ABSTRACT

The Spanish National Health Service (Sistema National de Salud, SNS) provides universal healthcare coverage to essentially the whole Spanish population. The economic recession and Euro-crisis has hit Spain particularly hard and has resulted in some drastic austerity measures in the healthcare sector. The AEMPS is the authority in Spain which is responsible for the grant of national marketing authorizations and mutual recognition procedures over medicinal products. Pharmaceutical prices for reimbursed prescription drugs are controlled through the Comisin Interministerial de Precios de los Medicamentos (CIPM), which is a sub-department of the Ministry of Health and Consumer Affairs. Prices for new chemical entities are determined on the basis of manufacturing and R&D costs, budget impact and international price comparisons, particularly with France and Italy. The influence of health economic data on pricing and reimbursement decisions is limited in Spain. Spain has been a country of focus in the long-lasting battle on parallel trade in the European Union.