For the past 15 years, Spain has included a reference pricing system for medicines in its reimbursement system. However, this reference pricing system was substantially modified on three occasions in the past three-and-a-half years. The latest modification was enacted on March 21 2014. After a lengthy process, Royal Decree 177/2014(1) was published in the Official Gazette on March 25 2014.
The government originally intended to develop the new reference pricing system by way of ministerial order. However, the Council of State stated that this was not possible, and that the revisions had to be enacted by royal decree. The modification of the reference pricing system was thus delayed for several months. In addition, it is envisaged that a further ministerial order will be approved by early May 2014.