A systematic scoping review of medicine availability and affordability in Africa.

BACKGROUND: The most recent World Medicines Situation Report published in 2011 found substantial medicine availability and affordability challenges across WHO regions, including Africa. Since publication of the 2011 report, medicine availability and affordability has risen on the international agenda and was included in the Sustainable Development Goals as Target 3.8. While numerous medicine availability and affordability studies have been conducted in Africa since the last World Medicines Situation Report, there has not been a systematic analysis of the methods used in these studies, measures of medicine availability and affordability, categories of medicines studied, or geographic distribution. Filling this knowledge gap can help inform future medicine availability and affordability studies, design systems to monitor progress toward Sustainable Development Goal Target 3.8 in Africa and beyond, and inform policy and program decisions to improve medicine availability and affordability. METHODS: We conducted a systematic scoping review of studies assessing medicine availability or affordability conducted in the WHO Africa region published from 2009-2021. RESULTS: Two hundred forty one articles met our eligibility criteria. 88% of the articles (213/241) reported descriptive studies, while 12% (28/241) reported interventional studies. Of the 198 studies measuring medicine availability, the most commonly used measure of medicine availability was whether a medicine was in stock on the date of a survey (124/198, 63%). We also identified multiple other availability methods and measures, including retrospective stock record reviews and self-reported medicine availability surveys. Of the 59 articles that included affordability measures, 32 (54%) compared the price of the medicine to the daily wage of the lowest paid government worker. Other affordability measures were patient self-reported affordability, capacity to pay measures, and comparing medicines prices with a population-level income standard (such as minimum wage, poverty line, or per capita income). The most commonly studied medicines were antiparasitic and anti-bacterial medicines. We did not identify studies in 22 out of 48 (46%) countries in the WHO Africa Region and more than half of the studies identified were conducted in Ethiopia, Kenya, Tanzania, and/or Uganda. CONCLUSION: Our results revealed a wide range of medicine availability and affordability assessment methodologies and measures, including cross-sectional facility surveys, population surveys, and retrospective data analyses. Our review also indicated a need for greater focus on medicines for certain non-communicable diseases, greater geographic diversity of studies, and the need for more intervention studies to identify approaches to improve access to medicines in the region.

Combining legal epidemiology and implementation science to improve global access to medicines: challenges and opportunities.

Laws and policies affecting access to medicines have been in the global health spotlight for decades, yet our understanding of their effects remains substantially underdeveloped. The emerging field of legal epidemiology combined with the methods of implementation science presents an opportunity to help address this gap. Legal epidemiology refers to the scientific study and deployment of law as a factor in the cause, distribution, and prevention of disease and injury in a population. Legal epidemiology studies consist of a systematic collection and coding of laws and policies relating to a particular topic. Quasi-experimental or observational research methods can then be applied to take advantage of natural experiments resulting from heterogenous adoption and/or implementation of laws and policies. Often legal epidemiology studies fail to account for heterogenous law implementation processes, presenting a need and opportunity to integrate implementation science methods. Researchers may face challenges in integrating these methods for access to medicines studies, including data access issues and a complex legal and implementation environment. Yet, the opportunities presented by increasingly transparent legal environments, improved monitoring of medicine availability, universal health coverage expansion, and electronic health and insurance records integration may facilitate overcoming these challenges. Improved collaboration and communication between researchers, health authorities, manufacturers, and health providers from public and private sectors will be critical. In spite of the challenges, combining the fields of legal epidemiology and implementation science may present an important strategy toward creating a legal and policy environment that supports global and equitable access to medicines.

Comparing COVID-19 physical distancing policies: results from a physical distancing intensity coding framework for Botswana, India, Jamaica, Mozambique, Namibia, Ukraine, and the United States.

BACKGROUND: Understanding the differences in timing and composition of physical distancing policies is important to evaluate the early global response to COVID-19. A physical distancing intensity monitoring framework comprising 16 domains was recently published to compare physical distancing approaches across 12 U.S. States. We applied this framework to a diverse set of low and middle-income countries (LMICs) (Botswana, India, Jamaica, Mozambique, Namibia, and Ukraine) to test the appropriateness of this framework in the global context and to compare the policy responses in these LMICs with a sample of U.S. States during the first 100-days of the pandemic. RESULTS: The LMICs in our sample adopted wide ranging physical distancing policies. The highest peak daily physical distancing intensity during this period was: Botswana (4.60); India (4.40); Ukraine (4.40); Namibia (4.20); Mozambique (3.87), and Jamaica (3.80). The number of days each country stayed at peak policy intensity ranged from 12-days (Jamaica) to more than 67-days (Mozambique). We found some key similarities and differences, including substantial differences in whether and how countries expressly required certain groups to stay at home. Despite the much higher number of cases in the US, the physical distancing responses in our LMIC sample were generally more intense than in the U.S. States, but results vary depending on the U.S. State. The peak policy intensity for the U.S. 12-state average was 3.84, which would place it lower than every LMIC in this sample except Jamaica. The LMIC sample countries also reached peak physical distancing intensity earlier in outbreak progression compared to the U.S. states sample. The easing of physical distancing policies in the LMIC sample did not discernably correlate with change in COVID-19 incidence. CONCLUSIONS: This physical distancing intensity framework was appropriate for the LMIC context with only minor adaptations. This framework may be useful for ongoing monitoring of physical distancing policy approaches and for use in effectiveness analyses. This analysis helps to highlight the differing paths taken by the countries in this sample and may provide lessons to other countries regarding options for structuring physical distancing policies in response to COVID-19 and future outbreaks.

Policy considerations for scaling up access to HIV pre-exposure prophylaxis for adolescent girls and young women: Examples from Kenya, South Africa, and Uganda.

Adolescent girls and young women (aged 15-24 years; AGYW) continue to carry a disproportionate burden of HIV in sub-Saharan Africa. Pre-exposure prophylaxis (PrEP) helps reduce the risk of acquiring HIV for persons at substantial risk, including AGYW. As countries plan for the rollout of PrEP across sub-Saharan Africa, PrEP policies and programs could address the unique needs of AGYW. The purpose of this analysis was to identify policy considerations to improve AGYW access to PrEP. After reviewing the literature, we identified 13 policy considerations that policymakers and stakeholders could evaluate when developing or reviewing PrEP-related policies. We sorted these considerations into five categories, which together comprise an AGYW Access to PrEP Framework: AGYW-friendly delivery systems, clinical eligibility and adherence support, legal barriers and facilitators, affordability, and community and AGYW outreach. We also reviewed policies in three countries (Kenya, South Africa, and Uganda) to explore how PrEP-related policies addressed these considerations. Some of these policies addressed some of the 13 policy considerations, but none of the policies directly addressed the unique needs of AGYW for accessing PrEP. To improve access to PrEP for AGYW, country policies could include specific components that address these 13 considerations. To reach AGYW effectively, each country could use the 13 considerations we have identified to analyze current policies to identify existing programmatic barriers to AGYW accessing HIV services and address these barriers in PrEP-related policies.

In a Protest Nation - Integrative Policy Negotiation Should be a Core Public Health Competency.

The year 2020 was been a year of protest in the United States the likes of which we have not seen in decades. In many ways, America's history is a history of protest, but its history also shows the power and potential of demonstrations and dialogue to lead to broad coalitions for policy and public health action. The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is one example that illustrates the collective power of demonstration and dialogue. To achieve the level of public support needed for meaningful and sustainable responses to major public health challenges, integrative policy negotiation should become a core public health competency. We have developed a series of hypothetical case-based role plays to practice integrative policy negotiation in the context of public health policy advocacy in a hypothetical country called Countryland. These tools are included as appendices and are free to use and adapt. If every public health professional becomes fluent in integrative policy negotiation, maybe we can look back on 2020 as the year that started a new era of pragmatic protest that finally achieves the enduring public health policy changes that we desperately need.

A framework policy analysis of national health insurance policymaking in sub-Saharan Africa.

National health insurance (NHI) is a financing mechanism established by a national government with the goal of covering all or almost all of its citizens. A number of low- and middle-income countries have established NHIs as part of a strategy to progress towards universal health coverage. The establishment of an NHI presents a potentially significant shift in national health sector governance, but little is available in the literature regarding how policymaking authority and health governance is shared between NHIs and ministries of health (MOHs). To answer this question, we conducted a descriptive, qualitative comparative analysis of policies, including legislation, guidelines and webpages, from four sub-Saharan African countries that have established or are in the process of establishing an NHI scheme as of 2019 (Ghana, Kenya, Zambia and South Africa). We developed a novel conceptual framework comprising 16 NHI policy domains and conducted a deductive review of relevant policies. We then extracted and indexed policy elements according to this framework to facilitate comparative analysis. We found substantial variation across countries in the types of policies developed and the decision-making authority around those policies. MOHs in all four countries retained at least some decision-making power over the NHIs through regulations and appointment of board members. However, NHIs were often delegated policymaking authority in key areas including financing mechanisms, provider payments, member payments, benefit schemes, accreditation and relationships with private health insurance schemes. The results of this analysis illustrate many aspects of health regulatory power and oversight that will need to be defined as part of establishing NHIs. The approaches from these four countries and the conceptual framework presented in this manuscript may be helpful for other countries in evaluating differing approaches to shared health governance between NHIs and MOHs.

Strengthening policy coding methodologies to improve COVID-19 disease modeling and policy responses: a proposed coding framework and recommendations.

BACKGROUND: In recent months, multiple efforts have sought to characterize COVID-19 social distancing policy responses. These efforts have used various coding frameworks, but many have relied on coding methodologies that may not adequately describe the gradient in social distancing policies as states "re-open." METHODS: We developed a COVID-19 social distancing intensity framework that is sufficiently specific and sensitive to capture this gradient. Based on a review of policies from a 12 U.S. state sample, we developed a social distancing intensity framework consisting of 16 domains and intensity scales of 0-5 for each domain. RESULTS: We found that the states with the highest average daily intensity from our sample were Pennsylvania, Washington, Colorado, California, and New Jersey, with Georgia, Florida, Massachusetts, and Texas having the lowest. While some domains (such as restaurants and movie theaters) showed bimodal policy intensity distributions compatible with binary (yes/no) coding, others (such as childcare and religious gatherings) showed broader variability that would be missed without more granular coding. CONCLUSION: This detailed intensity framework reveals the granularity and nuance between social distancing policy responses. Developing standardized approaches for constructing policy taxonomies and coding processes may facilitate more rigorous policy analysis and improve disease modeling efforts.

Strengthening health policy development and management systems in low- and middle- income countries: South Africa's approach.

The development and management of health policies, strategies and guidelines (collectively, policies) in many low- and middle-income countries (LMICs) are often ad hoc and fragmented due to resource constraints a variety of other reasons within ministries of health. The ad hoc nature of these policy processes can undermine the quality of health policy analysis, decision-making and ultimately public health program implementation. To identify potential areas for policy system strengthening, we reviewed the literature to identify potential best practices for ministries and departments of health in LMICs regarding the development and management of health policies. This review led us to identify 34 potential best practices for health policy systems categorized across all five stages of the health policy process. While our review focused on best practices for ministries of health in LMICs, many of these proposed best practices may be applicable to policy processes in high income countries. After presenting these 34 potential best practices, we discuss the potential of operationalizing these potential best practices at ministries of health through the adoption of policy development and management manuals and policy information management systems using the South Africa National Department of Health's experience as an example.

Subcellular targeting is a key condition for high-level accumulation of cellulase protein in transgenic maize seed.

Ethanol from lignocellulosic biomass is being pursued as an alternative to petroleum-based transportation fuels. To succeed in this endeavour, efficient digestion of cellulose into monomeric sugar streams is a key step. Current production systems for cellulase enzymes, i.e. fungi and bacteria, cannot meet the cost and huge volume requirements of this commodity-based industry. Transgenic maize (Zea mays L.) seed containing cellulase protein in embryo tissue, with protein localized to the endoplasmic reticulum, cell wall or vacuole, allows the recovery of commercial amounts of enzyme. E1 cellulase, an endo-beta-1,4-glucanase from Acidothermus cellulolyticus, was recovered at levels greater than 16% total soluble protein (TSP) in single seed. More significantly, cellobiohydrolase I (CBH I), an exocellulase from Trichoderma reesei, also accumulated to levels greater than 16% TSP in single seed, nearly 1000-fold higher than the expression in any other plant reported in the literature. The catalytic domain was the dominant form of E1 that was detected in the endoplasmic reticulum and vacuole, whereas CBH I holoenzyme was present in the cell wall. With one exception, individual transgenic events contained single inserts. Recovery of high levels of enzyme in T2 ears demonstrated that expression is likely to be stable over multiple generations. The enzymes were active in cleaving soluble substrate.

Manganese peroxidase from the white-rot fungus Phanerochaete chrysosporium is enzymatically active and accumulates to high levels in transgenic maize seed.

Manganese peroxidase (MnP) has been implicated in lignin degradation and thus has potential applications in pulp and paper bleaching, enzymatic remediation and the textile industry. Transgenic plants are an emerging protein expression platform that offer many advantages over traditional systems, in particular their potential for large-scale industrial enzyme production. Several plant expression vectors were created to evaluate the accumulation of MnP from the wood-rot fungus Phanerochaete chrysosporium in maize seed. We showed that cell wall targeting yielded full-length MnP, whereas cytoplasmic localization resulted in multiple truncated peroxidase polypeptides as detected by immunoblot analysis. In addition, the use of a seed-preferred promoter dramatically increased the expression levels and reduced the negative effects on plant health. Multiple independent transgenic lines were backcrossed with elite inbred corn lines for several generations with the maintenance of high-level expression, indicating genetic stability of the transgene.