Global Forum on Law Justice and Development
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Uganda Report: Strengthening the Legal Environment for the Elimination of Falsified and Substandard Medicines

The full report on “Strengthening the Legal Environment for the Elimination of Falsified and Substandard Medicines” is now available. The report is the third product of the pilot and preliminary phase of a larger initiative to build a knowledge base and collection of tools to support a whole-of-government approach to manage public health problem of falsified and substandard (FS) medicines in any country.  See also the executive summary.

The initiative also produced a “Guide to the Development of a National Strategy for Strengthening the Legal and Regulatory Environment for the Elimination of Falsified and Substandard Medicines” and “Assessment Tool to Evaluate National Actions to Address Falsified and Substandard medicines”, which will be further tested and refined as this project continues, for use in other jurisdictions.

The initiative was jointly conceived and coordinated by four organizations: the World Bank, the International Development Law Organization (IDLO), the O'Neill Institute for National and Global Health Law at Georgetown University, and the United Nations Interregional Crime and Justice Research Institute (UNICRI). The National Drug Authority of the Government of Uganda partnered with the four organizations to ensure a successful pilot.

Abstract

Falsified and substandard medicines (FS) are a known public health problem. FS medicines represent various threats to patients: they may contain an insufficient amount or no active ingredient, or dangerous ingredients. Drug resistance, treatment failure and death have been associated with these products. While the prevalence in developed markets is likely below 1%, it is estimated that up to and more than 15% of all drugs sold in developing countries constitute a threat to patients. Many factors facilitate the spread of FS medicines. One of the most important, in developing countries, is the need for strong national drug regulation. Added to the complexity in finding effective solutions is that falsified medicines are manufactured and sold by criminal individuals and organizations, exploiting weak national legislation and enforcement, and an unsuspecting and uninformed public.

This report on the Legal Environment for the Elimination of Falsified and Substandard Medicines is the result of the pilot and preliminary phase of a larger initiative to build a knowledge base and collection of tools to support a whole-of-government approach to manage the public health problem of falsified and substandard medicines in any country. The initiative is designed to provide the pilot country, Uganda, with guidance on steps it can take to address the problem of FS medicines within its borders and with its neighbors. Also as a result of this initiative, an assessment  tool and guide to developing a national strategy to address FS medicines were developed, which will be further tested and refined as this project continues, for use in other jurisdictions.

The findings of the pilot of the initiative, an assessment mission to Uganda in June 2015, are presented, as are recommendations and guidance on strategies and actions Uganda can take with regard to its legal systems and regulatory approaches.

The initiative was jointly conceived and coordinated by four organizations: the World Bank, the International Development Law Organization (IDLO), the O'Neill Institute for National and Global Health Law at Georgetown University, and the United Nations Interregional Crime and Justice Research Institute (UNICRI). The National Drug Authority of the Government of Uganda partnered with the four organizations to ensure a successful pilot.

The initiative build on prior related work and good practices, and international law. This includes the work of the World Health Organization and the World Bank, and the United Nations Convention against Transnational Organized Crime, the MEDICRIME Convention of the Council of Europe, and other sources. The project takes into account not only national but also cross border and regional solutions. As exemplified by the initiatives of the East African Community (EAC). The project was financed with support from the World Bank through the Global Forum on Law, Justice and Development.

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