Background: In the UK, where healthcare is a devolved matter, England and Scotland have different policies to reduce waiting lists for elective surgery. England is redirecting NHS funding to the private sector using commercial contracts, Scotland is expanding in-house capacity. Objective: To compare trends in admissions, waiting times and inequalities in England and Scotland for hip and knee replacement surgery between April 1997 and March 2019. Methods: An ecological study of NHS funded elective primary hip and knee replacement comparing admission rates, slope index of inequality for admissions and trend gradients for waiting time inequality using interrupted time series. Results: Between 1997/98 and 2018/19, the admission rate for hip and knee replacements increased by 110 % to 137.9 per 100,000 and 185 % to 145.4 per 100,000 respectively for England and by 90 % to 144.8 per 100,000 and 163 % to 137.5 per 100,000 respectively for Scotland. Between 2008 and 2019, Scotland increased in-house NHS provision by 18 % for both hip and knee surgeries. In contrast in England NHS in-house capacity for hip and knee replacements fell by 8 % and 18 % respectively, with the private sector substituting for direct NHS provision; NHS funded private providers increased seven-fold to 155. Waiting times fell in both countries and trends were pro-rich in both countries after 2008. Inequality in admissions increased in England at two and a half times the rate of Scotland. Conclusions: Contracting out NHS funded elective surgery to the private sector in England is associated with the creation of a two-tier system within the NHS.

This study analyzes National Health Service (NHS)-funded elective primary hip and knee replacement admissions and waiting times in England by provider (the NHS and private), socioeconomic deprivation and comorbidity, both prior to the introduction of Independent Sector Treatment Centers from 1997 to 2003 and following the rapid expansion in NHS contracts with the private sector from 2008 to 2019. Between 1997 and 2019, NHS-funded admission rates more than doubled. Between 2003 and 2008, when the proportion of patients treated in the private sector was negligible, admissions to the NHS increased and waiting times more than halved. After 2008, following the expansion in use of private providers by the NHS, NHS admission rates fell and waiting times rose for all patients. Waiting times for private providers were half those for the NHS, and the poorest 20 percent waited longer than the richest 20 percent. Between 2003 and 2019, inequalities in waiting time rose for the poorest 20 percent. The introduction of private providers into the NHS is associated with a contraction in in-house NHS provision, increasing waiting times for all patients and a two-tier system operating in favor of the rich.

The Public Health Laboratory Service (PHLS) was an integral part of England's post-war communicable disease control. Its central reference and surveillance facilities and network of laboratories in NHS hospitals was an international exemplar. Under neoliberal economic policy from the 1980s it faced intense scrutiny and expenditure constraints. Attempts to transfer its peripheral laboratories to the NHS were successfully opposed by arguing that public health needs would not be prioritised. The 1990s introduction of the internal market and capital charging fractured the complex relationships that had developed between the PHLS and NHS. Required to enter market-like contractual arrangements with NHS bodies, it found most of its funding switched from government grant to contract-generated income. This was unsustainable. The PHLS was dismantled in 2003 without a clear rationale, ostensibly because of complexity, preferential financial treatment, and professional rivalries. When Covid-19 arrived, England lacked an established and extensive public health laboratory network.

Access to essential medicines is still suboptimal in many countries. Recent studies examining the registration of medicines at the country level show that a considerable proportion of essential medicines do not have any corresponding products registered for use at the country level and therefore cannot be available at all times. Conversely, many non-essential medicines are registered by regulatory authorities for local markets, potentially facilitating inappropriate drug use and antimicrobial resistance. Addressing this public health gap requires linking the data on national drug registers with national essential medicines lists. Achieving this linkage will necessitate the development of common data variables and standards for both drug registers and essential medicines lists. This linkage would provide medicines regulators and health policy-makers with information on the gaps in the registration of essential medicines and allow them to take steps to prioritize registration of these medicines. This approach would improve availability of essential medicines for public health priorities and prevent over-registration of unnecessary medicines.

Objectives:(a) To critically appraise the quality of data submitted by sub-Saharan African (SSA) cancer registries to GLOBOCAN 2020 and (b) compare the quality of data of the registries common to GLOBOCAN 2008 and 2020. Design:Critical appraisal of cancer registry data quality using the Parkin and Bray framework. Setting and Participants:GLOBOCAN 2020 cancer registry estimates for 46 countries in SSA. Forty-three registries in 31 (SSA) countries were identified from the GLOBCAN 2020 supplementary documents, of which data from 28 registries in 23 sub-Saharan African countries were publicly available. Main outcomes measures:Data quality for 15 variables in four domains (comparability, validity, timeliness and completeness) were appraised using the Parkin and Bray framework. Results from the appraisal of GLOBOCAN 2020 sources were compared with previous findings for GLOBOCAN 2008. Results:Compared with GLOBOCAN 2008, GLOBOCAN 2020 country coverage had increased from 21 to 31 countries with 15 countries having no established registries. Out of a total possible score of 15 for data quality, 18 of the 28 publicly available GLOBOCAN 2020 registries fulfilled a score of 5 or more compared with seven registries in GLOBOCAN 2008. Of the 17 registries common to GLOBOCAN 2008 and 2020, nine showed an improvement in data quality. Conclusion:Country coverage and data quality have improved since GLOBOCAN 2008, however, overall data quality and coverage remain poor. GLOBOCAN 2020 estimates should be used with caution when allocating resources.

Background There is limited evidence to support use of fixed dose combination (FDC) drugs in the treatment of psychiatric disorders. This study aimed to examine the sales and regulatory status of psychotropic FDCs in India, in the context of two government regulatory initiatives.Methods Official documents were searched to establish an account of the initiatives and measures targeting psychotropic FDCs. This was integrated with private market data (2008 to 2020). Descriptive statistics were used to examine changes in FDC numbers/formulations and sales volumes in standard units (SU) over time.Results Psychotropic FDC sales volumes (percentage market share) increased from 0.8 billion SU (18.4%) in 2008 to 1.4 billion SU (20.1%) in 2020. The numbers (formulations) of FDCs also increased, from 28 (101) in 2008 to 33 (143) in 2020. Unapproved FDCs accounted for 69.3% of psychotropic FDC sales in 2008, decreasing slightly to 60.3% in 2020. Of 21 psychotropic FDCs considered under the regulatory initiatives, three went on to be banned, and two of these remained on the market in 2020.Conclusions Unapproved FDCs continue to account for most psychotropic FDC sales, potentially putting the public at risk because their safety and efficacy have not been evaluated.

Global Burden of Disease (GBD) estimates have significant policy implications nationally and internationally. Disease burden metrics, particularly for depression, have played a critical role in raising governmental awareness of mental health and in calculating the economic cost of depression. Recently, the World Health Organization ranked depression as the single largest contributor to global disability. The main aim of this paper was to assess the basis upon which GBD prevalence estimates for major depressive disorder (MDD) were made. We identify the instruments used in the 2019 GBD estimates and provide a descriptive assessment of the five most frequently used instruments. The majority of country studies, 356/566 (62.9%), used general mental health screeners or structured/semi-structured interview guides, 98/566 (17.3%) of the studies used dedicated depression screeners, and 112 (19.8%) used other tools for assessing depression. Thus, most of the studies used instruments that were not designed to make a diagnosis of depression or assess depression severity. Our results are congruent with and extend previous research that has identified critical flaws in the data underpinning the GBD estimates for MDD. Despite the widespread promotion of these prevalence estimates, caution is needed before using them to inform public policy and mental health interventions. This is particularly important in lower-income countries where resources are scarce.

Objectives To determine alignment between national and World Health Organization (WHO) treatment recommendations, medicines prioritisation in country's essential medicines list (EML), and medicines availability in National drug register. Design An audit of medicines for malaria, tuberculosis, hypertension and type 2 diabetes mellitus listed in the national standard treatment guidelines (STGs) of Kenya, Tanzania and Uganda, as of March 2021, against WHO treatment guidelines, and respective country EML and National drug register. Setting Not applicable. Participants None. Main outcome measures Proportion of medicine in country's STGs that align with WHO treatment recommendations, country's EML and country's drug register. Results Some disease areas had two sets of treatment guidelines – national STGs and disease-specific treatment guidelines (DSGs) developed at different times with different recommended medicines. Both STGs and DSGs included medicines not recommended by the WHO or not listed on the country EML and drug register. Non-WHO-recommended medicines accounted for 17/68 (25%), 10/57 (18%) and 3/30 (10%) of all STG medicines in Kenya, Tanzania and Uganda, respectively. For tuberculosis, the numbers and proportion of STG medicines listed on the respective national EMLs were 2/6 (33%), 15/19 (79%) and 4/5 (80%) in Kenya, Tanzania and Uganda. All tuberculosis medicines included in Kenya's and Uganda's STGs were registered compared with only 12/19 (63%) tuberculosis medicines in Tanzania's STG. Conclusions Alignment between treatment guidelines, EMLs and drug registers is crucial for effective national pharmaceutical policy. Research is needed to understand the inclusion of medicines on STGs and DSGs which fall outside WHO treatment guidelines; the non-alignment of some STGs and DSGs, and STGs and DSGs including medicines which are not on country EML and drug register.

Parliament has imposed duties on the government and NHS in England aimed at reducing health inequalities. AIM: to understand the effect on inequalities of government policies, which require the NHS in England to outsource elective surgery to the private sector. We analysed the numbers of admissions for hip and knee replacement surgery from the least and most deprived population quintiles in three time periods: before the introduction of the policies (1997/98-2002/03); following the implementation of the independent sector treatment centre programme (2003/04-2006/07); and after the extension of 'choice at referral' (2007/08-2018/19). RESULTS: despite admission rates doubling and trebling for hip and knee replacements, respectively, between 1997/98 and 2018/19, inequality grew to the detriment of the most deprived. Inequality grew at the fastest rate during period 3; admission rates to the NHS fell while admissions to the private sector continued to rise. By 2018/19 almost a third of NHS funded procedures were provided privately. In 1997/98, for every 10 patients admitted for hip and knee surgery from the most deprived quintile, 13 and 9, respectively were admitted from the least deprived, by 2018/19 the gap had widened to 19 and 15, respectively. Socio-economic inequalities for hip and knee replacement have widened as outsourcing of NHS treatment to the private sector has increased. The NHS must rebuild in-house capacity and provision instead of outsourcing care.

Objectives To audit national drug registers (NDRs) in Kenya, United Republic of Tanzania and Uganda with respect to national Essential Medicine Lists (EMLs) and to conduct an analysis of highly registered products including a sub-analysis of highly registered antimicrobial products. Design Retrospective analysis of registration of essential medicines and medicinal products on NDRs as of February 2018. Setting Not applicable. Participants None. Main outcome measures Registration status of essential medicines by country, essential medicine status of registered products by country and medicines with more than 50 registrations across all three countries. Results A high proportion of essential medicines are not registered: Kenya 28% (175/632), United Republic of Tanzania 50% (400/797) and Uganda 40% (266/663). Of registered products on the NDRs, more than half are not essential: Kenya 71% (4350/6151), United Republic of Tanzania 64% (2278/3590) and Uganda 58% (2268/3896). When the three NDRs were combined, there were 42 medicines with over 50 registered products, accounting for 30% (4153/13637) of products, many of which were non-essential. Conclusions Non-registration of essential medicines is a barrier to availability. Over-registration of medicines, particularly non-essential medicines, diverts regulatory resources towards registering non-priority and, sometimes, clinically sub-optimal medicines. The East African Community Medicines Registration Harmonization Project has the potential to improve access to key medicines if registration of essential medicines is prioritised and registration of non-essential medicines is restricted.

BACKGROUND:Essential medicines (EMs) are those that satisfy the basic healthcare needs of the population. However, access to EMs remains a global health challenge. The World Health Organization (WHO) and the East African Community (EAC) manufacturing plan 2017-2027 support local production of EMs as a strategy to improve access to medicines. The aim of this study was to determine for each therapeutic class on the national essential medicine lists (NEMLs) of Kenya, Tanzania and Uganda, the number of EMs produced in each country.METHODS:In 2018, we analysed NEMLs and national drug registers (NDRs) in each country to identify local manufacturers and local products by EM status. For each local manufacturer we determined the number of EM products and individual EMs, and analysed EMs in each therapeutic class by registration status and whether produced locally.RESULTS:There were nine companies manufacturing locally in Kenya, four in Tanzania and six in Uganda. Most local medicine products were non-EM products. Of the 946 locally produced products in Kenya, 310 were EM products; of the 97 locally produced products in Tanzania, 39 were EM products; and of the 181 locally produced products in Uganda, 100 were EM products. Many local EM products were duplicate. Only a small proportion of EMs on each NEML were produced locally: 21% (92/430) in Kenya, 5% (24/510) in Tanzania, and 10% (55/526) in Uganda. Kenya, Tanzania and Uganda had no local EM products in 13/32, 17/28 and 15/32 therapeutic classes, respectively. The proportion of EMs that were registered varied across the countries from 327 (76%) in Kenya, 269 (53%) in Tanzania, and 319 (60%) in Uganda.CONCLUSIONS:This study highlights the importance of auditing NDRs and NEMLs for local production to inform regional and national local manufacturing strategies. EMs should be prioritized for local production and drug registration to ensure that production is aligned with local health needs.

In India, states have licensed the manufacture of large numbers of fixed-dose combination (FDC) drugs without the required prior approval of the central regulator. This paper describes two major regulatory initiatives to address the problem, which began in 2007 and 2013, and examines whether they have been sufficient to remove centrally unapproved systemic antibiotic FDCs from the market. Information was extracted from documents published by the central regulator and the ministry of health, including the National List of Essential Medicines (NLEM), and court judgments, and analysed alongside sales volume data for 2008–2020 using PharmaTrac market dataset. The regulatory initiatives permitted 68 formulations to be given de facto approvals (‘No Objection Certificates’) outside the statutory regime, banned 46 FDCs and restricted one FDC. Market data show that FDCs as a proportion of total antibiotic sales increased from 32.9 in 2008 to 37.3

Background A critical appraisal of Global Burden of Disease (GBD) 2000 estimates for Major Depressive Disorder (MDD) identified an absence of reliable data and representative studies in many countries. GBD 2017 introduced methodological changes, amended inclusion criteria, and expanded the number of data sources. This study critically appraises the quality of the studies underpinning the GBD 2017 estimates for MDD with respect to i) the GBD 2017 inclusion criteria and ii) population coverage. Methods Of 431 studies underpinning the GBD 2017 estimates, 400 were retrieved. Country-level samples used in multi-country studies were disaggregated to give 467 country-level studies. Each study was critically appraised with respect to the four GBD 2017 inclusion criteria: representativeness, study method and sample, diagnostic criteria and publication from 1980 onwards. Population coverage was calculated. Results Less than half of studies (221/467, 47.32%) were nationally representative. Only 262/467 (56.10%) of studies reported specifically on MDD and more than a third did not use DSM or ICD criteria: 94/467 (20.13%) did not specify any diagnostic criteria and 68/467 (14.56%) relied on self-reported depression for diagnosis. Only 62/467 (13.28%) of studies were from 2011–2017. Only 107/195 (54.87%) of countries were covered by a single prevalence study. Conclusion GBD 2017 estimates for MDD are based on incomplete country and population coverage. The inclusion of studies with non-representative populations, that do not use diagnostic criteria and the lack of specific data on MDD reduces the reliability of estimates and limits their value for policy making.

Purpose In Scotland, in 2002, the National Waiting Times Unit was launched to reduce NHS waiting times. This was accompanied by a series of waiting time targets across the NHS in Scotland. The purpose of this study is to analyse changes in equality of access to treatment by socioeconomic deprivation associated with this initiative. Methods Trends in annual cataract rates were calculated using secondary care admissions' Scottish Morbidity Record (SMR01) data on NHS funded elective cataract procedures for patients treated in Scotland from 01 April 1997 to 31 March 2019. An interrupted time series model was used to analyse socioeconomic differences in waiting times by deprivation quintile over three time periods; pre and post waiting time initiative, and post austerity. Results Cataract Surgical Rates more than doubled from 3,723 per million population in 1997/1998 to 7,896 per million population in 2018/2019. Mean waiting time fell from 129.5 days in 1997/1998 to 87.7 days in 2018/2019. Inequality in mean waiting time between most and least deprived cataract patients increased by 1.34 days per quarter between 01 April 1997 and 30 June 2002 and following the waiting time initiative fell by 0.41 days per quarter through to 31 March 2010; and then decreased by 0.002 days per quarter between 01 April 2010 and 31 March 2019. Conclusion The waiting time initiative had a major impact on reducing inequality in waiting times between socioeconomic groups. The onset of austerity in 2010 was associated with a very small and insignificant increase in inequality.

Objectives:To critically appraise the quality of the studies underpinning the Global Burden of Disease (GBD) 2017 estimates for Major Depressive Disorder (MDD) with respect to i) the GBD 2017 inclusion criteria and ii) population coverage. Design:Systematic critical appraisal. Setting:Not applicable. Participants:Not applicable. Main outcome measures:Each study was critically appraised with respect to the four GBD 2017 inclusion criteria: representativeness, study method and sample, diagnostic criteria and publication from 1980 onwards. Population coverage was calculated. Results:Less than half of studies (221/467, 47.3%) were nationally representative. Only 262/467 (56.1%) of studies reported specifically on MDD and more than a third did not use DSM or ICD diagnostic criteria: 94/467 (20.1%) did not specify any diagnostic criteria and 68/467 (14.6%) relied on self-reported depression for diagnosis. Only 62/467 (13.3%) of studies were conducted during the period 2011-2017. Only 107/195 (54.9%) of countries had one or more prevalence studies. Conclusions:GBD 2017 estimates for MDD are based on incomplete country and population coverage. The inclusion of studies with non-representative populations, that do not use diagnostic criteria and the lack of specific data on MDD reduces the reliability of estimates and limits their value for policy making.

Objectives To critically appraise the quality of the studies underpinning the GBD 2017 estimates for MDD with respect to i) the GBD 2017 inclusion criteria and ii) population coverage. Methods Of 431 studies underpinning the GBD 2017 estimates, 400 were retrieved. Country-level samples used in multi-country studies were disaggregated to give 467 country-level studies. Each study was critically appraised with respect to the four GBD 2017 inclusion criteria: representativeness, study method and sample, diagnostic criteria and publication from 1980 onwards. Population coverage was calculated by country, by region and in total. Results Only 262/467 (56.10%) of studies reported specifically on MDD and more than a third did not use DSM or ICD criteria: 94/467 (20.13%) did not specify any diagnostic criteria and 68/467 (14.56%) relied on self-reported depression for diagnosis. Overall, 107/195 (54.87%) of countries were covered by at least one prevalence study. Population coverage varied by region from only 6.28/100,000 in the SEARO region compared with 7617.09/100,000 in the PAHO region. Regional estimates of coverage were distorted by overrepresentation of some countries, for example respondents from the USA accounted for 90.61% of PAHO region respondents despite the USA only making up approximately a third of the total PAHO population and similarly, Vietnamese respondents accounted for 73.60% of WPRO region respondents although Vietnam only makes up 5% of the total WPRO population. Less than half of studies (221/467, 47.32%) were nationally representative. The majority of studies (400/467; 85.63%) provided sufficient information to assess the quality of the study; 10 did not report on the age group and 57 did not report response rates. Only 62/467 (13.28%) of studies were from 2011-2017. Conclusions Studies that do not use diagnostic criteria or report specifically on MDD were included in the GBD 2017 estimates for MDD. Self-reported estimates of depression are known to inflate estimates and the lack of specific data of on MDD may have led to the inclusion of cases that would not meet diagnostic criteria for MDD. The estimates were also based on incomplete country and population coverage and there was a lack of nationally representative studies. Given these critical flaws in the data, underpinning the GBD 2017 estimates they are not uniformly reliable and, as such, may have only limited value in international policymaking. At country level policymakers should interpret the estimates with caution, as reliance on poor quality data will lead to the misallocation of resources in prioritising disease conditions and health services.

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.

Objective:To establish the extent to which Rugby Union was a compulsory physical education activity in state-funded secondary schools in England and to understand the views of Subject Leaders for Physical Education with respect to injury risk.Method:A cross-sectional research study using data obtained under the Freedom of Information Act (2000) from 288 state-funded secondary schools.Results:Rugby Union was delivered in 81% (n = 234 of 288) of state-funded secondary school physical education curricula, including 83% (n = 229 of 275) of state-funded secondary school boys' and 54% (n = 151 of 282) of girls' physical education curricular. Rugby Union was compulsory in 91% (n = 208 of 229) of state-funded secondary schools that delivered it as part of the boys' physical education curriculum and 54% (n = 82 of 151) of state-funded secondary schools that delivered contact Rugby Union as part of the girls' physical education curriculum. Subject Leaders for Physical Education also perceived Rugby Union to have the highest risk of harm of the activities they delivered in their school physical education curriculum.Conclusion:Notwithstanding discussions of appropriate measures (i.e., mandatory concussion training, Rugby Union specific qualifications and CPD) to reduce injury risk, it is recommended that Rugby Union should not be a compulsory activity given that it has a perceived high risk of injury and is an unnecessary risk for children in physical education.