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 - Shadow Minister (Policy Renewal and Development)
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.
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 estimate she has made of the timeframe for the provision of technology to tallow for annual prescriptions for HRT.
Answered by Maria Caulfield
The technology already exists to allow prescribers to issue annual prescriptions for hormone replacement therapy (HRT). The estimated timeframe for the introduction of the HRT prescription prepayment certificate is 1st April 2023.
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, if she will relax the restrictions on dispensing pharmaceuticals in GP surgeries to enable more patients to obtain their medication from the surgery.
Answered by Neil O'Brien - Shadow Minister (Policy Renewal and Development)
There are no plans to do so. These measures are in place to protect the viability of community pharmacies and the provision of services.
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 plans she has to use provisions of the Health and Care Act 2022 to regulate non-surgical cosmetic procedures; and whether that regulation is a policy priority.
Answered by Maria Caulfield
We are committed to improving the safety of cosmetic procedures by ensuring that the regulatory framework allows consumers to make informed and safe choices. Officials are considering how a future licensing scheme for non-surgical cosmetic procedures in England may be implemented. Any future licensing requirements would be subject to both stakeholder engagement and public consultation to inform the scope and details of the scheme.