The European Commission, the European Parliament and the Council of the European Union have reached a political agreement on the Critical Medicines Act, a major legislative push aimed at preventing medicine shortages and strengthening pharmaceutical supply chains across Europe.
The agreement comes as European countries continue to grapple with medicine shortages exposed by the COVID-19 pandemic, manufacturing disruptions and geopolitical tensions. The proposed law seeks to reduce dependence on a limited number of foreign suppliers, while boosting pharmaceutical manufacturing capacity within the European Union.
For India, one of the world’s largest suppliers of generic medicines and active pharmaceutical ingredients, the move signals a potentially significant shift in Europe’s pharmaceutical procurement and manufacturing strategy. The Act introduces measures that could increasingly favour manufacturing within the EU for certain critical medicines.
Under the proposed legislation, EU member states will be required to diversify medicine supply chains during public procurement procedures. For medicines considered critical, contracting authorities will have to prioritise reliable and diversified supply sources. In cases where the EU is heavily dependent on one or a few third countries, the law goes further by requiring authorities to favour “manufacturing in the EU”.
The legislation also proposes the creation of Strategic Projects aimed at expanding or modernising EU manufacturing capacity for critical medicines and their active substances. These projects will receive easier access to national and EU funding, along with fast-tracked administrative support. Orphan medicines, used for rare diseases, will also benefit from faster permitting processes.
The European Medicines Agency welcomed the agreement, calling it an important step towards strengthening the resilience, security and sustainability of Europe’s critical medicines supply.
“At a time of increasing global disruptions, resilient and secure supply chains for critical medicines are essential to protect public health across the EU,” EMA Executive Director Emer Cooke said in a statement.
The legislation also introduces new rules around contingency stocks. If member states require companies to maintain emergency medicine reserves, they must ensure such measures do not negatively affect supplies in other EU countries. Countries will also have to share updated information on stockpiles available for redistribution during emergencies through a Voluntary Solidarity Mechanism.
Another key provision allows collaborative procurement among EU member states to address disparities in access to critical medicines, orphan drugs and other medicines of common interest.
The law additionally opens the door for strategic partnerships with international partners to broaden supply chains and reduce overdependence on limited suppliers.
The EMA said the Critical Medicines Act complements broader reforms to the EU pharmaceutical framework adopted earlier this year. Together, the reforms aim to strengthen Europe’s pharmaceutical resilience while ensuring medicines remain safe, effective and accessible.
As part of preparations for implementation, the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products is already evaluating vulnerabilities in supply chains linked to medicines listed under the Union’s critical medicines list. The list currently includes more than 200 active substances considered essential for healthcare systems across the EU.
The agency is also expanding the European Shortages Monitoring Platform, a digital system designed to improve data-sharing between regulators and industry on potential medicine shortages.
The political agreement now awaits formal approval from the European Parliament and the Council before the legislation can come into force.
