The GS1 Healthcare industry group has put into place a supply chain model for the pharmaceutical industry as part of its 2015 Readiness program. The model uses a standard serialized track-and-trace system, known as “e-pedigree”, to track movements of such products throughout the supply chain from manufacturer to retailer. Under the model, each product would have a unique ID number on a radio frequency identification (RFID) tag or a bar code, along with its expiration date and manufacturing source.
The readiness program was prompted by California’s aggressive legislation to clamp down on burgeoning growth of counterfeit drugs, which threaten lives and health on a massive scale. Counterfeit drugs are a $200 billion worldwide industry. There are more fakes than real drugs in the market, according to the World Customs Organization anti-counterfeiting coordinator. In 2007-8 alone, the insertion of fake drugs into the supply chain rose nearly 600 percent. Fake anti-malaria drugs kill an estimated 100,000 Africans a year.
Despite several delays in implementation and push backs of the effective date, California Business and Professions Code section 4163 provides that by 2016 a wholesaler or repackager of prescription drugs or devices must not sell or acquire such drugs without providing or receiving a pedigree to show that it was authentic and legitimately obtained. The importance of this law is in the difficulty it will pose for counterfeiters to move fake drugs through the system, and the evidence and ease of conviction it will create in prosecuting such attempts. Further, the value of the marketed product will be profoundly affected. Before, one looked solely at the physical condition of the product and its packaging. When this system is implemented, receiving the pedigree will have a decided impact as well.