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 steps she is taking to (a) monitor and (b) report on the performance of the Medicines and Healthcare Products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
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, whether she has received representations from the scientific community on the efficiency of the Medicines and Healthcare products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
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, whether she plans to take steps to help increase productivity in the Medicines and Healthcare products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
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 steps she is taking to help increase the capacity of the Medicines and Healthcare products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
Asked by: Dan Carden (Labour - Liverpool, Walton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she plans to take steps to implement recommendations in the report by the APPG on Hormone Pregnancy Test entitled Bitter Pill: Primodos - the forgotten thalidomide, published on 27 February 2024.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
We remain hugely sympathetic to the families who believe that they have suffered because of using Hormone Pregnancy Tests (HPTs). In 2017 an independent Expert Working Group (EWG) conducted a comprehensive review of the available scientific evidence and concluded that the data did not support a causal association between the use of HPTs, such as Primodos, and adverse pregnancy outcomes. This remains the Government’s position. The Government has committed to reviewing any new evidence related to HPTs and a possible causal association with adverse pregnancy outcomes.
On the recently published recommendations of the HPT All-Party Parliamentary Group, we have no plans to set up an independent review to examine the findings of the EWG. In the interests of transparency, all evidence collected and papers considered by the EWG were published in 2018, along with full minutes of its discussions. Details of conflicts of interests and how these were managed were also published. The Government is reviewing Professor Danielsson’s publication to consider if it presents any new evidence or analyses not already considered by the EWG on HPTs, and will be seeking independent expert advice from the Commission on Human Medicines in due course.
Asked by: Matthew Offord (Conservative - Hendon)
Question to the Department for Environment, Food and Rural Affairs:
To ask the Secretary of State for Environment, Food and Rural Affairs, if he will make it his policy to reduce the cap on concentration levels per individual type of poly- and perfluoroalkyl substances that require immediate water treatment from 100 nanograms per litre to 10 nanograms per litre.
Answered by Robbie Moore - Parliamentary Under-Secretary (Department for Environment, Food and Rural Affairs)
The guideline value on individual types of PFAS of 100 nanograms per litre was set in 2021 based on an assessment of existing scientific knowledge. It was agreed with the UK Health Security Agency (UKHSA) to be a robust level with an appropriate margin to ensure our drinking water is safe to drink. There is no evidence of PFAS concentrations above this value in drinking water supplies.
Nevertheless, work is continuing with other government departments, regulators and the devolved administrations to assess levels of PFAS occurring in the environment, their sources and potential risks to safeguard current high drinking water quality and ensure our regulations remain fit for purpose.
Asked by: Henry Smith (Conservative - Crawley)
Question to the Home Office:
To ask the Secretary of State for the Home Department, if he will make an assessment of the potential merits of introducing a fee for a project licence under the Animals (Scientific Procedures) Act 1986 and using the funds generated to (a) support the further development of non-animal methods and (b) improve enforcement of the regulatory framework.
Answered by Tom Tugendhat - Minister of State (Home Office) (Security)
The Government charges fees for regulation under the Animals (Scientific Procedures) Act 1986 on a full cost recovery basis. The Government has no plans to introduce a fee for project licences. The Government will shortly increase the current fees to maintain high standards of regulation.
The Government recently announced that it will double investment, from £10m to £20m per annum, in research to achieve the three Rs (replacement, reduction and refinement) and develop non-animal alternatives. The Government will also publish a plan to accelerate the development, validation and uptake of technologies and methods to reduce reliance on the use of animals in science.
Asked by: Peter Gibson (Conservative - Darlington)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment she has made of the adequacy of investment in establishing a vaccine library.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Development of a vaccine library, including the adequacy of investment, will be a collaborative, global effort. The Government provides funding to the Coalition for Epidemic Preparedness Innovations (CEPI) through the Department of Health and Social Care and the Foreign, Commonwealth and Development Office. The CEPI plays a key role in funding and coordinating the global research and development effort to develop a vaccine library.
The UK Health Security Agency’s (UKHSA) Vaccine Development and Evaluation Centre (VDEC) makes a significant contribution to the development of a vaccine library through work in developing and evaluating new vaccines and vaccine technologies, some of which is funded by the CEPI.
The UKHSA is also reviewing the recommendations from the International Pandemic Preparedness Secretariat (IPPS) report, in the context of the United Kingdom, and working across Government to strengthen our 100 Days Mission endeavours even further.
More broadly, an established clinical countermeasures programme, including vaccines, is a core component of our pandemic preparedness and response capability. The programme is informed by scientific and clinical assessment of the evidence base, and is kept under review, building on lessons learned from previous outbreaks including COVID-19.
Asked by: Jeff Smith (Labour - Manchester, Withington)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she has made an assessment of the potential implications for her Department’s policies of the report by the APPG on Hormone Pregnancy Test entitled Bitter Pill: Primodos - the forgotten thalidomide, published on 27 February 2024.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
We remain hugely sympathetic to the families who believe that they have suffered due to the use of Hormone Pregnancy Tests (HPTs). In 2017 an independent Expert Working Group conducted a comprehensive review of the available scientific evidence, and concluded that the data did not support a causal association between the use of HPTs, such as Primodos, and adverse pregnancy outcomes. This remains the Government’s position. The Government has committed to reviewing any new evidence related to HPTs, and a possible causal association with adverse pregnancy outcomes.
Asked by: Jeff Smith (Labour - Manchester, Withington)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if she will implement the recommendations in the report by the APPG on Hormone Pregnancy Test entitled Bitter Pill: Primodos - the forgotten thalidomide, published on 27 February 2024.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
We remain hugely sympathetic to the families who believe that they have suffered due to the use of Hormone Pregnancy Tests (HPTs). In 2017 an independent Expert Working Group conducted a comprehensive review of the available scientific evidence, and concluded that the data did not support a causal association between the use of HPTs, such as Primodos, and adverse pregnancy outcomes. This remains the Government’s position. The Government has committed to reviewing any new evidence related to HPTs, and a possible causal association with adverse pregnancy outcomes.