National medicines policy development, Saudi Arabia.

Medicines are at the core of every health system. The World Health Organization recommends countries develop national medicines policies that guide production, procurement, prescription and provision of medicines so that people can access the medicines they need at prices they can afford, while avoiding irrational use. However, the development of such policies is rarely straightforward. We describe important components of the national medicines policy in Saudi Arabia, which was developed within a broader transformation of the health system and the economy. The new policy formalizes existing best practices, shapes emerging policies and sets a direction for future development in four main areas. First, the policy seeks to consolidate institutional roles to provide greater cohesion; second it aims to reshape procurement and prescribing habits, with a greater focus on cost containment; third, it lays out policies which focus on assuring a secure supply of good-quality medicines, including essential medicines with limited profit potential and new products. Finally, the policy supports the growth of the domestic pharmaceutical industry, including the development of human resources. Many sectors and institutions joined in the development of the medicines policy, which was underpinned by a review of the past and current pharmaceutical context in Saudi Arabia, and good practices globally. The resulting policy was built on evidence and endeavours to give clear direction to the pharmaceutical industry and implementing agencies on rules and requirements, professional norms and institutional roles. At the same time, it maintains flexibility to allow for adaptation in a rapidly evolving institutional landscape.

Les médicaments sont au cœur de tout système de santé. L'Organisation mondiale de la Santé recommande aux pays d'élaborer des politiques pharmaceutiques nationales qui déterminent la production, l'obtention, la prescription et la fourniture de médicaments, afin que la population puisse accéder aux traitements requis à un prix abordable sans toutefois tomber dans un usage irrationnel. Mais cette élaboration est rarement simple. Dans le présent document, nous abordons les principaux aspects de la politique pharmaceutique nationale en Arabie saoudite, développée dans le cadre d'une vaste transformation de l'économie et du système de santé. Cette nouvelle politique officialise les bonnes pratiques existantes, façonne les projets émergents et définit une orientation pour l'évolution future dans quatre domaines clés. Premièrement, elle cherche à renforcer le rôle des institutions pour améliorer la cohésion. Deuxièmement, elle vise à remanier les habitudes d'obtention et de prescription, en se focalisant sur la maîtrise des coûts. Troisièmement, elle établit des mesures destinées à assurer un approvisionnement sûr en médicaments de qualité, y compris en nouveaux produits et médicaments essentiels au potentiel de rentabilité limité. Et quatrièmement, elle soutient la croissance de l'industrie pharmaceutique dans le pays, notamment le développement des ressources humaines. De nombreux secteurs et institutions ont contribué à l'élaboration de cette politique, qui s'appuie sur une analyse du contexte pharmaceutique antérieur et actuel en Arabie saoudite ainsi que sur les bonnes pratiques mondiales. Le résultat repose sur des éléments et efforts tangibles. Il montre clairement à l'industrie pharmaceutique et aux organismes de mise en œuvre la marche à suivre en matière de règles et d'exigences, de normes professionnelles et de rôles institutionnels. Et dans le même temps, il prévoit suffisamment de flexibilité pour s'adapter à un paysage institutionnel en constante mutation.

Los medicamentos son el núcleo de todo el sistema sanitario. La Organización Mundial de la Salud recomienda a los países que desarrollen políticas nacionales de medicamentos que guíen la producción, la adquisición, la prescripción y el suministro de estos, de modo que las personas puedan acceder a los medicamentos que necesitan a precios que puedan pagar, evitando al mismo tiempo un uso irracional. Sin embargo, la elaboración de estas políticas no suele ser sencilla. En este documento se describen componentes importantes de la política nacional de medicamentos en Arabia Saudita, que se desarrolló en el marco de una transformación más amplia del sistema sanitario y la economía. La nueva política formaliza las mejores prácticas existentes, da forma a las políticas emergentes y establece una dirección para el desarrollo futuro en cuatro áreas principales. En primer lugar, la política busca consolidar las funciones institucionales para proporcionar una mayor cohesión; en segundo lugar, pretende remodelar los hábitos de adquisición y prescripción, centrándose más en la contención de los costes; en tercer lugar, establece políticas que se centran en asegurar el suministro de medicamentos de buena calidad, incluidos los productos nuevos y los medicamentos esenciales con un potencial de beneficio limitado. Por último, la política apoya el crecimiento de la industria farmacéutica nacional, incluido el desarrollo de los recursos humanos. Varios sectores e instituciones participaron en la elaboración de la política de medicamentos, que se sustentó en una revisión del contexto farmacéutico pasado y actual en Arabia Saudita, y de las buenas prácticas a nivel mundial. La política resultante se creó a partir de pruebas y se esfuerza por dar una orientación clara a la industria farmacéutica y a los organismos de ejecución sobre las reglas y requisitos, las normas profesionales y las funciones institucionales. Asimismo, mantiene la flexibilidad para permitir la adaptación en un panorama institucional que evoluciona muy rápido.

A systematic review of pooled procurement of medicines and vaccines: identifying elements of success.

INTRODUCTION: Pooled procurement of health commodities has increasingly been promoted as a solution to reduce prices, increase availability, and achieve more efficient procurement processes. However, little is known about what is required to implement pooled procurement mechanisms successfully and how they function under specific circumstances. Therefore, the aim of this systematic review is to synthesize empirically grounded insights by identifying the elements that are essential for setting up and operating pooled procurement mechanisms of medicines and vaccines. METHODS: Our review was based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched PubMed, Scopus and Web of Science for empirical studies on pooled procurement of medicines and vaccines using various search terms. Publications were assessed based on predetermined eligibility criteria. RESULTS: Our initial search yielded 1596 publications, of which 44 were eventually included in our review. Most of the included articles focused on pooled procurement mechanisms that operated on a sub-national level (43%), procured a variety of products (38%), and were set up with the goal to contain costs (64%). The review identified several elements that are essential for pooled procurement mechanisms to function. We organized these elements around three key actors in the mechanism: buyers, the pooled procurement organization, and suppliers. To participate in pooled procurement, buyers need a sufficient level of technical capacity, financial capacity and compatible laws and regulations. To carry out pooled procurement, the pooled procurement organization needs sufficient financial capacity, technical capacity, and independent operations. To supply the mechanism with health commodities, suppliers need sufficient incentives, such as a sufficient market size and a prompt payment mechanism. CONCLUSION: Pooled procurement mechanisms are very diverse. They differ in characteristics and organizational structures and are set up to achieve a variety of goals. While certain essential elements are more likely to increase successful implementation and functioning of pooled procurement mechanisms, the organizational structure must be aligned with the goals of the mechanism, and adapted to the local contextual environment.

Why falsified medicines reach patients: an analysis of political and economic factors in Romania.

INTRODUCTION: To protect patients against falsified medicines, countries around the world implement stringent regulations. Despite efforts to protect supply chains in the European Union (EU), authorities continue to find falsified medicine. We studied how in Romania, one of the poorest EU countries, political and economic factors influence the risk of patients being exposed to falsified medicines. METHODS: For this case study, we reviewed 131 documents and interviewed 22 purposively selected key informants. RESULTS: In Romania, several politically and economically motivated policies have led to persistent medicine shortages. Following the 2007 accession to the EU, fierce competition led to a decline in domestic medicine production. Soon after, the government introduced a tax on reimbursed medicines to support the national health budget. Prior to the 2015 elections, medicine prices were abruptly lowered to provide voters with the cheapest medicine in Europe. The low prices incentivised traders to buy medicines in Romania and sell them elsewhere in the EU. The high taxes and low prices led manufacturers to withdraw medicines from the market and impose product quotas to limit parallel trading. The accumulated effect of these market responses translated into persistent shortages of essential medicine, which have pushed patients and health professionals to unregulated markets with a high risk of exposure to falsified medicine. CONCLUSION: Strategies against falsified medicine with a narrow focus on safeguarding quality in the regulated supply are insufficient. To protect patients, governments must also ensure that patients have access to affordable medicines, as shortages provide an opportunity for those selling fake products.

Continuity of CVD treatment during the COVID-19 pandemic: evidence from East Java, Indonesia.

BACKGROUND: In Indonesia, the world's fourth most populous country, cardiovascular diseases (CVDs) are a leading cause of death and disability. Government efforts to reduce the burden of CVD include a community-based prevention and early detection programme, and the provision of medicines to prevent cardiovascular events. Disruptions to medicine supply chains, service provision, and movement during the COVID-19 pandemic potentially threatened the continuity of these efforts. We investigated the distribution and dispensing of common CVD medicines in Malang district, East Java, before the pandemic and early in its course. METHODS: From January to October 2020, we collected monthly data on stock levels, sales or dispensing volumes, and price for five common CVD medicines (amlodipine, captopril, furosemide, glibenclamide and simvastatin), from a public and a private distributor, and from public health facilities (n = 4) and private pharmacies (n = 2). We further complied monthly data on patient numbers in two primary health centres. We tracked changes in stocks held and volumes dispensed by medicine type and sector, comparing the three months before the local COVID-19 response was mobilised with the subsequent seven months. We conducted interviews with pharmacists (n = 12), community health workers (n = 2) and a supply chain logistics manager to investigate the reasons for observed changes, and to learn details of any impacts or mitigation measures. RESULTS: The pandemic affected demand more than supply, causing medicine stocks to rise. Restricted service provision, lock-down measures and fear of infection contributed to a sharp drop in patient numbers and dispensing volumes in the public sector. Meanwhile private sector sales, especially of lower-priced CVD medicines, rose. Community health workers attributed some poor health outcomes to interruption in regular patient check-ups; this interruption was aggravated by formal mitigation policies. CONCLUSIONS: Fears that COVID-19 would interrupt medicine availability were unfounded in East Java. Public sector patients may have compensated for reduced service access by switching to private pharmacies. Mitigation policies that ignored administrative procedures were not effective.

Variation in Price of Cardiovascular and Diabetes Medicine in Indonesia, and Relationship with Quality: A Mixed Methods Study in East Java.

Lower-middle income Indonesia, the world's fourth most populous country, has struggled to contain costs in its mandatory, single-payer public health insurance system since the system's inception in 2014. Public procurement policies radically reduced prices of most medicines in public facilities and the wider market. However, professional associations and the press have questioned the quality of these low-cost, unbranded generic medicines. We collected 204 samples of four cardiovascular and one antidiabetic medicines from health facilities and retail outlets in East Java. We collected amlodipine, captopril, furosemide, simvastatin, and glibenclamide, sampling to reflect patients' likelihood of exposure to specific brands and outlets. We recorded sales prices and maximum retail prices and tested medicines for dissolution and percentage of labeled content using high-performance liquid chromatography. We conducted in-depth interviews with supply chain actors. All samples, including those provided free in public facilities, met quality specifications. Most manufacturers make both branded and unbranded medicines. Retail prices varied widely. The median ratio of price to the lowest price for an equivalent product was 5.1, and a few brands sold for over 100 times the minimum price. Prices also varied between outlets for identical products because retail pharmacies set prices to maximize profit. Because very-low-cost medicines were universally available and of good quality, we believe richer patients who chose to buy branded products effectively protected medicine quality for poorer patients in Indonesia because manufacturers cross-subsidize between branded and unbranded versions of the same medicine.

A study of the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using exposure-based sampling.

BACKGROUND: The WHO has warned that substandard and falsified medicines threaten health, especially in low and middle-income countries (LMICs). However, the magnitude of that threat for many medicines in different regions is not well described, and high-quality studies remain rare. Recent reviews of studies of cardiovascular and diabetes medicine quality recorded that 15.4% of cardiovascular and 6.8% of diabetes samples failed at least one quality test. Review authors warn that study quality was mixed. Because they did not record medicine volume, no study reflected the risk posed to patients. METHODS AND FINDINGS: We investigated the quality of five medicines for cardiovascular disease and diabetes in Malang district, East Java, Indonesia. Our sample frame, based on dispensing volumes by outlet and price category, included sampling from public and private providers and pharmacies and reflected the potential risk posed to patients. The content of active ingredient was determined by high-performance liquid chromatography and compared with the labelled content. Dissolution testing was also performed.We collected a total of 204 samples: amlodipine (88); captopril (22); furosemide (21); glibenclamide (21) and simvastatin (52), comprising 83 different brands/products. All were manufactured in Indonesia, and all samples met specifications for both assay and dissolution. None was suspected of being falsified. CONCLUSIONS: While we cannot conclude that the prevalence of poor-quality medicines in Malang district is zero, our sampling method, which reflects likely exposure to specific brands and outlets, suggests that the risk to patients is very low; certainly nothing like the rates found in recent reviews of surveys in LMICs. Our study demonstrates the feasibility of sampling medicines based on likely exposure to specific products and underlines the dangers of extrapolating results across countries.

Challenges in maintaining medicine quality while aiming for universal health coverage: a qualitative analysis from Indonesia.

INTRODUCTION: Indonesia, the world's fourth most populous nation, is close to achieving universal health coverage (UHC). A widely-publicised falsified vaccine case in 2016, coupled with a significant financial deficit in the national insurance system, has contributed to concern that the rapid scale-up of UHC might undermine medicine quality. We investigated the political and economic factors that drive production and trade of poor-quality medicines in Indonesia. METHODS: We reviewed academic publications, government regulations, technical agency documents and news reports to develop a semi-structured questionnaire. We interviewed healthcare providers, policy-makers, medicine regulators, pharmaceutical manufacturers, patients and academics (n=31). We included those with in-depth knowledge about the falsified vaccine case or the pharmaceutical business, medicine regulation, prescribing practice and the implementation of UHC. We coded data using NVivo software and analysed by constant comparative method. RESULTS: The scale-up of UHC has cut revenues for physicians and pharmaceutical manufacturers. In the vaccine case, free, quality-assured vaccines were available but some physicians, seeking extra revenue, promoted expensive alternatives. Taking advantage of poor governance in private hospitals, they purchased cut-price 'vaccines' from freelance salespeople.A single-winner public procurement system which does not explicitly consider quality has slashed the price paid for covered medicines. Trade, industrial and religious policies simultaneously increased production costs, pressuring profit margins for manufacturers and distributors. They reacted by cutting costs (potentially threatening quality) or by market withdrawal (leading to shortages which provide a market for falsifiers). Shortages and physician-promoted irrational demand push patients to buy medicines in unregulated channels, increasing exposure to falsified medicines. CONCLUSION: Market factors, including political pressure to reduce medicine prices and healthcare provider incentives, can drive markets for substandard and falsified medicines. To protect progress towards UHC, policy-makers must consider the potential impact on medicine quality when formulating rules governing health financing, procurement, taxation and industry.

Is Indonesia achieving universal health coverage? Secondary analysis of national data on insurance coverage, health spending and service availability.

OBJECTIVES: To analyse the relationship between health need, insurance coverage, health service availability, service use, insurance claims and out-of-pocket spending on health across Indonesia. DESIGN: Secondary analysis of nationally representative quantitative data. We merged four national data sets: the National Socioeconomic Survey 2018, National Census of Villages 2018, Population Health Development Index 2018 and National Insurance Records to end 2017. Descriptive analysis and linear regression were performed. SETTING: Indonesia has one of the world's largest single-payer national health insurance schemes. Data are individual and district level; all are representative for each of the country's 514 districts. PARTICIPANTS: Anonymised secondary data from 1 131 825 individual records in the National Socioeconomic Survey and 83 931 village records in the village census. Aggregate data for 220 million insured citizens. PRIMARY OUTCOME MEASURES: Health service use and out-of-pocket payments, by health need, insurance status and service availability. Secondary outcome: insurance claims. RESULTS: Self-reported national health insurance registration (60.6%) is about 10% lower compared with the insurer's report (71.1%). Insurance coverage is highest in poorer areas, where service provision, and thus service use and health spending, are lowest. Inpatient use is higher among the insured than the uninsured (OR 2.35, 95% CI 2.27 to 2.42), controlling for health need and access), and poorer patients are most likely to report free inpatient care (53% in wealth quintile 1 vs 41% in Q5). Insured patients spend US$ 3.14 more on hospitalisation than the uninsured (95% CI 1.98 to 4.31), but the difference disappears when controlled for wealth. Lack of services is a major constraint on service use, insurance claims and out-of-pocket spending. CONCLUSIONS: The Indonesian public insurance system protects many inpatients, especially the poorest, from excessive spending. However, others, especially in Eastern Indonesia cannot benefit because few services are available. To achieve health equity, the Indonesian government needs to address supply side constraints and reduce structural underfunding.

Substandard and Falsified Medicines: Proposed Methods for Case Finding and Sentinel Surveillance.

The World Health Organization and others warn that substandard and falsified medicines harm health and waste money, especially in low- and middle-income countries. However, no country has measured the market-wide extent of the problem, and no standardized methods exist to estimate the prevalence of either substandard or falsified medicines. This is, in part, because the task seems overwhelming; medicine markets are huge and diverse, and testing medicines is expensive. Many countries do operate some form of postmarket surveillance of medicine, but their methods and goals differ. There is currently no clear guidance on which surveillance method is most appropriate to meet specific public health goals. In this viewpoint, we aimed to discuss the utility of both case finding and risk-based sentinel surveillance for substandard and falsified medicines, linking each to specific public health goals. We posit that choosing the system most appropriate to the goal, as well as implementing it with a clear understanding of the factors driving the production and sale of substandard and falsified medicines, will allow for surveillance resources to be concentrated most efficiently. We adapted principles used for disease outbreak responses to suggest a case-finding system that uses secondary data to flag poor-quality medicines, proposing risk-based indicators that differ for substandard and falsified medicines. This system potentially offers a cost-effective way of identifying "cases" for market withdrawal, enhanced oversight, or another immediate response. We further proposed a risk-based sentinel surveillance system that concentrates resources on measuring the prevalence of substandard and falsified medicines in the risk clusters where they are most likely to be found. The sentinel surveillance system provides base data for a transparent, spreadsheet-based model for estimating the national prevalence of substandard and falsified medicines. The methods we proposed are based on ongoing work in Indonesia, a large and diverse middle-income country currently aiming to achieve universal health coverage. Both the case finding and the sentinel surveillance system are designed to be adaptable to other resource-constrained settings.

Sharing health data: good intentions are not enough.

Epidemiologists and public health researchers are moving very slowly in the data sharing revolution, and agencies that maintain global health databases are reluctant to share data too. Once investments in infrastructure have been made, recycling and combining data provide access to maximum knowledge for minimal additional cost. By refusing to share data, researchers are slowing progress towards reducing illness and death and are denying a public good to taxpayers who support most of the research. Funders of public health research are beginning to call for change and developing data sharing policies. However they are not yet adequately addressing the obstacles that underpin the failure to share data. These include professional structures that reward publication of analysis but not of data, and funding streams and career paths that continue to undervalue critical data management work. Practical issues need to be sorted out too: how and where should data be stored for the long term, who will control access, and who will pay for those services? Existing metadata standards need to be extended to cope with health data. These obstacles have been known for some time; most can be overcome in the field of public health just as they have been overcome in other fields. However no institution has taken the lead in defining a work plan and carving up the tasks and the bill. In this round table paper, we suggest goals for data sharing and a work plan for reaching them, and challenge respondents to move beyond well intentioned but largely aspirational data sharing plans.

What Makes a National Pharmaceutical Track and Trace System Succeed? Lessons From Turkey.

BACKGROUND: Track and trace systems are increasingly being implemented as a technological solution to secure pharmaceutical supply chains. Turkey was the first country to implement a full pharmaceutical track and trace system throughout the entire regulated domestic supply chain. This article explores the emergence and functioning of this system and the consequences for substandard and falsified medicine with a focus on the underlying political and economic factors. METHODS: This study uses an explanatory case study approach that combined interviews with purposefully selected key informants and document analyses. RESULTS: The main drivers for implementing the pharmaceutical track and trace system in Turkey centered on the elimination of reimbursement fraud and the prevention of falsified medicine in the regulated supply chain. Although stakeholders experienced both physical and software-related problems in implementation, the alignment of incentives of all stakeholders with the power of the state, along with leeway for adaptations, ultimately resulted in a successful process. This track and trace system provides a clean regulated supply chain, minimizes reimbursement fraud, facilitates fast market recalls, and can flag likely medicine shortages. Staff previously engaged in pharmacy inspections now concentrate on ensuring production quality, which reduces the risk of substandard medicines. CONCLUSIONS: In Turkey, 4 factors drove the successful implementation of pharmaceutical track and trace: the political determination to eliminate reimbursement fraud, a large pharmaceutical market dominated by a single payer, medicine reimbursement being contingent on verified dispensing and prescription, and flexibility to adapt the system according to the needs of stakeholders during implementation.

Identifying market risk for substandard and falsified medicines: an analytic framework based on qualitative research in China, Indonesia, Turkey and Romania.

Introduction: Substandard and falsified medicines undermine health systems. We sought to unravel the political and economic factors which drive the production of these products, and to explain how they reach patients. Methods: We conducted in-depth case studies in China, Indonesia, Turkey and Romania. We reviewed academic papers and press reports (n = 840), developing semi-structured questionnaires. We interviewed regulators, policy-makers, pharmaceutical manufacturers, physicians, pharmacists, patients and academics (n=88). We coded data using NVivo software, and developed an analytic framework to assess national risks for substandard and falsified medicines. We tested the framework against cases reported to the World Health Organization, from countries at all income levels. Results: We found that increasing political commitment to provision of universal health coverage has led to public procurement policies aimed at lowering prices of medical products. In response, legitimate, profit-driven pharmaceutical companies protect their margins by cutting costs, or withdrawing from less profitable markets, while distributors engage in arbitrage. Meanwhile, health providers sometimes protect profits by 'upselling' patients to medicines not covered by insurers. Cost-cutting can undermine quality assurance, leading to substandard or degraded medicines. Other responses contribute to shortages, irrational demand and high prices. All of these provide market opportunities for producers of falsified products; they also push consumers outside of the regular supply chain, providing falsifiers with easy access to customers. The analytic framework capturing these interactions explained cases in most high and middle-income settings; additional factors operate in the poorest countries. Conclusions: Most efforts to secure medicine quality currently focus on product regulation. However, our research suggests market mechanisms are key drivers for poor quality medicines, including where political commitments to universal health coverage are under-resourced. We have developed a framework to guide country-specific, system-wide analysis. This can flag risks and pinpoint specific actions to protect medicine quality, and thus health.

HIV risk in Karachi and Lahore, Pakistan: an emerging epidemic in injecting and commercial sex networks.

The objective of this study was to measure HIV prevalence and risk behaviour in injecting drug users (IDUs), male sex workers (MSWs), Hijras (transgenders), female sex workers (FSWs) and male truckers in Karachi and Lahore, Pakistan. The design was a linked-anonymous cross-sectional study of individuals identified at key venues or through peer referral. Approximately 400 respondents in each group (200 for Hijras) responded to a standardized questionnaire and were tested for HIV antibodies at each site. In Karachi, 23% of IDUs and 4% of MSWs were HIV positive, and HIV-positive individuals were identified in all risk groups in at least one city. Two-thirds of all IDUs used a shared needle in the previous week, and unprotected commercial sex activity with men and women was high. The HIV epidemic has entered IDU and male and female commercial sex networks in Karachi and Lahore. Targeted intervention services must be scaled up and risk group surveillance intensified.

In the eye of the beholder: to make global health estimates useful, make them more socially robust.

A plethora of new development goals and funding institutions have greatly increased the demand for internationally comparable health estimates in recent years, and have brought important new players into the field of health estimate production. These changes have rekindled debates about the validity and legitimacy of global health estimates. This paper draws on country case studies and personal experience to support our opinion that the production and use of estimates are deeply embedded in specific social, economic, political and ideational contexts, which differ at different levels of the global health architecture. Broadly, most global health estimates tend to be made far from the local contexts in which the data upon which they are based are collected, and where the results of estimation processes must ultimately be used if they are to make a difference to the health of individuals. Internationally standardised indicators are necessary, but they are no substitute for data that meet local needs, and that fit with local ideas of what is credible and useful. In other words, data that are both technically and socially robust for those who make key decisions about health. We suggest that greater engagement of local actors (and local data) in the formulation, communication and interpretation of health estimates would increase the likelihood that these data will be used by those most able to translate them into health gains for the longer term. Besides strengthening national information systems, this requires ongoing interaction, building trust and establishing a communicative infrastructure. Local capacities to use knowledge to improve health must be supported.

Sharing individual patient and parasite-level data through the WorldWide Antimalarial Resistance Network platform: A qualitative case study.

BACKGROUND: Increasingly, biomedical researchers are encouraged or required by research funders and journals to share their data, but there's very little guidance on how to do that equitably and usefully, especially in resource-constrained settings. We performed an in-depth case study of one data sharing pioneer: the WorldWide Antimalarial Resistance Network (WWARN). METHODS: The case study included a records review, a quantitative analysis of WAARN-related publications, in-depth interviews with 47 people familiar with WWARN, and a witness seminar involving a sub-set of 11 interviewees. RESULTS: WWARN originally aimed to collate clinical, in vitro, pharmacological and molecular data into linked, open-access databases intended to serve as a public resource to guide antimalarial drug treatment policies. Our study describes how WWARN navigated challenging institutional and academic incentive structures, alongside funders' reluctance to invest in capacity building in malaria-endemic countries, which impeded data sharing. The network increased data contributions by focusing on providing free, online tools to improve the quality and efficiency of data collection, and by inviting collaborative authorship on papers addressing policy-relevant questions that could only be answered through pooled analyses. By July 1, 2016, the database included standardised data from 103 molecular studies and 186 clinical trials, representing 135,000 individual patients. Developing the database took longer and cost more than anticipated, and efforts to increase equity for data contributors are on-going. However, analyses of the pooled data have generated new methods and influenced malaria treatment recommendations globally. Despite not achieving the initial goal of real-time surveillance, WWARN has developed strong data governance and curation tools, which are now being adapted relatively quickly for other diseases. CONCLUSIONS: To be useful, data sharing requires investment in long-term infrastructure. To be feasible, it requires new incentive structures that favour the generation of reusable knowledge.

Indonesia's road to universal health coverage: a political journey.

In 2013 Indonesia, the world's fourth most populous country, declared that it would provide affordable health care for all its citizens within seven years. This crystallised an ambition first enshrined in law over five decades earlier, but never previously realised. This paper explores Indonesia's journey towards universal health coverage (UHC) from independence to the launch of a comprehensive health insurance scheme in January 2014. We find that Indonesia's path has been determined largely by domestic political concerns ­ different groups obtained access to healthcare as their socio-political importance grew. A major inflection point occurred following the Asian financial crisis of 1997. To stave off social unrest, the government provided health coverage for the poor for the first time, creating a path dependency that influenced later policy choices. The end of this programme coincided with decentralisation, leading to experimentation with several different models of health provision at the local level. When direct elections for local leaders were introduced in 2005, popular health schemes led to success at the polls. UHC became an electoral asset, moving up the political agenda. It also became contested, with national policy-makers appropriating health insurance programmes that were first developed locally, and taking credit for them. The Indonesian experience underlines the value of policy experimentation, and of a close understanding of the contextual and political factors that drive successful UHC models at the local level. Specific drivers of success and failure should be taken into account when scaling UHC to the national level. In the Indonesian example, UHC became possible when the interests of politically and economically influential groups were either satisfied or neutralised. While technical considerations took a back seat to political priorities in developing the structures for health coverage nationally, they will have to be addressed going forward to achieve sustainable UHC in Indonesia.

Using HIV surveillance data: recent experiences and avenues for the future.

HIV surveillance systems provide information that is crucial to our understanding of epidemic dynamics among different populations in different settings. Surveillance data are also used for advocacy, to inform policies and programming, and for monitoring. Multiple data sources may be used and will expand in the future as service statistics from prevention and treatment programmes become available. Important and new priorities in HIV surveillance data use at the national and local levels can build on past experience with surveillance reports, national estimates, advocacy materials, and communications to the media. A new framework, integrated analysis of data from expanded surveillance systems and other sources, is proposed to inform improved programming. The approach allows making effective programme choices, based on the analysis of biological and behavioral data and the coverage of interventions in an integrated fashion. The comparison of surveillance data with financial data provides added insights in the adequacy of the response. These findings and experiences set a new agenda for technical and structural directions to improve data use in countries.

HIV, STIs, and sexual behaviors among men who have sex with men in Phnom Penh, Cambodia.

A probability sample of 206 men who have sex with men from 16 sites in Phnom Penh were surveyed about sexual behaviors and tested for HIV and sexually transmitted infections (STIs). HIV and syphilis prevalence was 14.4% and 5.5%, respectively. Out of the total sample, 81% reported anal sex with any male partners in the past 6 months, and 61.2% reported having had vaginal sex. In the past 6 months, 82.8% of the sample reported having male partners who paid them to have sex. Self-reported sexual orientation did not match well with self-reported sexual behavior. Significant risk factors for HIV infection were anal sex with multiple partners, unprotected vaginal sex with commercial female partners in the past month, and any STI. Complex sexual networks indicate that men who have sex with men act as a bridge between higher and lower HIV prevalence populations. Better prevention efforts structured around behaviors rather than sexual identities are needed.