Recent Journal Articles by Tamara Hafner

SummaryThe COVID-19 pandemic limits pricing policy options for vaccines. It is therefore necessary to consider what appropriate policy options governments can use to ensure affordable and equitable access to these novel products. Commonly used policies such as fostering competition, generic substitution, and external and internal reference pricing will not work for novel vaccines.

This paper describes the technical approach used by a donor-funded program to strengthen multisectoral coordination on antimicrobial resistance (AMR) in 11 countries as part of their efforts to advance the objectives of the Global Health Security Agenda and discusses some of the challenges and lessons learned.The program conducted a rapid situational analysis of the Global Health Security Agenda and AMR landscape in each country and worked with the governments to identify the gaps, priorities, and potential activities in multisectoral coordination on AMR. Using the World Health Organization (WHO) Joint External Evaluation tool and the WHO Benchmarks for International Health Regulations (2005) Capacities as principal guidance, we worked with countries to achieve key milestones in enhancing effective multisectoral coordination on AMR. The program conducted a rapid situational analysis of the Global Health Security Agenda and AMR landscape in each country and worked with the governments to identify the gaps, priorities, and potential activities in multisectoral coordination on AMR. The program’s interventions led to the achievement of key benchmarks recommended actions, including the finalization of national action plans on AMR and tools to guide their implementation; strengthening the leadership, governance, and oversight capabilities of multisectoral governance structures; establishing and improving the functions of technical working groups on infection prevention and control and antimicrobial stewardship; and coordinating AMR activities within and across sectors.

As many low- and middle-income countries launch prepayment schemes to achieve universal health coverage, few are covering products from retail drug outlets (pharmacies and drug shops). This case study aims to characterize barriers and facilitators related to incorporating retail drug outlets into national prepayment schemes based on the experience of the Tanzanian National Health Insurance Fund’s (NHIF) certification of pharmacies and accredited drug dispensing outlets. We reviewed government documents and interviewed 26 key informants including retail outlet owners and dispensers and central and district government authorities representing eight districts overall. Important enablers for NHIF/retail outlet engagement include widespread awareness of NHIF in the community, NHIF’s straightforward certification process, and their reimbursement speed. All of the retail respondents felt that NHIF helps their business and their clients to some degree. As for barriers, retailers thought that NHIF needed to provide more information to them and to its members, particularly regarding coverage changes. Some retailers and government officials thought that the product reimbursement prices were below market and not adjusted often enough, and pharmacy respondents were unhappy about claim rejections for what they felt were insignificant issues. All interviewees agreed that one of the biggest problems is poor prescribing practices in public health facilities. They reiterated that prescribers need more supervision to improve their practices, particularly to ensure adherence to standard treatment guidelines, which NHIF requires for approving a claim.

Well-functioning national regulatory authorities (NRAs) ensure access to safe, effective, quality-assured, and affordable medical products. However, the benefits of their work are often unseen and difficult to attribute, thereby making NRAs undervalued and under-resourced, particularly in low- and middle-income countries. This paper offers three key arguments NRAs and other stakeholders can use to advocate for greater investment in regulatory systems strengthening—medical products regulation effectively safeguards public health; effective regulation improves health system’s efficiency by increasing access to affordable medical products, contributing to universal health coverage; and robust regulation strengthens local pharmaceutical manufacturing and bolsters pharmaceutical trade. NRAs’ critical role in health systems is indisputable, yet they need to better promote their value to receive the requisite resources to function effectively.

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 response to emergency public health challenges such as HIV, TB, and malaria has been successful in mobilising resources and scaling up treatment for communicable diseases. However, many of the remaining challenges in improving access to and appropriate use of medicines and services require pharmaceutical systems strengthening. Incorporating pharmaceutical systems strengthening into global health programmes requires recognition of a few ‘truths’. Systems strengthening is a lengthy and resource-intensive process that requires sustained engagement, which may not align with the short time frame for achieving targets in vertical-oriented programmes. Further, there is a lack of clarity on what key metrics associated with population and patient level outcomes should be tracked for systems strengthening interventions. This can hinder advocacy and communication with decision makers regarding health systems investments. Moving forward, it is important to find ways to balance the inherent tensions between the short-term focus on the efficiency of vertical programmes and broader, longer-term health and development objectives. Global health programme design should also shift away from a narrow view of medicines primarily as an input commodity to a more comprehensive view that recognizes the various structures and processes and their interactions within the broader health system that help ensure access to and appropriate use of medicines and related services.