updated.