At times like these I often think of an old movie from 1981 called “Modern Problems” which starred Chevy Chase as a hapless air traffic controller who faced problem after problem, some of which wouldn’t even have existed 20 years earlier. For some reason I can’t explain, I sometimes think of that movie when I’m about to click the “Publish” button on an essay. As soon as that button is clicked, my thoughts are instantly transmitted to the world (hundreds of people in the case of RxTrace) in a neat little package.
Almost immediately after clicking the Publish button on last Friday’s essay, “IBM Divests EPCIS and ePedigree Suite” I had thoughts of another possibility that IBM’s recent action might explain. Too late. My thoughts were already being read by people. A “modern problem”. Fortunately I can send this follow-up.
At the end of my last essay I said I had recently concluded that the jump to a fully automated pharma supply chain upstream visibility system is too big and complex to be achievable by every company in the U.S. supply chain by the California dates. I want to explain that statement in a future essay (soon), but before I do I want to explore some of the track and trace models that are being considered by both GS1 and the FDA. I particularly want to look at the viability of each model because I think we will find that some just aren’t (viable), and that will help narrow the search.
I’ll look at the three basic models that the FDA mentioned in their recent workshop: Centralized, Semi-Centralized and Distributed (or Decentralized as the FDA called it). There are others, but it seems that they can all be either based on, or reduced to, one of these three basic models.
In this essay I am looking at track & trace models from a global viewpoint, which is something that GS1 is doing but the FDA may not. Attacks on the pharma supply chain are a global problem and global problems demand global solutions or gaps will be left for criminals to exploit.
In this essay, I’m not going to discuss the attributes of a track & trace system from a regulator’s point of view. I’m not going to discuss input into the FDA’s Track & Trace workshop that occurs this week and I’m not going to speculate on the outcome of that meeting. Instead, I’m going to talk about the attributes of a track & trace application from the viewpoint of any global pharma manufacturer who is facing the regulatory mandates for serialization and traceability in a growing list of countries around the world, and from the viewpoint of any solution provider who is thinking about what they need to include in their solution offering so that those global pharma companies find it attractive enough to buy.
To those kinds of companies, the potential for new non-binding guidance from the U.S. is important, but perhaps less so than an increasing number of binding regulations from around the world. Whatever the FDA—and especially the U.S. Congress—may do in the future will be important when selecting a track & trace solution, but the U.S. is only one of the countries in the world and pharma companies that do business in those other countries do not have time to wait for the U.S. to figure out their approach before making investments.
Who owns supply chain visibility data? Does the manufacturer of a product retain any rights to track that product after it enters the supply chain? What if the product is a pharmaceutical and it is found to have a life-threatening defect? Should technology or standards availability play any role in answering these questions?
These kinds of questions come up occasionally in discussions of track and trace systems design when people talk about the future of “full supply chain visibility” and how easy recalls will be executed because of it. The implication is that the manufacturer of a drug will be able to perform a targeted recall because they will be able to see exactly where their product is in the supply chain.
But one could easily make the argument that it is no longer “their product” once it enters the supply chain. True, they invented, manufactured and labeled it, and in a recall situation we all have a strong desire for them to get it back quickly and efficiently, but that doesn’t change the simple fact that they don’t own it anymore. And if they don’t own the product anymore then they don’t automatically own the knowledge of where it is either.
I’m not a lawyer but it seems to me that once a product is sold the seller gives up all rights to that product. The buyer can do whatever they want to with it, within the law of course. Recalls that are necessary for reasons that might be life-threatening are special and supply chain members should do everything they can to find and return any item that is involved in a recall. But is it necessary for the manufacturer to have instant access to the location of all of the affected product?
Serialization and track and trace will allow all supply chain participants to know a lot more than they do today about the location of recalled items just using the data that they clearly own. Compared with today, an individual company will know very quickly if they have ever received, shipped or currently have in stock the recalled units. If they currently have them in stock they will be able to place an immediate hold on those items to prevent them from being shipped to a customer until they have been collected and returned. If they have previously shipped the items to a customer they will know exactly which customers were involved and which unit went where. But that’s it. The knowledge of what their customers might have done with those products once they receive them is not owned by the seller. Continue reading Who owns supply chain visibility data?→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.