Written Evidence Apr. 24 2024
Inquiry: NHS leadership, performance and patient safetyFound: NHL0086 - NHS leadership, performance and patient safety Royal Pharmaceutical Society Written Evidence
Written Evidence Apr. 24 2024
Inquiry: NHS leadership, performance and patient safetyFound: NHL0081 - NHS leadership, performance and patient safety Patient Safety Commissioner Written Evidence
Written Evidence Apr. 24 2024
Inquiry: NHS leadership, performance and patient safetyFound: NHL0013 - NHS leadership, performance and patient safety UKCVFamily Written Evidence
Written Evidence Apr. 24 2024
Inquiry: NHS leadership, performance and patient safetyFound: NHL0014 - NHS leadership, performance and patient safety Patient Experience Library Written Evidence
Correspondence Apr. 23 2024
Committee: Statutory Inquiries CommitteeFound: They represent an important avenue to identify and learn lessons, and they are never established without
Mentions:
1: Andrew Stephenson (Con - Pendle) It is vital that people have access to the medicines they need. - Speech Link
2: Kirsty Blackman (SNP - Aberdeen North) Medicines Agency have disrupted the previously smooth supply of medicines. - Speech Link
3: Victoria Atkins (Con - Louth and Horncastle) innovative medical technology for patients and the NHS. - Speech Link
4: Victoria Atkins (Con - Louth and Horncastle) He will understand that I and others are keeping this under very close review, and the chief medical - Speech Link
Mentions:
1: Lord Markham (Con - Life peer) quality set by the UK independent regulator, the Medicines and Healthcare products Regulatory Agency - Speech Link
2: Lord Farmer (Con - Life peer) A considerable number of cardiologists, other medical practitioners and scientists have raised concerns - Speech Link
3: Lord Markham (Con - Life peer) For the understanding of noble Lords, every medical vaccine has side-effects, but the MHRA has investigated - Speech Link
4: Lord Hannan of Kingsclere (Con - Life peer) We had vaccine passports and travel bans, and it now seems that both the WHO and Pfizer knew at the time - Speech Link
5: Lord Markham (Con - Life peer) the Midlife MoT, which is designed to give people a 10-year risk analysis; have put blood pressure devices - Speech Link
Apr. 22 2024
Source Page: Quality Prescribing Strategy for Respiratory A Guide for Improvement 2024-2027Found: However, there is often a mismatch between prescribing guidelines for specific medical conditions and
Apr. 22 2024
Source Page: I. List of ministerial responsibilities. 88p. II. List of non-ministerial departments and executive agencies. 22p. III. Letter dated 19/04/2024 from Alex Burghart MP to the Public Administration and Constitutional Affairs Committee regarding documents for deposit, and copying them for deposit in the House libraries. 1p.Found: List of non-ministerial departments and executive agencies. 22p. III.
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.