After a period of proliferation of disease-specific initiatives, over the past decade and especially since 2005 many organizations involved in global health have come to direct attention and resources to the issue of health systems strengthening. We explore how and why such attention emerged. A qualitative methodology, process-tracing, was used to construct a case history and analyse the factors shaping and inhibiting global political attention for health systems strengthening. We find that the critical factors behind the recent burst of attention include fears among global health actors that health systems problems threaten the achievement of the health-related Millennium Development Goals, concern about the adverse effects of global health initiatives on national health systems, and the realization among global health initiatives that weak health systems present bottlenecks to the achievement of their organizational objectives. While a variety of actors now embrace health systems strengthening, they do not constitute a cohesive policy community. Moreover, the concept of health systems strengthening remains vague and there is a weak evidence base for informing policies and programmes for strengthening health systems. There are several reasons to question the sustainability of the agenda. Among these are the global financial crisis, the history of pendulum swings in global health and the instrumental embrace of the issue by some actors.

No abstract

Many low-income and middle-income countries lack the capacity to effectively and efficiently regulate medical products in their countries. To support countries in strengthening their capacity, WHO has developed the Global Benchmarking Tool (GBT) as the global standard for objectively assessing regulatory capacity for medicines and vaccines. The GBT is a game changer because it is the first globally accepted tool for assessing and strengthening national regulatory authorities. The inclusion of an institutional development plan in the GBT methodology provides context-specific actionable steps countries can take to advance their system’s functionality and maturity. The GBT facilitates coordination and improves the effectiveness of regulatory strengthening efforts. The tool also facilitates regulatory reliance and harmonisation, which helps to improve timely access to quality-assured medicines, and creates incentives for trade, particularly in countries and regions with a strong pharmaceutical manufacturing base. The GBT is a necessary tool for creating strong and effective regulatory systems, which are critical for ensuring the efficacy, safety and quality assurance of medicines and populations’ timely access to these medicines. In outlining the benefits of the GBT, this paper also offers some specific ideas for strengthening the GBT framework and process.

Pharmaceutical products are indispensable for improving health outcomes. 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. This work adds clarity to the concept of pharmaceutical systems and their strengthening by proposing holistic definitions on the basis of systems thinking. It provides a practical starting point for measuring the progress of pharmaceutical systems strengthening.

No abstract