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Organizations will collaborate on a proposed GS1 standard
After a lot of legal huffing and puffing over a “conspiracy” and a claim of $30 million in damages, TraceLink has withdrawn its antitrust lawsuit against the Healthcare Distribution Alliance, filed in October. In federal court, the litigation had only got to the point where a judge would rule on the first wave of objections by HDA, which claimed that TraceLink’s suit was a misreading of antitrust law.
A joint news release states that the parties have “resolved the misunderstandings that led to their dispute,” and that they “will work together with other industry players to propose interoperable standards and guidelines for pharmaceutical product master data” to the GS1 organization, which has already defined many of the standards for product data exchange. Such a standard appears to be a new element in the ongoing evolution of software and business practices for compliance with the Drug Supply Chain and Security Act (DSCSA). DSCSA has a nominal go-live date of November 2023, with interim milestone capabilities to be met as well.
TraceLink’s suit began after HDA launched (with the help of a software and data services vendor, ValueCentric) the Origin data service. Origin is meant to be a master data repository of the identifying codes of pharma products (specifically, the Global Trade Item Number—GTIN—which had been defined by GS1). TraceLink offers a comparable service within its Life Sciences Cloud; however, that service is part of an overall DSCSA compliance program, whereas Origin is akin to a dictionary where trading partners would look up product codes.
The capability of a manufacturer to load the same data into both services exists and, with yet-to-be-established business agreements, to share the data could be established; however, there appears to be a need for an API to enable data in one repository to be accessed by the other. That’s where a GS1 standard could be helpful. But much of this data-sharing awaits guidance from FDA on how it expects hundreds of manufacturers, and thousands of distributors, pharmacies and healthcare organizations to store and retrieve product data. Based on recent FDA public workshop discussions, industry is looking for a federated system of multiple repositories that would communicate with each other; FDA is leaning toward a central repository. (In Europe, where the pharma supply chain must comply with the EU’s Falsified Medicines Directive by 2019, each nation will nominally have its own central repository.)
HDA is a trade association dominated by the Big Three wholesalers; TraceLink is a privately held IT company whose software is now in use (according to TraceLink) by some 400 trading partners in the US and abroad. Although the organizations are making nice-nice now, it remains to be seen whether they (and other vendors and industry participants) will be able to come together on a GS1 standard in time for 2023 compliance. Meanwhile, the relatively straightforward processes of creating a GS1-compliant GTIN, and slapping a readable barcode on pharma packages, appears to be their own challenges; a recent GS1 report (based on data from McKesson and AmerisourceBergen) points to low compliance levels on both issues.