ISSN: 2642-6315
Authors: Hailu Zeru*
Executive Summary: A semi-structured questionnaire based descriptive study was conducted from May to June 2018 in four regions of Ethiopia, including Oromia, Tigray, SNNP and Afar with the objective of assessing the regulatory alignment between federal and regional veterinary drugs regulatory bodies and identifying the major factors contributing to the fragmentation of regulatory functions between the agencies. Heads of the regulatory bodies, experts working within the regulatory bodies and private business actors were interviewed for the study purpose. A review of legislations was also done to assess the regulatory functions given to the regulatory bodies and their coincidence to each other. Key Findings: Veterinary drug and animal feed administration and control proclamation 728/2011 is the core national governing legislation for the regulation of veterinary drugs and animal feeds. Following directive, Veterinary Drug Retail Outlets Certification and Control Directive 02/2015 is also issued by VDFACA to administer and control the retail outlets. The regulatory functions of trans-regional and trans-boundary production, import, export and distribution of veterinary drugs are given to the federal veterinary drugs and animal feed administration and control authority (VDFACA); while the regional regulatory bodies are given the responsibility of regulating trade and distribution activities conducted within the regional territories. But functions that could be done concurrently by both agencies and the system of harmonizing the regulatory activities are not covered in the legislations. The border line between feed and medicine is not covered on the legislations, leading to conflict of interest between feed and medicine regulators on the regulation of medicated feeds. The inspection procedures of how to inspect, what to inspect, how frequent to inspect, inspection approaches, and sampling techniques are not described in the directives. Even though, the proclamation gives the responsibility to issue a list of veterinary drugs that may be prescribed by veterinary professionals other than veterinarians and those which could be dispensed without prescription, it is not yet issued; which is affecting the good distribution and retail practice. Oromia regional state is the only region established an independent veterinary drug and feed regulatory body. In the rest three study regions (Tigray, SNNP and Afar) regulatory body is not established due to poor awareness of regional lawmaking and higher executive bodies and shortage of budget; and the regulation is being done by delegation. Only one expert is assigned to work on veterinary medicines regulation in Oromia region, but animal health experts are assigned to work as a secondary responsibility in the other regions. These all experts don’t have a short or long term training certificate or academic background on regulatory affairs. So that, the study showed that they lack a skill to identify illegal drug related defects. The federal VDFACA and regional regulatory bodies never planned together and shared report of their regulatory activities. They don’t have also an official meeting schedule to discuss on common regulatory challenges and their possible solutions. There are no tools and an experience of reporting product related risks to each other. Horizontal integration and cooperation of regions is not also started yet; which leads to have the regulatory bodies different awareness and regulatory performance. Systems are not established to involve professionals, private sectors and the community in the regulation of veterinary medicines. Conclusion and Recommendations: Legislative, structural, communication and regulatory tools related gaps are identified in this study; which are enervating the regulatory alignment between federal and regional regulatory bodies. Harmonization of legislations and regulatory tools, development of vertical and horizontal communication mechanisms, harmonization of regulatory plans and capacity development and awareness creation programs should be done to align the regulatory activities and ensure uniform regulatory awareness and performance.
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