A Pharmaceutical Regulatory Framework in Ethiopia Critical Evaluation of Its Legal Basis and Implementation

Abstract

BACKGROUND: Effective and enforceable national regulations describing the manufacture and(re)packaging, export and import, distribution and storage, supply and sale, information and pharmaco-vigilance of medicines are required to consistently ensure optimal patient benefit. Expansion ofpharmaceutical industries in many countries with advancement in transport technologies facilitated notonly trade of genuine pharmaceutical products but also the circulation of poor quality medicines acrossthe globe. In Ethiopia, even though “The Pharmacists and Druggists Proclamation No 43/1942” wasused to regulate both the professions and the facilities where they were practiced, comprehensiveregulation of the pharmaceutical market was introduced in 1964 by a regulation called “PharmacyRegulation No. 288/ 1964”. This legislation formed the legal basis for official establishment of drugregulation in the history of Ethiopia, enabling the regulation of the practice of pharmacists, druggistsand pharmacy technicians; manufacturing, distribution, and sale of medicines. In June 1999, a newregulation called the “Drug Administration and Control Proclamation No. 176/1999” repealed mostparts of the regulation 288/1964. The law established an independent Drug Administration and ControlAuthority (DACA) with further mandate of setting standards of competence for licensinginstitutions/facilities. DACA was re-structured as Food, Medicine and Health Care Administration andControl Authority (EFMHACA) of Ethiopia by the “Proclamation No. 661/2009” in 2010 bearingadditional responsibilities like regulation of food, health care personnel and settings. The mere existenceof this legal framework does not guarantee complete absence of illegal, substandard and falsifiedproducts as well as illegal establishments in the pharmaceutical chain. Therefore, the objective of theresearch is to assess the pharmaceutical regulatory system in Ethiopia and to reveal possible reasons fordeficiencies in the pharmaceutical chain.METHODS: An archival review, an in-depth interview of key informants and an institutions-basedcross-sectional survey study were conducted during March to April 2013. The comprehensiveness of thepharmaceutical law to protect public health relative to three selected African countries (South Africa,Tanzania and Uganda) and European Union, and implementation was assessed.RESULTS: The study revealed that Ethiopia does have a written national drug policy upon which theMedicines Regulatory Proclamation 661/2009 is based. According to this proclamation, the EthiopianThe Food, Medicines and Healthcare Administration and Control Authority is mandated to execute theregulatory activities as per the council of ministers regulation 189/2010. The legal framework for