Animal Health

BWA - Legal Hub - Animal health - Picture © Manon Mispiratceguy

SUMMARY

Botswana laws on animal health are comprehensive. The primary legislation regulating this sector are Diseases of Animals Act, 1977 and Diseases of Animals Stock Regulations, 1926. They provide for the prevention and control of diseases of animals; importation, exportation and movement of animals; and the provision of quarantine of animals. The Diseases of Animals Act obliges every owner or person in control of any animal affected or suspected of being affected by any disease (listed in the Act) to report to the nearest departmental officer, administrative officer, or police officer and to isolate such animal.  Movement and selling of diseased animals is prohibited. The Director of the Department of Veterinary Services can declare any area to an infected are. After this declaration, the authorities may impose the following measures: restricting movement of animals to and from the infected areas; isolation of infected animals; and ordering inoculation, dipping, treating or slaughtering of animals for the purpose of disease control. Specifically, when a place is declared as infected with Foot and Mouth Disease (FMD), the movement of cloven hooved animals in the infected areas is restricted. Persons leaving infected areas are expected to comply with reasonable precautions for preventing the spread of disease. Animals killed for diseases control purposes are compensated.
    
The  Minister can declare certain areas as stock-free zones for the purposes of controlling diseases. Fences may be erected and maintained, and the sinking of boreholes within 8 km of any fence is prohibited. These zones act as buffer zones and the fences condones movement of animals from one zone to another. As part of disease control measures, the law empowers veterinary inspectors to vaccinate animals. The Public Health Act, 2014 empower the Director of Health Services to declare a public health emergency where animal diseases affect public health.  The importation of stock and wild animals requires a permit. In case of stock, the importer may be requested to present a certificate from a government veterinary surgeon of the country of origin. Similarly, a permit is required to import into or transport through or re-export from Botswana any wild animal, or trophy, meat, or eggs thereof.  The Diseases of Animals Act require all prospective stock exporters of animals to be authorised by the Director, while the Control of Livestock Industry Act require prospective exporters of cattle to be registered and authorised by the Director of Veterinary Services. Similarly, the WCNPA require prospective exporters of wildlife products to get a permit be authorised by the Director of Wildlife and National Parks. 

The manufacturing, selling, distribution, importation, and exportation of Veterinary Medical Products (VMPs) are regulated by the Medicines and Related Substances Act, 2013 and Medicines and Related Substances Regulations of 2019 and complemented by Guidelines issues by Botswana Medicines Regulatory Authority (BOMRA). All establishment that manufactures and dispenses WMPs must be licensed. To ensure safety and quality of VMPs, the law require manufactures of medicines to supply to BOMRA all information which indicates that the premises to be used are suitable for the purpose and will be operated in accordance with standards of good practice in the manufacture and quality control of medicines. BOMRA provides guidelines (Guideline for Good Manufacturing Practice- Document No: BOMRA/IL/IL/P08/G01) to all licensed and prospective manufacturers on the requirements for current Good Manufacturing Practice (cGMP). The Guidelines for Operating a Veterinary Medicinal Products Retailer, 2022 - Document No: BOMRA/IL/IL/P03/G01 indicate medicines that may only be taken on prescription. Veterinary surgeons are permitted to prescribe VPMs to all animals whether under their care or not, and a copy of the prescription is to be left for a period of one year. prescribers to keep a copy of each issued prescription.  Upon being aware of a safety, efficacy or quality problem which could have detrimental effects on public health, BOMRA or holder of market authorisation may recall concerned VMPs.
     
The import, export, distribute or sell medicines require a licence and shall be under the continuous supervisory control of a veterinary surgeon. The Medicines and Related Substances Regulations as read with the Guidelines for Import/Export of Medicines, 2020 - Document No: BOMRA/IL/IE/P02/G01 provides the legal framework on importing VMPs. The importation of all consignments of medicinal products is channelled through the designated ports of entry and are cleared by customs and the Ministry of Health (Port health) in consultation with BOMRA. Upon arrival at the ports, the medicines are inspected by BOMRA, and Port Health Officers to ensure that they comply with the approved specifications and regulations before they are released. The Customs Act, 2018 empowers the Commissioner General of BURS to arrange for destruction of VMPs to safeguard public health. 
    
The veterinary profession is regulated by the Veterinary Surgeons Act, 2011. All veterinarians must train as such and registered with the Veterinary Surgeon Council. The functions of registered veterinarians include purchasing, keeping, using, prescribing or supplying without licence, any goods, poisons or drugs required solely for the treatment of animals under his or her care in the course of his or her practice.  
    
The Department of Veterinary Services is key in disease control and prevention in Botswana. The Departmental officers have numerous powers such as instructing the owner of any stock to assemble such stock or any part thereof at any specified place for the purpose of inspection or inoculation.  The Minister's powers include establishing quarantine stations and declaring stock-free zones for the purpose of disease control. The Veterinary Surgeon Council registration of Veterinary surgeons and encourages and promotes efficiency in the practice of veterinary medicines, while the Botswana Medicines Regulatory Authority is responsible for regulation all medicines and related substances in Botswana, including veterinary medical products.  District Councils have the power to protect public health at the district level, including declaring infected zones and enforcing regulations. The Public Health Act outlines the powers of various health officials, including the Minister of Health, Director of Health Services, and Health Officers, in preventing and addressing communicable diseases. The Botswana Unified Revenue Service plays a role in importation and exportation of veterinary medicines, with the authority to refuse importation and order destruction if necessary. 
    
The Medicines and Related Substances Regulations allow for collaboration between different authorities to establish guidelines for efficient importation and exportation of medicines. The Guidelines for Import/Export of Medicines, 2020 - Document No: BOMRA/IL/IE/P02/G01 and the Guideline for facilitation at Port of Entry, 2021 - Document No: BOMRA/IL/IE/P05/G03 specify the roles of customs officials, Port Health Officials, and the Botswana Medicines Regulatory Authority (BOMRA) to ensure smooth operations at ports of entry. Customs will be the first point of contact for imported medicines, and BURS will forward the consignment to Port Health for verification and inspections. The Public Health Act enables cooperation between the Director of Health Services and local authorities in appointing environmental health officers who are responsible for controlling environmental health matters. The Director also works with customs, immigration, and other relevant authorities to establish points of entry for port health services.
 

SURVEILLANCE AND MONITORING

DISEASE CONTROL

CONTINGENCY PLANNING AND EMERGENCY RESPONSE

IMPORT CONTROL AND EXPORT CERTIFICATION

VETERINARY LABORATORIES

VETERINARY MEDICINAL PRODUCTS (VMP)

INSTITUTIONAL FRAMEWORK RELEVANT TO ANIMAL HEALTH