Spain misses 180-day drug target

Spain is getting faster at adding new medicines to public funding, but it is still missing its own legal timetable by a wide margin. The latest WAIT data, published in May 2026 by EFPIA and IQVIA, tracks access to 168 innovative medicines across 36 countries and shows that delays and restrictions remain a defining part of the access picture in Europe. (farmaindustria.es) In Spain, the pattern is familiar: more medicines are reaching reimbursement lists, but many still arrive late and some arrive with narrower funded use than the European authorization allows. (farmaindustria.es) ### If Spain is improving, why is this still a problem? Spain’s progress is real in the data. Farmaindustria said in May 2025 that Spain had increased the share of EMA-authorized medicines it funds to 71%, up from 62% a year earlier, based on the 2024 WAIT indicator. The same dataset showed the average time between authorization and funding at 616 days, down from 661 days. (farmaindustria.es) The problem is that 616 days is still far beyond the 180-day maximum that Spanish and European reimbursement rules are supposed to meet. That gap is why the story is not just about improvement, but about the distance between legal deadlines and real-world access. ### What exactly does the WAIT report measure? (farmaindustria.es) The 2026 WAIT indicator covers 168 innovative medicines with central marketing authorization between 2021 and 2024, with availability measured as of Jan. 5, 2026. EFPIA says the report tracks not only whether a medicine appears on a public reimbursement list, but also whether access is limited by restrictions or conditions on use. That matters because a medicine can be “available” on paper and still be harder to get in practice. EFPIA said restrictions are now more common across Europe, with only 28% of medicines fully available on public reimbursement lists in 2025, down from 42% in 2019, while 17% were available only under restricted conditions. (farmaindustria.es) (globallegalinsights.com) ### Where is the bottleneck in Spain? Spain’s Health Ministry has argued that timelines are shortening. In its own report published on May 5, 2025, the ministry said the time from authorization to a financing decision for medicines authorized in 2023 had fallen to 345 days from 519 days for medicines authorized in 2020. Secretary of State Javier Padilla said the ministry wanted to end what he called a “dependence on reports prepared by third parties” and publish its own historical series. (farmaindustria.es) The difference between the ministry’s figure and the WAIT figure reflects methodology as much as politics. The ministry measures time to the financing decision, while WAIT tracks a broader path to public availability, which can extend beyond the initial decision and can also reflect restrictions. (efpia.eu) ### Why do restrictions matter as much as delays? Restrictions matter because EMA authorization does not automatically mean Spain will fund every approved indication in the same way. The WAIT framework explicitly counts line-of-therapy, formulary and related limits when assessing availability. For patients, that can mean a medicine exists in the system but only for narrower groups than the European label allows. For people relying on Spain’s public system, including retirees, the practical issue is not only entitlement to care but whether a specific new treatment is funded quickly and for the indication their doctor wants to use. (diariofarma.com) That distinction is an inference drawn from the WAIT methodology and Spain’s reimbursement data. (farmaindustria.es) ### What changes could affect this next? Spain’s next procedural changes are tied to the draft medicines law, the future pricing and reimbursement decree, and the pending health technology assessment regulation. Farmaindustria said those measures should define the access model for innovative medicines in the coming years, while Padilla has said the ministry plans a public dashboard to track access data. (farmaindustria.es) The next benchmark will be whether those reforms move Spain closer to the 180-day ceiling in future WAIT releases and in the ministry’s own published series. EFPIA’s 2026 indicator uses availability data as of Jan. 5, 2026, making the next annual update the clearest test of whether the shorter decision times translate into faster and less restricted patient access. (farmaindustria.es 1) (farmaindustria.es 2)