Case Study |Digital Authentication Prevents Drug Counterfeiting and Diversion in High-Risk Markets

“Anything we can do to protect the drug pack without changing the look of it is high on my priority list because additions and changes can require regulatory approval.”

Customer

A patient-focused, global pharmaceutical brand that builds on a distinguished 235-year history to develop highly innovative medicines. Their operations span over 70 regions worldwide with products marketed in approximately 100 countries. This values-based leader has a long-standing relationship with Systech.

Challenge

As a participant in the Access to Medicine (AtM) program, the company provides specialized drugs for GI, oncology and vaccines to patients in underserved regions that also are at highest risk for counterfeiting and product diversion.

Committed to patient health, the company launched a global product protection project to strengthen supply chain security in high counterfeiting areas, including Kenya, the Philippines and Ukraine. 

The company faces three major challenges in these markets:

  • High concentrations of counterfeit goods and minimal or no anti-counterfeit regulations.
  • Parallel trade, which is legal in the European Union (EU), increases the appetite for product diversion. More product diversion channels provide more and easier insertion points for counterfeit goods.
  • Loss of visibility once their products leave the manufacturing facility, making it difficult to tighten protections at the tail end of the supply chain.

“Serialization by itself will not end counterfeiting. It will help address the problem but won’t end it altogether.”

- Brand Protection Technologies Manager

Solution

For its initial product protection project, the company established digital authentication for oncology medicines manufactured in the EU before shipment to Kenya. The solution incorporated technology from the Systech Brand Protection Suite™ to establish anti-counterfeit and anti-diversion protections that worked with measures already in place.

The pharmaceutical leader takes a multi-layered approach to anti-counterfeiting—understanding that serialization is critical but not sufficient protection against counterfeiting. The new solution creates a unique digital signature, or “e-Fingerprint®,” based on micro-variances in the existing barcode on each package. The e-Fingerprint is stored on a secure cloud, then used to authenticate products at the individual item level through a smartphone app.

To reduce product diversion, the solution incorporated Systech’s track-and-trace system to implement the supply chain visibility the company needed. The enterprise-wide platform integrates internal and external serialized item information systems to provide real-time data on any unique package from the factory to the administering physician. 

“I like that Systech’s solution doesn’t require any type of proprietary reader that you have to keep track of and provide to partners.”

Benefits

Extremely fast and cost-effective solution                         

The digital authentication solution established effective protection for some of the company’s highest-value products in one of its highest-risk markets. The solution has been an excellent fit for the African market, where cellphone usage rates are high even in less technologically developed areas.

Implementation was extremely fast and cost-effective compared to other anti-counterfeiting measures that could include packaging changes or major production line overhauls. From initial hardware installation on the first packaging line to product testing, implementation took four days, with validation adding another two.

The success and relatively low cost of the pilot program demonstrated the potential for wide-scale implementation because the solution is:

  • Non-additive – Leveraged existing packaging for covert protection, so no need for art changes or line overhauls
  • Secure – Cannot be reverse-engineered, removed or duplicated
  • Simple – Mobile app for authentication works with standard smartphones, reducing complexity and eliminating expense of specialized readers
  • Globally accessible – Traceability and authentication from anywhere in the world for products at any point in the supply chain down to administering physicians

Product safety is a constant battle...

“For the first line we installed this on, the plant manager was so pleased with the technology that he came up with the money for the initial install of the hardware.”

– Brand Protection Technologies Manager