SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Medicinal Products Reimbursed medicinal products have a maxi- mum ex-factory price ( precio de venta labora- tori o; PVL) set by the Interministerial Committee for the Price of Medicines (ICPM), a committee of the MOH. The PVL is the maximum price for the units of the reimbursed product that will be reimbursed by the Spanish NHS. To determine the PVL, Spain has always followed a cost-plus system, under which the maximum PVL should correspond to the cost of the product plus a given profit margin; this is what Royal Decree 271/1990 contemplates in accordance with the provisions of Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products for human use. As a matter of practice, however, the price-approval process entails negotiation with the authorities, where the cost and profit margin are not the main variables considered. In the firm’s experience, companies should be prepared for prices to be determined based on: • a comparative pharmaco-economic evalua- tion of the medicinal product and its competi- tors; and • the price of the medicinal product in other EU member states. Companies must also be ready for the authorities to consider other issues, such as the activities performed by the company in Spain (eg, R&D, manufacturing) and any relationship with a local company through a co-marketing or licensing arrangement. Reimbursed medicinal products also have a so-called notified price, which is the price at which the MAH may market such reim-
bursed product outside the Spanish NHS (eg, units supplied on a patient-payment basis). The notified price is in fact free, although accord- ing to Article 94.4 of Royal Legislative Decree 1/2015, it must be notified to the MOH, who may oppose to it on the grounds of protecting the public interest. The notified price is, by defini- tion, higher than the PVL. Finally, the MOH is working on an update of the rules governing the price and reimbursement of medicinal products. At the end of 2024, the MOH launched a public consultation on this matter. Medical Devices Unlike medicinal products, the vast majority of medical devices used at NHS hospitals do not have a maximum PVL determined at the nation- al level. Instead, the price of such products is determined/negotiated on a case-by-case basis in public procurement proceedings. Furthermore, certain medical devices/products for non-hospitalised patients (eg, bandages, gauze, catheters, urine collection bags) have a specific reimbursement regime laid down in Royal Decree 9/1996, which includes determina- tion of the maximum PVL at the national level. This Royal Decree is expected to be replaced in the near future by a new one that is current- ly being drafted by the MOH (a first draft was released in late 2024). 8.2 Price Levels of Pharmaceuticals or Medical Devices As per Spanish regulations, the MOH is not allowed to reference international prices. Interna- tional referencing was contemplated in the Law on Medicinal Products before 2012, but Royal Decree-Law 16/2012 of 20 of April removed any reference to this practice in 2012; subsequently, international referencing had no legal basis in
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