Asked by: Caroline Nokes (Conservative - Romsey and Southampton North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the National Disability Strategy published 28 July 2021, which of his Department’s commitments in that strategy that have not been paused as a result of legal action have (a) been fully, (b) been partially and (c) not been implemented.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
In January 2022, the High Court declared the National Disability Strategy (NDS) was unlawful because the UK Disability Survey, which informed it, was held to be a voluntary consultation that failed to comply with the legal requirements on public consultations.
The Department had eight policies included in the National Disability Strategy.
The following commitments have been fully implemented, working with the Department for Levelling Up, Housing and Communities, invest £71 million in the Care and Supported Housing Fund (CASSH) Fund (2021-22), work with disabled people and disability organisations at every stage of social care reform, NHS England to expand Learning from lives and deaths, people with a learning disability and autistic people (LeDeR) programme to include autistic people by March 2022, the Home Office and the Department will jointly lead a review into the protections and support available to adults abused in their own homes by people providing their care, coordinating inputs from wider Government, disabled people, carers organisations and other interested parties, following an independent review of the Disabled Facilities Grant published in December 2018, Department for Levelling Up, Housing and Communities and the Department of Health and Social Care will jointly publish new government guidance for local authorities in England on effective delivery of the £573 million Disabled Facilities Grant in 2021.
The following commitment has been partially implemented, subject to evaluation, the Department to make training on autism and learning disability available for all 2.7 million health and adult social care staff. The following commitment has not yet been implemented, develop an autism public understanding initiative by autumn 2021. The following commitment has been paused; establish a new disability data working group in 2021 to improve health and social care data.
We remain fully committed to supporting disabled people in the UK through creating more opportunities, protecting their rights and ensuring they fully benefit from, and can contribute to, every aspect of our society. To support this, the Department will be providing further details of our recent achievements to improve disabled people’s lives in the forthcoming Disability Action Plan consultation due for publication in the summer.
Ahead of this, the Minister for Disabled People, Health and Work will write providing a list of these achievements and will place a copy in the House Library.
Asked by: Caroline Nokes (Conservative - Romsey and Southampton North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps the Medicines and Healthcare products Regulatory Agency is taking to reduce backlogs in D150 applications.
Answered by Will Quince
Delays to the processing of marketing authorisation applications have resulted from a combination of factors, including implementation of new licensing pathways and the need to divert resource to deal with urgent and unforeseen public health issues like the COVID-19 pandemic. The Medicines and Healthcare products Regulatory Agency (MHRA) is changing its assessment processes to speed up the processing of submitted applications. Resource issues are being addressed as a matter of priority with targeted recruitment. The MHRA is also implementing a new IT system to manage licensing applications and improve processing times.
Asked by: Caroline Nokes (Conservative - Romsey and Southampton North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many products in the D150 submission category have been waiting for Medicines and Healthcare products Regulatory Agency approval for over 150 days; and how many of those products are specifically for women’s health.
Answered by Will Quince
The Medicines and Healthcare products Regulatory Agency (MHRA) offers a 150-day assessment timeline for all high-quality marketing authorisation applications.
A total of 1,016 medicinal products have been waiting for MHRA marketing authorisation approval for more than 150 days. Of these, 36 are for women’s health.
Asked by: Caroline Nokes (Conservative - Romsey and Southampton North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, by what date he expects the Medicines and Healthcare products Regulatory Agency to be able to process all D150 submissions within the 150 day timescale.
Answered by Will Quince
The statutory timelines for processing national applications is 210 days. However, the Medicines and Healthcare products Regulatory Agency (MHRA) is working towards progressing priority applications and good quality submissions within 150 days. To achieve this, the MHRA is proactively engaging with the relevant Trade Associations on how best to improve the quality of marketing authorisation applications, including workshops to support companies. With the measures put in place, the MHRA anticipates that all priority and good quality dossiers that are compliant with legislative data requirements received from 1 January 2024 will be progressed within 150 days. Applications that do not meet these requirements will be progressed within the statutory 210 days.
Asked by: Caroline Nokes (Conservative - Romsey and Southampton North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when the Medicines and Healthcare products Regulatory Agency plans next to review the list of priority conditions which determine the speed with which applications for licenses for new medicines are considered.
Answered by Will Quince
The Medicines and Healthcare products Regulatory Agency (MHRA) does not have a specific list of conditions to which it gives priority when reviewing applications for new medicine licenses. However, it does prioritise applications where there is a public health need, for instance a new medicine which offers a treatment which is not yet available or a generic medicine where there might otherwise be a risk to supply. When deciding whether to prioritise a medicine, the MHRA collaborates with the Department and National Health Service to make sure its decisions align with their priorities.
Asked by: Caroline Nokes (Conservative - Romsey and Southampton North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, which conditions are considered a priority by the Medicines and Healthcare products Regulatory Agency when assessing applications for new licences for medicines.
Answered by Will Quince
The Medicines and Healthcare products Regulatory Agency (MHRA) does not have a specific list of conditions to which it gives priority when reviewing applications for new medicine licenses. However, it does prioritise applications where there is a public health need, for instance a new medicine which offers a treatment which is not yet available or a generic medicine where there might otherwise be a risk to supply. When deciding whether to prioritise a medicine, the MHRA collaborates with the Department and National Health Service to make sure its decisions align with their priorities.
Asked by: Caroline Nokes (Conservative - Romsey and Southampton North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how priority conditions are determined when the Medicines and Healthcare products Regulatory Agency considers applications for licensing of new medicines.
Answered by Will Quince
The Medicines and Healthcare products Regulatory Agency (MHRA) does not have a specific list of conditions to which it gives priority when reviewing applications for new medicine licenses. However, it does prioritise applications where there is a public health need, for instance a new medicine which offers a treatment which is not yet available or a generic medicine where there might otherwise be a risk to supply. When deciding whether to prioritise a medicine, the MHRA collaborates with the Department and National Health Service to make sure its decisions align with their priorities.
Asked by: Caroline Nokes (Conservative - Romsey and Southampton North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department has mechanisms which allow blood bank supplies from non-covid-19-vaccinated donors available to non-covid-19-vaccinated patients who stipulate that preference.
Answered by Neil O'Brien
Blood bank supplies are not identified based on the donor’s COVID-19 vaccination status. The Joint United Kingdom Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC) provides guidelines for the blood transfusion services in the UK. In July 2021, JPAC published a position statement, which was updated in November 2022, stating that blood services cannot provide information on the COVID-19 vaccine status of donors to recipients and it is not necessary from a safety or efficacy perspective.
This is based on advice from the Medicines and Healthcare products Regulatory Agency that no additional blood and plasma safety measures are recommended in relation to the occurrence of suspected adverse reactions to COVID-19 vaccines. Individuals vaccinated with COVID-19 vaccines may be accepted as donors, provided they feel well.