Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

One of the definitions states that regionalism means a common policy or project aimed at increasing informal links and economic, political and social transactions which strengthen integration processes, intensify intergovernmental cooperation and create regional identity among the community. According to the above, it was assumed that firstly, states in a group are stronger and more effective and secondly, that regionalism and regionalization may be regarded as a way to solve some regional problems and to contribute to the development of individual states. This narrative became especially attractive for underdeveloped and dysfunctional regions as it offered an opportunity for changes. As a result, a quantitative increase in regional initiatives started. The article is dedicated to the integration processes in the East Africa region. The main aim of the paper is to examine the situation in East Africa, regarding the role that the East African Community has played in this area. Moreover, an attempt has been made to analyze the integration model adopted by the organization and find out if the EAC is able to solve the main regional problems or rather to propose a failed solution and maintain dysfunctional patterns in the organization.

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Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

10.21203/rs.3.rs-35630/v3 ◽

2020 ◽

Author(s):

Margareth Ndomondo-Sigonda ◽

Jacqueline Miot ◽

Shan Naidoo ◽

Nelson Enos Masota ◽

Brian Ng'andu ◽

...

Keyword(s):

Public Health ◽

Monitoring And Evaluation ◽

Good Manufacturing Practice ◽

Structured Interviews ◽

East African ◽

East African Community ◽

Medical Products ◽

Inspection Systems ◽

African Community ◽

Regulatory Harmonization

Abstract Background: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods: An exploratory mixed-method design using both qualitative and quantitative data, was employed. Data was collected from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat through a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 whereas 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer. A set of 14 indicators grouped into 6 categories were used to measure NMRAs performance. Results: Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification.Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

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East Africa politics mars region's crisis role

Emerald Expert Briefings ◽

10.1108/oxan-db200233 ◽

2015 ◽

Keyword(s):

Food Security ◽

Supply Chains ◽

East Africa ◽

Political Crisis ◽

The Political ◽

East African ◽

Content Type ◽

East African Community ◽

African Community ◽

Step Down

Significance Opposition parties reject the new dates, stating that their main demand is for Nkurunziza to step down before polls take place. The new dates adhere to East African Community (EAC) recommendations to delay elections. While the regional bloc may have more influence over Burundi than other external players, it will struggle to play an effective diplomatic role in ending the political crisis. Impacts A prolonged crisis will worsen a poorly performing economy, which is heavily dependent on foreign support. Belgium, the largest donor, may cut further bilateral support should Nkurunziza secure a third mandate. Economic disruption continues to hurt agricultural supply chains across the country, risking food security.

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Regionalism and Regional Politics of African States (on the Example of the Countries of the East African Community)

Izvestiya of Altai State University ◽

10.14258/izvasu(2021)5-12 ◽

2021 ◽

pp. 78-82

Author(s):

V.R. Filippov

Keyword(s):

East Africa ◽

Federal State ◽

Regional Politics ◽

East African ◽

African Countries ◽

East African Community ◽

Post Colonial ◽

Economic Association ◽

African Community ◽

High Level

The subject of the study was the East African Commonwealth, an economic association that currently unites Kenya, Tanzania, Uganda, Burundi, Rwanda and Southern Sudan. Particular attention is paid to the integration processes in Africa in the post-colonial period, the doctrine of federalism in the political discourse of African countries, the causes of the crisis and the dissolution of the EAC in the seventies of the last century, as well as the economic and political reasons for reintegration of YOU. Special attention is paid to the evolution of the EAC from an economic alliance to a political one and the prospect of forming a federative state on the basis of the SAC. The author identifies the factors that led to the economic consolidation of the EAC, as well as those determinants of development of the commonwealth, which make it extremely difficult to form a unified federal state in East Africa. It is concluded that the further regionalization of the African continent and the realization of the federal project in East Africa will be hindered by such factors as the high level of conflict in the EAC member countries, tribalism, cultural, confessional and linguistic heterogeneity, and the ambition of leaders and political elites.

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Harmonization of medical products regulation: a key factor for improving regulatory capacity in the East African Community

BMC Public Health ◽

10.1186/s12889-021-10169-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Margareth Ndomondo-Sigonda ◽

Jacqueline Miot ◽

Shan Naidoo ◽

Nelson E. Masota ◽

Brian Ng’andu ◽

...

Keyword(s):

Public Health ◽

Monitoring And Evaluation ◽

Good Manufacturing Practice ◽

Structured Interviews ◽

East African ◽

East African Community ◽

Medical Products ◽

Inspection Systems ◽

African Community ◽

Regulatory Harmonization

Abstract Background Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11–2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance. Results Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification. Conclusions The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

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Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

10.21203/rs.3.rs-35630/v5 ◽

2020 ◽

Author(s):

Margareth Ndomondo-Sigonda ◽

Jacqueline Miot ◽

Shan Naidoo ◽

Nelson Enos Masota ◽

Brian Ng'andu ◽

...

Keyword(s):

Public Health ◽

Monitoring And Evaluation ◽

Good Manufacturing Practice ◽

Structured Interviews ◽

East African ◽

East African Community ◽

Medical Products ◽

Inspection Systems ◽

African Community ◽

Regulatory Harmonization

Abstract Background: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods: An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance. Results: Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification.Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

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Commentary: mobile laboratories for SARS-CoV-2 diagnostics: what Europe could learn from the East African Community to assure trade in times of border closures

Globalization and Health ◽

10.1186/s12992-021-00700-9 ◽

2021 ◽

Vol 17 (1) ◽

Author(s):

Florian Gehre ◽

Hakim Lagu ◽

Emmanuel Achol ◽

Michael Katende ◽

Jürgen May ◽

...

Keyword(s):

Public Health ◽

East Africa ◽

Economic Losses ◽

Main Body ◽

Mobile Laboratory ◽

East African ◽

East African Community ◽

Laboratory Network ◽

National Public Health ◽

African Community

Abstract Background The emergence of SARS-CoV-2 mutants might lead to European border closures, which impact on trade and result in serious economic losses. In April 2020, similar border closures were observed during the first SARS-CoV-2 wave in East Africa. Main body Since 2017 the East African Community EAC together with the Bernhard-Nocht-Institute for Tropical Medicine BNITM established a mobile laboratory network integrated into the National Public Health Laboratories of the six Partner States for molecular diagnosis of viral haemorrhagic fevers and SARS-CoV-2. Since May 2020, the National Public Health Laboratories of Kenya, Rwanda, Burundi, Uganda and South Sudan deployed these mobile laboratories to their respective borders, issuing a newly developed “Electronic EAC COVID-19 Digital Certificate” to SARS-CoV-2 PCR-negative truck drivers, thus assuring regional trade. Conclusion Considering the large financial damages of border closures, such a mobile laboratory network as demonstrated in East Africa is cost-effective, easy to implement and feasible. The East African Community mobile laboratory network could serve as a blueprint for Europe and other countries around the globe.

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Focus on psychiatry in East Africa

The British Journal of Psychiatry ◽

10.1192/bjp.181.4.354 ◽

2002 ◽

Vol 181 (4) ◽

pp. 354-359 ◽

Cited By ~ 24

Author(s):

Frank Njenga

Keyword(s):

East Africa ◽

British Empire ◽

Political Integration ◽

Customs Union ◽

East African ◽

East African Community ◽

African Community ◽

Economic Reality ◽

Court Of Appeal ◽

Legislative Assembly

East Africa is made up of Kenya, Uganda and Tanzania, all previous colonies of the British Empire which attained their independence in the early 1960s. At the time of independence, the East African community held the three countries together. Political expedience broke up the community in 1977 but greater wisdom and economic reality have brought the three countries back together in December 2001, in the form of a common Legislative Assembly and Court of Appeal. A Customs Union is expected soon, ahead of full political integration.

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History of regional integration in East Africa: the case of East African Community

OOO Zhurnal Voprosy Istorii ◽

10.31166/voprosyistorii202005statyi13 ◽

2020 ◽

Vol 2020 (05) ◽

pp. 119-128

Author(s):

Claire Ayuma Amuhaya ◽

Brian Mugabe ◽

Augustin Ndayisaba

Keyword(s):

East Africa ◽

Regional Integration ◽

East African ◽

East African Community ◽

History Of ◽

African Community

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Prospects for free movement in the East African Community

Regions & Cohesion ◽

10.3167/reco.2013.030306 ◽

2013 ◽

Vol 3 (3) ◽

pp. 103-122 ◽

Cited By ~ 1

Author(s):

John Oucho

Keyword(s):

East Africa ◽

Regional Integration ◽

Migration Policy ◽

Common Market ◽

Free Movement ◽

East African ◽

East African Community ◽

African Community ◽

Afrique Australe ◽

Afrique De L’Est

This article traces the evolution of regional integration in East Africa, discussing its nature, scope, triumphs, and challenges. It reviews the Protocol on the Establishment of the East African Community Common Market (PEEACCM), which develops aspects of free movement policy that were implicit in earlier editions of the EAC regional integration. The article then addresses the several challenges that exist to free movement in the EAC as it endeavors to usher in the larger Southern and East Africa COMESA–EAC–SADC Tripartite Agreement and even wider continental-level coordination. It concludes that a managed migration policy rather than free movement might be more appropriate. Spanish Este artículo traza la evolución de la integración regional en África del Este, discutiendo su naturaleza, alcances, triunfos y desafíos. Se revisa el Protocolo para el Establecimiento del Mercado Común de la Comunidad de África del Este (conocido como Protocolo de Mercado Común), el cuál desarrolla aspectos de la política de libre circulación que estaban implícitas en las previas ediciones sucesivas a la integración regional en la Comunidad de África del Este (CAE). Posteriormente, el artículo aborda los diversos desafíos que existen para la libre circulación en la CAE en contraste con los esfuerzos de la misma CAE por ser la vanguardia en el amplio Acuerdo Tripartita COMESA-CAE-SADC, que abarca países del sur y del este de África, y en la coordinación a nivel continental aún más amplia. El autor llega a la conclusión de que una política de gestión de la migración en lugar de libre circulación podría ser más apropiada. French Cet article retrace l'évolution de l'intégration régionale en Afrique de l'Est (AE), en discutant de sa nature, de sa portée, des succès et des défis qui se posent à elle. Il examine le Protocole portant sur la création du Marché commun d'Afrique orientale communautaire (PEACCM en anglais), qui développe des aspects de la politique de libre circulation qui étaient implicites dans les éditions précédentes des accords d'intégration de l'AE. L'article aborde ensuite les nombreux défis qui se posent à la libre circulation dans la CAE, comment les CAE s'efforcent également d'inaugurer la plus grande Afrique australe et orientale de l'Accord tripartite COMESA-EAC-SADC et de la coordination encore plus large au niveau continental. Il conclut qu'une politique de gestion des migrations pourrait être plus appropriée que la libre circulation.

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