Yesterday TraceLink which runs a pharmaceutical digital supply network, announced that it has created a blockchain pilot for the requirements of the Drug Supply Chain Security Act (DSCSA). The company has submitted the solution to the Food and Drug Administration’s (FDA) Pilot Project Program announced a month ago.
In 2013 the US introduced the DSCSA in part to address the significant counterfeit drug market which is estimated at $200 billion globally. The solution is to make the drugs traceable by ensuring serialization so there is an identifier on each package and the ability to trace the history. To address the challenge participants in the supply chain need to interoperate. That includes manufacturers, repackagers, wholesale distributors, pharmacies and hospitals.
By November 29th this year distributors need to verify returned pharmaceutical packages to ensure they’re not counterfeit. Returns amounts to $7 billion a year, so the aim is to prevent counterfeit drugs being re-sold by legitimate wholesalers.
There’s been some debate about whether the pharma sector will be to meet the overall 2023 deadline with or without blockchain. The fact the the FDA found the need to launch a pilot program speaks volumes.
Tracelink which is backed by Goldman Sachs and Vulcan Capital, believes its existing database of partners will give it an advantage. In 2017 it commissioned more tha 460 million serial numbers and processed 2.5 billion events (not using blockchain).
“The 275,000+ partners on our end-to-end digital supply network are already validated, which provides companies with a unique opportunity to leverage blockchain technology, while ensuring the safe exchange of data,” said Shabbir Dahod, president and CEO, TraceLink. Trace Histories is the company’s DSCSA solution to meet the 2023 deadline requiring full unit traceability across the supply chain. It has additional solutions for other DSCSA deadlines.
Dahod continued: “Trace Histories maintains the pseudonymity of blockchain participants and control of confidential information within each participant’s system by only enabling the disclosure of information necessary to respond to verified trace requests.”
“We have been working on this submission since the FDA announced the program last month and are excited to partner with several pharmaceutical manufacturers, wholesale distributors, retail pharmacy chains, and hospital networks to help the industry gain real world insights to collaborate on a solution that will enhance patient safety and solve for difficult business challenges. Feedback and insight from the pilot program will be invaluable in informing solutions meant to help companies meet the 2023 deadline.”
We’ve contacted TraceLink to find out more about the technology being used.