Substandard Health Products

Strict compliance with Global Fund’s Quality Assurance Policies and timely testing of medicines and commodities before their distribution are key in safeguarding health product quality and the effectiveness of Global Fund programs. Read more on mitigating health product quality.

The effectiveness of Global Fund programs is fundamentally tied to the quality of medicines and health products employed, which is about US$2 billion, roughly half of the Global Fund’s investments every year. Fighting the three diseases and promoting public health rests heavily on the assurance that products meet rigorous quality standards and are safe to use. The Global Fund recently revised its policy on Quality Assurance of Health Products bringing together various standards and requirements.

In 2017, the World Health Organization indicated that one in ten medical products in developing countries is substandard or falsified, such as fake tuberculosis testing kits that give poor results or ineffective nets that do not protect against malaria. INTERPOL launched operation ‘Pangea XVI’ in October 2023 to counter illicit medicines. The operation, which ran from October 3 to 10, led to 72 arrests worldwide and the seizure of over US$ 7 million in potentially dangerous pharmaceuticals, underscoring the need to act against substandard and fake medicines and health products.

The Office of the Inspector General’s (OIG) work highlights that the quality of products could be compromised at critical phases of the production and supply chain. Through our work here, which is very complex and highly technical, we specifically identified sub-standard Long-Lasting Insecticidal Nets (LLINs) and condoms as being particularly susceptible, a troubling reality. These cases explain the inherent risks and consequences of compromising the quality of health products, putting at risk the safeguarding of public health worldwide.

Long-Lasting Insecticidal Nets

Investigation Report ENGLISH or FRENCH

This case reviewed the operations of a prominent manufacturer and supplier of LLINs. The OIG received concerning information indicating that the manufacturer used unapproved manufacturing methods for binding insecticide to the nets and that there had been a deliberate attempt to falsify manufacturing data to cover up the non-conformity. The consequence of these actions is a significant loss of insecticide after washing, leading to unpredictable performance throughout the lifespan of the nets.

The manufacturer failed to provide the necessary manufacturing data and records, hampering OIG's ability to uncover evidence of data falsification and fraud at the factory level. Consequently, OIG had to rely on retrospective laboratory testing to draw its conclusions. The manufacturer not only disregarded approved manufacturing requirements but also failed to control the quality of over 52 million nets, resulting in sub-standard products which were purchased for US$106m of Global Fund grant funds. The ramifications extend beyond financial considerations, as the breach of quality standards could potentially compromise the effectiveness of the LLINs in combating insect-borne diseases.

A critical revelation from the OIG review was the unchallenged red flags in the Principal Recipients’ (PRs) and Secretariat processes. The quality control testing applied to the nets did not align with the World Health Organization's (WHO) quality requirements. This oversight raises concerns about the broader integrity of LLIN distribution channels and the need for enhanced scrutiny to prevent similar incidents in the future. The Global Fund has subsequently taken measures to strengthen quality assurance processes.

Fraud marks Condoms ‘Unfit for Use’

Country	GHANA
	Investigation Report ENGLISH

A fraud scheme led to the distribution of sub-standard condoms in Ghana benefiting from Global Fund's support putting the health and well-being of vulnerable populations at risk.

The Global Fund financed the acquisition of 130 million condoms in this implementing country, a move aimed at combatting the spread of HIV.

Following a rigorous tender process, the country’s Ministry of Health selected a local trading company to supply the condoms. This company seemed to offer the best value and appeared to meet all the necessary requirements. In its bid documents, the chosen company asserted that the condoms originated from a WHO-certified manufacturer, a crucial criterion mandated by the government's regulations.

The condoms were subsequently imported, and distributed to high-risk populations, including sex workers and men who have sex with men. Concerning reports soon surfaced, with users complaining about the inferior quality of the condoms. In response, the Ministry of Health conducted tests that uncovered that the condoms were defective and unfit for use.

Prompted by information from the Global Fund Secretariat and the Local Fund Agent, the Office of the Inspector General initiated an investigation. Its findings revealed that the supplier, in its bid proposal, had submitted documents, including a manufacturer authorization form, that falsely suggested the condoms were produced by a WHO-certified manufacturer. The OIG confirmed that the manufacturer authorization form was a counterfeit document. The supplier's false statements had effectively masked the true origins of the products. The condoms had been produced by companies lacking authorization to manufacture condoms due to their failure to meet minimal quality standards.

Mitigating Health Product Quality

These cases serve as a reminder of the importance of transparency and diligence in the procurement of essential healthcare supplies. The consequences of fraudulent practices in such critical areas have a direct impact on the health and safety of vulnerable populations.

This underscores the necessity for strict oversight and accountability to safeguard public health in global health initiatives with a strong focus on:

• Strict compliance with Global Fund’s Quality Assurance policy.
• Timely testing of medicines and commodities at appropriate stages of the supply chain, including before their distribution.
• Monitoring supply chain for adverse reactions or complaints of product quality.
• Verifying that suppliers are prequalified by appropriate regulatory bodies as part of the procurement process and before contracts are signed.
• Verifying pre-shipping testing certificates of manufacturers.

More resources on Identifying Fraud

To empower individuals and organizations with the knowledge and skills needed to detect the signs of fraud in similar contexts, we offer valuable resources.

Explore our e-lessons page, where you can access essential insights and guidance on identifying red flags.