SPAIN Trends and Developments Contributed by: Joan Carles Bailach, Lluís Alcover, Laia Rull and Pablo Mansilla, Faus Moliner
Faus Moliner Abogados Rambla de Catalunya 135 08008 Barcelona Spain Tel: +34 93 292 21 00 Email: bcn@faus-moliner.com Web: www.faus-moliner.com
At the end of 2024, the Spanish Government approved its Pharmaceutical Industry Strategy 2024-2028 (the “Strategy” ), a long-anticipated development for Spain’s pharmaceutical sector. The Strategy is a government action plan within the framework of the Recovery, Transformation, and Resilience Plan. With the involvement of four ministries (Health, Treasury, Industry and Tourism and Science, and Innovation and Universities), it aims to steer innovation towards address - ing public health needs. The Strategy seeks to create a sector that not only contributes to the population’s well-being but also enhances com- petitiveness, fosters economic development and ensures the sustainability of the National Health System (NHS). The Strategy focuses on three key areas: equi- table access to medicines, the sustainability of the NHS and promoting innovation and com- petitiveness in the pharmaceutical industry. The Spanish government aims to foster an ecosys- tem where innovation, production, access and sustainability are integrated. One of the Strategy’s key pillars is improving access to new medicines in Spain while manag- ing the budgetary impact. A set of global meas-
ures is proposed to enable the system to adopt efficient access mechanisms and control phar- maceutical expenditure through more proactive monitoring of this spending. The measures and actions included in the Strat- egy stem from the need to create a system for evaluating the efficiency of healthcare technol- ogies, and for financing and pricing medicinal products, which will provide essential resources for Spain. In parallel to building this evaluation system, the Strategy proposes other necessary changes to ensure quick and sustainable access to inno- vation, while also guaranteeing the supply of essential and strategic products within the NHS. Among the measures, actions to improve timely access to medicinal products throughout their life cycle are included – specifically focusing on compassionate use and access between the stages of authorisation and decisions pertaining to pricing and reimbursement – without compro- mising price negotiations or sustainability. Addi- tionally, the Strategy considers modification of the pricing and reimbursement procedure to pro- vide, among other things, clear criteria, predict-
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