Dave Mason, Supply Chain Compliance and Serialization Lead at Novartis is to contribute to the panel entitled Futureproofing Pharmaceutical Supply Chain Security on Tuesday, September 14 starting at 6:00 pm at EIC 2021.
To give you sneak preview of what to expect, we asked Dave some questions about this panel.
So what is going on in United States is there's a rule called drug supply security act. It is one of the only serialization acts in the world that requires change of ownership. It's not a dispense model like in the EU where you just, you scan it at the pharmacy and verify the serial number. In the US, you have to exchange data between your supply chain partners and also they can make requests, asking for the validity of the serial number or batch number or expiration date. So what we're looking at here is we need some kind of electronic or digital system to verify the players in the DSC systems. They are who they say they are their authorized training partner. And then in the US and authorized trading partner, somebody with a valid state license or FCI, that's FDA, facility establishment ID. And that's mainly for manufacturers.
What Novartis is doing to meet and secure the supply chain and comply with DSE ESA. There are several attributes. We are putting a serial number on cases and sellable units and aggregating. We are implementing a VRS system through SAP, which is a wholesale sellable returns where the wholesaler can request if the serial number, the expiration date, the batch number of G10 or authentic, that is going to be expanded to other entities in the supply chain towards 2023. And especially to partners that are indirect. And what we need here is to do this is credentialing digital ID because what's happening here is I'm getting a request from somebody for a verification, or I'm sending product out and it's called cash to order. And I have to verify that who I'm sending that product out to has a valid state license.
So what we're doing to use this, digital ID is we're putting it in, embedding it in our systems with the cooperation of SAP and other supply chain partners. So, we can secure the network because it's a distributed network. It's not a centralized database, it's a distributed network. So we need to know, as we communicate with 70,000 supply chain partners, who you are, are you saying who you are and are you an authorized trading partner? So that's how we're building out to secure the supply chain, not just to meet the doc USA requirements, but to assure that Novartis is sending product to, to the correct individuals and that they're not bad actors.
Yeah. So what we will do is we will discuss how we built out digital ID for VRS and with SAP at other supply chain partners with other service providers in that work in the United States, we will talk about what we currently are doing in piloting, and we're now going to our production model. And also we have four service providers who had cooperated through OCI to build an inoperable credit digital ID system and where it also can be expanded in the future, like order to cash and maybe other opportunities for 2023 and at what the importance of this is, and also why we did it. We'll find out is that we were using and other methods to identify partners. And that was not sufficient. We were finding that there was no registrations that, uh, people who are using them were not the people who said they were using them. So we will go through all that in this panel and show the importance of digital identity.