Strategic autonomy of the pharmaceutical supply chain is essential to the sustainability of patient care in the U.S. and the EU.

The COVID 19 crisis has further exacerbated the structural problem which has been building up throughout the recent decade. The fact that many APIs can only be sourced outside the U.S. and Europe and that the production of some drugs (e.g., injectables) was exited years ago due to low sustainability of margins, left both continents with limited supplies of some specific but vital drugs.

In the past 12 months, this situation has become a growing concern and a priority for the United States administration and the European Commission who both decided that the best way to address it would be to re-shore the manufacturing of essential pharmaceuticals. This is best illustrated by the EU Commission’s “New Industrial Strategy: building a stronger single market for Europe’s recovery“ issued last May and the U.S. White House report on Building Resilient Supply Chains issued this month, in addition to the Pharmaceutical Strategy . These two policies are very similar in their conclusions that it is essential to re-shore the production of critical APIs and drug products respectively in the EU and the U.S. and secure a robust and resilient pharmaceutical supply chain.

Key components of the supply chain (APIs, excipients and precursors, as well as primary packaging such as vials or capsules) need to be part of a global trade of products which comply with the strictest and highest quality, security and environmental standards.

Such a coordinated action would also entail the need to reinforce controls and inspections on non-U.S. or non-EU manufacturing sites.

Read our full joint press release.