The Council of Ministers (Consejo de Ministros, CoM) approved Spain’s 2026 Annual Regulatory Plan on 5 May. The plan includes a planned Law on Medicines and Medical Devices (Ley de los Medicamentos y Productos Sanitarios) under the Ministry of Health (Ministerio de Sanidad, MS), with objectives that include changes to the reference-price system, public-financing criteria and the treatment of medicine costs in early-access programmes.
The current official outline builds on the 2025 draft law and explanatory material. The draft would retain a national reference-pricing system, but reshape the way off-patent competition operates. Reference groups would generally be formed at ATC5 level, where there is at least one generic or biosimilar, with exceptions for some hospital-use medicines, medicines with special dispensing restrictions, clinical packs, plasma-derived medicines and orphan medicines. The draft also allowed full or partial exemption where a product offers an objective patient improvement or strategic advantage for the National Health System.
The more novel proposal is the system of selected prices. For each homogeneous group, companies would offer prices for a six-month period. The Ministry would then identify the lowest-priced medicine, a selected-price group with a defined price range, and non-selected products. Patient choice and pharmacist-dispensing rules would apply across those categories. The proposal would also allow prices within a homogeneous group to move up or down between periods, within any maximum and minimum limits set by the Ministry.
The draft links that flexibility to competition and supply. The number of medicines included in the selected-price group, and the price range, would take account of consumption, budget impact, the number of products in the group, shortage risk, environmental impact and strategic autonomy. Products setting the lowest price would receive incentives, including exemption from some mandatory deductions and a 50% reduction in volume-based payments to the National Health System while they keep that position.
The early-access provisions would also affect launch economics. The Ministry’s explanatory material states that compassionate use should generally be supplied without cost, and that use between marketing authorisation and the final pricing and reimbursement decision should not cost more than the final financing agreement, with compensation or repayment mechanisms where needed.
The 2026 plan confirms that these issues remain in the legislative pipeline, but the final bill has not yet been adopted. The version sent to Parliament will show how far the Government has adjusted the 2025 draft after consultation and stakeholder feedback, particularly on off-patent pricing, supply incentives and the role of pharmacy substitution.
Source: Council of Ministers, Spain; Ministry of Health, Spain
Link: Plan Anual Normativo 2026 (Annual Regulatory Plan 2026); Anteproyecto de Ley de los medicamentos y productos sanitarios (Draft law on medicines and medical devices)
Date: 5 May 2026; 8 April 2025
