Asked by: Paula Barker (Labour - Liverpool, Wavertree)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare products Regulatory Agency plans to consult representatives of (a) patient organisations and (b) the pharmaceutical industry on its plans for new regulatory recognition routes for medicines under the international recognition framework, starting on 1 January 2024.
Answered by Will Quince
Regarding the first part of the question on consultation with patient organisations, the Medicines and Healthcare products Regulatory Agency (MHRA) held a workshop on 3 November 2022 to obtain patient views on the MHRA’s proposals for a new International Recognition Framework. The MHRA intends to hold another patient workshop this Summer to discuss its proposals in further detail.
Regarding consultation with members of the pharmaceutical industry, the MHRA has held a number of workshops and focus groups with Trade Associations and their members to generate insight from industry subject matter experts. This has included a workshop on the MHRA’s early-stage prototype for the recognition framework to obtain feedback on practical implications. The MHRA will continue to closely engage with key stakeholder groups in the development of its International Recognition Framework.
Asked by: Paula Barker (Labour - Liverpool, Wavertree)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, which cancer medicines have received (a) an innovation passport and (b) other support under the Medicines and Healthcare products Regulatory Agency’s Innovative Licensing and Access Pathway; and if he will make an assessment of the impact of the pathway on the time taken for innovative treatments to become available to patients.
Answered by Will Quince
The Innovative Licensing and Access Pathway (ILAP) was launched in January 2021, and has seen strong interest from both small and large companies in a variety of therapeutic settings. Companies who successfully gain an Innovation Passport designation are able to apply for the next step; the Target Development Profile. There are currently 55 cancer drugs that have been awarded an innovation passport as part of the Innovative Licensing and Access Pathway. Eight of these products have accessed the Target Development Profile and a further seven are in progress.
Holding an innovation passport is required to apply for Project Orbis. Project Orbis provides a framework for concurrent submission and review of oncology products among international partners, aiming to deliver faster patient access to innovative cancer treatments. 27 innovation passport holders have applied for Project Orbis.
Following the McLean report there is ongoing work to ensure enhanced speed and efficiency of ILAP.
Asked by: Paula Barker (Labour - Liverpool, Wavertree)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, which cancer medicines are being reviewed by the Medicines and Healthcare products Regulatory Agency under Project Orbis as of 14 June 2023.
Answered by Will Quince
The Medicines and Healthcare products Regulatory Agency (MHRA) does not publish details on applications currently under review as this is considered commercially sensitive information. That said, details of the products approved by the MHRA under Project Orbis are published on the MHRA website available at the following link:
https://www.gov.uk/guidance/guidance-on-project-orbis#overview-of-orbis-project-approvals
Asked by: Paula Barker (Labour - Liverpool, Wavertree)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the adequacy of the National Institute for Health and Care Excellence's preparedness for quickly assessing new medicines licensed through the Medicines and Healthcare products Regulatory Agency's international recognition framework that will be in place from 1 January 2024.
Answered by Will Quince
The new international recognition framework will allow the Medicines and Healthcare products Regulatory Agency (MHRA) to make the most of the expertise and decision-making of trusted regulatory partners to streamline assessments of specific products. As a result, cutting-edge medicines that have been approved in other countries will be licensed in the United Kingdom more quickly. The MHRA will continue to closely engage with key stakeholder groups in the development of their International Recognition Framework.
The National Institute for Health and Care Excellence (NICE) is committed to publishing guidance on new medicines close to the point of licensing wherever possible, and works closely with the MHRA to ensure that its appraisal timelines are aligned with the regulatory process. In 2022/23, NICE piloted a proportionate approach to health technology evaluation to drive rapid patient access to effective new medicines by optimising use of its appraisal capacity. NICE recommended five treatments through this proportionate approach, benefitting around 175,000 patients. For these topics, the appraisal process was completed 45% faster.
The Government is working with NICE and MHRA to consider the need for further changes to ensure that it is able to issue timely guidance.
Asked by: Paula Barker (Labour - Liverpool, Wavertree)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what estimate his Department has made of the potential impact of the Medicines and Healthcare products Regulatory Agency international recognition framework, starting on 1 January 2024, on the average time taken for medicines to become available to NHS patients.
Answered by Will Quince
The new international recognition framework will allow the Medicines and Healthcare products Regulatory Agency (MHRA) to make the most of the expertise and decision-making of trusted regulatory partners to streamline assessments of specific products. As a result, cutting-edge medicines that have been approved in other countries will be licensed in the United Kingdom more quickly. The MHRA will continue to closely engage with key stakeholder groups in the development of their International Recognition Framework.
The National Institute for Health and Care Excellence (NICE) is committed to publishing guidance on new medicines close to the point of licensing wherever possible, and works closely with the MHRA to ensure that its appraisal timelines are aligned with the regulatory process. In 2022/23, NICE piloted a proportionate approach to health technology evaluation to drive rapid patient access to effective new medicines by optimising use of its appraisal capacity. NICE recommended five treatments through this proportionate approach, benefitting around 175,000 patients. For these topics, the appraisal process was completed 45% faster.
The Government is working with NICE and MHRA to consider the need for further changes to ensure that it is able to issue timely guidance.
Asked by: Paula Barker (Labour - Liverpool, Wavertree)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to help increase the level of uptake for the bowel cancer screening programme.
Answered by Neil O'Brien
In 2019 the Faecal Immunochemical Test (FIT) was rolled out in England for the bowel screening programme. FIT has found to be both more accurate and more acceptable to patients, because of its non-invasive nature.
To increase uptake of screening NHS England ran a ‘help us to help you’ campaign about bowel screening in February and March 2023. The aim of this campaign was to encourage people to take up the offer of bowel cancer screening.
Asked by: Paula Barker (Labour - Liverpool, Wavertree)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent steps his Department has taken to provide funding for mental health services for people under the age of 18.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
It is the responsibility of integrated care boards (ICBs) to make available appropriate provision to meet the health and care needs of their local population, and we are supporting them to expand mental health services through the NHS Long Term Plan, which commits to increasing investment into mental health services by at least £2.3 billion a year by 2023/24 so that an additional two million are able to access National Health Service funded mental health support.
The spend for children and young people’s mental health services has increased from £841.4 million in 2019/20 to £994.8 million 2021/22, with a planned spend of £1.0815 billion in 2022/23. This funding is across both NHS specialised commissioning which includes eating disorders services and local commissioning. The source of this data is from the NHS England dashboard. Previous and most recent NHS mental health dashboards is available at the following link:
www.england.nhs.uk/publication/nhs-mental-health-dashboard
Asked by: Paula Barker (Labour - Liverpool, Wavertree)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will take steps to ensure that doorways in new hospital buildings are wide enough to allow beds to pass through them.
Answered by Will Quince
NHS England provides guidance for designing new hospitals. The current guidance is Health Building Note (HBN) 00-04 Circulation and Communication Spaces which sets out the door and corridor width requirements for bed movement.
Asked by: Paula Barker (Labour - Liverpool, Wavertree)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the adequacy of operation waiting times in the Liverpool Wavertree constituency as of 6 February 2023.
Answered by Will Quince
No specific assessment has been made.
Asked by: Paula Barker (Labour - Liverpool, Wavertree)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the scale of mental ill-health amongst the male population; and what plans his Department has to help reduce the number of deaths from male suicide.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
‘Adult Psychiatric Morbidity Survey: Survey of Mental Health and Wellbeing, England, 2014’
Showed that one in five women (20.7%) and one in eight men (13.2%) were estimated to have symptoms of common mental health disorders.
From 2019/20, we are investing £57 million in suicide prevention through the NHS Long Term Plan. This will see investment in every area by 2023/24 to support local suicide prevention plans and establish suicide bereavement support services. We have ensured that this funding is testing different approaches to reaching men in local communities.
We also announced in May 2022 that 113 suicide prevention voluntary, community and social enterprises received a share of £5.4 million funding in 2021/22 to prevent suicide in high-risk groups, including men.
In addition, every local authority area has a suicide prevention plan in place, and the guidance we issued to local authorities highlights the importance of working across all local services, including the voluntary sector, to target high risk groups such as men.
The Department is working closely with the National Suicide Prevention Strategy Advisory Group and wider stakeholders over the coming months to develop the new National Suicide Prevention Strategy. This will include discussions on issues relating to high-risk groups, such as men.