ARLINGTON, Va. — The Healthcare Distribution Alliance (HDA), in coordination with the Center for Supply Chain Studies, announced the successful conclusion of an industry-wide pilot of an interoperable ‘authorized trading partner’ credentialing ecosystem to support the requirements of the federal traceability law, the Drug Supply Chain Security Act (DSCSA).

Pilot participants, other industry members and service providers who intend to adopt this model have launched the Open Credentialing Initiative (OCI), a user group that will publish frameworks, address recommendations, work on standardizing artifacts and explore other use cases.

‘This successful pilot is a testament to the hard work of the manufacturers, distributors and solution providers that came together to work through a complex traceability challenge and achieve an open-source solution to help enhance the safety and security of the U.S. pharmaceutical supply chain,” said Justine Freisleben, vice president, Industry Relations, HDA. ‘Leveraging the deep knowledge of our members, HDA is pleased to foster industry partnerships that help trading partners understand and comply with DSCSA implementation requirements.’

Launched in April 2020, the pilot brought together a cross-sector team of pharmaceutical supply chain stakeholders to test the use of decentralized identifiers and verifiable credentials to establish the DSCSA-defined authorized trading partner status of companies managing automatic product information verifications for saleable returns. The team included manufacturers, a wholesale distributor and dispensers, along with SAP, rfxcel, Spherity and Legisym, with support from GS1. The pilot expanded on a successful proof of concept to prove that W3C standards-based technologies could be used between manufacturers and wholesalers representing both direct and indirect trading partners supported by separate VRS solutions.

As noted by the team in the final report, the pilot demonstrated:

• Consensus roles and responsibilities of stakeholders;
• The due diligence necessary of credential issuers;
• Enforcement of compartmentalized access to signing capabilities and private keys;
• An architecture that employs existing verification router service solution and GS1 standards to process serialized saleable returns;
• The use and role of decentralized identifiers, verifiable credentials and verifiable presentations;
• The records necessary to support audits and investigations; and,
• The trustworthiness of the credentialing ecosystem to safely allow digital interactions between previously unknown companies.

‘I am sure the legislators who authored the DSCSA never could imagine how challenging it would be to determine the identity and authorization status of trading partners in a digital eco-system,’ said Bob Celeste, Founder, Center for Supply Chain Studies. ‘Fortunately, the manufacturers, distributors and solution providers were successful in piloting a design that fits from a compliance, business operations and technology perspective.’

While the pilot executed business procedures related to returns, results are scalable to verify the authorized trading partner status for other required interactions under the law. Based on open standards, the architecture for the solution can be implemented by any company, and the pilot team is working to share and execute a roadmap for industry-wide adoption.

Additional pilot materials are available through the Center for Supply Chain Studies website.

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