The MediLedger Project

Building an Open Network for the Pharmaceutical Supply Chain

2017 progress report

Compliance with track and trace regulations.

Patient safety and drug supply security. 

Easier reconciliation of exceptions.

Extensible platform for business transformations. 

Open specification.

Based on the blockchain.

For Trading Partners

Meeting the spirit of the law with a platform that allows the verification of each EPCIS message like it was a financial transaction does not simply deliver a new level of safety for patients but establishes a new platform for trading partners to transform their businesses. The transactional aspect allows to further optimize the supply chain with exception handling and reimagined business processes.

For Solution Providers

The open specifications allows solution providers to plug-in their products into this GS1-complaint ecosystem. The exchange of messages becomes a simple task over the network. The extensibility of the platform will also allow solutions providers to create new business solutions that leverage the established network.

For Regulators

While respecting the sensitive nature of the data of the trading partners, regulators access to critical information for investigating events is streamlined via automation with the additional benefit that data provided by trading partners is fully verifiable against the cryptographically secure ledger based on the blockchain.

About Us

The MediLedger Project was started in 2017 by Chronicled to bring together leading Pharmaceutical Manufacturers and Distributors to explore blockchain technology to meet track and trace regulations, and to provide a step function improvement in the overall operation of the supply chain.

Our intention is to create a permissioned blockchain network for the pharmaceutical industry based on open standards and specifications. Nodes will be distributed - operated by industry participants and technology providers who serve the industry. This is possible due to solving the data privacy - business rules can be enforced, but no business intelligence is shared on the blockchain.

We believe this will create a rich, open development environment focused on delivering innovative services to the industry that current technologies can not offer.

why?

Problem Statement

Unit-level serialization requirements of the Drug Supply Chain Safety Act (DSCSA) go into effect this year to improve drug security, but lack controls to prevent counterfeits and protect patients.

Next year saleable returns requirements mean that pharma distributors will need to verify a returned product’s authenticity before they can resell it. Annually, there are ~60M drug units returned by dispensers and currently, there is no simple, fast way for the distributors to contact the manufacturer to verify the product.

By 2023 the law requires that all prescription drugs can be tracked and traced through the supply chain using an interoperable system. However, there is no defined interoperable system today.

The FDA is looking for the industry to develop their own solution. Existing solutions are designed to meet today’s regulation, but do not have interoperability.

WHAT?

The Opportunity

To deliver an interoperable system leveraging blockchain technology that enables a trusted consortium of drug manufacturers, distributors, and dispensers to:

  • Reduce cost  and effort of regulatory adherence while improving security and improving public safety.
  • Stop the counterfeit / adulterated product from entering the US supply chain.
  • Improve overall business operations of the pharmaceutical supply chain.

HOW?

The Solution

We have brought together industry leading companies to establish vision and a path forward in two distinct areas:

Industry Vision
How could a blockchain platform be established for the Pharma supply chain? How could it operate to maximize participation, and how can an open system architecture deliver a competitive market for companies to deliver services to industry? Ongoing work is defining the governance and structure of the network, with applications going live Q3, 2018.

Technology Development
We have identified industry’s requirements to meet track and trace compliance, as well as operate in a shared ecosystem. Interest is growing on what processes can be improved with an industry-wide network recording the change of ownership of prescription medicines.  We are working to deliver solutions to demonstrate the value blockchain solutions can add to the existing solutions industry has today.

Our current focus:

  • Saleable Returns
    2019 requires all saleable returns must verify that the serial number is authentic. We are creating a dynamic global look-up directory on the blockchain to allow companies and service providers to easily identify the electronic addresses they need to query to verify the serial number.
  • Exception Management
    As inventory is moved using serial numbers, industry needs a solution that can reconcile exceptions based on available data automatically.
  • Interoperable DSCSA system
    We know the future is a system that verifies and authenticates medicine with each transaction. Our blockchain solution will enable improved supply chain security: no illicit product can enter the trusted network, or if it tries it will be identified. Investigations and recalls will be fast and accurate.
  • Financial Processes
    Now that we have a record of change of ownership for prescription medicine, can we automate all the financial transactions associated with it?  Blockchain is designed for automated payments - the complex world of drug reimbursement can be vastly improved.
  • Chain of Custody
    In the new world of personalized medicines, the need to have improved chain of custody of medicines is not only required by regulators, but is a matter of life and death for critically ill patients.  Blockchain can provide an immutable record of custody, as well as ensuring all business rules are enforced for each step the drug takes.

Pharma Industry Working Group

We know that the real value in industry will come with widespread adoption of blockchain technology, working on a common platform to provide true interoperable capability that never existed before. We are excited to have brought together a consortium of leading drug manufacturers and distributors to drive the industry conversation of solutions that can allow the industry to operate together in one system.

Our 2017 Pilot Goals and Accomplishments

In 2017, we embarked on a journey to help key thought-leaders in the Pharma supply chain understand blockchain and explore what this technology could do that current technology solutions could not address.  We built proof of concept systems to demonstrate that we could record the change of ownership of prescription medicines in a way that leaked no business intelligence to participants, but was still able to enforce the business rules:  e.g. this serial number is authentic; this drug comes from the Market Authorization Holder; no serial number can exist in the system more than once;  this drug is being sold to me from the current rightful owner.

We are excited by the progress we have made, and are continuing our work in 2018 to establish the MediLedger Network and start launching commercial decentralized applications (DApps) to serve the industry.

Our 2018 Working Group Goals

Establish the framework for MediLedger: a permissioned blockchain ecosystem for the Pharma supply chain:

  • Establish the distributed MediLedger network of nodes.
  • Establish the MediLedger governance.
  • Drive structure of industry blockchain platform, including standards, functionality, business priorities.

Continue to provide guidance/influence on the requirements  and direction of DSCSA and related product solutions.

  • Ensure company specific requirements are included in design.
  • Opportunity to test data/product ownership transfer between partner companies.
  • Opportunity to establish nodes and gain experience through node management Service Provider Integration.

Service Provider Engagement

  • We believe that service providers to the industry are critical to the operation and growth of the MediLedger platform. We are providing the standards and schema for our system as open source for use in this network to help grow and foster a community of developers who want to innovate in the pharmaceutical industry. We know blockchain solutions can improve operations in ways that current technology can not - combined with service provider’s understanding of their customers, we feel the opportunity to transform the pharmaceutical supply chain is here. We are bringing together service providers in 2018 to establish who wants to participate in creating and growing this ecosystem.

We are in discussion with additional companies to join our 2018 working group as well as service providers who want to participate in our network - please contact us if you would like further information.

Team

MediLedger is supported by the Pharma supply chain expertise as well as  software, engineering, product, IoT, and applied cryptography teams at Chronicled.