Strengthening regulation for medical products in Tanzania: An assessment of regulatory capacity development, 1978-2020.

Improving medicines regulation can lead to better population health, but how this process works in low- and middle-income countries remains underexplored. Tanzania's pharmaceutical sector is often cited as a successful example of a well-functioning regulatory system in a developing country, attributed to the work of the Tanzania Food and Drugs Authority (TFDA), now the Tanzania Medicines and Medical Devices Authority (TMDA). This raises the question: how was this regulatory capacity developed, and what lessons can other countries learn from Tanzania's experience? This paper analyzes changes in Tanzania's pharmaceutical regulation over three periods of significant sectoral reform. A desk review was conducted of Tanzania's policies, laws, regulations, guidelines, procedures, and institutional reports. The study reveals that Tanzania's regulatory capacity improved significantly through targeted reforms that addressed challenges in key regulatory areas. The three key periods examined are: 1) The separation of medicines regulation from food safety (1978-2003), 2) The expansion of regulatory domains and the establishment of a semi-autonomous regulatory agency (2003-2011), and 3) The expanded role of the Pharmacy Council to include premises regulation (2011-2020). The development of a well-functioning regulatory system in Tanzania resulted from advancements in four key areas: 1) The evolution of a legal regulatory framework, 2) Strong stakeholder engagement, 3) Continuous capacity building, and 4) Effective organizational leadership. Tanzania's regulatory system has evolved from being relatively ineffective to leading regional harmonization efforts in East Africa. This progress was not linear, requiring sustained effort, collaboration, and support from key development partners such as the Global Fund, WHO, and UNDP. Future efforts to enhance regulatory effectiveness should focus on creating adaptive systems that respond to changing needs, rather than solely prescriptive functions.

The Lancet and colonialism: past, present, and future.

The historical and contemporary alignment of medical and health journals with colonial practices needs elucidation. Colonialism, which sought to exploit colonised people and places, was justified by the prejudice that colonised people's ways of knowing and being are inferior to those of the colonisers. Institutions for knowledge production and dissemination, including academic journals, were therefore central to sustaining colonialism and its legacies today. This invited Viewpoint focuses on The Lancet, following its 200th anniversary, and is especially important given the extent of The Lancet's global influence. We illuminate links between The Lancet and colonialism, with examples from the past and present, showing how the journal legitimised and continues to promote specific types of knowers, knowledge, perspectives, and interpretations in health and medicine. The Lancet's role in colonialism is not unique; other institutions and publications across the British empire cooperated with empire-building through colonisation. We therefore propose investigations and raise questions to encourage broader contestation on the practices, audience, positionality, and ownership of journals claiming leadership in global knowledge production.

Coverage and determinants of infant postnatal care in Nigeria: A population-based cross-sectional study.

Importance: In 2019, Nigeria had the largest number of under-5 child deaths globally and many of these deaths occurred within the first week of life. The World Health Organization recommends infant postnatal care (PNC) attendance to support newborn survival; however, utilization of PNC is known to be low in many contexts. Objective: This study examined coverage and individual-level determinants of infant PNC attendance in Nigeria. Methods: Nigeria Demographic Health Survey (NDHS) 2018 data were used to evaluate infant PNC coverage and determinants. Infant PNC was defined as receipt of care within 2 days of birth. Children delivered up to 2 years before the 2018 NDHS were included. We examined predictors of infant PNC with modified Poisson regression models to estimate relative risks (RRs). Results: The national coverage of infant PNC was 37.3% (95% confidence interval [CI]: 35.8%-38.7%). Significant heterogeneity in PNC attendance existed at state and regional levels. Facility delivery was strongly associated with the uptake of PNC (RR: 6.07; 95% CI: 5.60-6.58). Greater maternal education, maternal employment, urban residence, female head of household, and greater wealth were also associated with an increased likelihood of PNC visits. Interpretation: The uptake of infant PNC is low and interventions are urgently needed to promote equity in access and increase demand for PNC in Nigeria.

Equity and gender mainstreaming in public policy: A scoping review protocol.

BACKGROUND: Despite growing attention paid to health equity and efforts to promote gender mainstreaming-a global strategy to promote gender equality-how policymakers have 'institutionalized' this in their work is less clear. Therefore, this planned scoping review seeks to search the peer-reviewed and grey literature to compile evidence on the ways in which policymakers have routinely or systematically considered equity and/or gender in their work. METHODS: A scoping review will be undertaken by drawing on the PRISMA guidelines for Scoping Reviews (PRISMA-ScR). With the expert guidance of a research librarian, Ovid MEDLINE, Ovid EMBASE, PAIS Index, and Scopus databases will be searched, in addition to custom Google searches of government documents. The search will be conducted from 1995 and onwards, as there were no hits prior to this date that included the term "gender mainstream*" in these databases. The inclusion criterion is that: (i) texts must provide information on how equity and/or gender has been considered by government officials in the development of public policy in a routine or systematic manner (e.g., descriptive, empirical); (ii) both texts produced by government or not (e.g., commentary about government action) will be included; (iii) there are no restrictions on study design or article type (i.e., commentaries, reports, and other documents, would all be included); and (iv) texts must be published in English due to resource constraints. However, texts that discuss the work of nongovernmental or intergovernmental organizations will be excluded. Data will be charted by: bibliographic information, including the authors, year, and article title; country the text discussed; and a brief summary on the approach taken. DISCUSSION: This protocol was developed to improve rigour in the study design and to promote transparency by sharing our methods with the broader research community. This protocol will support a scoping review of the ways in which policymakers have routinely or systematically considered equity and/or gender in their work. We will generate findings to inform government efforts to initiate, sustain, and improve gender and equity mainstreaming approaches in policymaking.

Evolution in key indicators of maternal and child health across the wealth gradient in 41 sub-Saharan African countries, 1986-2019.

BACKGROUND: Aggregate trends can be useful for summarizing large amounts of information, but this can obscure important distributional aspects. Some population subgroups can be worse off even as averages climb, for example. Distributional information can identify health inequalities, which is essential to understanding their drivers and possible remedies. METHODS: Using publicly available Demographic and Health Survey (DHS) data from 41 sub-Saharan African countries from 1986 to 2019, we analyzed changes in coverage for eight key maternal and child health indicators: first dose of measles vaccine (MCV1); Diphtheria-Pertussis-Tetanus (DPT) first dose (DPT1); DPT third dose (DPT3); care-seeking for diarrhea, acute respiratory infections (ARI), or fever; skilled birth attendance (SBA); and having four antenatal care (ANC) visits. To evaluate whether coverage diverged or converged over time across the wealth gradient, we computed several dispersion metrics including the coefficient of variation across wealth quintiles. Slopes and 5-year moving averages were computed to identify overall long-term trends. RESULTS: Average coverage increased for all quintiles and indicators, although the range and the speed at which they increased varied widely. There were small changes in the wealth-related gap for SBA, ANC, and fever. The wealth-related gap of vaccination-related indicators (DPT1, DPT3, MCV1) decreased over time. Compared to 2017, the wealth-gap between richest and poorest quintiles in 1995 was 7 percentage points larger for ANC and 17 percentage points larger for measles vaccination. CONCLUSIONS: Maternal and child health indicators show progress, but the distributional effects show differential evolutions in inequalities. Several reasons may explain why countries had smaller wealth-related gap trends in vaccination-related indicators compared to others. In addition to service delivery differences, we hypothesize that the allocation of development assistance for health, the prioritization of vaccine-preventable diseases on the global agenda, and indirect effects of structural adjustment programs on health system-related indicators might have played a role.

Colonisation and its aftermath: reimagining global surgery.

Coloniality in global health manifests as systemic inequalities, not based on merit, that benefit one group at the expense of another. Global surgery seeks to advance equity by inserting surgery into the global health agenda; however, it inherits the biases in global health. As a diverse group of global surgery practitioners, we aimed to examine inequities in global surgery. Using a structured, iterative, group Delphi consensus-building process drawing on the literature and our lived experiences, we identified five categories of non-merit inequalities in global surgery. These include Western epistemology, geographies of inequity, unequal participation, resource extraction, and asymmetric power and control. We observed that global surgery is dominated by Western biomedicine, characterised by the lack of interprofessional and interspecialty collaboration, incorporation of Indigenous medical systems, and social, cultural, and environmental contexts. Global surgery is Western-centric and exclusive, with a unidirectional flow of personnel from the Global North to the Global South. There is unequal participation by location (Global South), gender (female), specialty (obstetrics and anaesthesia) and profession ('non-specialists', non-clinicians, patients and communities). Benefits, such as funding, authorship and education, mostly flow towards the Global North. Institutions in the Global North have disproportionate control over priority setting, knowledge production, funding and standards creation. This naturalises inequities and masks upstream resource extraction. Guided by these five categories, we concluded that shifting global surgery towards equity entails building inclusive, pluralist, polycentric models of surgical care by providers who represent the community, with resource controlled and governance driven by communities in each setting.

Where Is Equity in HiAP? Comment on "A Realist Explanatory Case Study Investigating How Common Goals, Leadership, and Committed Staff Facilitate Health in All Policies Implementation in the Municipality of Kuopio, Finland".

Health equity is no longer a central feature of Health in All Policies (HiAP) approaches despite its presence in select definitions of HiAP. In other words, HiAP is not just about considering health, but also health equity. But as HiAP has become more mainstream, its success around health equity has been muted and largely non-existent. Given the normative underpinning and centrality of equity in HiAP, equity should be better considered in HiAP and particularly when considering what 'successful' implementation may look like. Raising health on the radar of policy-makers is not mutually exclusive from considering equity. Taking an incremental approach to considering equity in HiAP can yield positive results. This article discusses these ideas and presents potential actions to restore HiAP's once central equity objectives, which include: seeking synergies focused on health equity with those who hold different convictions, both in terms of goals and measures of success; considering the conditions that allow HiAP to be fostered, such as good governance; and drawing on research on HiAP and other multisectoral approaches.

Conceptual approaches in combating health inequity: A scoping review protocol.

INTRODUCTION: What are the different ways in which health equity can be sought through policy and programs? Although there is a central focus on health equity in global and public health, we recognize that stakeholders can understand health equity as taking different approaches and that there is not a single conceptual approach. However, information on conceptual categories of actions to improve health equity and/or reduce health inequity is scarce. Therefore, this study asks the research question: "what conceptual approaches exist in striving for health equity and/or reducing health inequity?" with the aim of presenting a comprehensive overview of approaches. METHODS: A scoping review will be undertaken following the PRISMA guidelines for Scoping Reviews (PRISMA-ScR) and in consultation with a research librarian. Both the peer-reviewed and grey literatures will be searched using: Ovid MEDLINE, Scopus, PAIS Index (ProQuest), JSTOR, Canadian Public Documents Collection, the World Health Organization IRIS (Institutional Repository for Information Sharing), and supplemented by a Google Advanced Search. Screening will be conducted by two independent reviewers and data will be charted, coded, and narratively synthesized. DISCUSSION: We anticipate developing a foundational document compiling categories of approaches and discussing the nuances inherent in each conceptualization to promote clarified and united action.

Probing key informants' views of health equity within the World Health Organization's Urban HEART initiative.

To date, no studies have assessed how those involved in the World Health Organization's (WHO) work understand the concept of health equity. To fill the gap, this research poses the question, "how do Urban Health Equity Assessment and Response Tool (Urban HEART) key informants understand the concept of health equity?", with Urban HEART being selected given the focus on health equity. To answer this question, this study undertakes synchronous electronic interviews with key informants to assess how they understand health equity within the context of Urban HEART. Key findings demonstrate that: (i) equity is seen as a core value and inequities were understood to be avoidable, systematic, unnecessary, and unfair; (ii) there was a questionable acceptance of need to act, given that political sensitivity arose around acknowledging inequities as "unnecessary"; (iii) despite this broader understanding of the key aspects of health inequity, the concept of health equity was seen as vague; (iv) the recognized vagueness inherent in the concept of health equity may be due to various factors including country differences; (v) how the terms "health inequity" and "health inequality" were used varied drastically; and (vi) when speaking about equity, a wide range of aspects emerged. Moving forward, it would be important to establish a shared understanding across key terms and seek clarification, prior to any global health initiatives, whether explicitly focused on health equity or not.

Assessing the World Health Organization: What does the academic debate reveal and is it democratic?

The World Health Organization (WHO), the leading global authority in public health, routinely attracts loud calls for reform. Although Member States negotiate reform internally, academic debate is more public, and can generate ideas and provide independent accountability. We investigate why authors advocate for WHO reform so commonly. We wondered if this literature had potentially useful themes for WHO, what methods and evidence were used, and we wanted to analyze the geography of participation. We conducted a systematic review using four databases to identify 139 articles assessing WHO or advocating for reform. We discuss these using categories we derived from the management literature on organizational performance. We also analyzed evidence, country of origin, and topic. The literature we reviewed contained 998 claims about WHO's performance or reform, although there were no standard methods for assessing WHO. We developed a framework to analyze WHO's performance and structure a synthesis of the claims, which find WHO imperiled. Its legitimacy and governance are weakened by disagreements about purpose, unequal Member State influence, and inadequate accountability. Contestation of goals and strategies constrain planning. Structure and workforce deficiencies limit coordination, agility, and competence. WHO has technical and normative authority, but insufficient independence and legal power to influence uncooperative states. WHO's identity claims transparency, independence, and courage, but these aspirations are betrayed in times of need. Most articles (88%) were commentaries without specified methods. More than three-quarters (76%) originated from the US, the UK, or Switzerland. A quarter of papers (25%) focused on international infectious disease outbreaks, and another 25% advocated for WHO reform generally. Many criticisms cite wide-ranging performance problems, some of which may relate to obstructive behavior by Member States. This literature is incomplete in the geographic representation of authors, evidence, methods, and topics. We offer ideas for developing more rigorous and inclusive academic debate on WHO.

Evaluating healthy cities: A scoping review protocol.

BACKGROUND: The Healthy Cities project supports municipal policymakers in the struggle to safeguard the health of urban citizens around the world (and in other limited geographies such as islands). Although Healthy Cities has been implemented in thousands of settings, no synthesis of implementation experiences have been conducted. In this article, we develop a scoping review protocol that can be applied to collect evidence on process evaluations of Healthy Cities. METHODS: To develop a scoping review protocol that could identify experiences evaluating the Healthy Cities project, we followed the PRISMA guidelines for Scoping Reviews (PRISMA-ScR). We applied these guidelines in consultation with a research librarian to design a search of the peer-reviewed literature, specifically Ovid Medline, Ovid Embase, Web of Science Core Collection, and Scopus databases, and a grey literature search. DISCUSSION: In addition to the aim of collecting evidence on Healthy Cities process evaluation experiences, the broader goal is to spark discussions and inform future evaluations of Healthy Cities. This work can also inform other evaluations of initiatives seeking to raise socio-political change, such as those focused on enhancing intersectoral and multisectoral action.

Colonialism, malaria, and the decolonization of global health.

This paper explores the decolonization of global health through a focus on malaria and European colonialism in Africa. We employ an historical perspective to better articulate what "colonial" means and to specify in greater detail how colonial ideas, patterns, and practices remain an obstacle to progress in global health now. This paper presents a history of malaria, a defining aspect of the colonial project. Through detailed analysis of the past, we recount how malaria became a colonial problem, how malaria control rose to prominence as a colonial activity, and how interest in malaria was harnessed to create the first schools of tropical medicine and the academic specialization now known as global health. We discuss how these historical experiences shape malaria policy around the world today. The objective of this paper is to advance discussion about how malaria and other aspects of global health could be decolonized, and to suggest directions for future analysis that can lead to concrete steps for action.

Interrogating the World Bank's role in global health knowledge production, governance, and finance.

BACKGROUND: In the nearly half century since it began lending for population projects, the World Bank has become one of the largest financiers of global health projects and programs, a powerful voice in shaping health agendas in global governance spaces, and a mass producer of evidentiary knowledge for its preferred global health interventions. How can social scientists interrogate the role of the World Bank in shaping 'global health' in the current era? MAIN BODY: As a group of historians, social scientists, and public health officials with experience studying the effects of the institution's investment in health, we identify three challenges to this research. First, a future research agenda requires recognizing that the Bank is not a monolith, but rather has distinct inter-organizational groups that have shaped investment and discourse in complicated, and sometimes contradictory, ways. Second, we must consider how its influence on health policy and investment has changed significantly over time. Third, we must analyze its modes of engagement with other institutions within the global health landscape, and with the private sector. The unique relationships between Bank entities and countries that shape health policy, and the Bank's position as a center of research, permit it to have a formative influence on health economics as applied to international development. Addressing these challenges, we propose a future research agenda for the Bank's influence on global health through three overlapping objects of and domains for study: knowledge-based (shaping health policy knowledge), governance-based (shaping health governance), and finance-based (shaping health financing). We provide a review of case studies in each of these categories to inform this research agenda. CONCLUSIONS: As the COVID-19 pandemic continues to rage, and as state and non-state actors work to build more inclusive and robust health systems around the world, it is more important than ever to consider how to best document and analyze the impacts of Bank's financial and technical investments in the Global South.

When Do Governments Support Common Goods for Health? Four Cases on Surveillance, Traffic Congestion, Road Safety, and Air Pollution.

Common goods such as air, water, climate, and other resources shared by all humanity are under increasing pressure from growing population and advancing globalization of the world economy. Safeguarding these resources is generally considered a government responsibility, as common goods are vulnerable to market failure. However, governments do not always fulfill this role, and face many challenges in doing so. This observation-that governments only sometimes address common goods problems-informs the central question of this paper: when do governments act in support of common goods? We structure our inquiry using a framework derived from three theories of agenda setting, emphasizing problem perception, the role of actors and collective action patterns, strategies and policies, and catalyzing circumstances. We used a poll of experts to identify important common goods for health: disease surveillance, environmental protection, and accountability. We then chose four historical cases for analysis: the establishment of the Epidemic Intelligence Service in the US, transport planning in London, road safety in Argentina, and air quality control in urban India. Our analysis of the collective evidence of these cases suggests that decisions to advance government action on common goods require a concisely articulated problem, a well-defined strategy for addressing the problem, and leadership backed by at least a few important groups willing to cooperate. Our cases reveal a variety of collective action patterns, suggesting that there are many routes to success. We consider that the timing of an intervention in support of common goods depends on favorable circumstances, which can include a catalyzing event but does not necessarily require one.