Dismantling the National Health Service in England.

The National Health Service was established in the United Kingdom in 1948 as a universal, comprehensive service free at the point of delivery, which is publicly provided, funded, and accountable. Market incrementalism in England has eroded this system over three decades. The recently enacted Health and Care Act will erode it further. This article first explains briefly how legislation and policy initiatives in 1990, 2003, and 2012 furthered development of the market and private provision of health services, and then describes the main structural changes in the new Act and their implications. England is now moving decisively toward a marketized, two-tier, mixed-funding system with several similarities to the United States.

Socioeconomic inequality, waiting time initiatives and austerity in Scotland: an interrupted time series analysis of elective hip and knee replacements and arthroscopies.

OBJECTIVES: National Health Service (NHS) waiting times have long been a political priority in Scotland. In 2002, the Scottish government launched a programme of investment and reform to reduce waiting times. The effect on waiting time inequality is unknown as is the impact of subsequent austerity measures. DESIGN: An interrupted time series analysis between the most and least socioeconomically deprived population quintiles since the introduction of waiting time initiative 1 July 2002 and austerity measures 1 April 2010. SETTING: All NHS-funded elective primary hip replacement, primary knee replacement and arthroscopy patient data in Scotland from 1 April 1997 to 31 March 2019. PARTICIPANTS: NHS Scotland funded patients treated in Scotland. MAIN OUTCOME MEASURES: Trends and changes in mean waiting time. RESULTS: There were 135,176, 122,883 and 173,976 NHS funded hip replacement, knee replacement and arthroscopy patients, respectively, in Scotland between 1 April 1997 and 31 March 2019. From 1 July 2002 to 31 March 2010, waiting time inequality between the most and least deprived patients fell and increased thereafter. For hip replacements before 1 July 2002, waiting time inequality increased 1.07 days per quarter; this changed at 1 July 2002 with significant slope change of -2.32 (-3.53, -1.12) days resulting in a decreasing rate of inequality of -1.26 days per quarter. On 1 April 2010 the slope changed significantly by 1.84 (0.90, 2.78) days restoring increasing inequality at 0.58 days per quarter. Knee replacements and arthroscopies had similar results. CONCLUSIONS: The waiting time initiative in Scotland is associated with a reduction in waiting time inequality benefiting the most socioeconomically deprived patients. Austerity measures may be reversing these gains.

An ecological study of NHS funded elective hip arthroplasties in England from 2003/04 to 2012/13.

OBJECTIVES: To examine the impact of NHS-funded private provision on NHS provision, access and inequalities. DESIGN: Ecological study using routinely collected NHS inpatient data. SETTING: England. PARTICIPANTS: All individuals undergoing an NHS-funded elective hip arthroplasty in England from 2003/2004 to 2012/2013. MAIN OUTCOME MEASURES: Annual crude and standardised rates of hip arthroplasties per 100,000 population performed by NHS and private providers between 2004/2005 and 2012/2013. RESULTS: Age standardised rates of hip arthroplasty increased from 116.4 (95% CI 115.4-117.4) to 148.7 (147.6-149.8) per 100,000 between 2004/2005 and 2012/2013. Provision shifted from NHS providers to private providers from 2007/2008; NHS provision decreased 8.6% and private provision increased 188% between 2007/2008 and 2012/2013. There is evidence of risk selection; private sector hip arthroplasties on NHS patients from the most affluent areas increased 228% from 10.8 (10.2-11.5) to 35.4 (34.3-36.5) per 100,000 compared to an increase of 186% from 8.8 (8.1-9.4) to 25.2 (24.1-26.4) per 100,000 among patients from the least affluent areas between 2007/2008 and 2012/2013. There was no statistically significant (p > 0.05) widening in any measure of inequality (absolute, relative difference and slope and relative slope of index inequality) in hip arthroplasty rates between 2004/2005 and 2012/2013. CONCLUSION: Private provision substituted for NHS provision and did not add to overall provision favouring patients living in the most affluent area. Continuing the trend towards private provision and reducing NHS provision is likely to result in risk selection and widening inequalities in provision of elective hip arthroplasty in England.

Correcting India's Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines.

BACKGROUND: Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India's pharmaceutical industry and its large export market makes the problem more acute. METHODS: The focus of this study is a case study of Maharashtra, which has 29% of India's manufacturing units and 38% of its medicines exports. India's regulations were reviewed, comparing international, national and state inspection norms with the actual number of inspectors and inspections. Twenty-six key informant interviews were conducted to ascertain the causes of the shortfall. RESULTS: In 2009-2010, 55% of the sanctioned posts of drug inspectors in Maharashtra were vacant. This resulted in a shortfall of 83%, based on the Mashelkar Committee's recommendations. Less than a quarter of the required inspections of manufacturing and sales units were undertaken. The Indian Drugs and Cosmetics Act and its Rules and Regulations make no provisions for drug inspectors and workforce planning norms, despite the growth and increasing complexity of India's pharmaceutical industry. CONCLUSION: The Maharashtra Food and Drug Administration (FDA) falls short of the Mashelkar Committee's recommended workforce planning norms. Legislation and political and operational support are required to produce needed changes.

"Liberalizing" the English National Health Service: background and risks to healthcare entitlement. / A "liberalização" do Serviço Nacional de Saúde da Inglaterra: trajetória e riscos para o direito à saúde.

The recent reform of the English National Health Service (NHS) through the Health and Social Care Act of 2012 introduced important changes in the organization, management, and provision of public health services in England. This study aims to analyze the NHS reforms in the historical context of predominance of neoliberal theories since 1980 and to discuss the "liberalization" of the NHS. The study identifies and analyzes three phases: (i) gradual ideological and theoretical substitution (1979-1990) - transition from professional and health logic to management and commercial logic; (ii) bureaucracy and incipient market (1991-2004) - structuring of the bureaucracy focused on administration of the internal market and expansion of pro-market measures; and (iii) opening to the market, fragmentation, and discontinuity of services (2005-2012) - weakening of the territorial health model and consolidation of health as an open market for public and private providers. This gradual but constant liberalization has closed services and restricted access, jeopardizing the system's comprehensiveness, equity, and universal healthcare entitlement in the NHS.

The impact of the Medicines Control Council backlog and fast-track review system on access to innovative and new generic and biosimilar medicines of public health importance in South Africa.

The fast-track registration policy of the South African National Department of Health allows for rapid registration of new medicines of public health importance and of all medicines on the Essential Medicines List, most of which are generics. No limit is placed on the number of generic brands of a medicine that can be submitted for fast-track registration. This, together with resource constraints at the regulator, may delay access to important new medicines, new fixed-dose combinations of critical medicines or affordable versions of biological medicines (biosimilars). One reason for not limiting the number of fast-track generic applications was to promote price competition among generic brands. We found this not to be valid, since market share correlated poorly with price. Generic brands with high market share were, mostly, those that were registered first. We propose that the number of generic brands accepted for fast-tracking be limited to not more than seven per medicine.

A "liberalização" do Serviço Nacional de Saúde da Inglaterra: trajetória e riscos para o direito à saúde / La "liberalización" del Servicio Nacional de Salud de la Inglaterra: trayectoria y riesgos para el derecho a la salud / "Liberalizing" the English National Health Service: background and risks to healthcare entitlement

Resumo: A recente reforma do Serviço Nacional de Saúde (NHS) inglês por meio do Health and Social Care Act de 2012 introduziu mudanças importantes na organização, gestão e prestação de serviços públicos de saúde na Inglaterra. O objetivo deste estudo é analisar as reformas do NHS no contexto histórico de predomínio de teorias neoliberais desde 1980 e discutir o processo de "liberalização" do NHS. São identificados e analisados três momentos: (i) gradativa substituição ideológica e teórica (1979-1990) - transição da lógica profissional e sanitária para uma lógica gerencial/comercial; (ii) burocracia e mercado incipiente (1991-2004) - estruturação de burocracia voltada à administração do mercado interno e expansão de medidas pró-mercado; e (iii) abertura ao mercado, fragmentação e descontinuidade de serviços (2005-2012) - fragilização do modelo de saúde territorial e consolidação da saúde como um mercado aberto a prestadores públicos e privados. Esse processo gradual e constante de liberalização vem levando ao fechamento de serviços e à restrição do acesso, comprometendo a integralidade, a equidade e o direito universal à saúde no NHS.

Resumen: La reciente reforma del Servicio Nacional de Salud (NHS) inglés a través de la Health and Social Care Act de 2012 introdujo cambios importantes en la organización, gestión y prestación de los servicios de salud pública en Inglaterra. El objetivo de este estudio es analizar las reformas del NHS en el contexto histórico del predominio de las teorías neoliberales desde 1980 y discutir el proceso de "liberalización" del NHS. Fueron identificados y se analizaron tres momentos: (i) sustitución gradual ideológica y teórica (1979-1990) -transición de la lógica profesional y de salud para una lógica de gestión/negocio; (ii) la burocracia y el mercado incipiente (1991-2004) -estructuración de la burocracia dedicada a la gestión del mercado interior y la expansión de las medidas pro-mercado; y (iii) la apertura del mercado, la fragmentación y la discontinuidad de los servicios (2005-2012) -fragilización del modelo de salud territorial y consolidación de la salud como un mercado abierto para los proveedores públicos y privados. Este proceso gradual y constante de la liberalización ha provocado el cierre de los servicios y la restricción del acceso, comprometiendo la integridad, justicia y derecho universal a la salud en el NHS.

Abstract: The recent reform of the English National Health Service (NHS) through the Health and Social Care Act of 2012 introduced important changes in the organization, management, and provision of public health services in England. This study aims to analyze the NHS reforms in the historical context of predominance of neoliberal theories since 1980 and to discuss the "liberalization" of the NHS. The study identifies and analyzes three phases: (i) gradual ideological and theoretical substitution (1979-1990) - transition from professional and health logic to management and commercial logic; (ii) bureaucracy and incipient market (1991-2004) - structuring of the bureaucracy focused on administration of the internal market and expansion of pro-market measures; and (iii) opening to the market, fragmentation, and discontinuity of services (2005-2012) - weakening of the territorial health model and consolidation of health as an open market for public and private providers. This gradual but constant liberalization has closed services and restricted access, jeopardizing the system's comprehensiveness, equity, and universal healthcare entitlement in the NHS.

Aid conditionalities, international Good Manufacturing Practice standards and local production rights: a case study of local production in Nepal.

BACKGROUND: Local pharmaceutical production has been endorsed by the WHO as a means of addressing health priorities of developing countries. However, local producers of essential medicines must comply with international pharmaceutical standards in order to be eligible to compete in donor tenders. These standards determine production rights for on-patent and off-patent medicines, and guide international procurement of medicines. We reviewed the literature on the impact of Good Manufacturing Practice (GMP) on local production; a gap analysis from the literature review indicated a need for further research. Over sixty interviews were conducted with people involved in the Nepali pharmaceutical production and distribution chain from 2006 to 2009 on the GMP areas of relevance: regulatory capacity, staffing, funding and training, resourcing of GMP, inspectors' interpretation of the rules and compliance. RESULTS: Although Nepal producers have increased their overall share of the domestic market, only the public manufacturer, Royal Drugs, focuses on medicines for public health programmes; private producers engage mainly in brand competition for private markets, not essential medicines. Nepali regulators and producers state that implementation of GMP standards is hindered by low regulatory capacity, insufficient training of staff in the industry, financial constraints and lack of investment for upgrading capital. The transition period to mandatory compliance with WHO GMP rules is lengthy. Less than half of private producers had WHO GMP in 2013. Producers are not directly affected by international harmonisation of standards as they do not export medicines and the Nepali regulator does not enforce the WHO standards strictly. Without an international GMP certificate they cannot tender for donor dependent health programmes. CONCLUSIONS: In Nepal, local private manufacturers focus mainly on brand competition for private consumption not essential medicines, the government preferentially procures essential medicines from the only public producer while donor funded programmes rely on international manufacturers compliant with international GMP standards. We also found evidence of private hospitals bypassing national medicines approvals process. Policies in support of local pharmaceutical production in developing countries as a source of essential medicines need to examine carefully how GMP regulations impact on regulators, local industry and production of essential medicines in practice.

Pharmacovigilance in India, Uganda and South Africa with reference to WHO's minimum requirements.

BACKGROUND: Pharmacovigilance (PV) data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI) interviews and compares them with the World Health Organization's (WHO's) minimum PV requirements for a Functional National PV System. METHODS: A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs), members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO's minimum requirements. RESULTS: All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO. CONCLUSION: A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory bodies in regulating the market ensuring the safety and effectiveness of medications. National PV systems in the study countries needed strengthening. Greater attention to funding is needed to coordinate and sustain PV activities. Our study highlights a need for developing more systematic approaches to regularly monitoring and evaluating PV policy and practices.

Childhood injury in Tower Hamlets: Audit of children presenting with injury to an inner city A&E department in London.

INTRODUCTION: Childhood injury is a leading cause of mortality and morbidity worldwide with the most socio-economically deprived children at greatest risk. Current routine NHS hospital data collection in England is inadequate to inform or evaluate prevention strategies. A pilot study of enhanced data collection was conducted to assess the feasibility of collecting accident and emergency data for national injury surveillance. AIMS: To evaluate the reliability and feasibility of supplementary data collection using a paper-based questionnaire and to assess the potential relationship between income deprivation and incidence of paediatric injury. METHODS: Clinical staff conducted an audit of injuries in all patients under 16 years between June and December 2012 through completion of a questionnaire while taking the medical history. Descriptive statistics were produced for age, sex, time of arrival, activity at time of injury, mechanism and location of injuries. The association between known injury incidence and area level income deprivation (2010 English Index of Multiple Deprivation [IMD] Income Deprivation Domain from home postcode) was assessed using Spearman's rank correlation. Representativeness of the audit was measured using z-test statistics for time of arrival, age, sex and ethnicity. RESULTS: The paper audit captured 414 (6.5%) of the 6358 under-16 injury-related attendances recorded on the NHS Care Record Service Dataset. Comparison of the audit dataset with NHS records showed that the audit was not representative of the larger dataset except for sex of the patient. There was a positive correlation between injury incidence and income deprivation measured using IMD score where data were available (n = 384, p < 0.001). Nearly half of the attendances were due to falls, slips or trips (49.8%) and more than half were due to either leisure (32.9%) or sport (18.1%) activities. CONCLUSION: There is evidence of area level income inequalities in injury incidence among children attending the Royal London Hospital. The audit failed to capture a high proportion of cases, likely due to the paper-based format used. This study highlights the importance of routinely collecting enhanced injury data in computerized hospital admission systems to provide the necessary evidence base for effective injury prevention. The findings have contributed to plans for implementation.