With positive momentum building on plans for the second half of 2025, European Union legislators have taken an important step towards introducing a new regional framework focused on expanding supplies of critical medicines and resolving potential drug shortages.
According to an announcement on May 12, the Council of the European Union and the European Parliament have reached a tentative agreement on this regulation, allowing the European Union to move forward with its proposed Critical Medicines Act (CMA).
The framework, which still needs to be finalized and formally approved by the EU Council and Parliament, was introduced last March to avoid shortages of medicines such as antibiotics, insulin and painkillers by boosting local manufacturing, diversifying Europe’s supply chains and encouraging greater cooperation between member states.
The agreement is broken down into changes to the EU’s public procurement procedures, joint drug procurement initiatives, contingency stock safeguards and access to orphan medicines within the EU.
Much of the framework revolves around prioritizing the manufacturing of medicines and their active ingredients in the EU, reducing the group’s dependence on non-European countries such as India, China and the US, while also requiring countries to consider the resilience of supply in their procurement plans.
The bloc also aims to ease the burden on member states to jointly request medicine supplies, with European countries also being asked to more transparently share information on emergency stockpiles of medicines. The CMA also introduces measures for countries to reallocate products to other EU member states “on a voluntary basis” if necessary, according to a statement from the European Council.
The European Medicines Agency said it welcomed the agreement.
“Resilient and safe supply chains for critical medicines are essential to protect public health across the EU amid increasing global disruption,” EMA executive director Emer Cooke said in a statement on Tuesday.
He added: “Today’s interim agreement on the Essential Medicines Act is an important milestone towards strengthening Europe’s capacity to improve the availability, supply and production of essential medicines.”
The EMA issued a warning over both the coronavirus pandemic and recent geopolitical tensions that have exposed vulnerabilities in Europe’s pharmaceutical supply chains. Recent disruptions have come in the form of pressure on pharmaceutical supply chains resulting from the United States and Israel’s ongoing war with Iran, in addition to threats of import tariffs by the second Trump administration.
As part of the CMA implementation process, the EMA’s steering group on medicines shortages and supply, MSSG, is conducting a supply chain vulnerability assessment, focusing on an initial roster of more than 200 products included on the EU’s Critical Medicines List, the agency said.
The CMA framework works in conjunction with another proposal to reform the EU’s medicines law, colloquially known as the ‘medicine package’.
In December, the Council of the European Union and the European Parliament similarly agreed on a framework for medicines law, following a negotiation process that tweaked the plan first introduced in 2023.
The Pharmaceutical Framework, which has sometimes drawn opposition from the pharmaceutical industry, aims to streamline the region’s regulatory ecosystem, better support intellectual property protection for innovative medicines, avoid shortages and broadly improve the EU’s competitiveness in life sciences.
