Spain

Many companies submit budget impact analyses, but health economic submissions are not mandated and its place in the approval is not specified in the new Pharmaceutical Law. The economic recession and euro-crisis has hit Spain particularly hard and has resulted in some drastic austerity measures in the healthcare sector. Spain’s 17 healthcare regions have full budget responsibility since 2003. By the end of 2018, more than 50 biosimilars were approved in Spain, a substantial growth from 38 in 2017. The biosimilar market in Spain is reaching an important share of the total consumption of the original and biosimilar molecules. Spain has been a country of focus in the long-lasting battle on parallel trade in the European Union. At the time of accession to the European Union in 1986, Spain and Portugal were excluded from parallel trade until 1995. Since that time, companies have been trying to combat parallel trade from Spain, as its low prices caused significant issues within Europe.