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: 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: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what progress they have made in aligning medical device regulations with those of international counterparts, and what impact this alignment is expected to have on patient safety, healthcare efficiency and innovation in the life sciences sector.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Following the Medicines and Healthcare products Regulatory Agency’s (MHRA) Consultation on the future regulation of medical devices in the United Kingdom, we have committed to undertaking full reform of the current regulatory regime for medical devices in the UK. The MHRA’s Roadmap towards the future regulatory framework for medical devices sets out a route to deliver, enabling regulation via a series of new statutory instruments (SIs). Priority measures to protect patient safety will be put in place this year, with core elements of the new framework intended to be in place by 2025. A draft statutory instrument to introduce strengthened post market surveillance requirements is planned to be laid in the first part of 2024. A copy of the roadmap is attached.
Following the announcement on the Chancellor’s Life Sciences Growth package in May 2023, we continue to progress the development of a framework for international recognition, including through targeted engagement with stakeholders, building on the outline proposals for alternative routes to market which were included in our 2021 consultation. The planned regulations are also designed to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances.
Implementing the remainder of the changes outlined in the June 2022 Government response to the 2021 consultation is ongoing. In September 2023, we launched the Innovative Devices Access Pathway as pilot, building the UK offer to innovators of medical devices addressing un-met clinical needs. In the coming year, we also plan to lay further SIs, bringing clarity to industry of the requirements they will need to meet to launch products in the UK in the future. Whilst these changes were outlined in the 2022 government response, we will ramp up our targeted engagement to ensure implementation is done smoothly and in a way that protects ongoing safe supply of products to UK patients.
Asked by: Chi Onwurah (Labour - Newcastle upon Tyne Central)
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 improve the (a) adoption and (b) spread of medical technologies across the NHS.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
In February 2023, the Government published its first ever strategy for MedTech, outlining our priorities for improving the adoption and spread of safe, effective and innovative medical technologies across the National Health Service.
As part of this effort, we are implementing solutions to streamline the innovation adoption pathway. We are focusing on clarifying signals to industry on what innovation the NHS needs, reforming regulation, providing product assessments based on real world evidence, and improving procurement processes.
We recently launched the Innovative Devices Access Pathway pilot in September 2023. The pilot will test a pre-regulatory, access pathway for eight pilot technologies that meet a clinical unmet need in the NHS. This accelerated pathway will support the adoption of transformative technologies into the NHS and to patients.
The Government is investing £30 million in the Health Tech Adoption and Acceleration Fund. Funding has been disseminated to all 42 integrated care systems to invest in proven technology that will help cut waiting lists, speed up diagnosis and deliver new and improved ways to treat patients.
The Department has partnered with the National Institute for Health and Care Excellence to develop and pilot a process for evaluations that compare similar MedTech products in use across the NHS. These evaluations will improve NHS decision makers ability to identify which products offer value for money and are worth adopting more widely.
The Medicines and Healthcare products Regulatory Agency is updating the medical device regulatory framework. The new framework is designed to protect patient safety, support innovation within the United Kingdom’s life sciences sector and improve access to innovative medical devices.
Asked by: Chi Onwurah (Labour - Newcastle upon Tyne Central)
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 improve the regulatory environment for medical devices and technology.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is progressing reforms to the Medical Devices Regulations 2002. These are outlined in the Government response to the consultation on the future regulation of medical devices in the United Kingdom published in June 2022.
On 9 January, the MHRA published a roadmap, which sets out a clear path for the development of new and robust regulations for medical devices over 2024 and 2025. The new regulations will put patient safety first, whilst enhancing the United Kingdom’s position as a world-leading environment for medical technology innovators.
In September 2023, the Department, in partnership with the MHRA, the National Institute of Care Excellence, NHS England, Health Technology Wales and Scottish Health Technology Group, launched the Innovative Devices Access Pathway pilot. The pilot provides an accelerated pathway for innovative technologies that meet an unmet need in the National Health Service, including regulatory and support to streamline their adoption into the NHS.
Asked by: Robin Walker (Conservative - Worcester)
Question to the Department for Education:
To ask the Secretary of State for Education, what guidance her Department provides schools on protecting children with allergies; and if she will make an assessment of the potential merits of requiring schools to have access to adrenaline injections for pupil safety.
Answered by Damian Hinds - Minister of State (Education)
In 2014, the government introduced a new duty on schools to support pupils with all medical conditions and published the ‘Supporting pupils at school with medical conditions’ statutory guidance for schools and others. This guidance does not specify which medical conditions should be supported in schools. Instead, it focuses on how to meet the needs of each individual child and how their medical condition affects school life.
Schools also have duties under the Equality Act 2010 to make reasonable adjustments to their practices, procedures, and policies to ensure that they are not putting those with certain long-term health problems at a substantial disadvantage.
Under the Human Medicines (Amendment) Regulations 2017, all schools can buy adrenaline auto-injector (AAI) devices without a prescription, for emergency use in children who are at risk of anaphylaxis, but their own device is not available or not working. The Department of Health and Social Care has published guidance on using emergency AAIs in schools, which can be found at: https://www.gov.uk/government/publications/using-emergency-adrenaline-auto-injectors-in-schools.
Asked by: Giles Watling (Conservative - Clacton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether it is his Department's policy to authorise novel pharmaceutical products, therapies or medical devices for first-time human clinical trials by the MHRA on a case-by-case basis without relying on a standardised complement of pre-clinical animal toxicity or efficacy data; and what steps he is taking to promote the use of non-animal pre-clinical data.
Answered by Will Quince
There is no United Kingdom legislation that mandates animal testing. We do, however, work to a series of International Council of Harmonisation and Committee for Medicinal Products for Human Use guidelines that describe ways to evaluate different non-clinical aspects of medicines, many of which use animals. These aspects include safety pharmacology, repeat dose toxicity, genotoxicity, carcinogenicity, reproductive toxicity, phototoxicity, and immunotoxicity.
The non-clinical assessors have always taken the approach that data from a suitably validated model that has been demonstrated to be predictive could be submitted in lieu of animal data. On a case-by-case basis, a non-clinical assessor will also accept appropriate justifications for not conducting animal tests, for example, no pharmacologically relevant species.
In terms of promoting use of non-animal methods, we do not consider this to be within the remit of non-clinical assessors. Rather, it is for those using these methods to tell the Medicines and Healthcare products Regulatory Agency (MHRA) how they have validated them, or at least why they rely on the results and an assessor will then judge whether the data is appropriate to support the trial. The MHRA supports the developers of products by its offer of scientific advice services, the Innovation Office and the Innovative Licensing and Access Pathway.
The MHRA fully supports the National Centre for the 3Rs (Replacement, Reduction and Refinement), and agency staff play an active role in projects to support adoption and adherence to the 3Rs principles in medicines regulation worldwide.
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 he has made an assessment of the potential merits of requiring two clinicians to be present in order to access medication in the NHS.
Answered by Will Quince
National Health Service organisations will already have their own policies on access to medicines in a clinical setting. Additionally, the General Medical Council has good practice in prescribing and managing medicines and devices which sets out prescriber responsibilities relating to the prescriptions they sign.
The Royal Pharmaceutical Society and the Royal College of Nursing have issued Professional Guidance on the Administration of Medicines in Healthcare Settings and Professional guidance on the safe and secure handling of medicines. Staff must be trained, and access to the locked medicines cupboard is by approved healthcare professionals only. In many organisations two healthcare professionals will be required to sign out any controlled drug and/or other medicines for administration to patients in line with organisational risk assessments.
It is the responsibility of individual health and care professionals to work within the requirements of their regulated profession, which is set by the relevant regulatory body. The nine professional health and care regulators are overseen by the Professional Standards Authority for Health and Social Care who carry out annual reviews of regulators’ performance.
Further the Care Quality Commission, the independent regulator of health and social care, monitor, inspect and regulate service providers and have powers to act against providers that do not have adequate systems in place to ensure the proper and safe use of medicine.