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The departure of the UK from the European Union (EU) and affiliated European regulatory bodies, including the European Medicines Agency, on Dec 31, 2020, has resulted in the Medicines and Healthcare products Regulatory Agency becoming an independent national regulator. This change has required a fundamental transformation of the UK drug regulatory landscape, creating both opportunities and challenges for future development of oncology drugs. New UK pharmaceutical policies have sought to make the UK an attractive market for drug development and regulatory review, by offering expedited review pathways coupled to strong collaborative relations with other leading international medicines regulators, outside of Europe. Oncology is a key global therapy area for both drug development and regulatory approval, and the UK Government has been keen to show regulatory innovation and international collaboration through approval of new cancer medicines. In this Policy Review, we examine the new UK regulatory frameworks, policies, and global collaborations affecting new oncology drug approvals after departure from the EU. We explore some of the challenges that might lie ahead as the UK creates new and independent regulatory review and approval processes for the next generation of cancer medicines. [ABSTRACT FROM AUTHOR]

The regulatory state that developed in Britain and elsewhere in the 1980s and 1990s was characterised by independent agencies, efficiency-based objectives, 'econocratic' analysis, and an emphasis on output- and outcome-based legitimacy. Yet, with economic regulation becoming increasingly politicised, the 'responsible' regulatory state has come under pressure. How have British regulators adapted to these changes? Building primarily on interviews with regulators, we find that the regulatory state has become more responsive to broader political and public concerns. Key responsible features have been maintained, but new responsive layers have been added, contributing to a broadening of decision-making and conceptions of regulation, a greater role for communication and outward-oriented activities, and a widening of stakeholder engagement and accountability. Though supporting theories of organisational reputation and survival, the (ongoing) changes raise new questions about how much 'political space' independent economic regulators can feasibly and legitimately occupy. [ABSTRACT FROM AUTHOR]

The growing reliance on non-governmental independent regulators in many social and economic domains, including corporate financial reporting, has brought to the fore concerns over their regulatory accountability. This study looks at one aspect of the regulatory due process-regulatory impact assessment (IA). Drawing on the analytical framework developed by Bovens (Public accountability: a framework for the analysis and assessment of accountability arrangements in the public domain. CONNEX papers, Research Group 2, Democracy and Accountability in the EU, 2006, Eur Law J 13(4): 447–468, 2007), we evaluate the contribution of IA as an instrument for enhancing regulatory accountability in the context of the Financial Reporting Council, an independent regulator for the accountancy profession in the UK. The study's findings suggest that, despite an increasing level of sophistication in the manner in which IA is used within FRC, the contribution of IA to regulatory accountability remains limited. Specifically, there are concerns as to whether IA is used to achieve a transparent and fair regulatory process or simply to maintain an image of good governance and justify policy decisions that would have been made even in the absence of IA. [ABSTRACT FROM AUTHOR]

Organizations wax and wane, and some cease to exist altogether. The Standards Board for England was abolished after a 10-year life. Created to regulate the ethical behavior of local politicians in England, the ethics of politics was undermined by the politics of ethics. This article analyzes the life of the Standards Board initially through the lens of a life-cycle approach to organizations but finds that a problem-cluster approach provides a sharper picture. Over its lifetime, the Standards Board faced a number of crises; its failure to resolve these crises and an unfavorable political climate led to its demise. [ABSTRACT FROM AUTHOR]

The article presents details on the origin, purpose and operation of the Independent Commission for the Location of Victims' Remains (ICLVR), as well as on some cases of missing persons and investigations involved in dealing with the cases. The commission was established by the governments of Great Britain and Ireland in 1999. It cites the functions of the commission including receiving information relating to the location of the remains of missing victims. The commission also facilitates identification of the location and recovery of the remains of a number of missing persons who were killed and buried secretly during the conflict in Northern Ireland by unlawful paramilitary groups.

The Internet Watch Foundation (IWF) is a UK-based self-regulatory organization that seeks to reduce the availability of child sexual abuse and criminally obscene content on the Internet. One of the methods used by this organization is the creation of a blacklist of content, which the members disable access to through the use of filtering technologies. The work of the IWF raises fundamental questions about how to regulate free speech in the digital age; it carries out work of critical importance, but if unchecked its operations can have a significant impact on the right to freedom of expression. This article examines whether the IWF’s regulatory structure is sufficient to protect and respect freedom of expression online. The analysis is both internal to the organization by looking at its governance documents, and external to the IWF by examining the applicability of human rights laws. Through this examination, wider issues in Internet regulation and human right are analysed, in particular the increasing impact of businesses on human rights such as free speech, the sufficiency of self-regulation to address human rights issues, and the limits in extending direct application of human rights laws to private organizations. This article concludes by identifying the risks with self-regulatory regimes when human rights are at stake and by framing the principles needed for accountability of such bodies as the IWF for freedom of expression. [ABSTRACT FROM AUTHOR]

While trust is seen as central to most social relations, most writers, including sociologists of science, assume that modern trust relations – especially those in regulatory relationships – tend towards the impersonal. Drawing on ethnographic material from one kind of scientific oversight body – research ethics committees based in the UK NHS – this paper argues that interpersonal trust is crucial to regulatory decision-making and intimately bound up with the way in which these oversight bodies work, and that as such they build on, rather than challenge, the trust-based nature of the scientific community. [ABSTRACT FROM PUBLISHER]

Independent regulatory agencies, faced with multiple and often conflicting demands from regulatory stakeholders, yet operating at arm's length from government, may be under considerable pressure to demonstrate the legitimacy of their decisions and the regime they administer. This article considers how regulators employ presentational strategies to establish and maintain their legitimacy by documenting the findings of a comparative study of two independent agencies responsible for the regulation of trade practices in their respective jurisdictions: the UK Office of Fair Trading and the Australian Competition and Consumer Commission. Its findings demonstrate that presentational activities may be an important means by which regulators give concrete expression to their obligations of transparency, promote the effectiveness of the regime they administer, and publicly demonstrate how their work serves the community. The mass media is relied upon by both agencies as the primary vehicle through which they seek to communicate to their targeted audiences and the public at large, actively seeking to manage the ambivalence that infuses the regulatory enterprise. [ABSTRACT FROM AUTHOR]

This article explores the formation of public organizations’‘domain perception’, that is, their internal interpretation and external articulation of their role and its boundaries. The analysis is based on non-participant observation research of the UK Financial Ombudsman Service (FOS), and archival research of its predecessor organization, which handled consumer complaints regarding the retail selling of financial products. I show that the FOS’s articulation of its domain emphasized the strictly individual and confidential nature of its complaint handling, rather than formulation of general principles to guide firms’ sale practices. This domain perception embodied an implicit exchange between the ombudsman and the retail financial industry on behalf of consumers, and distinguished the ombudsman’s role from that of the Financial Services Authority and the civil courts. The case is employed as means for theory building regarding the nature of public organizations’ domain perceptions and the process by which such constructs develop in regulatory contexts. [ABSTRACT FROM AUTHOR]

This paper develops a framework with which to interrogate how well pharmaceutical innovation and regulation are performing to produce drugs that improve health. That framework comprises five key dimensions: therapeutic advance of drug product innovations; safety standards in drug testing; use of surrogate measures of clinical benefit; independence of regulatory agencies; and public access to regulatory science. It is concluded that: more demanding regulatory intervention is required in order to increase the proportion of drug innovation that actually offers therapeutic benefits over existing products; drug regulatory agencies need much greater independence from the pharmaceutical industry; the erosion of safety standards since 1990 needs to be reversed; accelerated approvals of drugs based on surrogate, rather than clinical endpoints, require much greater critical attention; and much more extensive public access to regulatory science is required in order for regulatory decision-making to be thoroughly accountable to the public and the wider scientific community. [ABSTRACT FROM AUTHOR]

The article focuses on the election of vice-presidents for the British Board of Film Censors (BBFC). The Video Recordings Act made the BBFC the government's designated video censorship and classification agency in 1984. James Ferman, BBFC secretary since 1975, placed Lord Goodman's name before Home Office minister David Mellor as an appropriate appointment. Home secretary Jack Straw defeated Ferman and the BBFC and appointed two vice presidents in 1998.

The article presents a discussion on whether there is still a need for the Scottish Law Commission. It discusses the events that brought the commission into existence, and the works that the commission have accomplished. It also discusses how James Arthur David Hope became a member of the faculty of advocates.

Examines what the Russell Commission has to say about voluntary action and its proposals for engaging the youth of the "goodwill mountain" in Great Britain. Focus on volunteering as a vital part in the overall policy approach to young people; Overview of the 2005 Green Paper, titled "Youth Matters"; Implications that the Russell Commission may have for young people.

Focuses on the establishment of the Royal Commission on Standards of Conduct in Public Life tasked to address problems of corruption in Great Britain. Politicians and other leading public officials convicted of corruption during 1974; Responsibilities of the commission; Factors that influenced the government's decision to enact the commission; Overview of the status of political corruption in the country.

Quangos (a vogue term for central non-departmental bodies) have been one of the growth sectors in British government in recent decades. But the election to office (in 1979) of a Conservative government committed to retrenchment and the curbing of quangos might lead us to expect 'quangocide' -- a massacre of quangos. What actually took place in the review of non-departmental bodies announced in January 1980 was nothing of the kind. Rather, it amounted to a combination of cuts in future spending, personnel changes, a degree of cosmetic and of `politically selective' surgery, and a degree of rather weak 'medicine'. On past evidence, quangos seem to be a fairly hardy breed, and the gap between pre-election rhetoric and the realpolitik of actions in office may be explained by the fact that quangos are instruments too useful to politicians of any colour to be lightly discarded. [ABSTRACT FROM AUTHOR]

‘The machinery of the Parliamentary Commissioner for Administration does not necessarily provide a model to be followed closely for the investigation of complaints alleging maladministration in local government. Nevertheless the Government thinks that there should be imposed arrangements for investigating citizens' complaints.’ These words in the White Paper on Local Government in England were a positive indication by the Conservative Government of the day that they would establish a complaints procedure for local government. The machinery for this was incorporated into the Local Government Act 1974 which came into force in April 1974. In this article we shall examine the reasons for the establishment of the Commission for Local Administration, the relevant provisions of the Local Government Act 1974 and the work of the Commission at the end of its second year. Whilst it is still too soon to draw any positive conclusions about the effectiveness of the new procedures some indications of the problems the Commission is facing might be made. [ABSTRACT FROM AUTHOR]

The article focuses on the major legislative services to the British Parliament, emphasizing the Royal Commission of Inquiry as a technique in fact-finding and policy determination. British constitutional practice has evolved a series of fact-finding and advisory techniques to assist the Parliament in the performance of its duties. Legislative services have become an integral function of the parliamentary system. The effectiveness of these services has been enhanced by the absence of a division of powers so fundamental in the American concept of government. The major legislative services to the Parliament include: Royal Commissions of Inquiry; Bill drafting by the Parliamentary Counsel to the Treasury; Library and reference services; Department and inter-departmental committees; Departmental advisory bodies; Departmental technical committees. The Royal Commission is used largely: to prepare the way for a pre-determined policy; to find the most politically feasible solution to a problem facing the Government; to supply factual information on legislative problems for which the Government has an open mind and is seriously seeking a solution.

Focuses on papers dealing with how a new Great Britain Supreme Court could work and how judges could be appointed in the future unveiled by Lord Falconer, Secretary of State for Constitutional Affairs. Focus of the first paper; Reason of the British government for proposing the establishment of an independent Judicial Appointment Commission; Principal issues discussed in the third paper.

The article features the appointment of the first member of the UNO Atomic Energy Commission. Sir Alexander Cadogan, permanent Under Secretary of the British Foreign Office and Britain's representative on the UNO Security Council, has been appointed to represent Britain on the Atomic Energy Commission. Sir James Chadwick, the discoverer of the neutron, has been appointed by the British Government as Cadogan's alternate. The American delegate to the Atomic Energy Commission has not yet been appointed.

The article highlights the views of Michael Rawlins, chairman of the Great Britain National Institute for Health and Clinical Excellence, on the regulation and governance of health research. Rawlins described the regulation of trials in the country as disproportionate and asymmetrical. He offered an overview of the Academy of Medical Science's review of medical research governance. He explained how broad definitions in the directive of clinical trial and investigational medicinal products result to problems with consistency. Rawlins also considers the proposed establishment of a new single regulatory agency to govern health research.

The article discusses the function of the Complementary & Natural Healthcare Council (CNHC) in Great Britain. It states that CNHC is a regulatory body that was established in the public interest to cover a wide number of professional disciplines wherein they have to meet its standards before they can apply for registration. It notes that Kate Ling from the Department of Health has confirmed that the organization is the only voluntary regulatory body which was endorsed by the official government. It highlights the requirements for entry standards such as meeting the agreed standards of proficiency for a certain profession or discipline.

The author reflects on the United Kingdom's response to the European Union Third Money Laundering Directive. She suggests that the UK's response, which led to the implementation of the Money Laundering Regulations 2007, are designed to counter money laundering and particularly the financing of terrorism. The author comments on some of the key concerns about the introduction of the new regulatory requirements, such as cost compliance and the impact of UK competitiveness and reputational risks.

Reports that Dipesh Shah, chief executive of the United Kingdom Atomic Energy Authority, has supported the bill which will implement the government's plans to set up a Nuclear Decommissioning Authority (NDA). Duty of the NDA to lead civil nuclear clean-up efforts; Key provisions of the energy bill; Independent statutory police authority of the Civil Nuclear Constabulary.

Announces the establishment of the Commission for Equality and Human Rights, designed to deal with discrimination and inequality issues in Great Britain. Roles and responsibilities of the commission; Background of the commission.

The author comments on a white paper issued by Great Britain's National Health Service regarding a practice-based commissioning (PBC) consortium committee. The author presents several scenarios that will show the impact of PBC consortia to primary care. According to the author, the PBC plans is a conflict of interest for general practitioners to commission services in which they have a financial stake.

The article offers news briefs related to veterinary medicine in Great Britain including the hands-on training courses for graduates in farm practice, the DNA test for foal immunodeficiency syndrome or Fell pony syndrome offered by the Animal Health Trust, and the government request for the establishment of an independent body to monitor compliance with a new groceries supply chain code of practice (GSCOP).

The article focuses on the Commission on the Future of Nursing and Midwifery of Great Britain which aims to address confusion over the roles and titles of nursing and midwifery staff. Among the topics identified by the commission is raising the standard of healthcare support workers and making sure that nurses are prepared to lead services. According to health minister and commission chair Ann Keen, majority of nurses and midwives already perform their job well with those who utilize National Health Service (NHS) services.

The article focuses on a charter called Voices into Action which reflects the commitment made by the Care Quality Commission (CQC) in 2009 to listen to the opinion of the public in England about their experiences of health and social care services. It notes the goals of CQC such as including users in the inspection process and establishing user panels. The author stresses the need for stability to promote development following reforms in community participation in the area of health and social care, and inspection system.

The article provides information for two websites related to medical care in Great Britain. Information about the responsibilities of the health and social care regulator, Care Quality Commission, can be found at www.cqc.org.uk. The website of the Clinical Knowledge Summaries, www.cks.library.nhs.uk, is a resource for evidence-based practice and a place for audio podcast discussions.

The article reports on the launch of the Care Quality Commission (CQC) in England. The CQC brings the services of the Healthcare Commission, Mental Health Act Commission and Commission for Social Care Inspection into one independent regulator. Obi Amadi, lead professional officer of Unite/Community Practitioner's & Health Visitor's Association (CPHVA), expressed that the CQC endorses patient involvement in the country.

Ruth Williams looks at the latest healthcare proposals out for consultation. [ABSTRACT FROM AUTHOR]

The article focuses on the launch of an independent review team to help improve access to a National Health Service (NHS) dentist in Great Britain. The team which has been appointed by Department of Health Secretary Alan Johnson will investigate the reason behind the variations in access in dental care and advise how everyone who wants to see an NHS dentist can do so.

The article focuses on the efforts of the British Department of Environment, Food and Rural Affairs (DEFRA) to seek views on the future of the Veterinary Medicines Directorate (VMD). Options include merging the VMD with Animal Health, the Health and Safety Executive or the Medicines and Healthcare Products Regulatory Agency, or retaining the VMD as an executive agency of DEFRA.

The article reports on the establishment of the Care Quality Commission by the Department of Health in Great Britain. It is stated that the new regulatory body will regulate health including dentistry and social care by merging most of the functions of the Commission for Social Care Inspection, the Healthcare Commission and the Mental Health Act Commission.

The article offers information on the findings of the report entitled "Time to Care?" published by the Commission for Social Care Inspection (CSCI). According to the findings, councils should re-think the way they organize home care services in Great Britain. The report suggests that councils should consider new ways to organize care services to respond more sensitively to people's needs. The report shows that social care agencies should engage with older people to know their requirements and problems about social service.

Reports on the establishment of Great Britain's National Clinical Assessment Authority (NCAA), a regulatory body which is intended to monitor the clinical behavior of medical doctors. Case of Harold Shipman, a general practitioner (GP) who murdered patients in his care; Belief of the medical community that the NCAA will be ineffective; GP monitoring policy improvements favored by the British Medical Association (BMA).