SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
7.5 Trade Blocs and Free Trade Agreements The import authorisation referred to in 7.2 Importer of Record of Pharmaceuticals and Medical Devices is not required if the product originates from another EU country (intra-community trade), or from Norway, Iceland or Liechtenstein, by virtue of the agreement for the European Economic Area (EEA) recognising the free movement of goods between the contracting parties, signed in Porto on 2 May 1992. In this case, a distribution licence is sufficient. For more information on distribution requirements, please see 6.1 Whole- sale of Pharmaceuticals and Medical Devices . 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Reimbursed medicinal products have a maximum ex- factory price ( precio de venta laboratorio PVL) set by the Interministerial Committee for the Price of Medi- cines (ICPM), a committee of the MOH. The PVL is the maximum price for the units of the reimbursed prod- uct 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 experi- ence, companies should be prepared for prices to be determined based on: • a comparative pharmaco-economic evaluation of the medicinal product and its competitors; and • the price of the medicinal product in other EU member states. Medical Devices Medicinal Products 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 reimbursed product outside the Spanish NHS (eg, units supplied on a patient-payment basis). The notified price is in fact free, although according to Arti- cle 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 definition, 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 medi- cal devices used at NHS hospitals do not have a maxi- mum PVL determined at the national level. Instead, the price of such products is determined/negotiated on a case-by-case basis in public procurement pro- ceedings. Furthermore, certain medical devices/products for non-hospitalised patients (eg, bandages, gauze, catheters, urine collection bags) have a specific reim- bursement regime laid down in Royal Decree 90/2026, which regulates the selective reimbursement proce- dure of medical devices for non-hospitalised patients. This Royal Decree establishes the procedure for reim- bursement as well as the setting of their maximum industrial price ( PVL máximo ), the applicable whole- sale and pharmacy margins, and the conditions for their dispensing. 8.2 Price Levels of Pharmaceuticals or Medical Devices As per Spanish regulations, the MOH is not allowed to reference international prices. International refer- encing 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 Spain, and the judgments of the Supreme Court of 28 October 2015 and 11 November 2015 confirmed this.
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