How to Navigate the Reshoring of Pharmaceutical Manufacturing

In recent years, geopolitical and economic trends have been encouraging pharmaceutical drug manufacturers to shift their active pharmaceutical ingredient (API) sourcing and physical manufacturing plants onto domestic soil or near-shore locations. This has been a gradually turning tide that accelerated this year due to the COVID-19 pandemic and, in its wake, a presidential Executive Order requiring all essential medicines to be manufactured within the United States. While the U.S. Food and Drug Administration (FDA) has not yet disclosed the list of essential medications, it has become apparent that having a strategy for the reshoring of pharmaceutical manufacturing is crucial.

There are also intellectual property (IP) protection advantages when reshoring manufacturing, as limitations in international IP laws expose protected proprietary knowledge to infringement. The strength and protections afforded by U.S. IP laws are far more developed, and there is substantial jurisprudence by the U.S. courts in determining whether there is a violation of IP rights. Even remedies of IP infringement tend to be higher in the United States than most other jurisdictions. Lastly, with the increased demand on production, coupled with the fluctuations in the supply chain, manufacturers are likely to experience potential delays.

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