MediLedger 'can meet DSCSA’s drug verification target'

A blockchain-based system has successfully completed pilot testing and can meet the 2023 deadline in the US for pack-level traceability of medical product ownership, according to its developers.

The MediLedger project – administered by tech company Chronicled – has been put through its paces by a consortium of more than two dozen drugmakers, distributors, third-party logistics companies and tech firms in the pilot, and has shown that it can track the legal change of ownership of prescription medicines.

The US Drug Supply Chain Security Act (DSCSA) requires full unit level traceability across the supply chain by 2023, and with that in mind the FDA called for pilot project participants at the beginning of 2019 to try to work out how to meet that deadline, and find approaches that are interoperable, i.e. they can be applied across organisations of all sizes running varying IT systems.

Using a system based on blockchain – the technology underlying virtual currencies like Bitcoin – provides a way to keep the transactional data transparent to supply chain participants, preventing illegal activity like counterfeit and diversion, as well as secure, according to a just-published report on the pilot by the MediLedger team.

Unlike the European Medicines Verification System (EMVS) and other medicine traceability initiatives around the world, the DSCSA doesn’t include a central repository for transactional data.

That means the US supply chain could suffer as companies “struggle with keeping data accurately and completely shared across a wide variety of partners, systems and technical formats,” says the report, and that could affect the ability to find and quarantine suspect products.

The system “can avoid these significant risks,” say its developers – which include big biopharma companies GlaxoSmithKline, Roche/Genentech, Novartis, Pfizer, Eli Lilly and Sanofi – without any sensitive, proprietary data being shared on the blockchain.

MediLedger would have a different structure, consisting of private nodes that communicate peer-to-peer as well as with the entire blockchain.

It consists of three main technologies: private messaging between authorised trading partners to share confidential information; a blockchain ledger to register proof of authenticity and execute smart contracts without allowing as break in the chain of custody; and another privacy layer (using a tech known as ‘zero knowledge proof’) to further ensure no business data is needlessly revealed.

“Through this project, we have shown that blockchain has the capability to be the technology underlying an interoperable system for the pharmaceutical supply chain, as mandated by DSCSA,” says the report.

“When using a single blockchain solution, transaction throughput, speed, and reasonable cost can be achieved to meet stakeholder needs,” it adds. The system has to tie into and underpin the unique serialized 2D barcodes that given each medicine pack an individual identity and have been applied to new packs since 2018.

Currently MediLedger is being deployed to solve verification of saleable drug returns within the US, which is viewed as one of the big challenges facing the industry as the Healthcare Distribution Alliance (HDA) estimates that 60 million drug units are returned annually.

“The authenticity of the drug transaction information can be confirmed with each transaction allowing for expedited suspect investigations and recalls,” according to its developers.

There are potential challenges ahead. MediLedger isn’t the only platform included in the pilot phase, and there are clear challenges in making disparate track and trace systems interoperable, particularly given the lack of universal standards.

Developing standards for elements such as messaging, system interoperability and authorised trading partner identification would increase the chances of meeting the 2023 deadline, says the consortium.

A second platform built on MediLedger will launch this year to tackle other business needs, such as contracts and chargeback reimbursements between manufacturers, wholesalers and group purchasing organisations.