East African Community Partner States Research Articles

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

BackgroundAvailability of correct and adequate information about medicines is an important aspect in ensuring rational use of medicines and hence facilitating safety and expected efficacy of medicines during therapy. Package inserts have proven to be a good source of information to the prescribers and patients whereby they have been useful in highlighting important information pertaining proper use and handling of the medicines. The present study was aimed at establishing the extent to which package inserts of medicines circulating on the markets of the East African Community (EAC) Partner States conform to medicines information requirements as established in the harmonized guidelines as well as national guidelines.MethodsA total of 99 package inserts from six (6) types of medicines namely Albendazole, Artemether/Lumefantrine (ALu), Ciprofloxacin, Paracetamol, Amoxicillin and Metronidazole were purposefully collected from three EAC Partner States: Kenya, Tanzania and Uganda. The medicines were selected based on their indications as first line treatments, high rates of utilization within the medicines supply system and their positions in treatment of diseases of public importance across EAC Partner States. The inserts were evaluated on the availability of information regarding fifteen (15) parameters as extracted from the EAC harmonized guidelines for registration of medicines. Moreover, comparisons were made between the percentage conformity of the branded versus generic products, markets from which the samples were collected, origin of the manufacturer and type of medicine.ResultsMajority (93.9–100%) of the medicines’ package inserts highly conformed to the inclusion of the information regarding the description and composition of the medications, indications, dosage and methods of administration, warnings and precautions, contraindications and storage conditions. However, the information on handling and disposal, container package description, excipients used, clinical pharmacology of the medicines, and directions regarding overdose ranked the least in conformance with conformity ranging from 13.1–52.5%.The parameter with the lowest observed percentage conformity among the branded products scored 50% as compared to 10.8% among the generic products. Moreover, there was no significant difference (P<0.05) in the percentage conformity of the package inserts collected from each of the three Partner States as compared to the average from studied medicines. A generally good conformity was observed among medicines manufactured by European based manufacturers as compared to those based in Asia and EAC Partner States. In addition, PIs of Albendazole, Ciprofloxacin, Amoxicillin and Artemether/Lumefantrine did show overall high conformity across most of the product information requirements.ConclusionOur study revealed the existence of a significant number of medicinal products circulating on the markets of EAC Partner States without necessary compliance with all product information requirements. We therefore recommend that NMRAs ensure thorough pre-market assessment of product information as well as strengthening their post marketing surveillance to ensure that medicines circulating on the market comply to medicines information requirements at all times. Emphasis should also be given to manufacturers on the importance of inclusion of appropriate and adequate product information for the safety of patients, including advocating for inclusion of patient-friendly and easy to understand medicines information.

Renewable Energy in the East African Communitys and its Role in Sustainable Development

The article analyses the role of renewable energy in the process of the development of the energy market of the East African Community (EAC) . The author underlines the necessity of finding solutions for such challenges as rising wood and charcoal prices, deforestation, lack of affordable and reliable electricity for a large number of consumers. The study reveals that nowadays the percentage of people with access to modern sources of energy is very low, varying from 7 % in Burundi to 36% in Kenya, although the EAC countries made significant progress in 2000s. Most people in rural areas rely on traditional biomass for cooking and heating, which leads to ecological and health problems. The author concludes that renewable energy development is considered by the Community as one of the prospective ways for providing energy to remote regions in view of abundant solar, wind and geothermal resources. Their strategy aims at the construction of micro and mini hydro stations, stand-alone solar PV systems and off-grids for rural population usage. The study shows that the investment in off-grid renewables has been steadily rising in recent times . Analyzing grid-connected power generation electricity, the author elicits that it is also based on renewable electricity, which accounts for 65% of the total amount. Kenya, with the highest installed capacity in this sector, is investing mainly in geothermal, solar and wind sources of energy, while the others are focusing on hydropower and solar. For the purpose of attracting private investment, the EAC partner states adopted different regulations, including Feed-in Tariff, zero-VAT and GET FIT Programme. The author assumes that renewable energy financing is one of the main challenges despite the support of different international financial institutions, such as the World Bank, UNIDO, AfDB and others. Nowadays energy efficiency measures are becoming important instruments for the EAC countries resulted in power savings. The other important trend is increasing cooperation among them due to their grid-connected power systems in the East African Power Pool. In this context, in November 2017, the EAC Partner States adopted Energy Security Policy Framework, in order to ensure the sustainable development of their energy sector.

Income Convergence in the East African Community

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

Human Rights Protection by International Courts – What Role for the East African Court of Justice?

The present article argues that the East African Court of Justice (EACJ), although originally not conceived as a human rights body, has a role to play as a protector of human rights in the East African region. It underlines the contribution the EACJ could make in spelling out jurisprudential standards for human rights protection in the specific regional context and suggests enhancing judicial dialogue between the EACJ and increasingly assertive national courts of the East African Community Partner States. Drawing upon the existing jurisprudence of the EACJ, the article also discusses the treaty basis for the Court's human rights jurisdiction, the standard of review, the various doctrines the Court uses, the Court's accessibility, the time limits for individual references, the burden of proof and the nature of the EACJ's judgments.

Can 'The Is' and 'The Ought' be Married? Creating a Sustainable Legal Framework for Intangible Property in the East African Community

The Common Market Protocol of the East African Community (EAC) serves the purpose of encouraging free movement of goods and services across the borders of the EAC Partner States. However, recent legal battles in Uganda and Rwanda highlight the fact that the territorial nature of Intellectual Property Rights is at variance with the spirit of free trade within the EAC, and the legal protection meant to go with such free trade. Coupled with this is the fact that national borders sometimes cut across ethnic groupings that share cultural traits. There is an increasing need to protect Traditional Knowledge (TK) and Traditional Cultural Expressions (TCEs) from misappropriation and exploitation, which inevitably pit different communities and their host countries against each other within the EAC. This is primarily due to the fact that the Partner States within the EAC have responded differently to the need for policy and legal frameworks regarding the protection of TK and TCEs. This paper looks at the contrast between the general interests of the EAC Partner States as portrayed in key treaties that they have signed, and their legal obligations and interests as derived from their respective policy and legal frameworks pertaining to the protection of Intellectual Property, TK and TCEs. The paper points out the underlying challenges that have enabled the situation as it is to be different from what it ought to be in terms of generating enjoyment of free movement of goods and services, as well as promoting a better IP and quasi-IP (TK and TCEs) environment in the EAC. The paper goes on to argue that specific reforms are needed within the EAC region as a whole, as well as within each Partner State, so as to generate a win-win situation.

How Can the East African Community Guard Against Base Erosion and Profit Shifting While Working Towards Deeper Integration? Lessons from the European Union

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.

Regulation of medical diagnostics and medical devices in the East African community partner states.

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

Accession to the East African Community (EAC) offers many potential benefits for the Republic of South Sudan. For instance, access to ports in Kenya and regional transportation corridors could increase the competitiveness of South Sudanese products. EAC membership could also open up new regional and international markets for South Sudanese products and strengthen South Sudan's negotiating position vis-a-vis non-EAC countries. Moreover, EAC membership may result in knowledge transfer between EAC partner states and increased regional investment. This in turn could promote the development of better domestic infrastructure and generate significant welfare gains. South Sudanese participation in non-economic EAC cooperation programs could also enhance regional security, food security, and natural resource management.But EAC membership could also have detrimental effects. EAC members are expected to implement a variety of economic and non-economic programs, not all of which may be in South Sudan's interest. For instance, EAC policies like common external tariffs (CETs) and common investment rules could constrain South Sudan's ability to implement trade and investment promotion policies. In addition, EAC membership may hurt South Sudanese consumers and entrepreneurs through elevated CETs on consumer goods and exposure to regional competition. Additionally, continued use of non-tariff barriers and political resistance in EAC partner states may prevent full realization of the potential positive benefits of EAC membership. Lastly, as seen in the case of the EAC-EU Economic Partnership Agreement, EAC membership could require South Sudan to make trade concessions to non-EAC countries.As South Sudan appears committed to pursuing EAC membership, it is now necessary to develop a considered negotiation strategy to maximize the potential benefits of integration and mitigate its negative effects. As demonstrated by the Rwanda case study in Part III, this strategy can be implemented through a multi-step process that focuses on determining the positive and negative impact of EAC membership on South Sudan's development and economy, educating local stakeholders, strengthening vulnerable sectors, and mitigating the negative effects of integration.

Challenges of Incorporating the Economic Acquis Communautaire of the East African Community in a New Common Market

Headquartered in Arusha, Tanzania, the East African Community (EAC) is a regional intergovernmental organisation of five Partner States (Burundi, Kenya, Rwanda, Tanzania and Uganda). The EAC Treaty entered into force on 7 July 2000. Kenya, Tanzania and Uganda officially launched the EAC on 15 January 2001. Burundi and Rwanda became full EAC Partner States with effect from 1 July 2007. The Partner States undertake to establish a Customs Union, a Common Market, subsequently a Monetary Union and ultimately a Political Federation among themselves. In March 2004, the Partner States signed the EAC Customs Union Protocol and it came into effect in January 2005. A “fully fledged” Customs Union entered into force five years later on 1 January 2010. In November 2009, the EAC Heads of State signed and approved the EAC Common Market Protocol. In tandem with the ratification process, and operational start target of 1 July 2010, Partner States are endeavouring to ensure the enactment of relevant enabling legislation to give effect to the EAC Common Market Protocol by 21 August 2010.What mechanisms will Partner States institute to give legal effect to the provisions of the Common Market Protocol by 21 August 2010? This was the question asked of Partner States in the process of drafting this paper. This article presents the results of that evaluation. It evaluates the substantive content of the EAC’s economic acquis communautaire and assesses the progress made by each Partner State to approximate their national laws with the regional framework.Presented at the SIEL 2010 Conference in Barcelona.

Assessing the Assessments: Case Study of an Emergency Action Plan for the Control of Water Hyacinth in Lake Victoria

This study evaluates the impact assessment methodologies used by Uganda's Water Hyacinth Control Programme in Lake Victoria, a domestic project with transboundary implications. The Control Programme sought to reduce infestations of water hyacinth (Eichhornia crassipes), an aquatic weed native to South America, through the use of integrated chemical, mechanical and biological methods. The environmental impact assessment for the project was conducted by Aquatics Unlimited, with support from the United States Agency for International Development. Although the case study involves a domestic impact assessment, it raised transboundary concerns. One of the major outcomes of the assessment was recognition of the need for informed involvement of the other riparian countries, Kenya and Tanzania, in the assessment process to ensure a regional effort among all three East African Community Partner States to control water hyacinth and other invasive weeds in Lake Victoria.