Botswana- Statutory law - Animal health
Animal Health
Botswana
SUMMARY
Botswana laws on animal health are comprehensive. The primary legislation regulating this sector are the Diseases of Animals Act (DAA), 1977 and the Diseases of Animals Stock Regulations, 1926. These laws provide for the prevention and control of diseases of animals; importation, exportation and movement of animals; and the provision of quarantine of animals. The DAA, 1977 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. Activities such as the movement and selling of diseased animals are prohibited. The law empowers the Director of the Department of Veterinary Services (DVS) to declare any area an infected area. Once such a declaration is made, the authorities may impose the following measures: restricting movement of animals to and from the infected areas; isolating infected animals; and ordering the inoculation, dipping, treating or slaughtering of animals for disease control. Specifically, when a place is declared as infected with foot-and-mouth disease, 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. Compensation is provided for animals killed for disease control.
The law also authorizes the Minister to 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 restrict the 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 empowers 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. With regard to 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, transport through or re-export from Botswana any wild animal, or trophy, meat or eggs thereof. The DAA, 1977 requires all prospective stock exporters of animals to be authorized by the Director, while the Control of Livestock Industry Act requires prospective exporters of cattle to be registered and authorized by the Director of Veterinary Services. Similarly, the WCNPA, 1992 requires prospective exporters of wildlife products to obtain a permit authorized 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 (MRSA), 2013 and the Medicines and Related Substances Regulations (MRSR) 2019, and complemented by Guidelines issues by Botswana Medicines Regulatory Authority (BoMRA). All establishments that manufacture and dispense WMPs must be licensed. To ensure the safety and quality of VMPs, the law requires manufacturers of medicines to supply to BoMRA all information that indicates that the premises to be used are suitable for the purpose and shall be operated in accordance with standards of good practice in the manufacture and quality control of medicines. BoMRA provides guidelines (Guidelines 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. The Guidelines for Operating a Veterinary Medicinal Products Retailer, 2022 – Document No. BoMRA/IL/IL/P03/G01 indicate VMPs that may only be taken on prescription. Veterinary surgeons are permitted to prescribe VMPs to all animals whether under their care or not, and a copy of the prescription is to be kept for a period of one year. The law requires prescribers to keep a copy of each issued prescription. Upon being aware of a safety, efficacy or quality problem that could have detrimental effects on public health, BoMRA or any holder of market authorization may recall concerned VMPs.
The import, export, distribute or sale of VMPs requires a licence and shall be under the continuous supervisory control of a veterinary surgeon. The Medicines and Related Substances Regulations (MRSR), 2019 as read with the Guidelines for Import/Export of Medicines, 2020 – Document No. BoMRA/IL/IE/P02/G01 provides the legal framework for importing VMPs. The importation of all consignments of VMPs 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 the destruction of VMPs to safeguard public health.
The veterinary profession is regulated by the Veterinary Surgeons Act (VSA), 2011. All veterinarians must train as such and be registered with the Veterinary Surgeon Council. The functions of registered veterinarians include purchasing, keeping, using, prescribing or supplying without a 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 (DVS) 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 it or any part thereof at any specified place for 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 registers veterinary surgeons, and encourages and promotes efficiency in the practice of veterinary medicines, while BoMRA is responsible for the regulation of all medicines and related substances in Botswana, including VMPs. 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, the Director of Health Services and Health Officers, in preventing and addressing communicable diseases. BURS plays a role in the importation and exportation of veterinary medicines, and has the authority to refuse importation and order destruction if necessary.
The Medicines and Related Substances Regulations (MRSR), 2019 provide 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 BoMRA in order to ensure smooth operations at ports of entry. Customs shall be the first point of contact for imported medicines, and BURS shall forward the consignment to Port Health for verification and inspections. The Public Health Act,2014 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.
GENERAL PROVISIONS
The veterinary profession is mainly regulated by the Veterinary Surgeons Act (VSA), 2011. Act defines the term ‘veterinary surgery’ as the practice of veterinary medicine, or the giving or providing of any treatment, test, advice, diagnosis or attention normally performed, given or provided by a veterinary surgeon at an established location. A ‘paraprofessional' is defined as a person other than a veterinary surgeon who is authorized by the Veterinary Surgeon Council to carry out designated duties to veterinary medicine under the supervision of a veterinary surgeon. Section 3 of the VSA, 2011 establishes the Veterinary Surgeon Council, which regulates veterinary professionals.
VETERINARIANS
The Veterinary Surgeon Act (VSA) requires all veterinarians to be registered. As per section 7, it is an offence to perform functions of a veterinarian unless registered. The minimum qualification for veterinary surgeons is a degree from a university or recognised institute, while for paraprofessionals, it is a diploma from a recognized institute. Moreover, the Council may require that the applicant sit for an examination in order to satisfy itself that the applicant has the requisite knowledge and skills to qualify for registration to practise veterinary surgery in Botswana. Also, written evidence is needed indicating that the applicant is a person of good character and repute, and a fit and proper person to be registered as a veterinary surgeon. The applicant must indicate the names and addresses of three referees known to him/her for at least two years who would be prepared to certify the applicant's character and reputation to the Council. In Botswana, an individual cannot be registered as a veterinary surgeon under the following circumstances. First, if they have been struck off the register of any registering authority for veterinary surgeons outside Botswana and have not been reinstated. Second, if the Council or the High Court in Botswana or any equivalent body or court outside Botswana has not ordered the restoration of their name to the Register. This regulation ensures that only qualified and duly authorized veterinary surgeons are eligible for registration in Botswana. Section 44 allows for revocation of the licence of a veterinary surgeon if he/she is convicted of an offence under the VSA, 2011.
The functions of a registered veterinarian are prescribed in the Act and may include purchasing, keeping, using, prescribing or supplying without a 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 functions that may be performed by non-veterinarians are specified in the Act and listed in Schedule 1, Part III. These functions include administering first aid for the purpose of saving an animal's life, relieving pain, and performing operations as prescribed in the Schedule.
VETERINARY PARA-PROFESSIONALS
The Veterinary Surgeon Act (VSA) defines a veterinary paraprofessional as a person other than a veterinary surgeon, who is authorized by the Council to carry out designated duties relating to veterinary medicine under the supervision of a veterinary surgeon. A list of paraprofessionals is maintained by the Veterinary Surgeons Council. Part II of the VSA lists functions that may be carried out by unqualified persons, that is, paraprofessionals, which include the provision of medical treatment as regulated by the Act, vaccination and advisory services on any matter relating to veterinary medicine, and carrying of meat inspection in accordance with the provisions of the legislation on meat inspection. One of the mandates of the Veterinary Surgeons Council determines the minimum standards of training required for degrees and diplomas holders so that they be registered to practise as veterinary paraprofessionals. The Council also determines the standards of professional conduct of persons practising as veterinary paraprofessionals.
SURVEILLANCE AND MONITORING
NOTIFIABLE DISEASES
The Diseases of Animals Act (DAA), 1977 and the Diseases of Stock Regulations, 1926 are the principal legislations providing for: the prevention and control of diseases of animals; the importation, exportation and movement of animals; and the provision of quarantine of animals in certain circumstances. The Diseases of Animal Act recognizes various diseases such as anthrax and foot-and-mouth disease.
Section 3 of the DAA, 1977 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. The Diseases of Stock Regulations, 1926 require that if the owner of any place or stock or if any veterinary surgeon called in by the owner has reason to suspect that any stock in the owner’s charge or possession or in respect of which the veterinary surgeon has been called is suffering or died from a disease, the owner or veterinary surgeon must report this to the nearest official as quickly as possible and isolate such animal.
Additionally, Regulation 3 specifies a list of diseases that are considered notifiable diseases. This list includes diseases that are considered “diseases of economic importance”, these being diseases responsible for direct monitory loss and material loss such as foot-and-mouth disease.
The Regulations require that communities be notified when a particular place is declared an infected area and of the name of the disease affecting the said area. When a notifiable disease has been identified or reasonably suspected, the law prohibits the movement of the infected stock from one place to another, and the sale of stock with breeding diseases. The Director of Veterinary Services determines the management of all disease outbreaks. The DAA, 1977 imposes criminal sanctions for violating the provisions of the Act, and offences attract a fine not exceeding BWP5 000 or imprisonment for a term not exceeding five years, or both, and to corporal punishment.
The DAA, 1977 obliges every owner or person in control of any animal affected or suspected of being affected by any disease to, as far as is practicable, keep such animal separated from other unaffected animals. Similarly, Regulation 32 of the Diseases of Stock Regulations, 1926 imposes an obligation on the owner of animals to isolate the affected animal upon becoming aware of the occurrence of disease.
The DAA, 1977 defines departmental officer as any veterinary officer, livestock officer, stock inspector or veterinary assistant employed by the Government. Hence, the competent authority (i.e. the Botswana Government) is empowered to appoint veterinary inspectors to take actions necessary to ensure and enforce compliance with veterinary legislation. Additionally, the Veterinary Surgeon Act establishes the Council, which is responsible for registration of veterinary surgeons or paraprofessional, and encourages and promote efficiency in the practice of veterinary medicines.
Section 14 of the DAA, 1977 protects officials from legal action when exercising functions in good faith in connection with the diagnosis, control, prevention or treatment of disease, including the preparation of biological products. This provision ensures that officials can carry out their responsibilities without fear of legal consequences.
VETERINARY INSPECTION
Departmental officers are empowered to inspect any stock wherever it may be kept, driven or depastured. The purpose of these inspections is twofold: to ascertain whether any stock is suffering from a disease and to determine whether the regulations regarding the cleaning and disinfection of said the inspected place have been properly applied. Further, the law grants departmental officers the powers to access premises and vehicles for carrying out inspections, access documents, detain and seize stock, and to destroy infected stock or animals.
Given that departmental inspectors are government employees are bound by the Public Services Act, 2008. The Act enjoins them to utilize government resources at their disposal in an efficient, responsible and accountable manner, and to continuously improve their performance in delivering services. Also, any conduct that tends to bring the public service into disrepute constitutes misconduct, which attracts a disciplinary hearing, and penalties include dismissal. Other laws that restrain departmental officers from misusing their powers include the Penal Code, 1964, which prohibits the abuse of office, and the Corruption and Economic Crime Act, 1994, which criminalizes corruption.
DISEASE CONTROL
ZONING AND COMPARTMENTALIZATION
The Diseases of Animals Act (DAA), 1977 authorizes the Director of the Department of Veterinary Services- (DVS), including the Deputy Director of Veterinary Services and any veterinary officer authorized by the Director, to declare any area an infected area. Once an area is declared an infected area, the authorities may impose the following measures: restricting the movement of animals to and from the infected areas; isolating infected animals; and ordering inoculation, dipping, treating or slaughtering of animals for the purpose of disease control. Specifically, when an area is declared 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. Also, the carcass of any animal infected with disease shall be disposed of in accordance with any general or specific instructions issued by the departmental officer.
At the district level, the Local Government Act, 2013 grants powers to the District Councils to take steps in addition to those taken by any other authority to safeguard and promote public health, and prevent the occurrence of, or to deal with, any outbreak or prevalence of any disease. By virtue of this section, District Councils through the Council Secretary may declare an area as an infected zone to deal with the occurrence or prevalence of any disease.
The Diseases of Animal Act also authorizes the Minister to 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 prevent the movement of animals from one zone to another. Also, the President, in consultation with the Director of Veterinary Services, is authorized to establish compartments within the country to prevent the introduction or spreading of any disease. Similarly, the Director of the DVS may declare any area a disease-free zone.
CONTROL MEASURES
The Diseases of Animals Act 1977 and the Diseases of Stock Regulations, 1926 provide the legal framework on diseases control measures. One of the control measures is the regulation of movement of people and animals within, into and out of any zone. Where any areas have been declared infected, the respective District Officer is required to notify the affected communities. Notifications must be placed on easily accessible areas indicating the farms or areas that have been declared infected. The Director may, by order published in the Gazette, for the purpose of preventing disease, prohibit the movement into or out of any infected area of any animal, carcass, litter, dung or fodder, except under a permit issued by a veterinary officer. Regulations authorize the competent authority to regulate the movement of people and of animals in and out of any zone in case of anthrax, breeding diseases and foot-and-mouth disease.
The law also authorizes the Director or other authorized officials to implement disinfection measures for the prevention of the spread of diseases. Moreover, the DAA, 1977 authorizes the Minister and Director to establish quarantine stations. The veterinary inspector may quarantine animals suspected to be suffering from specific diseases (e.g. anthrax, rinderpest, swine fever and swine erysipelas) or that have been exposed to the risk of contracting such disease. The owner of any animal held in quarantine is liable for all charges arising from any test, inoculation, dipping or treatment carried out while such animal is in quarantine.
The Diseases of Stock Regulations, 1926 empower departmental inspectors to treat or vaccinate animals for disease control. Director shall record its identification number, any vaccinations or other medical treatment and the specimen of the animal in a database. An owner of an animal shall keep on an on-farm record for the animal information on any medical treatment of such animal, such as vaccinations, de-worming and dipping.
Under the DAA, compensation is only available in the case where an animal, when slaughtered, is found not to be infected or likely to spread infection of any disease, and when animals that may be infected with disease are slaughtered in order to prevent the further spread. The Diseases of Stock Regulations, 1926 provide for payment of compensation in specific circumstances; this compensation is determined from time to time by the Government.
Violating any of the control measures provided in the DAA attracts a fine of BWP5 000 or imprisonment for a term not exceeding five years, or to both, and to corporal punishment. Failure to comply with the Diseases of Stock Regulation attracts a fine not exceeding BWP100 for first offences. For second and subsequent offences, the penalty is imprisonment without the option of a fine, for a term not exceeding six months.
CONTINGENCY PLANNING AND EMERGENCY RESPONSE
CONTINGENCY PLANNING
The National Disaster Risk Management Plan 2009–2014 provides for a contingency plan, but does not define ‘contingency plans’. It defines ‘contingency planning’ as "a management process that analyses specific potential events or emerging situations that might threaten society or the environment and establishes arrangements in advance to enable timely, effective and appropriate responses to such events and situations”. Botswana has contingency plans for the following diseases: foot-and mouth disease, Highly pathogenic avian influenza (plan under review) and peste des petits ruminants (also known as sheep or goat plague).
EMERGENCY RESPONSE
In the absence of any specific legislation for disaster risk management, emergency responses are currently backed by the Constitution, the Emergency Powers Act, 1966, the Public Health Act, 2014, and the National Disaster Risk Management Plan, 2009. The Constitution grants the President the powers to declare an emergency of any kind. the proclamation of an emergency may be revoked sooner than the stated duration. If not revoked, it expires, at the lapse of the duration. However, the law does not state the conditions under which a declaration of a disease emergency must be revoked. The Emergency Power Act empowers the President to make emergency regulations specifying the emergency at hand. For disaster-induced emergencies, the President shall declare an emergency when the National Committee on Disaster Management (NCDM) has advised him or her to do so.
The Public Health Act empowers the Director of Health Services to declare a public health emergency where animal diseases affect public health. The emergency is called if the Director is satisfied that the situation so dictates and that it is not practicable for a declaration of a state of emergency or disaster to be made under the Emergency Powers Act. Section 23 of the Public Health Act requires that the declaration of emergency made by the Director be based on risk. The duration of such emergency is a maximum of seven days and may be extended if necessary. The law does not specify the conditions of revoking a declaration, save to provide that it may be revoked sooner than the stated time. If not revoked, it expires.
As per the National Disaster Risk Management Plan, once a declaration of an emergency has been proclaimed, it must be communicated to different stakeholders using various medium such as mass messaging systems and at community gatherings organized to communicate the warnings and messages. The National Disaster Risk Management Plan empowers the competent authority to request assistance from others such as the police and military, which may offer transport and security services. Section 4 of the Emergency Powers Act empowers the President to put in place the necessary regulations to control risks, even if they are inconsistent with other enactments. Also, this law grants exceptional powers that may be exercised during an emergency such as animal diseases emergencies. These powers include the acquisition on behalf of the Republic of any property other than land.
IMPORT CONTROL AND EXPORT CERTIFICATION
IMPORT
The Disease of Stock Regulations, 1926 regulates the importation of animals into Botswana. The importation of stock and wild animals requires a permit issue by the Director of Veterinary Services and the Director of Wildlife and National Parks, respectively. The importer may be requested to present a certificate from a government veterinary surgeon of the country of origin. The World Organization for Animal Health’s Terrestrial Animal Health Code provides guidance on importation of animals.
The Diseases of Animals Act (DAA) as read with the Diseases of Animals (Animal Information and Traceability System) Regulations (commonly referred to as the Botswana Animal Information and Traceability System, or BAITS), empowers the Director to designate ports of entry for the importation of animals. All prospective importers of animals and animal products are to be authorized by the Director. An application for an importation permit must state the number and kind of the desired stock to be introduced and their breed and sex, stating, in the case of cattle, whether they have been or are to be kept for dairying or beef and the country, and the particular district and farm from which they come and the route by which they will travel. Under the Wildlife Conservation and National Parks Act (WCNPA), 1992 a permit is required to import into, transport through or re-export from Botswana any wild animal, or trophy, meat or eggs thereof. All imported animals may be quarantined or detained at the border for an examination to ascertain if the stock is disease-free. The Department of Animal Production (DAP) issues import permits for domestic animals, while the Department of Wildlife and National Parks (DWNP) handles permits for wild animals. Subsequently, the Department of Veterinary Services (DVS) conducts disease compliance vetting for all import permits.
The Public Health Act, 2014 empowers the Minister, after consultation with the National Health Council, to prohibit, restrict or regulate the immigration or importation into Botswana of any animal, article or thing likely to introduce any communicable disease. The Customs Act, 2018empowers the inspector to refuse the importation of any products on the grounds of protecting public health, to destroy or order the return of any products at the importer's cost. Port Health officers, who are authorized by the Public Health Act, 2014 are responsible for conducting inspections of products to ensure that they meet health standards. It is an offence to fail to comply with the provisions of the Public Health Act, 2014 and the sanction is a fine not exceeding BWP5 000, or imprisonment for a term not exceeding 12 months, or both.
EXPORT
Currently, the Diseases of Animals Act (DAA), 1977 requires all prospective stock exporters of animals to be authorized by the Director of Veterinary Services to export them. Meanwhile the Control of Livestock Industry Act, 1941 mandates that all prospective exporters of cattle must be registered and in possession of an export permit issued by the Director of Veterinary Services. Similarly, the Wildlife Conservation and National Parks Act (WCNPA), 1992 requires prospective exporters of wildlife products to obtain an export permit from the Director of Wildlife and National Parks. The law requires prospective exporters to acquire an export permit form a government veterinary officer for every case of export. The law requires the inspection of any cattle or small stock for acquiring an export permit. It is a criminal offence to attempt to export animals without a permit.
The Diseases of Stock Regulations, 1926 provide for the detention of stock at the border until examined by an official appointed for this purpose. Moreover, the Customs Act, 2018empowers the customs officer to carry out an inspection of goods, which include animals and animals products, for customs purposes.
VETERINARY LABORATORIES
GENERAL PROVISIONS
The Diseases of Animals (Prohibition of use of Anabolic Hormones and Thyrostatic Substances) Regulations, 1987 defines an ‘approved laboratory’ as a laboratory under the direct supervision of the Director of Veterinary Services. The Botswana National Veterinary Laboratory (BNVL) is under the National Agriculture Research and Development Institute. The competent authority is the DVS under the Ministry of Agriculture. The BNVL is the sole confirmatory DVS diagnostic laboratory, which has two recently established satellite laboratories in the field. It handles samples from passive surveillance, clinical cases and disease surveillance programmes, and for food safety, particularly the control of food hygiene samples from export abattoirs. National and regional foot-and-mouth disease-specific diagnostic and investigatory needs, including post-vaccinal monitoring, are carried out jointly by the Botswana Vaccine Institute (BVI) and the BNVL. Both laboratories have a mandate as World Organisation for Animal Health (WOAH) Reference Laboratories: Botswana Vaccine Institute for foot-and-mouth disease and BNVL for contagious bovine pleuropneumonia. The Director may authorize specific laboratories to process veterinary samples.
VETERINARY MEDICINAL PRODUCTS (VMP)
GENERAL PROVISIONS
The Medicines and Related Substances Act (MRSA), 2013 provides for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances in Botswana. Section 3 of this Act establishes Botswana Medicines Regulatory Authority (BoMRA) as the competent authority responsible for regulation of all medicines and related substances in Botswana, including veterinary medical products (VMPs).
REGISTRATION
The Medicines and Related Substances Act (MRSA), requires the Botswana Medicines Regulatory Authority (BoMRA) to maintain a register of approved medicines including Veterinary Medical Products (VMPs). All medicines must be registered by BoMRA before being manufactured, stored, processed, distributed or sold. The registration is not time-limited, but the Authority may, by order published in the Gazette, declare any medicine to be a banned medicine, in which case the medicine shall not be registered, or if already registered, such registration shall be cancelled. It is an offence to import, export, manufacture, distribute, sell, dispense, prescribe or advertise any medicine or other substance that is unregistered. The sanction is a fine of BWP100 000, or imprisonment for 10 years, or both. Additionally, the medicines may be seized and disposed at the request of BoMRA, and BoMRA may at the same time withdraw any approval or authorization previously given by it to that person.
LICENSING
As per the Medicines and Related Substances Act (MRSA), all establishments that manufacture and dispense medicines including VMPs must be licensed. The premises where VMPs are sold must be under the continuous supervision of a person authorized in writing by the Director of Veterinary Services. Failure to comply with any of the above requirements is a criminal offence that attracts a fine not exceeding BWP15 000 or imprisonment for a term not exceeding three years, or both. Further, the Authority may suspend the licence pending compliance with any directions it considers necessary, of a VMP facility that is not being operated in accordance with good professional standards. In cases of non-compliance with the directives of the Botswana Medicines Regulatory Authority (BoMRA), the licence may be cancelled, and the stock must be disposed of within six months, in a manner approved by BoMRA. The import, export, distribute or sell of medicines require a licence and shall be under the continuous supervisory control of a veterinary surgeon.
A person who contravenes these provisions commits an offence, and is liable, in the case of import, export, distribution or selling of VMPs, dispensing or keeping in storage contrary to such conditions as may be prescribed any VMP after the date of expiry indicated on the package of the VMP, to a fine not exceeding BWP100 000, or to imprisonment for term not exceeding 10 years, or to both. BoMRA may withdraw a licence issued under section 28 or 31 where it is satisfied that the medicine is being imported, exported, distributed or sold otherwise than in accordance with the conditions of a licence.
The law mandates the licensing of all establishments that manufacture VMPs The applicant must supply to BoMRA all information that 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 manufacturing and quality control of VMPs. The manufacturing of VMPa must be under the continuous supervisory control of a person authorized by the Director of Veterinary Services and possesses such practical experience as prescribed by BoMRA. BoMRA may cancel the licence where it is satisfied that its conditions are not being observed, or that the manufacture of any VMP is not being carried out in accordance with the provisions of the MRSA or standards of good practice in the manufacture and quality control of VMPs. Once a licence has been cancelled, the licence holder shall cease all manufacturing.
SAFETY AND QUALITY CONTROL
The Medicines and Related Substances Act (MRSA) provides for safety and quality control measures on all VMPs. The Botswana Medicines Regulatory Authority (BoMRA) provides guidelines (Guidelines 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.
The MRSA further requires any person who uses a veterinary medicinal product (VMP) on an animal under his or her care, or who uses medicated feed to feed an animal that he or she keeps in a feed lot or other premises to ensure that the animal is not slaughtered for consumption before the prescribed withdrawal period has elapsed and the prescribed maximum residue limit allowable in meat has fallen within the limit allowed. A record of all medicines administered to animals must be kept by the owner.
The MRSA requires that labelling requirements be in accordance with the requirements imposed by the Authority. These labelling requirements are set forth in the Medicines and Related Substances Regulations, 2019. The labelling requirements including information indicating the manufacturer, expiry date, any special storage conditions, any warnings or precautions, and any directions for use if sold without prescription. The Medicines and Related Substances Regulations indicate that the disposal of VMPs must be in line with the guidelines set by BoMRA. These guidelines are readily available on BoMRA’s website and are constantly updated. Changing the manufacturing process, labelling or packaging of a VMP without the prior authorization of BoMRA is an offence that attracts a fine not exceeding BWP50 000, or imprisonment for a term not exceeding three years, or both. Furthermore, the Act grants BoMRA the power to seize and dispose of VMPs, as well as revoke any prior approvals or authorizations granted by it to an individual.
PRESCRIPTION AND USE
The Medicines and Related Substances Act (MRSA) permits veterinary surgeons to prescribe veterinary medicinal products (VMPs) to all animals whether under their care or not. The MRSA as read with the Guidelines for Operating a Veterinary Medicinal Products Retailer, 2022 – Document No. BoMRA/IL/IL/P03/G01 indicates the medicines that may only be taken on prescription. These medicines are listed in Schedules 1A, 1B, 1C and 1D, 2 and 3. Schedule 1A, 1B, 1C and 1D medicines are only dispensed only to those with a written prescription from a registered Veterinary Surgeon, whereas Schedule 2 and 3 medicines and vaccines may be prescribed by a registered Veterinary Surgeon or an authorized paraprofessional. Dispensing Schedule 4 veterinary medicines does not require a prescription. The law requires prescribers to keep a copy of each issued prescription for a period of one year. The MSRA imposes criminal sanctions for offences related to VMPs' prescription and use regulations. The sanction is a fine not exceeding BWP5 000 or imprisonment for a term not exceeding one year, or both. Also, the Authority may at the same time withdraw any approval or authorization previously given by BoMRA to that person.
PHARMACOVIGILANCE AND RECALL
The Medicines and Related Substances Act (MRSA) obligates any person who believes that an animal has suffered an adverse reaction from receiving a veterinary medicinal product (VMPs), or that a person has experienced an adverse reaction from handling a VMP to report to the Botswana Medicines Regulatory Authority (BoMRA). A report must also be prepared when the adverse reaction is as a result of clinical trials. BoMRA may, without prior consultation from the holder of market authorization, recall a medicine. Further, holders of market authorization upon being aware of a safety, efficacy or quality problem that could have detrimental effects on public health are obliged, in consultation with BoMRA, to recall the medicine. Failure to report and recall by holders of market authorization is an offence that attracts a fine not exceeding BWP100 000 and imprisonment not exceeding 10 years, or both. The Act further authorizes BoMRA to withdraw any rights and licences granted to the licence holder as a result of violating the law.
IMPORT
The Medicines and Related Substances Act (MRSA), and the Medicines and Related Substances Regulations (MRSR), 2019 as read with the Guidelines for Import/Export of Medicines, 2020 – Document No. BoMRA/IL/IE/P02/G01 provides the legal framework for importing VMPs. The Guidelines incorporate the World Health Organization guidelines on import procedures for Medicines No. 917, 2003. According to the MSRA, all individuals aspiring to import VMPs must acquire import licences, and it is mandatory for the importer to be a resident of Botswana. All VMPs to be imported must be registered by Botswana Medicines Regulatory Authority BoMRA. The law requires that the importation be under the continuous supervisory control of a veterinary surgeon. Also, medicines must be imported by importers whose premises are dully licensed by BoMRA. 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 VMPs are inspected by the BoMRA, Customs or Health inspector to ensure that they comply with the approved specifications and regulations before they are released. The Customs Act, 2018 empowers the Commissioner General to arrange for the destruction of VMPs to safeguard public health. Failure to adhere to the import regulations is an offence that attracts a fine not exceeding BWP100 000, or imprisonment for a term not exceeding 10 years, or both. In the event that an individual is found guilty, the MSRA has the authority to request the court to order the seizure and disposal of the VMPs, and determine the method of disposal. In addition, BoMRA has the power to revoke any approval or authorization previously granted to the person in question.
EXPORT
Exportation of VMPs is regulated by the Medicines and Related Substances Act (MRSA) and the Medicines and Related Substances Regulations, 2019, as read with the Guidelines for Import/Export of Medicines, 2020 – Document No. BoMRA/IL/IE/P02/G01. Under the MSRA, all exporters of VMPs must obtain export licences for each consignment. The Customs and Excise Regulations permits the inspection of export wherever BoMRA deems it fit. Failure to adhere to the export regulations is an offence that attracts a fine not exceeding BWP100 000, or imprisonment for a term not exceeding 10 years, or both. Also, where the person is found guilty, the Authority may request the court for an order to seize and dispose of the VMPs. BoMRA may at the same time withdraw any approval or authorization previously given by it to that person.
Under the MRSA, the import of VMPs must be under the control of a veterinary surgeon. A ‘veterinary surgeon’ is a person registered as a veterinary surgeon under the VSA, 2011 (Cap. 61:04). Therefore, the prospective importer must be registered as a veterinary surgeon.
INSTITUTIONAL FRAMEWORK RELEVANT TO ANIMAL HEALTH
INSTITUTIONAL SET-UP
The Diseases of Animals Act (DAA) defines the powers of the Minister implementing this Act, the Director of Veterinary Services and departmental officers in relation to animal health. The powers of the Minister include establishing quarantine stations and declaring stock-free zones for the disease control. Departmental officers have the power to instruct the owner of any stock to assemble the stock or any part thereof at any specified place for the purposes of inspection or inoculation. They may also enter on any land, building, shed, place, carriage, van, truck, vessel or aircraft containing, conveying or used for conveying animals in order to inspect or examine any stock, carcass, article or vehicle to ascertain whether or not the provisions of this Act are being properly carried out. The Veterinary Surgeons Act (VSA), 2011 establishes the Veterinary Surgeons Council, whose responsibilities include the registration of veterinary surgeons, and encourages and promotes efficiency in the practice of veterinary medicine, whereas the MRSA establishes the Medicines Regulatory Authority (BoMRA) as the competent authority responsible for the regulation of all medicines and related substances in Botswana, including veterinary medical products (VMPs).
District Councils are granted powers under the Local Government Act, 2013 to protect and promote public health at the district level. This includes taking additional measures beyond those taken by other authorities to prevent the occurrence of diseases or address outbreaks. By utilizing this authority, District Councils, through the Council Secretary, have the power to declare an area as an infected zone in order to effectively address and manage the occurrence or prevalence of any disease within that area. Additionally, the Act provides for the establishment of a law enforcement office in every Council, which consists of law enforcement officers whose main duties are to enforce the Council’s regulations and directives. They have the power to arrest, enter, search and seize any goods and properties.
The Public Health Act, 2014 defines the powers of the Minister of Health, the Director of Health Services, Health Officers, and Port Health officers. The Minister may, after consultation with the National Health Council, prohibit, restrict or regulate the immigration or importation of any animal, article, or other object that may introduce a communicable disease into Botswana. The Minister is also authorized to take precautionary measures to prevent the introduction of communicable diseases. The Director of Health Services serves as the primary technical adviser on national health issues and oversees the inspection, sampling and examination of vaccines used for the prevention and treatment of animal diseases. Health officers are responsible for notifying the Director of Health Services of any abnormal sickness or mortality in animals. The Act also outlines the powers and responsibilities of Port Health officers at ports of entry, such as implementing Port Health programmes, ensuring compliance with public health laws, detaining and reporting quarantinable diseases, and conducting inspections to enforce the provisions of the Public Health Act.
The Botswana Unified Revenue Service (BURS) is a fundamental institution involved in the importation and exportation of VMPs. BURS serves as the initial point of contact for imported medicines, and its Commissioner General has the authority to refuse the importation of VMPs and order their destruction in order to protect public health.
The Ombudsman Act creates the Office of the Ombudsman. Its tasks include investigating complaints against governmental departments and private entities and offer suitable reliefs. The Veterinary Surgeon Council established under the VSA, 2011 provides for the establishment of a Grievances and Disciplinary Committee to investigate disciplinary cases and impose penalties on persons who contravene the Act.
INSTITUTIONAL COOPERATION AND COORDINATION
The Medicines and Related Substances Regulations, 2019 provides for collaboration with other authorities in order to benchmark and facilitate the development of requirements and guidelines for efficient operations and the prudent use of resources. Coordination is essential, for example, in the importation and exportation of medicines and related substances. 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 provides for the roles of the different parties, chiefly customs officials, Port Health officials and Botswana Medicines Regulatory Authority BoMRA). The latter guidelines defines areas of cooperation and clarifies the roles between BoMRA and Port of Entry (PoE) personnel (customs officials and Port Health officials) to ensure seamless operations at ports of entry, highlights and describes activities to be undertaken at PoE and clarifies who will carry out the activities. The guidelines indicate that customs, Botswana Unified Revenue Service (BURS), will be the first point of contact for imported medicines. Upon identifying the consignment as medicines and related substances, BURS will forward them to Port Health for document verification and inspections.
The Public Health Act, 2014 facilitates cooperation between the Director of Health Services and local authorities in the designation of environmental health officers by the Director of Health Services. These officers are responsible for exercising control over environmental health matters. Furthermore, the Director collaborates with the departments responsible for customs and immigration, as well as other relevant authorities to establish points of entry for the provision of Port Health services.
DELEGATION OF POWERS
The law on animal health provides for the delegation of powers. The Diseases of Animals Act 1977 allows the Director of Veterinary Services to delegate his/her authority to any person. Similarly, the Medicines and Related Substances Regulations, 2019 allow the Chief Executive Officer to delegate the exercise of any of his or her powers under this Act to any senior officer of the Authority. The Diseases of Stock Regulations, 1926 empower the Minister to delegate his/her functions to any person by name for a period not exceeding three months at any one time, subject to conditions, exceptions and qualifications as prescribed. Under the Public Health Act, 2014 the Director of Health Services may delegate, in writing, any of his or her functions or powers under this Act to any person, class of persons, public authority or agency. The Local Government Act, 2012 allows the Council to delegate its functions to bodies, trusts and other bodies established by it, as well as to any other person in accordance with government policies. The Council may revoke or amend any delegation, with reasons, and attach conditions to the delegation, including general or directions on how to exercise the delegated power.