Generic drug makers in Spain say the country’s reference pricing system has driven medicine prices so low that many products are no longer profitable. Elena Casaus, secretary general of the Asociación Española de Medicamentos Genéricos (Aeseg), spoke bluntly at the VII Simposio del Observatorio de la Sanidad de EL ESPAÑOL-Invertia. Current rules are cutting prices to the bone, she said, leaving some generic makers unable to continue supplying the market.
Casaus pointed to a contradiction in European health policy: Brussels wants to secure supplies of critical medicines, but Spain’s pricing rules, she argued, work against that goal. Seven out of ten medicines in Europe are generics. Their share is even higher among drugs the European Medicines Agency lists as critical.
The Spanish Ministry of Health is seeking to preserve part of the pharmaceutical reform through a separate royal decree on pricing and reimbursement. The decree has received the necessary departmental approvals and is awaiting review by the State Council and the Council of Ministers.
The collapse of Spain’s new medicines law has made matters worse. The bill was under parliamentary review before the general election was called. It would have introduced dynamic pricing to help generics regain ground in pharmacies. With the law on hold, the old system remains in place and industry risks persist. The Ministry of Health says the sector must operate under the current legal structure unless changes are made through lower-level regulations.
The proposed royal decree may introduce dynamic pricing and speed up administrative procedures. Pricing and reimbursement decisions would take 180 days under the standard process and 90 days under the accelerated one. The draft also addresses the transition from EU-wide drug registration to Spanish pricing and reimbursement. Both generic and original drug manufacturers have criticized dynamic pricing because it relies mainly on generic market share, rather than the number of competitors or actual pharmacy sales.
Aeseg is part of Europe’s wider health emergency plan. Casaus said the group is helping roll out the continent’s medical countermeasures strategy, which covers threat identification and the full process of getting medicines produced, stored, purchased and moved quickly during a crisis. Spain is a major player: it ranks second in the EU for industrial production capacity, with 38 facilities. Of these, 27 make medicines; the rest handle analysis and batch release, along with logistics for imported drugs.
Across Europe, work is underway to map and strengthen supply chains. A voluntary network of manufacturers is being set up to allow a rapid response to emergencies. The Athina platform is also in development and will use artificial intelligence to track manufacturers’ locations and how medicines move. The goal is full readiness by 2030.
Casaus doubts these plans will work without effective industrial policy and funding at both EU and national levels. She asked who will pay once strategic projects are in place. Last year, a legal structure was created to let member states pay manufacturers to fill supply gaps in public services, with compensation of up to 20 million euros a year. To have an impact, national governments need to incorporate it into their own industrial policies.
Spain’s problems extend beyond pharmaceuticals. As reported earlier, sectors such as car parts and logistics are also facing rising costs and supply issues. Critical supply chains remain vulnerable.
Casaus said safeguarding supplies of basic medicines requires strong production and storage, backed by new technology. But Spain’s current support programs, including the CDTI and Plan Profarma, do not meet the sector’s needs. Without targeted investment, Spain could lose both its current strengths and its future in drug manufacturing.
Aeseg says Spain and Europe need pricing rules that support industry and safeguard supply chains, protecting the country’s ability to guarantee impressive medicines. The current path endangers generic makers and weakens the wider healthcare system. Policymakers must adapt to the market or risk losing access to life-saving drugs.
