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Legislative Status of Veterinary Medicinal Products in Egypt

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Legislative Status of Veterinary Medicinal Products in Egypt Legislative Status of Veterinary Medicinal Products in Egypt TECHNICAL REPORT Under action A2.1 of the Egyptian Vulture New LIFE project (LIFE16 NAT/BG/000874) Hana Y. ElSafoury Nature Conservation Egypt (NCE) 2020 Recommended citation ElSafoury, H. 2020. Legislative Status of Veterinary Medicinal Products in Egypt. Technical report under action A2 of the Egyptian Vulture New LIFE project. Nature Conservation Egypt, Egypt. 55 p. Subject and purpose of the report This report is written under action A2.1 of the Egyptian Vulture New LIFE Project (LIFE16 NAT/BG/000874; www.LifeNeophron.eu), in regard to desk research of legislation and publicly available information on VMPs and NSAIDs. This project is funded by the European Commission and co-funded by the “A. G. Leventis Foundation.” The implementation of the project is done by global partners of BirdLife International1 as well as APLORI, CMS’ Raptors MoU and Green Balkans. The NCE2 is contributing to this project as part of Birdlife Middle East and Birdlife Africa. The main goal of Action A2 is to identify the scale and significance of negative impacts of the use of antibiotics and other VMPs, and in particular NSAIDs in livestock farming on EV populations and propose alternatives. More specifically, this study aims to: Explore the use of VMPs with a proven negative effect on vultures with emphasis on NSAIDs aceclofenac, ketoprofen, carprofen, flunixin, diclofenac, and nimesulide. In addition, all medications containing “fenac”, as well as metamziole (also known as “analgin”), ibuprofen, mefenamic acid, tolfenamic acid, paracetamol (also known as acetaminophen), phenylbutazone, carprofen and piroxicam would be studied with priority, because their impact on vultures was expected to be also strongly negative. Investigate and identify potential alternatives to the dangerous drugs and advocate for their implementation. Research in this report contributes to Action A2.1 through online research and phone call interviews with veterinarians. The next step would be visits to areas with EV populations to understand the circulation and use of VMPs/NSAIDs on the ground. A lab within the Veterinary College at Cairo University was identified to conduct toxicology and histopathology reports with collections from the field. 1 https://www.birdlife.org/worldwide/partnership/birdlife-partners 2 http://www.natureegypt.org Contents Subject and purpose of the report ................................................................................................. 2 Summary ......................................................................................................................................... 4 List of abbreviations ........................................................................................................................ 5 Overview of legislation and entities that regulate VMPs in Egypt ................................................. 6 The main procedures related to VMPs in Egypt ............................................................................. 8 Registration, import and production ........................................................................................................ 8 Use ............................................................................................................................................................ 9 Trade ......................................................................................................................................................... 9 List of Veterinary Medicinal Products in Egypt ............................................................................. 10 Obstacles of successful implementation of laws .......................................................................... 12 Conclusions ................................................................................................................................... 14 References .................................................................................................................................... 14 Annexes ......................................................................................................................................... 15 Annex 1: The administrative arms to the GOVS facilitating the movement of VMPs around Egypt ...... 15 Annex 2: List of registered VMPs/NSAIDs in Egypt ................................................................................. 16 Summary This report is a result of desk research done in the winter of 2019-2020 by Nature Conservation Egypt on the legislation and regulation of VMPs in Egypt. The aim of this research is to begin to understand the threats VMPs with a proven negative effect on vultures and more specifically NSAIDs pose on Egyptian Vulture populations. In Egypt, the main regulatory bodies for VMPs are the General Orgnaization for Veterinary Services3 (under the Ministry of Agriculture), and the newly found Egyptian Drug Authority (EDA, under the Ministry of Health). VMP production and sales are restricted to registered companies, veterinarians and agro-pharmacies by law. However, based on the observation of veterinarians, due to the limited market for VMPs, they mostly rely on medications manufactured for humans and adjust dosage based on animal weight. One of the main NSAID used and prescribed is Diclofenac. In rural parts of Egypt, there is a shortage of veterinarians and agro-pharmacies. Therefore, consumers rely on general pharmacies (that sell both human and animal medicinal products) and the sales personnel therein (not always doctors and certainly not veterinarians) to get medicine for animals without much guidance on proper usage. This muddling between the human and veterinarian pharmaceutical spheres causes a lot of ambiguity and lack of monitoring of VMP trade and usage in Egypt. The EDA has a spreadsheet with all VMPs circulating in the country (Annex 2), but the list does not include guidelines on usage or doses. Approved VMPs include ketoprofen, carprofen, flunixin, diclofenac, and phenylbutazone (known to be particularly harmful to vultures). There is no national database that lists dangerous/illegal VMPs or guidebooks that warn consumers of overuse. As multiple veterinarians noted, there is no inherit problem with NSAIDs, it is an issue of reckless overuse and dosage. The vague laws that regulate VMPs, the shortage in knowledgeable veterinarians in rural parts of Egypt and the lack of public information on VMPs/NSAIDs proper usage and side effects leaves room for livestock poisoning and as a result, vulture poisoning. 3 http://www.govs.gov.eg/FrontEnd/en/Default.aspx List of abbreviations APLORI – A.P. Leventis Ornithological and Research Institute EDA – Egyptian Drug Authority EV – Egyptian vulture GOVS – General Organization for Veterinary Services MoU – Memorandum of Understanding MRL – Maximum Residue Limit NCE – Nature Conservation Egypt NODCAR – National Authority for Drug Control and Research NORCB – National Commission for Research and Control of Biologics NSAID – Non-steroidal anti-inflammatory drugs OiE – World Organization for Animal Health VMP – Veterinary Medicinal Products WTO – World Trade Organization Overview of legislation and entities that regulate VMPs in Egypt The main regulatory bodies for VMPs are the GOVS4 (under the Ministry of Agriculture), and the newly found EDA (under the Ministry of Health). Under the GOVS, there is the General Administration for Services and Guidance (a which regulates VMPs on a local level and (اﻻدارة العامة للخدمات و اﻻرشاد translation of works closely with local veterinary offices in governorates. Annex 1 shows all the administrative bodies managed by the GOVS. Presidential Decree No. 382 of 1976 according to Law No. 127 of 1955 regarding pharmaceutical practices established the NODCAR as the main research body to ensure the safety of drugs circulated in Egypt and Presidential Decree No. 398 of 1995 according to Law No. 127 of 1955 regarding pharmaceutical practices established the NORCB as the veterinary equivalent of the NODCAR. In 2019, the EDA replaced both NODCAR and NORCB as the official body that can give legal certifications for medicinal products’ producers, sellers and distributors. This new authority was approved by the Health Committee in the Parliament in an effort to regulate all drug circulation in the country. There is no sector of the Health Committee in the Parliament that is specifically dedicated to VMPs. In fact, there are no veterinarians in the Health Committee. This is an issue that the Egyptian Veterinary Syndicate5 has been addressing through public requests for veterinarian representation in the Health Committee to ensure that future decisions and changes in laws in regard to pharmacies or drug circulation take into account the veterinarian perspective. Ministerial Decree No. 187 of 19846 established the GOVS as the main legal entity that regulates everything to do with veterinary services in Egypt. Ministerial Decree No. 1616 of 2000 and Ministerial Decree No. 1834 of 20007 restrict VMPs use and circulation to veterinary doctors and agro-pharmacies certified by the GOVS. This stipulation is reinforced by Law No. 127 of 1955 in regard to pharmaceutical 4 http://www.govs.gov.eg/FrontEnd/en/Default.aspx 5 https://egy-vet-synd.org/vet2/# 6 Article 53 of 1966 regarding agricultural practice 7 Law No. 53 of 1966 regarding agricultural practice from the Ministry of Agriculture and article 127 of 1955 regarding pharmaceutical practices practices which regulates
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