Does structural form matter?:A comparative analysis of pooled procurement mechanisms for health commodities

IntroductionPooled procurement can be seen as a collaboration initiative of buyers. Such mechanisms have received increased attention during the Covid-19 pandemic to improve access to affordable and quality-assured health commodities. The structural form of pooled procurement mechanisms ranges from a third-party organization that procures on behalf of its buyers to a buyer’s owned mechanism in which buyers operate more collaboratively. However, little is known about how these types of pooled procurement mechanisms differ in terms of characteristics, implementation and developmental process. To fill this gap, we compared four pooled procurement mechanisms. Two buyer’s owned mechanisms: the Organisation of the Eastern Caribbean States (OECS) and the Pacific Island Countries (PIC). And two third-party mechanisms: the Global Drug Facility (GDF) and the Asthma Drug Facility (ADF).MethodsFor this qualitative study, we used a multiple case-study design. The cases were purposefully selected, based on a most-similar case study design. We used the Pooled Procurement Guidance to collect data on individual cases and compared our findings between the case studies. For our analysis, we drew upon peer-reviewed academic articles, grey literature documents and 9 semi-structured interviews with procurement experts.ResultsBuyers within a buyer’s owned mechanisms differ in procurement systems, financing structures, product needs and regulatory and legal frameworks. Therefore, buyers within such mechanisms require relative alignment on motivations, goals and operations of the mechanism. Our study showed that buyers’ relative homogeneity of characteristics and their perceived urgency of the problems was particularly relevant for achieving that alignment.Third-party organization mechanisms require less alignment and consensus-building between buyers. To participate, buyers need to align with the operations of the third-party organization, instead of other buyers. Elements that were essential for the successful implementation and operation of such mechanisms included the procurement secretariat’s ability to create local and global awareness around the problem, to induce political will to act upon the problem, to mobilize sufficient funding and to attract qualified staff.ConclusionTo successfully sustain pooled procurement mechanisms over time, key actors should drive the mechanism through continuous and reflexive work on stakeholder engagement, mobilization of funding and alignment of interests and needs

What Makes a National Pharmaceutical Track and Trace System Succeed?

__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

__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

Does structural form matter? A comparative analysis of pooled procurement mechanisms for health commodities

Abstract Introduction Pooled procurement can be seen as a collaboration initiative of buyers. Such mechanisms have received increased attention during the Covid-19 pandemic to improve access to affordable and quality-assured health commodities. The structural form of pooled procurement mechanisms ranges from a third-party organization that procures on behalf of its buyers to a buyer’s owned mechanism in which buyers operate more collaboratively. However, little is known about how these types of pooled procurement mechanisms differ in terms of characteristics, implementation and developmental process. To fill this gap, we compared four pooled procurement mechanisms. Two buyer’s owned mechanisms: the Organisation of the Eastern Caribbean States (OECS) and the Pacific Island Countries (PIC). And two third-party mechanisms: the Global Drug Facility (GDF) and the Asthma Drug Facility (ADF). Methods For this qualitative study, we used a multiple case-study design. The cases were purposefully selected, based on a most-similar case study design. We used the Pooled Procurement Guidance to collect data on individual cases and compared our findings between the case studies. For our analysis, we drew upon peer-reviewed academic articles, grey literature documents and 9 semi-structured interviews with procurement experts. Results Buyers within a buyer’s owned mechanisms differ in procurement systems, financing structures, product needs and regulatory and legal frameworks. Therefore, buyers within such mechanisms require relative alignment on motivations, goals and operations of the mechanism. Our study showed that buyers’ relative homogeneity of characteristics and their perceived urgency of the problems was particularly relevant for achieving that alignment. Third-party organization mechanisms require less alignment and consensus-building between buyers. To participate, buyers need to align with the operations of the third-party organization, instead of other buyers. Elements that were essential for the successful implementation and operation of such mechanisms included the procurement secretariat’s ability to create local and global awareness around the problem, to induce political will to act upon the problem, to mobilize sufficient funding and to attract qualified staff. Conclusion To successfully sustain pooled procurement mechanisms over time, key actors should drive the mechanism through continuous and reflexive work on stakeholder engagement, mobilization of funding and alignment of interests and needs

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

From promise to practice: a guide to developing pooled procurement mechanisms for medicines and vaccines

Introduction: Buyers of medicines and vaccines are increasingly interested in pooling their procurement to improve access to affordable and quality-assured health commodities. However, the academic literature has provided no detailed description of how pooled procurement mechanisms are set up and develop over time. These insights are valuable as it increases our understanding of implementing and operating pooled procurement mechanisms successfully. Therefore, the aim of this paper is twofold. First, to explore how such mechanisms evolve over time. Second, to clarify the work that is needed to set up and sustain a pooled procurement mechanism. These findings have been translated into our Pooled Procurement Guidance document. Methods: This qualitative study draws upon theoretical insights from organizational life cycles, collaborative and network governance, semi-structured interviews with procurement experts and academic and grey literature documents on pooled procurement of medicines and vaccines. Results: We identified four general developmental stages of pooled procurement mechanisms: promise, creation, early operational and mature. The promise stage is characterized by initiating engagement between participating actors, while they try to convert their perceived problem(s) or opportunities into a shared vision. The creation stage is where the participating actors formalize and design the mechanism through consensus-building, articulation of a shared plan, and mobilize resources to put the shared plan into action. The early operational stage is where the shared plan is being executed. The newly established or appointed procurement organization is required to learn fast from experience while showing flexibility to the changing needs of buyers and suppliers. Once operations are routinized, the mechanism enters the mature stage. During this stage, the pooled procurement organization develops into a trusted player that provides sufficient incentives for all actors involved. Importantly, pooled procurement mechanisms can stagnate or turn inactive at any time during the developmental process when alignment between actors is threatened. Conclusions: Pooled procurement mechanisms evolve over time. Setting up such mechanisms is a collaborative process that relies on intentional efforts by key actors involved. To increase the lifespan of pooled procurement mechanisms, key actors need to sustain a relative alignment of goals, needs, motivations and purpose of the mechanism throughout its entire life cycle

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

From promise to practice: a guide to developing pooled procurement mechanisms for medicines and vaccines

Abstract Introduction Buyers of medicines and vaccines are increasingly interested in pooling their procurement to improve access to affordable and quality-assured health commodities. However, the academic literature has provided no detailed description of how pooled procurement mechanisms are set up and develop over time. These insights are valuable as it increases our understanding of implementing and operating pooled procurement mechanisms successfully. Therefore, the aim of this paper is twofold. First, to explore how such mechanisms evolve over time. Second, to clarify the work that is needed to set up and sustain a pooled procurement mechanism. These findings have been translated into our Pooled Procurement Guidance document. Methods This qualitative study draws upon theoretical insights from organizational life cycles, collaborative and network governance, semi-structured interviews with procurement experts and academic and grey literature documents on pooled procurement of medicines and vaccines. Results We identified four general developmental stages of pooled procurement mechanisms: promise, creation, early operational and mature. The promise stage is characterized by initiating engagement between participating actors, while they try to convert their perceived problem(s) or opportunities into a shared vision. The creation stage is where the participating actors formalize and design the mechanism through consensus-building, articulation of a shared plan, and mobilize resources to put the shared plan into action. The early operational stage is where the shared plan is being executed. The newly established or appointed procurement organization is required to learn fast from experience while showing flexibility to the changing needs of buyers and suppliers. Once operations are routinized, the mechanism enters the mature stage. During this stage, the pooled procurement organization develops into a trusted player that provides sufficient incentives for all actors involved. Importantly, pooled procurement mechanisms can stagnate or turn inactive at any time during the developmental process when alignment between actors is threatened. Conclusions Pooled procurement mechanisms evolve over time. Setting up such mechanisms is a collaborative process that relies on intentional efforts by key actors involved. To increase the lifespan of pooled procurement mechanisms, key actors need to sustain a relative alignment of goals, needs, motivations and purpose of the mechanism throughout its entire life cycle

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