EU advances scheme to bolster manufacturing autonomy, avert drug shortages

After positive momentum on the plan in late 2025, European Union lawmakers have taken a critical step toward implementing a new framework for the bloc focused on boosting supplies of critical medicines and navigating potential drug shortages. 

The EU Council and the European Parliament have reached a provisional agreement around the regulation, pushing forward the union’s proposed Critical Medicines Act (CMA), according to a May 12 release. 

The framework—which must now be finalized and formally approved by the EU Council and Parliament—was introduced last March in a bid to avert shortfalls of drugs like antibiotics, insulin and painkillers by bolstering local manufacturing, diversifying European supply chains and fostering greater cooperation between member states. 

The agreement is broken down across changes to EU public procurement procedures, collaborative drug procurement efforts, contingency stock safeguards and the bloc’s access to orphan medicines. 

Much of the framework revolves around prioritizing EU manufacturing of drugs and their active ingredients, reducing the group’s reliance on countries beyond Europe, such as India, China and the U.S., while also tasking countries with weighing supply resiliency in their procurement plans. 

The bloc also aims to lessen the burden on its member states to make joint requests for medicine supplies, and European countries are also being pushed to share information on their contingency stocks of medicines more transparently. The CMA also introduces measures for states to reallocate products to other EU members, when necessary and “on a voluntary basis,” according to the European Council’s release. 

The European Medicines Agency said it welcomed the agreement.

“At a time of increasing global disruptions, resilient and secure supply chains for critical medicines are essential to protect public health across the EU,” Emer Cooke, EMA’s executive director, said in a Tuesday statement. 

He continued, “Today’s provisional agreement on the Critical Medicines Act marks a significant milestone towards strengthening Europe’s capacity to improve the availability, supply and production of critical medicines.”

The EMA flagged both the COVID-19 pandemic and recent geopolitical tensions that have exposed vulnerabilities in Europe’s pharmaceutical supply chain. Recent disruptions have come in the form of the second Trump administration’s import tariff threats, plus pressures on drug supply chains stemming from the U.S. and Israel’s ongoing war with Iran. 

As part of the CMA implementation process, EMA’s steering group on drug shortages and supply, MSSG, is conducting supply chain vulnerability assessments, focusing on an initial roster of more than 200 products included on the EU’s critical medicines list, the agency said. 

The CMA framework will work in tandem with separate proposals to revise the EU’s pharmaceutical legislation, known colloquially as the “pharmaceutical package.” 

In December, the EU Council and European Parliament similarly agreed on the pharmaceutical legislation framework after a negotiation process that made tweaks to the plan first introduced in 2023. 

The pharma framework, which has at times drawn pushback from the industry, aims to streamline the regulatory ecosystem in the bloc, better support IP protections for innovative drugs, circumvent shortages and broadly make the EU more competitive in life sciences.