Expired medicines: the challenge of securing critical medicines for Europe

In March, two days before the European Commission put forward its proposal for the Critical Medicines Act, 11 European health ministers argued that Europe’s outsized dependence on imported critical medicines is the Achilles heel of the bloc’s collective security, not just a matter of public health concern. With imports from Asia, and particularly China, accounting for over 40% of the European Union’s medicines and 80% of the active pharmaceutical ingredients (APIs) used to make them, this urgent call to ‘securitise’ the governance of critical medicine supply chains was indeed timely. But it was also politically expedient, as it followed less than a week after Ursula von der Leyen unveiled the ReArm Europe Plan, which is expected to cost around €800 billion.

Critical medicines (also called essential medicines) are drugs that are vital for addressing the most important health needs of a population, including life-threatening conditions and chronic illnesses. First published in 2023, the EU maintains a Union list of critical medicines comprising nearly 288 active substances across a wide range — vaccines, rare-disease treatments, generics, inhalers, antiepileptics, and more. Without these, one of the world’s foremost health systems and its care system for an aging population would collapse.

Europe’s Achilles heel

While the Critical Medicines Act (CMA) aims to foster manufacturing within the EU, diversify supply chains, and enhance stockpiling capacity, Europe’s true Achilles heel is not, as the ministers implied in March, the threat of Chinese or Indian export bans. A more real and present danger is the one posed by drug-resistant microbes with which diplomatic or trade negotiations are impossible. Antimicrobial resistance, combined with the EU’s broken innovation ecosystem, is Europe’s real vulnerability. Drug-resistant bacteria already cause over 35,000 deaths each year in the EU. Crucially, over a quarter of the Union list comprises anti-infective agents that face vulnerability from antimicrobial resistance. Any provision for contingency stocks of critical medicines is only as effective as the waning efficacy of these drugs. To make matters worse, in May, Europe’s last manufacturer of ingredients for some vital antibiotics announced the closure of its biggest domestic factory to shift production to China — a stark reminder of the unsustainability of the current health security paradigm.

Negotiations on the Critical Medicines Act continue, aiming for legislation in the last quarter of 2025. While sustainable supply chains, streamlined procurement, and coordinated stockpiling are critically important aspects of the proposed act, these measures alone are not a panacea for the very vulnerable position the EU finds itself in.

The market for antibiotics is broken. The last new class of antibiotics to reach the market was discovered before the fall of the Berlin Wall, in 1987. Furthermore, the global supply of the ingredients for this crucial (albeit old) ‘technology’ is controlled by China, which produces around 45% of the global antibiotic APIs. This is no less important than Chinese control of rare-earth minerals.

Europe is falling behind in clinical trials

Pharmaceutical research and development is an essential part of the continuum of health security that also includes safeguarding supplies of critical medicines and ensuring the responsible and optimal use of existing antimicrobials. But Europe has fallen far behind in the field of clinical trials, foregoing both its capacity to innovate and the production of existing medicines. Half of all clinical trials in the world take place in just four countries: the US, China, India, and Japan. Despite global clinical trials increasing by 38% over the past decade, the proportion of these trials being conducted within the European Economic Area has halved over the same period.

Europe’s diminishing attractiveness for industry-led clinical research can be attributed to less favourable regulatory and funding environments when compared to the US and China. Recent measures like the Health Technology Assessment Regulation and Clinical Trials Regulation may be ‘too little, too late.’ Conducting multi-country trials is challenging in Europe due to regulatory fragmentation and lack of coordination between countries. This often pushes commercial trial sponsors to choose other regions like the US and China, which also benefit from larger populations and favourable demographics to recruit participants.

But pharmaceutical innovation is not simply a matter of incentivising industry. Globally, clinical trials are predominantly sponsored by non-commercial (or, in other words, public-sector) stakeholders, with a relatively stable split of 70% to 30% between non-commercial and commercially sponsored trials. In China, non-commercial trials account for over 77% of all trials. Within the EU, however, non-commercial trials represent a meagre 50%. This indicates that, by global standards, the EU and its member states are significantly underspending on clinical trials while over-relying on industry to innovate.

Stepping up amidst uncertainty

The ongoing shift away from a global rules-based order assures one thing: unpredictability. An uncertain outlook can diminish market-led innovation; therefore, governments must step in to counterbalance this effect. Government funding for research and development, for example, played a catalytic role in spurring innovation in the field of vaccines during the COVID-19 pandemic. But as the pandemic also made abundantly clear, those most vulnerable to unpredictability in times of crisis are the same segments of the population that already rely on critical medicines for their survival.

The Critical Medicines Act can help to safeguard European health security from becoming a casualty of geopolitics, but this isn’t simply a procurement issue. Policymakers must also pay attention to the integral role that innovation and combating antimicrobial resistance play in the efficacy of the EU’s critical medicines toolbox. Governments in Europe need to work together to increase the share of non-commercially sponsored clinical trials in order to catch up with global leaders like the US and China. A significant portion of this investment must focus on mitigating the antibiotics market failure, without which the world is headed towards losing 10 million lives per year by 2050.

Tags: Europe, medicines, Health