Spain Pharmaceutical Sector

Spain has a universal national health system that covers to a varying degree the cost of medicines, depending on the age, health situation and labor status of the patient. Nonetheless, as with most other European markets with well-developed national health services, Spain faces the ongoing challenge of reducing the weight of the healthcare sector within the national budget, in particular the pharmaceutical component.  

The Spanish Ministry of Health is reportedly in the process of finalizing a plan with this objective in mind and one of the proposed areas is to promote the use of generic drugs (biosimilars). Generics account for 40 percent + of units dispensed but only 21 percent of total pharmaceutical expenses.  The use of generics in Spain is close to the EU average of near 50 percent but, according to sector sources, there is still room for improvement.  Expenditures in 2020 were reported at Euros 11.7 billion for pharmacy-dispensed prescriptions and Euros 6.8 billion for medicines dispensed within the hospital network.

Following on previous but discontinued guidance to prescribe generics in lieu of original medicines even when both had the same price, sources indicate that the Ministry of Health is now considering establishing “a price differential between the generic or biosimilar with respect to the original drug during the first year of its effective commercialization.” This would mean that the generics’ market share would increase significantly during the first year of business.  There has also been talk of giving the end-user an option to pay the difference in price between the cheaper generic product and the original medicine if the end-user should prefer the latter. 

While this project has been approved by the Permanent Commission of Pharmacy within the Ministry of Health, it has yet to be ratified by the Government. Nonetheless, given the pressure to control government spending, and despite ongoing initiatives by the pharmaceutical sector to identify ways to accommodate the government´s need to reduce costs, it is generally anticipated that the agreement will eventually make its way through the different administrative bodies.  

Other options under discussion to reduce costs include classifying drugs according to therapeutic indication rather than by active component; or to have the deductions currently applied by the pharmaceutical companies for the use of more mature drugs (claw back) be applied for the benefit of the government rather than for the pharmacies, as is currently the case.

For more information contact Office.Madrid@trade.gov.