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Responsible Business Practices
Product Quality & Safety

Counterfeiting & Illicit Trade

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Counterfeit, illegally diverted and tampered-with healthcare products place people at risk of serious health problems—potentially even death—and undermine confidence in product quality, safety and reliability, which, at Johnson & Johnson, is central to everything we do. Additionally, counterfeit healthcare products negatively impact the economy of healthcare by diverting income and tax revenues from those who work to improve healthcare. Illicit trade adds a cost burden of monitoring and control for healthcare systems, and can negatively impact health outcomes.

We believe the illicit trade of healthcare products must be stemmed for the benefit of all, and we strongly support stricter regulation in this area. For example, we supported the passage of the H.R. 5663 Safeguarding Therapeutics Act, giving the FDA FDA U.S. Food and Drug Administration View entire glossary the authority to destroy counterfeit medical devices and combination products at ports of entry. The bill was enacted after being signed by the President on January 5, 2021.

Our mandatory biennial Code of Business Conduct training for all employees includes a module on counterfeit products and illicit trade to help employees be proactive in protecting our patients and consumers. Illicit trade complaints are also incorporated as a category of complaints into the Product Quality Complaint/Adverse Event training that all employees are required to take. In addition, we provide dedicated training modules for employees in certain functions to continue their education on anti-counterfeiting and product protection best practices. Outside of the Company, we regularly train government officials to help them identify suspect versions of Johnson & Johnson products. In 2020, we launched our Global Brand Protection Customs Program for customs and border protection officials, which delivered global product protection training virtually via 37 sessions, due to the COVID-19 pandemic.

Anti-counterfeiting best practices training delivered in 2020:

Johnson & Johnson employees
customs and border patrol officials

In 2020, we deployed multi-faceted protection capabilities to reduce the threat of counterfeiting, theft, cyberattacks and other forms of illicit trade for our COVID-19 vaccine, as described in the section COVID-19: Advancing a Vaccine. We also continued the ongoing fight against counterfeit healthcare products in several ways:

Customs, government and other partnerships: We record our trademarks with customs and border protection agencies to stop illicit trade at ports of entry around the world. Our customs and government partnerships resulted in an increase of suspect product notifications and related seizures from the previous year. This increases confidence that our patients and consumers will receive genuine Johnson & Johnson products. We also continue to engage with seven external trade groups, alliances, organizations and agencies—either in leadership positions or as a member of industry working groups—to help collaboratively combat trade in counterfeit healthcare products.

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Introducing a tool to assess counterfeit risk: During 2020, we deployed a new prioritization tool that analyzes data from various sources to determine the brands at the greatest risk for illicit trade. Our Segmentation Tool uses market and business intelligence and multiyear internal data to improve decision-making in the best interests of patient protection.

Adding security measures: We introduced a sophisticated security feature to the existing tamper-evident seal already in use at our pharmaceutical packaging sites in Europe. The new seal was designed for use on critical pharmaceutical products in markets at high risk for illicit trade. We also started using digital authentication features across our product portfolios to enhance the ability to authenticate products when they are in the market.

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