MediLedger Project Gearing Up for Saleable Returns: Part II

In the second half of this Q&A, Heather Zenk discusses the role of regulators, the hurdles to overcome and the next steps for the project.

The pharmaceutical industry is abuzz with concern over how to best meet the traceability requirements spelled out in the Drug Supply Chain Security Act (DSCSA). 

Per the DSCSA, by Nov. 27, 2019 wholesale distributors will have to verify serialized product identifiers of saleable returned packages or sealed homogenous cases of product that are intended for further distribution (section 582(c)(4)(D)).

In 2018, a group of companies launched the MediLedger Project, which brings together major pharmaceutical manufacturers and distributors to create a collaborative network. 

Heather Zenk, Vice President, Global Secure Supply Chain Operations at AmerisourceBergen, is a knowledgeable member of the working group. “Using blockchain, the project creates evolving solutions for track-and-trace regulations, and provides a step-function improvement in the overall operation of the supply chain,” she explains.

Part I highlighted the initiative, the role of blockchain and hurdles to overcome. Here Zenk discusses the role of regulators, the hurdles to overcome and the next steps for the project.

Q: Will regulators have access to the MediLedger platform or will the ledgers be used to show transaction data later, if needed? Will that be up to individual companies?

A: With the MediLedger platform, we anticipate manufacturers, distributors, health systems and pharmacies or any other party that could handle products to have access to data in a secure environment that does not allow visibility from unauthorized parties. Regulators would be able to request audits or request information, as needed, knowing those reports are authentic and reflective of data from across the supply chain. That is the promise of blockchain technology: to provide a platform where information, with the necessary context to interpret it meaningfully, can be shared securely.

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