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Showing posts with the label Critical Medicines Act

EU Pharmaceutical Supply Chain: How to Shrink Upstream Risk Without Shrinking Access

Europe’s pharmaceutical landscape is undergoing a significant change due to its medicine shortage problem, which has a stubborn root cause: fragile upstream links. The situation becomes apparent at the pharmacy counter, but it originates much earlier, at the level of raw materials, intermediates, and APIs, which are overwhelmingly sourced outside the EU. Recent audits and policy moves acknowledge this head-on; the European Court of Auditors (ECA) pointed out chronic shortages through 2024, driven by dependence on Asian suppliers and thin market incentives, as more than 80% of antibiotic APIs used in Europe are imported from Asia. Over the last 18 months, Brussels has moved from diagnosis to action. There’s now a Union List of Critical Medicines updated in December 2024, and HERA has published a vulnerability assessment for that list. In March 2025, the Commission proposed the Critical Medicines Act with tools such as strategic projects, stockpiling, and supply chain transparency. Mem...