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, how the Medicines and Healthcare products Regulatory Agency is held accountable for its decisions.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) performs the functions of my Rt hon. Friend, the Secretary of State for Health and Social Care, under United Kingdom legislation, relating to the regulation of medicines, medical devices, and blood products for transfusion. The MHRA also performs the functions of my Rt hon. Friend, the Secretary of State for Health and Social Care in relation to the standardisation and control of biological medicines including vaccines, blood products, and other substances which cannot be characterised chemically, and which require special testing measures to ensure their safety and efficacy.
My Rt hon. Friend, the Secretary of State for Health and Social Care has ministerial responsibility for, and oversight of, the MHRA’s delivery and performance. The MHRA seeks ministerial agreement for policy and legislative framework changes. Ministers are not involved in individual decisions made by the MHRA. The MHRA is held to account through regular established mechanisms including quarterly and annual accountability reviews. A framework agreement between the Department and the MHRA also sets out the governance structure within which both parties operate, with further information available at the following link:
The MHRA also publishes performance figures each month, as well as its annual report and accounts, and the minutes of the latest Annual Accountability Review with the MHRA is available at the following link:
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 is she taking to review the decisions 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) performs the functions of my Rt hon. Friend, the Secretary of State for Health and Social Care, under United Kingdom legislation, relating to the regulation of medicines, medical devices, and blood products for transfusion. The MHRA also performs the functions of my Rt hon. Friend, the Secretary of State for Health and Social Care in relation to the standardisation and control of biological medicines including vaccines, blood products, and other substances which cannot be characterised chemically, and which require special testing measures to ensure their safety and efficacy.
My Rt hon. Friend, the Secretary of State for Health and Social Care has ministerial responsibility for, and oversight of, the MHRA’s delivery and performance. The MHRA seeks ministerial agreement for policy and legislative framework changes. Ministers are not involved in individual decisions made by the MHRA. The MHRA is held to account through regular established mechanisms including quarterly and annual accountability reviews. A framework agreement between the Department and the MHRA also sets out the governance structure within which both parties operate, with further information available at the following link:
The MHRA also publishes performance figures each month, as well as its annual report and accounts, and the minutes of the latest Annual Accountability Review with the MHRA is available at the following link:
Asked by: Caroline Dinenage (Conservative - Gosport)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Answer of 23 June 2023 to Question 189729 on Medicines and Healthcare products Regulatory Agency, whether she plans to initiate a priority review for medical devices.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Priority Review programme is not currently planned, but the Government is taking other significant steps for medical device regulatory reform, as part of a broader Medical Technology Strategy. Further information on the Medical Technology Strategy is available at the following link:
https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices, and designates United Kingdom Approved Bodies to conduct conformity assessments against the relevant regulatory requirements. The MHRA works closely with Approved Bodies to ensure their timely assessment.
Following a consultation on the future regulation of medical devices in 2021, the MHRA is leading a programme of work to introduce updated regulations for medical devices that prioritise patient safety, improve patient access to innovative medical devices, and ensure the UK remains an attractive market for medical technology innovators. In January of this year, the MHRA published a MedTech Regulatory roadmap that sets out the main activities in implementing the future regulations throughout 2024 and 2025. An international recognition framework for medical devices will form part of the future regulatory framework, which will provide an alternative route to the UK’s market, by leveraging approvals from comparable international regulators. The MHRA aims to publish an outline of the International Recognition Framework for medical devices later this spring, aligned to the Life Sciences Council, subject to necessary approvals.
In addition, the MHRA is leading the reform of the medical devices regulatory landscape and includes a new pathway to accelerate access to safe, innovative medical devices to help meet the unmet needs of patients. The Innovative Devices Access Pathway aims to bring new medical technologies and solutions to the National Health Service, to support the medical needs that are not currently being met. There are eight innovative medical technologies included in the pilot phase.
We are working alongside others to further the Life Sciences Vision, particularly improving regulation and regulatory processes around medical devices, and supporting broader ambitions in the vision aligned to the conditions set out in the Major Conditions Strategy. As we work to update the medical devices regulatory landscape, the MHRA is taking the Major Conditions Strategy into consideration, including the six groups of major health conditions.
The National Institute for Health and Care Excellence (NICE) is not a regulator but makes recommendations for the NHS on whether selected medical devices should be routinely adopted by the NHS, based on an assessment of their costs and benefits. Medical devices are prioritised for the NICE’s evaluation, in line with NICE’s published topic selection manual.
Asked by: Caroline Dinenage (Conservative - Gosport)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she plans to develop a Priority Review programme for medical devices.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Priority Review programme is not currently planned, but the Government is taking other significant steps for medical device regulatory reform, as part of a broader Medical Technology Strategy. Further information on the Medical Technology Strategy is available at the following link:
https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices, and designates United Kingdom Approved Bodies to conduct conformity assessments against the relevant regulatory requirements. The MHRA works closely with Approved Bodies to ensure their timely assessment.
Following a consultation on the future regulation of medical devices in 2021, the MHRA is leading a programme of work to introduce updated regulations for medical devices that prioritise patient safety, improve patient access to innovative medical devices, and ensure the UK remains an attractive market for medical technology innovators. In January of this year, the MHRA published a MedTech Regulatory roadmap that sets out the main activities in implementing the future regulations throughout 2024 and 2025. An international recognition framework for medical devices will form part of the future regulatory framework, which will provide an alternative route to the UK’s market, by leveraging approvals from comparable international regulators. The MHRA aims to publish an outline of the International Recognition Framework for medical devices later this spring, aligned to the Life Sciences Council, subject to necessary approvals.
In addition, the MHRA is leading the reform of the medical devices regulatory landscape and includes a new pathway to accelerate access to safe, innovative medical devices to help meet the unmet needs of patients. The Innovative Devices Access Pathway aims to bring new medical technologies and solutions to the National Health Service, to support the medical needs that are not currently being met. There are eight innovative medical technologies included in the pilot phase.
We are working alongside others to further the Life Sciences Vision, particularly improving regulation and regulatory processes around medical devices, and supporting broader ambitions in the vision aligned to the conditions set out in the Major Conditions Strategy. As we work to update the medical devices regulatory landscape, the MHRA is taking the Major Conditions Strategy into consideration, including the six groups of major health conditions.
The National Institute for Health and Care Excellence (NICE) is not a regulator but makes recommendations for the NHS on whether selected medical devices should be routinely adopted by the NHS, based on an assessment of their costs and benefits. Medical devices are prioritised for the NICE’s evaluation, in line with NICE’s published topic selection manual.
Asked by: Caroline Dinenage (Conservative - Gosport)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether (a) the Medicines and Healthcare products Regulatory Agency and (b) NICE will prioritise the regulatory timelines for medical devices that (i) respond to conditions outlined in the Major Conditions Strategy and (ii) where there is unmet need.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Priority Review programme is not currently planned, but the Government is taking other significant steps for medical device regulatory reform, as part of a broader Medical Technology Strategy. Further information on the Medical Technology Strategy is available at the following link:
https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices, and designates United Kingdom Approved Bodies to conduct conformity assessments against the relevant regulatory requirements. The MHRA works closely with Approved Bodies to ensure their timely assessment.
Following a consultation on the future regulation of medical devices in 2021, the MHRA is leading a programme of work to introduce updated regulations for medical devices that prioritise patient safety, improve patient access to innovative medical devices, and ensure the UK remains an attractive market for medical technology innovators. In January of this year, the MHRA published a MedTech Regulatory roadmap that sets out the main activities in implementing the future regulations throughout 2024 and 2025. An international recognition framework for medical devices will form part of the future regulatory framework, which will provide an alternative route to the UK’s market, by leveraging approvals from comparable international regulators. The MHRA aims to publish an outline of the International Recognition Framework for medical devices later this spring, aligned to the Life Sciences Council, subject to necessary approvals.
In addition, the MHRA is leading the reform of the medical devices regulatory landscape and includes a new pathway to accelerate access to safe, innovative medical devices to help meet the unmet needs of patients. The Innovative Devices Access Pathway aims to bring new medical technologies and solutions to the National Health Service, to support the medical needs that are not currently being met. There are eight innovative medical technologies included in the pilot phase.
We are working alongside others to further the Life Sciences Vision, particularly improving regulation and regulatory processes around medical devices, and supporting broader ambitions in the vision aligned to the conditions set out in the Major Conditions Strategy. As we work to update the medical devices regulatory landscape, the MHRA is taking the Major Conditions Strategy into consideration, including the six groups of major health conditions.
The National Institute for Health and Care Excellence (NICE) is not a regulator but makes recommendations for the NHS on whether selected medical devices should be routinely adopted by the NHS, based on an assessment of their costs and benefits. Medical devices are prioritised for the NICE’s evaluation, in line with NICE’s published topic selection manual.
Asked by: Jim Shannon (Democratic Unionist Party - Strangford)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to increase the public's awareness of the side effects that can arise from taking weight loss drugs such as Ozempic.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) plays a pivotal role in ensuring the safety, efficacy, and quality of medicines and healthcare products available to patients in the United Kingdom. Patient safety remains the MHRA’s highest priority, and they take every opportunity to encourage reporting of any safety concerns to the Yellow Card scheme, which helps to improve the safe use of medicines and medical devices for everyone.
New medicines including, Mounjaro and Wegovy, are intensively monitored to ensure that any new safety concerns are identified promptly. The Commission on Human Medicines and the MHRA encourages the reporting of all suspected reactions to newer drugs and vaccines, which are denoted by an inverted Black Triangle symbol. This symbol appears next to the name of a relevant product in drug safety updates, the British National Formulary and the Nurse Prescribers’ Formulary, the monthly index of medical specialities, the electronic medicines compendium, and advertising material. Patient information leaflets accompanying licensed medicines in the UK must include a description of the adverse reactions which may occur in normal use of the medicinal product, as well as information on how to report them. All adverse reactions must be reflected in the leaflet, in language that the patient will understand.
The MHRA has received a small number of reports of falsified and unlicenced medicines being sold illegally online as a treatment for weight loss. The agency has issued public health messaging warning of the dangers of buying such medicines from illegal trading sources online.
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.