South Africa: Score Justification Summary

1.1.1a National plan for AMR priority pathogens

Score: 100

There is evidence that South Africa has a national AMR plan for the surveillance, detection and reporting of priority pathogens. The Department of Health has the 'Antimicrobial Resistance National Strategy Framework: A One Health approach 2018 – 2024'. This plan outlines key strategic objectives, of which no. 3 is to "Optimise surveillance and early detection of AMR". ¹ As of June 2025, South Africa has not officially released a new national Antimicrobial Resistance (AMR) strategy to succeed the previous framework.
The WHO Strategic Partnership for Health Security and Emergency Preparedness (SPH) Portal reports a active plan: ”National AMR action plan developed”. ²

1.1.1b Capacity of national lab/lab system to test for AMR priority pathogens

Score: 100

There is publicly available evidence of a national laboratory/laboratory system which tests for all 7+1 priority AMR pathogens in South Africa. The National Health Laboratory Service (NHLS) has designated sentinel sites, which test for all priority AMR pathogens, namely the ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter spp., Escherichia coli) and Mycobacterium tuberculosis. ³⁴⁵ The NHLS has laboratories in all nine provinces and has the responsibility of supporting the national and provincial health departments in healthcare delivery. It also provides laboratory and related public health services to over 80% of the population through a national network of laboratories. Its specialised institutes include the National Institute for Communicable Diseases (NICD), the National Institute for Occupational Health (NIOH), and the South African Vaccine Producers (SAVP) among others as its subsidiaries. ⁶

1.1.1c National environmental surveillance for AMR residues/organisms

Score: 0

There is insufficient evidence that the government of South Africa conducts environmental detection or surveillance activities for antimicrobial residues or AMR organisms. The Joint External Evaluation for South Africa, conducted in 2017, details a existing surveillance system for AMR pathogens, but does not include mention of environmental surveillance. ⁷ There is national legislation governing water quality, existing in paragraph 137 of the National Water Act of 1998. This stipulates that the Ministry of Water and Sanitation is responsible for the establishment of a monitoring system of surface water, with a focus on water quality. This legislation does not, however, mention specific testing for AMR organisms. ⁸ Monitoring programmes run by the Department of Water and Sanitation (DWS) include the National Microbial Monitoring Programme (NMMP), which assesses trends of faecal pollution and associated health risks, but again, does not specifically mention environmental detection or surveillance activities. ⁹ The National Action Plan objectives of DoH include "monitoring water quality by performing microbiological, physical and chemical tests for fitness for human consumption through a sampling process" and "waterborne and sanitation related disease surveillance" in its sub-objective 4.4 (Environmental Health and Water Quality monitoring). ¹⁰ The 2021 Surveillance Reports for Antimicrobial Resistance and Consumption of Antimicrobials acknowledges that "surveillance within the water-plant-food interface remains limited". ¹¹

1.1.2a National law(s) requiring prescription for antibiotic use (humans)

Score: 50

There is national legislation in place in South Africa requiring prescriptions for antibiotic use for humans. The Medicines and Related Substances Act is the national classification system that controls how medicines are made available to the public. ¹² Most antibiotics are classified under Schedule 4, meaning that they require a prescription from a medical practitioner. ¹³ The Joint External Evaluation (JEE, 2025) for South Africa states that the country has guidelines and practices in place to ensure appropriate antimicrobial use in both public and private human healthcare facilities (P4.4. Optimal use of antimicrobial medicines in human health). ¹⁴ A pilot survey in 2022 concluded that "antibiotics were sold in privately owned pharmacies without a prescription in 80% (16/20) of cases while no antibiotics were dispensed in corporate (franchised) pharmacies" which highlights gaps in the enforcement of the legislation. ¹⁵

1.1.2b National law(s) requiring prescription for antibiotic use (animals)

Score: 0

There is insufficient legislation that requires the prescription of antibiotics to animals, because the regulatory framework is dualistic, allowing certain antibiotics to be accessed without a veterinary prescription under specific conditions. The latest legislation in this regard is covered in the Antimicrobial Resistance National Strategy Framework: A One Health approach 2018-2024. The document states that "antimicrobials intended for use in animals and registered under Act 101 (Medicines and Related Substances, 1965) can only be administered or prescribed by a veterinarian". ¹⁶¹⁷ The Act controls how medicines are made available to doctors and veterinarians. Antibiotics generally require a prescription from a medical practitioner, ¹⁸¹⁹ but the Fertilisers, Farm, Feeds, Agricultural Remedies and Stock Remedies Act of 1947 does allow the sale of antimicrobials without a prescription as a feed additive. The Department of Health (DoH) does note this practice as being a contributing factor to AMR and is reviewing the relevant regulations. ²⁰²¹ The Joint External Evaluation for South Africa, conducted in 2017, states that South Africa is lacking in this regard ²². A March 2020 article from the Journal of Global Antimicrobial Resistance states, "It is estimated that antibiotic utilisation will increase 67% by the year 2030, with almost twice this increase in countries such as China, Brazil, India, South Africa and Russia". A 2021 study in PeerJ lists many other factors for veterinarians to prescribe antibiotics beside clinical signs and symptoms: "the choice of antimicrobials depended on the cost of antibiotics (77.2%), route of administration (81.5%), and risk of potential adverse reactions (79.6%)". ²³²⁴ Although South Africa has developed and implemented a Antimicrobial Resistance National Strategy Framework for 2018-2024, with one of the strategic objectives being to promote the appropriate use of antimicrobials in human and animal health, and recommendations are listed in 5.3.3 of the South African Veterinary Strategy (2016-2026), there is no evidence that there have been significant progress on strategic aims, or new regulations issued. ²⁵²⁶

1.2.1a Laws/plans on zoonotic disease

Score: 100

South Africa has both a national law, and protocols, on zoonotic diseases. In the Animal Health Act of 2002, although zoonotic disease is never specifically referred to, animal disease is defined as "a impairment or disturbance of the normal function of any organ or the body of any animal that is caused by any protozoon, bacterium, virus, fungus, prion, rickettsia, parasite, other organism or substance". This includes all zoonotic diseases, and comprehensive control measures are referred to in Section 28 (1) of the Act. ²⁷ The Joint External Evaluation for South Africa, conducted in 2017, found that "all zoonotic diseases of relevance have been prioritized and legislated as notifiable to both human and animal health authorities" and that a "standard operating procedure (SOP) exists for detecting and responding to priority zoonotic diseases, with ongoing situation reports and laboratory reports also shared as necessary". ²⁸ The Department of Health (DoH) has developed the Antimicrobial Resistance National Strategy Framework: A One Health approach 2018-2024, which states that "Controlled and Notifiable Diseases including zoonotic disease which impact human health are already reported to Directorate of Animal Health within Department of Agriculture, Forestry and Fisheries (DAFF)". ²⁹ The Department of Agriculture, Land Reform and Rural Development has protocols in place to control the spread of certain animal diseases. ³⁰ The National Vector Control Strategy (2023–2027) primarily focuses on vector-borne diseases, but it recognizes the significance of zoonotic diseases transmitted by vectors. It aims to strengthen integrated vector management and surveillance systems to mitigate the risk of zoonotic disease outbreaks. ³¹

1.2.1b Laws/plans on zoonotic disease spillover from animals to humans

Score: 0

There is no publicly available evidence that South Africa has plans or equivalent strategy document(s) which include measures for risk identification and reduction for zoonotic disease spillover events from animals to humans. The National Vector Control Strategy (2023–2027) recognizes the significance of zoonotic diseases transmitted by vectors, however, it lacks specific provisions for spillover risk assessment and mitigation. ³² The National Institute for Communicable Diseases (NICD) operates a Centre for Emerging Zoonotic and Parasitic Diseases (CEZPD) whose objectives include supporting "control, surveillance, detection and outbreak response systems for emerging zoonotics and parasitic diseases" but has no countermeasures listed. ³³ No further information could be found in the Joint External Evaluation report of 2017 ³⁴, or on the websites of the ministries of Health ³⁵ or Agriculture ³⁶.

1.2.1c Laws/plans for surveillance & control of multiple zoonotic pathogens

Score: 100

There is evidence that South Africa has national plans, guidelines, or laws that account for the surveillance and control of multiple zoonotic pathogens of public health concern. The Animal Diseases Act of 1984 sets the requirement that owners of livestock must monitor their animals and report on disease surveillance to the central government. Specifically, section 17 of the Act mandates that when animals "has become or can reasonably be suspected of having become infected with a controlled animal disease, immediately report such incidence in the prescribed manner to the national executive officer and provincial executive officer". ³⁷ The National Health Act of 2003 supports disease surveillance, including zoonoses, through the Department of Health (DoH) and the National Institute For Communicable Diseases (NICD). ³⁸ The recent Joint External Evaluation (JEE, 2025) finds that South Africa's 2016 list of prioritized zoonotic diseases requires updating to address evolving epidemiology, but strong cross-sectoral communication, rapid response mechanisms, and comprehensive legislation aligned with Codex Alimentarius support effective management of zoonotic threats (page 22). ³⁹ Furthermore, there are Guidelines on Management and Control of Human Anthrax in South Africa. ⁴⁰ The Department of Health issued a document in 2015 (National guidelines for recognition and management of Viral Haemorrhagic Fevers), which includes surveillance and control measures for Lassa fever, Rift Valley Fever, Chikungunya and Ebola among others. ⁴¹ There is no publicly accessible information that the Department of Agriculture (DoA) has a national plan covering zoonotic diseases. The DoA does publish protocols aimed at restricting contagion of animal diseases. ⁴²

1.2.1d Cross-ministerial department/agency/unit for zoonotic disease

Score: 0

There is a dedicated departmental unit for zoonotic diseases in South Africa, but there is no evidence that this unit functions across ministries. The Centre for Emerging Zoonotic and Parasitic Diseases (CEZPD) operates within the National Institute for Communicable Diseases (NICD). The NICD falls under the National Health Laboratory Service. ⁴³ CEZPD aims to be the national and international centre of excellence for emerging and re-emerging zoonotic diseases. The official aim of the CEZPD is to function as a resource for knowledge and expertise to the South African government and assist in the planning and implementation of relevant policies and programs, as well as harness innovation in science and technology to support the surveillance, detection and the outbreak response systems. ⁴⁴ The One Health Program in South Africa is a cross-ministerial initiative led by the Department of Health (DoH), the Department of Agriculture, Land Reform and Rural Development (DALRRD), and NICD, anchored in the National One Health Forum, but it is not a independent department or agency. ⁴⁵

1.2.1e Presence of One Health strategic plan

Score: 0

South Africa does not have a One Health strategy but is in the process of developing one.⁴⁶ The Joint External Evaluation (JEE, 2025) for South Africa recommends that the country should finalize the One Health Strategy, standardize One Health preparedness and response activities at national and provincial levels, and create a directory of members.⁴⁷

1.2.2a Surveillance/reporting mechanism for zoonotic disease for livestock owners

Score: 100

There is a national law in place that requires livestock owners to conduct disease surveillance of animals, as well as a manual to assist with the implementation of a national reporting system. The Animal Health Act of 2002 sets out clear legal obligations for owners of animals to report signs or suspicion of controlled and notifiable animal diseases. Specifically, Section 17 of the Act requires any person who suspects that a animal ”has become or can reasonably be suspected of having become infected with a controlled animal disease, immediately report such incidence in the prescribed manner to the national executive officer and provincial executive office”. ⁴⁸ To support implementation, the Department of Agriculture, Land Reform and Rural Development (DALRRD) maintains the Animal Disease Reporting Manual. The current version (2016) states "All outbreaks or suspected outbreaks of diseases that might warrant a emergency response (listed in the manual) must be reported on the correct form (included at the end of this document) within 24 hours of detection. Animal owners and animal health technicians must notify the state vet of the area immediately". The manual further specifies that provinces are encouraged, but not legally required, to report all World Organisation for Animal Health (WOAH, formerly OIE) diseases not explicitly listed in the Act. ⁴⁹

1.2.2b Laws/regulations on data confidentiality to protect livestock owners

Score: 100

South Africa provides legal safeguards for the confidentiality of information generated through animal disease surveillance, ensuring privacy and professional discretion. The Animal Health Act of 2002 explicitly protects information obtained via surveillance: Section 25 prohibits anyone from disclosing business- or occupation-related information acquired under the Act, unless disclosure is necessary to enforce the Act or it is required for legal proceedings or a court orders disclosure or the Minister authorises it in the public interest or it is required by another law. ⁵⁰

1.2.2c Wildlife zoonotic disease surveillance

Score: 100

There is publicly available evidence that South Africa conducts surveillance of zoonotic disease in wildlife (e.g., wild animals, insects, other disease vectors), poultry and livestock. The National Institute for Communicable Diseases (NICD) runs mosquito-based malaria vector surveillance and publishes reports summarising nationwide mosquito collections and pathogen testing. ⁵¹ The NICD's Centre for Emerging Zoonotic and Parasitic Diseases itself states that it undertakes "surveillance of drug-resistant malaria and vector control strategies in South Africa". ⁵² a answer from the Minister of Forestry, Fisheries and the Environment reports that South African National Parks veterinarians "take samples and analyse them for disease surveillance purposes" in free-ranging wildlife. ⁵³ A 2023 government surveillance bulletin records active and passive surveillance for backyard and commercial chickens, ostriches and mentions that since 2021, non-poultry (wild bird) events are also reportable (2.2.2). ⁵⁴ As for livestock, routine surveillance is demonstrated by the Department of Agriculture's "Foot and Mouth Disease Outbreak and Surveillance Update" reports. ⁵⁵ The 2025 Joint External Evaluation (JEE) reports that strong legislation underpins surveillance and rapid response in both the animal and human health sectors; however, some departments still lack online monitoring systems, which can cause delays. ⁵⁶

1.2.3a Annual reporting to OIE on zoonotic disease incidence

Score: 100

There is publicly available evidence of a mechanism for reporting notifiable diseases to The World Organisation for Animal Health (WOAH). The World Animal Health Information System (WAHIS, run by the World Organisation for Animal Health [WOAH]) shows animal disease events from South Africa from every year since 2005, and biannual reports from every year since 2007 ⁵⁷⁵⁸.

1.2.4a Number of veterinarians per 100,000 people

Score: 7.37

1.2.4b Number of veterinary para-professionals per 100,000 people

Score: 3.27

1.2.5a Inclusion of private sector in national plan/law on zoonotic disease

Score: 0

There is no national legislation, regulation, or strategy in South Africa that mandates public–private mechanisms for controlling or responding to zoonotic diseases. However, voluntary collaboration with the private sector is encouraged and occurs in practice through the national One Health Program and sectoral initiatives. South Africa’s Veterinary Strategy, published by the Department of Agriculture, Land Reform and Rural Development (DALRRD), acknowledges the absence of formal mechanisms for engaging the private sector in zoonotic disease control: "The industry proposed creation of a disease control agency (private-public-partnership) which will cater for the development of VS with regard to disease management" ⁵⁹ The Joint External Evaluation (JEE) for South Africa, completed in 2017, makes no mention of any mechanisms for working with the private sector in controlling or responding to zoonoses. ⁶⁰ The One Health Program (coordinated by the National Department of Health (DoH) and DALRRD, operational since 2014) fosters cross-sectoral collaboration between the public sector, academic institutions, and private veterinarians. Although it includes non-state actors, participation is voluntary, and there is no legal obligation or defined protocol governing private sector roles in outbreak response or surveillance. ⁶¹ No further information could be found in the Animal Health Act of 2002. ⁶²

1.3.1a Updated national records of especially dangerous pathogen/toxin inventories

Score: 0

There is no sufficient evidence that South Africa has a record, updated within the past 5 years, of facilities in which dangerous substances are stored or processed or inventories thereof. The 2025 Joint External Evaluation (JEE) for South Africa finds that laboratories that handle human or animal health work must be officially registered or approved by the relevant authorities and moving pathogens, GMOs, or any biological samples requires a government-issued transfer permit (page 28), but no central database is mentioned. ⁶³ Some government agencies keep records of facilities and substances in their own capacity. Regulations under the National Health Act of 2003 require entities handling human pathogens to apply for licenses; the Department of Health (DoH) keeps these records but regular updates are not required except in the case of acquisitions or imports. ⁶⁴ The Department of Agriculture, Forestry and Fisheries (DAFF, now Department of Agriculture) requires laboratories to register substances on their lists of pathogens and toxins. ⁶⁵ The Department of Trade Industry and Competition (DTIC) requires registration of entities in charge of any activity involving its own list of controlled biological materials, and changes to registration information should be submitted within 14 days. ⁶⁶ Although South Africa has submitted Confidence Building Measures every year since 2006 under the Biological Weapons Convention (BWC), access to the reports is restricted, and the text is not publicly available. ⁶⁷

1.3.1b Biosecurity laws on facility security for especially dangerous pathogens

Score: 100

There is evidence that South Africa has in place regulations related to biosecurity which address requirements such as physical containment, operation practices, failure reporting systems, and/or cybersecurity of facilities in which especially dangerous pathogens and toxins are stored or processed. Government Notice R.1887 of 16 March 2022 (GG 46051) classifies pathogens into Risk Groups 1–4 and make it illegal to handle Groups 2-4 organisms unless the facility meets the specified biorisk requirements. Key clauses include: operation practices (sections 4-15), failure reporting systems (section 5) and physical containment (sections 10-11, 13, 15). ⁶⁸ This is also acknowledged by the 2025 Joint External Evaluation (JEE, page 28). ⁶⁹

1.3.1c Agency for enforcement of biosecurity laws/regulations

Score: 100

The Department of Agriculture, Land Reform and Rural Development (DALRRD) enforces biosecurity legislation through a structured, multi-layered framework grounded in statutory authority, operational protocols, and on-the-ground oversight. Under the Animal Health Act of 2002, DALRRD is empowered to establish and manage quarantine stations at borders or points of entry for animals and animal products, issue import permits and set strict conditions for the movement, inspection, detention, and release of animals, livestock products, and related conveyances. ⁷⁰⁷¹ Travellers and traders must comply with rigorous biosecurity import requirements, enforced by DALRRD alongside other agencies. The Border Management Authority (BMA) is tasked with intercepting and inspecting high-risk biological materials at all official entry points. ⁷²⁷³ The 2022 Task Team report on animal biosecurity (appointed by the DALRRD minister) pointed out "poor controls and enforcement of regulations" and "poor coordination". ⁷⁴ In August 2025, the government announced the formation of a Biosecurity Council, intended as a inter-agency coordinating body. ⁷⁵

1.3.1d Consolidation of especially dangerous pathogens into minimum # of facilities

Score: 50

There is public evidence that shows that South Africa has taken action to consolidate its inventories of especially dangerous pathogens and toxins into a minimum number of facilities, but no evidence of active steps to reduce the number of facilities permitted to hold pathogens. The most recent Joint External Evaluation (JEE, 2025) states that high-consequence agents are consolidated in as few facilities as possible following thorough assessments using a biosafety level (BSL) checklist and that only a limited number of laboratories are authorized to hold these pathogens (P7.1. Whole-of-government biosafety and biosecurity system is in place for human, animal and agriculture facilities). ⁷⁶ The 2022 Hazardous Biological Agents Regulations control the types of materials and number of laboratories that can handle them, limiting the number of facilities that deal with especially dangerous pathogens. ⁷⁷ There is no evidence, however, of active steps to reduce the number of facilities permitted to hold pathogens on the websites of the Department of Health, the Department of Agriculture, the Department of Forestry, Fisheries and the Environment, the Department of Trade, Industry and Competition, the Department of Science, Technology and Innovation or the Verification Research, Training & Information Centre (VERTIC). ^787980818283. Although South Africa has submitted Confidence Building Measures every year since 2006 under the Biological Weapons Convention (BWC), access to the reports is restricted, and the text is not publicly available. ⁸⁴

1.3.1e Capacity to conduct tests for anthrax/Ebola without culturing live pathogens

Score: 100

There is public evidence of South Africa having the capacity to conduct Polymerase Chain Reaction (PCR)-based diagnostic testing for anthrax and Ebola, which would preclude culturing a live pathogen. The National Institute for Communicable Diseases (NICD) has the capacity to conduct testing for especially dangerous pathogens including anthrax and Ebola. ⁸⁵⁸⁶
Testing for especially dangerous pathogens is available at the NICD's Centre for Emerging Zoonotic and Parasitic Diseases (CEZPD), which has a special viral pathogens laboratory. ⁸⁷

1.3.2a Biosecurity training using a standardised, required approach

Score: 0

There is no publicly available evidence that South Africa requires biosecurity training, using a standardized, required approach, such as through a common curriculum or a train-the-trainer program, for personnel working in facilities housing or working with especially dangerous pathogens, toxins, or biological materials with pandemic potential. The country does require training for everyone working with Hazardous Biological Agents (HBAs) in the 2022 HBA Regulations (section 4). ⁸⁸ However, no standardized approach, no common curriculum or train-the-trainer program is known. South Africa's 2025 Joint External Evaluation (JEE) notes that the National Institute for Communicable Diseases (NICD) and other reference laboratories provide regular biosafety/biosecurity courses but the country lacks a standardized cross-sector curriculum for biosafety and biosecurity training and it should develop a national biorisk-management curriculum to ensure consistent access to standardized training (P7.2. Biosafety and biosecurity training and practices in all relevant sectors [including human, animal and agriculture]). ⁸⁹ There is no publicly available evidence on a consolidated training curriculum on the websites of the Department of Health, the Department of Agriculture, the Department of Forestry, Fisheries and the Environment, the Department of Trade, Industry and Competition, the Department of Science, Technology and Innovation or the Verification Research, Training & Information Centre (VERTIC). ^909192939495. Although South Africa has submitted Confidence Building Measures every year since 2006 under the Biological Weapons Convention (BWC), access to the reports is restricted, and the text is not publicly available. ⁹⁶

1.3.3a Personnel checks for permission to access to especially dangerous pathogens

Score: 0

There is no publicly available evidence of the existence of regulations and licensing conditions that require drug testing, background checks or psychological fitness checks for personnel at facilities with biological materials that could cause pandemics. The manuals for laboratory approvals from the Department of Agriculture (DoA) do not list these checks as a requirement. ⁹⁷ The South African National Accreditation System (SANAS), the national standards agency, works with DoA to approve laboratories according to the international standard ISO/IEC 17025:2017(en). Accreditation is based on the quality and safety of physical environment, laboratory equipment and procedures, rather than security. ⁹⁸⁹⁹ There is no evidence of drug testing, background checks or psychological fitness checks related specifically to biosecurity on the websites of the Department of Health, the National Health Laboratory Service (NHLS), or the National Institute for Communicable Diseases (NICD) within the NHLS. ^100101102 The NHLS states on its careers page that "candidates may be required to undergo competency/psychometric assessments" and "will be subjected to criminal record checks, citizen verification, financial record checks, qualification/study verification, previous employment verification, and social media accounts behavior/comments verifications" but no information is provided on the content or the reason of these checks. ¹⁰³ Nothing in the 2025 Joint External Evaluation for South Africa suggests that personnel are subject to these checks (P7. Biosafety and biosecurity). ¹⁰⁴ There is no publicly available evidence on the websites of the Department of Agriculture (DoA), the Department of Defence (DoD), the National Laboratory Association of South Africa (NLA-SA) or the Verification Research, Training and Information Centre (VERTIC) that personnel are subject to drug testing, background checks or psychological testing. ^105106107108 Although South Africa has submitted Confidence Building Measures in 2025 under the Biological Weapons Convention, access to the report is restricted, and the text is not publicly available. ¹⁰⁹

1.3.4a National transport regulations for Category A and B infectious substances

Score: 100

South Africa has a comprehensive, publicly accessible framework for the safe and secure transport of infectious substances, including both Category A (UN 2814, UN 2900) and Category B (UN 3373), through a combination of national regulations, sector‐specific rules, and published standards. Road transport regulations: the “Regulations relating to the Transportation of Dangerous Goods and Substances by Road” (GNR 103 of 12 October 2001) implement the UN Model Regulations (ADR) domestically. These regulations explicitly require consignors and carriers to classify, package, mark and document infectious substances according to UN 2814, UN 2900 and UN 3373, and to comply with applicable South African National Standards (SANS), such as SANS 10228 (classification) and SANS 10231 (vehicle and operational requirements). ^110111112 Civil aviation regulations: under the Civil Aviation Act, Part G of the Civil Aviation Regulations (“Security and Carriage of Cargo and Dangerous Goods”) mandates compliance with ICAO’s Technical Instructions for the Safe Transport of Dangerous Goods by Air. It requires all air operators to accept, handle and carry infectious substances only when properly classified, packaged, labeled and declared in accordance with international standards. ¹¹³¹¹⁴ Maritime transport regulations: the Merchant Shipping (Dangerous Goods) Regulations, issued under the Merchant Shipping Act 57 of 1951, provide for the safe carriage of all classes of dangerous goods by sea, including infectious substances (Class 6.2). These regulations specify packaging, documentation, marking and stowage requirements aligned with the IMDG Code (ICAO-equivalent for maritime). ^115116117

1.3.5a Laws/regulations on cross-border transfer and end-user screening

Score: 100

South Africa has a legal framework to manage cross-border transfer and end-user screening of especially dangerous pathogens and toxins, including those with pandemic potential. The National Health Act of 2003 and Regulation R9699 of 2012 (GNR 35099, No. 35099) specifically regulate import, export, acquisition, storage, transfer, and usage of human pathogens of biosafety levels 3-5. They require the issuance of import/acquisition permits valid for single transaction and written consent from both supplier and receiver labs before any pathogen transfer. These rules explicitly cover cross-border transfers through import permits. ¹¹⁸¹¹⁹ Under the National Health Act and Notice 1229 of 2015 (GNR 1229, No. 39561) Port Health Services implement regulations at all points of entry (ports, airports, border posts), covering inspection and permitted or prohibited goods and cargo, thus providing a legal basis for controlling incoming shipments that may contain dangerous pathogens or toxins. ¹²⁰ The Non-Proliferation of Weapons of Mass Destruction Act of 1993 establishes the South African Council for Non-Proliferation and regulates "controlled goods", including biological agents and toxins, through a permit and inspectorate system. Facilities must obtain permits for import/export, and border/customs authorities are empowered to enforce. It forms part of South Africa’s implementation of UNSCR 1540 and the Biological Weapons Convention. ¹²¹¹²² Under Regulation R9699, for BSL 3–5 pathogens, every acquisition/import requires a permit, and the receiving lab must already be registered at the correct BSL level. These permit applications require submission of detailed usage plans and host institutional BSL certification; the Director-General reviews and may conduct inspections to verify intended end-use. ¹²³ The Non-Proliferation Act enables designated inspectors to verify permits, inspect facilities, and assess whether "controlled goods" (including pathogens and toxins) are being delivered to approved end-users. The permit requirement and border scrutiny form a control barrier against illicit transfers. ¹²⁴

1.4.1a Biosafety laws/regulations

Score: 100

South Africa has in place national biosafety legislation and regulations, particularly focused on the safe handling of genetically modified organisms (GMOs), biological materials, and pathogens with dual-use potential. These legal instruments are implemented through multiple acts and supporting regulations that are actively in force. South Africa’s principal biosafety legislation is the Genetically Modified Organisms Act 15 of 1997, which has been amended and is currently in force. This Act regulates the development, production, use, and application of GMOs to ensure environmental and human health safety. Its most recent amendments, including the 2006 update and 2010 regulations, introduced stricter compliance mechanisms and brought South Africa in line with international biosafety frameworks such as the Cartagena Protocol on Biosafety (to which South Africa is a party). ^125126127 The National Health Act of 2003, particularly its provisions on health laboratories and communicable diseases, gives the Minister of Health the authority to regulate the handling of dangerous pathogens and clinical specimens. ¹²⁸ The Animal Health Act of 2002 governs biosafety with regard to zoonotic diseases and veterinary laboratories. The Act is in force and mandates notification and control measures for listed animal diseases that could have biosafety implications. ¹²⁹ The World Health Organisation's (WHO) most recent Joint External Evaluation (JEE) for South Africa (2017) confirms that South Africa has established biosafety and biosecurity frameworks. The report highlights that there are legal provisions for laboratory biosafety, pathogen control, and dual-use research regulation. However, it also notes gaps in national-level coordination and the need for a comprehensive biosafety strategy. ¹³⁰ South Africa has ratified the Biological and Toxin Weapons Convention (BTWC) and has enacted supporting legislation to implement its obligations, including measures relevant to biosafety. According to the VERTIC BWC Legislation Database, South Africa has enforceable legal measures to prohibit and control biological weapons and related materials, which overlap with biosafety and biosecurity regulatory frameworks. ¹³¹¹³²

1.4.1b Agency for enforcement of biosafety laws/regulations

Score: 100

South Africa has established agencies responsible for the enforcement of biosafety legislation and regulations. The core functions related to biosafety are primarily carried out by the Department of Health (DoH) and the Department of Agriculture, Land Reform and Rural Development (DALRRD). The Department of Health (DoH) is responsible for biosafety enforcement in the human health sector, particularly in relation to pathogen handling, laboratory containment, and the prevention of laboratory-acquired infections. The legal basis is the National Health Act 61 of 2003, which, in Section 90 (1), mandates the regulation and licensing of health establishments, including laboratories handling hazardous biological materials. ¹³³ The National Institute for Communicable Diseases (NICD) enforces biosafety standards in its high-containment laboratories (BSL-3 and BSL-4). ¹³⁴ The NICD provides national guidelines on biosafety practices and biosafety level requirements, conducts risk assessments, and ensures personnel training and waste management. ¹³⁵ The National Health Laboratory Service Act of 2000 governs the National Health Laboratory Service (NHLS) and NICD. ¹³⁶ The DALRRD enforces biosafety regulations related to genetically modified organisms (GMOs) and agricultural biotechnology. The central law in this domain is the Genetically Modified Organisms Act of 1997, which is in force and has been amended several times to enhance risk assessment and enforcement provisions. ¹³⁷ The WHO Joint External Evaluation (2017) confirms the existence of established institutional roles for biosafety in South Africa. The JEE specifically evaluates biosafety capacity, finding that the country maintains national biosafety standards and guidelines aligned with WHO and international norms, particularly in high-containment facilities. ¹³⁸

1.4.2a Biosafety training using a standardised, required approach

Score: 0

There is no publicly available evidence that South Africa requires biosafety training, using a standardized, required approach, such as through a common curriculum or a train-the-trainer program, for personnel working in facilities housing or working with especially dangerous pathogens, toxins, or biological materials with pandemic potential. The country does require training for everyone working with Hazardous Biological Agents (HBAs) in the 2022 HBA Regulations (section 4). However, no standardized approach, no common curriculum or train-the-trainer program was identified in the document. ¹³⁹ South Africa's 2025 Joint External Evaluation (JEE) notes that the National Institute for Communicable Diseases (NICD) and other reference laboratories provide regular biosafety/biosecurity courses but the country lacks a standardized cross-sector curriculum for biosafety and biosecurity training and it should develop a national biorisk-management curriculum to ensure consistent access to standardized training (P7.2. Biosafety and biosecurity training and practices in all relevant sectors [including human, animal and agriculture]). ¹⁴⁰ There is no publicly available evidence on a consolidated training curriculum on the websites of the Department of Health, the Department of Agriculture, the Department of Forestry, Fisheries and the Environment, the Department of Trade, Industry and Competition, the Department of Science, Technology and Innovation or the Verification Research, Training & Information Centre (VERTIC). ^{141142143144145146}. Although South Africa has submitted Confidence Building Measures every year since 2006 under the Biological Weapons Convention (BWC), access to the reports is restricted, and the text is not publicly available. ¹⁴⁷

1.5.1a Evidence of national assessment of dual-use research

Score: 0

There is no publicly available evidence that South Africa has conducted a assessment to determine whether ongoing research is occurring with regard to especially dangerous pathogens, toxins, pathogens with pandemic potential, and/or other dual-use research. The Joint External Evaluation (JEE) report for South Africa (2017) concludes that the country lacks assessment on dual-use research, although the South African Council for Non-Proliferation of Weapons of Mass-Destruction (under the Department of Trade and Industry) registers facilities holding dangerous agents and technologies. ¹⁴⁸ There is no evidence of dual-use research assessments being conducted by the National Health Research Ethics Council (NHREC) and its guidelines do no refer to dual-use. ¹⁴⁹ There is no additional information on the websites of the Department of Health (DoH), the Department of Defence, the Department of Agriculture, or the Department of Science, Technology and Innovation. ^150151152153 No further information could be found on the Verification Research, Training & Information Centre (VERTIC) website. ¹⁵⁴ Although South Africa has submitted Confidence Building Measures every year under the Biological Weapons Convention, access to the report is restricted, and the text is not publicly available. ¹⁵⁵

1.5.1b National law/regulation on oversight of dual-use research

Score: 0

South Africa does not have legislation requiring oversight of research with especially dangerous pathogens, toxins, pathogens with pandemic potential and/or other dual-use research. The Joint External Evaluation (JEE) report for South Africa (2017) concludes that the country lacks legislation on dual-use research, although the South African Council for Non-Proliferation of Weapons of Mass-Destruction (under the Department of Trade and Industry) registers facilities holding dangerous agents and technologies. ¹⁵⁶ There is no evidence of dual-use research regulation by the National Health Research Ethics Council (NHREC) and its guidelines do no refer to dual-use. ¹⁵⁷ There is no additional information on the websites of the Department of Health (DoH), the Department of Defence, the Department of Agriculture, or the Department of Science, Technology and Innovation. ^158159160161 No further information could be found on the Verification Research, Training & Information Centre (VERTIC) website. ¹⁶² Although South Africa has submitted Confidence Building Measures every year under the Biological Weapons Convention, access to the report is restricted, and the text is not publicly available. ¹⁶³

1.5.1c Existence of agency responsible for oversight of dual-use research

Score: 0

There is no publicly available evidence that South Africa has a agency responsible for oversight of research with especially dangerous pathogens, toxins, pathogens with pandemic potential and/or other dual-use research. The Joint External Evaluation (JEE) report for South Africa (2017) concludes that the country lacks legislation on dual-use research, although the South African Council for Non-Proliferation of Weapons of Mass-Destruction (under the Department of Trade and Industry) registers facilities holding dangerous agents and technologies. ¹⁶⁴ There is no evidence of dual-use research regulation by the National Health Research Ethics Council (NHREC) and its guidelines do no refer to dual-use. ¹⁶⁵ There is no additional information on the websites of the Department of Health (DoH), the Department of Defence, the Department of Agriculture, or the Department of Science, Technology and Innovation. ^166167168169 No further information could be found on the Verification Research, Training & Information Centre (VERTIC) website. ¹⁷⁰ Although South Africa has submitted Confidence Building Measures every year under the Biological Weapons Convention, access to the report is restricted, and the text is not publicly available. ¹⁷¹ Minimal oversight is secured under the Occupational Health and Safety Act of 1993 and the Regulations for Hazardous Biological Agents (Government Notice R 1390 of December 2001), as its scope is "every employer and self-employed person at a workplace where HBA [hazardous biological agents] is deliberately produced, processed, used, handled, stored or transported" (Section 2. (2)a). ¹⁷²¹⁷³

1.5.2a Requirement to screen synthesised DNA against list prior to sale

Score: 0

There is no publicly available evidence that South Africa has any national legislation, regulations, policies, or other guidance requiring the screening of synthesised DNA before it is sold. In the past years, legislation has been predominantly focused on Genetically Modified Organisms (GMOs), which are also the focus of Biosafety South Africa, a public body under the Department of Science, Technology and Innovation (DSTI) which advises stakeholders on biosafety and risk analysis best practice. ^174175176 Risks related to synthesised DNA are neither addressed in a Bio-Economy Strategy published by the DSTI in 2014 or its Bioeconomy Portal, nor is there any public evidence of requirements for screening of synthesised DNA before it is sold in the other legislation or policy documents published by the DSTI, Department of Health, the Ministry of Agriculture or the Ministry of Defence. ^{177178179180181182} There is also no mention of such a policy in the Joint External Evaluation for South Africa (2017). ¹⁸³ No further information could be found on the Verification Research, Training & Information Centre (VERTIC) website. ¹⁸⁴ Although South Africa has submitted Confidence Building Measures in the past under the Biological Weapons Convention, access to the reports is restricted, and the text is not publicly available. ¹⁸⁵

1.6.1a Immunization rate for humans (measles/MCV2)

Score: 50

1.6.1b Availability of vaccination figures for livestock (FMD) through OIE database

Score: 100

There are official foot-and-mouth disease (FMD) vaccination figures for livestock publicly available through the WOAH database. FMD vaccination data is available, however only until 2008. ¹⁸⁶

1.6.1c Equitablenature of national immunization strategy/plan

Score: 100

There is evidence that a national immunization strategy/plan exists in South Africa. The current plan is the Expanded Programme on Immunisation in South Africa (EPI-SA) Policy Framework (2015) with two companion implementation tools: the Vaccinator's Manual and a Revised Childhood Immunisation Schedule, issued by the Department of Health. It aims to "achieve fully immunised coverage for children below 1 year of 95% at national level and 90% in all districts by the year 2015 and 98% at national level by the year 2018" and to "ensure universal access to quality immunisation services" (page 6). The programme includes vaccines for eleven preventable diseases. Equity strategies are present in the plan, including the Reach Every District (RED) Strategy (Modules 11, 14). ¹⁸⁷¹⁸⁸ A new national-level immunisation strategy (National Immunization Strategy and Immunization Agenda 2030) is finalised but still awaiting the Minister's formal endorsement and full roll-out – reported by the 2025 Joint External Evaluation (JEE) by the WHO (page 31). ¹⁸⁹

1.6.1d Vaccine hesitancy and build public trust coverage in vaccines in national immunization strategy/plans

Score: 100

There is evidence that the national immunization strategy/plan includes measures to address vaccine hesitancy and build public trust in vaccines. The Expanded Programme on Immunisation in South Africa (EPI-SA) Policy Framework (2015, with two companion implementation tools: the Vaccinator's Manual and a Revised Childhood Immunisation Schedule) devotes a entire Module 11 to keeping "continuous support from community leaders, politicians, health professionals, the public and the media", recognising that a "successful EPI relies on commitment and continuous support" from those groups. The same module provides a detailed checklist headed "Important Information On Risk-Benefit Communication", telling vaccinators to discuss both the benefits and risks of vaccination. Module 10 details Communication Around Adverse Events, requiring continuous communication, honesty and a thorough investigation when a child dies after a immunization event (page 106). Section 13.3 orders that case definitions and health-promotion material "should be translated into local languages, which are clearly understood by the community and widely disseminated". Because these duties are embedded in mandatory modules, the EPI-SA actively manages vaccine hesitancy and fosters public trust. ¹⁹⁰ The 2025 Joint External Evaluation (JEE) report shows that these goals are not always met: reaching every child and attaining ≥95% coverage with measles-containing vaccine (MCV) remains challenging due to vaccine hesitancy, drop-outs, and insufficient community engagement (page 32). ¹⁹¹

1.6.1e National advisory group for immunization strategy/plan

Score: 100

There is evidence that a national advisory group exists that provides technical guidance and advice on the immunization strategy/plan to the government. The National Advisory Group on Immunisation (NAGI) serves as the country's standing, expert body that gives the government technical guidance on vaccines and the national immunisation strategy. The website of the Department of Health states "the NAGI will provide the department with ongoing and timely medical, scientific and public health advice relating to vaccines and a immunisation strategy". ¹⁹²

1.6.1f Presence of an immunization programme for influenza

Score: 100

There is evidence that South Africa has a immunization programme for influenza. South Africa's latest Primary Healthcare Standard Treatment Guidelines (STG) & Essential Medicines List's Chapter 13 (Immunisation) lists the influenza vaccine with dosage, target groups and detailed administration instructions. ¹⁹³ Operational evidence comes from the 2021-2022 Annual Report of the Department of Health, which reports that in that year "a total of 871,910 seasonal influenza vaccines were distributed and 612,848 (70.3%) vaccines were administered" (page 38). ¹⁹⁴ The latest Joint External Evaluation (2025) also confirms that the routine immunization schedule includes 13 antigens, covering childhood, adolescent, maternal, and influenza vaccinations as well (page 31). ¹⁹⁵ For a 2-year period, the Department of Health ordered around 2.5 million vaccines for public sector use (page 5). ¹⁹⁶ The vaccine is available free of charge in public clinics on first come, first-served basis to people falling into the risk groups and can also be purchased in the private sector for those who would like to protect themselves from influenza, according to a 2024 media statement from the government. ¹⁹⁷

1.7.1a Strategy/plan for resilience of health system

Score: 100

There is evidence that South Africa has a strategy or plan to develop a health system that is resilient to the challenges that climate change and changing seasonal weather patterns pose, that includes the threat of infectious diseases. The Department of Health (DoH) issued the National Climate Change & Health Adaptation Plan, which is a approved, government-led strategy that explicitly builds a climate-resilient health system and treats the evolving threat of infectious disease as a central climate-sensitive risk. The proposed activities are assigned to the DoH and other agencies, with time-frames, budgets and a monitoring framework. ¹⁹⁸ A 2024 DoH webinar slide deck notes that the "review of National Climate Change and Health Adaptation Plan 2014/19 to Climate change and health adaptation strategy and implementation plan" is still ongoing (slide 14). ¹⁹⁹

2.1.1a Capacity of national lab system to conduct 5 or more WHO core tests

Score: 100

South Africa's national laboratory has the capacity to conduct diagnostic tests for at least 5 of the 10 WHO-defined core tests. The National Health Laboratory Service (NHLS) 2024 Laboratory User Handbook lists all the tests (including, for example influenza, polio, HIV, tuberculosis, malaria, typhoid) in Table 25-1. ²⁰⁰

2.1.1b Plan to conduct testing during a public health emergency

Score: 50

There is evidence that there is a national strategy for conducting testing during a public health emergency, which includes considerations for testing for novel pathogens, planned scaling capacity, but no clear defining goals for testing. The 2009 National Guidelines on Epidemic Preparedness and Response (NGEPR) mentions "emergence of unknown/novel pathogens and re-emergence of infectious diseases of epidemic potential" in its preface. ²⁰¹ The COVID-19 playbooks then showed that South Africa can rapidly draft pathogen-specific tests (PCR and Ag-RDT validation) within that umbrella. ²⁰² NGEPR Annexure A lists "Provide laboratory surveillance and training [capacity development]" as a responsibility for National Health Laboratory Service (NHLS)/National Institute For Communicable Diseases (NICD). ²⁰³ The NHLS 2025-2030 Strategic plan also includes capacity increases for number of laboratories that are South African National Accreditation System (SANAS) accredited from 175 to 215. ²⁰⁴

2.1.2a Existence of an accredited national lab serving as a reference facility

Score: 100

There is publicly available evidence to show that the reference laboratories in South Africa under the National Health Laboratory Service (NHLS) are all accredited in accordance with ISO standards. NHLS laboratories are accredited by the South African National Accreditation System (SANAS) for compliance with international standards (ISO 15189:2012). ²⁰⁵ The recent Joint External Evaluation (JEE, 2025) by the World Health Organisation (WHO) has also confirmed that all national central laboratories have ISO 15189:2012 certification. ²⁰⁶

2.1.2b External quality assurance of a national lab serving as a reference facility

Score: 100

There is publicly available evidence that South Africa has a national laboratory that serves as a reference facility which is subject to external quality assurance review. The National Institute for Communicable Diseases (NICD), which is under the National Health Laboratory Service (NHLS), provides "reference diagnostic services and surveillance for communicable diseases such as influenza, poliomyelitis, tuberculosis and measles, among others". ²⁰⁷ The NICD is not only subject to external quality assurance (such as ISO 15189:2012 accreditation) but itself conducts the External Quality Assessment Programme (EQUAP) through which it evaluates other laboratories in the WHO Africa region. ²⁰⁸²⁰⁹ The Joint External Evaluation (JEE) for South Africa (2025) mentions high-level internal and external quality assurance for NHLS laboratories, including the NICD. ²¹⁰

2.2.1a Nationwide specimen transport system

Score: 100

South Africa's public-health laboratory network is served by a formally financed, nationwide specimen-referral and transport system operated through the National Health Laboratory Service (NHLS) and a panel of contracted couriers.
The recent Joint External Evaluation (JEE, 2025) by the World Health Organisation (WHO) explicitly states under its indicator D1.1. Specimen referral and transport system that the NHLS runs a government-funded, nationwide specimen referral network through its own labs and contracted couriers, ensuring swift transport for human health samples and priority animal disease tests. ²¹¹ The system is based on the National Health Laboratory Service Act of 2000 whose Section 5(1)(a) obliges the NHLS to "establish, operate, maintain and coordinate laboratories and related undertakings" required for those services. This language is what gives NHLS its legal mandate to run the courier network that moves specimens between hundreds of facilities and the NHLS laboratories. ²¹² NHLS lists the actual courier services on its website. ²¹³

2.2.2a Plan to rapidly authorize/license laboratories to scale-up testing during an outbreak

Score: 0

There is no publicly available evidence that there is a plan in place to rapidly authorize or license laboratories to supplement the capacity of the national public health laboratory system to scale-up testing during a outbreak. There is no national plan for surges; however, the Regulations on the Registration of Microbiological Laboratories gives the option for the Director-General to issue a 90-day permit "for a single acquisition, receipt or importation of human pathogens" (section 6) which can allow additional laboratory capacity. ²¹⁴ There is no evidence concerning rapid authorisation or licensing of laboratories on the websites of the Department of Health, the Department of Agriculture, the National Health Laboratory Service (NHLS) or the Public Health Institute of South Africa (PHISA) websites. ^215216217218

2.3.1a Evidence of ongoing event-based and indicator-based surveillance and analysis

Score: 100

There is evidence that the country is conducting ongoing event-based and indicator-based surveillance and analysis for notifiable and novel infectious diseases and that the data is being analyzed on a daily basis. The Notifiable Medical Conditions Surveillance System (NMCSS) receives continuous, real-time electronic laboratory feeds through the National Health Laboratory Service (NHLS) and private laboratories. ²¹⁹ Chapters 1 and 2 of the Regulations relating to the surveillance and the control of notifiable medical conditions (Govt Gazette No 41330, 15 Dec 2017) obliges every public or private laboratory to notify any diagnosed case (including respiratory disease caused by a novel respiratory pathogen) through the use of national department forms and tools for reporting notifiable medical conditions, electronic or written, and to ensure adherence to the notification procedures stipulated in these Regulations. It also defines the list of notifiable medical conditions that require immediate reporting in Annexure 1. ²²⁰ The most recent Joint External Evaluation (JEE) for South Africa (2025) explicitly discusses the purpose and performance of real-time surveillance in the country (D2. Surveillance). ²²¹ The NICD releases a monthly surveillance report that summarizes data on cases diagnosed and notified using the NMCSS. ²²² The NMCSS 2023 Annual Report notes that the platform "collects […] information from national, regional and local levels" and that "data is reviewed daily by public-health officials". ²²³

2.3.1b Evidence of a mechanism (such as IHR focal point) for reporting notifiable diseases to the WHO within the set timeline

Score: 100

There is publicly available evidence of a mechanism (such as IHR focal point) in South Africa for reporting notifiable diseases to the WHO within the set timeline. In Regulations Relating to the Surveillance and Control of Notifiable Medical Conditions, 2017 (Government Gazette No. 41330, GN R.1434), Regulation 3(2)(e)-(f) obliges the Director-General of Health to "designate and ensure the functioning of the National IHR Focal Point" and to "notify the WHO IHR Contact Point through the National IHR Focal Point within 24 hours of epidemiological assessment of all events which may constitute a public-health emergency of international concern". The same Gazette defines "national (IHR) Focal Point" as the 24-hour contact centre for WHO communications, embedding the reporting channel in law. ²²⁴ The 2025 Joint External Evaluation (JEE) mission report for South Africa notes that five appointees are responsible for the fulfilment of the National IHR Focal Point function, though it urges further institutional strengthening. ²²⁵ Evidence for the actual reporting is seen in WHO's Disease Outbreak News, where the last report for South Africa about a Mpox outbreak explicitly states that the "International Health Regulations (IHR) National Focal Point (NFP) of the Republic of South Africa notified WHO". ²²⁶

2.3.2a Electronic national and sub-national reporting surveillance system

Score: 100

There is publicly available evidence that the government operates a electronic reporting surveillance system at both the national and the sub-national level. The Notifiable Medical Conditions Surveillance System (NMCSS) receives continuous, real-time electronic laboratory feeds through the National Health Laboratory Service (NHLS) and private laboratories. ²²⁷ Chapters 1 and 2 of the Regulations relating to the surveillance and the control of notifiable medical conditions (Govt Gazette No 41330, 15 Dec 2017) obliges every public or private laboratory to notify any diagnosed case through the use of national department forms and tools for reporting notifiable medical conditions, electronic or written, and to ensure adherence to the notification procedures stipulated in these Regulations. It also defines the list of notifiable medical conditions that require immediate reporting in Annexure 1. ²²⁸ The Notification Process explicitly states that in case of a electronic notification, "the notification will automatically be sent to all relevant focal people at Health Establishment, Sub-District, District, Province & National". ²²⁹

2.3.2b Collection of ongoing/real-time lab data by electronic surveillance system

Score: 50

There is publicly available information to show that electronic surveillance systems in South Africa collect ongoing/real time data, but detailed disaggregated analysis is limited. The Notifiable Medical Conditions Surveillance System (NMCSS) receives continuous, real-time electronic laboratory feeds through the National Health Laboratory Service (NHLS) and private laboratories. ²³⁰ Chapters 1 and 2 of the Regulations relating to the surveillance and the control of notifiable medical conditions (Govt Gazette No 41330, 15 Dec 2017) obliges every public or private laboratory to notify any diagnosed case through the use of national department forms and tools for reporting notifiable medical conditions, electronic or written, and to ensure adherence to the notification procedures stipulated in these Regulations. It also defines the list of notifiable medical conditions that require immediate reporting in Annexure 1. ²³¹ The most recent Joint External Evaluation (JEE) for South Africa (2025) explicitly discusses the purpose and performance of real-time surveillance in the country (D2. Surveillance). ²³² The NICD releases a monthly surveillance report that summarizes data on cases diagnosed and notified using the NMCSS. ²³³ The reporting (both paper-based and electronic) contains limited breakdown of demographic data, only age and gender information is collected (see Annexure B and C of Standard Operating Procedures: Reporting of Notifiable Medical Conditions. ²³⁴ The JEE also points out the limited possibility for analysis of health disparities. ²³⁵

2.3.3a National wastewater surveillance programme or initiative

Score: 100

There is evidence that South Africa has an ongoing national wastewater surveillance programme. The National Institute for Communicable Diseases (NICD) is the national public health institute tasked with disease surveillance in South Africa. The Wastewater Genomics Syndicate, situated within the Centre for Vaccines and Immunology at NICD, spearheads wastewater and environmental surveillance (WES) for communicable diseases. Environmental surveillance commenced in 2018 as part of the global effort to eradicate polio. Samples from wastewater treatment plants (WWTP) across the country are tested for polio. In 2020, amidst the challenges posed by the COVID-19 pandemic, the NICD swiftly built on the polio surveillance network to commence WES for SARS-CoV-2.²³⁶

2.4.1a Common usage of electronic health records

Score: 50

South Africa does have national‐level electronic record platforms, most notably the Health Patient Registration System (HPRS), however, the government's own strategy documents and regulations show that parts of a full longitudinal Electronic Health Record (EHR) are still being built out, and large parts of the public sector continue to rely on paper files. EHRs are therefore present but not yet commonly or uniformly used across all facilities; they are in phased national roll-out with interoperability standards now in force. The 2025 Joint External Evaluation (JEE) notes the use of paper-based patient record systems in some facilities (R3.2. Utilization of health services). ²³⁷ The National Digital Health Strategy for South Africa 2019-2024 plans a roadmap to "be developed to digitise all health systems" and "achieving a electronic health record for South Africa […] to integrate existing solutions on a common platform", but it notes that for the HPRS, "the diagnostic, treatment and billing modules needed for a EHR […] are yet to be developed". ²³⁸ The 2021 Health Normative Standards Framework (HNSF) for Interoperability in Digital Health (Government Gazette 47337, 21 Oct 2022) specifies the standards for sharing electronic health record documents. ²³⁹ Electronic record-keeping is especially important for South Africa's recently introduced National Health Insurance (NHI) programme, the Chief Directorate of Health Systems Digital Information website mandates that "every person (health system user) in the country must have a portable electronic health record that every provider adds to each time they see the user and provide care". ²⁴⁰ Based on the 2023-2024 Annual Report of the Department of Health, "a total of 66 million records have been captured in the HPRS database […] and 3 227 public health facilities […] are using the HPRS". ²⁴¹ Reports from parliamentary committees, research articles and news outlets name, among others, the following obstacles: inadequate infrastructure (outdated systems, connectivity issues), insufficient training of personnel, lack of national leadership, and insufficient investment. ^242243244

2.4.1b Public health system access to individual electronic health records

Score: 0

The South African national public health system has access to electronic health records of individuals in the country, although the number of users appears to be limited at present. The Department of Health Annual Report 2023-2024 states that the Department has "also established key components of the national electronic medical record (EMR), which will allow us as Users of the health system, to access our one common record no matter where we go for our healthcare", but "as the NHI Act is being implemented, these systems will be more widely used so that we can all benefit from real continuity of care". ²⁴⁵ The most recent Joint External Evaluation (JEE, 2025) also points out that some facilities continue to rely on manual record-keeping (R3.2. Utilization of health services). ²⁴⁶ Reports from parliamentary committees, research articles and news outlets name, among others, the following obstacles: inadequate infrastructure (outdated systems, connectivity issues), insufficient training of personnel, lack of national leadership, and insufficient investment. ^247248249

2.4.1c Existence of data standards for health record data comparability

Score: 100

South Africa has formally-adopted national data-exchange and vocabulary standards for all electronic health-record (EHR) systems, drawn directly from internationally recognised ISO, HL7, IHE standards. The legal vehicle is the Health Normative Standards Framework (HNSF) (Government Gazette No. 47337 of 21 October 2022). The Gazette makes the HNSF binding on every information system that generates, stores or exchanges electronic health information for the national health system and requires conformance testing before such systems may be procured or deployed (page 119). ²⁵⁰ The HNSF also establishes the actual standards (based on the 2014 HNSF): "the family of standards based on the HL7 v3 Reference Information Model (RIM); the standards based on the ISO 13606 Parts 1-5 / OpenEHR Reference Model (RM); and the interoperability standards-based profiles developed by the global organisation, Integrating the Health Enterprise (IHE)" (page 118). ²⁵¹ The recent WHO Joint External Evaluation (JEE, 2025) encourages South Africa to implement digital data-collection systems within health facilities and clinics, and create interoperability capabilities that link platforms with related sectors (page viii). ²⁵² Interoperability of electronic record-keeping is especially important for South Africa's recently introduced National Health Insurance (NHI) programme, the Chief Directorate of Health Systems Digital Information website says that "The new system cannot function without a comprehensive and interoperable digital information system. Clear and accurate data on users, providers, benefits, products, and outcomes are essential to a functioning system" and that "everything must be coded for the system to work, and these need to be universal codes, universally adopted (used by every role-player in both public and private sectors), and preferably international, to allow benchmarking". ²⁵³ However, practical implementation is hindered by "inadequate funding, ambiguous guidelines, weak governance, and conflicting interests among stakeholders.", according to a 2024 study (Policy framework for integrating data interoperability at public hospitals in South Africa). ²⁵⁴

2.4.2a Data sharing mechanisms

Score: 0

South Africa does have mechanisms at the relevant ministries responsible for animal, human, and wildlife surveillance to share data, but those arrangements are still largely case-by-case (for example, when a rabies or brucellosis event is detected). Based on the recent Joint External Evaluation (JEE, 2025), a national One-Health Steering Committee (co-chaired by the Department of Health, Department of Forestry, Fisheries and the Environment, and Department of Agriculture, Land Reform and Rural Development) is already in place, and the Multisectoral National Outbreak Response Team coordinates outbreak response (page 22). However, the report also points out that the country still lacks a fully interoperable Integrated Disease Surveillance and Response (IDSR) platform (page 23). ²⁵⁵ There is no evidence that a central electronic data sharing system has been developed since on the websites of the Department of Health, the Department of Forestry, Fisheries and the Environment, or the Department of Agriculture ^256257258.

2.4.3a Availability of de-identified health surveillance data on disease outbreaks

Score: 100

South Africa routinely publishes de-identified, aggregate surveillance data for both human and animal infectious-disease events on official government websites. The National Institute for Communicable Diseases (NICD) posts monthly and annual Notifiable Medical Conditions Surveillance System (NMCSS) reports that tabulate case counts for every notifiable disease by province, age-group and week of onset. The reports contain only aggregated figures and are freely downloadable from the NICD website. ²⁵⁹²⁶⁰ The NICD published a NMCSS Data Interpretation sheet to further help the public understand reported data. ²⁶¹ For a selection of diseases, a daily updated dashboard is also available. ²⁶² A Weekly Respiratory Pathogens Surveillance Report is published on the NICD website. ²⁶³ Monthly disease and outbreak reporting is available for animal diseases on the website of the Department of Agriculture. ²⁶⁴²⁶⁵

2.4.4a Confidentiality legislation/regulations for identifiable health information

Score: 100

South Africa does have laws and regulations that safeguard the confidentiality of identifiable health information for individuals, such as that generated through health surveillance activities. The National Health Act 2003 (NHA) states that "all information concerning a user, including information relating to his or her health status, treatment or stay in a health establishment, is confidential" and may be disclosed only with the person's consent, by court order, or when another law expressly allows it (Section 14). ²⁶⁶ A surveillance-specific regulation (Regulations Relating to the Surveillance and Control of Notifiable Medical Conditions, GN R1434 of 2017) repeats the NHA standard and makes it specific to all information "concerning a case, contact or carrier of a notifiable medical condition" (Section 18). ²⁶⁷ The Protection of Personal Information Act of 2013 (POPIA) designates data concerning a person’s health as "special personal information" that may not be processed unless one of the narrow justifications in Section 27 applies, such as a clear public-health purpose coupled with adequate safeguards (Section 26). ²⁶⁸

2.4.4b Inclusion of cyber protections in health data confidentiality law/regulation

Score: 100

There is evidence of that legislation and/or regulations safeguarding the confidentiality of identifiable health information for individuals, such as that generated through health surveillance activities, includes mention of protections from cyber attacks (e.g., ransomware). The National Health Act 2003 (NHA) states that "all information concerning a user, including information relating to his or her health status, treatment or stay in a health establishment, is confidential" and may be disclosed only with the person's consent, by court order, or when another law expressly allows it (Section 14). ²⁶⁹ A surveillance-specific regulation (Regulations Relating to the Surveillance and Control of Notifiable Medical Conditions, GN R1434 of 2017) repeats the NHA standard and makes it specific to all information "concerning a case, contact or carrier of a notifiable medical condition" (Section 18). ²⁷⁰ The Protection of Personal Information Act of 2013 (POPIA) designates data concerning a person’s health as "special personal information" that may not be processed unless one of the narrow justifications in Section 27 applies, such as a clear public-health purpose coupled with adequate safeguards (Section 26). ²⁷¹ The Cybercrimes Act of 2020 criminalises cyber attacks on health records. Sections 2-7 create offences of unlawful access to, interference with, or acquisition of data. These provisions apply to any computer-stored data, including confidential medical files. ²⁷²

2.4.5a Cooperative commitments or agreements within regions

Score: 0

South Africa has formally undertaken to share public-health surveillance data with other countries during emergencies through both its domestic regulations and international agreements, although there is only one evidence of specific country-wise collaboration. South Africa is a State Party to the WHO International Health Regulations 2005 (IHR) (Appendix 1). ²⁷³ The most recent WHO Joint External Evaluation (JEE, 2025) records that South Africa made significant progress in implementing the IHR and that a 24/7 IHR Secretariat (National IHR Focal Point) is already in place to send urgent communications to WHO and other States Parties. ²⁷⁴ Articles 6-7 of the IHR require notifying the WHO within 24 hours of all events that may constitute a Public Health Emergency of International Concern, thereby creating a standing commitment to share surveillance data internationally whenever an emergency arises. ²⁷⁵ The obligation is given direct force in national law by Regulations Relating to the Surveillance and Control of Notifiable Medical Conditions (GN R1434 of 2017), where Section 3(2)(f) mandates the Director-General to "notify the WHO IHR Contact Point through the National IHR Focal Point within 24 hours of epidemiological assessment, of all events which may constitute a public health emergency of international concern". ²⁷⁶ South Africa ratified the Southern African Development Community (SADC) Protocol on Health on 28 July 2000 (Government Gazette No. 21362). Article 6 of the Protocol obliges each Member State to "share information on health-systems research and surveillance" and to "co-operate and assist each other in regional communicable and non-communicable diseases". ²⁷⁷

2.5.1a National support to conduct contact tracing in the event of a public health emergency

Score: 100

South Africa has a established national system in place to provide support at the sub-national level to conduct contact tracing in the event of a public health emergency. Sections 5-6 of the Regulations Relating to the Surveillance and Control of Notifiable Medical Conditions (GN R1434 of 2017) require every district, and sub-district to use national case definitions, reporting forms and electronic tools supplied by the Department of Health (DoH). They must also appoint a focal person for surveillance and ensure that national guidelines are followed at each level, creating uniform metrics for case and contact data country-wide. ²⁷⁸ There are nation-wide training programmes that cascade to provinces and districts, for example, in Septemer 2023 the DoH and WHO trained 150 health personnel drawn from all nine provinces to "lead the implementation and training for the Integrated Disease Surveillance and Response (IDSR) system". These trainers are responsible for rolling the curriculum down to district, facility and community teams, including contact-tracing cadres, so that methods are harmonised nationally. ²⁷⁹ Run jointly by the DoH, the National Institute for Communicable Diseases (NICD) and partner universities, the South African Field Epidemiology Training Programme (SAFETP) provides a 2-year "didactic and practical training in which the resident is grounded in the academic basics of applied epidemiology and is assigned to field sites where s/he learns by doing while being mentored by supervisors in projects that address key public health priorities within the respective countries and within the regions. The programme also has Frontline course targeting public health professionals in the area of surveillance at national, provincial, district and local levels." ²⁸⁰ This Programme is also highlighted as a strengh in the 2025 Joint External Evaluation by the WHO (D2.3. Analysis and information sharing). ²⁸¹ The JEE also notes that South Africa maintains a Multisectoral National Outbreak Response Team (MNORT) with formal terms of reference, alongside mirrored provincial outbreak-response and incident-management teams. These structures possess "capacity for rapid mobilisation and deployment of officials" and are cited as a core national strength that supports sub-national response activities (pages viii). ²⁸² The October 2024 IDSR progress brief records that the DoH, with WHO and Canadian support, is costing a business case for country-wide IDSR implementation and building a digital platform; this secures both the funding stream and the technology that provinces and districts will use for real-time contact-tracing data flow. ²⁸³

2.5.1b Provision of wraparound services to enable self-isolation/quarantine as recommended

Score: 100

South Africa provides wraparound services to enable infected people to isolate, both medically and economically. The Regulations Relating to the Surveillance and Control of Notifiable Medical Conditions (GN R1434 of 2017) empower health officers to order isolation or quarantine and to ensure that "a case or carrier" or "person who has been in contact with a case or carrier" "of a notifiable medical condition […] must subject himself or herself to further medical examination" and then "the health care provider may prescribe prophylaxis, treatment or implement isolation or quarantine procedures, if deemed necessary" (Chapter 3, Section 14 (2-4)). ²⁸⁴ The recent Joint External Evaluation (JEE, 2025) states that a dedicated emergency workforce is already in place to guarantee sufficient healthcare resources during pandemics or epidemics; and secured funding allows health facilities to be swiftly upgraded and expanded so they can meet both day‑to‑day and surge demands, thus assuring the continuity of essential health services (including home-based care). (R3.3. Continuity of essential health services (EHS). ²⁸⁵ South Africa has tiered economic support. First, Section 22 of the Basic Conditions of Employment Act of 1997 (BCEA) obliges every employer to grant paid sick-leave for up to "the number of days the employee would normally work in a six-week period" in every 36-month cycle. ²⁸⁶ Second, the Labour Relations Act of 1995 (LRA) protects the job security of employees who are temporarily unable to work: "If a employee is temporarily unable to work in these circumstances, the employer should investigate the extent of the incapacity or the injury. If the employee is likely to be absent for a time that is unreasonably long in the circumstances, the employer should investigate all the possible alternatives short of dismissal" (Schedule 8 – Code Of Good Practice: Dismissal, Section 10(1)). ²⁸⁷ Third, once paid sick-leave runs out, under the Unemployment Insurance Act of 2001, Section 20(1)(a-b) "a contributor is entitled to the illness benefits contemplated in this Part for any period of illness if the contributor is unable to perform work on account of illness; the contributor fulfils any prescribed requirements in respect of any specified illness". ²⁸⁸ The Covid-­19 Temporary Relief Scheme (GN 215 of 26 March 2020) explicitly specifies this for quarantine in Secion 4.1: "Where a employee is in quarantine for 14 days due to Covid-19 pandemic, the employee shall qualify for illness benefit." ²⁸⁹ Fourth, under Section 187(1)(f) of the LRA, "a dismissal is automatically unfair […] if the reason for the dismissal is […] that the employer unfairly discriminated against a employee, directly or indirectly, on any arbitrary ground, including […] disability." Because illness that impairs the employee's ability to work has been treated by the courts as a disability, any dismissal whose real reason is that illness falls squarely under this section. ²⁹⁰ Example court cases include Jansen v Legal Aid South Africa or New Way Motor & Diesel Engineering (Pty) Ltd v Marsland, confirming that firing someone during a period of recognised illness is automatically unfair discrimination on the grounds of disability. ²⁹¹²⁹²

2.5.2a Strategy for tracing and quarantining international travelers

Score: 0

There is no publicly available evidence of a joint plan or cooperative agreement between the public health system and border control authorities to identify suspected and potential cases for international travellers and trace and quarantine their contacts in the event of a public health emergency. While the Border Management Authority (BMA) "is responsible for the execution of frontline border law enforcement functions related to, inter alia, port health; […] biosecurity; food safety and phytosanitary control", at most points of entry (POE) even suspected cases cannot be quarantined according to the 2025 Joint External Evaluation (JEE, POE1. Core capacity requirements at all times for POE (airports, ports and ground crossings)), furthermore, there is no publicly available information on contact tracing and contact quarantining. ²⁹³²⁹⁴
The JEE acknowledges that in order to foster strong coordination and collaboration in both routine situations and public‑health emergencies, POE take part in a range of multi‑stakeholder committees (covering aviation, maritime and cross‑border sectors, NATJOINTS structures, outbreak‑response teams at national, provincial and district levels, and other relevant bodies) and that POE have set up administrative agreements with relevant partners, such as nearby health facilities and emergency medical services, to ensure a effective response during public‑health emergencies, however, there is no mention of contact tracing and contact quarantining (pages 70-71). ²⁹⁵ There was no further evidence on the websites of the Department of Health, the National Health Laboratory Service (NHLS), the BMA, or the Public Health Institute of South Africa (PHISA). ^296297298299

2.6.1a Access to field epidemiology training program in country and/or abroad

Score: 100

There is a applied field epidemiology training program (such as FETP) available in country, but there is no evidence that the government provides resources to send citizens to another country to participate in applied epidemiology training programs. Run jointly by the Department of Health, the National Institute for Communicable Diseases (NICD) and partner universities, the South African Field Epidemiology Training Programme (SAFETP) provides a 2-year "didactic and practical training in which the resident is grounded in the academic basics of applied epidemiology and is assigned to field sites where s/he learns by doing while being mentored by supervisors in projects that address key public health priorities within the respective countries and within the regions. The programme also has a Frontline course targeting public health professionals in the area of surveillance at national, provincial, district and local levels". Residents "graduate with a Master of Science (MSc) in Field Epidemiology from either the University of Pretoria or the University of the Witwatersrand". ³⁰⁰ This Programme is also highlighted as a strength in the 2025 Joint External Evaluation by the WHO (D2.3. Analysis and information sharing). ³⁰¹ Several university-level courses are also available. The University of South Africa (UNISA) embeds a four-stage Epidemiology stream in its Diploma in Animal Health. ³⁰² The BSc (Hons) in Biostatistics specialising in Epidemiology & Biostatistics at the University of Pretoria is a one-year, 120-credit programme. ³⁰³ The University of the Witwatersrand offers a MSc in Epidemiology with streams in Field Epidemiology and Infectious-Disease Epidemiology. ³⁰⁴ Stellenbosch University runs a structured MSc in Clinical Epidemiology covering fundamental and applied epidemiological methods, biostatistics and systematic reviews over two years. ³⁰⁵ The University of Cape Town Master of Public Health degree lists Epidemiology and Biostatistics as core components and offers dedicated epidemiology modules within its flexible coursework plus mini-dissertation structure. ³⁰⁶ For advanced research training, the PhD specialising in Epidemiology at the University of Pretoria admits candidates with relevant master's/medical degrees and requires a minimum of two years' full-time doctoral research. ³⁰⁷ There is no information via the websites of the Department of Health or the National Institute for Communicable Diseases or in the JEE report to suggest that the South African government provides resources to send citizens to another country to participate in applied epidemiology training programs. ^308309310

2.6.1b Existence of field epidemiology training for animal health professionals

Score: 100

Some of the available field epidemiology training programmes in South Africa are explicitly inclusive of animal health professionals. Run jointly by the Department of Health, the National Institute for Communicable Diseases (NICD) and partner universities, the South African Field Epidemiology Training Programme (SAFETP) provides a 2-year "didactic and practical training in which the resident is grounded in the academic basics of applied epidemiology and is assigned to field sites where s/he learns by doing while being mentored by supervisors in projects that address key public health priorities within the respective countries and within the regions. The programme also has a Frontline course targeting public health professionals in the area of surveillance at national, provincial, district and local levels". Residents "graduate with a Master of Science (MSc) in Field Epidemiology from either the University of Pretoria or the University of the Witwatersrand". Educational requirements include medical or veterinary degrees. ³¹¹ This Programme is also highlighted as a strength in the 2025 Joint External Evaluation by the WHO (D2.3. Analysis and information sharing). ³¹² Several university-level courses are also available. The University of South Africa (UNISA) embeds a four-stage Epidemiology stream in its Diploma in Animal Health. ³¹³ The University of the Witwatersrand offers a MSc in Epidemiology with streams in Field Epidemiology and Infectious-Disease Epidemiology, where applicants come from a veterinary background as well. ³¹⁴

2.6.2a Evidence of at least 1 trained field epidemiologist per 200,000 people

Score: 0

There is no public evidence that South Africa currently maintains at least one trained field epidemiologist for every 200 000 people. The latest population estimate of South Africa is 63 015 904 according to the Department of Statistics South Africa. ³¹⁵ Thus, the country needs at least 315 epidemiologists. Based on the Annual Overview 2023-2024 of the National Institute for Communicable Diseases (NICD), who organizes the South African Field Epidemiology Training Programme, "to date, the programme has trained more than 130 graduates". ³¹⁶ This, together with the 2021 article on the website of the NICD that states that "to date the program has trained 98 epidemiologists", it is unlikely that South Africa has reached the goal of 315 epidemiologists. ³¹⁷ The 2025 Joint External Evaluation (JEE) states that South Africa has not yet mapped the human resources needed to support the implementation of the IHR (2005) (page 45). ³¹⁸

3.1.1a National emergency response plan for diseases with pandemic potential

Score: 33.33

South Africa has a overarching national public health emergency response plan in place which addresses planning for multiple communicable diseases with epidemic or pandemic potential but it has not been published yet. A draft National Health Emergency Response Operations Plan (NHEROP, 2022 – awaiting Director-General endorsement but already operational), a master plan that operationalises the Disaster Management Act for the health sector is cited in the 2025 Joint External Evaluation (JEE, page 49) and other government records (for example in the 2022-2023 Annual Report of the Department of Health, page 39) but has not been published. ³¹⁹³²⁰

3.1.1b National public health emergency response plan published in past 3 years

Score: 0

There is no publicly available evidence that South Africa's overarching national public health emergency response plan has been updated in the last 3 years. A draft National Health Emergency Response Operations Plan (NHEROP, 2022 – awaiting Director-General endorsement but already operational), a master plan that operationalises the Disaster Management Act for the health sector is cited in the 2025 Joint External Evaluation (JEE, page 49) and other government records (for example in the 2022-2023 Annual Report of the Department of Health, page 39) but has not been published. ³²¹³²²

3.1.1c One health principles by covering multiple threat types

Score: 0

There is no publicly available evidence that if a overarching national public health emergency response plan is in place, it follows one health principles by covering multiple threat types, e.g. antimicrobial resistance, zoonotic disease spillover, biological accidents or deliberate acts. A draft National Health Emergency Response Operations Plan (NHEROP, 2022 – awaiting Director-General endorsement but already operational), a master plan that operationalises the Disaster Management Act for the health sector is cited in the 2025 Joint External Evaluation (JEE, page 49) and other government records (for example in the 2022-2023 Annual Report of the Department of Health, page 39) but has not been published. ³²³³²⁴

3.1.1d Vulnerable populations in national public health emergency response plan

Score: 0

There is no publicly available evidence that if a overarching national public health emergency response plan is in place, it includes consideration of the impact of health equity or mechanisms for identifying and considering the needs of vulnerable populations (e.g. lower socioeconomic status, age, minority ethnic groups, etc). A draft National Health Emergency Response Operations Plan (NHEROP, 2022 – awaiting Director-General endorsement but already operational), a master plan that operationalises the Disaster Management Act for the health sector is cited in the 2025 Joint External Evaluation (JEE, page 49) and other government records (for example in the 2022-2023 Annual Report of the Department of Health, page 39) but has not been published. ³²⁵³²⁶

3.1.2a Mechanism to engage private sector in outbreak preparedness/response

Score: 100

South Africa has a formally-defined, government-led mechanism for engaging the private sector in outbreak emergency preparedness and response. The legal foundation is the Disaster Management Act of 2002 (DMA) and its National Disaster Management Framework (NDMF). Section 5 of the Act obliges the Minister of Cooperative Governance & Traditional Affairs to set up a National Disaster Management Advisory Forum (NDMAF). ³²⁷ The NDMF (Government Gazette 48874, 30 June 2023) repeats that obligation and spells out its purpose: the Forum is "the mechanism for relevant national role-players to consult one another and coordinate their activities" on disaster-risk issues. Membership must include "relevant NGOs, international relief agencies, community-based organisations (CBOs), organised labour and agriculture, higher education institutions and the private sector". ³²⁸ Because a biological outbreak is classified as a disaster hazard under the Framework (page 67), this Forum is the standing channel through which private companies are drawn into national-level preparedness planning and response. ³²⁹ The 2025 Joint External Evaluation (JEE) acknowledges that South Africa can rapidly assemble response teams for domestic or global emergencies, tapping into public, private, and nonprofit resources as needed (R1.4. Activation and coordination of health personnel in a public health emergency). ³³⁰ Section 8 of the DMA also establishes the National Disaster Management Centre (NDMC), while section 15(1) directs that the Centre "must […] act as a advisory and consultative body on issues concerning disasters and disaster management to […] the private sector" and that it "must monitor" national compliance with the Act and framework. The same section places the NDMC at the heart of policy, information management and funding recommendations for any kind of disaster, including disease outbreaks. ³³¹

3.1.3a Policy/plan/guidelines in place to implement non-pharmaceutical interventions (NPIs)

Score: 100

There is publicly available evidence that South Africa has a policy, plan and/or guidelines in place to implement non-pharmaceutical interventions (NPIs) during a epidemic or pandemic for more than one disease. South Africa has multiple government-issued instruments that lay out how non-pharmaceutical interventions (NPIs) such as isolation, quarantine, social-distancing measures and mandatory masking must be applied during outbreaks (covering all notifiable communicable diseases, seasonal pandemic influenza and COVID-19). The Regulations Relating to the Surveillance and Control of Notifiable Medical Conditions empower health authorities to order mandatory medical examination, isolation and quarantine of carriers, contacts and sufferers of communicable diseases (section 15). ³³² A COVID-19–specific regulation made the wearing of a face mask mandatory in all indoor public spaces, codifying social-distancing protocols (regulation 67). This demonstrates that South Africa has operative legal instruments to deploy NPIs for COVID-19. ³³³

3.2.1a Completion of biological-focused IHR exercise with the WHO in past year

Score: 100

There is publicly available evidence that a national-level biological threat-focused exercise (either with the World Health Organization [WHO] or separately) was completed in the last year; there is no evidence that South Africa has activated their national emergency response plan for a infectious disease outbreak in the past year. The Africa Centres for Disease Control and Prevention (Africa CDC), of which South Africa is a member state, has declared its first Public Health Emergency of Continental Security (PHECS) for mpox since its inception in 2017. ³³⁴ One day later, the World Health Organisation (WHO) declared mpox a public health emergency of international concern (PHEIC) under the International Health Regulations (2005) (IHR). ³³⁵ In March 2025, the Department of Health has "activated outbreak response teams in the province" of Gauteng, but not a national emergency response plan. ³³⁶
In the recent Joint External Evaluation report (JEE, 2025), among the supporting documents supplied, there is a "Pandemic Preparedness Plan Simulation Exercise Report (conducted 19 – 21 August 2024)" (page 86), however, no further information is provided in the report. ³³⁷ a August 2024 article from the WHO News website reports that "from 19–21 August 2024, multidisciplinary and multilevel stakeholders convened in Johannesburg, South Africa, to participate in a tabletop simulation exercise aimed at testing and refining the draft National Respiratory Pathogen Pandemic Plan" (Exercise PanPRET-1). ³³⁸ Based on the WHO definition, a Exercise PanPRET-1 is "A national/institutional, multisectoral simulation exercise that spans more than six technical areas and allows for customized injects to suit local needs. This exercise supports countries and institutions in reviewing and refining critical preparedness strategies such as multisectoral coordination, risk communications and community engagement (RCCE), and triggers for decision-making (escalating and de-escalating operations)". ³³⁹

3.2.1b Evidence of bio-focused exercise to identify gaps/best practices

Score: 0

There is no publicly available evidence that South Africa has, in the past year, identified a list of gaps and best practices in response, either to a infectious disease or a biological-threat focused exercise, and developed a plan to improve response capabilities. As of July 2025, the World Health Organisation (WHO) lists South Africa as a country that does have a After-Action Review planned, but none have been completed. ³⁴⁰ The WHO country page for South Africa has no further information. ³⁴¹ The 2025 Joint External Evaluation (JEE) lists among challenges in "Activation and coordination of health personnel in a public health" (R1.4.) that no structured, ongoing program of training or simulation exercises currently exists for frontline workers. ³⁴² There is no further evidence of other after action reviews or best practice planning on the websites of the Department of Health, the National Institute of Communicable Diseases (NICD) or the Department of Agriculture. ^343344345

3.2.2a Evidence of national-level biological threat-focused exercise that includes private sector

Score: 0

There is no publicly available evidence that South Africa in the past year has undergone a national-level biological threat-focused exercise that has included private sector representatives. In the recent Joint External Evaluation report (JEE, 2025), among the supporting documents supplied, there is a "Pandemic Preparedness Plan Simulation Exercise Report (conducted 19 – 21 August 2024)" (page 86), however, no further information is provided in the report. ³⁴⁶ a August 2024 article from the WHO News website reports that "from 19–21 August 2024, multidisciplinary and multilevel stakeholders convened in Johannesburg, South Africa, to participate in a tabletop simulation exercise aimed at testing and refining the draft National Respiratory Pathogen Pandemic Plan" (Exercise PanPRET-1), but there is no mention of private sector representatives. ³⁴⁷ The latest record on the WHO Simulation Exercise page is from May 2024. ³⁴⁸ The WHO country page for South Africa has no further information. ³⁴⁹ There is no further evidence of such a exercise on the websites of the Department of Health, the National Institute of Communicable Diseases (NICD) or the Department of Agriculture. ^350351352

3.3.1a Existence of Emergency Operations Center (EOC)

Score: 100

South Africa does have a Emergency Operations Centre. Based on the recent Joint External Evaluation report from 2025, the Department of Health (DoH) runs two Public Health Emergency Operations Centres (PHEOCs): one, housed at the department's headquarters, oversees all health‑related hazards, while the other, located at the National Institute for Communicable Diseases (NICD), focuses specifically on communicable disease outbreaks (page 49). The report, however, also notes that there is no clear distinction between the two PHEOCs (page 51). ³⁵³ The NICD website describes that the Outbreak Response Unit (ORU) is responsible for the Emergency Operations Centre (EOC). ³⁵⁴ The two national PHEOCs (DoH & NICD) manage day-to-day public-health incidents, while the National Disaster Management Centre (NDMC) provides a all-hazards EOC once a event is declared a disaster. ³⁵⁵

3.3.1b Requirement for EOC to conduct/evidence EOC conducts at least annual drills

Score: 0

There is no publicly available evidence that South Africa's Emergency Operations Centers (EOC) are required to conduct a drill for a public health emergency scenario at least once per year or that they do. Neither South Africa's governing legislation (e.g., the Disaster Management Act) nor the public-health guidance reviewed in the 2025 Joint External Evaluation (JEE) establishes a standing requirement that the national Public Health Emergency Operations Centre (PHEOC) run a drill every year. The JEE finds that simulation exercises have taken place, but only on a ad-hoc basis; it therefore urges South Africa to "develop and test the all-hazards plans at national and provincial level" and to launch and fully implement national and provincial PHEOCs with a clear remit to coordinate public health emergency operations across the country, without prescribing a annual schedule. ³⁵⁶³⁵⁷

3.3.1c EOC activation within 120 minutes of identification of emergency/scenario

Score: 0

There is insufficient public evidence to show that any South African Emergency Operations Centre (EOC) has conducted, within the last year, a coordinated emergency response or emergency response exercise activated within 120 minutes of the identification of the public health emergency/scenario.
While the recent Joint External Evaluation (JEE, 2025) for South Africa reports that PHEOC training has been conducted and that the country is able to rapidly deploy response teams (page 51), there is no specific mention of timelines. ³⁵⁸ There is no further information available on the websites of the Department of Health or the National Institute for Communicable Diseases (NICD). ³⁵⁹³⁶⁰

3.4.1a Joint exercise/procedures for potential deliberate biological events

Score: 100

South Africa does have publicly available standard operating procedures, guidelines, memorandums of understanding (MOUs), or other agreements between public health, animal health, the private sector and security authorities to respond to a potential deliberate biological event, but there is no public evidence that public health, animal health, the private sector and national security authorities have carried out a exercise to respond to one. The National Joint Operational and Intelligence Structure (NATJOINTS) "comprises of various government departments as led by State Security Agency (SSA), South African Police Service (SAPS) and South African National Defence Force (SANDF) [and] meets on a regular basis to assess the safety and security of the country". ³⁶¹ According to a announcement from the South African Police Service, the new Operational Centre opened in 2024, "fitted with necessary equipment and machinery as well as technology advancements to ensure all agencies work seamlessly with agility and in unison against any and every threat that may face the country" and it "accommodate[s] representatives from 39 government departments, agencies, state owned enterprises, and private sector stakeholders within the NATJOC". ³⁶² The core playbook for chemical or biological agents or radioactive materials (CBR) is the CBR Manual (Government Gazette No 28437, Notice 143 of 2006). Part III focuses on biological incidents and is explicitly limited to criminal (deliberate) incidents, providing common incident-command structures, dispatch rules, on-scene safety zones and decontamination steps. ³⁶³ The 2011 Healthcare Workers Handbook On Bioterrorism adds considerations for health care workers and emphasises that "a bioterrorist attack will require a collaborative response from the Department of Health together with the SAPS, MHS [Military Health Service] and other stakeholders" (page 3). ³⁶⁴ The 2025 Joint External Evaluation (JEE) reports that in response to suspected or confirmed biological events, public health and security sectors coordinate through the National Joint Operational and Intelligence Structure (NATJOINTS), which ensures real-time, multi-sectoral coordination and information flow between national, provincial, and district levels (P3.2. Multisectoral coordination mechanisms). The Department of Health (a permanent member of NATJOINTS), works closely with key security agencies through a robust, multi-level coordination framework designed to manage events of national interest, including public health emergencies (R2.1. Public health and security authorities [e.g., law enforcement, border control, customs] are involved during a suspect or confirmed biological event). ³⁶⁵ There are no publicly available standard operating procedures, guidelines, memorandums of understanding (MOUs), or other agreements between the animal health, the private sector and security authorities to respond to a potential deliberate biological event. Neither the Department of Health or the National Disaster Management Centre or the SAPS websites contain details of having carried out a exercise to respond to a potential deliberate biological event. ^366367368

3.5.1a Risk communication plan for specific use during a public health emergency

Score: 100

South Africa does have in place a risk communication plan that is specifically intended for use during a public health emergency. According to the latest Joint External Evaluation by the WHO (JEE, 2025), South Africa has formed risk communication and community engagement (RCCE) operational teams and working groups to align partners and activities across multiple work streams. The RCCE systems and resources are functioning at every level and within all relevant sectors, and they are fully embedded in the overall emergency‑response framework. ³⁶⁹ A draft National Health Emergency Response Operations Plan (NHEROP, 2022 – awaiting Director-General endorsement but already operational), a master plan that operationalises the Disaster-Management Act for the health sector, devotes a stand-alone functional area to "Risk Communication & Community Engagement". The plan is cited in the JEE (page 49) and other government records (for example, in the 2022-2023 Annual Report of the Department of Health, page 39) but has not been published. ³⁷⁰³⁷¹

3.5.1b Inclusion of different population & sector needs in risk communication plan

Score: 100

South Africa's risk communication plan outlines how messages will reach populations and sectors with different communications needs. The latest Joint External Evaluation for South Africa (JEE, 2025) affirms that national‑level risk communication and community engagement (RCCE) teams work closely with regional and community actors, turning national and local behavioural and epidemiological insights into locally tailored risk‑communication. The Department of Health extends its community reach by mobilising partners' networks, knowledge and resources. Existing community structures are utilized: traditional and religious leaders, counsellors, traditional health practitioners and even taxi associations; messages are dispersed in local languages via familiar media and influencers (pages 63-64). ³⁷² There is evidence of this structured communication from the COVID-19 pandemic communication strategy of the South African Government: it prescribes a Integrated Communication Strategy, including, among others, using all official languages (spoken and sign), provincial communicators and a variety of channels for risk communication. ³⁷³

3.5.1c Designation of a specific government spokesperson during a public health emergency

Score: 0

There is insufficient evidence that South Africa designates a specific position within the government to serve as the primary spokesperson to the public during a public health emergency. There is no mention of a specific position serving as primary spokesperson in the Joint External Evaluation of South Africa (JEE, 2025), on any of the websites of the National Institute for Communicable Diseases (NICD) or the Department of Health. ^374375376 The JEE mentions a single spokesperson but without any detail (for example whether it is a government position at all) (page 64). ³⁷⁷

3.5.2a Government use of media platforms to share info on public health emergencies

Score: 100

There is publicly available evidence that in the past year the public health system has actively shared messages via online media platforms to inform the public about ongoing public health concerns and/or dispel rumors, misinformation or disinformation. The 2025 Joint External Evaluation (JEE) reports that South Africa maintains strong social listening and infodemic management systems, using online and offline monitoring, dedicated teams, and trained RCCE members to track trends, address misinformation, and adapt risk communication strategies. Communication platforms established during COVID-19, along with the Digital Health Promotion Platform, continue to amplify health messages online through proactive outreach and nationwide dissemination (pages 47-49). ³⁷⁸ At the national level, the Department of Health (DoH) has repeatedly used its official website to push timely updates and to address falsehoods. For example, on 26 June 2025, it issued a media statement titled "Minister Of Health Responds To Disinformation On COVID-19 Vaccines", explicitly acknowledging and countering a ongoing "campaign of misinformation and disinformation". On 16 July 2025, it published a press statement on the rollout of mpox vaccination with links to official vaccination sites, and in early August 2025, it posted a updated mpox public information leaflet. These are direct, public-facing online communications about current health risks. ^379380381 The Department has also used its official social-media channels to both inform and debunk. In February–July 2025, the Department's X (Twitter) account posted: myth-busting messages during African Vaccination Week ("Debunking misinformation with #ViralFactsAfrica"), a specific correction that garlic is not a cure for HIV ("This is misinformation intended to mislead the public"), and further posts highlighting the need to combat misinformation around TB vaccines. These are explicit government statements, on official channels, expressly aimed at dispelling misinformation. The same themes appear on the Department's official Facebook page, which carried mpox information and videos linked back to health.gov.za resources. ^382383384385

3.5.2b Evidence that senior leaders have shared mis/disinformation on infectious diseases

Score: 100

There is no publicly available evidence that senior leaders (president or ministers) have shared misinformation or disinformation on infectious diseases in the past two years. On the contrary, government communications actively warned against misinformation: for example, during the 2024 mpox outbreak the Department of Health and the National Institute for Communicable Diseases (NICD) repeatedly urged the public to fact-check mpox information and avoid spreading fake news, signalling a official anti-misinformation posture. ³⁸⁶³⁸⁷

3.6.1a Percentage of households with Internet

Score: 78.59

3.6.2a Mobile-cellular telephone subscriptions per 100 inhabitants

Score: 92.76

3.6.3a Gender gap in access to a mobile phone (percentage points)

Score: 93.33

3.6.4a Gender gap in access to the Internet (percentage points)

Score: 37.5

3.7.1a Restrictions on export/import of medical goods due to an infectious disease outbreak

Score: 100

There is no publicly available evidence that in the past year, South Africa has implemented restrictions on export/import of medical goods (e.g. medicines, oxygen, medical supplies, PPE) due to a infectious disease outbreak. A comprehensive search of Government Gazette notices, South African Revenue Service (SARS) "Prohibited and Restricted Imports and Export list" updates and International Trade Administration Commission (ITAC) control notices issued between 6 August 2024 and 6 August 2025 shows no new licensing or ban on the export or import of medicines, vaccines, personal protective equipment, laboratory consumables or other medical goods that were linked to a infectious disease outbreak. ³⁸⁸³⁸⁹

3.7.1b Restrictions on movement and/or exports/imports due to disease outbreak

Score: 100

There is publicly available evidence that in the past year, South Africa has implemented restrictions on export/import of non-medical goods (e.g. food, textiles, etc) due to a infectious disease outbreak. In 2024, South Africa formally restricted the movement and exportability of certain non-medical goods (animal products/food) in response to a confirmed foot-and-mouth disease (FMD) outbreak. The Minister of Agriculture, Land Reform and Rural Development, acting under the Animal Diseases Act, declared a Disease Management Area (DMA) and prohibited the movement of cloven-hoofed animals, animal products and genetic material into, out of or within the DMA except under a state-veterinarian permit, through Government Notice No. 5064 in Government Gazette No. 50977 of 26 July 2024. ³⁹⁰

3.7.2a Evidence of travel ban due to an infectious disease outbreak

Score: 100

There is no publicly available evidence that South Africa has in the past year implemented inbound or outbound travel restrictions due to a infectious disease outbreak. The Department of Health explicitly stated during the 2024/25 mpox response that Africa Centres for Disease Control and Prevention (Africa CDC) and WHO's declarations "do not translate into trade and travel restrictions". ³⁹¹ South Africa's COVID-19 entry/exit measures under the Notifiable Medical Conditions regulations were withdrawn on 22 June 2022, and the government's official notices shows no replacement travel-health regulations enacted in 2024–25. ³⁹²³⁹³

3.7.2b Risk-based approach to international travel-related measures

Score: 100

There is publicly available evidence that South Africa uses a risk-based approach to international travel-related measures. The recent Joint External Evaluation (JEE, 2025) states that South Africa maintains multisectoral outbreak response teams that conduct risk assessments to guide international travel-related public health measures. Guidance documents on topics such as yellow fever and COVID-19 are available. Port Management Committees operate at points of entry to coordinate health measures, supported by national and cross-border collaboration frameworks for information sharing and harmonizing protocols. Bilateral port-level arrangements with neighbouring countries enable direct communication and coordination (POE3.Risk-based approach to international travel-related measures). ³⁹⁴ As standing practice, South Africa applies yellow-fever travel measures that are explicitly tied to risk: official Department of Health materials direct that travellers from or to risk countries obtain vaccination and explain measures taken to prevent introduction of the virus via travellers and vectors. ³⁹⁵

4.1.1a Doctors per 100,000 people

Score: 11.52

4.1.1b Nurses and midwives per 100,000 people

Score: 12.99

4.1.1c Updated health workforce strategy to address human resource shortfalls

Score: 100

There is publicly available evidence that South Africa has a health workforce strategy in place (which has been updated in the past five years) to identify fields where there is a insufficient workforce and strategies to address these shortcomings. The Department of Health (DoH) adopted a 10-year Human Resources for Health (HRH) Strategy, 2020-2030 in October 2020. The Ministerial Task Team (MTT) "conducted a review of development policies and strategies for health, health systems and HRH; conducted in-depth interviews with key informants; commissioned specific technical analyses on [the] health labour market in South Africa, health workforce needs and costs, health workforce needs of primary health care" and then worked in five workstreams (Health workforce needs and costs; Education and training; Leadership, management and governance; Conditions of service; Information, monitoring and evaluation) to address shortcomings (pages 16-17). ³⁹⁶ The 2025 Joint External Evaluation confirms that South Africa's 10-year HRH strategy, aligned with a endorsed nursing strategy and backed by political leadership, extends to 2030, incorporates labour market analysis, and involves the DoH in developing the scarce skills list led by the Department of Home Affairs (D3.1. Multisectoral workforce strategy). ³⁹⁷

4.1.1d Health system capacity for essential health services

Score: 100

There is evidence that South Africa has sufficient capacity within the health system to deliver essential health services.

The Joint External Evaluation of the International Health Regulations (2005) core capacities of South Africa conducted in 2024 gives South Africa a score of 4 for this measure, the highest possible. This is based on the EHS package has been defined, guidelines for maintaining continuity of EHS have been developed and are implemented at national and intermediate levels, and a system for monitoring continuity of the services is in place. South Africa has established national, provincial and district outbreak response teams. In addition, there is an established inter-ministerial team. These ensure coordinated and effective responses during public health emergencies and collaboration among public and private sectors during responses. The inter-ministerial team facilitates collaboration and resource sharing across various government sectors, enhancing the overall emergency response capability. The established specialized emergency workforce ensures adequate healthcare resources during pandemics or epidemics (such as the COVID-19 pandemic); however, these resources are not adequate for all emergencies. Secured funding is available to upgrade and expand health facilities to accommodate both routine and emergency needs within a short space of time.³⁹⁸

The Global Health Observatory of the World Health Organisation (WHO) lists Coverage of essential health services as one of its targets, where South Africa scored 71 (out of 100) in 2021. "Coverage of essential health services is defined as the average coverage of essential services based on tracer interventions that include reproductive, maternal, newborn and child health, infectious diseases, non-communicable diseases and service capacity and access, among the general and the most disadvantaged population". ³⁹⁹ However, in 2022, South Africa was one of four African countries that surpassed the WHO threshold density of 4.45 health workers per 1000 people needed to deliver essential health services and achieve universal health coverage.⁴⁰⁰

4.1.1e Essential health services continuity plan for public health emergencies

Score: 100

There is evidence that South Africa can ensure continuity of essential health services during a public health emergency. The 2025 Joint External Evaluation (JEE) lists that dedicated funds are in place to rapidly upgrade and expand health facilities, ensuring they can meet both routine demands and emergency surges as a strength (R3.3. Continuity of essential health services (EHS)). The JEE also remarks that the EHS continuity plan is in draft that needs to be finalized (ibid.). ⁴⁰¹ In August 2024, the Presidency adopted the Second Presidential Health Compact 2024-2029; Pillar 10 of that Compact (Pandemic Prevention, Preparedness and Response) lists, among other key interventions, "6. Safeguarding the resilience of the health system to ensure continuity of essential health services by defining a non-negotiable compendium of care that must persist even in the most dire health emergencies" (page 20). The Compact also points out the need to finalize the continuity plan (page 81). ⁴⁰² There is operational evidence that the plan is already being applied: the 2021-2022 Annual Report of the Department of Health confirms that a inter-ministerial team set up a dedicated continuity of EHS (CEHS) work-stream during COVID-19 and that "all 9 provinces developed plans for continuity of essential health services", allowing routine care to continue while hospitals managed pandemic caseloads (page 48). ⁴⁰³

4.1.2a Hospital beds per 100,000 people

Score: 59.2

4.1.2b In-country capacity to isolate patients with highly communicable diseases

Score: 100

There is publicly available evidence that South Africa has the capacity to isolate patients with highly communicable diseases in a biocontainment patient care unit and/or patient isolation room/unit located within the country. The Department of Health's Practical Manual for Implementation of the National IPC Strategic Framework (October 2021) sets binding structural requirements: "In hospitals there should be at least two isolation/single rooms with en-suite ablution facilities per 24 beds. Only in hospitals that have designated in infectious disease units, the number of isolation beds should increase to three or four per 24 beds depending on the disease profile of the community, such as high TB" (page 130). ⁴⁰⁴ The 2025 Joint External Evaluation describes that the health system faces several challenges, including inadequate infrastructure, such as the absence of isolation wards in many health facilities. Most points of entry, especially land borders, lack dedicated areas for interviewing and/or temporarily isolating suspected or ill travellers. ⁴⁰⁵

4.1.2c Demonstrated capacity / evidence of plan to expand isolation capacity

Score: 100

There is publicly available evidence that South Africa has demonstrated capacity to expand isolation capacity in response to a infectious disease outbreak in the past two years. When the multi-province cholera outbreak centred on Hammanskraal intensified in 2023, the National Department of Health set up a "well-equipped temporary field health facility (Kanana Cholera Treatment Centre)" next to the Jubilee District Hospital. The centre began operating 24/7 on 26 May 2023; it was built specifically to take suspected and confirmed cholera patients, relieving pressure on the hospital's existing wards. ⁴⁰⁶ A second official advisory from the Gauteng Department of Health explains that a 300-bed Alternative Building Technologies (ABT) structure, originally erected for COVID-19, was re-configured in August 2023, when two entire ABT wards were set aside, one for patients suspected of cholera and one for laboratory-confirmed cases. ⁴⁰⁷ The recent Joint External Evaluation (JEE, 2025) notes, however, that in general, South Africa lacks isolation wards (page 56) and the JEE recommends investing in them as a priority action (page 59), also at points of entry (page 72). ⁴⁰⁸

4.2.1a National procurement protocol for the acquisition of routine laboratory/medical supplies

Score: 100

There is a national and international procurement protocol in place which can be utilized by the Ministries of Health and Agriculture in South Africa for the acquisition of laboratory and medical supplies for routine needs. Based on the Public Finance Management Act of 1999 (PFMA) section 38(1)(a)(iii), every accounting officer (i.e. the Director-Generals of Health and Agriculture) must create and run a fair, equitable, transparent, competitive and cost-effective procurement system for all goods and services, including laboratory equipment, reagents, media, PPE and other medical supplies. ⁴⁰⁹ This is operationalised by the National Treasury Regulations issued under the PFMA, Part 16A "Supply-Chain Management". ⁴¹⁰ The Treasury has established a Central Supplier Database (CSD) that "maintains a database of organisations, institutions and individuals who can provide goods and services to government" and a eTender portal that "displays on a daily basis all public sector tenders in South Africa". ⁴¹¹⁴¹² There are procurement portals on the websites for the Department of Health, the Department of Agriculture and the National Health Laboratory Service (NHLS). Procurement occurs through a public tender process and details on current and past tenders are available online. ^413414415

4.2.2a Stockpile of medical supplies for national use during a public health emergency

Score: 0

There is not enough evidence that South Africa has a stockpile of medical supplies for national use during a public health emergency defined by the overarching national public health emergency response plan (from 3.1.1a). A draft National Health Emergency Response Operations Plan (NHEROP, 2022 – awaiting Director-General endorsement but already operational), a master plan that operationalises the Disaster Management Act for the health sector is cited in the 2025 Joint External Evaluation (JEE, page 49) and other government records (for example in the 2022-2023 Annual Report of the Department of Health, page 39) but has not been published. ⁴¹⁶⁴¹⁷ For vaccines and routine supplies, the JEE confirms South Africa operates a resilient emergency logistics and supply chain system with a overall stock visibility system that monitors medicine and vaccine availability at all levels, and notes regular monitoring of emergency supplies across levels of the system (R1.5. Emergency logistic and supply chain management). It also records ten provincial vaccine depots that are always adequately stocked, helping avoid stock-outs downstream (P8.2. National vaccine access and delivery). While this demonstrates robust availability of monitoring and buffer stocks, the JEE does not describe a single, named, comprehensive national strategic emergency stockpile with published contents. ⁴¹⁸ Recent disease-specific guidance further shows targeted stockpiling rather than a single all-hazards stockpile. For mpox, Department of Health (DoH) training materials instruct that "a small stockpile should be maintained" for rapid post-exposure vaccination of close contacts and at-risk workers (page 13). ⁴¹⁹ There is no information about a plan to ensure equitable distribution in a emergency on the website of DoH. ⁴²⁰

4.2.2b Stockpile of laboratory supplies for national use during a public health emergency

Score: 0

There is insufficient evidence that South Africa has a stockpile of laboratory supplies (e.g. reagents, media) for national use during a public health emergency. The Department of Health's (DoH) 2024/25 Annual Performance Plan explains that the National Surveillance Centre provides visibility of medicine availability using a Stock Visibility System (SVS) and related systems, however, it does not refer to a national reserve of laboratory supplies. ⁴²¹ The 2023/24 National Health Laboratory Service (NHLS) Annual Report discusses procurement and inventory, yet it offers no policy or mechanism labelled as a national stockpile. ⁴²² The latest Joint External Evaluation (JEE, 2025) notes that South Africa has a emergency logistics and supply-chain system and stock visibility for medicines and vaccines, while visibility for medical supplies remains a challenge (R1.5. Emergency logistic and supply chain management). The JEE text does not identify any national stockpile of laboratory supplies. ⁴²³ There is no further evidence of laboratory supply stockpiles on the websites of the Department of Health, the NHLS, the National Disaster Management Centre (NDMC) or the South African Health Products Regulatory Authority (SAHPRA). ^424425426427

4.2.2c Annual review of national stockpile to ensure sufficient supply

Score: 0

There is no publicly available evidence that the country conducts or requires a annual review of the national stockpile to ensure the supply is sufficient for a public health emergency. The most recent WHO Joint External Evaluation (JEE) for South Africa explicitly notes that, although South Africa has a resilient emergency logistics and supply-chain system with stock visibility tools for medicines, the emergency logistics and supply-chain mechanism has not been "exercised, reviewed, evaluated or updated on a regular basis". ⁴²⁸ No information on reviewing the stockpiles can be found on the websites of the Department of Health, the National Health Laboratory Service (NHLS), the National Disaster Management Centre (NDMC) or the South African Health Products Authority (SAHPRA). ^429430431432

4.2.3a Plan/agreement to produce/procure medical supplies during a public health emergency

Score: 100

There is evidence of a plan to leverage public and/or private sector domestic manufacturing capacity in South Africa to produce medical supplies for national use during a public health emergency. The Department of Trade, Industry and Competition (DTIC) and the Department of Health (DoH) co-signed the Medical Technology (MEDTECH) Master Plan in 2024 together with organised labour and the domestic device and diagnostics industry. The plan establishes "a executive industry oversight committee" drawn from government, industry, academia and labour to steer implementation and "develop agreements on areas for intervention, collaboration, and commitments for ongoing investment and development" (page 2). Its vision for 2035 is "a digitalised, integrated and cohesive ecosystem that enables, supports and encourages development, growth, and competitiveness of local medical technology value chains to produce reliable, safe, quality, and affordable MEDTECH for domestic and export markets" (ibid.). ⁴³³ The Second Presidential Health Compact 2024-2029 also plans on leveraging domestic manufacturing: "In our pursuit to secure health products, we are committed to strengthening local manufacturing through preferential procurement, regulatory harmonisation, and streamlining supply chain mechanisms" (page 3). ⁴³⁴ The most recent Joint External Evaluation (JEE, 2025) notes the limited domestic manufacturing capacity of in-vitro diagnostics (D1.4. Effective national diagnostic network) and medical devices (R1.5. Emergency logistic and supply chain management), and treats the industrial plans above as essential follow-up actions to close the gap it identifies. ⁴³⁵
There is also evidence of a plan/mechanism to procure medical supplies for national use during a public health emergency. The Guideline For Section 21 Access To Unregistered Medicines prepared by the South African Health Products Regulatory Authority (SAHPRA) allows unregistered medicines to be authorised for sale for a identified Public Health Emergency (PHE) (3.4 Public health emergency (PHE)). ⁴³⁶ The JEE confirms that funding pathways for public‑health crises are already in place: the National Health Emergency Response Operations Plan includes a dedicated financing component, and the Public Financial Management Act contains emergency‑procurement provisions (R1.5. Emergency logistic and supply chain management). ⁴³⁷ Article 27 b) of the Southern African Development Community Protocol on Health provides additional potential resources for South Africa through international cooperation. ⁴³⁸

4.2.3b Plan/agreement to produce/procure lab supplies during a public health emergency

Score: 100

There is publicly available evidence that South Africa has a plan/agreement to leverage public and/or private sector domestic (including regional) manufacturing capacity to produce laboratory supplies (e.g. reagents, media) for national use during a public health emergency. South Africa's public science system formally launched local manufacturing of COVID-19 diagnostic reagents and test kits during the national state of disaster. The Council for Scientific and Industrial Research (CSIR) states that, in collaboration with CapeBio and with public R&D funding, it developed locally produced PCR test kits and reagents as a response to a worldwide shortage of diagnostics. ⁴³⁹ CSIR also records that "in July 2021, [the South African Health Products Regulatory Authority] gave the greenlight for the local manufacturing of the test kits" and that local production of reagents would increase access and reduce reliance on imports (page 49); a explicit plan to use domestic production to secure lab supplies in the emergency. ⁴⁴⁰ The National Health Laboratory Service (NHLS) itself also maintains in-country manufacturing capacity for laboratory reagents and media through its Diagnostic Media Products (DMP) unit, which "manufactures and supplies a wide range of high quality diagnostic reagents, ready to use kits and microbiological culture media". ⁴⁴¹ The Department of Trade, Industry and Competition (DTIC) and the Department of Health (DoH) co-signed the Medical Technology (MEDTECH) Master Plan in 2024 together with organised labour and the domestic device and diagnostics industry. The plan establishes "a executive industry oversight committee" drawn from government, industry, academia and labour to steer implementation and "develop agreements on areas for intervention, collaboration, and commitments for ongoing investment and development" (page 2). Its vision for 2035 is "a digitalised, integrated and cohesive ecosystem that enables, supports and encourages development, growth, and competitiveness of local medical technology value chains to produce reliable, safe, quality, and affordable MEDTECH for domestic and export markets" (ibid.). ⁴⁴² The Second Presidential Health Compact 2024-2029 also plans on leveraging domestic manufacturing: "In our pursuit to secure health products, we are committed to strengthening local manufacturing through preferential procurement, regulatory harmonisation, and streamlining supply chain mechanisms" (page 3). ⁴⁴³ The most recent Joint External Evaluation (JEE, 2025) notes the limited domestic manufacturing capacity of in-vitro diagnostics (D1.4. Effective national diagnostic network) and medical devices (R1.5. Emergency logistic and supply chain management), and treats the industrial plans above as essential follow-up actions to close the gap it identifies. ⁴⁴⁴
There is also evidence of a plan/mechanism to procure laboratory supplies (e.g. reagents, media) for national use during a public health emergency. The Guideline For Section 21 Access To Unregistered Medicines prepared by the South African Health Products Regulatory Authority (SAHPRA) allows unregistered medicines (including diagnostics) to be authorised for sale for a identified Public Health Emergency (PHE) (3.4 Public health emergency (PHE)). ⁴⁴⁵ The JEE confirms that funding pathways for public‑health crises are already in place: the National Health Emergency Response Operations Plan includes a dedicated financing component, and the Public Financial Management Act contains emergency‑procurement provisions (R1.5. Emergency logistic and supply chain management). ⁴⁴⁶ Article 27 b) of the Southern African Development Community Protocol on Health provides additional potential resources for South Africa through international cooperation. ⁴⁴⁷

4.2.3c Mechanism emergency logistics and supply chain management

Score: 100

There is publicly available evidence that South Africa has a system or mechanism for national and subnational levels both in the public and private sectors for emergency logistics and supply chain management and evidence that it is not exercised, reviewed, evaluated and updated on a regular basis. During the COVID-19 response, Department of Health standard operating procedures (SOP) formalized emergency supply planning and allocation via a national "Control Tower", and explicitly used the Stock Visibility System (SVS) to capture stock at vaccination and other sites for replenishment and redistribution in both the public and private sectors; this is evidence of a centrally coordinated emergency logistics process. ⁴⁴⁸ Another SOP prescribed the preparation of cold chain equipment on COVID-19 vaccination sites, detailing equipment types, temperature monitoring routines, stock checks, and handling/contingency steps. ⁴⁴⁹ The most recent WHO Joint External Evaluation (JEE, 2025) for South Africa explicitly notes that, although South Africa has a resilient emergency logistics and supply chain system with stock visibility tools for medicines, the emergency logistics and supply chain mechanism has not been "exercised, reviewed, evaluated or updated on a regular basis". ⁴⁵⁰

4.3.1a Plan/program/guidelines for dispensing MCMs during a public health emergency

Score: 100

There is evidence that South Africa has a plan, program, or guidelines in place for dispensing medical countermeasures (MCM) for national use during a public health emergency (i.e., antibiotics, vaccines, therapeutics and diagnostics). The 2025 Joint External Evaluation (JEE) for South Africa explicitly confirms that the country has a resilient emergency logistics and supply chain management system (R1.5. Emergency logistic and supply chain management), a national plan for mass vaccination in outbreaks with disseminated SOPs (P8.3. Mass vaccination for epidemics of VPDs), Section 21 guidelines for emergency approval of unregistered medicines/vaccines (ibid.), and South African Health Products Regulatory Authority (SAHPRA) donation guidelines for medicines, devices and in-vitro diagnostics (R1.5. Emergency logistic and supply chain management). ⁴⁵¹ SAHPRA issues the guideline "Availability of medicines for use in a Public Health Emergency (PHE)" and maintains the Section 21 framework for access to unregistered medicines, both used to fast-track approval/availability in a PHE. ⁴⁵² Receipt and distribution of donated MCMs are governed by SAHPRA's national donation guideline, which prescribes the principles and processes for donations of medicines, medical devices and IVDs. ⁴⁵³

4.3.2a Plan to receive foreign health personnel during a public health emergency

Score: 0

There is no publicly available evidence that South Africa has a public plan in place to facilitate a workforce surge in a emergency. The recent Joint External Evalution (JEE, 2025) reports that neither a national multisectoral strategic plan for surge nor the required gap analysis is available (D3.4. Workforce surge during a public health event); it also notes that there are no national and intermediate level plans describing systems for pre-deployment, deployment and post-deployment of surge personnel (R1.4. Activation and coordination of health personnel in a public health emergency). The JEE further records that the National Health Emergency Response Operations Plan (NHEROP) exists but is still in a draft format (R1.1. Emergency risk and readiness assessment). The report lists as strengths that South Africa prepared a COVID-19 healthcare personnel surge plan and that the Department of Health's (DoH) Pandemic Preparedness and Response Plan addresses the health workforce; but it still concludes that a comprehensive national surge strategy has not been established (D3.4. Workforce surge during a public health event). ⁴⁵⁴ The DoH has a overarching workforce strategy, the 2030 Human Resources for Health Strategy, but this is a mid-term plan targeting baseline healthcare coverage. ⁴⁵⁵ There is no evidence of a surge plan on the website of the DoH. ⁴⁵⁶

4.3.2b Plan to facilitate workforce surge in an emergency

Score: 0

There is no publicly available evidence that South Africa has a plan in place to receive health personnel from other countries to respond to a public health emergency. The most recent WHO Joint External Evaluation (JEE) of South Africa (2025) states explicitly that the country currently lacks national and intermediate-level plans that define a system for the pre-deployment, deployment, and post-deployment of surge personnel, including the processes for sending and receiving individuals or teams during public health emergencies and that there is a need to develop comprehensive plans for emergency medical teams and rapid response teams (R1.4. Activation and coordination of health personnel in a public health emergency). ⁴⁵⁷ South Africa's legal framework does enable international cooperation, but it does not itself establish a reception plan for foreign health teams. The Disaster Management Act requires that the national disaster management framework facilitate South Africa's cooperation in international disaster management (section 7(2)(c)) and that the National Disaster Management Centre (NDMC) maintain links with foreign organisations and have access to international expertise and assistance (sections 16(2)(f) and 16(3)). It also requires keeping information on emergency response capacity in neighbouring states and relevant international relief agencies (section 17(2)(j)). These provisions describe cooperation, directories and information exchange; they do not set out procedures or SOPs for receiving foreign health personnel. ⁴⁵⁸

4.3.2c Plan to redeploy existing health personnel within the country

Score: 0

There is no publicly available evidence for a public plan in place to redeploy (either geographically or role redeployment) existing health personnel within South Africa. The most recent WHO Joint External Evaluation (JEE) of South Africa (2025) states explicitly that the country currently lacks national and intermediate-level plans that define a system for the pre-deployment, deployment, and post-deployment of surge personnel, including the processes for sending and receiving individuals or teams during public health emergencies and that there is a need to develop comprehensive plans for emergency medical teams and rapid response teams (R1.4. Activation and coordination of health personnel in a public health emergency). ⁴⁵⁹ There is no evidence of a redeployment plan on the website of the Department of Health. ⁴⁶⁰

4.4.1a Constitutional guarantee of citizens’ right to medical care

Score: 75

The Constitution of South Africa explicitly guarantees citizens' right to medical care. Based on WORLD Policy Analysis Center data, medical care is a guaranteed right. ⁴⁶¹ Section 27 (1) (a) of the Constitution reads: "Everyone has the right to have access to health care services". ⁴⁶²

4.4.1b Access to skilled birth attendants (% of population)

Score: 95.59

4.4.1c Out-of-pocket health expenditures per capita, PPP (current international $)

Score: 87.85

4.4.1d Coverage of essential health services through universal health coverage

Score: 91.67

4.4.1e Total population pushed below a relative poverty line by household health expenditure (60% of media daily per capita consumption or income)

Score: 96.09

4.4.1f Rate of mortality amenable to health care

Score: 40.76

4.4.2a Guaranteed paid sick leave

Score: 66.67

In South Africa, workers are guaranteed paid sick leave. Based on WORLD Policy Analysis Center data, paid sick leave is guaranteed. ⁴⁶³ Section 22 of the Basic Conditions of Employment Act (BCEA) of 1997 obliges every employer to grant paid sick-leave for up to "the number of days the employee would normally work in a six-week period" in every 36-month cycle. ⁴⁶⁴ The BCEA neither explicitly includes nor excludes mental health problems as a basis for sick leave. Section 23 (2) requires that, in certain cases, a "medical certificate must be issued and signed by a medical practitioner or any other person who is certified to diagnose and treat patients and who is registered with a professional council", thus implicitly including psychiatrists and psychologists as well. ⁴⁶⁵ According to the Law For All website, the certificate does not have to name the diagnosis; "medical condition" is enough, thus allowing any mental problem to be included. ⁴⁶⁶ Illness that impairs the employee's ability to work has been treated by the courts as a disability, and Section 187 (1) (f) of the Labour Relations Act of 1995 (LRA) explicitly prohibits discriminating against disability. ⁴⁶⁷ Example court cases include Jansen v Legal Aid South Africa or New Way Motor & Diesel Engineering (Pty) Ltd v Marsland, confirming that firing someone during a period of recognised illness is automatically unfair discrimination on the ground of disability. ⁴⁶⁸⁴⁶⁹ However, there is no explicit mention of sick leave for mental health problems in the WORLD Policy Analysis Center database or in BCEA. ⁴⁷⁰⁴⁷¹

4.4.3a Government prioritisation of care for healthcare workers during response

Score: 100

There is publicly available evidence that the South African government issued legislation, a policy, or a public statement committing to provide prioritized healthcare services to healthcare workers who become sick as a result of responding to a public health emergency. The Department of Health issued a official Strategy to protect the health and safety of health workers that explicitly commits to priority clinical support for healthcare workers (HCWs) who become infected while responding to a emergency. The strategy states that symptomatic HCWs must receive "preferential access to testing sites" (section 4.1), and that once tested, "prioritized medical care and testing including specific testing sites being available for healthcare workers and fast tracking of results" (figure 2). ⁴⁷²

4.5.1a Existence of system for communication during a public health emergency

Score: 0

There is no publicly available evidence of a system in place in South Africa specifically for public health officials and healthcare workers to communicate during a public health emergency. The Department of Health (DoH) 2022/23 Annual Report explicitly notes that work is underway to establish a Public Health Emergency Operations Centre (PHEOC) and describes it as "a centralised location from which public health officials communicate, collaborate and coordinate the response to health emergencies" (1.2 b)), and two Centres have opened since, however, according to the 2025 Joint External Evaluation (JEE), though the PHEOC Handbook has been developed and validated, it is still awaiting endorsement from the Director-General (R1.2. Public health emergency operations centre [PHEOC]) and the integration between the PHEOC and the incident management system has not yet been established (R1.3. Management of health emergency response) – these factors hinder the introduction of proper communication channels. ⁴⁷³⁴⁷⁴ The Disaster Management Act of 2002 describes a framework for communication links with disaster management role players (section 16), but it does not give details about how this should work, either for a health emergency or otherwise. ⁴⁷⁵ The National Institute for Communicable Diseases (NICD) has both a Emergency Operations Centre, charged with coordinating responses to public health emergencies, and a Communications Unit, but there is no evidence that either has a specific communication plan for health officials and healthcare workers. ⁴⁷⁶

4.5.1b Inclusion of public and private sector in healthcare communication system

Score: 0

There is no publicly available evidence of a system in place in South Africa specifically for public health officials and healthcare workers to communicate during a public health emergency, regardless of the sector. The Department of Health (DoH) 2022/23 Annual Report explicitly notes that work is underway to establish a Public Health Emergency Operations Centre (PHEOC) and describes it as "a centralised location from which public health officials communicate, collaborate and coordinate the response to health emergencies" (1.2 b)), and two Centres have opened since, however, according to the 2025 Joint External Evaluation (JEE), though the PHEOC Handbook has been developed and validated, it is still awaiting endorsement from the Director-General (R1.2. Public health emergency operations centre [PHEOC]) and the integration between the PHEOC and the incident management system has not yet been established (R1.3. Management of health emergency response) – these factors hinder the introduction of proper communication channels, and only consider the public sector. ⁴⁷⁷⁴⁷⁸ The Disaster Management Act of 2002 describes a framework for communication links with disaster management role players (section 16), but it does not give details about how this should work, either for a health emergency or otherwise. ⁴⁷⁹ The National Institute for Communicable Diseases (NICD) has both a Emergency Operations Centre, charged with coordinating responses to public health emergencies, and a Communications Unit, but there is no evidence that either has a specific communication plan for health officials and healthcare workers. ⁴⁸⁰

4.6.1a Evidence of national public health system monitoring and tracking of HCAIs

Score: 100

There is evidence that the South African national public health system is monitoring for and tracking the number of healthcare associated infections (HCAI) that take place in healthcare facilities. The National Infection Prevention and Control (IPC) Strategic Framework, issued by the Department of Health (DoH) in 2020, is a document that "provides the framework to develop and support a national IPC programme at all levels of health care delivery in the public and private sector". Under section 7.4 Core Component 4 (Healthcare-associated infection surveillance) it lists requirements for healthcare associated infection (HAI) surveillance. ⁴⁸¹ The Practical Manual for Implementation of the Framework contains a whole chapter (Chapter 5) on Surveillance Of Healthcare Associated Infections that describes monitoring and tracking directions, and dedicates a subsection (5.3.2) for surveillance. ⁴⁸² This monitoring system is not yet fully developed, according to the 2025 Joint External Evaluation (JEE), which explains that South Africa has introduced a national HAI strategy and provinces that have conducted HCAI surveillance are reporting, however, because there is still no unified, country‑wide reporting framework, its scope is limited and the country lacks a fully integrated national HCAI surveillance system, making it difficult to track infection patterns and mount a coordinated response (page 60). ⁴⁸³ The National Institute For Communicable Diseases (NICD) has a dedicated Centre for Healthcare-associated Infections, Antimicrobial Resistance and Mycoses (CHARM) whose objectives include conducting surveillance of healthcare-associated infections. ⁴⁸⁴

4.6.1b Infection prevention and control programme

Score: 100

There is publicly available evidence of a infection prevention and control programme in place nationally in South Africa. The Department of Health (DoH) has adopted a National Infection Prevention and Control (IPC) Strategic Framework (2020) that sets out the national IPC programme, aligned to WHO IPC core components, and assigns national functions such as training. The Department's own publication states that "training is one of the key functions of the national IPC programme" (section 7.3), and the framework is accompanied by a Practical Manual for Implementation of the National Infection Prevention and Control Strategic Framework to guide roll-out across public and private facilities. ⁴⁸⁵⁴⁸⁶ The 2025 Joint External Evaluation (JEE) confirms the presence of a IPC programme and recommends steps to establish a firm IPC structure as well as to secure the appropriate funds (R4.1. IPC programmes). ⁴⁸⁷

4.6.1c National plan to ensure a safe environment in health facilities

Score: 100

There is publicly available evidence of a plan to ensure a safe environment in South African health facilities nationally. The Minister of Health has prescribed the Norms and Standards Regulations Applicable to Different Categories of Health Establishments under the National Health Act. The regulations state that their purpose is "to promote and protect the health and safety of users and health care personnel" (section 3) and then require each health establishment to, among others, maintain infection prevention and control (IPC) programmes (section 8), handle health-care waste safely (section 9), manage buildings and engineering services (power, water, medical gases, ventilation, sewerage) (sections 14-16), provide security services (section 17), and comply with the Occupational Health and Safety Act (section 20). ⁴⁸⁸ The national enforcement mechanism is the Office of Health Standards Compliance (OHSC), created in law by the National Health Amendment Act to protect health and safety by inspecting health establishments and enforcing compliance with prescribed norms and standards. The OHSC's published Enforcement Policy further sets out how it inspects, certifies and enforces compliance to "protect users and health care personnel from harm" (section 12.1.1 b)), confirming that non-compliance triggers regulatory action (section 13). ⁴⁸⁹ The Department of Health has adopted a National IPC Strategic Framework and a Practical Manual for Implementation that apply to public and private facilities and guide compliance with IPC standards to reduce healthcare-associated infections and improve safety. ⁴⁹⁰⁴⁹¹ The most recent Joint External Evaluation (JEE, 2025) confirms the existence of a norms and standards guidance document and also notes that country faces severe financial, staffing, infrastructure, and service delivery challenges, worsened by poor management, security issues, and rising disasters (R4.3. Safe environment in health facilities). ⁴⁹²

4.7.1a Requirement for ethical review before beginning a clinical trial

Score: 100

There is publicly available evidence that there is a national requirement for ethical review (e.g., from a ethics committee or via Institutional Review Board approval) before beginning a clinical trial. South Africa has a national legal requirement that any health research involving human participants (including clinical trials) must receive prior approval from a registered Health Research Ethics Committee (HREC) before the research begins. The Department of Health's Regulations Relating to Research with Human Participants state that researchers "must submit the research proposal for ethics review and approval to a registered health research ethics committee […] before commencing with the research" (section 3 (a)) and that "all health research proposals involving human participants must be reviewed by a health research ethics committee which is registered with the [National Health Research Ethics] Council" (section 6 (a)). The same regulations also require that research "undergo independent review by a registered health research ethics committee" (section 2 (g)). ⁴⁹³ The 2024 South African Ethics in Health Research Guidelines set out the principles, processes, and structures for conducting health research, as confirmed by the 2025 Joint External Evaluation (R1.6. Research, development and innovation). ⁴⁹⁴⁴⁹⁵

4.7.1b Expedited approval for clinical trials of unregistered MCMs during epidemics

Score: 100

There is evidence for both a expedited process for approving clinical trials for unregistered medical countermeasures and recognition of clinical trial results taking place elsewhere to treat ongoing pandemics or epidemics. The Medicines and Related Substances Act of 1965, section 21 lets the South African Health Products Regulatory Authority (SAHPRA) "authorise sale of unregistered medicines, medical devices or IVDs for certain purposes". ⁴⁹⁶ SAHPRA's guideline, Availability of Medicines for Use in a Public Health Emergency (PHE) (Aug 2023) sets specific timelines: (a) a 30 working-day target for Section 21 PHE applications, and (b) a 90 working-day target (priority) or rolling review while new data are submitted for full registration (3.1). To further expedite the process, "the Authority may rely on the on the decisions of other regulatory agencies it aligns with, as well as recognise test reports and lot release certifications from such sources" (6.1). ⁴⁹⁷ SAHPRA's guideline, Electronic Submission Of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events), explicitly states in section 3.1 (Responses for new Clinical Trial Application), section 4 (Applications For Protocol Amendments During Conduct Of Clinical Trials), and section 6 (Application For Bioequivalence Studies) that "Public Health Emergency (PHE) Applications are expedited with the response provided within 10 working days". ⁴⁹⁸ The mechanism is not automatic, but the May 2024 Reliance Guideline allows SAHPRA to base its decision on approvals of Recognized Regulatory Authorities (including, for example, corresponding authorities of the European Union, the United Kingdom, Switzerland, the United States, Canada, Japan, Australia) (4.1). This means that "during the review process the Authority considers information regarding the review status of the clinical trial with other Regulatory Authorities" (10). ⁴⁹⁹ The 2025 Joint External Evaluation (JEE) also acknowledges the expedited approval of unregistered drugs and vaccines (P8.3. Mass vaccination for epidemics of VPDs and R1.5. Emergency logistic and supply chain management). ⁵⁰⁰

4.7.2a Existence of agency responsible for approving new human MCMs

Score: 100

There is publicly available evidence that South Africa has a government agency responsible for approving new medical countermeasures for humans. The South African Health Products Regulatory Authority (SAHPRA) is the statutory body that is "monitoring, evaluating, investigating, inspecting and registering all health products. This includes clinical trials, complementary medicines, medical devices and in vitro diagnostics", that is, new medical countermeasures (MCMs). ⁵⁰¹ SAHPRA's legal powers are set out in Sections 2, 2A and 2B of the Medicines and Related Substances Act of 1965 (as amended) and its regulations; those powers include scientific assessment of quality, safety, efficacy, post-marketing surveillance and the ability to issue emergency Section 21 authorisations for unregistered MCMs. ⁵⁰² The WHO Joint External Evaluation 2025 mission report for South Africa confirms that SAHPRA is the responsible national authority for registration and approval of vaccines, medicines, therapeutics and other countermeasures. (P4.4. Optimal use of antimicrobial medicines in human health). ⁵⁰³

4.7.2b Expedited approval for human MCMs during public health emergencies

Score: 100

There is evidence for both a expedited process for approving medical countermeasures (MCM) for human use and recognition of approval decisions taking place elsewhere during public health emergencies. The Medicines and Related Substances Act of 1965, in Section 21, permits the South African Health Products Regulatory Authority (SAHPRA) to "authorise sale of unregistered medicines, medical devices or IVDs for certain purposes". ⁵⁰⁴ SAHPRA's guideline, Availability of Medicines for Use in a Public Health Emergency (PHE) (Aug 2023) sets specific timelines: (a) a 30 working-day target for Section 21 PHE applications, and (b) a 90 working-day target (priority) or rolling review while new data are submitted for full registration (3.1). To further expedite the process, "the Authority may rely on the on the decisions of other regulatory agencies it aligns with, as well as recognise test reports and lot release certifications from such sources" (6.1). ⁵⁰⁵ SAHPRA's guideline, Electronic Submission Of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events), explicitly states in section 3.1 (Responses for new Clinical Trial Application), section 4 (Applications For Protocol Amendments During Conduct Of Clinical Trials), and section 6 (Application For Bioequivalence Studies) that "Public Health Emergency (PHE) Applications are expedited with the response provided within 10 working days". ⁵⁰⁶ The mechanism is not automatic, but the May 2024 Reliance Guideline allows SAHPRA to base its decision on approvals of Recognized Regulatory Authorities (including, for example, corresponding authorities of the European Union, the United Kingdom, Switzerland, the United States, Canada, Japan, Australia) (4.1). This means that "during the review process the Authority considers information regarding the review status of the clinical trial with other Regulatory Authorities" (10). ⁵⁰⁷ The 2025 Joint External Evaluation (JEE) also acknowledges the expedited approval of unregistered drugs and vaccines (P8.3. Mass vaccination for epidemics of VPDs and R1.5. Emergency logistic and supply chain management). ⁵⁰⁸

5.1.1a Submission of IHR reports to the WHO in past year

Score: 100

South Africa has submitted a IHR Self-Assessment Annual Report (SPAR) to the WHO for the last calendar year, with the latest submission in 2024.⁵⁰⁹

5.1.2a Existence of specific risk reduction strategies for epidemics and pandemics

Score: 0

There is no evidence of a South African national risk reduction strategy which substantially mentions epidemics or pandemics. South Africa's primary disaster-risk law, the Disaster Management Act of 2002, mandates "a integrated and co-ordinated disaster management policy that focuses on preventing or reducing the risk of disasters" across all hazards (page 2). The Act therefore supplies one, multi-hazard legal scaffold for risk-reduction; there is no clause creating a separate regime for health emergencies. ⁵¹⁰ The accompanying Policy framework for disaster risk management in South Africa classifies epidemic diseases as biological natural hazards, placing them inside the same policy umbrella as floods or fires (Table 2.3). ⁵¹¹ The most recent review of the Framework (Government Gazette 48874, June 2023) keeps that approach; no separate track is provided for epidemics or pandemics. ⁵¹²

5.2.1a Existence of public health emergency agreements with regional neighbors

Score: 100

There is publicly available evidence that South Africa has numerous cross-border agreements, protocols, or MOUs with neighboring countries, or as part of a regional group, with regards to public health emergencies. The Southern African Development Community (SADC) Protocol on Health (1999) urges member states to collaborate regionally on health by coordinating initiatives that boost overall public health, unifying efforts in epidemic preparedness and disease control, strengthening and harmonising laboratory and clinical services, establishing cross‑border referral systems for specialised care, engaging jointly with international health partners, and aligning health‑service standards (Article 3), and is the legal foundation for public health emergency control measures in Southern Africa. Because it commits every Member State, including South Africa, to joint surveillance, prevention and response, it remains the overarching treaty framework for any cross-border emergency cooperation today. ⁵¹³ The Inter-governmental Memorandum of Agreement establishing the SADC Humanitarian & Emergency Operations Centre (SHOC, 2023) creates a autonomous centre that is "responsible for the coordination of regional disaster risk preparedness, response and early recovery to support Member States affected by disasters" and for mobilising emergency supplies. Public-health emergencies are explicitly within the Centre's disaster mandate, giving South Africa a operational regional mechanism for rapid joint action. ⁵¹⁴ The MOSASWA Cross-Border Malaria Agreement between Mozambique, South Africa and Eswatini aims to harmonise malaria policies and coordinate surveillance across shared borders. The agreement is implemented through joint vector-control operations and data sharing that are activated whenever malaria outbreaks threaten to spill over frontiers. ⁵¹⁵ South Africa's 2025 WHO Joint External Evaluation (JEE) notes that port‑level bilateral agreements with neighboring countries facilitate communication and information exchange (POE3.Risk-based approach to international travel-related measures). ⁵¹⁶

5.2.1b Existence of animal health emergency agreements with regional neighbors

Score: 50

South Africa has cross-border strategies, as part of a regional group, with regards to animal health emergencies.

South Africa has been a member of the African Union since 1994. ⁵¹⁷ In 2019, the African Union Inter-African Bureau for Animal Resources (AU-IBAR) enacted the Animal Health Strategy for Africa 2019-2035, which includes the goal of promoting the establishment of early warning, emergency response mechanisms and disaster fund for animal resources at national, regional and continental levels. ⁵¹⁸ It includes goals to adapt emergency preparedness and response framework guidelines, train and simulate exercises at regional and national levels, establish regional response teams and mechanism, and establish a continental-level disaster fund. ⁵¹⁹ Nevertheless, there is no evidence that such measures have been implemented on the African Union website. ⁵²⁰

Additionally, South Africa signed the Southern African Development Community (SADC) Protocol on Health in 1999 that includes several health-related issues, including public health emergencies. ^{521 522} However, the document does not include measures related to animal health emergencies. ⁵²³

In addition, the SADC and the WOAH signed a memorandum of understanding (MOU) in 2024 pertaining to cooperation between the bodies, including in animal health with regular exchange of information. ⁵²⁴

As a member of the Southern African Development Community (SADC), the country is party to the SPS Annex VIII to the SADC Protocol on Trade, which serves as a binding regional agreement covering both public and animal health. This protocol specifically harmonizes sanitary and phytosanitary (SPS) measures across member states to protect human, animal, and plant life while facilitating trade. By adopting this Annex, the country commits to aligning its national regulations with international standards such as Codex Alimentarius (for public health/food safety). Regarding emergencies, the Annex establishes a framework for cross-border cooperation and transparency that includes provisions for handling health crises. It requires member states to notify the SADC Secretariat and other members of any emergency SPS measures taken to address serious health risks (such as disease outbreaks or food safety incidents) within 48 hours. Furthermore, the protocol creates the SADC Sanitary and Phytosanitary Coordinating Committee, which acts as a regional mechanism to facilitate technical assistance, information exchange, and coordinated responses to transboundary animal diseases and public health threats. ⁵²⁵

5.3.1a Biological and Toxin Weapons Convention status

Score: 100

South Africa has signatory and ratification status to the Biological Weapons Convention (BWC). Based on membership information on the BWC website, South Africa is a State Party. ⁵²⁶ The date of ratification is November 3, 1975 according to the United Nations Treaty Collection database. ⁵²⁷ The 2025 Joint External Evaluation (JEE) also confirms membership (page 73). ⁵²⁸

5.3.1b Submission of CBMs to the Biological and Toxin Weapons Convention

Score: 100

South Africa has submitted confidence building measures for the Biological Weapons Convention (BWC) in the past three years. According to the database on the BWC Electronic Confidence Building Measures Portal, South Africa submitted reports every year in the last 20 years. ⁵²⁹

5.3.1c Submission of UNSCR 1540 reports

Score: 100

South Africa has provided the required United Nations Security Council Resolution (UNSCR) 1540 report to the Security Council Committee. According to the database on the 1540 Committee website, South Africa submitted its initial national implementation report to the 1540 Committee on 31 January 2005, thereby meeting the resolution's reporting requirement. It has since filed three voluntary updates on 3 January 2006, 14 December 2007, and most recently on 30 June 2020 to keep the Committee informed of further measures. ⁵³⁰ The 2025 Joint External Evaluation (JEE) also confirms membership (page 28). ⁵³¹

5.3.1d Extent of UNSCR 1540 implementation on public health emergencies

Score: 100

5.3.2a Membership in global health security and/or biological weapons agreements

Score: 0

South Africa is not a partner to the Global Partnership Against the Spread of Weapons and Materials of Mass Destruction (GP), according to GP's website. ⁵³²
South Africa is not a participant in the Australia Group (AG), according to AG's website. ⁵³³ South Africa does not endorse the Proliferation Security Initiative (PSI), according to PSI's website. ⁵³⁴

5.4.1a Completion and publication of JEE (or GHSA pilot external assessment) report

Score: 100

South Africa has completed a Joint External Evaluation (JEE) and published a full public report in the last five years. The latest JEE report was published in June 2025 on the WHO Publications website ⁵³⁵. The WHO Strategic Partnership for Health Security and Emergency Preparedness (SPH) Portal has also been updated to reflect the publication. ⁵³⁶

5.4.2a Completion and publication of PVS report (past five years)

Score: 0

South Africa has not completed and published a Performance of Veterinary Services (PVS) assessment in the last five years. Based on the available information in the PVS database of the World Organisation for Animal Health (WOAH), South Africa completed its last assessment in 2012. ⁵³⁷

5.4.2b Completion and publication of PVS gap analysis (past five years)

Score: 0

South Africa has not completed and published a Performance of Veterinary Services (PVS) gap analysis in the last five years. Based on the available information in the PVS database of the World Organisation for Animal Health (WOAH), South Africa completed its last gap analysis in 2014. ⁵³⁸

5.5.1a Evidence of allocated national funds to improve capacity to address epidemic threats

Score: 100

There is publicly available evidence that South Africa has allocated national funds to improve capacity to address pandemic or epidemic threats within the past three years. The National Treasury's 2024 Estimates of National Expenditure for Vote 18 (Health; which was approved later by the Appropriation Act of 2024 and the Adjustments Appropriation Act of 2024) describes that the Communicable Diseases subprogramme "improves surveillance for disease detection; strengthens preparedness and core response capacity for public health emergencies in line with international health regulations; and facilitates the implementation of influenza prevention and control programmes, tropical disease prevention and control programmes, and malaria elimination" (page 351). This is accompanied by medium-term budgets across 2024/25-2026/27. ^539540541 The most recent Joint External Evaluation reports that "South Africa funds public health emergency responses mainly through local and provincial budgets, with additional support from national health bodies, a Disaster Fund, and National Treasury allocations under the Disaster Management Act and the Public Financial Management Act; though accessing these funds is often slow, inadequate for large-scale crises, and in cases like the recent WHO-declared mpox emergency, has forced reliance on vaccine donations" (pages 13-14). ⁵⁴²

5.5.2a National budget to address gaps identified in JEE, NAPHS or GHSA roadmap

Score: 0

The Joint External Evaluation (JEE) report does not allocate or describe specific funding from the national budget (covering a time-period either in the future or within the past five years) to address the identified gaps. The 2025 Joint External Evaluation (JEE) report notes that South Africa's IHR-related work is financed mainly from the domestic budget (page 13), but it does not spell-out concrete, line-item appropriations that have been set aside to close the gaps the mission identified. It mentions that "budgets are updated annually, with expenditure reviews used to develop and revise budgets" (ibid.) but does not specifically mention addressing the gaps found in the report. ⁵⁴³

5.5.2b National budget to address gaps identified in PVS assessment or gap analysis

Score: 0

South Africa has not completed and published a Performance of Veterinary Services (PVS) assessment or gap analysis in the last five years. Based on the available information in the PVS database of the World Organisation for Animal Health (WOAH), South Africa completed its last assessment in 2012, its last gap analysis in 2014. ⁵⁴⁴

5.5.3a Emergency public financing during a public health emergency

Score: 0

South Africa does not have a publicly identified special emergency public financing mechanism or funds which the country can access in the face of a public health emergency. While South Africa has domestic, government-controlled channels that can be opened rapidly for a public-health emergency, there is no publicly-announced reserve that is set aside exclusively for outbreaks and no formal, published agreement with the World-Bank Pandemic Fund or other multilateral facility. The 2025 Joint External Evaluation (JEE) describes that early public‑health emergency responses are first financed through district and local budgets, and that larger incidents can draw on provincial or National Department of Health resources to deploy surge staff. Additional money may be released from the Disaster Fund once a crisis is formally classified under the Disaster Management Act , and Section 16 of the Public Financial Management Act lets the National Treasury allocate emergency funds. However, these national mechanisms are not health emergency-specific and often provide too little, and the formal declaration and disbursement processes are slow and rigid (page 13). ⁵⁴⁵ South Africa is not eligible to receive International Development Association (IDA) resources. ⁵⁴⁶ Although there is news about the African Epidemic Fund from the Africa Centres for Disease Control and Prevention (Africa CDC) from March 2025, no information can be found on specifics on the Africa CDC website or other sources. ⁵⁴⁷ There is no evidence on the website of the National Department of Health that South Africa has any special emergency public financing mechanism. ⁵⁴⁸

5.5.4a Commitments to improve domestic or foreign capacity for epidemic threats

Score: 0

There is no publicly available evidence that senior leaders (president or ministers) in South Africa have made a public commitment to support other countries to improve capacity to address pandemic or epidemic threats by providing financing or support or improve the country's domestic capacity to address pandemic or epidemic threats by expanding financing or requesting support to improve capacity. Although there is news about the African Epidemic Fund from the Africa Centres for Disease Control and Prevention (Africa CDC) from March 2025, no information can be found on specifics on the Africa CDC website or other sources. ⁵⁴⁹ No evidence could be found on the websites of the Department of Health, the Public Health Institute of South Africa (PHISA) or the National Health Laboratory Service (NHLS). ^550551552

5.5.4b Investments to improve domestic or foreign capacity for epidemic threats

Score: 100

There is public evidence that South Africa has, in the past three years, both provided other countries with and requested financing support to improve capacity to address epidemic threats. The Global Fund is "a worldwide partnership to defeat HIV, tuberculosis (TB) and malaria", all epidemic threats in South Africa and many African countries. ⁵⁵³ The database of the Fund shows both pledges and contributions from South Africa (13/8.6 million USD in the 2023-2025 period) and funds allocated to South Africa (536 million USD in the 2023-2025 period). ⁵⁵⁴⁵⁵⁵ In July 2025, South Africa launched a Pandemic Fund (a World Bank-hosted financial intermediary fund) project "to provide catalytic financing that strengthens countries' capacity for pandemic prevention, preparedness, and response". ⁵⁵⁶

5.5.4c Evidence that the country has fulfilled its full WHO contribution within the past two years

Score: 100

There is public evidence that South Africa has fulfilled its full contribution to the WHO within the past two years (2023 and 2024). The WHO's 2023 and 2024 financial reports show that South Africa has paid its entire mandatory contribution for both of the most-recent years (Annexes 1) and even sent money ahead for the next cycle (Annexes 3). ⁵⁵⁷⁵⁵⁸

5.6.1a Sharing of genetic/biological data and materials beyond influenza

Score: 0

There is no publicly available plan or policy for sharing genetic data, clinical specimens, and/or isolated specimens (biological materials) along with the associated epidemiological data with international organizations and/or other countries that goes beyond influenza. There is no publicly available evidence of a plan or policy on the websites of the Department of Health (DoH); the National Institute for Communicable Diseases (NICD), the National Health Laboratory Service (NHLS) or the Department of Agriculture. ^559560561562

5.6.1b Evidence of non-compliance with sample sharing element of PIP framework

Score: 100

There is no publicly available evidence that South Africa has not shared samples in accordance with the Pandemic Influenza Preparedness (PIP) framework in the past two years. There is evidence in reports (sections Influenza specimens shared with WHO Collaborating Centres) that the country shared samples both in 2023 and in 2024 with WHO. ⁵⁶³⁵⁶⁴

5.6.1c Evidence of non-sharing of pandemic pathogen samples during an outbreak

Score: 100

There is no publicly available evidence that South Africa has not shared pandemic pathogen samples during a outbreak in the past two years. No evidence was found via the World Health Organisation (WHO) website. ⁵⁶⁵ A search for media articles on this topic produces no relevant results. There is evidence that South Africa shared samples of COVID-19 and H5N1 avian influenza during outbreaks. ⁵⁶⁶⁵⁶⁷

6.1.1a Policy formation

Score: 75

6.1.1b Quality of bureaucracy

Score: 50

6.1.1c Excessive bureaucracy/red tape

Score: 75

6.1.1d Vested interests/cronyism

Score: 50

6.1.1e Corruption

Score: 41

6.1.1f Accountability of public officials

Score: 50

6.1.1g Human rights risk

Score: 100

6.1.2a Orderly transfers of power

Score: 75

6.1.3a Risk of social unrest

Score: 25

6.1.4a Risk of terrorism

Score: 75

6.1.4b Level of illicit arms flows within the country

Score: 50

6.1.4c Risk of organized criminal activity

Score: 25

6.1.5a Presence or risk of armed conflict

Score: 100

6.1.6a Government territorial control

Score: 100

6.1.7a International tensions

Score: 50

6.2.1a Adult literacy rate (15+ years old, both sexes)

Score: 96.7

6.2.2a UNDP Gender Inequality Index score

Score: 65.83

6.2.3a Poverty gap at $1.90 a day (2011 PPP) (%)

Score: 75.72

6.2.3b Share of employment in the informal sector

Score: 50

6.2.3c Coverage of social insurance programs (% of population)

Score: 33.33

6.2.4a Public confidence in government

Score: 100

6.2.5a Robust, open, diverse local media and reporting

Score: 100

6.2.6a Gini coefficient

Score: 37

6.3.1a Adequacy of road network

Score: 75

6.3.2a Adequacy of airports

Score: 75

6.3.3a Adequacy of power network

Score: 25

6.4.1a Urban population (% of total population)

Score: 28.9

6.4.2a Change in forest area (percentage points)

Score: 72.79

6.4.3a Natural disaster risk

Score: 75

6.5.1a Total life expectancy (years)

Score: 52.97

6.5.1b NCD mortality rate

Score: 74.52

6.5.1c Population aged 65+

Score: 59.03

6.5.1d Tobacco use (% of adults)

Score: 22.83

6.5.1e Level of adult obesity (%)

Score: 64.64

6.5.1f Age-standardised prevalence of mental health disorders (per 100 000 people)

Score: 62.13

6.5.2a Access to potable water

Score: 89.99

6.5.2b Access to at least basic sanitation facilities

Score: 76.97

6.5.2c Percentage of health-care facilities with no access to any electricity supply

Score: 72.92

6.5.3a Domestic general government health expenditure per capita (PPP)

Score: 71.58

6.5.4a Trust medical and health advice from the government

Score: 50

6.5.4b Trust medical and health advice from medical workers

Score: 50