Conflating Counterfeited with Substandard Medicines is Unhelpful. Here’s Why I Lenias Hwenda

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In African markets, the prevalence of counterfeit medicines, intentionally manufactured to deceive, is a significant problem that threatens public health and safety. Counterfeiting medical products is one of the most profitable trades in Africa because they fill a need for affordable medications in an environment with a high disease burden and a high demand for medications that are limited in availability, have high cost beyond the reach of most people and where medications are often in frequent shortage creating enormous demand and business opportunities for medicines counterfeiters. Amongst all goods that can be counterfeited, none are more damaging than those that impact the health and wellbeing of patients like counterfeited medicines. In Africa, the most counterfeited medications are those for highest burden diseases like malaria, tuberculosis and HIV/AIDS. Counterfeited medicines for malaria and tuberculosis are estimated to kill close to a million people each year.

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Whilst counterfeited medical products are a global problem, their disproportionate impact on African nations makes them a uniquely African challenge. We may not know the true magnitude of the trade in counterfeited medical products in Africa because of the clandestine nature of their manufacture, distribution and sale which makes it difficult to measure accurately. However, what is certain is that trade in counterfeited medications is thriving in Africa. While the World Health Organization (WHO) opts to use terms like "sub-standard" and "falsified" medicines, the reluctance to label these dangerous products deliberately and fraudulently mis-labelled with respect to their identity and or source as "counterfeited" may inadvertently shield the very perpetrators it seeks to combat. This article delves into why distinguishing between substandard and counterfeit medicines is crucial and argues for the explicit naming of counterfeit medicines to safeguard patient safety across Africa.

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Substandard medical products are those that fail to meet quality standards or specifications but do so unintentionally. These discrepancies can arise due to errors in manufacturing, handling, or distribution processes. On the other hand, counterfeit medicines are defined as products made in exact imitation of legitimate items, with the intention to deceive or defraud. They are deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products, where the products may contain the wrong ingredients, no active ingredients, insufficient active ingredients, or fake packaging.

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The distinction between these two terms is not merely semantic but carries significant implications for public health strategies, law enforcement, and regulatory actions. Substandard medicines are often the result of systemic failures within pharmaceutical manufacturing and distribution value chains, which can be addressed through improvements in regulatory oversight, quality control, and supply chain management. Counterfeit medicines, however, represent a criminal intent to exploit these systemic weaknesses for financial gain, often at the cost of human lives.

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Failing to explicitly call out counterfeited medicines as such plays into the hands of counterfeiters for several reasons. First, it dilutes the perceived severity of the act of counterfeiting, treating it as a lesser offense than the deliberate endangerment of lives that it truly is. Second, it may lead to inadequate legal and regulatory responses. The fight against counterfeit medicines requires not just regulatory and quality improvements but stringent enforcement of laws against organized crime, fraud and deception. Third, the lack of clear distinction muddies public understanding and awareness of the risks associated with counterfeit medicines, which is essential for empowering patients and healthcare providers to make informed decisions.

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The WHO's preference for the term "falsified" over "counterfeit" stems from a desire to focus on the public health implications rather than the intellectual property aspects often associated with counterfeiting. However, this approach might underplay the malicious intent behind counterfeit medicines. The deliberate manufacture and distribution of counterfeit medicines is a crime that endangers public health, and its naming should reflect the severity and intentionality of these actions.

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In Africa, where health systems are often under-resourced and the demand for affordable medicines is high, counterfeit medicines pose a significant risk. They can lead to treatment failure, disease resistance to treatment, and even death. The economic impact is also profound, undermining trust in healthcare systems and imposing additional costs on patients and governments alike.

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To effectively combat this threat, it is imperative to maintain a clear distinction between substandard and counterfeit medicines. This distinction enables targeted interventions: improving manufacturing and regulatory frameworks to prevent substandard medicines and deploying legal and enforcement measures to eradicate counterfeit medicines. Public education campaigns can also be tailored to raise awareness about the dangers of counterfeit medicines specifically, equipping patients with the knowledge to protect themselves. In conclusion, while terms like "substandard" and "falsified" medicines address aspects of the broader issue of medicine quality and integrity, explicitly recognizing and acting against counterfeit medicines is critical. Only by naming and confronting the deliberate act of counterfeiting head-on can we hope to safeguard patient safety and public health in Africa and beyond. When it comes to the crime of trading in counterfeited medical products – the name is everything. That is why we must stop conflating the deliberate act of medicines counterfeiting with the unintentional processes that may result in substandard medications.