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Countless Hollywood movies present the film’s heroes trapped in some dire circumstance, with hope fading, only to be saved by the arrival of reinforcements/allies/best buddies at the very end. Something of the same scenario is playing out with blockchain as a method of securing pharma supply chains. “Protecting the supply chain” is a stated goal of the US Drug Supply Chain Security Act (DSCSA), now five years old, and Falsified Medicines Directive (FMD) of the European Union. Both have near term deadlines; both have had delays in implementation; and both have significant obstacles to full implementation.
In the case of FMD, what looked like a streamlined “bookend” approach (authenticating product integrity at the beginning and end of the supply chain—manufacturer and dispenser—and gliding over the intermediaries) is showing unexpected complexity; only a handful of nations in the EU are ready for the February 2019 start date.
With DSCSA, the barcoding part is well along—a significant investment on the part of industry—but there are growing concerns over how serialized product data are to be shared and accessed. FDA hints at a central repository of all US information; industry is pushing for some type of “federated” system where each manufacturer’s data is accessible via some sort of switching point (the Origin database, proffered by the Healthcare Distribution Alliance, is a partial solution here).
Blockchain has been talked up for about two years now as a way to address the data-sharing issues, but the problem is that while technical issues are gradually being addressed, “governance”—who will manage such a network, and how parties can be explicitly included or excluded from the network—remains little more than a talking point.
A possible near-term outcome is for highly restricted blockchains to be set up around, say, a particular group of drugs, or a segment of the supply chain such as specialty pharmacies. We’ll be watching for such networks to arise, while keeping a (worried) eye on continued DSCSA and FMD progress.