How Johnson & Johnson is fighting counterfeit medical products

Photo courtesy of GBP LATAM team

Stolen contact lenses sold through a fake online pharmacy. Prescription medication missing active ingredients. Surgical sutures made from subpar materials.

Illicit, fraudulent or substandard drugs and medical devices—like the examples above—are part of a highly lucrative global counterfeit healthcare market, estimated to generate as much as $432 billion each year.

More importantly, this illegal market poses a danger to the health of patients around the world, who are at risk of serious health concerns if they use a fake medication or receive a substandard device.

To combat unlawful trade, Johnson & Johnson relies on its Global Brand Protection (GBP) team—a squad of employees worldwide with expertise that encompasses the supply chain, quality control, commercial, packaging, information technology, law enforcement, intellectual property law and cybersecurity.

“The counterfeit healthcare market can extend into any of the company’s products at any place around the world, so constant safeguarding and monitoring of our supply chain and marketplaces is crucial,” explains Taira Bell, Johnson & Johnson’s Vice President of Global Brand Protection. Thanks to the team’s vigilance, “we’ve been successful in protecting millions of patients worldwide from potentially harmful and substandard products,” she says.

Here’s a look at how this highly specialized team operates and why their work is so important.

Stopping illicit trade in counterfeit drugs and devices

Illicit trade is a significant threat that affects every industry, from designer handbag knockoffs to counterfeit currency. “The challenge for Johnson & Johnson, though, is that illicit healthcare products have such an enormous impact on our patients,” says Bell.

Counterfeit medicine, for instance, often lacks active pharmaceutical ingredients, which means it can’t provide therapeutic benefits. Stolen medications may not have been properly stored or handled. And fake surgical supplies and medical devices could have been manufactured in unsanitary, squalid conditions or without quality controls, factors that jeopardize the health of users.

Illicit trade has a disturbingly far reach. It has been linked to organized crime, child labor, human trafficking and even terrorism. It undermines patient and consumer confidence in the safety and quality of a product. It also diverts revenue from legitimate healthcare companies like Johnson & Johnson into the pockets of fraudsters.

“When we take everything into account and look at the importance of protecting patients as well as our business, we need to have a holistic solution,” says Bell. “We can’t just be reactive. We have to go the extra mile to be preventive.”

Tim Mohn, Director, GBP Strategy and Risk Management, has been with Johnson & Johnson for nearly two decades. “I came into this role because I was shocked to learn that there was illicit trade happening all over the world, including the U.S.,” he says. “I wanted to be part of the solution.”

“Johnson & Johnson doesn’t want to just go after the bad products and seize them,” explains Mohn. “We’re constantly asking, ‘What are the things we can do to reduce our risks of these counterfeits ever being produced in the first place?’”

The company tackles the challenge by assessing risks and building protection into products before they even launch, as well as monitoring for and responding to counterfeiting and unlawful activity after products are available on the market.

This is all in close partnership with governments, law-enforcement agencies, academia, industry groups and global partners to increase our reach and effectiveness. Here’s a closer look.

Anticipating challenges before a product launches

When it comes to pharmaceuticals and medical devices, counterfeiters and fraudsters tend to be interested in “high volume” products like contact lenses, which must be purchased frequently, or “high value” medications that tend to be more costly, such as cancer treatments. “If there’s an angle to make money, these criminals will try to exploit it,” says Mohn.

We’re always asking, ‘How might bad guys try to disrupt this product?’ And then we seek to build in an array of controls before the product is ever released-Tim Mohn

As a new device or therapy nears the stage when it will enter the market, GBP team members conduct an “illicit trade assessment”—determining if the product is high volume or high value and is expected to be distributed in a part of the world where counterfeiting is prevalent.

The new product and any potential vulnerabilities are scrutinized to the smallest detail. For instance, what form will the product be: Capsule? Tablet? Liquid? How will it be shipped? How is it dispensed? What guardrails are already in place to control it from being stolen or duplicated? What could be done to protect it further?

“We’re always asking, ‘How might bad guys try to disrupt this product?’” says Mohn. “And then we seek to build in an array of controls before the product is ever released.”

Based on this detailed assessment, the GBP team designs a tailored protection program that includes product security features. These might be visible to the naked eye or more advanced features that are only “visible” to those with additional training and technology to detect them.

Johnson & Johnson’s safeguards incorporate lessons learned from multiple industries, including currencies. Security features alone aren’t enough to deter bad actors and a network of controls—and people—is needed to truly protect patients.

Monitoring and responding after a product hits the marketplace

Following every product launch, “it’s our job to make sure that when a Johnson & Johnson product is purchased or used, it is legitimate,” says Mohn.

Through its partners, Johnson & Johnson conducts 24-7 online monitoring of the dark web, social media marketplaces, pop-up digital pharmacies and other corners of the internet where bad actors attempt to sell fake or stolen products. Johnson & Johnson also trains customs and law-enforcement agents around the world to identify duplicates.

Advanced data and analytics help the team stay ahead of threats to disrupt the distribution route a product takes from the manufacturer to the pharmacy or healthcare provider.

“We’re watching to see if the demand for the product is greatly different than what we’d expect it to be,” explains Mohn.

For instance, a sudden spike in buyers in a particular area of the world could indicate that legitimate products are being purchased and illegally shipped to other locations. On the other hand, a lull in buyers can imply that people are shopping via an alternative source, which may or may not be distributing legitimate products.

When a counterfeit case does come in, “our team assesses if we have enough information to launch an investigation,” says Bell. “That can mean working with a third-party law-enforcement agency to try to find the source of the manufacturer so that we can then disrupt the network.”

Forming ongoing partnerships to remain vigilant

GBP team members are experts on combating illicit trade, “but our team doesn’t act alone,” says Bell. “When you think about the size of the issue, we have to effectively collaborate. We have a whole host of internal stakeholders that we partner with, along with an array of external stakeholders, be it academia, industry partners, law enforcement or health authorities.”

Illicit traders, for example, can easily hide behind online listings on social media or e-commerce platforms, making it tough for Johnson & Johnson to root out the actual source. Thanks to close monitoring, “we might be able to take those listings or entities down, but then they pop right back up, disguising themselves as someone else,” Bell says.

Actively partnering with the marketplaces themselves is crucial to fully shutting down illicit traders. “These legitimate marketplaces don’t want a reputation as a platform where counterfeits are being sold,” says Bell. Some of the ones that Johnson & Johnson partners with, like Amazon, often have their own extensive counterfeit crimes unit.

GBP team members also work alongside the U.S. and foreign governments. In 2023, Johnson & Johnson signed an agreement with the U.S. Chamber of Commerce designed to make criminal illicit trade investigations more efficient. The pact allows the National Intellectual Property Rights Coordination Center (IPR Center)—the U.S. frontline response to global intellectual property theft—to share critical information with key federal agencies like U.S. Customs and Border Protection, plus private-sector partners.

“When we move a product from vendor A to vendor B, we want to make sure that vendor A doesn’t sell our molds and dies,” says Bell. “So part of our value chain integrity is making sure not just the products, but also our proprietary manufacturing materials, don’t get stolen.”

Specialized training for national and international law-enforcement agencies across the globe is another GBP priority. When agents in the U.S. and other countries know how to spot counterfeit products, they’re more likely to find them—and proactively reach out to Johnson & Johnson when these products are discovered.

Johnson & Johnson was also the pilot healthcare company in the Africa Traceability and Verification System (TRVST), a patient safety initiative launched by UNICEF in 2022. It’s the first system in low- and middle-income countries to use barcodes to monitor a product’s journey through the supply chain.

Bell sits on boards of influential industry groups across the globe, including the International AntiCounterfeiting Coalition (IACC). “We want to understand, ‘what are some of the challenges that our peers and industry are facing? How do they tackle illicit trade?’ Then, we leverage best practices and benchmarks across our companies,” she explains. “We’re all fighting against the same bad guys. We all want to protect our consumers, our patients and our healthcare professionals.”

Patients and purchasers can play a role, too

For as much as the GBP team accomplishes, purchasers have an important role to play, too—mainly by being on alert for counterfeit or compromised products. Prescription or medical device pricing that seems too good to be true is a big red flag.

So is seeing a product for sale in a market or channel where it doesn’t typically belong.

“Buy from authorized sources, and if you see something, say something,” advises Bell. “I know that sounds cliche, but if you do suspect that a product doesn’t look like it normally looks and doesn’t smell like it normally smells, or the graphics look substantially different or the cost is outrageously cheaper than what you would normally pay…please report that to Johnson & Johnson so we can investigate.”

Some people might hear the phrase “brand protection” and not be sure what it means. “To me, ‘brand protection’ is a clear call to action to join the global fight against illicit medical products and to put patient safety front and center,” says Bell.

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