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four of which include information that suggest the suspected adverse reactions persisted after mirtazapine was withdrawn.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suspected mirtazapine related sexual dysfunction, and reports of sexual dysfunction that persisted after the drug was withdrawn, each year from 2014 to 2024:
Year | Reports of sexual dysfunction | Reports of sexual dysfunction that continued after mirtazapine was withdrawn |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.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, on what date work on digitally linking Medicines and Healthcare products Regulatory Authority Yellow Card information to NHS clinical records (a) began and (b) is expected to be completed.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) has been working with the National Health Service to explore approaches to facilitate digital linkage of Yellow Card information to clinical records, and to potentially enable faster access to information, where considered necessary for an assessment. Any such approach would be subject to strict information governance controls and prior consultation with stakeholder groups.
In 2020, the MHRA began delivery of a substantially enhanced Yellow Card platform under the SafetyConnect programme, aligned to the recommendations in Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review. The new infrastructure is designed with the intent of enabling connectivity to other systems, to facilitate the exchange of information. During that time the MHRA has engaged with the NHS around the evolving technical options for robust and secure connectivity and enhanced user journeys. The first step in these enhancements is use of the common NHS login capability within Yellow Card, which is expected to go live in 2024.
Deeper connectivity between systems will be subject to internal and external stakeholder engagement and substantial information governance controls, with elements completed over a phased and multi-year work plan.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
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 adequacy of funding provided to the Medicines and Healthcare products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
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 (a) monitor and (b) report on the performance of the Medicines and Healthcare Products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
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 from the scientific community on the efficiency of the Medicines and Healthcare products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she plans to take steps to help increase productivity in the Medicines and Healthcare products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
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 help increase the capacity of the Medicines and Healthcare products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
Asked by: Lord Campbell-Savours (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the case for reviewing the expiry dates of antibiotics, including in respect of savings for public expenditure.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA), the Government agency responsible for ensuring that medicines and medical devices work and are acceptably safe, has not made an assessment on the case for reviewing the expiry dates of antibiotics.
Medicine expiry dates, including for antibiotics, are necessary to ensure that the safety and effectiveness of a medicine is maintained over its long-term shelf life. The active ingredient in many medicines can degrade over time resulting in a loss of potency or the formation of impurities in the product. Physical changes to a medicine such as discolouration, may also occur upon prolonged storage. Medicine expiry dates are supported by stability studies completed by the pharmaceutical company, which demonstrate that a medicine remains safe and effective throughout its shelf life. Any change to the expiry date of a medicine requires an independent review of the stability data by the MHRA.
Companies can and often do extend the shelf life of their medicines once the product is on the market, and as additional stability data become available. It is not possible, however, to extend the expiry date of all medicines unilaterally in the absence of supporting stability data.
Asked by: Lord Allen of Kensington (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the comments by the Royal College of Nursing that the fall in each of the past three years in applications to university nursing courses is a direct threat to patient safety, and what actions they are taking to improve patient safety in England.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The number of applicants continues to outstrip the places on offer. Nursing training places are competitive, and lead to an attractive and important career in the National Health Service.
Record numbers of nurses are now working in the NHS, and the first ever NHS Long Term Workforce Plan, backed by over £2.4 billion of funding, will add 24,000 more nurse and midwifery training places by 2031.
Over the last decade, the Government and system partners have delivered major initiatives to advance patient safety in the NHS. This includes implementing the first NHS Patient Safety Strategy, establishing the independent Health Services Safety Investigations Body to address the most serious patient safety incidents, and appointing the first Patient Safety Commissioner to champion the patient voice in relation to the safety of medicines and medical devices.
Asked by: Lord Norton of Louth (Conservative - Life peer)
Question to the Cabinet Office:
To ask His Majesty's Government, further to the Written Answer by Baroness Neville-Rolfe on 8 February (HL1937), whether they will list the 19 non-statutory and 23 statutory inquiries established under the Inquiries Act 2005, along with the (1) length, (2), cost, and (3) sponsoring department, for each of those inquiries.
Answered by Baroness Neville-Rolfe - Minister of State (Cabinet Office)
The Cabinet Office collects data on the duration and cost of inquiries from departments, inquiries’ own reports, and other publicly available information.
We have provided details on all statutory and non-statutory inquiries established since 2005 in the table below.
In some cases, information in the table below has come from reports from outside the Government. We have not included the costs for ongoing inquiries, which are published at different frequencies on inquiry or departmental websites, and we have not included the details for any investigations commissioned by NHS England (some of which were counted in the total number of non-statutory inquiries in our previous response, answered on 8th February 2024, UIN HL1937). It has been noted where the publicly available information provides the cost excluding VAT.
Inquiry | Sponsor Department | Legislative Basis | Year established | Duration in months (from announcement to publication of final report) | Reported final costs where publicly available |
Jalal Uddin Inquiry | HO | Inquiries Act 2005 | 2023 | Ongoing | - |
Cranston Inquiry | DfT | Non-statutory | 2023 | Ongoing | - |
Andrew Malkinson Inquiry | MoJ | Non-statutory | 2023 | Ongoing | - |
Thirlwall Inquiry | DHSC | Inquiries Act 2005 | 2023 | Ongoing | - |
Inquiry into the preventability of the Omagh bombing | NIO | Inquiries Act 2005 | 2023 | Ongoing | - |
Independent inquiry relating to Afghanistan | Ministry of Defence | Inquiries Act 2005 | 2022 | Ongoing | - |
Dawn Sturgess Inquiry | HO | Inquiries Act 2005 | 2022 | Ongoing | - |
Fuller Inquiry | DHSC | Non-statutory | 2022 | Ongoing | - |
Angiolini Inquiry | HO | Non-statutory | 2022 | Ongoing | - |
UK Covid-19 Inquiry | Cabinet Office | Inquiries Act 2005 | 2022 | Ongoing | - |
Lampard Inquiry | DHSC | Inquiries Act 2005 | 2021 | Ongoing | - |
Jermaine Baker inquiry | HO | Inquiries Act 2005 | 2020 | 29 | £4.1m |
Post Office Horizon IT inquiry | DBT | Inquiries Act 2005 | 2020 | Ongoing | - |
Manchester Arena inquiry | HO | Inquiries Act 2005 | 2019 | 41 | £35.6m |
Brook House Inquiry | HO | Inquiries Act 2005 | 2019 | 46 | £18.7m |
The Independent Medicines and Medical Devices Safety Review | Department of Health | Non-statutory | 2018 | 29 | £1.7m |
Independent Inquiry into the issues raised by Ian Paterson | Department of Health | Non-statutory | 2018 | 26 | £1.9m |
Grenfell Tower Inquiry | Cabinet Office | Inquiries Act 2005 | 2017 | Ongoing | - |
Infected Blood Inquiry | Cabinet Office | Inquiries Act 2005 | 2017 | Ongoing | - |
Independent inquiry into the award of the Magnox decommissioning contract by the Nuclear Decommissioning Authority (NDA) and its subsequent termination | BEIS | Non-statutory | 2017 | 48 | [unknown] |
Anthony Grainger Inquiry | HO | Inquiries Act 2005 | 2016 | 40 | £2.6m |
The Independent Inquiry into Child Sexual Abuse | HO | Inquiries Act 2005 | 2015 | 99 | £192.7m (as of Dec 2022) |
Undercover Policing Inquiry | HO | Inquiries Act 2005 | 2015 | Ongoing | - |
Gosport Independent Panel | Department of Health | Non-statutory | 2014 | 42 | £13m |
The Litvinenko Inquiry | HO, FCO and 3 x Intelligence Agencies | Inquiries Act 2005 | 2014 | 18 | £2.4m (exc. VAT) |
Harris Review / Independent review of self-inflicted deaths of young adults in custody aged between 18 and 24 | MoJ | Non-statutory | 2014 | 17 | £0.2m |
The Morecambe Bay Maternity and Neonatal Services Investigation | Department of Health | Non-statutory | 2013 | 18 | £1.1m |
Daniel Morgan Independent Panel | HO | Non-statutory | 2013 | 97 | £17.6m |
The Leveson Inquiry | DCMS and HO | Inquiries Act 2005 | 2011 | 16 | £5.4m |
The Azelle Rodney Inquiry | MoJ | Inquiries Act 2005 | 2010 | 40 | £2.6m |
Mid Staffordshire NHS Foundation Trust Inquiry 2013 / The Francis Inquiry | Department of Health | Inquiries Act 2005 | 2010 | 36 | £13.7m |
The Detainee Inquiry | Cabinet Office | Non-statutory (Committee of Privy Counsellors) | 2010 | 45 | £2.3m (exc. VAT) |
The Hillsborough Independent Panel | HO | Non-statutory | 2009 | 33 | Less than £5m |
The Al Sweady Inquiry | MoD | Inquiries Act 2005 | 2009 | 61 | £24.9m (exc. VAT) |
Independent Inquiry into care provided by Mid Staffordshire NHS Foundation Trust January 2001 – March 2009 | Department of Health | Non-statutory | 2009 | 7 | - |
The Iraq Inquiry / The Chilcot Inquiry | Cabinet Office, FCO, DfID | Non-statutory (Committee of Privy Counsellors) | 2009 | 85 | £13.1m |
The Bernard (Sonny) Lodge Inquiry | MoJ | Inquiries Act 2005 | 2009 | 10 | £0.4m |
The Baha Mousa Inquiry | MoD | Inquiries Act 2005 | 2008 | 39 | £13m |
Inquiry into Human Tissue Analysis in UK Nuclear Facilities / Redfern Inquiry | DTI - BERR - DECC | Non-statutory | 2007 | 43 | - |
Contaminated Blood and Blood Products Inquiry | Department of Health | Non-statutory | 2007 | 48 | £75k |