Relevant Cases

Price 
 regulation

Drug prices regulation

Royal Decree 177/2014, regulating the National Health System’s benchmark prices system, established the criterion that the lowest price a drug is commercialized in any European Union member State shall automatically set the maximum price for its commercialization in Spain.

In the name and on behalf of the Federación Empresarial de Farmacéuticos Españoles (FEFE) we filed the contentious administrative appeal no. 387/2014 against Royal Decree 177/2014, before the Supreme Court.

The Supreme Court Judgment of November 11, 2015 effectively annuls this Royal Decree criterion for establishing the price of drugs since this regulation violates the non-delegable legislation principle.