Spain Passes Major Pharmaceutical Reform

Spain's Council of Ministers approved a draft Law on Medicines and Medical Devices, reforming core principles of the country's pharmaceutical policy that have been in place for the past two decades. Among the key innovations: nurses and physiotherapists will be granted prescribing rights, an authority previously limited strictly to doctors, dentists, and podiatrists.

The draft bill will now be submitted to the Congress of Deputies for final debate and parliamentary approval.

Generics Will Be Allowed to Compete on Price

The primary economic driver behind the reform focuses on drug pricing mechanisms. Currently, groups of identical medications covered by the public healthcare system carry uniform prices at pharmacies. Under the new law, these products will be allowed to vary in price. The Ministry of Health will set a maximum reimbursement cap, allowing generic manufacturers to lower prices below the threshold to compete against one another.

Conversely, pharmaceutical companies producing brand-name medications will be permitted to set prices higher than the state reimbursement cap, with patients paying the difference out-of-pocket. Within the maximum reimbursement amount covered by the state, patients will continue to pay existing income-adjusted co-payments—meaning pensioners will pay nothing unless they choose a brand-name option over a generic.

The Health Ministry aims to incentivize generic consumption and reduce national pharmaceutical expenditures.

Combatting Drug Shortages

The law officially introduces the classification of "strategic medicines"—defined as essential treatments with vulnerable supply chains. To prevent pharmacy stockouts, the Spanish Agency for Medicines and Medical Products (AEMPS) will be empowered to implement special economic and regulatory measures to safeguard supply. Manufacturers, distributors, and pharmacies will also be required to report inventory levels more transparently to help the ministry track and forecast potential shortages.

Accelerated Access to Innovative Medications

The legislation creates a new fast-track mechanism for novel, non-equivalent therapies. Currently, new treatments must wait until the Health Ministry and the pharmaceutical company complete price negotiations. Under the new rules, a 180-day window will allow hospitals and medical centers to begin administering innovative drugs before a final pricing agreement is reached.

During this interim phase, the medication will be reimbursed at the price proposed by the manufacturer, subject to subsequent review. If the drug fails to deliver expected clinical outcomes or the final agreed price is lower than initially charged, the pharmaceutical company will be required to refund or compensate the financial difference.

Home Dispensing for Vulnerable Patients

The reform also establishes regulations to "facilitate access to medicines in exceptional health emergencies or when a patient's clinical condition, dependency, disability, or vulnerability restricts mobility." In practice, this will enable eligible patients to receive necessary medications at home without needing to physically visit a community or hospital pharmacy.

The Ministry of Health emphasized that the measure does not represent a move toward "online commercial sales," but rather seeks to "bring medication dispensing closer to patients under justified circumstances."