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The future of healthcare supply chain security

We know more about how healthcare supply chain security will work in 2024 than looking forward in any previous 10-year period.

Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work in 2024 than looking forward in any previous 10-year period.

In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in 10 years. These include:

In the U.S.

• The FDA Safety and Innovation Act (FDASIA)
•The FDA Unique Device Identification final rule (UDI)
•The Drug Supply Chain Security Act (DSCSA)

In the E.U.

•The Falsified Medicines Act (FMA)
•The Harmonized Unique Device Identification Framework
•The anticipated Delegated Acts related to the FMA

Most of these laws and regulations deal, at least in part, with the identification of drugs and devices in a security context in the two largest markets for those products in the world. 

Author Mark Davison recently discussed transatlantic alignment in the near term as the result of some of these new laws, but I want to look even farther out. By 2024, all of these laws will be fully operational. What will these supply chains look like then? Here are my predictions.

Reaping the benefits of standards

Drug and device manufacturers will be able to harmonize the identification of their products using standards that are recognized in a large portion of the world. The application of GS1 standards in pharmaceuticals extends well beyond just the U.S. and the E.U. so that supply chain will experience the greatest harmonization. 

The mix of GS1 and HIBCC standards in the device supply chain will likely continue in some parts of the globe but at least companies should be able to choose one or the other for all of their products based on where those products are marketed. So even though the world may not harmonize around one set of standards, a given company should be able to.

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