25 February 2021
The Global Fund is committed to ensuring optimal and quality-assured medicines and health products as part of its mission to fight infectious diseases and strengthen systems for health. Long-lasting insecticidal nets (LLINs) are one of the most effective forms of malaria control, and have played a pivotal role in dramatically reducing malaria deaths and cases. The Global Fund has vastly expanded access to LLINs in malaria-endemic countries, which has helped cut global malaria death rates by 60% since 2000.
As a significant buyer of LLINs, the Global Fund has a particular responsibility and role in the procurement and supply of quality-assured LLINs to families who urgently need them. The Global Fund actively works with all its partners, including technical organizations and manufacturers, to constantly improve quality, efficiency and safety, and to maximize impact.
The LLIN market is relatively new and evolving compared to the diagnostics and pharmaceuticals markets. To improve quality assurance, in 2016 the World Health Organization created a new vector control prequalification unit with the aim of bringing more stringent regulatory requirements and oversight. While maintaining quality control is important, implementing this upstream quality assurance in design and manufacturing is equally critical. Suppliers’ quality and risk management systems also play a role here. The Global Fund supports all efforts to identify and prevent sub-standard production and to ensure that products are of adequate quality and perform as expected.
The Office of the Inspector General (OIG) investigation into TANA Netting, a manufacturer and supplier of LLINs, found that TANA did not adhere to approved manufacturing requirements and failed to control product quality, potentially reducing the nets’ life span. While the OIG investigation was going on, the Global Fund suspended all existing orders for new LLINs with the firm, transferred planned orders to other contracted suppliers and contracted independent testing on the LLINs in question. The Global Fund worked closely with the respective national programs and partners in the countries affected to weigh the risks and benefits of using the nets. Many national programs decided to distribute the nets to ensure populations at risk were protected. Manufacturing requirements are critical to ensuring the highest possible impact. We take some reassurance in the fact that the type of quality failings seen mean that the families still benefited from significant levels of protection from these nets.
Failures in production practices are unacceptable and a range of systemic issues will need to be considered to ensure we guard against anything similar in the future. Following the OIG report, the Secretariat has developed a series of actions to improve the Global Fund’s quality assurance and processes, strengthening the requirements of the manufacturers’ quality management systems, use of subcontractors and product quality requirements in the framework agreements.
The Secretariat has implemented increased assurances, stipulating that suppliers must inform the Global Fund of any critical deficiencies identified. The Secretariat has also selected a panel of suppliers to undertake quality assurance, quality control and risk management services, and is revising its operational guidelines for pre-shipment inspection, sampling and testing.
The Global Fund is working with WHO and the U.S. President’s Malaria Initiative on the review of LLIN efficacy through a comprehensive landscaping study. The Secretariat aims to report the findings in the first half of 2021.The Secretariat will also be supporting the role of key external partners, allocating US$750,000 to help fund the WHO in product assessments and onsite inspections of LLIN manufacturing.
Looking ahead, internal agreed time-bound actions include:
The Office of the Inspector General is an integral and important part of risk management, conducting independent audits and investigations to complement the active risk management and controls put in place by the Secretariat with oversight by the Board of the Global Fund. The Global Fund Secretariat thanks the OIG for this investigation report, which upholds our commitment to ensuring we deliver quality-assured products, and our proactive approach to detecting and being fully transparent about problems in implementation of our grants.
The Global Fund is committed to constantly strengthening measures to increase value for money, and improving the effectiveness of health investments so they can reach the people most in need, in countries and communities all over the world.