access to medicine

Managed entry agreements (MEAs)—a type of formal institutional arrangement between pharmaceutical companies and payers for sharing the risk with respect to the introduction of new pharmaceutical technologies—may expand access to new pharmaceutical technologies for non-communicable diseases. Although common in high-income countries (HICs), there is limited evidence of their use in low- and middle-income countries (LMICs). This article aims to document international experiences of countries implementing MEAs and potential barriers and facilitators for their use in LMICs. We reviewed published literature sources on MEAs over the past 10 years considering peer-reviewed publications and gray literature data. While the use of MEAs in LMICs is very limited, this could be the result of limited empirical evidence on its use and possibly due to the use of a different taxonomy for describing MEAs in these settings. Since there is limited evidence on their use in LMICs, the identified cases of implementation in HICs may serve to inform the interest on MEAs in resource limited settings. Therefore, further research in this field especially in the context of LMICs may be of value for the global community as all countries are embarking into fairer and sustainable Universal Health Coverage.

Market intelligence data, United Nations Commodity Trade Statistics for insulin trade, the International Medical Products Price Guide for prices of human insulin and additional web searches were used as data sources. A total of 34 insulin manufacturers were identified. Most countries and territories are reliant on a limited number of supplying countries. The overall median government procurement price for a 10‐ml, 100‐IU/ml vial during the period 1996–2013 equivalent was US$4.3, with median prices in Africa and low-income and low‐ to middle‐ income countries being higher over this period.This research shows the high variability of insulin prices and the reliance on a few sources, both companies and countries, for global supply. In addressing access to insulin, countries need to use existing price data to negotiate prices, and mechanisms need to be developed to foster competition and security of supply of insulin, given the limited number of truly global producers.

The objective of this study was to describe the conceptual and implementation approach of selected digital health technologies that were tailored in various resource-constrained countries. Drawing from our multi-year institutional experience in more than 20 high disease-burden countries that aspire to meet the 2030 United Nations Sustainable Development Goal 3, we screened internal project documentation on various digital health tools that provide clarity in the conceptual and implementation approach. Taking into account geographic diversity, we provide a descriptive review of five selected case studies from Bangladesh (Asia), Mali (Francophone Africa), Uganda (East Africa), Mozambique (Lusophone Africa), and Namibia (Southern Africa). A key lesson learned is to harness and build on existing governance structures. The use of data for decision-making at all levels needs to be cultivated and sustained through multi-stakeholder partnerships. The next phase of information management development is to build systems for triangulation of data from patients, commodities, geomapping, and other parameters of the pharmaceutical system. A well-defined research agenda must be developed to determine the effectiveness of the country- and regional-level dashboards as an early warning system to mitigate stock-outs and wastage of medicines and commodities.

An extensive body of work on access to and use of medicines has resulted in an assortment of tools measuring various elements of pharmaceutical systems. Until now however, there has been little attempt to conceptualize a pharmaceutical system as an entity and define its strengthening in a way that allows for measuring systems strengthening. The narrow focus of available tools limits their value in ascertaining which interventions result in stronger, more resilient systems. We sought to address this shortcoming by revisiting the current definitions, frameworks and assessment tools related to pharmaceutical systems. We conducted a comprehensive literature review and consulted with select pharmaceutical experts. On the basis of our review, we propose that a pharmaceutical system consists of all structures, people, resources, processes, and their interactions within the broader health system that aim to ensure equitable and timely access to safe, effective, quality pharmaceutical products and related services that promote their appropriate and cost-effective use to improve health outcomes. We further propose that pharmaceutical systems strengthening is the process of identifying and implementing strategies and actions that achieve coordinated and sustainable improvements in the critical components of a pharmaceutical system to make it more responsive and resilient and to enhance its performance for achieving better health outcomes. Finally, we established that, in addition to system performance and resilience, seven components of the pharmaceutical system are critical for measuring pharmaceutical systems strengthening: pharmaceutical products and related services; policy, laws and governance; regulatory systems; innovation, research and development, manufacturing, and trade; financing; human resources; and information.

In 2010, the Ministry of Health (MoH) asked USAID for technical assistance to implement interventions to improve the HIV/AIDS supply chain system. Assessments revealed that fragmentation of the pharmaceutical system contributed to stock-outs and expiration of antiretroviral (ARVs) and other medicines and supplies used by disease control programs. The implementation of an integrated system was proposed as the most efficient and sustainable alternative to confront the HIV/AIDS pharmaceutical supply problems.

Ensuring that medicines which achieve important health outcomes are available, accessible to all, used appropriately, and sustainably affordable is essential for realizing universal health coverage. Stakeholder cooperation and use of information and financing system levers provide opportunities to work toward this goal.

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