Spain has confirmed that a wide-ranging medicines-law reform remains in its 2026 legislative programme, giving an official signal that the Government intends to revisit several core elements of national pharmaceutical policy during the year.
The Council of Ministers approved the Plan Anual Normativo 2026 (Annual Regulatory Plan 2026) on 5 May 2026. Under the health section, the plan includes a proposed Ley de los Medicamentos y Productos Sanitarios (Medicines and Medical Devices Law), led by the Ministry of Health (Ministerio de Sanidad).
The plan intends the proposed law to adapt the system to new therapeutic and technological developments, deepen pharmaceutical-expenditure rationalisation, incentivise rational medicines use and incorporate lessons from the pandemic. It goes on to identify several areas that would sit directly within access policy.
The proposed law will modify the reference-price system and adapt health technology assessment to Regulation (EU) 2021/2282 on health technology assessment. It will also define more clearly the criteria for public financing of medicines and medical devices, and address the treatment of medicine costs in early-access programmes.
The plan refers separately to incentives for generics and biosimilars, and to criteria for pharmacist substitution.
The law will also clarify the prescription nomenclature used in the national medicines system for prescribing, financing and administrative purposes. The proposed law will also introduce a definition of strategic medicines, reinforce certain notification obligations, revise the system for calculating the contribution under the additional sixth provision and clarify responsibilities for the control of medicine advertising.
The proposal brings together several strands that have appeared separately in recent Spanish pharmaceutical policy: expenditure control, off-patent competition, early access, HTA alignment and supply-sensitive treatment of selected medicines. The next substantive step will be publication of a draft bill or consultation text. Up to that point, the plan remains a formal statement of legislative intent.
Source: Council of Ministers, Spain
Link: Plan Anual Normativo 2026 (Annual Regulatory Plan 2026)
Date: 5 May 2026
