At the VII Simposio del Observatorio de la Sanidad in Madrid, pharmaceutical executives warned that Europe’s medicine supply chains remain fragile. The continent cannot risk another round of shortages like those seen during the last pandemic. The European Medicines Agency says the EU is rolling out new pharmaceutical laws and the Critical Medicines Act to keep critical medicines available across all member states. The focus is on preventing shortages and encouraging the development of new antibiotics.
Javier Urzay, subdirector general of FarmaIndustria, put it plainly: “When we talk about strategic autonomy, we’re not just talking about producing critical or strategic medicines, but also about the capacity to generate new idea.” Spain has 180 pharmaceutical plants, a strong base for building reserves and growing the industry. But Urzay says public policy must lead the way. The EU aims to diversify its sources and produce more critical medicines and ingredients at home. It also wants companies to give early warning of supply problems. These steps are part of the latest EU policy changes.
El País reported that a recent shortage of the hormone therapy Lenzetto in Spain affected nearly 400,000 women. Supply is not expected to return to normal before 2027.
Artificial intelligence is already changing how shortages are managed. Manuel Ventosa of Fenin, but, warned against thinking Spain can go it alone. “The strategic advantage is not about making everything for our own consumption in Spain, but about working at the European level,” he said. Ventosa wants a stable, long-term plan to raise productivity and give the sector greater certainty. That fits the EU’s idea of “open strategic autonomy.” Official EU statements say the goal is to reduce risk, not achieve total self-reliance. The approach includes using more suppliers, keeping stock and spotting shortages early.
New idea is still slow to reach patients. Ventosa criticized Spain’s sluggish adoption and said medicine purchasing should reward real value and impact. “New idea must reach the patient, and in Spain it does so very slowly. This is where we need to work,” he said. The new European pharmaceutical reform aims to speed up access and tighten shortage checks, while allowing generics and biosimilars to enter sooner. The European Medicines Agency has highlighted these changes in recent reports.
Vaccine supply remains fragile. Juan Manuel Montoro, Moderna’s director for Spain and Portugal, said vaccines are especially vulnerable to disruptions. He distinguished strategic autonomy from total self-sufficiency: no country can control every step or all raw materials. Montoro supports “open strategic autonomy” and cited Moderna’s partnership with Rovi during the pandemic as a safety net. Alliances matter.
The European Medicines Agency says the EU’s new SoHO regulation aims to improve access to plasma and human-derived medicines, while making them safer. The transition period for national implementation runs until August 2027. Current plasma shortages are already linked to delays or cancellations of critical infusions.
Montoro also said countries with strong production networks attract more global investment. Urzay agreed that Spain can learn from successful European models. He says the next government must decide how to build and run medicine reserves, potentially through new public procurement rules.
Costs are rising. Ventosa urged the government to link fixed medicine prices to global cost increases. He warned that frequent political changes undermine long-term plans. “Every time the political sign changes, our plans change. It’s impressive to look at the long term,” he said.
New vaccine technologies are helping bypass old bottlenecks. Montoro says these advances provide more freedom in a tense world and lower the risk of shortages during emergencies. “We must approach these new technologies to avoid problems in reserves,” he said.
Can Spain build a real reserve with current public funding? Urzay compared the cost to insurance. “You don’t pay for the product, you pay a kind of rent for the space, which is a lower price. There are solutions, and I think costs must be weighed against benefits.” He says a clear contract setting out everyone’s rights and duties matters more than the money.
Spain’s push for strategic autonomy in pharma fits a broader European trend. Earlier reporting has noted that major manufacturers are also investing in local production to protect supply chains and jobs. The question is whether Spain can use its industry and new policies to become a hub for European medicine production.
Spain is seeking ability to recover through new idea and partnerships, backed by smart rules rather than self-reliance. Its factories give it a real chance to lead in medicine production if public investment and stable rules can match that capacity, alongside new technology. The next government must decide whether to treat strategic reserves as another cost or as critical insurance for Spain’s health and economy.
