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Date Published: 15/04/2025

Spanish health ministry defends drug reform as industry warns of shortages

Spanish government says new rules will boost access to cheaper medicines, not create supply risks

The Ministry of Health in Spain has defended its new medicines bill after facing criticism from parts of the pharmaceutical sector and some medical bodies, who warn the proposed changes could lead to shortages and risk patient safety.

The reform, still in draft form, includes a new pricing system that aims to encourage more competition between companies making generic and biosimilar drugs. The goal, says the ministry, is to lower prices without limiting access.

Javier Padilla, Secretary of State for Health, rejected claims that the new rules would act as a kind of auction and insisted the plan would focus mainly on medicines that have lost patent protection but still enter the market at a very high cost. “It is a procedure to encourage competition in situations with high prices, especially at the early stages,” he explained during a press briefing on Monday April 8. “It is not an auction model.”

Pharmaceutical industry representatives have warned that the pricing system could make some drugs commercially unviable, leading to supply problems. Others argue it could discourage innovation and put smaller companies at a disadvantage. The General Council of Official Colleges of Pharmacists has also expressed concern, while the Medical Association fears certain parts of the reform could undermine professional oversight.

Padilla responded by saying that these concerns relate to just a small part of the proposed legislation. “Out of 146 articles and 22 additional provisions, we only have doubts about one and a half articles. I think this could be the draft with the least uncertainty ever brought before Congress,” he said.

Nurses welcome expanded role

The draft law also includes a long-awaited change that would allow nurses and physiotherapists to prescribe more medicines — something that has already sparked debate in the medical world. Some doctors argue this could compromise patient safety, but nurses’ organisations have strongly supported the move.

“The truth is that what we can do now is very basic. We practically prescribe things that any ordinary citizen can buy at a pharmacy,” said Lucía García, head of Cross-Cutting Policies at the Federation of Health and Health Sectors of the CCOO. The reform would give more autonomy to Spain’s 345,000 nurses, letting them prescribe certain medications without needing authorisation from a doctor in every case.

Padilla stressed that this change reflects real-life practice and will provide nurses with more legal protection to match their training and responsibilities. He added that the law aims to equalise qualifications that carry the same professional level.

Another measure in the bill would allow pharmacists to substitute a prescribed medicine with an alternative that contains the same active ingredient if the original is unavailable — a move intended to support continuity of care.

The Ministry of Health says it will meet with parliamentary groups over the coming weeks to seek agreement before the bill enters the full legislative process.

Image: aleksandarlittlewolf/freepik

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