The role of health systems for health security: a scoping review revealing the need for improved conceptual and practical linkages.

BACKGROUND: Practical links between health systems and health security are historically prevalent, but the conceptual links between these fields remain under explored, with little on health system strengthening. The need to address this gap gains relevance in light of the COVID-19 pandemic as it demonstrated a crucial relationship between health system capacities and effective health security response. Acknowledging the importance of developing stronger and more resilient health systems globally for health emergency preparedness, the WHO developed a Health Systems for Health Security framework that aims to promote a common understanding of what health systems for health security entails whilst identifying key capacities required. METHODS/ RESULTS: To further explore and analyse the conceptual and practical links between health systems and health security within the peer reviewed literature, a rapid scoping review was carried out to provide an overview of the type, extent and quantity of research available. Studies were included if they had been peer-reviewed and were published in English (seven databases 2000 to 2020). 343 articles were identified, of those 204 discussed health systems and health security (high and medium relevance), 101 discussed just health systems and 47 discussed only health security (low relevance). Within the high and medium relevance articles, several concepts emerged, including the prioritization of health security over health systems, the tendency to treat health security as exceptionalism focusing on acute health emergencies, and a conceptualisation of security as 'state security' not 'human security' or population health. CONCLUSION: Examples of literature exploring links between health systems and health security are provided. We also present recommendations for further research, offering several investments and/or programmes that could reliably lead to maximal gains from both a health system and a health security perspective, and why these should be explored further. This paper could help researchers and funders when deciding upon the scope, nature and design of future research in this area. Additionally, the paper legitimises the necessity of the Health Systems for Health Security framework, with the findings of this paper providing useful insights and evidentiary examples for effective implementation of the framework.

Economic evaluation of alternative testing regimes and settings to detect undiagnosed HIV in Australia.

BACKGROUND: The study aimed to estimate the comparative costs per positive diagnosis of previously undetected HIV in three testing regimes: conventional; parallel and point of care (POC) testing. The regimes are analysed in six testing settings in Australia where infection is concentrated but with low prevalence. METHODS: A cost model was developed to highlight the trade-offs between test and economic efficiency from a provider perspective. First, an estimate of the number of tests needed to find a true (previously undiagnosed) positive diagnosis was made. Second, estimates of the average cost per positive diagnosis in whole of population (WoP) and men who have sex with men (MSM) was made, then third, aggregated to the total cost for diagnosis of all undetected infections. RESULTS: Parallel testing is as effective as conventional testing, but more economically efficient. POC testing provide two significant advantages over conventional testing: they screen out negatives effectively at comparatively lower cost and, with confirmatory testing of reactive results, there is no loss in efficiency. The average and total costs per detection in WoP are prohibitive, except for Home Self Testing. The diagnosis in MSM is cost effective in all settings, but especially using Home Self Testing when the individual assumes the cost of testing. CONCLUSIONS: This study illustrates the trade-offs between economic and test efficiency and their interactions with population(s) prevalence. The efficient testing regimes and settings are presently under or not funded in Australia. Home Self Testing has the potential to dramatically increase testing rates at very little cost.

The political economy of universal health coverage: a systematic narrative review.

The uptake and implementation of universal health coverage (UHC) is primarily a political, rather than a technical, exercise, with contested ideas and diverse stakeholders capable of facilitation or resistance-even veto-of the policy uptake. This narrative systematic review, undertaken in 2018, sought to identify all peer-reviewed publications dealing with concepts relating to UHC through a political economy framing. Of the 627 papers originally identified, 55 papers were directly relevant, with an additional eight papers added manually on referral from colleagues. The thematic analysis adapted Fox and Reich's framework of ideas and ideologies, interests and institutions to organize the analysis. The results identified a literature strong in its exploration of the ideologies and ideas that underpin UHC, but with an apparent bias in authorship towards more rights-based, left-leaning perspectives. Despite this, political economy analyses of country case studies suggested a more diverse political framing for UHC, with the interests and institutions engaged in implementation drawing on pragmatic and market-based mechanisms to achieve outcomes. Case studies offered limited detail on the role played by specific interests, though the influence of global development trends was evident, as was the role of donor organizations. Most country case studies, however, framed the development of UHC within a narrative of national ownership, with steps in implementation often critical political milestones. The development of institutions for UHC implementation was predicated largely on available infrastructure, with elements of that infrastructure-federal systems, user fees, pre-existing insurance schemes-needing to be accommodated in the incremental progress towards UHC. The need for technical competence to deliver ideological promises was underlined. The review concludes that, despite the disparate sources for the analyses, there is an emerging shared narrative in the growing literature around the political economy of UHC that offers an increasing awareness of the political dimensions to UHC uptake and implementation.

Knowledge and awareness of HIV self-testing among Australian gay and bisexual men: a comparison of never, sub-optimal and optimal testers willingness to use.

This paper explores the willingness to use and pay for HIV Self-testing (HIVST) among Australian gay and bisexual men (GBM). Bivariate and univariate multinominal logistic regression of data from an online survey was performed. Thirty-one (13%) had never HIV tested and 41.9% (88) were testing sub-optimally by Australian guidelines. Half (58.4%, 136) had never heard of HIVST, however, 56.2% (131) reported willingness to use HIVST, with sub-optimal (OR=2.13; p < 0.01) and never-testers (OR=2.01; p < 0.10) significantly more likely to do so than optimal-testers. Most were confident (51.7%, 119) or somewhat confident (29.1%, 67) accessing support following a reactive result, however, never-testers were significantly less confident compared to previous testers (OR=3.47; p< 0.05). Less than a quarter (23.6%, 57) were willing to pay for a kit with AUD$15 (R2 = 0.9882) the estimated preferred price. This research confirms that HIVST is an important and accepted adjunct to established HIV testing modalities, particularly among sub-optimal and never-testers and that online (61.6%, 143) or clinic-based (61.6%, 143) dissemination are preferred. Research examining how best to disseminate HIVST in a range of safe and effective models needs to continue to ensure HIVST is part of a comprehensive strategy that facilitates usage and linkages to care.

Access to hepatitis C virus treatment: Lessons from implementation of strategies for increasing access to antiretroviral treatment.

At September's 2017 United Nations General Assembly, a state-of-the-art HIV medicine was announced to be made available at just $75 per person per year. There have been a number of strategies that the global AIDS community and countries have utilized to reduce prices and make antiretrovirals (ARVs) accessible for people living with HIV/AIDS. There appears to be an opportunity for the treatment of hepatitis C virus infection using direct-acting antivirals (DAAs) to benefit from the often painful and laboured history of driving down the prices of ARVs. In general, the success of lowering prices for ARVs has stemmed from the politics needed to initially support generic entry into the on-patent market. The use of flexibilities present in the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have been used to overcome patent barriers, with the use of compulsory licenses and/or the threat of their use as instruments for strengthening the bargaining power in price negotiations. These strategies have been combined with new financing mechanisms that have promoted more effective procurement and price negotiations. Partnership among the different stakeholders has also been critical in this regard. Countries have also invested in their health systems and implemented several strategies to reduce stigma and discrimination to increase access to and improve utilization of ARVs. This article suggests that any future international initiatives to increase access to DAAs can learn from these lessons surrounding price reduction, improved financing, advocacy, as well as health systems strengthening and stigma reduction. Adopting and reconfiguring these strategies will also incur substantial savings in time, money and lives.

Successes and challenges of the millennium development goals in Ethiopia: lessons for the sustainable development goals.

We analysed the performance of Ethiopia in achieving the health-related millennium development goals (MDGs) with the aim of acquiring lessons for the sustainable development goals (SDGs). Ethiopia achieved most of the health MDGs: a 67% reduction in under-five mortality, a 71% decline in maternal mortality ratio, a 90% decline in new HIV infections, a decrease in malaria-related deaths by 73% and a more than 50% decline in mortality due to tuberculosis. We argue that these achievements are due to implementation of a mix of comprehensive strategies within the health system and across other sectors of the government. Scaling up of interventions by disease control programmes (including the health extension programme) and strengthening of the health system have played important roles towards the achievements. These health gains could not have been realised without progress in the other MDGs: poverty reduction, education, access to safe drinking-water and peace and stability of the country. However, the gains were not equitable, with differences between urban and rural areas, among regions and socioeconomic strata. Ethiopia's remarkable success in meeting most of the targets of the health-related MDGs could be explained by its comprehensive and multisectoral approach for health development. The inequity gap remains a challenge that achieving the health-related SDGs requires the country to implement strategies, which specifically target more marginal populations and geographic areas. This also needs peace and stability, without which it is almost impossible to improve health.

Access to medicines and hepatitis C in Africa: can tiered pricing and voluntary licencing assure universal access, health equity and fairness?

BACKGROUND: The recent introduction of Direct Acting Antivirals (DAAs) for treating Hepatitis C Virus (HCV) can significantly assist in the world reaching the international target of elimination by 2030. Yet, the challenge facing many individuals and countries today lies with their ability to access these treatments due to their relatively high prices. Gilead Sciences applies differential pricing and licensing strategies arguing that this provides fairer and more equitable access to these life-saving medicines. This paper analyses the implications of Gilead's tiered pricing and voluntary licencing strategy for access to the DAAs. METHODS: We examined seven countries in Africa (Egypt, Ethiopia, Nigeria, Democratic Republic of Congo, Cameroon, Rwanda and South Africa) to assess their financial capacity to provide DAAs for the treatment of HCV under present voluntary licensing and tiered-pricing arrangements. These countries have been selected to explore the experience of countries with a range of different burdens of HCV and shared eligibility for supply by licensed generic producers or from discounted Gilead prices. RESULTS: The cost of 12-weeks of generic DAA varies from $684 per patient treated in Egypt to $750 per patient treated in other countries. These countries can also procure the same DAA for 12-weeks of treatment from the originator, Gilead, at a cost of $1200 per patient. The current prices of DAAs (both from generic and originator manufacturers) are much more than the median annual income per capita and the annual health budget of most of these countries. If governments alone were to bear the costs of universal treatment coverage, then the required additional health expenditure from present rates would range from a 4% increase in South Africa to a staggering 403% in Cameroon. CONCLUSION: The current arrangements for increasing access to DAAs, towards elimination of HCV, are facing challenges that would require increases in expenditure that are either too burdensome to governments or potentially so to individuals and families. Countries need to implement the flexibilities in the Doha Declaration on Trade Related Intellectual Property Rights agreement, including compulsory licensing and patent opposition. This also requires political commitment, financial will, global solidarity and civil society activism.

Cautionary Notes on a Global Tiered Pricing Framework for Medicines.

Recently, there has been a policy momentum toward creating a global tiered pricing framework, which would provide differentiated prices for medicines globally, based on each country's capacity to pay. We studied the most influential proposals for a tiered pricing framework since the 1995 World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights. We synthesized 6 critical questions to be addressed for a global framework to function and explored the many challenges of implementation. Although we acknowledge that there is the potential for an exceptional global commitment that would benefit both producers and those in developing countries in need of wider access to medicines, our greatest concern is to ensure that a global framework does not price out the poor from pharmaceutical markets nor threaten current flexibilities within the international patent regime.

Could international compulsory licensing reconcile tiered pricing of pharmaceuticals with the right to health?

BACKGROUND: The heads of the Global Fund and the GAVI Alliance have recently promoted the idea of an international tiered pricing framework for medicines, despite objections from civil society groups who fear that this would reduce the leeway for compulsory licenses and generic competition. This paper explores the extent to which an international tiered pricing framework and the present leeway for compulsory licensing can be reconciled, using the perspective of the right to health as defined in international human rights law. DISCUSSION: We explore the practical feasibility of an international tiered pricing and compulsory licensing framework governed by the World Health Organization. We use two simple benchmarks to compare the relative affordability of medicines for governments - average income and burden of disease - to illustrate how voluntary tiered pricing practice fails to make medicines affordable enough for low and middle income countries (if compared with the financial burden of the same medicines for high income countries), and when and where international compulsory licenses should be issued in order to allow governments to comply with their obligations to realize the right to health. An international tiered pricing and compulsory licensing framework based on average income and burden of disease could ease the tension between governments' human rights obligation to provide medicines and governments' trade obligation to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights.

Access to medicines, market failure and market intervention: a tale of two regimes.

This study explores how an 'Intellectual Property Rights (IPR)/trade regime' has generated a particular set of problems regarding access to medicines despite patents on drugs being presented as economically necessary for reward and future drug innovation. These problems have also inspired and informed activities by so-called new actors in global health. This study argues that a parallel 'pro-access regime' has developed in order to correct some of the most high-profile issues associated with a dysfunctional global pharmaceutical market, especially problems regarding price and innovation that have been exacerbated by stringent global patent rights on new drugs. Therefore, the IPR/trade regime's basic role in global-health governance diverges from how it has been framed and understood, not least of all by its constituent agents and donors. The pro-access regime encompasses new actors in health such as Global Health Partnerships (e.g., GAVI Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria), major philanthropic foundations (e.g., the Gates and Clinton Foundations) and new access initiatives (e.g., UNITAID). The study problematises these actors' governance roles with respect to the overarching authority of the IPR/trade regime and makes a case that the two regimes should be understood as being closely connected with respect to the governance of access to medicines and the global political economy of pharmaceuticals.