Counterfeiting & Illicit Trade
We strive to ensure that all who use our products have unequivocal confidence in their quality, safety and authenticity. We aggressively continue to manage risks related to illicit trade to protect patients and consumers from potential harm. When a counterfeit product is purchased, everyone—except for the counterfeiter—loses. The consumer or patient does not get the product they paid for and, more important, could be at risk of serious health problems—potentially even death. Fake products undermine confidence in the quality, safety and reliability of healthcare products which, at Johnson & Johnson, are central to everything we do. Counterfeiting may also fund other illegal activities such as terrorism, organized crime, child labor, etc., with far-reaching adverse effects on people, communities and healthcare systems.
We believe the illicit trade of healthcare products must be eliminated for the benefit of all, and we strongly support stricter regulation in this area. Similarly, we supported the passage of the H.R. 5663 Safeguarding Therapeutics Act, giving the FDA FDA U.S. Food and Drug Administration the authority to destroy counterfeit medical devices and combination products at ports of entry. The bill came into force in January 2021.
During 2021, we continued to reinforce our programs and actions to help stamp out illicit trade in the following ways:
Adopting new ways of monitoring and detecting illicit trade through enhanced product security intelligence and analytics, addressing the growing sophistication of illicit trade and the expansion of online marketplaces. Advanced technology is a critical component of our protection against illicit trade. Our new mobile app provides field-based product authentication capabilities to enhance product security. We maintain round-the-clock monitoring of more than 1.6 million global websites, more than 30 social media sites, almost 800 marketplaces and 60 dark web locations. We also examine new data sources for shipments through customs monitoring programs.
Protecting our COVID-19 vaccine from illicit trade through best-in-class product protection features. An example last year in Kenya saw individuals posing as healthcare workers administering a fake version of our COVID-19 vaccine—one of the many ways in which illegal activity that can cause serious harm to people and communities is showing up.
To protect our patients, our Global Brand Protection (GBP) team built advanced overt and covert product security features into vaccine packaging and intensified monitoring of internet marketplaces and the dark web for COVID-19 pandemic product risks and threats, including drugs and COVID-19 vaccines from other manufacturers. We also worked across our supply chain to uphold our high Enterprise standards for security and IP IP Intellectual Property protection. COVID-19 anti-counterfeit training was delivered by our teams to customs and border protection authorities in several countries alongside the provision of our proprietary mobile app to enable rapid product authentication in the field.
Enhancing our response protocol for addressing identified illicit trade incidents. Once a suspect product or shipment has been identified, a swift and thorough response is essential. Depending upon the unique circumstances (e.g., safety risk and jurisdiction), we may pursue civil enforcement actions in parallel with criminal prosecution when illicit trade is uncovered. This parallel approach was used, for example, to fight counterfeits of our branded surgical product used to control bleeding in surgeries worldwide. We pursued civil litigation to have the counterfeit products removed from circulation from the U.S. marketplace; criminal prosecution efforts are still ongoing.
Training employees and law enforcement: Annually, all employees receive mandatory training on identifying and reporting Product Quality Complaint/Adverse Events, which includes a module on illicit trade complaints. Also mandatory for employees is a biennial CBC training, which also includes a module on counterfeit products and illicit trade to help employees be proactive in protecting our patients and consumers. Outside the Company, we regularly train members of law enforcement to help them identify suspect versions of Johnson & Johnson products through our GBP Customs Program for customs and border protection officials.
Maintaining our wide-ranging networks and partnerships for enhanced product protection: promoting laws designed to render counterfeiting and piracy unprofitable and undesirable is a common industry goal that drives alliances between governmental and regulatory agencies and brand owners. At Johnson & Johnson, our GBP team is a member of and holds leadership roles in several illicit trade prevention consortiums. The team works with government agencies around the world to encourage legislation that seeks to dismantle illegitimate supply chains and punish those found guilty of illicit trade. As many of our products are governed by Ministries of Health, we also work with them to enact changes designed to better protect patient safety.
We are also members of and/or hold board positions on several additional region-specific industry groups.
A selection of anti-counterfeiting industry organizations we engaged with in 2021:
- International Anti-Counterfeiting Coalition;
- Center for Anti-Counterfeiting and Product Protection at Michigan State University;
- Rx-360 – The International Pharmaceutical Supply Chain Consortium;
- Pharmaceutical Security Institute;
- Alliance for Safe Online Pharmacies; and
- International Trademark Association.