Asked by: Claire Hanna (Social Democratic & Labour Party - Belfast South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he has had discussions with the Department of Health in Northern Ireland on the use of (a) Lecanemab and (b) Donanemab in the treatment of dementia.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Department is working closely together with system partners to plan for the implementation of new dementia medicines such as lecanemab and donanemab, should they be granted a marketing authorisation in the United Kingdom and a positive National Institute for Health and Care Excellence (NICE) recommendation. Partners include the Medicines and Healthcare products Regulatory Agency, NICE, NHS England, the Office for Life Sciences, and the devolved administrations, including the Department of Health in Northern Ireland.
Asked by: Chi Onwurah (Labour - Newcastle upon Tyne Central)
Question to the Department for Levelling Up, Housing & Communities:
To ask the Secretary of State for Levelling Up, Housing and Communities, whether his Department has had meetings with the Office for Life Sciences since 1 January 2023.
Answered by Simon Hoare - Parliamentary Under Secretary of State (Department for Levelling Up, Housing and Communities)
In line with the practice of successive administrations, details of internal meetings are not normally disclosed.
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: Andrew Rosindell (Conservative - Romford)
Question to the Department for Business and Trade:
To ask the Secretary of State of Business and Trade, what estimate she has made of the contribution of domestic medicinal cannabis production to the economy.
Answered by Kevin Hollinrake - Minister of State (Department for Business and Trade)
The Department for Business and Trade (DBT) actively assists life sciences companies in their endeavours to invest, expand, and export, thereby generating employment and economic growth.
UK-based life sciences businesses receive support from DBT through trade missions to key markets, participation in major trade events, tackling market access barriers, upskilling exporters, and guidance on entering new markets. Although routine assessments of the economic impact of specific life sciences’ subsectors like medicinal cannabis are not conducted, DBT is committed to supporting companies of various sizes throughout their export and inward investment endeavours while adhering to national regulatory guidelines.
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: Gregory Campbell (Democratic Unionist Party - East Londonderry)
Question to the Department for Business and Trade:
To ask the Secretary of State for Business and Trade, what steps she is taking to support the (a) life and (b) health science sector in Northern Ireland.
Answered by Nusrat Ghani - Minister of State (Minister for Europe)
The Department for Business Trade is committed to ensuring that the life and health science sector is supported in Northern Ireland. Last year, a life and health sciences sector specialist was appointed to DBT’s Northern Ireland trade and investment hub. This dedicated resource ensures that businesses have access to DBT services, helping them to increase international exports, attract inward investment, and ensure sector interests are represented in trade policy.
The sector was at the forefront of last year's Northern Ireland Investment Summit, where local companies showcased new technologies and cutting-edge innovations to an audience of over 180 global investors.
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 discussions she is having with pharmaceutical organisations on releasing drugs for clinical trials for the treatment of less survivable cancers.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
In March 2021, the Government published Saving and Improving Lives: The Future of UK Clinical Research Delivery, setting out ambitions to reform clinical research delivery in the United Kingdom. This sets out how we will improve patient access to clinical trials in all areas, including cancer. This, together with the Government response to the O’Shaughnessy review backed by up to £121 million of funding, will help to drive improvements in recruitment to clinical trials and approval processes which lead to quicker study set up. Implementation of our vision for clinical trials brings together stakeholders from across the research system, including industry, and we continue to have regular engagement with industry partners through established forums.
The UK’s Cancer Mission, a key element of the Life Sciences Vision, will also bring together industry, academia, and the National Health Service to collaborate and make progress on cancer, including by driving the development and commercialisation of new cancer medicines.
Asked by: Mark Eastwood (Conservative - Dewsbury)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent progress her Department has made on consulting on proposed amendments to Part IX of the Drug Tariff; and if she will make an assessment of the potential impact of the proposed amendments on (a) the medical technology ecosystem, (b) innovation relating to the the Life Sciences Vision and (c) the wider UK economy.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
A targeted consultation on Medical Devices in Primary Care: Proposals for updating Part IX of the Drug Tariff-medical devices available for prescribing in primary care was issued on 6 October 2023.
The consultation on Part IX of the Drug Tariff sets out a series of proposals to modernise Part IX of the Drug Tariff. The objectives of the proposals are to ensure Part IX consistently includes devices that are of good quality and effectiveness; ensure that the Tariff product list is refreshed going forward and existing and new products are only adopted or continued to be used if able to demonstrate value to the National Health Service and patients; and update processes on Part IX applications to support the adoption of innovation that can improve patient outcomes and the quality of life for patients.
The consultation was fully closed for responses at 4 January 2024. The Department is considering all the responses before finalising any proposed amendments to Part IX of the Drug Tariff. Therefore, the Department will share a response to the consultation and an updated assessment of the impacts in due course.
In forming the proposals, that have been consulted on, the department has had extensive engagement with industry, the health and care sector, NHS commissioners and patient representative groups. There will be further engagement with these stakeholders for any amendments to Part IX that are taken forward.
Asked by: Baroness Jones of Whitchurch (Labour - Life peer)
Question to the Department for Science, Innovation & Technology:
To ask His Majesty's Government what sectoral strategies have been produced by the Department of Science, Innovation and Technology since its establishment.
Answered by Viscount Camrose - Parliamentary Under Secretary of State (Department for Science, Innovation and Technology)
The sectoral strategies produced by the Department of Science, Innovation and Technology since its establishment are:
DSIT also recently published its National Vision for Engineering Biology.
Strategies produced prior to the department’s establishment that are key to our sectors include:
Asked by: Henry Smith (Conservative - Crawley)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she is taking steps to protect (a) Bupa, (b) HCA Healthcare and (c) other major private healthcare providers from (i) BGI Group and (ii) MGI Tech.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
Organisations which hold sensitive biological data are subject to the UK General Data Protection Regulation (GDPR). In addition, organisations such as Genomics England, UK Biobank and NIHR BioResource actively consider national security in decision making about partnerships with companies overseas.
As part of the new UK Biological Security Strategy, the Government is undertaking a programme of work to assess how we can minimise the risks from biological data to protect our burgeoning bioeconomy, without stifling innovation, and build confidence in sharing personal data to improve health outcomes in the United Kingdom and across the world. The Office for Life Sciences has begun this work, in consultation with relevant Departments and Agencies across Government, and key partners such as Genomics England and UK Biobank.