The Issue

Background

Medical products play a crucial role in modern healthcare, ensuring the safety and well-being of consumers. The introduction of "expiry dates" was intended to provide reliability for consumers and accountability for manufacturers [i]. Unfortunately, this system has led to the generation of tons of hazardous waste, giving rise to significant medical¹, environmental², financial³, and social issues⁴, particularly in low-income contexts⁵.

The U.S. FDA's requirement for expiration dates on medical products, implemented since 1979, employs a conventional paper-based labeling system at the point of production. Expiration dates, with legal implications extending for multiple years without revision, are calculated conservatively. The entire process operates within a regulatory framework where national authorities approve and confirm each expiry date. But research reveals a staggering fact: over 90% of medical products remain safe and potent for several decades beyond their labeled expiry date.⁶ The core of the expiry problem, therefore, lies not in scientific limitations but in logistical and legal constraints.

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Implications

Despite long-term stability tests proving that more than 90% of medical products could extend their expiration dates for decades without compromising safety or effectiveness,⁷ ⁸ approximately half a million tons of medical products go to waste annually, leading to a myriad of issues, especially in low-resource contexts.⁹ These issues include:

• Compromised Healthcare Quality: Limited funds in healthcare are squandered on procurement, transport, handling, and disposal of expired products. With the expected substantial increase in the pharma market's share in healthcare expenditure, the impact on healthcare delivery will exacerbate further.

• Resource Depletion: Medical expiries reduce the availability of resources such as public budgets, manufacturing and transport capacity, and raw materials, including scarce and expensive pharmacological ingredients.

• Social Inequality: Less than 1% of medical production capacity is located in Africa and South America. Premature expiries effectively transform expenditure in these continents into revenue for medical producers predominantly situated in rich countries, contributing to increased social inequality on local and global levels.

• Public Health Risk: Improper disposal of medical waste poses a public health risk, especially in areas without adequate and costly disposal infrastructure. Toxic medical waste can foster drug-resistant bacteria and introduce harmful substances into the environment, affecting aquatic life.

The Unequal Impact

While the implications apply universally to health systems, low-resource contexts face heightened vulnerability to the impact of medical expiries. Factors such as higher relative pharmaceutical expenditure and elevated logistics costs make these countries significantly more vulnerable compared to high-income countries.¹⁰

Furthermore, global pharmaceutical exports are distributed unevenly, with Europe and North America accounting for 86%, while South America, Africa, and Oceania combined make up just 1%.¹¹ These figures underscore how medical expiries contribute to accelerating global inequality by transforming additional expenditures in low-income countries into additional revenue for high-income countries.