The lack of simple, standard, low cost product master data synchronization threatens to derail the industry’s general consensus-plan to use GS1’s Electronic Product Code Information Services (EPCIS) as the basis of the interoperable electronic data exchange to meet the 2023 requirements of the Drug Supply Chain Security Act (DSCSA) (see “HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS”). This is probably why the Healthcare Distribution Alliance (HDA) tried to get out in front and offer their Origin master data synchronization service last year (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”). And it likely underlies why TraceLink filed a lawsuit against HDA a few months later (see “Tracelink vs. HDA” and “What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data”, and also see the standard disclaimer below). That lawsuit has since been settled out of court.
Without everyone holding the identical product master data for every drug they might receive, EPCIS messages used to document DSCSA transactions will need to carry that master data. That would induce a heavy load on everyone in the supply chain. Each EPCIS Commission event would need to include a copy of the product master data. This would require lots of duplicate data being passed and retained throughout the supply chain.
What we need is a simple, standard and low cost way for drug manufacturers to publish their product master data so that any authorized member of the supply chain who might receive their products can obtain a copy of that data in advance. That way the drug manufacturer would not need to include that duplicative master data in every EPCIS Commission event, and thus significantly reduce the volume of data being passed from sellers to buyers as part of every downstream transaction involving their products. In short, simple, standard, low cost master data availability is what will enable the use of EPCIS events for meeting the DSCSA in 2023.
Today, GS1 offers the Global Data Synchronization Network (GDSN) standard for formatting supply chain master data and the publish/subscribe data exchange architecture that allows manufacturers to publish their product master data and allows distributors and retailers to subscribe to that data (see “An Open Letter to GS1, RE: GDSN Marketing” and “Before You Sign Up For GDSN, Get Your Data In Order With A Data Quality Program”). The only problem is, GDSN is not simple and it is not low cost. In fact, it is “middle-man heavy”, requiring companies known as GDSN Data Pools to help end-user companies get it to work and to provide value-added services. This is fast becoming an archaic model.
I my view, GS1 should immediately redesign GDSN around blockchain. Larger manufacturers, wholesale distributors and dispensers/retailers could bypass the middle-men (data pools) because they would provide their own expertise. They would choose to fill the role as a GDSN blockchain “node” to publish and subscribe to raw GDSN standard formatted data traffic. By eliminating the requirement for the middle-men for end-user companies large enough not to need them, costs would be stripped to the bone. Smaller companies who need the value-added services and expertise offered by the GDSN Data Pools would continue to subscribe through those organizations, helping to simplify their participation. I assume GS1 or their Member Organizations (MOs) have contracts with the GDSN Data Pool companies that might prevent this kind of “opening up”, so there is slim chance something like this will happen.
Another way to do it is for HDA Origin to adopt this approach, using GS1 data formatting standards other than the full GDSN architecture. But since Origin is already defined as a middle-man approach, unless they are willing to radically shift their business model, there is slim chance this will happen.
Other profit-based companies may try to corner the market on supply chain master data—even using a private blockchain approach—and use it as a wedge against their competitors. I enjoyed reading Scott Pugh’s recent essay, “Blockchain: Grounded Optimism”, particularly where he says,
“We also can’t deny that some of the more traditional track and trace vendors don’t want to see blockchain in pharma succeed (despite what their marketing might say) for the simple reason that the benefit of blockchain—providing a connected ecosystem for the exchange of traceability data between disparate organizations—strikes at the very heart of the singular perceived benefit which millions of dollars has been spent promoting.”
I recommend reading his full essay. I don’t fully agree with everything Scott says in his essay, but this sentence reflects exactly what I’ve been thinking lately. Glad to see him beat me to publishing that sentiment. I fear that vested interests and previous big investments by vendors will end up blocking the introduction of simple, standard and low cost master data exchange—whether using blockchain or something else—and that could result in a collapse in the ability of EPCIS to be used to meet the DSCSA 2023 requirements.
Up to this point I’ve only been talking about product master data. I’ve left company, trading partner and location master data out of my discussion, but a comparable problem exists with it too (see “GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance”). The industry needs to solve these problems fast or we’re all just wasting our time.
F, F, F, FULL DISCLOSURE
In the interest of full disclosure when mentioning the former lawsuits of friends in a competitive environment, the reader should be aware that the author is currently employed by Systech International, a competitor of TraceLink in one product area. Systech International is currently a solution provider member of the HDA. Back in 2007 and 2008 the author was employed by SupplyScape, the predecessor company to TraceLink and run mostly by the same people. From 2002 to 2007, and then from 2008 to 2012 the author was employed by Cardinal Health, one of the “Big 3” wholesale distributors who is an important member of the HDA. During 2013 and 2014 the author’s own consultancy was a solution provider member of HDA. The author has also been a long-time active member of GS1 and GS1 US. RxTrace is wholly owned by Dirk Rodgers Consulting, LLC and is not owned or controlled by any other company.