Zimbabwe - Statutory law - Animal health
Animal Health
Zimbabwe
SUMMARY
The law provides definitions of who qualifies to be professional assistants and veterinary surgeons. To practise in Zimbabwe in the veterinary field, it is required to be registered in the register established by the Council of Veterinary Surgeons. The Council has the mandate to regulate the profession of veterinary surgery and medicines and for improving veterinary services in Zimbabwe. Any person can be removed from the register for having contravened provisions of the Veterinary Surgeons Act, such as being found to be an unfit person on grounds such as medical reasons and abuse of drugs. Certain acts can be undertaken by people who are not registered as veterinarians. These functions include providing non-surgical treatments, performing minor operations, providing first aid and carrying out an action at the request of a registered veterinarian surgeon. While there is no definition of “veterinary para-professional” in the Veterinary Surgeons Act and Regulations, two categories of professionals are required to be registered to practice activities linked to veterinary medicine. These are the embryo transfer technician and the veterinary laboratory technologist.
The reporting of notifiable diseases is mandatory under the Animal Health Act and the list of notifiable disease is provided by the Animal Health (General) Regulations. The Animal Health Act grants the Minister of Agriculture powers through regulations to take the necessary steps and measures towards the eradication and prevention of diseases and pests in Zimbabwe. There is, however, no express provision for the formulation of contingency plans. The Public Health Act also contain provisions for the control and prevention of infectious and epidemic diseases that concern, to some extent, animal health. This Act grants the Minister of Health powers to prescribe specific measures (zoning, disinfection, etc.).
Controlling the transmission of diseases is also curtailed through measures at the various ports of entry. When entering the country’s borders, it is required to immediately report in writing to authorized personnel of an infectious animal or thing in one’s possession. An authorized person can isolate an animal that may be infected, contaminated or infested with a disease or pest. Other ancillary powers of an authorized person include prohibiting the movement of persons, animals, vehicles or infectious thing or other materials, such as burying or disposing an animal or its waste material in cases where it is suspected of being affected. The importation and exportation of animals in Zimbabwe requires the possession of a permit. Some countries are, however, exempt from this requirement on the basis that they meet the sanitary requirements. The list of countries in the regulations is not exhaustive. Other countries are exempt from this requirement based on a certificate signed by a veterinary surgeon employed by the government of the country from which the product is being imported.
REGULATION OF THE VETERINARY PROFESSION
GENERAL PROVISIONS
The Veterinary Surgeons Act (Professional Conduct) Regulations provide definitions of a professional assistant and a veterinary surgeon. A professional assistant is defined as a veterinary surgeon employed as a professional assistant in the practice of a veterinary surgeon or a partnership of veterinary surgeons. A veterinary surgeon is defined as a registered veterinary surgeon. The Veterinary Surgeons Act establishes the Council of Veterinary Surgeons, whose mandate is to carry out actions that are “necessary or desirable for the proper regulation of the practice of the profession of veterinary surgery and medicine and the improvement of veterinary services in Zimbabwe”.
VETERINARIANS
The Veterinary Surgeons Act requires that to practise in Zimbabwe all veterinarians must be registered in a register maintained by the Registrar of the Council of Veterinary Surgeons. Qualified veterinarians who visit the country would still be required to be registered temporarily. One will be removed from the register for contravening the provisions of the Act. A veterinarian’s name can be erased from the register when, for example, he or she has been absent from Zimbabwe for three consecutive years, or fails to pay the registration fees, or has requested that his/her name be erased. Furthermore, a veterinarians’ registration can be revoked when he or she is deemed unfit due to health reasons, drug addiction and/or a violation of drugs legislation. The Veterinary Surgeons Act lists the minimum educational requirements that certify the competency to practise as a veterinarian. The person must be above 21 years, hold a qualification in veterinary science as the Council may prescribe, and be in possession of a valid registration certificate. The Veterinary Surgeons Act lists a number of functions that can be performed by people who are not registered veterinarians, including providing non-surgical treatments, carrying out minor operations, providing first aid and carrying out an action at the request of a registered veterinarian surgeon. The Act makes it an offence for any individual to practise veterinarian medicine based on a forged registration certificate. The Act also makes it an offence for any individual to impersonate a registered person in order to practise veterinarian medicine.
VETERINARY PARA-PROFESSIONALS
While there is no definition of “veterinary para-professional” in the Veterinary Surgeons Act and Regulations, two categories of professionals are required to be registered to practice activities linked to veterinary medicine. These are the embryo transfer technician and the veterinary laboratory technologist.
The Veterinary Surgeons Act (Embryo Transfer Technicians) Regulations specify the functions that can be undertaken by a registered embryo transfer technician. These functions include carrying out embryo transfer work; collecting, evaluating, processing, packing, transferring or storing embryo; preparing donor and recipient animals; performing minor operations; and conducting tests, giving advice and carry out diagnoses. An embryo transfer technician can only carry out the task under the supervision of a registered veterinary surgeon who should also have sufficient experience in embryo transfer techniques. The Veterinary Surgeons Act (Veterinary Laboratory Technologist) Regulations also specify the functions that can be undertaken by a registered veterinary laboratory technologist. These functions include: performing diagnostic tests according to standard operating procedures; developing and validating new diagnostic tests; ensuring that all necessary quality standards are met; ensuring the efficient performance of diagnostic tests through the proper use and maintenance of laboratory equipment and infrastructure; accurately recording and reporting all results in a timely manner; maintaining a high level of professionalism; and safeguarding client confidentiality at all times. A veterinary laboratory technologist can only undertake tasks under the supervision of a registered veterinary surgeon who should also have sufficient experience in veterinary diagnostic techniques.
The Veterinary Surgeons Act (Embryo Transfer Technicians) Regulations specify the necessary qualifications to be able to qualify as embryo transfer technicians and veterinary laboratory technologists. An embryo transfer technician must be a holder of a Bachelor of Science in Agriculture, with a major in Animal Science that includes a course on reproductive physiology and having passed a course approved by the Council of Veterinary Surgeons in embryo transfer. A veterinary laboratory technologist must
- have a Bachelor of Science Degree and post-qualification experience in excess of two years, or Part I and II (General) Diploma Examinations in Veterinary Laboratory Technology or the equivalent thereof; and
- having successfully completed the Part III Specialist Diploma Examinations in Veterinary Laboratory Technology or its equivalent or have a relevant Master’s Degree.
The Veterinary Surgeons Act makes it an offence for any person to practise veterinarian medicine based on a forged registration certificate. It is an offence according to the Act to impersonate a registered person in order to practise veterinarian medicine. Various actions whose violations would attract criminal offences and fines are listed in the Act. The fine does not exceed level 7 and/or imprisonment for a period not exceeding two years.
SURVEILLANCE AND MONITORING
NOTIFIABLE DISEASES
The Public Health Act provide a list of notifiable diseases and mandates local authorities to transmit information on these diseases at the end of each week to the Chief Health Officer. The Act also requires local authorities to immediately report suspected cases of epidemic diseases and any unusual sickness or mortality among animals. The Animal Health (General) Regulations provide a list of notifiable diseases. The reporting of notifiable diseases is mandatory. The Animal Health Act requires that, when reporting the disease or suspected disease, it should also include smears of an animal that was infected. The owner of an animal or the occupier of land who has an animal on that land that he/she knows is or suspects to be suffering from a notifiable disease shall report the case without delay to the nearest authorized person or police officer, as well as to owners or occupiers of adjoining land that is susceptible to the notifiable disease. The police officer who receives a report must forward it without delay to the nearest office of the Department of Veterinary Services. Veterinary surgeons who discover the existence of a notifiable disease during the course of their work must, without delay, report the matter to the nearest office of the Department of Veterinary Services. An owner of animal who knows or suspects it to be suffering from a disease or to have died from a notifiable disease shall isolate it or its carcass until instructions have been received from an authorized person. The Animal Health Act obliges any person who enters Zimbabwe to immediately report in writing to authorized personnel of an infectious animal or thing that is within their possession. An authorized person can isolate an animal that may be infected, contaminated or infested with a disease or pest. Further, the law empowers authorized personnel to detain any other animal that he/she suspects could have come in close proximity with the animal and could spread the disease. These powers also include the prohibition of the movement of persons, animals, vehicles or infectious or other materials, such as burying or disposing of the animal or its waste material in case it is suspected of being affected. The movement of such infected animals or transmitting pests constitutes an offence that attracts a fine not exceeding level 10 and/or imprisonment for a period not exceeding five years.
VETERINARY INSPECTION
The Animal Health Act empowers the Director of Veterinary Services to delegate powers given to him/her to authorized persons in order to be able to carry out their mandate. These powers include entering any vehicle or land or do anything necessary in order to perform his/her duties. These powers also include the ability to access documents, take samples, and set aside, suspend or withdraw permits. Officials are protected from liability provided that they performed their task in good faith.
DISEASE CONTROL
ZONING AND COMPARTMENTALIZATION
The Minister of Health is given powers under the Public Health Act to declare any disease as being an infectious disease or an epidemic disease and prescribe special measures, which could include designating infected zones through a statutory instrument. The Animal Health Act grants the Minister of Agriculture powers to gazette a statutory instrument regulating zoning and compartmentalization; however, currently, there are no regulations on zoning and compartmentalization.
CONTROL MEASURES
To respond to emergencies, the Public Health Act allows the Minister of Health to request the local authorities to undertake disinfection and cleaning work in cases where it is believed that contamination or infection of any infectious or epidemic disease could have transpired. Local authorities can be requested by the Minister to set up disinfection and cleaning stations. The Animal Health Act allows authorized personnel to regulate the movement of people, animals and vehicles within the country. The Act empowers authorised persons to quarantine animals believed to have been infected with a disease, and to dispose of stray animals that enter into Zimbabwe and to destroy an animal that has been seized. The Animal Health Act does not specifically give the veterinary inspectors powers to treat or vaccinate animals for the purposes of disease control, nor the obligation to inform the affected communities before undertaking any measures to control the disease outbreak. In cases where an animal is destroyed, with the exception of when the animal is confiscated, compensation can be paid as per section 24 of the Animal Health Act and should come from appropriated funds set aside by an Act of Parliament. The Animal Health Act identifies a number of actions that are deemed illegal and subject to criminal and administrative sanctions. In most instances, the person convicted of an offence is liable to a fine not exceeding level 10 and/or to imprisonment for a period not exceeding five years.
CONTINGENCY PLANNING AND EMERGENCY RESPONSE
CONTINGENCY PLANNING
The Animal Health Act grants the Minister of Agriculture powers through regulations to take the necessary steps and any other measures towards the eradication and prevention of diseases and pests in Zimbabwe. There is, however, no express provision for the formulation of contingency plans. The Public Health Act does not make a specific provision for the formulation of contingency plans but mandates the Provincial Health Administration and the District health officer to prepare strategic plans in conformity with the national health policy annually.
EMERGENCY RESPONSE
The Animal Health Act does not contain any specific provision setting out powers and responsibilities to declare animal health emergencies and what measures can be taken to address them. While the Act grants the Minister of Agriculture wide powers in terms of section 5 (the Minister may, by regulation, order or notice in a statutory instrument, do any or all of the matters or things specified in the Schedule), the Schedule does not specifically list the declaration of animal health emergencies. The Public Health Act allows the Minister of Public Health to appoint an epidemic committee to coordinate the response for preventing or dealing with an outbreak of any formidable epidemic disease.
IMPORT CONTROL AND EXPORT CERTIFICATION
IMPORT
The Control of Goods (Import and Export) (Agriculture) Order requires the possession of a permit to be able to import products listed within the regulations. Several listed animals in the Animal Health (Import) Regulations are subject to an importation permit before they are allowed to enter the country. However, several countries are exempt from such import permit on the basis that they meet the sanitary requirements. These animals include bovine animals, sheep, goats, all wild animals and fish, among other animals. The importation of any animal into Zimbabwe if assumed that it could pose a serious risk to human, animal and plant health, may be prohibited. The Animal Health Act empowers the appropriate inspector with the powers to prohibit, restrict or control for a certain period not above 28 days the movements of persons, animals or infectious things into the country. An animal seized at the time of importation can be destroyed, and the relevant costs shall be incurred by the person responsible for the importation. If there is any monetary value realized from any animal product derived from the destruction of the animal, it shall be paid to the importer. The Animal Health Act identifies sanctions that may be applied to any person who violates its provisions relating to the importation of animals or animal products. These sections include a fine not exceeding level 6, and/or imprisonment for a period not exceeding one year.
EXPORT
The Control of Goods (Import and Export) (Agriculture) Regulations require that, to export products listed in the regulations, the exporter must be in possession of a permit issued upon a written application made to the Secretary for Industry and International Trade. The Animal Health Act identifies sanctions that may be applied for having violated its provisions on the exportation of animals or animal products. These sections include a fine not exceeding level 6, and/or imprisonment for a period not exceeding one year.
VETERINARY LABORATORIES
GENERAL PROVISIONS
The Veterinary Surgeons (Veterinary Laboratories) Regulations provide a definition of a veterinary laboratory as premises used by a veterinary surgeon as a veterinary laboratory. Only persons in possession of a valid certificate are authorized to manage veterinary laboratories under the regulation oversight of the Council of Veterinary Surgeons, established as per section 3 of the Veterinary Surgeons Act. The Medicines and Allied Substances Control Act designates the Zimbabwe Regional Medicines Control Laboratory as the laboratory responsible for verifying the quality and standard of all samples submitted to it.
VETERINARY MEDICINAL PRODUCTS (VMP)
GENERAL PROVISIONS
The Medicines and Allied Substances Control Act defines veterinary medicine as any substance or mixture of substances used, manufactured, or sold for the sole purposes of diagnosis, providing treatments, or restoring or correcting the physical or mental function of an animal. Complimentary medicines are defined as substance or mixture used, manufactured, or sold as a mitigation or prevention of a disease to humans and animals.
REGISTRATION
The Medicines and Allied Substances Control Act requires that all medicines be registered before being sold. Section 27 of the same act establishes the Medicines Register which is organized in two parts: Part I relating to medicines which are not veterinary medicines; Part II relating to veterinary medicines. Sanctions may be applied for violating provisions relating to the registration and sale of veterinary medicines. These sanctions include a fine not exceeding level 12, and/or imprisonment for a period not exceeding two years.
LICENSING
The Medicines and Allied Substances Control Act requires establishments or premises that manufacture and dispense medicines to be licensed and all licenced premises to be registered by the Director General of the Medicines Control Authority, who is also mandated to keep a record of the premises including the conditions placed on the authorizations. This is the same Act that is applicable for Veterinary Medicinal Products (VMPs). The legislation is complemented by the Medicines and Allied Substances Control (General) Regulations which set out the requirements for any person who wishes to obtain a licence for premises. It is necessary to comply with the set minimum requirements that are listed in the Third Schedule of the Regulations. These same requirements also apply to those selling complementary medicines even for a general dealer’s licence. The Medicines and Allied Substances Control Act defines sanctions that may be applied for violating provisions relating to the authorization/licensing for the manufacture, storage, processing, distributing, and selling of VMPs. These sanctions include a fine not exceeding level 12 and/or imprisonment for a period not exceeding two years. The Medicines and Allied Substances Control (General) Regulations also define sanctions that may be applied for violating provisions relating to authorization/licensing for the manufacture, storage, processing, distributing, and selling of VMPs. These sections include a fine not exceeding level 7, and/or imprisonment for a period not exceeding six months.
SAFETY AND QUALITY CONTROL
The Medicines and Allied Substances Control Act requires that veterinary medicines can only be registered if the safety, quality and therapeutic efficacy and its effect on the health of animals can be assured. The other requirement for registration is that the premises at which the medicine is manufactured, and all manufacturing processes must be satisfactory. When the medicine is manufactured outside Zimbabwe, the law requires that “a valid certificate of registration in respect of such medicine issued by the authority in the country of origin of that medicine has been produced to the satisfaction of the Authority” be produced.
The Medicines and Allied Substances Control (Complementary Medicines) Regulations state that complementary medicine once approved should have a certificate of approval issued to the applicant or principal as the case may be. The regulations require any person dispensing medicine to ensure that the medication that has a shelf life of less than three months before expiry be returned to the manufacturer, agent or distributor, as the case may be. The manufacturer, agent or distributor that receive the expired medicine shall store the medicine in a quarantine area of the premises and reimburse or replace the medicine.
The Medicines and Allied Substances Control Act provides for the labelling of medicines: no person shall sell any registered medicine unless it is labelled with its registered name and registered number. Labelling requirements for all medication including Veterinary Medicinal Products (VMPs) are also provided for under the Medicines and Allied Substances Control (Complementary Medicines) Regulations. The label should provide a “registered name, strength and form of the medicine” and the name of supplier and the category of users concerned among other information. The regulations also prescribe labelling requirements that should be complied with for VMPs. The labelling should “bear or incorporate a label on the package in which such complementary medicine is sold, […] printed in clear and indelible letters in the English language and any other language as may be directed or approved by the Authority […]". Under the Medicines and Allied Substances Control (Complementary Medicines) Regulations, when medication becomes prohibited or restricted, the person in possession of the medication should inform the Authority of such possession. The same medication should then be disposed in the manner instructed by the Authority. The regulations also require that a person in the business of wholesale dealing should keep records on the acquisition and disposal of complementary medicine. The Medicines and Allied Substances Control (General) Regulations identify sanctions that may be applied for violating provisions on VMP safety and quality control. These sanctions include a fine not exceeding level 7, and/or imprisonment for a period not exceeding six months. The Medicines and Allied Substances Control (Complementary Medicines) Regulations also define penalties that may be applied for violating provisions on VMP safety and quality control. These sections include a fine not exceeding level 7, and/or imprisonment for a period not exceeding six months.
PRESCRIPTION AND USE
The Medicines and Allied Substances Control Act provides that any person who compounds or dispenses a medicine or veterinary medicine shall follow the pharmacopoeia prescribed by the Minister of Health through statutory instruments and the written instructions of a medical practitioner or veterinary surgeon on whose prescription the medicine is prepared or dispensed. The Medicines and Allied Substances Control (General) Regulations require prescriptions for certain drugs before they are dispensed to the public. Section 74 of the Regulations provide that no person shall supply any medicine listed in the Ninth Schedule otherwise than in accordance with the written prescription of a medical practitioner, dental practitioner or veterinary surgeon, as the case may be. According to the Regulations, every person who dispenses a prescription preparation shall ensure that the prescription is not dispensed more than once, unless the prescriber has directed otherwise. Further, at the time of dispensing, it must be written on the prescription the name and address of the supplier and the date on which the prescription is dispensed.
PHARMACOVIGILANCE AND RECALL
The issue of pharmacovigilance is not regulated in the Medicines and Allied Substances Control Act. Hence, there is no legal obligation on any person who reasonably believes that an animal has experienced an adverse reaction from receiving a Veterinary Medicinal Product (VMP), or that a person has experienced an adverse reaction from handling a VMP, to report this to the Medicines Control Authority of Zimbabwe. The Zimbabwe National Pharmacovigilance Policy Handbook [which does not create legal obligations and is non-binding] mandates members of the health professionals to report all cases of pharmacovigilance to the Medicines Control Authority of Zimbabwe. The determination to recall any suspected VMP likely to cause harm is made by the Medicines Control Authority of Zimbabwe. This determination would also take into account the potential hazard of the defective product and extent of product distribution. The Zimbabwe National Pharmacovigilance Policy Handbook provides for a process that should be followed if a VMP product should be recalled on the basis that it is likely to cause serious adverse harm or the product is defective. The recall can be initiated by a number of entities which include the manufacturer, the wholesaler or the competent authority.
IMPORT
Under the Medicines and Allied Substances Control (Import and Export of Medicines) Regulations, any person who wishes to import any registered medicine in Zimbabwe must be in possession of the necessary permit. The importer should further have been appointed as an authorized importer by the Director General of the Medicines Control Authority. However, it is not clear in these Regulations whether or not a new permit is required for each shipment.
EXPORT
The Medicines and Allied Substances Control (Import and Export of Medicines) and the Medicines and Allied Substances Control (Import and Export of Precursors and Certain Chemical Substances) Regulations require that only authorized persons be allowed to export Veterinary Medicinal Products (VMPs) from the country. Authorized persons are defined as holders of a permit issued by the Director General of the Medicines Control Authority. The Regulations stipulate that medication can only be exported outside the country in accordance with the terms and conditions provided by the Medicines Control Authority of Zimbabwe. The terms and conditions may include inspection of the products to see if they correspond to the form submitted. The application for an exportation licence is to be accompanied by information such as quantity of the goods to be exported, which would need to be verified before actual exportation.
Under the Medicines and Allied Substances Control (Import and Export of Medicines) Regulations, the exporter must notify the Medicines Control Authority within 30 days of the exportation of the medicine. The law does not indicate the time frame within which the medicine should leave the country after inspection. According to the Medicines and Allied Substances Control (Import and Export of Precursors and Certain Chemical Substances) Regulations, it is an offence to export VMPs out of the country without a permit or fail to comply with the conditions of the permit or make a false declaration for the sole purpose of obtaining a permit. Violation of these regulations attracts a fine not exceeding level 7 and/or imprisonment for a period not exceeding six months.
INSTITUTIONAL FRAMEWORK RELEVANT TO ANIMAL HEALTH
INSTITUTIONAL SET-UP
The Animal Health Act defines three levels of power and responsibilities. Firstly, the Minister, secondly the Director who is the officer in charge of the Department of Veterinary Services of the Ministry; and lastly the authorized personnel who are authorized in terms of section 20(1)(b) to do or perform any act which may be done or performed in terms of this Act. The Medicines and Allied Substances Control Act establishes the Medicines Control Authority of Zimbabwe, while the Veterinary Surgeons Act establishes the Council of Veterinary Surgeons.
INSTITUTIONAL COOPERATION AND COORDINATION
The Animal Health Act, Veterinary Surgeons Act and the Medicines and Allied Substances Control Act do not contain provisions for cross-sectoral coordination in animal health emergencies and in the prevention of the spread of disease. The Public Health Act provides for a system of reciprocal notification of diseases outbreaks that may affect both man and animals between the Ministry of Health and the Department of Veterinary Services (Ministry of Agriculture) as well as a system of consultation as to the making of regulations or the taking of measures in connection therewith.
DELEGATION OF POWERS
The Animal Health Act permits the Director of Veterinary Services, with the Minister of Agriculture’s approval, to delegate powers that were delegated to him/her under the Act in relation to a particular matter or class of issues. The Act does not, however, define the class of matters that are subject to such delegation. A person to whom a power has been delegated under the Act shall exercise the power subject to the orders of the Director. The delegation of a power shall not preclude the exercise of the power by the Director. The Director may, at any time, revoke a delegation of authority made or granted under the Act. The Medicines and Allied Substances Control Act empowers the Medicines Control Authority to delegate its powers to its executive committee and inspectors. The Executive Committee and the inspectors report to the Authority, which reports to the Minister of Health.