54-656: The Medicines and Healthcare products Regulatory Agency ( MHRA ) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with
108-554: A "digital front door" for patients, with increasing functionality to be added and remote consultations with GPs are to be encouraged. £25 million is to be provided in 2022/23 to support the rapid digitisation of social care, including adopting Digital Social Care Records. In response to Government spending reduction targets following the 2008-9 international financial crisis and subsequent recession , DH in common with several other Government Departments resorted to large-scale staffing reductions. In order to minimise redundancy costs,
162-456: A city), larger-area PCTs (e.g. covering a whole county), PCT clusters (e.g. quarter of London or South of Tyne and Wear) and the currently unspecified Clinical Commissioning Groups. The tendency to introduce each reorganisation before its predecessor has had time to settle down and generate improved performance has attracted censure amongst healthcare professions in the UK and beyond, including reference to
216-400: A joined-up health and social care record by March 2025 in which all clinical teams will have access to a complete view of a person's record that they can contribute to. In 2022 86% of trusts had "some form of electronic patient record" but only 45% of social care providers used a digital social care record, and 23% of care home staff cannot access the internet consistently. The NHS app is to be
270-407: A number of hospitals missed the completion target, and as of June 2008 one in four NHS trusts was not meeting the government's standards on hygiene. Its advice to primary care on prescribing drugs such as proton pump inhibitors has been criticised as wasteful. The DH has attracted criticism for its handling of the outcome of Modernising Medical Careers , in particular in the changes it made to
324-808: A single authority the medical and public health functions of central government. This took on the medical duties of the Board of Education , the duties of the Privy Council under the Midwives Acts, the powers of the Home Secretary in relation to the Children Act 1908 ( 8 Edw. 7 . c. 67), and the duties of the Insurance Commissioners and the Welsh Insurance Commissioners. In the early part of
378-639: Is a ministerial department of the Government of the United Kingdom . It is responsible for government policy on health and adult social care matters in England, along with a few elements of the same matters which are not otherwise devolved to the Scottish Government , Welsh Government or Northern Ireland Executive . It oversees the English National Health Service (NHS). The department
432-709: Is a part of a government department that is treated as managerially and budgetarily separate, to carry out some part of the executive functions of the United Kingdom government , Scottish Government , Welsh Government or Northern Ireland Executive . Executive agencies are "machinery of government" devices distinct both from non-ministerial government departments and non-departmental public bodies (or " quangos "), each of which enjoy legal and constitutional separation from ministerial control. The model has been applied in several other countries. Agencies include well-known organisations such as His Majesty's Prison Service and
486-462: Is led by the Secretary of State for Health and Social Care with three ministers of state and three parliamentary under-secretaries of state . The department develops policies and guidelines to improve the quality of care and to meet patient expectations. It carries out some of its work through arms-length bodies (ALBs) , including executive non-departmental public bodies such as NHS England and
540-535: Is not clear progress by November 2009, a new plan could be hatched. On the eve of the departure of Fujitsu as an outsourcing partner, Connelly said in April 2009 that she would open up sourcing to competition at "acute" sites in the south of England and offer toolkits by March 2010 to allow more local configuration of systems. In January 2009, MPs criticised DH for its confidentiality agreement with key supplier CSC and in March
594-736: Is now mainly occupied by staff from the department's arms-length bodies. New King's Beam House near Blackfriars Bridge was formerly a Department of Health office prior to the expiry of its lease in October 2011. Alexander Fleming House , Hannibal House and Eileen House (all in Elephant and Castle) were previously used by the department. The archives are at Nelson , Lancashire. The Department of Health and Social Care's ministers are as follows, with cabinet ministers in bold: - overall financial control and oversight of NHS delivery and performance - oversight of social care policy The permanent secretary at
SECTION 10
#1732902695673648-668: The 2018 British cabinet reshuffle , the department was renamed the Department of Health and Social Care. The department's headquarters and ministerial offices are at 39 Victoria Street , London . The department moved from its previous location in Richmond House , Whitehall in November 2017. Its other principal offices are Skipton House ( Elephant and Castle ), Wellington House near Waterloo station and Quarry House in Leeds . Wellington House
702-772: The Committee on the Safety of Medicines in 2005. The MHRA manages the Early Access to Medicines Scheme (EAMS), which was created in 2014 to allow access to medicines prior to market authorisation where there is a clear unmet medical need. Prior to the UK's departure from the European Union in January 2021, the MHRA was part of the European system of approval. Under this system, national bodies can be
756-610: The Driver and Vehicle Licensing Agency . The annual budget for each agency, allocated by HM Treasury , ranges from a few million pounds for the smallest agencies to £700m for the Court Service . Virtually all government departments have at least one agency. The initial success or otherwise of executive agencies was examined in the Sir Angus Fraser's Fraser Report of 1991. Its main goal was to identify what good practices had emerged from
810-704: The Local Government Act 1894 became rural and urban district councils. With the emergence of modern local government, some of its supervision was done by the Local Government Act Office, part of the Home Office. The Ministry of Health Act 1919 abolished the Local Government Board and transferred its powers and duties to a new department called the Ministry of Health, which consolidated under
864-679: The NHS Digital , and executive agencies such as the UK Health Security Agency and the Medicines and Healthcare products Regulatory Agency (MHRA). The DHSC also manages the work of the National Institute for Health and Care Research (NIHR). The expenditure, administration and policy of the department are scrutinised by the Health and Social Care Select Committee . Like many others,
918-551: The National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used for the parent organisation and one of the centres within the group. At the same time, CPRD was made a separate centre of the MHRA. The MHRA hosts and supports a number of expert advisory bodies, including the British Pharmacopoeia Commission , and the Commission on Human Medicine which replaced
972-537: The National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory centre within the group. The agency employs more than 1,200 people in London, York and South Mimms , Hertfordshire. The MHRA is divided into three main centres: The MHRA has several independent advisory committees which provide the UK Government with information and guidance on
1026-598: The Privy Council . Responsibility for health issues was also in part vested in local health boards , which existed from 1848 to 1894. In 1871, the Local Government Board was created to supervise such local functions as health and sanitation and also took over the functions of the Poor Law Board , which was abolished. The Public Health Act 1875 ( 38 & 39 Vict. c. 55) designated sanitary districts , which by
1080-447: The 20th century, medical assistance had been provided through these National Health Insurance Commissions. Most of the Local Government Board staff transferred to the new ministry. The co-ordination of local medical services was expanded in connection with emergency and wartime services, from 1935 to 1945, and these developments culminated in the establishment of the NHS in 1948. In 1968,
1134-606: The Blair administration. The NHS as of 1 April 2013 is no longer situated within the DH, as NHS England also went 'live' at the same time. Therefore, the DH has a further scrutiny role of NHS services and commissioning. In recent years the Department of Health and the NHS have come under considerable scrutiny for its use of IT. Since being elected to power in 1997 the Labour government had sought to modernise
SECTION 20
#17329026956731188-736: The DH for a position in the Cabinet Office in June 2009 and was replaced by Tim Donohoe and Carol Clarke. Connelly's role was to "deliver the Department's overall information strategy and integrating leadership across the NHS", according to the DH's website. That strategy, known as the National Programme for IT, is intended to do nothing less than revolutionise NHS information workflow and is costed at about £12.7bn. The success or otherwise of Connelly's reign will be based on her promise to end delays of electronic medical records. She has said that if there
1242-566: The Department of Health and Social Care is Sir Christopher Wormald KCB, who was appointed in 2016. Previous permanent secretaries: Following the resignation of Sir Nigel Crisp in March 2006, a separate post of Chief Executive of the National Health Service in England was created, held by Sir David Nicholson . Following the Health and Social Care Act 2012 and the creation of the independent NHS Commissioning Board, known as NHS England , this post has evolved into Chief Executive of
1296-456: The Department of Health was criticised by infection control experts and by the Lancet as a gimmick which failed to address the causes of in-hospital infections, by the firms doing the work as an attempt to avoid paying for regular better cleaning, and by NHS managers as ineffective. It also attracted criticism because only a quarter of the £60m funding for the scheme went to hospitals, and because
1350-547: The Gates Foundation for a number of initiatives spanning several financial years. June Raine has been the chief executive of the MHRA since 2019, succeeding Ian Hudson who had held the post since 2013. The MHRA's strategy is set by a board which consists of a chairperson (appointed for a three-year term by the Secretary of State for the Department of Health and Social Care ) and eight non-executive directors, together with
1404-710: The Health Select Committee, in October 2023 raising concerns about serious failures by MHRA and demanding an urgent investigation. Executive agency King Charles III [REDACTED] William, Prince of Wales [REDACTED] Charles III ( King-in-Council ) [REDACTED] Starmer ministry ( L ) Keir Starmer ( L ) Angela Rayner ( L ) ( King-in-Parliament ) [REDACTED] Charles III [REDACTED] [REDACTED] [REDACTED] The Lord Reed The Lord Hodge Andrew Bailey Monetary Policy Committee An executive agency
1458-563: The MHRA is too reliant on industry, and so not fully independent. In 2017, the MHRA was awarded over £980,000 by the Bill & Melinda Gates Foundation to fund its work with the foundation and the World Health Organization on improving safety monitoring for new medicines in low and middle-income countries. In response to a Freedom of Information request, in 2022 the MHRA stated that approximately £3 million had been received from
1512-554: The MHRA was criticised by the House of Commons Health Committee for, among other things, lacking transparency , and for inadequately checking drug licensing data. The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma , and in 2004 by David Healy in evidence to the House of Commons Health Committee, for having undergone regulatory capture , i.e. advancing
1566-494: The Ministry of Health was dissolved and its functions transferred (along with those of the similarly dissolved Ministry of Social Security) to the newly created Department of Health and Social Security (DHSS). Twenty years later, in 1988, these functions were split back into two government departments, forming the Department of Social Security (DSS) and the Department of Health, formally created in through The Transfer of Functions (Health and Social Security) Order 1988. Following
1620-612: The NHS prompted criticism of the government and the Department of Health, claiming that it paved the way for user charging, and so contradicting the NHS Plan 2000 which stated that "user charges are unfair and inequitable in they increase the proportion of funding from the unhealthy, old and poor compared with the healthy, young and wealthy". The report also introduces the concept of personal budgets . Darzi's report splits previously integrated services into 'core', 'additional' and 'enhanced' services, which critics say will lead to abandoning
1674-470: The NHS through the introduction of IT. Although the policy is correct in aim, many claim its execution is lacking. In September 2008 a new leadership team was established, CIO for Health, Christine Connelly, and director of programme and system delivery Martin Bellamy. Previous CIO Richard Granger was believed to have been the most highly paid civil servant in the UK and was a controversial figure. Connelly left
Medicines and Healthcare products Regulatory Agency - Misplaced Pages Continue
1728-720: The Pfizer-BioNTech vaccine was extended to young people aged 12–15 in June 2021, 5–11 in December 2021, and from six months in December 2022. The status of the Oxford / AstraZeneca vaccine was upgraded to conditional marketing authorisation on 24 June 2021. The MHRA confirmed in September 2021 that supplementary "booster" doses of these vaccines would be safe and effective, but stated that the Joint Committee on Vaccination and Immunisation had
1782-415: The United Kingdom. By 1997, 76% of civil servants were employed by an agency. The new Labour government in its first such report – the 1998 Next Steps Report – endorsed the model introduced by its predecessor. A later review (in 2002, linked below) made two central conclusions (their emphasis): " The agency model has been a success . Since 1988 agencies have transformed the landscape of government and
1836-719: The United States, the Clinton administration imported the model under the name "performance-based organizations." In Canada, executive agencies were adopted on a limited basis under the name special operating agencies . One example is the Translation Bureau under Public Services and Procurement Canada . Executive agencies were also established in Australia, Jamaica, Japan and Tanzania. Department of Health and Social Care The Department of Health and Social Care ( DHSC )
1890-480: The chief executive and chief operating officer. The current co-chairs are Amanda Calvert, Graham Cooke and Michael Whitehouse. On 2 December 2020, the MHRA became the first global medicines regulator to approve an RNA vaccine when it gave conditional and temporary authorization to supply for use of the Pfizer–BioNTech COVID-19 vaccine codenamed BNT162b2 (later branded as Comirnaty). This approval enabled
1944-654: The department was admonished by the Information Commissioner for its records management. In May 2011, Prime Minister David Cameron announced that he was considering scrapping the project. In 2022 Sajid Javid launched the Plan for Digital Health and Social Care , which includes "regulatory levers" will be used to: "signal that digitisation is a priority, identify the non-negotiable standards of digital capability, [and] explain how we will monitor and support compliance". Integrated care systems will be required to put in place
1998-410: The department with responsibility for the nation's health has had different names and has included other functions at different times. In the 19th century, several bodies were formed for specific consultative duties and were dissolved when they were no longer required. There were two incarnations of a Board of Health, in 1805 and 1831, and from 1854 to 1858 a General Board of Health reported directly to
2052-838: The interests of the drug companies rather than the interests of the public. The Cumberlege Report, also known as the Independent Medicines and Medical Devices Safety Review, is a comprehensive report commissioned by the UK government to investigate the harm caused by certain medical treatments and devices. Released in 2020, the report highlighted the suffering of thousands of patients who experienced complications from treatments such as pelvic mesh implants, sodium valproate, and Primodos. It criticized MHRA's failure to adequately respond to these issues, calling for improved patient safety measures, better regulation of medical devices, and increased support for those affected. The COVID Response & Recovery APPG wrote to Stephen Brine, chairperson of
2106-419: The ironic concept of 'redisorganization'. Andrew Lansley 's promise before the 2010 general election not to impose top-down reorganisation, followed by the instigation from ministerial level of one of the most fundamental NHS reorganisations yet envisaged , has generated especially widespread opprobrium, although some commentators have also suggested that this is to some extent completing the job started under
2160-407: The new model and spread them to other agencies and departments. The report also recommended further powers be devolved from ministers to chief executives. A series of reports and white papers examining governmental delivery were published throughout the 1990s, under both Conservative and Labour governments. During these the agency model became the standard model for delivering public services in
2214-726: The new organisation. The department has six chief professional officers who provide it with expert knowledge and also advise the Ministers, other government departments and the Prime Minister . The Chief Medical Officer and Chief Nursing Officer are also directors of the department's board. The department acts as a 'steward' for the health and adult social care system in England and oversees fifteen arms-length bodies (ALBs) : The department has two executive agencies : The department has thirteen executive non-departmental public bodies : The publication of Professor Lord Darzi 's review of
Medicines and Healthcare products Regulatory Agency - Misplaced Pages Continue
2268-442: The open-ended duty of care on which the NHS was founded. Fatal outbreaks of antibiotic-resistant bacteria ("superbugs"), such as methicillin-resistant Staphylococcus aureus (MRSA) and Clostridioides difficile , in NHS hospitals has led to criticism in 2008 of the department's decision to outsource cleaning via private finance initiative contracts as "cutting corners on cleaning". A "Deep Clean" initiative announced by
2322-449: The predominant impact was upon DH staff not employed through a traditional civil service 'headcount' contract, with a resultant emphasised effect upon more recent or innovative work-streams dependent upon seconded or externally hosted staff. This has attracted criticism from several of the professional and patient communities of interest concerned, for instance as regards the impact upon Improving Access to Psychological Therapies (IAPT) and
2376-530: The rapporteur or co-rapporteur for any given pharmaceutical application, taking on the bulk of the verification work on behalf of all members, while the documents are still sent to other members as and where requested. From January 2021, the MHRA is instead a stand-alone body, although under the Northern Ireland Protocol the authorisation of medicines marketed in Northern Ireland continued to be
2430-725: The regulation of medicines and medical devices. There are currently eight such committees: In 1999, the Medicines Control Agency ( MCA ) took over control of the General Practice Research Database (GPRD) from the Office for National Statistics . The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD). In April 2013, MHRA merged with
2484-423: The responsibility for medical training be removed from the DH. Successive DH ministerial teams have been criticised for repeated reorganisations of the NHS in England, where primary care commissioning responsibility, in particular, has been allocated to four different sets of organisations in the last ten years: PCGs, small area primary care trusts (PCTs) (e.g. covering a rural local authority district or part of
2538-515: The responsibility of the European Medicines Agency . However, as a result of the 2023 Windsor Framework , the MHRA is expected to once again deal with authorisation throughout the United Kingdom. The MHRA is funded by the Department of Health and Social Care for the regulation of medical devices , whilst the costs of medicines regulation is met through fees from the pharmaceutical industry . This has led to suggestions by some MPs that
2592-421: The responsive and effectiveness of services delivered by Government." Some agencies have, however, become disconnected from their departments ... The gulf between policy and delivery is considered by most to have widened." The latter point is usually made more forcefully by critics of the government, describing agencies as "unaccountable quangos ". Several other countries have an executive agency model. In
2646-480: The specialist training of doctors and the Medical Training Application Service (MTAS). These changes left "29,193 junior doctors from the UK and overseas... chasing 15,600 posts..." and resulted in accusations that the DH had broken the law by refusing to reveal scores to candidates. Ultimately there was a judicial review and a boycott of the system by senior doctors across the country. MTAS
2700-428: The start of the UK's COVID-19 vaccination programme . The regulator's public assessment report for the vaccine was published in 15 December. The MHRA went on to give conditional and temporary authorization to supply of further vaccines: AZD1222 from Oxford University and AstraZeneca on 30 December, mRNA-1273 from Moderna on 8 January 2021, and a single-dose vaccine from Janssen on 28 May 2021. The approval of
2754-484: The task of advising if and when they should be used in this way. Later that month, the MHRA said the Moderna vaccine could also be given as a booster dose. In August and September 2022, the MHRA approved the first bivalent COVID-19 booster vaccines. In January 2021, the MHRA expressed concern to the UK government over plans to deploy lateral flow tests in schools in England, stating that they had not authorised daily use of
SECTION 50
#17329026956732808-552: The tests due to concerns that negative results may give false reassurance. The government suspended the scheme the following week, citing risks arising from high prevalence of the virus and higher rates of transmission of a new variant. In July 2023, MHRA began a consultation to reclassify cough syrups containing codeine (an opiate ) as prescription-only medicines, in response to a rise in recreational drug abuse cases since 2018. There were 277 serious and fatal reactions to medicines containing codeine in 2021, and 243 in 2022. In 2005,
2862-546: The withdrawal of the practical assistance available to the NHS and local authorities via the national support teams . Most health policy in Scotland, Wales and Northern Ireland is devolved to the department's counterparts: The comparability factor (the proportion of spending in this area which is devolved) was 99.5% for all three countries for 2021/22. A number of health issues are, however, wholly or partly reserved to Westminster: In Northern Ireland, abortion law
2916-532: Was eventually scrapped and Patricia Hewitt , the then Secretary of State for Health, resigned following accusations that she had lied to the House of Commons over the system. Even after the abolition of MTAS, anger among the medical profession continued, with the British Medical Association commenting of the DH response that "Not only is this response too late, it does not go far enough". The official government inquiry into MMC recommended that
#672327