Prescribing controls on new medicines
Insider Insights

Spain: Increasing prescribing controls on new medicines


According to data from the Ministry of Health (Ministerio de Sanidad), 65.1% of medicines admitted to reimbursement in 2021 were subject to some sort of restriction on prescribing/dispensing. This compares to 52.8% of drugs in 2020 and 28.2% of drugs in 2011.

Of 548 non-generic medicines admitted to reimbursement in 2021, 39.2% were classified as hospital-use (uso hospitaliario) only, compared to 27.6% in 2020 (and just 15.7% in 2011). A further 59 drugs (10.8%) were classified as hospital diagnosis (diagnóstico hospitalario, requiring diagnosis from a hospital-based physician but which can subsequently be dispensed in the out-patient sector). This is comparable to 2020 when 40 new drugs (10.6%) were subject to hospital diagnosis but up significantly from 2011 when just 17 (3.8%) drugs were subject to this sort of control. Meanwhile another 39 new drugs (7.1%) were subject to an inspection visa (visa de inspección, a form of prior authorisation) which is on a par with 2020 (and 2011).

In total, 764 out of 2,048 new medicines were not granted reimbursement in 2021, corresponding to 37.3% of new medicines. This compares to 32.7% in 2020 and 16.6% in 2011.

Sources:, “Sanidad se aplica en la financiación selectiva y limitación de dispensación”, 18th January 2022

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