Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what are the (1) resources, and (2) capacity, of the Medicines and Healthcare products Regulatory Association (MHRA); and whether they have made an assessment of the current capacity of the MHRA to keep pace with the expected launches of the National Institute for Health and Care Excellence (NICE) approved medicines to the UK market.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department, regulates medicines, medical devices and blood components for transfusion in the United Kingdom. MHRA employs over 1380 staff and for 2021/22, its total resources were £167 million, funded mostly by income from fees and charges for both statutory and non-statutory sales of products and services. The fees that MHRA charges for its services reflect the cost of providing that service and these are set in legislation, following public consultation and Parliamentary scrutiny.
MHRA and the National Institute for Health and Care Excellence (NICE) work closely together to ensure that there is a joined-up, and timely approach to supporting access for National Health Service patients to new medicines. NICE aims wherever possible to publish final guidance on new medicines within 90 days of MHRA granting a marketing authorisation.
Asked by: Bill Wiggin (Conservative - North Herefordshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment they have made of the impact of the UK's departure from the EU on their ability to deliver successful policy outcomes.
Answered by Will Quince
We are using the provisions of the Medicines and Medical Devices Act 2021 to overhaul medical devices and clinical trial frameworks to ensure more rapid access to new and innovative medicines and medical devices. In addition, we are establishing new reciprocal healthcare arrangements with non-European Union countries and expanding the use of Global Health Insurance Cards.
Asked by: Stella Creasy (Labour (Co-op) - Walthamstow)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department has plans to (a) reform, (b) revoke or (c) retain the Human Medicines Regulations 2012.
Answered by Will Quince
Reforms to the Human Medicines Regulations 2012 are progressing under the Medicines and Medical Devices Act 2021. The Act supports the United Kingdom’s ambitions for the Life Sciences sector through regulations to increase innovation and support the development of new medical technologies. This includes placing the Early Access to Medicines Scheme on a statutory basis, supporting the continued safe deployment of COVID-19 and flu vaccines, and consulting on proposals for a new regulatory framework to enable innovative medicines to be manufactured and delivered at the point of care.
Through the Retained EU Law (Revocation and Reform) Bill, the Government is currently reviewing which retained European Union law should be repealed, reformed or preserved. The Government continues to work with a range of stakeholders to ensure that any such reforms maintain current standards in patient safety and public health. The Medicines and Healthcare products Regulatory Agency is participating in the review of all retained EU law within its responsibilities.
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 he has made an assessment of the effect of the EU Medical Devices Regulations assessment system on the availability medical device and health tech products in the UK; and what steps he is taking to provide patients in the UK with equal access to medical devices and health tech through the delivery of an effective UKCA marking system.
Answered by Will Quince
The future medical devices regime is an overhaul of the current regulatory framework, aimed at improving safety and incorporating measures to encourage innovation and offer alternative routes to market. This includes domestic assurance, which will allow an abridged assessment with the appropriate scrutiny and United Kingdom approved bodies can reject applications under the domestic assurance route if the evidence provided is insufficiently robust. A number of countries will be considered for the domestic assurance route, including the United States of America.
The Medicines and Healthcare products Regulatory Agency (MHRA) is working to build closer partnerships with global regulators and has established full membership of the International Medical Device Regulations Forum (IMDRF) and is an official observer of the Medical Devices Single Audit Programme (MDSAP), of which the US Food and Drug Administration is a member. The MHRA is engaging with the FDA within international fora and on a bilateral basis.
The transitional arrangements for medical devices are intended to minimise the risks to access for patients in the UK and facilitate the transition between the current and new regulatory framework whilst supporting the ongoing safe supply of essential medical devices. CE marked devices under the new European Union regulations will continue to be placed onto the UK market when the new regime comes into force for up to a period of five years, with a view to review this provision at the end of the five-year period. It is not anticipated that an extension of this provision will be required, as the intervening period will be used to support an increase in approved body capacity to ensure the UK has sufficient capacity to transition all medical devices to the UKCA marking system. The MHRA will work with international regulators to place the UKCA marking for medical devices on a global standing.
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, if his Department will take steps to help ensure that implementation of UK Conformity Assessed marking is aligned with other regulatory systems, including those of the US Food and Drug Administration and the EU’s Medical Devices Regulation, so that the UK is not geographically deprioritised through implementation of UKCA marking.
Answered by Will Quince
The future medical devices regime is an overhaul of the current regulatory framework, aimed at improving safety and incorporating measures to encourage innovation and offer alternative routes to market. This includes domestic assurance, which will allow an abridged assessment with the appropriate scrutiny and United Kingdom approved bodies can reject applications under the domestic assurance route if the evidence provided is insufficiently robust. A number of countries will be considered for the domestic assurance route, including the United States of America.
The Medicines and Healthcare products Regulatory Agency (MHRA) is working to build closer partnerships with global regulators and has established full membership of the International Medical Device Regulations Forum (IMDRF) and is an official observer of the Medical Devices Single Audit Programme (MDSAP), of which the US Food and Drug Administration is a member. The MHRA is engaging with the FDA within international fora and on a bilateral basis.
The transitional arrangements for medical devices are intended to minimise the risks to access for patients in the UK and facilitate the transition between the current and new regulatory framework whilst supporting the ongoing safe supply of essential medical devices. CE marked devices under the new European Union regulations will continue to be placed onto the UK market when the new regime comes into force for up to a period of five years, with a view to review this provision at the end of the five-year period. It is not anticipated that an extension of this provision will be required, as the intervening period will be used to support an increase in approved body capacity to ensure the UK has sufficient capacity to transition all medical devices to the UKCA marking system. The MHRA will work with international regulators to place the UKCA marking for medical devices on a global standing.
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, when she will publish guidance on the future regulation of (a) medicines, (b) health technologies and (c) vaccines in Northern Ireland.
Answered by Will Quince
The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the regulation of human medicines and medical devices from 1 January 2021 in the United Kingdom. This guidance includes vaccines, which are regulated as medicines.
The MHRA has updated the guidance to reflect changes made by the European Union to its medicine legislation in relation to the Northern Ireland Protocol and the introduction of the route for the Government to ensure equity of access to medicines for patients in Northern Ireland. Any future regulatory changes will be reflected in this guidance.
Asked by: Christian Wakeford (Labour - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to his letter to INFACT of 3 December 2021, in addition to the pregnancy prevention programme, what steps he is taking to ensure that (a) the future safety and (b) further support is directly improved for people and families affected by Sodium Valproate.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
In addition to the valproate pregnancy prevention programme, future safety of valproate is managed within the Medicines in Pregnancy Valproate Registry, based on a core register comprising routinely collected data. The Registry currently includes all women in England who are receiving National Health Service-prescribed valproate and identifies when they are pregnant and accessing NHS care for that pregnancy. Work is ongoing to extend the registry to include women in the devolved administrations.
The Medicines and Healthcare products Regulatory Agency will shortly bring forward legislation to support the implementation of medicines registries and improve systematic collection of data. This will ensure that neurodevelopmental disorders associated with valproate are better characterised and identified earlier if associated with other antiepileptic drugs.
As set out in the Government’s response to the Independent Medicines and Medical Devices Safety Review, published on 21 July 2021, we are working to improve the care pathways for children and families affected by medicines in pregnancy, including valproate. This includes tackling the variation in access to services across NHS regions to ensure that care is co-ordinated.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of the proposal by the Medical Technologies Directorate to adopt evidence assessment processes used in relation to pharmaceutical products to assess innovative medical devices.
Answered by Lord Kamall
The Medical Technologies Directorate is working with public sector and industry stakeholders to consider various approaches to the product pathway for medical devices as part of a wider strategy. Plans to publish this strategy will be brought forward in due course.
Clinicians have the professional autonomy to choose an appropriate treatment based on the best available evidence. Mandatory adoption of certain devices could interfere with this clinical judgement and undermine the patient-doctor relationship. We will consider the access and appropriate adoption of innovative devices with other organisations such as the National Institute for Health and Care Excellence and the Accelerated Access Collaborative.
Many aspects of the medicines model are not transferable given the differences between the two sectors in terms of product range, scope, diversity of suppliers and level of Government involvement in the market. A review of proposals which could drive consistency in evaluation of innovation will be taken forward as part of the strategy development work.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of the proposals by the Medical Technologies Directorate for mandatory adoption of innovative medical devices; and what proportion of all submissions to the Directorate are forecast to benefit from mandatory adoption.
Answered by Lord Kamall
The Medical Technologies Directorate is working with public sector and industry stakeholders to consider various approaches to the product pathway for medical devices as part of a wider strategy. Plans to publish this strategy will be brought forward in due course.
Clinicians have the professional autonomy to choose an appropriate treatment based on the best available evidence. Mandatory adoption of certain devices could interfere with this clinical judgement and undermine the patient-doctor relationship. We will consider the access and appropriate adoption of innovative devices with other organisations such as the National Institute for Health and Care Excellence and the Accelerated Access Collaborative.
Many aspects of the medicines model are not transferable given the differences between the two sectors in terms of product range, scope, diversity of suppliers and level of Government involvement in the market. A review of proposals which could drive consistency in evaluation of innovation will be taken forward as part of the strategy development work.
Asked by: Sarah Green (Liberal Democrat - Chesham and Amersham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department has taken to facilitate access to (a) financial redress and (b) ongoing treatment and care for patients adversely affected by surgical mesh.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Government published its response to the Independent Medicines and Medical Devices Safety Review on 21 July 2021 which confirmed that no redress schemes will be established. Our primary focus is on improving future medicines and medical devices safety through funding on initiatives that directly improve future safety, including specialist mesh centres and support for families affected by medicines in pregnancy.
There are now eight specialist centres in operation across England to provide comprehensive treatment, care and advice for women affected by implanted mesh. Progress is being made towards the establishment of a regional service with a provider in the South West.