SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
ucts for human use; (c) Royal Decree 577/2013, which regulates pharmacovigilance in relation to medicinal products for human use; (d) Law 14/2007 on biomedical research; and (e) Royal Decree 1015/2009 on access to medicinal products in special situations. • Price, reimbursement and promotion: (a) Royal Decree 271/1990, which regulates the prices of medicinal products reim- bursed by the National Health System; (b) Royal Decree 177/2014, which regulates the reference price system and homoge- neous groups of medicinal products in the National Health System and information on the reimbursement and prices of me- dicinal products and medical devices; (c) Royal Decree 823/2008, which establish- es the margins, deductions and discounts corresponding to the distribution and dispensation of medicinal products for human use; (d) Royal Decree 1416/1994, which regulates the advertising of medicinal products, and provisions established in Articles 38–40 of Royal Decree 1594/2009, which regulates medical devices (partially repealed by Royal Decree 192/2023); and (e) Royal Decree 870/2013, which regulates online sales to the public of non-prescrip- tion medicinal products. Regional authorities (Spain is divided into 17 autonomous regions) may also enact and enforce regulations that are applicable at their level and within their scope of competence (eg, pharmacy offices or healthcare provision). Furthermore, there is a self-regulatory framework established by trade associations (eg, Farmain- dustria, Fenin and Aeseg) that enforce their own codes of practice. These codes of practice have
a binding effect on their members and primarily govern advertising and interactions with health- care organisations, healthcare professionals and patients’ organisations. Although adherence to these trade associations or their codes of prac- tice is not mandatory, authorities often reference them as a reflection of the current social reality and take them into account in practice. Regulatory Authorities At the national level, the main regulatory authori- ties responsible for applying and enforcing regulations on medicinal products and medical devices are the Ministry of Health (MOH) and the Spanish Agency for Medicines and Medical Devices ( Agencia Española de Medicamentos y Productos Sanitarios AEMPS). Among other functions, the MOH is responsible for drafting and implementing the rules on pricing and reim- bursement of medicinal products. The AEMPS is responsible for the issuance of marketing authorisations (MAs) for medicinal products in Spain, which includes overseeing the authorisa- tion process through national, mutual recogni- tion and/or decentralised procedures, amongst other matters. At the regional level, regional regulatory authori- ties enforce regulations in the above-mentioned areas and enact rules within their scope of competence. Moreover, regions participate in the MOH’s committee responsible for evaluat- ing pricing and reimbursement applications for medicinal products. High-level co-ordination among all regional healthcare systems mainly occurs through the National Health Service (NHS) Interterritorial Council, which comprises the national Minister of Health and the 17 region- al ministers of health.
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