'We all have the same right to have health services': a case study of Namati's legal empowerment program in Mozambique.

BACKGROUND: Legal empowerment and social accountability are two strategies that are increasingly used to address gaps in healthcare in low- and middle-income countries, including failure to provide services that should be available and poor clinical and interpersonal quality of care. This paper is an explanatory case study of a legal empowerment effort that employs community paralegals and trains Village Health Committees (VHCs) in Mozambique. The research objective was to explore how community paralegals solved cases, the impact paralegals had on health services, and how their work affected the relationship between the community and the health sector at the local level. METHODS: The case study had two components: (1) a retrospective review of 24 cases of patient/community grievances about the health system, and (2) qualitative investigation of the program and program context. The case reviews were accomplished by conducting structured in-depth interviews (IDIs) with those directly involved in the case. The qualitative investigation entailed semi-structured Key Informant Interviews (KIIs) with district, provincial, and national health managers and Namati staff. In addition, focus group discussions (FGDs) were held with Health Advocates and VHC members. RESULTS: Case resolution conferred a sense of empowerment to clients, brought immediate, concrete improvements in health service quality at the health facilities concerned, and seemingly instigated a virtuous circle of rights-claiming. The program also engendered incipient improvements in relations between clients and the health system. We identified three key mechanisms underlying case resolution, including: bolstered administrative capacity within the health sector, reduced transaction and political costs for health providers, and provider fear of administrative sanction. CONCLUSIONS: This study contributes to the limited literature regarding the mechanisms of legal empowerment case resolution in health systems and the impact of hybrid legal empowerment and social accountability approaches. Future research might assess the sustainability of case resolution; how governance at central, provincial, and district level is affected by similar programs; and to what extent the mix of different cases addressed by legal empowerment influences the success of the program.

The right to exit and skilled labour emigration: Ethical considerations for compulsory health service programmes.

Compulsory (health) service contracts have recently received considerable attention in the normative literature. The service contracts are considered and offered as a permissible and liberal alternative to emigration restrictions if individuals relinquish their right to exit via contract in exchange for the state-funded tertiary education. To that end, the recent normative literature on the service programmes has particularly focused on discussing the circumstances or conditions in which the contracts should be signed, so that they are morally binding on the part of the skilled workers. However, little attention is devoted to the relevance of the right to exit for the debate on compulsory service programmes. In this paper, I argue that even if the service contracts are voluntary, and thus the would-be medical students voluntarily relinquish their right to exit, the reasons behind the right should be taken into account for the contracts to be morally valid. A clear understanding of the right to exit is a must in order not to breach its basic components and for the service contracts to be morally binding. To that end, I provide two accounts of the reasons to value the right to exit by presenting Patti Lenard's discussion of the right to exit and by reconstructing James Griffin's account of human rights. I conclude by offering brief ethical considerations for compulsory health service programmes grounded in the reasons to value the right to exit.

The Impatient Patient and the Unreceptive Receptionist: Darnley v Croydon Health Services NHS Trust [2018] UKSC 50.

In Darnley v Croydon Health Services NHS Trust [2018] UKSC 50, the Supreme Court held that a hospital receptionist's misleading statement about A&E waiting times constituted a breach of duty and that the claimant's decision, based on this misinformation, to leave the hospital did not break the chain of causation when he was left paralysed as a result of a head injury. In this commentary, I argue that while the Supreme Court's treatment of duty of care and breach is, for the most part, a model of doctrinal clarity, its treatment of the causation issue is problematic as it elides the test of whether there has been a break in the chain of causation with that for remoteness. I then comment on the Supreme Court's construction of the patient in medical negligence cases.

Legal access to medications: a threat to Brazil's public health system?

BACKGROUND: In Brazil, health is fundamental human right guaranteed by the Constitution of 1988, which created the Brazilian Universal Health System (Sistema Único de Saúde - SUS). The SUS provides medications for outpatient care via policy of pharmaceutical assistance (PA) programmes. Despite the advances in PA policies which include the improvement in access to medications, there has been a significant increase in lawsuits related to health products and services. This study aimed to characterize the medication processes filed between 2010 and 2014 against the Secretary of State for Health of São Paulo (State Health Department of São Paulo - SES/SP), in Brazil, following PA policies. METHODS: This descriptive study used secondary data on medication lawsuits filed against the SES/SP between 2010 and 2014. The data source was the S-Codes computerized system. RESULTS: In the period evaluated, the number of lawsuits filed concerning health-related products increased approximately 63%; requests for medications were predominant. Approximately 30% of the medications involved in court proceedings were supplied via PA programmes. With regard to medications supplied via specialized component, 81.3% were prescribed in disagreement with the protocols published by the Ministry of Health. Insulin glargine was the most requested medication (6.3%), followed by insulin aspart (3.3%). Because there is no scientific evidence that either of these medicines is superior for the treatment of diabetes, neither of them has been incorporated into the SUS by the National Commission for Technology Incorporation. The judicial data showed that most of the lawsuits involved normal proceedings (i.e., individual demands), were filed by private lawyers, and named the State of São Paulo as the sole defendant, demonstrating the individual nature of these claims. The data indicate inequality in the distribution between the number of cases and lawyers and the number of lawsuits and prescribers, evidencing the concentration of lawyers and physicians in filing lawsuits. CONCLUSION: The judicialization of health in the State of São Paulo with the characteristics presented herein is a threat to the SUS.

The factors affecting the institutionalisation of two policy units in Burkina Faso's health system: a case study.

BACKGROUND: This paper is one of three linked studies that attempts to understand the process of institutionalisation of policy units within Burkina Faso's health system. It examines the relationships between the existence of an institutional framework, data production capacity and other resource availability in the institutionalisation of policy units in health systems. It therefore contributes to our understanding of the dynamics linking the key drivers and indicators of institutionalisation. Additionally, it examines how factors within the managerial setting, including workplace environment, and budgetary and human resource availability, may influence the institutionalisation process. METHODS: The study used an explanatory qualitative case study approach, examining two policy units in Burkina Faso's Ministry of Health, the first of which had been institutionalised successfully and the other less so. Data were collected from key policymakers, including 13 connected with the first policy unit and 10 with the second, plus two funders. We also conducted a documentary analysis of the National Program for Health Development, two mid-term strategic plans, 230 action plans, eight Ministry of Health state budgets, eight Ministry of Health annual statistics reports, 16 policy unit budgets and published literature. RESULTS: The framework within which the government gave the policy unit its mandate and policy focus had the strongest effect on the institutionalisation process. Institutionalisation depended on political will, in both the host government and any donors, and the priority given to the policy unit's focus. It was also affected by the leadership of the policy unit managers. These factors were influenced by human resource capacity, and our findings suggest that, for successful institutionalisation in Burkina Faso's health system, policy units need to be given sufficient human resources to achieve their objectives. CONCLUSION: Policy units' institutionalisation in Burkina Faso's health system depend on the leadership of the unit managers to implement relevant activities, mobilise funding, and recruit and maintain enough human resources, as well as the mandate given by the government.

The National Trust: A viable model of care for adults with intellectual disabilities in India.

The longevity of people with intellectual disabilities is increasing in developing nations. However, developing nations lack a proper system of care for aging persons with intellectual disabilities. Until now the care has been provided by parents and relatives in the home environment in developing countries, but this scenario is also changing; therefore, there is a strong need to explore a plan of care for this population which is also feasible and replicable. The National Trust is an autonomous body of the Government of India which has developed a comprehensive plan of care for adults with intellectual disabilities. In this article, the National Trust is discussed using a socioecological model. The replicability and suitability of this model for other developing countries are discussed.

Addressing future challenges for cancer services: part I.

Jane Maher & Gina Radford speak to Gemma Westcott, Commissioning Editor Jane Maher has been Macmillan's Chief Medical Officer since 1999 and now shares the role as Joint Chief Medical Officer with general practitioner Rosie Loftus, reflecting the growing need for specialists and generalists to work more effectively together. She has been a National Health Service (NHS) Improvement Clinical Leader for over 10 years and is a Consultant Clinical Oncologist at Mount Vernon Cancer Centre where she has worked for more than 20 years, during which she helped develop nonsurgical oncology services in five district general hospitals. Jane chaired the Maher Committee for the Department of Health in 1995, led the UK National Audit of Late Effects Pelvic Radiotherapy for the Royal College Of Radiologists (RCR) in 2000 and, most recently, chaired the 'National Cancer Survivorship Initiative, consequences of treatment work stream'. She co-founded one of the first Cancer Support and Information services in the UK, winning the Nye Bevan award in 1992 and there are now more than 60 units based on this model. She is a member of the Older People and Cancer Clinical Advisory Group. She has written more than 100 published articles and is a UK representative for cancer survivorship in Europe and advises on Cancer survivorship programs in Denmark and Canada. Gina Radford is Deputy Chief Medical Officer for England, a post she took up in January 2015. Prior to that, she has held a number of roles in public health, at local and regional level. Most recently she was as Centre Director for Anglia and Essex for Public Health England, and as part of that role helped lead nationally on the public health response to Ebola. She was until very recently Chair of one of the NICE public health advisory committees. She has previously worked on a number of national projects, including leading the Department of Health's response to the Shipman Enquiry, undertaking a review of specialist public health for CMO Scotland, chairing a national short life working group looking at the issue of making difficult decisions in NHS Scotland, and undertaking the evaluation of the first pilot (regional bowel cancer detection pilot) for the Be Clear on Cancer National Awareness and Early Diagnosis campaign, on behalf of the Department of Health and Cancer Research UK. Outside work, Gina is a Licensed Lay Minister in the Church of England, and is training to be ordained. She enjoys riding, walking the somewhat aging dog, reading and is the village duck warden!

Public stewardship of private for-profit healthcare providers in low- and middle-income countries.

BACKGROUND: Governments use different approaches to ensure that private for-profit healthcare services meet certain quality standards. Such government guidance, referred to as public stewardship, encompasses government policies, regulatory mechanisms, and implementation strategies for ensuring accountability in the delivery of services. However, the effectiveness of these strategies in low- and middle-income countries (LMICs) have not been the subject of a systematic review. OBJECTIVES: To assess the effects of public sector regulation, training, or co-ordination of the private for-profit health sector in low- and middle-income countries. SEARCH METHODS: For related systematic reviews, we searched the Cochrane Database of Systematic Reviews (CDSR) 2015, Issue 4; Database of Abstracts of Reviews of Effectiveness (DARE) 2015, Issue 1; Health Technology Assessment Database (HTA) 2015, Issue 1; all part of The Cochrane Library, and searched 28 April 2015. For primary studies, we searched MEDLINE, Epub Ahead of Print, In-Process & Other Non-Indexed Citations, MEDLINE Daily and MEDLINE 1946 to Present, OvidSP (searched 16 June 2016); Science Citation Index and Social Sciences Citation Index 1987 to present, and Emerging Sources Citation Index 2015 to present, ISI Web of Science (searched 3 May 2016 for papers citing included studies); Cochrane Central Register of Controlled Trials (CENTRAL), 2015, Issue 3, part of The Cochrane Library (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register) (searched 28 April 2015); Embase 1980 to 2015 Week 17, OvidSP (searched 28 April 2015); Global Health 1973 to 2015 Week 16, OvidSP (searched 30 April 2015); WHOLIS, WHO (searched 30 April 2015); Science Citation Index and Social Sciences Citation Index 1975 to present, ISI Web of Science (searched 30 April 2015); Health Management, ProQuest (searched 22 November 2013). In addition, in April 2016, we searched the reference lists of relevant articles, WHO International Clinical Trials Registry Platform, Clinicaltrials.gov, and various electronic databases of grey literature. SELECTION CRITERIA: Randomised trials, non-randomised trials, interrupted time series studies, or controlled before-after studies. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study eligibility and extracted data, comparing their results and resolving discrepancies by consensus. We expressed study results as risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI), where appropriate, and assessed the certainty of the evidence using Grades of Recommendation, Assessment, Development and Evaluation (GRADE). We did not conduct meta-analysis because of heterogeneity of interventions and study designs. MAIN RESULTS: We identified 20,177 records, 50 of them potentially eligible. We excluded 39 potentially eligible studies because they did not involve a rigorous evaluation of training, regulation, or co-ordination of private for-profit healthcare providers in LMICs; five studies identified after the review was submitted are awaiting assessment; and six studies met our inclusion criteria. Two included studies assessed training alone; one assessed regulation alone; three assessed a multifaceted intervention involving training and regulation; and none assessed co-ordination. All six included studies targeted private for-profit pharmacy workers in Africa and Asia.Three studies found that training probably increases sale of oral rehydration solution (one trial in Kenya, 106 pharmacies: RR 3.04, 95% CI 1.37 to 6.75; and one trial in Indonesia, 87 pharmacies: RR 1.41, 95% CI 1.03 to 1.93) and dispensing of anti-malarial drugs (one trial in Kenya, 293 pharmacies: RR 8.76, 95% CI 0.94 to 81.81); moderate-certainty evidence.One study conducted in the Lao People's Democratic Republic shows that regulation of the distribution and sale of registered pharmaceutical products may improve composite pharmacy indicators (one trial, 115 pharmacies: improvements in four of six pharmacy indicators; low-certainty evidence).The outcome in three multifaceted intervention studies was the quality of pharmacy practice; including the ability to ask questions, give advice, and provide appropriate treatment. The trials applied regulation, training, and peer influence in sequence; and the study design does not permit separation of the effects of the different interventions. Two trials conducted among 136 pharmacies in Vietnam found that the multifaceted intervention may improve the quality of pharmacy practice; but the third study, involving 146 pharmacies in Vietnam and Thailand, found that the intervention may have little or no effects on the quality of pharmacy practice (low-certainty evidence).Only two studies (both conducted in Vietnam) reported cost data, with no rigorous assessment of the economic implications of implementing the interventions in resource-constrained settings. No study reported data on equity, mortality, morbidity, adverse effects, satisfaction, or attitudes. AUTHORS' CONCLUSIONS: Training probably improves quality of care (i.e. adherence to recommended practice), regulation may improve quality of care, and we are uncertain about the effects of co-ordination on quality of private for-profit healthcare services in LMICs. The likelihood that further research will find the effect of training to be substantially different from the results of this review is moderate; implying that monitoring of the impact is likely to be needed if training is implemented. The low certainty of the evidence for regulation implies that the likelihood of further research finding the effect of regulation to be substantially different from the results of this review is high. Therefore, an impact evaluation is warranted if government regulation of private for-profit providers is implemented in LMICs. Rigorous evaluations of these interventions should also assess other outcomes such as impacts on equity, cost implications, mortality, morbidity, and adverse effects.

[Quality of German medical services: a review]. / Qualität in der Medizin in Deutschland - eine Bestandsaufnahme.

In the current draft of the law on the reform of the support structures of hospital provision (German Hospital Structure Law) the future quality of provision is highly significant. Quality assurance measures are mandatory for hospitals. The Federal General Committee was legally charged with developing the relevant quality indicators for structural, procedural and outcome quality that are designed to form the criteria and the basis for planning decisions in the federal states. This involves a paradigm shift in quality assurance measures in hospitals. In the future, subject to the verified quality, this should have an influence on hospital planning, and the funding or regulation of hospital departments should also adhere to this prescribed quality. This review reveals the course of quality or quality assurance measures in medical services in Germany. The status of the institutions responsible for the quality of care in hospitals and the significance of quality indicators are explained.

Vet Centers. Final rule.

The Department of Veterans Affairs (VA) adopts as final an interim final rule that amends its medical regulation that governs Vet Center services. The National Defense Authorization Act for Fiscal Year 2013 (the 2013 Act) requires Vet Centers to provide readjustment counseling services to broader groups of veterans, members of the Armed Forces, including a member of a reserve component of the Armed Forces, and family members of such veterans and members. This final rule adopts as final the regulatory criteria to conform to the 2013 Act, to include new and revised definitions.

[The development of medical care in prison system of Russia (end of XVII-early XX centuries)].

The article considers historical medical aspect of development of medical care of convicts in Russia. The first mentioning about treatment of ill criminals relates to 1775. In 1788 the Regulations of prisons was prepared using experience ofprison systems of European states. From 1819, organization of medical care ofpopulation fell within the competence of the Ministry of Internal Affairs that created conditions for organization of medical care in prison system. The legal basics of medical care of convicts were adopted in 1831. In 1850, out of980 000 of jailed prisoners died 1598 (0.16%) of them. In 1879, in the prison Headquarters was organized position of inspector of medical care. This employee coordinated rendering of medical care of prisoners and developed sanitary hygienic measures. The primary unit of national penitentiary system made up authorities of management ofparticular places of confinement. In 1887physicians andfeldshers were accredited to them. The state placed very high demands to medical personnel. The treatment of ill prisoners implemented at the expense of the state. During analyzed period, uniform medical statistics of morbidity. It is demonstrated that special attention was paid to infectious diseases.

[On the issue of paid-for medical services in state health care institutions].

The paid medical services are provided by public and municipal health care institutions. At that, legal relationships occurring in the process of paid provision of medical services are at the stage of development and their further progress depends on considerable amount of components of economical and legal forms. The article considers main problems related to functioning of medical institutions in the field of rendering paid medical services. The main legal documents regulating rendering of medical services on paid basis are analyzed too.

[The problems of pharmaceutical support of patients with diabetes mellitus type II].

The diabetes mellitus acquires a character of sheer spreading global epidemic. Nowadays, in the Russian Federation number of patients with diabetes mellitus reaches 10 million. The accessibility of pharmaceuticals is one of main elements of support of effective treatment of disease. The analysis of federal and regional normative legal acts, territorial programs of state guarantees and data of portal of state purchases demonstrated inefficiency of actual regional system of medicinal support especially in modern economic situation. The necessity of optimization of state costs and also broadening of medicinal coverage of population, including pharmaceuticals for treatment of diabetes mellitus type II, requires development and implementation of step-by-step plan of reforming of regional system of preferential medicinal support.

Liberalising trade in health services: constraints and prospects for South Asian countries.

This paper attempts to examine the prospects and challenges associated with liberalising trade in health services in five South Asian countries, namely Bangladesh, India, Nepal, Pakistan and Sri Lanka. Country-specific secondary information, a brief literature review of empirical studies and debriefing sessions with key stakeholders are employed to explore the issues related to liberalising health services trade. The health sectors in India, Nepal and Pakistan are scheduled under General Agreement on Trade in Services (GATS) classification, whereas those in Bangladesh and Sri Lanka are not. In Bangladesh, there is opportunity for investment in joint venture hospitals under Mode 3. Nonetheless, India is the largest trader in health services under all four modes. In Sri Lanka, cross-border trade in healthcare services is found to be insignificant. Moreover, expertise in eye treatment in Nepal could also attract foreign investment in medical services under Mode 3. In contrast, Pakistan exhibits no potential under Mode 4, because of a lack of healthcare professionals. In this view, the prospects of trade in health services within the South Asian region under the four GATS modes are constrained by infrastructural, regulatory, perception-related, logistical and cultural problems. Considering the level of development and commercial opportunities, regional integration in the health sector could be explored in such areas as telemedicine, medical tourism, cross-border investment and capacity building of health personnel. These developments call for stronger and pro-active government-to-government collaboration in the South Asian Association of Regional Cooperation (SAARC) region in a transparent and accountable manner.

RECONCEPTUALIZING CONSENT FOR DIRECT-TO-CONSUMER HEALTH SERVICES.

The market for direct-to-consumer (DTC) health services continues to grow rapidly with former patients converting to customers for the opportunity to purchase varied diagnostic tests without the involvement of their clinician. For the first time a DTC genetic testing company is advertising health-related reports "that meet [Food and Drug Administration] standards for being clinically and scientifically valid." Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, but how should we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with terms and conditions as varied as the services performed? The doctrine of "informed consent" began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy--but in the DTC context should we hold providers to legal standards of informed consent and associated medical malpractice liability, or contractual obligations where consumers would seek remedy for breach? This Article analyzes the fine balance that must be struck in an industry where companies are selling services for entertainment or non-medical purposes that possess the capacity to produce serious and disquieting medical information. It begins by reviewing current standards of consent in the clinical setting from both a legal and ethical perspective and then lays forth current standards for DTC consent using two currently controversial case studies: that of keepsake fetal ultrasound and genetic testing. DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize the devices used for these procedures from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as "intended for entertainment purposes only," it can provide medical information as an incidental finding. 23andMe currently purports to be the only DTC genetics service that "includes" reports that meet FDA qualifications, despite disclaimers of intent to "provide medical advice." The attempted de-medicalization of these devices, therefore, has not been fully transformative, and DTC providers should have more robust ethical and legal duties than the average goods and services seller. This Article delineates these responsibilities, beginning with ethical duties surrounding marketing, entering into, and providing DTC services. It then turns to the legal paradigms necessary to enable, or at least allow for, DTC providers to meet these ethical obligations. While it argues that contractual, as opposed to fiduciary, requirements are most appropriate and that waivers of liability will likely be upheld, it also advocates for a heightened expectation of disclosure during contracting.

[Potentially excluded population from health coverage and health impact since Royal Decree 16/2012: The Central Catalonia experience]. / Población potencialmente excluida de cobertura sanitaria con el Real Decreto 16/2012 y sus repercusiones sanitarias: la experiencia desde la Cataluña Central.

OBJECTIVE: To assess the proportion of population potentially excluded from healthcare coverage since the Royal Decree-Law 16/2012. To describe the use of health services, the distribution of chronic and infectious diseases, and the pharmaceutical costs in 2012 of the persons potentially excluded compared to the those who maintain their coverage. DESIGN AND SETTING: An observational analytical cross-sectional study was designed and conducted on a Primary Care based population in the Central Catalonia Management Area of the Institut Català de la Salut PARTICIPANTS AND MAIN MEASUREMENTS: Individuals potentially excluded since the application of the Royal Decree-Law 16/2012 were selected and compared with individuals who maintained their healthcare coverage, randomly matched by sex, age and Primary Care service. The information obtained included the use of health services, the distribution of chronic and infectious diseases, and the pharmaceutical costs during the year 2012. RESULTS: A total of 1,699 individuals were identified as potentially excluded from healthcare coverage, 0.53% of the total of population (51.4% men), with a median of age of 34years (interquartile range, 28-43). The use of healthcare services, the chronic morbidity recorded, and the pharmaceutical costs during the year 2012 of the excluded individuals was lower than those of the non-excluded ones (P<.001). On the other hand, the infectious morbidity was higher in the excluded individuals (P<.001). CONCLUSIONS: The results of the study suggests that this legislative measure does not seem to be justified for medical or economic reasons. It could also cause public health problems and contribute to the risk of social fracture.