Position on Counterfeit / Falsified Medicines

A counterfeit medicine¹ is a medicine that has been deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient ingredients or with fake packaging. Similarly, falsified medicines¹ are medical products that deliberately/fraudulently misrepresent their identity, composition or source. As the distinctions between these two terms are subtle, for the purpose of this document both terms will be used in the same context.

The existence of counterfeit/falsified healthcare products is a significant concern as it can result in the presence of ineffective and potentially dangerous products in the marketplace. Moreover, it can undermine confidence in product safety and effectiveness while putting patients’ health and lives at serious risk.

There is abundant evidence of essential medicines, including life-saving medicines, being counterfeited/falsified globally. Distribution of medicines through questionable entities posing as legitimate online pharmacies as well as through social media platforms continues to be a significant problem.
 

A review of internet drug outlets in the US revealed that well over 90 percent of these so-called pharmacies do not follow basic patient safety and pharmacy practice standards.² Instances of illicit medicine sales through social media by unauthorized/unlicensed parties are also increasing rapidly.

With the increase in internet connectivity, questionable entities trafficking in counterfeit/falsified medicines have gained increased access to the global marketplace. Although this issue impacts all countries, countries where there are weak or non-existent regulatory systems bear the greatest risk of counterfeit/falsified medicines. It has been observed that 1 in 10 medical products in the supply chain of low-and middle-income countries was counterfeit/falsified according to the research by WHO.³

Astellas takes a firm position against counterfeit/falsified medicines, and other illicit activities that perpetuate the illegal medicines trade. However, Astellas recognizes that the Company cannot tackle this issue alone and that it has no official power to intervene directly.

Our goal is to help ensure that patients receive only genuine, legitimately distributed Astellas products. Given the potential harm to patient health from counterfeit or falsified medicines—and the risk that Astellas products may be targeted—Astellas operates the Astellas Product Security Council (“APSC”). The Council oversees the Company’s product security activities related to counterfeiting/falsification, diversion, and theft, and brings together a cross-functional team of subject matter experts to implement appropriate countermeasures.

• Astellas fully cooperates with health & regulatory authorities, law enforcement entities and other pharmaceutical companies on a global level regarding investigations, enforcement actions and other activities related to counterfeit/falsified medicines. Astellas maintains active membership in the Pharmaceutical Security Institute (PSI), a trade organization that provides a platform for member companies to share intelligence on pharmaceutical crimes affecting their products, collaborates on investigations of mutual interest and interacts regularly with key pharmaceutical-focused law enforcement contacts globally.
• Astellas monitors both virtual (internet) and physical markets to ensure a current and comprehensive understanding of activities involving our products occurring outside of the legitimate supply chain.
• Astellas develops and deploys packaging security features to enable authentication of our products and deter attempts to counterfeit/falsify those most at-risk.