Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market

BackgroundAntimicrobial resistance (AMR) is increasing worldwide, undermining strides in public health and the economy, particularly in low- and middle-income countries. Africa is the continent with the highest death rate attributed to antimicrobial-resistant infections. There is a lack of information on AMR mitigation strategies and their implementation in the region. The aim of this study was to analyze national strategies to tackle AMR with focus on AMR surveillance in the East African Community (EAC) and their implementation status including the analysis of strengths, weaknesses, opportunities, and threats.MethodsWithin our expert group (composed of representatives from the National Public Health Laboratories (NPHL), Ministries of Health of Burundi, Kenya, Rwanda, South Sudan, Tanzania, and Uganda) we used a qualitative approach to analyze AMR National Action Plans (NAPs), AMR surveillance programs, publications and reports on the AMR situation and strategies in the EAC. Results: We found varying levels of implementation of antimicrobial resistance (AMR) strategies among East African Community (EAC) Partner States. For example, progress in key steps for the sustainable implementation of National Action Plans on AMR (AMR-NAPs) ranged from 7% in Burundi to 94% in Kenya. The overall accomplishment of the WHO checklist for AMR surveillance also varied: 44% in South Sudan, 61% in Burundi, 89% in Rwanda, 94% in Tanzania, and 100% in both Uganda and Kenya. Within EAC Partner States, the detection of bacterial pathogens and their antimicrobial susceptibility profiles is coordinated by national reference laboratories. Most EAC countries have established AMR surveillance systems. However, challenges such as limited laboratory testing capacity, low representativeness of surveillance data, lack of integration among existing systems, and financial constraints undermine efforts to curb AMR.ConclusionsRegional collaboration among EAC Partner States is essential for an effective and sustainable response to antimicrobial resistance. Strengthening joint efforts will enable countries to share resources, harmonize surveillance systems, and address common challenges more efficiently. The EAC Regional Network of Reference Laboratories is one example of a regional mechanism that can support such collaboration. The findings of this study will inform the development of a regional AMR strategy focused on laboratory-based surveillance and help guide the prioritization of technical and financial support across the EAC region.Supplementary InformationThe online version contains supplementary material available at 10.1186/s13756-025-01662-y.

The relation between the East African Community (EAC) and the European Union (EU) has so far contributed towards the economic development of both regions. However, on the issues of trade, technical assistance and foreign aid, the relationship has not always been symbiotic. The EAC has heavily relied on EU funding and technical expertise to support it programmes. Out of 112,984,442 million USD, the EAC budget for 2024/2025, 61% of the funding comes from partners with the EU doing the heaviest financial lifting of 30%. In 2023/2024 budget, the EU cushioned the EAC budget with 40% technical budgetary support and in 2022/2023 budget, the EU contributed 50% support. Of the budgetary and programmes support, the EU has dictated the appropriation of the EAC budget. Large chunks of money have been going to line items compatible with the EU foreign policy. Although the EU is the main trade partner of the EAC, the relation has been quite dependent. This paper argues that the EAC bloc is quite parasitic in its relations with the EU. Because of this parasitic relationship, the EU has dictated the programmes of the EAC secretariat in leitmotif of “he who pays the piper, dictates the tune”. Although some EAC partner states and the EU member states have inked Economic Partnership Agreements (EPAs), the EAC is yet to fully liberalize its markets, meets the standards requirements of goods, improve on governance and human rights. Instead of implementing EPAs requirements, the EAC has been relying on the EU handouts. This relation has been off balance and set the EAC in a weaker position. For EU-EAC relations to be symbiotic and of equal benefits to both regions, EAC partner states have a caveat to improve on governance, human rights, and adherence to EPAs. Above all, the EAC should begin to delink itself from heavily reliance on EU funding for its programmes and projects and entirely fund these programmes and projects from partner states. This paper used elite interviews and secondary sources to understand the relationship between the EAC and the EU. It combines processing tracing, case study and comparative methods to contextualize and validate causal chains and casual processes. Furthermore, the paper theorizes regional integration and constructs the concept of the parasitic bloc to depict EAC-EU relations. Finally, it draws conclusion and recommends direction of future research.

IntroductionIn 2019, the East African Community (EAC) lost 12,048,918 disability-adjusted life-years (DALY) across all ages from neglected tropical diseases (NTDs). The specific objectives of the study reported in the paper were to estimate for EAC the monetary value of DALYs sustained by all ages from NTDs, and the potential productivity losses within the working age bracket of 15 years and above.MethodsThe EAC total monetary value of DALYs left({TMV{D_{EAC}}} right) lost from all 20 NTDs is the sum of each partner state’s monetary value of DALYs lost from all 20 NTDs. The ith partner state’s monetary value of DALY from jth disease equals ith state’s GDP per capita net of current health expenditure multiplied by DALYs lost from jth disease in 2019. The EAC total productivity losses left({TEP{L_{EAC}}} right) attributable to DALYs lost from all 20 NTDs is the sum of lost productivity across the seven partner states. The ith partner state’s productivity loss associated with jth disease equals ith state’s GDP per capita net of current health expenditure multiplied by DALYs lost from jth disease and the ith state’s labour force participation rate adjusted for underutilization (unemployment and time-related underemployment) in 2019.ResultsThe total 12,048,918 DALYs lost in EAC from NTDs had a TMV{D_{EAC}} of International Dollars (Int$) 21,824,211,076 and an average of Int$ 1811 per DALY. The 2,614,464 DALYs lost from NTD among 15-year-olds and above caused an estimated TEP{L_{EAC}} of Int$ 2,588,601,097 (0.392% of the EAC gross domestic product in 2019), and an average of Int$ 990.1 per DALY.ConclusionThe study succeeded in estimating the monetary value of DALYs sustained by all ages from 20 NTDs, and the potential productivity losses within the working age bracket of 15 years and above in the seven EAC partner states. The DALYs lost from NTD among 15-year-olds and above caused a sizeable loss in the economic productivity of EAC.

BackgroundMedical devices and in vitro diagnostic tests (IVD) are vital components of health delivery systems but access to these important tools is often limited in Africa. The regulation of health commodities by National Regulatory Authorities is intended to ensure their safety and quality whilst ensuring timely access to beneficial new products. Streamlining and harmonizing regulatory processes may reduce delays and unnecessary expense and improve access to new products. Whereas pharmaceutical products are widely regulated less attention has been placed on the regulation of other health products. A study was undertaken to assess regulation of medical diagnostics and medical devices across Partner States of the East African Community (EAC).MethodsData was collected during October 2012 through desk based review of documents and field research, including face to face interviews with the assistance of a structured questionnaire with closed and open ended questions. Key areas addressed were (i) existence and role of National Regulatory Authorities; (ii) policy and legal framework for regulation; (iii) premarket control; (iv) marketing controls; (v) post-marketing control and vigilance; (vi) country capacity for regulation; (vii) country capacity for evaluation studies for IVD and (viii) priorities and capacity building for harmonization in EAC Partner States.ResultsControl of medical devices and IVDs in EAC Partner States is largely confined to national disease programmes such as tuberculosis, HIV and malaria. National Regulatory Authorities for pharmaceutical products do not have the capacity to regulate medical devices and in some countries laboratory based organisations are mandated to ensure quality of products used. Some activities to evaluate IVDs are performed in research laboratories but post market surveillance is rare. Training in key areas is considered essential to strengthening regulatory capacity for IVDs and other medical devices.ConclusionsRegulation of medical devices and in vitro diagnostics has been neglected in EAC Partner States. Regulation is weak across the region, and although the majority of States have a legal mandate to regulate medical devices there is limited capacity to do so. Streamlining regulation in the EAC is seen as a positive aspiration with diagnostic tests considered a priority area for harmonisation.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-014-0524-2) contains supplementary material, which is available to authorized users.

Analysis of the Republic of South Sudan's Assession to the East African Community: Benefits, Detriments and Recommendations

The East African Community (EAC) is a regional integration project working towards the formation of a political federation. As a grouping of developing states, most EAC Partner States have legislated their own general anti-avoidance rules (GAARs) as a means to prevent base erosion and profit shifting. This article argues that the EAC federation, once formed, should continue this practice and legislate its own GAAR to protect its corporate tax base – one of the most important tax bases for African countries. This article further proposes a GAAR for the EAC that builds on the existing GAARs in the EAC Partner States and draws from international best practice through a comparative analysis of the GAARs in the EU Anti-Tax Avoidance Directive, the Income Tax Act in Canada and the Income Tax Act in South Africa. In so doing, the author proposes a GAAR for the EAC that is in keeping with international developments while adapting such developments to the EAC context.

The paper examines the comparative advantage of Uganda’s exports to the East African Community (EAC) partner states, and how it has evolved during the implementation of the EAC treaty. In addition, the paper seeks to identify commodities that Uganda should specialize in as a basis to enhance the ability to benefit from the special preferential treatment extended to Uganda by China. The paper applies various indices in the measurement of Uganda’s Revealed Comparative Advantage (RCA) on all products at Harmonised System (HS4)-digit product levels. The HS4-digit product level data was obtained from World Integrated Trade Solution (WITS) UNCTAD COMTRADE database. The empirical evidence of Uganda’s comparative advantage in this context is largely dependent on the individual country under consideration. However, it is evident that Uganda’s list of commodities for exports to the EAC partner states is rapidly expanding and the RCA has increased especially during the implementation of the Customs Union. This is plausibly explained by the removal of internal tariffs along Uganda’s borders with the EAC partner countries and the adoption of a common external tariff. The paper therefore recommends that the identified list of commodities with RCA should be the basis for strategically informing the Uganda industrialization strategy within the context of further EAC integration. Uganda has RCA in only 234 product lines from the list of 4,401 HS 6-digit level disaggregation, suggesting that Uganda will minimally benefit on the basis of revealed comparative advantage. As an alternative, Uganda should explore policy options that could address supply constraints in a bid to increase the range of products Uganda could export to China, as well as the regional Partner States.

In response to the largest recorded monkeypox virus outbreak outside of endemic Central and Western Africa, the East African Community (EAC), in cooperation with the Bernhard-Nocht- Institute for Tropical Medicine, coordinated an emergency monkeypox diagnostic training for the East African Region. As of June 2022, the Democratic Republic of Congo reported a steady increase of suspected monkeypox cases, increasing the risk of spill-over into the remaining six EAC Partner States. Within the existing EAC Mobile Laboratories project, laboratory experts of the National Public Health Laboratories of the remaining six EAC Partner States (Burundi, Rwanda, Tanzania, Kenya, Uganda, and South Sudan) participated in the workshop and were trained in the reception of suspect samples, DNA extraction and diagnosis using real-time polymerase chain reaction (RT-PCR). The EAC region is now equipped with the tools to prepare and rapidly respond to any emerging monkeypox outbreak.

The East African Community partner states aim to establish a Monetary Union by 2023. As advanced by the optimum currency area theory, countries seeking to enter into a monetary union should be as similar as possible to reduce their susceptibility to adverse economic shocks. The East African Monetary Union Protocol signed in 2013 stresses the need for convergence of macroeconomic variables as important preconditions before forming the monetary union. The benchmark macroeconomic indicators include a headline inflation rate of eight per cent, a fiscal deficit of three per cent of the country’s gross domestic product on net present value terms, a debt to gross domestic product ratio of 50 per cent and maintenance of a 4.5 months’ reserves of import cover. Article 82 (1) of the East African Community Treaty also compels partner states to work towards harmonizing their macro-economic policies especially those related to interest and exchange rates, fiscal and monetary policies. However, as argued by many scholars, nominal convergence alone cannot indicate how well countries will perform once they are in a monetary union. The criteria also fail to distinguish the countries that constitute an optimal currency area. An autoregressive distributed model was applied in regression analysis. Empirical findings supported the presence of conditional convergence and that per capita gross domestic product growth was positively influenced by physical capital and nominal exchange rate depreciation and negatively affected by human capital and inflation rate. From the foregoing, it can be concluded that reduction of income differences among the partner states can be fostered through increased investments in physical capital, maintenance of a competitive exchange rate regime and a low inflation rate regime. Keywords: Unconditional convergence, conditional convergence, Solow model, optimum currency areas and autoregressive redistributed lag model

The East African Community (EAC) is working towards establishing deeper integration between its six partner states. The EAC partner states are: Burundi, Kenya, Rwanda, South Sudan, Tanzania and Uganda. This paper analyses the lessons the European Union may offer the EAC in guarding against base erosion and profit shifting while implementing its integration project. Corporate tax and VAT have been identified as the two tax bases most at risk. This paper analyses the steps taken by the European Union to protect its corporate tax and VAT bases, and draws from the European Union’s proposed Common Consolidated Corporate Tax Base and its VAT harmonization efforts to recommend best practices for the EAC.

The East African Community (EAC) has been facing challenges in ensuring access to affordable and quality-assured medicines. To address these problems, the EAC Partner States have been working on implementing an inter-country pooled procurement mechanism since 2005. However, with limited progress to date. The aims of this study were to explore how the EAC pooled procurement mechanism has been developing over time, and to clarify the work and efforts made during this development process to draw lessons for enhancing such collaborative efforts. For this study, we carried out a multi-method qualitative case study. We used the Pooled Procurement Guidance to collect and structure our data drawn from academic papers, grey literature documents, observations and field notes. For the analysis, we used an inductive thematic analysis approach. Over the past two decades of the EAC's pooled procurement journey, we have identified two developmental stages so far: the promise stage and the creation stage. The promise stage was characterised by initial engagement and alignment efforts between Partner States. However, the lack of dedicated funding and ownership to drive the project forward led to stagnation of the process for some years. Following the establishment of a dedicated organisation, the pooled procurement mechanism entered the creation stage. This stage has been characterised by continuous alignment work consisting of project management, efforts to build inter-personal relationships, and facilitation of negotiations to harmonise goals, needs and operations. This process has been aided by broad and recurring involvement of regional experts. To successfully implement a pooled procurement mechanism, we suggest EAC Partner States to continue their alignment efforts, sustain political will and allocate sustainable funding using a phased implementation approach towards pooled procurement.

The purpose of this paper is to examine the influence of trade infrastructure components: port infrastructure, telephone usage and electricity on the export competitiveness of firms in the East African Community (EAC). The study adopted the structural gravity model and the Poisson Pseudo Maximum Likelihood (PPML), a nonlinear estimation method that was applied in STATA on balanced panel data for the period of 2007 to 2018. Data was obtained from World Bank International Trade Centre (ITC) and World Bank development indicators. Results show that telephone usage, electricity and port infrastructure are positive and significant predictors of export competitiveness in East African Community partner states. The results of this study show that electricity usage, telephone usage and port infrastructure are important contributors to improving export competitiveness in the EAC. There is a need to examine the intricate nature of the EAC economy in order to further this study’s findings. The EAC partner states need to embrace deep integration by removing the behind-the-border trade barriers, in addition to other trade restrictions, to create a common economic space among member states. This will further shrink the delivery time and the tracking and tracing of exports hence improving the competitiveness of EAC exports within the region and outside. Also, common and harmonized economic policies and regulations can be implemented through mutual recognition agreements where countries agree to recognize one another’s conformity assessments.

The East African Community (EAC) grapples with many challenges in tackling infectious disease threats and antimicrobial resistance (AMR), underscoring the importance of regional and robust pathogen genomics capacities. However, a significant disparity exists among EAC Partner States in harnessing bacterial pathogen sequencing and data analysis capabilities for effective AMR surveillance and outbreak response. This study assesses the current landscape and challenges associated with pathogen next-generation sequencing (NGS) within EAC, explicitly focusing on World Health Organization (WHO) AMR-priority pathogens. The assessment adopts a comprehensive approach, integrating a questionnaire-based survey amongst National Public Health Laboratories (NPHLs) with an analysis of publicly available metadata on bacterial pathogens isolated in the EAC countries. In addition to the heavy reliance on third-party organizations for bacterial NGS, the findings reveal a significant disparity among EAC member States in leveraging bacterial pathogen sequencing and data analysis. Approximately 97% (n = 4,462) of publicly available high-quality bacterial genome assemblies of samples collected in the EAC were processed and analyzed by external organizations, mainly in Europe and North America. Tanzania led in-country sequencing efforts, followed by Kenya and Uganda. The other EAC countries had no publicly available samples or had all their samples sequenced and analyzed outside the region. Insufficient local NGS sequencing facilities, limited bioinformatics expertise, lack of adequate computing resources, and inadequate data-sharing mechanisms are among the most pressing challenges that hinder the EAC’s NPHLs from effectively leveraging pathogen genomics data. These insights emphasized the need to strengthen microbial pathogen sequencing and data analysis capabilities within the EAC to empower these laboratories to conduct pathogen sequencing and data analysis independently. Substantial investments in equipment, technology, and capacity-building initiatives are crucial for supporting regional preparedness against infectious disease outbreaks and mitigating the impact of AMR burden. In addition, collaborative efforts should be developed to narrow the gap, remedy regional imbalances, and harmonize NGS data standards. Supporting regional collaboration, strengthening in-country genomics capabilities, and investing in long-term training programs will ultimately improve pathogen data generation and foster a robust NGS-driven AMR surveillance and outbreak response in the EAC, thereby supporting global health initiatives.

With the access-to-medicines conundrum facing its populations, the East African Community has adopted a policy framework which promotes a collective approach to resolving the access gap in the region. To this end, crucial policy documents on the implementation of TRIPS obligations, harmonisation of drug regulation and boosting regional manufacturing capacity have been adopted. This paper is a case study of the regional policy on the implementation of TRIPS obligations, specifically examining the extent to which partner states’ implementation of TRIPS obligations mirrors the regional recommendations. The paper finds that, while many partner states follow the regional recommendations on implementing TRIPS obligations, coherence remains a big challenge. This, the paper concludes, may affect the overall usefulness of a regional approach to solving the access conundrum.

Significant progress has been made by the East African Community partner states in implementing the East African Community customs union. Trade within the East African Community is now free from import duties, and partner states have adopted a three-band common external tariff. This chapter assesses how the customs union has supported intra-regional trade, competitiveness, and industrialization, in particular through the development of smokestack-free industries. It concludes that regional integration has provided a supportive environment for the development of competitive smokestack-free industries and exports, but significant opportunities still exist within the region. Recommendations are provided on what policy measures should be taken to harness these opportunities.