Pius Haas Jun 16, 2020 11:52:07 AM 12 min read

Patient Safety Means Doing More Than Just What’s Mandatory

Current pharma anti-counterfeiting standards come up short, and that’s damaging to your brand and your patients

No security method is perfect, and every sector could benefit from adding another layer of protection. This applies most to the pharmaceutical industry, where consumers rely on legitimate products being exactly what the box or bottle says they are. Unfortunately, pharmaceutical fakes are an increasing global problem that doesn’t recognize borders between developed and developing nations.

The damage counterfeiting does to the injured pharma brand is more damaging to the industry as a whole than it would be in an industry like fashion, for example. If a major clothing brand suffers reputational fallout from counterfeits, consumers have many other well-established options. Prescription medicines don’t have that kind of multi-brand awareness. If the public sees their drug stores are flooded with fakes, trust in the entire industry could be lost.

This makes it necessary for medical manufacturers to go above and beyond the pharma industry’s mandatory security requirements to safeguard their patients and secure the integrity of their products and brands.

The devastating dangers of counterfeit medicines

Let’s look worldwide at examples of counterfeiting’s human and brand impact. In America, the largest drug bust in New Jersey’s state history occurred in 2019 when around half a million fake tablets were seized mixing heroin with fentanyl. Many of these masqueraded as Xanax, America’s number-1 most-prescribed psychiatric medication. Large-scale counterfeiting of this nature is made easy due to the ready availability of illegal pill presses

Death on a massive scale was thankfully avoided, but the nation’s reliance on Xanax and the fact that the drug comes in various shapes and colors makes it much easier for counterfeiters to exploit the market for their own gain. This was 2019; 7 years after the introduction of the Drug Chain Supply Security Act, and yet major brands are still this vulnerable.

December 2019 saw Hong Kong’s biggest fake pharmaceutical haul of the decade, which is no small feat in one of the world’s worst counterfeiting regions. Millions of illicit pills exploited the intellectual properties of existing brands by being packaged as common drugs ready for shipment throughout China. 

This is in a nation where serialization was made mandatory in 2011, and the China National Drug Code (NDC) and a unique serial number are required on all primary and secondary medical packaging — yet still millions of fakes almost made it to market.

The EU is no safer, despite its mandatory requirement that tamper-proof and unique identifiers be added to medical packaging, 1.8 tons of illegal pharmaceuticals worth over 165 million Euros were seized in 2019. More than half of them were counterfeit or falsified. 

Each of these examples proves that mandatory measures are not enough anywhere in the world.

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Governments and global watchdogs are struggling

The World Health Organization, Europol/Interpol, the DEA/FDA, Operation Pangea … the list of dedicated bodies fighting pharmaceutical fakes goes on and on, but even with regulatory support from governments, their efforts need help.

Serialization is being heavily relied on, but it’s a data-dependent measure that’s vulnerable to human entry error and, as the above examples show, something counterfeiters can circumvent. Packaging designs, processes and intellectual properties are being hijacked, fooling suppliers, patients and professionals, and shaking trust in brands both inside and outside the supply chain. 

Medical manufacturers and supply chain managers must join the fight. Asking what they can do that international agencies can’t is understandable, but pharma producers underestimate their power. They are the ones sourcing, designing, manufacturing and distributing the product. and as such, they have great positive influence on how vulnerable it is.

U-NICA can help your pharmaceutical company exercise that power through secure practices that protect patients and brands from sourcing to shelf.

Join the U-NICA Protection Circle

Don’t put blind faith in watchdogs and governments to protect your consumers and brand. Team with U-NICA and become part of our Protection Circle®devoted to collecting, analyzing and sharing data on pharmaceutical counterfeits and their product/regional-specific risks.

Our resources give organizations the real-time global knowledge they need to be proactive in their own protection, as well as aiding intellectual property battles by providing insight and information to support arrests, raids, product seizures and prosecutions by authorities.

We can also help your whole supply chain trust each other by providing physical protection for pharmaceuticals. This is necessary because research has proven that counterfeiters have operatives at every stage of the pharma chain. U-NICA approach delivers anti-counterfeiting solutions that no counterfeiter can copy, and no supply chain node can tamper with.

Help pharma do more against counterfeits

U-NICA plastoTRACETM solution embeds security deeply into your product and seamlessly into your production process using overt measures like holographic branding and covert ones like invisible inks and tags (counterfeiters can’t crack what they can’t see). 

Our scryptoTRACE® solution compensates for the fact that there’s no global, universal standard for pharma product protection. It’s why we designed this solution to integrate not only with your own enterprise systems, but with foreign ones and any new and emerging anti-counterfeit approaches. 

scryptoTRACE® is a fully scalable, rapid-response answer to counterfeit concerns that addresses the entire product cycle. It’s an end-to-end brand value protection and product protection solution that can be integrated into every step of the product value chain, from design and manufacturing to distribution, sales and purchasing. 

The solution approaches product security from two directions:

  • It allows consumers to easily authenticate genuine products
  • It allows the product or brand owner to track counterfeiting activity and gain information that can help lead to arrests and prosecution

scryptoTRACE® uses passive image recognition technologies to authenticate products based on active markings — it’s like adding a fingerprint for your products. The suite provides a platform for marking, product recognition and secure verification. With these markings, every link in the supply chain can use our unique smartphone app to quickly and reliably determine a product’s authenticity. 

The markings can be overt, semi-covert, covert or forensic. Several different security levels can even be applied to the same object to allow different methods of authentication for consumers and experts (such as inspectors and customs officials).

U-NICA knows that lives depend on the integrity of pharma brands and products. Let us help your organization exceed mandatory security requirements and do more for patients. 

U-NICA is a team with a single purpose: supporting you in the fight to protect your brand’s integrity and value. Our staff operates globally and partners with universities and agencies to deliver the future of brand protection. Connect with me for more information on our constantly evolving open solution suite.

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Pius Haas

Has more than 30 years of experience in IT / IS management of strategic developments and business areas. Proven history as innovator, entrepreneur and business pioneer, able to launch, develop and implement tailor-made programs for customer needs in key industries. Has the ability to drive the conception, design and implementation of leading-edge technology solutions while motivating and supporting employees and partners to achieve performance goals with a single mission.

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