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: Lord Campbell-Savours (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the case for reviewing the expiry dates of antibiotics, including in respect of savings for public expenditure.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA), the Government agency responsible for ensuring that medicines and medical devices work and are acceptably safe, has not made an assessment on the case for reviewing the expiry dates of antibiotics.
Medicine expiry dates, including for antibiotics, are necessary to ensure that the safety and effectiveness of a medicine is maintained over its long-term shelf life. The active ingredient in many medicines can degrade over time resulting in a loss of potency or the formation of impurities in the product. Physical changes to a medicine such as discolouration, may also occur upon prolonged storage. Medicine expiry dates are supported by stability studies completed by the pharmaceutical company, which demonstrate that a medicine remains safe and effective throughout its shelf life. Any change to the expiry date of a medicine requires an independent review of the stability data by the MHRA.
Companies can and often do extend the shelf life of their medicines once the product is on the market, and as additional stability data become available. It is not possible, however, to extend the expiry date of all medicines unilaterally in the absence of supporting stability data.
Asked by: Lord Allen of Kensington (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the comments by the Royal College of Nursing that the fall in each of the past three years in applications to university nursing courses is a direct threat to patient safety, and what actions they are taking to improve patient safety in England.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The number of applicants continues to outstrip the places on offer. Nursing training places are competitive, and lead to an attractive and important career in the National Health Service.
Record numbers of nurses are now working in the NHS, and the first ever NHS Long Term Workforce Plan, backed by over £2.4 billion of funding, will add 24,000 more nurse and midwifery training places by 2031.
Over the last decade, the Government and system partners have delivered major initiatives to advance patient safety in the NHS. This includes implementing the first NHS Patient Safety Strategy, establishing the independent Health Services Safety Investigations Body to address the most serious patient safety incidents, and appointing the first Patient Safety Commissioner to champion the patient voice in relation to the safety of medicines and medical devices.
Asked by: Lord Norton of Louth (Conservative - Life peer)
Question to the Cabinet Office:
To ask His Majesty's Government, further to the Written Answer by Baroness Neville-Rolfe on 8 February (HL1937), whether they will list the 19 non-statutory and 23 statutory inquiries established under the Inquiries Act 2005, along with the (1) length, (2), cost, and (3) sponsoring department, for each of those inquiries.
Answered by Baroness Neville-Rolfe - Minister of State (Cabinet Office)
The Cabinet Office collects data on the duration and cost of inquiries from departments, inquiries’ own reports, and other publicly available information.
We have provided details on all statutory and non-statutory inquiries established since 2005 in the table below.
In some cases, information in the table below has come from reports from outside the Government. We have not included the costs for ongoing inquiries, which are published at different frequencies on inquiry or departmental websites, and we have not included the details for any investigations commissioned by NHS England (some of which were counted in the total number of non-statutory inquiries in our previous response, answered on 8th February 2024, UIN HL1937). It has been noted where the publicly available information provides the cost excluding VAT.
Inquiry | Sponsor Department | Legislative Basis | Year established | Duration in months (from announcement to publication of final report) | Reported final costs where publicly available |
Jalal Uddin Inquiry | HO | Inquiries Act 2005 | 2023 | Ongoing | - |
Cranston Inquiry | DfT | Non-statutory | 2023 | Ongoing | - |
Andrew Malkinson Inquiry | MoJ | Non-statutory | 2023 | Ongoing | - |
Thirlwall Inquiry | DHSC | Inquiries Act 2005 | 2023 | Ongoing | - |
Inquiry into the preventability of the Omagh bombing | NIO | Inquiries Act 2005 | 2023 | Ongoing | - |
Independent inquiry relating to Afghanistan | Ministry of Defence | Inquiries Act 2005 | 2022 | Ongoing | - |
Dawn Sturgess Inquiry | HO | Inquiries Act 2005 | 2022 | Ongoing | - |
Fuller Inquiry | DHSC | Non-statutory | 2022 | Ongoing | - |
Angiolini Inquiry | HO | Non-statutory | 2022 | Ongoing | - |
UK Covid-19 Inquiry | Cabinet Office | Inquiries Act 2005 | 2022 | Ongoing | - |
Lampard Inquiry | DHSC | Inquiries Act 2005 | 2021 | Ongoing | - |
Jermaine Baker inquiry | HO | Inquiries Act 2005 | 2020 | 29 | £4.1m |
Post Office Horizon IT inquiry | DBT | Inquiries Act 2005 | 2020 | Ongoing | - |
Manchester Arena inquiry | HO | Inquiries Act 2005 | 2019 | 41 | £35.6m |
Brook House Inquiry | HO | Inquiries Act 2005 | 2019 | 46 | £18.7m |
The Independent Medicines and Medical Devices Safety Review | Department of Health | Non-statutory | 2018 | 29 | £1.7m |
Independent Inquiry into the issues raised by Ian Paterson | Department of Health | Non-statutory | 2018 | 26 | £1.9m |
Grenfell Tower Inquiry | Cabinet Office | Inquiries Act 2005 | 2017 | Ongoing | - |
Infected Blood Inquiry | Cabinet Office | Inquiries Act 2005 | 2017 | Ongoing | - |
Independent inquiry into the award of the Magnox decommissioning contract by the Nuclear Decommissioning Authority (NDA) and its subsequent termination | BEIS | Non-statutory | 2017 | 48 | [unknown] |
Anthony Grainger Inquiry | HO | Inquiries Act 2005 | 2016 | 40 | £2.6m |
The Independent Inquiry into Child Sexual Abuse | HO | Inquiries Act 2005 | 2015 | 99 | £192.7m (as of Dec 2022) |
Undercover Policing Inquiry | HO | Inquiries Act 2005 | 2015 | Ongoing | - |
Gosport Independent Panel | Department of Health | Non-statutory | 2014 | 42 | £13m |
The Litvinenko Inquiry | HO, FCO and 3 x Intelligence Agencies | Inquiries Act 2005 | 2014 | 18 | £2.4m (exc. VAT) |
Harris Review / Independent review of self-inflicted deaths of young adults in custody aged between 18 and 24 | MoJ | Non-statutory | 2014 | 17 | £0.2m |
The Morecambe Bay Maternity and Neonatal Services Investigation | Department of Health | Non-statutory | 2013 | 18 | £1.1m |
Daniel Morgan Independent Panel | HO | Non-statutory | 2013 | 97 | £17.6m |
The Leveson Inquiry | DCMS and HO | Inquiries Act 2005 | 2011 | 16 | £5.4m |
The Azelle Rodney Inquiry | MoJ | Inquiries Act 2005 | 2010 | 40 | £2.6m |
Mid Staffordshire NHS Foundation Trust Inquiry 2013 / The Francis Inquiry | Department of Health | Inquiries Act 2005 | 2010 | 36 | £13.7m |
The Detainee Inquiry | Cabinet Office | Non-statutory (Committee of Privy Counsellors) | 2010 | 45 | £2.3m (exc. VAT) |
The Hillsborough Independent Panel | HO | Non-statutory | 2009 | 33 | Less than £5m |
The Al Sweady Inquiry | MoD | Inquiries Act 2005 | 2009 | 61 | £24.9m (exc. VAT) |
Independent Inquiry into care provided by Mid Staffordshire NHS Foundation Trust January 2001 – March 2009 | Department of Health | Non-statutory | 2009 | 7 | - |
The Iraq Inquiry / The Chilcot Inquiry | Cabinet Office, FCO, DfID | Non-statutory (Committee of Privy Counsellors) | 2009 | 85 | £13.1m |
The Bernard (Sonny) Lodge Inquiry | MoJ | Inquiries Act 2005 | 2009 | 10 | £0.4m |
The Baha Mousa Inquiry | MoD | Inquiries Act 2005 | 2008 | 39 | £13m |
Inquiry into Human Tissue Analysis in UK Nuclear Facilities / Redfern Inquiry | DTI - BERR - DECC | Non-statutory | 2007 | 43 | - |
Contaminated Blood and Blood Products Inquiry | Department of Health | Non-statutory | 2007 | 48 | £75k |
Asked by: Lord Storey (Liberal Democrat - Life peer)
Question to the Department for Education:
To ask His Majesty's Government what consideration has been given to making it compulsory to have EpiPens in all schools.
Answered by Baroness Barran - Parliamentary Under-Secretary (Department for Education)
In 2014, the government introduced a new duty on schools to support pupils with all medical conditions and published the ‘Supporting pupils at school with medical conditions’ statutory guidance for schools and others. This guidance does not specify which medical conditions should be supported in schools. Instead, the guidance focuses on how to meet the needs of each individual child and how their medical condition impacts on school life.
Schools also have duties under the Equality Act 2010 to make reasonable adjustments to their practices, procedures and policies to ensure that they are not putting those with certain long-term health problems at a substantial disadvantage.
Under the Medical and Healthcare Regulatory Agency Human Medicines (Amendment) Regulations 2017, all schools are able to buy adrenaline auto-injector (AAI) devices without a prescription, for emergency use in children who are at risk of anaphylaxis, but their own device is not available or not working. The Department for Health and Social care published guidance on using an emergency AAI in schools which can be found in the attached document.
Asked by: Baroness Redfern (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what plans they have to allow specialist orthoptists independent prescribing responsibilities, thereby obviating glaucoma patients' requirement for a duplicate appointment with an ophthalmologist for eye drop prescriptions, and avoiding unnecessary delay in treatment for these patients and others.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Prescribing is a high-risk activity, and it is widely agreed that it should only be carried out in a regulatory context. There is a process in place for making changes to prescribing responsibilities, to ensure those changes are safe and beneficial for patients. NHS England leads on developing clinical cases for change, in collaboration with the professional bodies, and the Commission on Human Medicines reviews proposals and provides advice. If proposals are progressed, changes must be made to the Human Medicines Regulations 2012, using the powers in the Medicines and Medical Devices Act 2021, and this requires a public consultation and regulations to be laid and debated in both Houses of Parliament and the Northern Ireland Assembly.
Regulated orthoptists are currently able to supply and administer certain medicines via exemptions or patient group directions. There are no plans to extend this to independent prescribing at this time.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question
To ask the Minister for Women and Equalities, If she will make an assessment of the potential impact on women's health of the Government's progress on implementing the recommendations of the report of the Independent Medicines and Medical Devices Safety Review entitled First Do No Harm, published on 8 July 2020.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Patient safety and women’s health is a top priority for this Government.
That’s why since the ‘First Do No Harm’ report we have:
o Appointed England’s first Patient Safety Commissioner
o Setup specialist centres for women impacted by mesh
o Piloted ways doctors can declare their interests
o And launched a national mandatory Medical Device Outcome Registry.
Beyond this, we published the first Women’s Health Strategy for England, which set out our plans for improving how the health and care system listens to women.
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 assessment they have made of the implications for policy in England of the US Food and Drug Administration’s announcement that it would be making the reporting of incidences of surgical burns or fires mandatory; and what discussions they have held with the Medicines and Healthcare Products Regulatory Agency and relevant stakeholders about this.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) has not had any meetings with the US Food and Drug Administration regarding the change to introduce mandatory reporting of incidences of surgical burns or fires to the MHRA, and we do not intend to impose mandatory reporting of these events.
Mandatory reporting of adverse effects from clinicians would require legislative change. It is not within the MHRA’s scope to compel this, and we do not have any jurisdiction over healthcare professionals. There is limited evidence that making reporting mandatory increases the ability to detect safety signals. There are professional guidelines in place for healthcare professionals to report safety issues, and the MHRA is working to proactively encourage reporting of adverse effects through improvements such as those within the new SafetyConnect system and outreach work. Manufacturers of medical devices are also required to report any incidents they receive to the MHRA.
Healthcare professionals and patients are encouraged to report any suspected adverse incidents with medicines or medical devices to the MHRA via the Yellow Card scheme.