Identifying market risk for substandard and falsified medicines

__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

Identifying market risk for substandard and falsified medicines: an analytic framework based on qualitative research in China, Indonesia, Turkey and Romania [version 1; peer review: 3 approved]

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

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

Supplementary data for Hasnida et al: Challenges in maintaining medicine quality while aiming for universal health coverage: a qualitative analysis from Indonesia.

These data support a case study of the economic and political drivers of substandard and falsified medicines in Indonesia. They include court records related to a case of widespread sale of falsified vaccines in Indonesia in 2016

Challenges in maintaining medicine quality while aiming for universal health coverage

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.</p

Supplementary material for Pisani et al: Substandard and falsified medicines: proposed methods for case finding and sentinel surveillance

These tables provide additional details to those presented in the manuscript. They include a more complete list of potential indicators, with alternatives depending on data availability; potential data sources; and suggested scoring methods. They accompany the draft paper Pisani et al: Substandard and falsified medicines: proposed methods for case finding and sentinel surveillance (2020-02-03

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

Supporting Data for: The political economy of substandard and falsified medicines: an evidence-informed risk-assessment framework based on a multi-country study

These data provide supplementary information for readers of the draft paper: The political economy of substandard and falsified medicines: an evidence-informed risk-assessment framework based on a multi-country study

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

This dataset contains supporting data for a study of the political and economic drivers of substandard and falsified medicines in middle income countries, led by Elizabeth Pisani. The full title of the paper is: Identifying market risk for substandard and falsified medicines: an analytic framework based on qualitative research in China, Indonesia, Turkey and Romania. (2019-04-08