Pharmaceutical Commerce - June 2018 - 4
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VOLUME 13, ISSUE 2
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4 \ Visit our website at www.PharmaceuticalCommerce.com \ 06.2018
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
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.