Maybe I’m just hyper sensitive to all things blockchain right now, but it sure seemed like the topic of blockchain permeated the sessions and the halls at last week’s GS1 Connect conference, GS1 US’s annual membership event. Oddly, all of the official blockchain content was outside the Healthcare track. The technology is certainly applicable in all industries and apparently there is interest in it outside of the healthcare vertical within GS1 US. But what I observed there leads me to think we are very close to an important tipping point.
There were two sessions aimed squarely at blockchain—both were in the “GS1 Standards and Solutions” track. One of those was presented by GS1 US itself as a presentation of foundational principles. The other was a deeper dive presented by Microsoft (for more on Microsoft and Blockchain, see “Microsoft Unveils Project Manifest, A Plan For Blockchain Product Tracking” and “Microsoft’s Blockchain Supply Chain Project Grows to 13 Partners”). Both sessions were very well attended, to nearly the room capacity. The topic also came up in several of the hallway conversations I was a part of.
During the event, GS1 US also published (via Dropbox, of all places) a brief new point-of-view statement called “GS1 recommends use of existing data standards in enterprise blockchain implementations”. The title says it all…No, really. Once you’ve read the title, you’ve learned pretty much everything contained in the document itself. GS1 US seems to fear that blockchain is leaping off the launch-pad at record speed without them.
If that is what they’re thinking, they shouldn’t worry. In my observation, some of the companies seeking viable solutions to the 2023 tracing requirements of the Drug Supply Chain Security Act (DSCSA) have latched onto blockchain, and I don’t think they are likely to let go. Those companies are already solidly in the GS1 standards camp and so, if blockchain becomes the ultimate solution for the industry to meet those 2023 requirements, GS1 Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) will certainly fill a central role. Maybe GS1 US has something to fear in other industry verticals, but not pharma.
In my view, blockchain and EPCIS/CBV fit together like a hand in glove. What one is missing, the other has, and vice versa. That is, they are almost perfectly complementary. Blockchain is a way of sharing data amongst trading partners that includes trust-enabling security, but it does not care what that data is or how it is formatted. GS1 EPCIS and CBV are highly developed standards that specify a data architecture for documenting supply chain events, but they contain nothing about security or data exchange. Put the two together and you have a full industry data exchange architecture.
If the U.S. pharma supply chain members can come to an agreement that this architecture offers their best opportunity to meet the 2023 DSCSA requirements, then we can get on with designing a full industry specification and solution providers can begin work on actual solution offerings. I believe the effort that will help show the way for the industry is the one going on right now under the direction of the Center For Supply Chain Studies and led by GS1 and pharma traceability veteran Bob Celeste (see “Thank You Bob Celeste!”). The project is called “DSCSA & Blockchain” (see “Could Blockchain Technology Be Used For DSCSA Compliance?”).
It appears as though every major company in the computer software and services industry is jumping onto the blockchain bandwagon, and its use for shipment tracing is a top focus. Microsoft is not alone. My bet is that the pharma supply chain 2023 DSCSA problem will lead to the first major implementation of blockchain, and it will exceed the size and scope of Bitcoin (the original wide-scale implementation of blockchain technology). All of these major software and services companies will want to be a (or, “the”) leader in pharma supply chain blockchain solution offerings.
The problem is, these big companies may know a lot about blockchain technical theory, but none of them knows anything about the DSCSA, or more importantly, the pharma supply chain. What do big companies do when a new, potentially high growth business opportunity becomes obvious? That’s right, they buy a smaller company that already has the knowledge and expertise necessary to make it happen. So my next prediction is, we are about to see some (more than one) mergers and acquisitions of smaller, private equity-funded companies who currently offer pharma serialization and tracing solutions and expertise by big, publicly-held computer software and services companies. Who’s going to be first? Who’s going to be last?
FDA SPEAKS AGAIN
Dr. Connie Jung of the FDA spoke in the Healthcare track. This time she said that lots of work is happening at the FDA for DSCSA. She said we will see some of the results of those efforts “very soon“. Regular readers of RxTrace will recall that she said we would see something “soon” last year at this event (see “FDA Speaks At GS1 Connect“). And at the HDA Traceability Seminar in November she said the word “soon” again (see “HDA Delivers Home Run To Record-Breaking Audience“). So what does “soon” and “very soon” mean? We now know that “soon” means something like “more than one year from now”, but I’m not sure how to interpret “very soon”. I guess we’ll just have to keep waiting to find out.