The Growing Problem of Fake and Substandard Medicines

The World Health Organization (WHO) defines substandard products as “those that do not meet quality standards and specifications, often due to poor manufacturing practices or inadequate quality control.” Falsified medical products “deliberately misrepresent their identity, composition or source. These products are often created and distributed with the intent to deceive consumers for financial gain.” SFs may contain the wrong ingredients, the wrong dose, or no active ingredients at all; they can be long-standing or new medicines, over-the-counter or prescription, branded or generic. In some cases, they contain dangerous substances and poisons, including mercury, antifreeze, paint, and rat poison.

The negative impacts of SFs are widespread and the environment in which the manufacture, transportation, distribution, and consumption of these maliciously manufactured products take place is complex. SFs are a public health threat and undermine people’s trust in healthcare systems – and kill an estimated over 1 million people each year. WHO estimates that at least one in ten medical products circulating in low- and middle-income countries (LMICs) is either substandard or falsified. Over 30 billion U.S. dollars may be spent annually on the procurement of substandard and falsified medicines in these countries.

A staggering 52.8% of all counterfeit medicines detected in the supply chain are related to life-saving treatments. 12.4% of antibiotics in LMICs are found to be SFs, which heavily links to the prevalence of antimicrobial resistance – resulting in an estimated 170 000 children dying each year from pneumonia due to substandard and falsified antibiotics in Sub-Saharan Africa alone. The size of the global counterfeit medicine market is approximately $200-432 billion, and continuing to expand. However, this is just the tip of the iceberg. Given patchy reporting, it is highly likely that these figures represent just a small proportion of the problem.

Fight the Fakes Alliance activities and how they address SFs challenges

In 2020, the Fight the Fakes Alliance (FtFA) evolved from a grassroot advocacy campaign into a new formal governance structure to take the fight against substandard and falsified medicines to the next level. FtFA participates in influencing policies and guidelines in order to protect public health and develop stronger health systems. This is achieved through advocacy, partnerships with like-minded partners, and fostering space for action against SFs. By inspiring and influencing policymakers, regulators, healthcare leaders, customs officers, international organizations, innovators, and all stakeholders that have a role to play in curbing SFs, the Alliance aims to drive systemic change.

Its activities are supported by policy resources, such as its white paper, a concerted effort by its members to outline the three priority enablers for transforming the fight against SFs through education and awareness, greater collaboration among stakeholders at transnational and national levels, and the acceleration of domestic anti-SFs initiatives. Through strategic partnerships with organizations engaged in combating substandard and falsified medicines worldwide, FtFA enables knowledge exchange, coordinates impacts, and strengthens policy advocacy to leverage the effectiveness of global programs. FtFA’s website and social media channels facilitate the distribution of key information, online tools, as well as useful links that highlight the dangers of SFs.