A new blockchain consortium has formed following a pilot for compliance with the Drug Supply Chain Security Act (DSCSA). Last year IBM, Walmart, Merck, and KPMG participated in an FDA pharmaceutical blockchain interoperability pilot to track and trace pharmaceuticals for DSCSA legislation. Now, IBM says the pilot partners have formed a blockchain alliance called the Pharmaceutical Utility Network (PhUN).
The group is currently exploring issues such as regulatory compliance, cold chain efficiency, drug shortages, drug recalls, and clinical trials.
IBM stated that: “PhUN takes an open-source platform-first approach — a similar concept to the Apple App Store — to empower stakeholders to comply with regulations and to use them as the basis for innovation.”
The alliance first came together to participate in the U.S. Food & Drug Administration’s (FDA) DSCSA Pilot Project Program. The FDA project aims to ensure interoperability is achieved when the DSCSA legislation comes into force. In turn, the legislation’s primary goal is to combat the counterfeit drug market, estimated at $200 billion globally, and the health risks this fraud causes. IBM said about 70% of all drugs in some countries are counterfeit.
The DSCSA mandates supply chain participants to provide a digital record of all pharmaceutical transactions, to better track and trace certain prescription drugs and their distribution in the U.S.
The interoperability pilot was the first use case trialed by the PhUN, which successfully used blockchain to reduce the time needed to track a prescription drug from up to 16 weeks to mere seconds.
The application allows users to identify, investigate, and notify a suspected counterfeit drug. IBM said it aims to formally launch and scale the solution to ensure DSCSA compliance across the pharma supply chain stakeholders. The solution tracks and traces products at a serialized unit level from the point of manufacture to the point of sale.
Meanwhile, Walmart has some history with IBM, especially with the IBM Food Trust, and requires suppliers of leafy greens to participate in the blockchain project. The former head of that initiative for Walmart, Frank Yiannas is now a deputy commissioner at the FDA on the food side. For the FDA pilots Walmart also participated in another pharma blockchain network, MediLedger, which has the three big wholesalers signed up.
Several others are exploring blockchain for the FDA pilot, including IDLogiq, Rymedi, TraceLink and UCLA Health.