SOUTH Africa’s 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 strengthens prevention, detection, and response mechanisms to combat SFMPs in the medical product supply chain. Grounded in the World Health Organisation’s (WHO) draft Handbook, the plan emerges from a year-long pilot collaboration between South African authorities and WHO, positioning South Africa as a pioneering leader in pharmaceutical regulation and health security.
The Global Threat of Substandard and Falsified Medical Products
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 misrepresent identity, composition, or source, often entering markets without regulatory approval. Substandard products are authorised medical products that fail to meet quality standards due to manufacturing errors or poor quality control.
The WHO estimates that SFMPs contribute to considerable preventable illnesses and deaths annually, with disproportionate impact in low- and middle-income countries. In Africa, 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.
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.
South Africa’s Pilot Role
South Africa was selected to pilot the WHO draft Handbook through an extensive consultative approach with stakeholders across government, regulatory bodies, law enforcement, industry, healthcare providers, academia, and civil society. Throughout 2025, South Africa conducted workshops and planning sessions to adapt the handbook’s principles into a viable, context-specific National Action Plan, generating critical insights for prevention, detection, and response.
The formal launch by the South African Health Products Regulatory Authority (SAHPRA), in partnership with the National Department of Health and WHO, symbolised the pilot’s closing phase and mobilised political, technical, and financial support for sustained implementation.
Political Commitment and Leadership
Health Minister Dr Pakishe Aaron Motsoaledi reinforced South Africa’s commitment to ensuring every medicine, vaccine, and health product is safe, effective, and of the highest quality. “The scourge of substandard and falsified 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. Through this National Action Plan, South Africa joins the global movement to protect its citizens and strengthens SAHPRA as a regulatory body,” affirmed 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 success in uniting previously siloed agencies through a powerful multi-sector steering committee.
Shenaaz El-Halabi, WHO representative in South Africa, stated: “South Africa’s NAP demonstrates 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 Development Goal 3 and WHO’s global strategy to ensure access to safe, effective, and quality-assured medical products for all.”
The Three-Pillar Framework
The NAP provides a five-year roadmap centred around three core pillars:
Prevention: Strengthening regulatory frameworks and legal instruments to reduce opportunities for SFMPs to enter the supply chain, including legislative reforms addressing cyber-enabled trafficking with stringent penalties and enhanced prosecution capacities.
Detection: Enhancing surveillance systems through track-and-trace systems, digital authentication tools, and real-time data analytics platforms. This includes improving laboratory infrastructure and building workforce capacity for prompt identification and reporting of suspect products.
Response: Optimising coordinated rapid responses involving regulatory authorities, law enforcement, judiciary, healthcare providers, and civil society stakeholders while ensuring supply chain continuity and quickly removing harmful products.
A Distinctive 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 Agriculture, Land Reform and Rural Development, and Trade, Industry and Competition departments. Stakeholders included regulatory bodies (Health Professions Council of South Africa, South African Pharmacy Council, Pharmaceutical Society of South Africa), law enforcement agencies (SAPS, National Prosecution Authority, SARS), industry partners, academic institutions, civil society groups, and the South African National AIDS Council. This broad collaboration consolidates expertise and resources, fostering shared responsibility and cohesive coordination.
Persistent Challenges
Despite its solid foundation, stakeholders acknowledged enduring challenges: weak enforcement due to limited resources, unregulated compounding practices, fragmented regulatory landscapes, corruption, and supply chain vulnerabilities. Growing incidents of non-compliant compounding pharmacies, wellness centres, and online sellers distributing medications with unknown ingredients increase risks of contamination and poor quality. Overlapping mandates and inadequate inter-agency communication contribute to enforcement inefficiencies, while demand pressures and medicine shortages create environments conducive to SFMP proliferation.
Strategic Recommendations
Key recommendations to bolster the NAP’s effectiveness include:
- Launching sustained public awareness programs about SFMP risks
- Advancing legislative updates to close loopholes and address cyber-enabled trafficking
- Embracing track-and-trace mechanisms, digital authentication, and real-time surveillance
- Investing in laboratory infrastructure and personnel training
- Promoting supply chain accountability and collaboration
- Engaging with the African Medicines Agency and the WHO for cross-border cooperation
- Signing MOUs with pharmaceutical companies, healthcare providers, and civil society for transparent supply chains
- Creating a collaborative ecosystem where government agencies, the private sector, and community watchdogs share responsibility for detecting and eliminating SFMPs
A Model for Global Impact
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 for other countries. The WHO plans to finalise and globally roll out this Handbook in 2026, leveraging lessons from South Africa’s pilot to refine guidelines for diverse contexts worldwide. This pioneering role cements South Africa’s position as a continental and global leader in pharmaceutical regulation and health security.
Profound Political and Economic Implications
At a critical juncture where government credibility and social cohesion face ongoing pressure, the NAP represents a powerful opportunity to fortify state legitimacy and public trust. Successful implementation would position South Africa as an exemplar of governance innovation, aligning with the National Development Plan 2030 priorities of building a capable, ethical state that addresses inequality and poverty.
The plan’s multi-sectoral collaboration model reinforces political unity across government departments, crucial in the multi-party framework established in 2024. Effective management of SFMPs addresses a public health risk disproportionately affecting marginalised populations, advancing social justice agendas while insulating the government from criticism related to corruption and regulatory failure.
Economically, improving medical product quality and safety supports innovation and confidence in the domestic pharmaceutical sector, potentially attracting investment, supporting local industry growth, and reducing the social cost of ineffective products. These outcomes bolster the economic governance framework aimed at inclusive growth and poverty reduction.
Through political will, scientific rigour, stakeholder collaboration, and innovative practices, South Africa’s NAP can lay the foundation for a health system resilient against poor-quality medicines. If successfully implemented, it will serve as a flagship achievement demonstrating the government’s ability to deliver concrete results, reinforcing governance credibility and deepening South Africa’s leadership role in health governance—vital factors for the nation’s democratic consolidation and long-term political stability.
