If successfully implemented, this plan will serve as a flagship achievement demonstrating the government’s ability to deliver concrete, life-impacting results, writes Ido Lekota
South Africa’s recent launch of its National Action Plan (NAP) for the Prevention of Substandard and Falsified Medical Products (SFMPs) marks a transformative milestone in the continent’s public health landscape.
This comprehensive, multi-sectoral strategy is designed to holistically strengthen the prevention, detection, and response mechanisms to the pervasive threat of SFMPs in the medical product supply chain. Grounded in the World Health Organization’s (WHO) draft Handbook, this plan emerges from a year-long pilot collaboration between SA authorities and the WHO, positioning South Africa as a pioneering leader both regionally and globally in pharmaceutical regulation and health security.
SFMPs represent a significant threat to global health, undermining treatment efficacy, endangering patient safety, and eroding public trust in healthcare systems. The WHO defines falsified medical products as those that deliberately or fraudulently misrepresent identity, composition, or source, often entering markets without regulatory approval. Conversely, substandard products are authorised medical products that fail to meet quality standards due to unintentional manufacturing errors or poor-quality control, impacting their safety and effectiveness.
The WHO estimates that worldwide, SFMPs contribute to a considerable number of preventable illnesses and deaths annually, with a disproportionate impact in low- and middle-income countries. In Africa, in particular, a significant percentage of circulating medical products fall into these categories, posing barriers to achieving Sustainable Development Goal 3, which aims for universal, safe health coverage for all people.
Addressing this issue requires robust regulatory oversight, multi-sectoral cooperation, and evidence-based interventions, motivating WHO’s development of a comprehensive draft Handbook for National Action Planning. This handbook offers a strategic framework to guide countries in prioritising actions, mobilising resources, and coordinating efforts to combat SFMPs effectively.
South Africa was selected to pilot the WHO draft Handbook for National Action Planning, a process involving an extensive consultative approach with stakeholders across government, regulatory bodies, law enforcement, industry, healthcare providers, academia, and civil society. This pilot was vital in testing the handbook’s guidance in a real-world, middle-income setting that presented complexities reflective of global challenges.
Throughout 2025, South Africa conducted workshops and collaborative planning sessions to adapt and operationalise the handbook’s principles into a viable, context-specific National Action Plan. The pilot generated critical insights into practical arrangements for prevention, detection, and response, ensuring the national plan was feasible, evidence-based, and strategically coherent.
The formal launch of the NAP by the South African Health Products Regulatory Authority (SAHPRA), in partnership with the National Department of Health and the WHO, symbolised the closing phase of the pilot and served as a platform to mobilise political, technical, and financial support for sustained implementation.
Health Minister Dr Pakishe Aaron Motsoaledi reinforced the country’s commitment to ensuring that every medicine, vaccine, and health product available to South Africans is safe, effective, and of the highest quality. Speaking during the NAP launch. Motsoaledi emphasised that SFMPs are a direct cause of preventable illness and death, and that combating these products anchors on coordinated and comprehensive strategies aligned with WHO guidance.
“The scourge of substandard and falsifies medical products is a global challenge, but its impact is particularly severe in the African region, where it undermines progress toward universal health coverage and the Sustainable Development Goals. The National Department of Health will ensure that the fight against substandard and falsified medical products is collective comprehensive and that it is encompassing WHO guidance of prevention, detection and rapid response… through this National Action Plan, South Africa joins the global movement to protect its citizens and consequently strengthening SAHPRA as a regulatory body,” averred the Minister.
Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA, described the NAP as possibly the most comprehensive governmental healthcare collaboration in South African history, noting its unique success in uniting previously siloed agencies through a powerful multi-sector steering committee.
Shenaaz El-Halabi, WHO representative in South Africa, underscored the NAP’s critical role in advancing national and global health security, patient safety, and trust in health institutions—elements essential for universal health coverage and sustainable development.
“South Africa’s NAP is a clear demonstration of the power of multi-sectoral collaboration, bringing together government agencies, regulators, healthcare providers, law enforcement, the private sector, academia, and civil society. It aligns with sustainable with Sustainable Development Goal 3 and WHO’s global strategy to ensure access to safe, effective, and quality-assured medical products for all,” she stated.
The NAP provides a five-year roadmap centered around three core pillars: prevention, detection, and response. These core pillars’ key components respectively include:
- Strengthening regulatory frameworks and legal instruments to reduce opportunities for SFMPs to enter the supply chain. This includes legislative reforms incorporating contemporary challenges such as cyber-enabled trafficking, with provisions for stringent penalties and enhanced prosecution capacities.
- Enhancing surveillance systems through investments in technology such as track-and-trace systems, digital authentication tools, and real-time data analytics platforms.
- This pillar also focuses on improving laboratory infrastructure and building workforce capacity for prompt identification and reporting of suspect products.
- Optimising coordinated rapid responses involving regulatory authorities, law enforcement (e.g., South African Police Service and National Prosecuting Authority), judiciary, healthcare providers, and civil society stakeholders. Ensuring continuity of the supply chain and avoiding shortages while removing harmful products quickly is a priority.
The plan also explicitly advocates evidence-based decision-making supported by continuous monitoring, evaluation, and adaptation. Political commitment is strongly emphasised, recognising that sustained support from the highest levels of government is vital for its effective implementation.
A distinctive feature of the NAP lies in its multi-sectoral approach. The plan was developed through a multi-lateral process led by SAHPRA and the National Department of Health, supported by WHO, with input from other departments including Agriculture, Land Reform and Rural Development; as well as Trade Industry and Competition.
Other stakeholders included regulatory bodies such as Health Professions Council of South Africa, South African Pharmacy Council, Pharmaceutical Society of South Africa, law enforcement agencies including the South African Police Services (SAPS) and the National Prosecution Authority and the South African Revenue Services (SARS).
Also included are industry partners and pharmaceutical companies, academic institutions offering research and training support, civil society and patient advocacy groups and the South African National Aids Council. This broad collaboration consolidates expertise and resources, fosters shared responsibility, and enables cohesive coordination in rolling out NAP interventions.
Despite the program’s solid foundation, stakeholders at the launch dialogue candidly acknowledged enduring challenges that could hinder the plan’s full success including: weak enforcement, unregulated compounding practices, fragmented regulatory landscapes, corruption and supply chain vulnerabilities.
Consequent to the challenges are, example, existing regulations often suffering from inadequate enforcement due to limited financial and human resources. This results in persistent circulation of SFMPs, especially compounded medications that escape rigorous regulatory oversight.
There are also growing incidents of non-compliant compounding pharmacies, wellness centers, and online sellers distributing medications with unknown or unverified active ingredients, increasing risks of contamination, poor quality, and lack of efficacy.
On the other hand, overlapping mandates, procedural complexities, and inadequate inter-agency communication contribute to enforcement inefficiencies, while malpractices undermine resource allocation and enforcement integrity, compromising healthcare outcomes.
Meanwhile, demand pressures, medicine shortages, and off-label usage create environments conducive to the proliferation of substandard and falsified products.
Drawing from stakeholders’ discussions, several strategic recommendations are proposed to address existing gaps and bolster the NAP’s effectiveness. These include:
- Launching sustained awareness programs to inform the public about the risks and impacts of SFMPs on health and trust in the medical system.
- Advancing legislative updates to close loopholes, address cyber-enabled trafficking, and empower prosecutors with greater capacity and sanctions.
- Embracing emerging technologies for product verification, such as track-and-trace mechanisms and digital authentication, alongside real-time surveillance dashboards.
- Investing in laboratory infrastructure, regulator and enforcement personnel training, and fostering innovation in detection methodologies to ensure sustainability.
- Promoting joint accountability and collaboration across all supply chain actors—from manufacturing to patient care—to ensure seamless information sharing and coordinated action.
- Engaging with bodies such as the African Medicines Agency and WHO to enhance cross-border collaboration, harmonize regulations, and counter transnational trafficking.
- Signing Memoranda of Understanding (MOUs) with pharmaceutical companies, wholesalers, healthcare providers, academia, and civil society to ensure transparent supply chains and research-driven responses.
- Strengthening scientific research on product quality, supporting laboratory infrastructure, and enhancing training for regulators and enforcement personnel ensuring sustainability and ongoing adaption of the plan.
- Creating a systemic ecosystem where multiple actors share responsibility and coordinate efforts to detect and eliminate SFMPs at every level—from manufacture and importation to distribution and consumption.
- Government agencies including SAHPRA, the Department of Health, law enforcement, customs, and judiciary sustaining open communication, sharing data and undertaking join operations.
- Pharmaceutical companies, wholesalers, and healthcare providers collaborating in enforcing quality standards and supply chain transparency.
- Collaboration with community groups and community watchdogs to enhance vigilance and reporting mechanisms—thereby transforming end users from passive recipients to active protectors of public health.
- Civil society, patient groups, and community watchdogs enhance the vigilance and reporting mechanisms, transforming end-users from passive recipients to active protectors of public health.
The NAP does not merely represent a symbolic policy declaration but a call to sustained, concerted action. Its implementation could significantly improve the integrity of the national health system, elevate regulatory oversight, enhance supply chain controls, and crucially, ensure patient safety amidst growing pharmaceutical market complexities.
As the first African country to pilot the WHO draft Handbook and formalise a comprehensive national strategy for SFMPs, South Africa provides a pioneering model that other countries can adapt and adopt. The WHO plans to finalise and roll out this Handbook globally in 2026, leveraging lessons learned in South Africa’s pilot to refine guidelines and operational tools for diverse contexts worldwide.
The success of this initiative depends on overcoming entrenched challenges through political will, robust scientific rigor, innovations in technology and governance, and sustained multi-sectoral collaboration.
In doing so, South Africa contributes not only to safeguarding its own citizens but to setting a continental and global benchmark in the fight against falsified and substandard medical products.
SA’s NAP launch’s timing is pivotal as it coincides with country completing its role as the WHO pilot country for the Global Draft Handbook on combatting SFMPs. This pilot was crucial for validating the Handbook’s guidelines, tools, and indicators in a real-world, middle-income country setting with complexities reflective of global challenges.
South Africa’s success in implementing the NAP offers a replicable model for other countries, providing the WHO with evidence-based refinements to finalise and globally roll out the Handbook in 2026. This pioneering role further cements South Africa’s position as a continental and global leader in pharmaceutical regulation, health security, and innovative public health governance.
The launch of the NAP against SFMPs heralds a transformative phase in the country’s health security agenda. As a pilot site for the forthcoming WHO Handbook, South Africa’s experience provides invaluable lessons and momentum for global efforts. Through political will, science rigor, stakeholder collaboration, and innovative practices, the nation can lay the foundation for a health system resilient against the dangers of poor quality medicines.
Politically, the successful implementation of South Africa’s National Action Plan (NAP) against substandard and falsified medical products (SFMPs) carries profound ramifications for the country. At a critical juncture in South Africa’s development, where government credibility, social cohesion, and economic resilience are under ongoing pressure, the NAP represents a powerful opportunity to fortify state legitimacy and public trust. By demonstrating effective governance, the government can strengthen its social contract with citizens, illustrating tangible commitment to safeguarding health and wellbeing.
Globally, a successful NAP would position South Africa as an exemplar of governance innovation and regulatory excellence, both continentally and globally. This leadership aligns with the country’s National Development Plan 2030 and Medium-Term Development Plan priorities of building a capable, ethical, and developmental state that addresses inequality, poverty, and public service delivery failures. The plan’s multi-sectoral collaboration model also reinforces political unity across different government departments and agencies, crucial in the multi-party government framework established in 2024. It signals the capacity for coordinated action amid diverse political interests, bolstering the ruling coalition’s image as an effective and responsive authority.
Moreover, effective management of SFMPs has the potential of addressing a significant public health and safety risk that disproportionately affects marginalised and vulnerable populations. Politically, reducing preventable morbidity and mortality from poor-quality medicines advances social justice agendas. It also helps insulate the government from criticism related to corruption and regulatory failure, which have historically undermined trust in public institutions.
Economically, by improving the quality and safety of medical products, the NAP has the potential to supports innovation and confidence in the domestic pharmaceutical sector. This could attract investment, support local industry growth, and reduce the social cost of ineffective or harmful products. These outcomes would bolster the broader economic governance framework aimed at inclusive growth and poverty reduction, enhancing the country’s political stability.
In summary, if successfully implemented, the NAP against SFMPs will serve as a flagship achievement demonstrating the government’s ability to deliver concrete, life-impacting results. It will reinforce governance credibility, strengthen public confidence, and deepen South Africa’s leadership role in health governance and regional cooperation. These political dividends have the potential to contribute to nation-building, social cohesion, and greater alignment with international development norms, vital factors for South Africa’s democratic consolidation and long-term political stability.
Ido Lekota is a media practitioner and an independent socio-political commentator.