EU agrees plan to tackle essential medicine shortages

Lawmakers in the EU have reached a provisional agreement to strengthen the bloc's critical medicine supply chain and avert the risk of shortages amid rising geopolitical tensions.

The Critical Medicines Act (CMA) was voted through last night by the Council of the EU and European Parliament and sets out a framework for diversifying supply chains and boosting manufacturing within the EU. The legislation still needs to be finalised by the two assemblies, but reaching an agreement makes that formal approval highly likely.

It comes as global supply chains are being hit by the war in Iran, which has affected the supply of materials used in the manufacture of pharmaceuticals, as well as other medicinal products used in their manufacture, such as syringes, intravenous bags, and personal protective equipment (PPE). At the same time, Europe is contending with disruption and uncertainty resulting from President Trump's capricious use of tariffs as a political lever.

The CMA has been welcomed by EMA director Emer Cooke, who said that "at a time of increasing global disruptions, resilient and secure supply chains for critical medicines are essential to protect public health across the EU."

The EMA noted that the EU has faced serious medicine shortages in recent years, notably during the COVID-19 pandemic, but the issue has become a recurring concern. One recently published study revealed that 136 medicines had been recorded as being in short supply by member states between January 2022 and October 2024 – a record level.

The CMA will sit alongside the EU's recently agreed pharmaceutical reform legislative package, which aims to introduce a simpler regulatory environment for medicines in the EU, provide more support for innovative new therapies, reduce the risk of medicines shortages, boost environmental protection standards, and tackle antimicrobial resistance.

Under the CMA, member states will have to "diversify and incentivise" resilience in medicine supply chains during public procurement procedures – in other words, to reduce their reliance on overseas suppliers and introduce an obligation to favour EU-based manufacturing when awarding contracts.

The plan also includes a provision to create "strategic projects" to modernise EU-based production of around 270 critical medicines and the ingredients needed to make them, with EU funding, and a collaborative procurement framework for member states. And in a nod to evolving global political relationships – with the EU forging closer ties to other countries, including Canada and Japan, as the US upends decades of the status quo – the CMA includes a clause to forge "strategic partnerships" with international partners.

Member states that require companies to hold contingency stocks will have to ensure that this does not negatively affect the supply of critical medicines in other countries in the EU.

"Today's agreement comes at a crucial moment, when the vulnerability of supply chains is so clearly exposed," said Olivér Várhelyi, EU Commissioner for Health and Animal Welfare.

"The Critical Medicines Act is Europe's essential safety-belt: preventing shortages, reducing dependence on single suppliers, and strengthening production closer to home to safeguard public health," he added.

"Patients in the EU must have access to the medicines they need, when they need them, and today's Act will help to make it happen."