Report on MediLedger blockchain network submitted to the FDA

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/tiero)
(Image: Getty/tiero)

Related tags: MediLedger, Blockchain, track and trace, Drug supply chain, DSCSA, Fda

A group of 24 companies is set to support blockchain technology to ensure compliance with the FDA’s DSCSA requirements and to tackle counterfeiting.

Leading pharmaceutical companies including Novartis, Sanofi, and Gilead, are among the supporters of the MediLedger Project, a blockchain-enabled technology platform initially launched by Chronicled in 2019​, aiming to protect the pharmaceutical supply chain and enable compliance to the Drug Supply Chain Security Act (DSCSA) requirements set by the US Food and Drug Administration (FDA).

Ahead of the package-level tracing element of DSCSA taking effect in 2023, the group behind MediLedger has proceeded to submit a report​ for review by the FDA, “detailing how and why blockchain can meet ... requirements for an interoperable, confidential change of ownership system in the US pharmaceutical supply chain,”​ the companies stated.

The proposed solution, according to the related announcement​, is a combination of industry ‘rules’ regarding how data will be shared and of the actual network in which data sharing will be operated.

During this process, no proprietary data will be shared openly, but instead it will be exchanged directly with necessary trading partners, leaving only cryptographic proofs, also known as ‘zero knowledge’ proofs, posted on the blockchain.

The participants claim that a ‘well-designed, industry-led, decentralized’ blockchain platform that has the potential to meet the purpose of protecting the supply chain, while Mack MacKenzie, VP of Digital Market Access and Revenue Management solutions at Pfizer, described the joint project as a “demonstration of broad industry commitment to an interoperable system.”

Industry-wide collaboration is a core precondition for the establishment of a blockchain network for data distribution. Previously, a representative of IBM explained​ how blockchain technology has come to assist companies within the industry address their ‘trust issues’.

However, broad collaboration within the industry also reflects improvement on investment scope, with AmerisourceBergen telling us recently​ that manufacturers are required to show the same will to invest in the supply chain ‘just as they do on R&D’.

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