Counterfeit healthcare products place people at risk of adverse events, serious health problems and potentially death. We aim to protect patients by safeguarding people and trust in our business against the risks posed by illicit trade, including product counterfeiting, tampering and illegal diversion. With an estimated 1 in 10 medical products in low- and middle-income countries being substandard or falsified,41 fighting illicit trade requires a holistic approach that includes partnerships and close collaboration across our business and with industry associations, tech solution vendors, academia and local, national and international bodies.
Key areas of progress in combating illicit trade in 2023 included:
Protecting patients around the world
Through a variety of internal programs and external partnerships, including with law enforcement, we were able to seize more than 1 million counterfeit products and prevent them from reaching patients. One example is FUGACAR (benzimidazole) in Vietnam. FUGACAR is used to treat intestinal worms in tropical regions. Following receipt of market intelligence that counterfeit FUGACAR was being sold in large quantities within Ho Chi Minh City, we collaborated with on-the-ground investigators and local police to investigate and take action. After months of planning and coordination with local law enforcement, various locations were raided, resulting in the arrest of multiple individuals and the seizure of raw materials, manufacturing equipment, packaging and finished products, thus disrupting a criminal enterprise and preventing counterfeit products from reaching and potentially harming patients.
Advancing drug protection measures
J&J has been an early adopter in regulations established to strengthen the supply chain in mature markets such as the U.S. and Europe while also partnering with NGOs to pilot programs in developing countries. We have adopted drug serialization and traceability measures across our portfolio, including requirements for medical devices that came into effect in 2023 for products marketed in Europe to ensure traceability between all stages of medical device development and post-market activities. In 2023, we piloted the UNICEF-led Traceability and Verification System (TRVST) on our products in selected markets in Africa. TRVST was created to improve patient safety by addressing the impact of counterfeit and diverted products within national supply chains.
Throughout the year, J&J conducted 88 specialized training sessions for approximately 5,200 law enforcement, customs and border protection agents which led to more than 20 instances where local authorities sought J&J’s help to assess whether the product was genuine or otherwise adulterated so authorities could determine whether the product should be removed from that market to proactively protect patients.
Strengthening anti-illicit trade impact
In 2023, J&J signed a collaboration agreement with the U.S. Chamber of Commerce with the goal of making criminal anti-illicit trade investigations more efficient. Through the National Intellectual Property Rights Coordination Center (IPR), which is part of the U.S. Department of Homeland Security, critical intelligence is shared about IP theft, fraud, trade violations and cyber intrusions by coordinating with 25 federal and international government agencies and private companies in combating global IP theft. With this information, we are better able to harness the collective power of the U.S. government and private entities to disrupt illicit supply chains and reduce instances of suspect products reaching patients.
41 WHO, “Substandard and falsified medical products,” https://www.who.int/en/news-room/fact-sheets/detail/substandard-and-falsified-medical-products, accessed February 2024.
