The US Food and Drug Administration (FDA) selected IBM, KPMG, Merck, and Walmart to participate in a pilot program to address the developing requirements of the Drug Supply Chain Security ACT (DSCSA).
Through this program, the four companies will assist drug supply chain stakeholders in developing an electronic interoperable system to identify and trace prescription drugs through US distribution networks.
Arun Ghosh, blockchain leader at KPMG, told us that entering the program was a ‘natural fit’ for the organization, as it continues to build on the momentum behind creating security on a blockchain -based platform.
Together the companies will create a shared permissioned blockchain network for real-time product monitoring. The network will work to reduce the timeframe for track and trace, and retrieval of distribution information.
“KPMG’s role in the program is not just to develop a business framework but to develop the analytics and decision points of how the blockchain serves up where the particular drug is in the supply chain, when it was shipped and where it was received. In that sense, KPMG will be building the analytical frameworks,” Ghosh explained.
Each company participating in the program has worked significantly in advancing blockchain processes and supply chain security. Craig Kennedy, SVP of supply chain at Merck, known as MSD outside the US and Canada, said in a statement, “Our supply chain strategy, planning and logistics are built around the customers and patients we serve.” He continued, “Reliable and verifiable supply helps improve confidence among all the stakeholders – especially patients.”
Tamperproof framework for biopharmaceuticals
The pilot program will work to establish a framework that will be essentially tamperproof, in an effort to eliminate counterfeiting across the drug supply chain.
Mark Treshock, IBM Global Solutions leader for blockchain in healthcare and life sciences, said in a statement, “Blockchain has the potential to transform how pharmaceutical data is controlled, managed, shared and acted upon throughout the lifetime history of a drug.”
This potential for transformation, according to Ghosh, is partly due to the technology’s ability to create a private and permissioned network, or an ‘immutable record’.
“If you look at any data breech or hacking story, the data is intercepted between transmission, usually. With blockchain the difference is now you’re creating a hashkey at every event that happens on that products workflow,” he said. “Once its on the chain, you can’t override it.”
The pilot program is scheduled to be complete in the fourth quarter of 2019 and will publish results in the FDA DSCSA program report, at which time the participants will evaluate how to move forward with blockchain systems.