Lots of people have been talking lately about what interoperable data exchange in the US pharma supply chain will look like after the Enhance Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) takes effect in November 2023 (see “Does Interoperability Change In 2023?”, “5 Myths About The DSCSA In 2023” and “Interoperability And The DSCSA”).
Increasingly, I’ve heard the opinion expressed that there will surely be multiple approaches adopted for exchanging data, and so it will be necessary for all of those approaches to be made interoperable with each other. Proponents of this idea claim it is unrealistic to expect a single approach to be accepted by all companies in the supply chain and therefore, having to deal with multiple approaches is inevitable. This kind of talk makes me nervous. Here’s why.
I am not a proponent of the multiple interoperable approaches to data exchange idea and I fear it originates from vendors who are eager to begin selling EDDS systems now—to lock their customers down with an approach to data exchange that favors that vendor. If you’re one of these vendors—or one of their customers—and you hear people talking about viable approaches that are not favorable to your current approach, then maybe the best you can do is convince everyone that a single approach to data exchange will never occur. That is, if some other approach is offered by competitors, they will have to ensure that your customers can interoperate with the alternate approach.
You can see this happening already with the Verification Router Service (VRS) initially defined by the Healthcare Distribution Alliance (HDA) (see “First Meeting of the HDA Verification Router Service Task Force” and “GS1’s Messaging Standard For Verification Of Product Identifiers”). I’m aware of at least two, and possibly three, different technical approaches to implementing the VRS functionality. At least one of those approaches is based on blockchain (see “Could Blockchain Technology Be Used For DSCSA Compliance?”, “Blockchain Reigns At GS1 Connect 2017” and “Blockchain Will Not Be Used For DSCSA Data Exchange”).
To make these different approaches interoperate, someone must create a “gateway” that will allow messages originating under one implementation to work with the other implementation. The more approaches there are in implementations, the more gateways that must exist to ensure interoperability across the supply chain. Gateways add complexity, increase response time and can add dangerous “brittleness” to the operation of the supply chain. In fact, the only desirable thing gateways of this type add to the supply chain is to allow choice in implementation approach. Absent a mandate by a governing authority of a specific approach, gateways are likely to occur, as they are in the solutions offered for the VRS.
I think today’s VRS architecture will be less complex than the full data exchange architecture necessary to meet the requirements of the EDDS. Don’t look to the FDA to mandate a specific approach (see “DSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific Technology”). If we end up with multiple technical approaches to that data exchange, we could see the use of gateways in that architecture as well. In my view, that would be unfortunate.
In comparison, look at the Falsified Medicines Directive (FMD) system of repositories in the EU. One design. No gateways. As I’ve pointed out before, that’s what happens when the regulation includes a mandate for the creation of a governance organization with the authority to specify the technology that everyone must follow (see “A US Medicines Verification Organization (USMVO)?”).
Back in 2015, Rx-360 published a Traceability Data Exchange Architecture white paper that was aimed at establishing an industry group similar to the EMVO to create a data exchange architecture for the industry to meet the DSCSA EDDS (see “InBrief: The Rx-360 Traceability Data Exchange Architecture White Paper”). At least, that was my impression of it. It was a noble effort, but unfortunately it seemed to die shortly after publishing and their paper appears to be no longer available.
Are there any industry efforts like that going on today? If there are, they are currently hidden or private. Hopefully the industry pilots being organized right now in response to the FDA’s pilots RFP will jumpstart a governance discussion this year (see “FDA Announces Start Of DSCSA Voluntary Piloting Program”). But even then, it may be a pipe dream to think that we will ever get everyone in the supply chain to agree on one technical approach. In that event, the one thing you can be sure of is that there will be lots of choices—and probably lots of gateways.
One thought on “DSCSA: Interoperable Data Exchange In 2023”
Dirk, I agree with you….
And the term “gateway” will become something that, non-technical, people think is a viable approach. “Just build a gateway!”
Even with VRS, there’s still no evidence (testing) that the gateway will work, and if it does, will it deliver reliable, sub-second, responses? I have my doubts.
The more complex a technical solution is, and the more technologies that are part of that solution, the more failures WILL occur. Technical failures, when it comes to DSCSA, WILL impact patients access to life saving drugs.
I’m hopeful that we don’t end up with multiple methods, but it might happen. That’s fine, but we must acknowledge that multiple methods will drive costs, and risks, into the supply chain that wouldn’t exist if we all aligned on a method and technology.
Hopefully the trading partners, who have the burden of cost, compliance, and risks, can lead the conversation vs. the technology providers.
Comments are closed.