Hospitals across Europe are running low on two vital cancer medicines, forcing doctors to make difficult choices about who gets treatment first. Regulators warn that these shortages could last through 2026.
The drugs, ifosfamide and cyclophosphamide, are widely used in chemotherapy and are considered essential for cancer care. Their limited availability is now affecting hospitals in multiple EU and EEA countries.
The shortages come as the European Union is advancing work on the Critical Medicines Act. The future legislation aims to strengthen the security of supply of key medicines.
Manufacturing disruption at the core
Minutes from a 5 March meeting of the EU’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) show that the shortages are linked to issues at the main supplier’s contract manufacturing site.
Regulators noted that “a number of manufacturing issues led to some temporary pauses in manufacturing starting October 2025”. This significantly limited output. Additional measures following a US FDA inspection further constrained production capacity.
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Baxter, a US pharmaceutical company, confirmed the disruption and its impact on supply to EU Perspectives. “Baxter recognizes the impact that supply constraints for ifosfamide may have on patients and those who care for them. Our priority is always to support patient care, and we will continue to navigate this situation,” the company stated.
Its contract manufacturer for ifosfamide had experienced a technical disruption. That reduced site operations and temporarily interrupted both manufacturing and product release.
Reduced capacity and global pressure
Production has resumed but remains below required levels. According to Baxter, the supply “will remain limited (…) with gradual improvement expected through the end of 2026”.
The company stressed that the complexity of manufacturing and the limited number of global suppliers are key factors. The company has been working with the European Medicines Agency since January. It is coordinating closely with its manufacturing partner to monitor inventory and reduce impact.
Production has resumed, but at reduced capacity that does not meet current demand. — Baxter
The MSSG minutes underline Europe’s dependence on a single supplier. Baxter “holds nearly 100 per cent market share for ifosfamide and significant share for cyclophosphamide”, regulators noted.
As a result, shortages are expected to affect most EU countries. Some member states face stockouts while others receive supply closer to historical levels. Only limited additional supply has been identified from alternative manufacturers, restricting the EU’s ability to offset the shortfall.
Uneven distribution raises concerns
Available supply is being managed through allocation mechanisms. Baxter has “implemented a detailed quota system to distribute available supply fairly across customers, in line with past usage”.
According to MSSG minutes, supply is distributed globally based on historical demand. However, regulators raised concerns about how this translates across member states. Members questioned the fairness and transparency of the allocation plans and highlighted disparities in supply, with some countries experiencing stockouts while others receive near full demand.
The shortage is already affecting clinical decision-making. Baxter indicated that clinicians “may wish to prioritise patients for whom alternative treatment options are limited”.
EU recommendations reflect this approach. Healthcare professionals are advised to ensure sufficient quantities before starting treatment and to prioritise existing patients during the shortage. The guidance also calls for “rational prescribing” to manage limited supply.
Regulatory response focuses on coordination
EU authorities are coordinating through the MSSG and the Medicines Shortages Single Point of Contact working party. The European Medicines Agency (EMA) recommendations say regulators are holding regular exchanges with the affected company and monitoring supply across member states.
We are now at a point where more than eight out of ten critical oncological medicines have one major supplier across the EU, which is clearly unsustainable. — Medicines for Europe
MSSG has called on manufacturers to implement “fair and equitable allocation” systems, provide regular supply updates, and optimise production where possible. Member states are encouraged to use regulatory flexibilities and track national supply and demand.
A fragile supply system
Industry groups say there are broader structural weaknesses. “Existing pricing and procurement systems are focused on achieving the lowest price without taking into account security of supply, overall sustainability or resilience of the system,” a trade association Medicines for Europe told EU Perspectives.
The group warned that manufacturers withdrawing from the market has increased reliance on a small number of suppliers. “We are now at a point where more than eight out of ten critical oncological medicines have one major supplier across the EU, which is clearly unsustainable.”
Supply expected to recover slowly
There is no immediate resolution. “Production has resumed, but at reduced capacity that does not meet current demand,” Baxter said.
The company added it is working with urgency alongside its manufacturing partner and in coordination with the EMA and other relevant stakeholders to restore supply as quickly and responsibly as possible.
Until then, shortages are expected to continue across Europe, affecting access to medicines considered essential for cancer care.