Launching healthcare products in Spain

Discover key facts about the healthcare market in Spain and learn about our latest market research for our pharmaceutical, medical device, and healthcare sector clients.

Key facts about the Spanish health market:

Funding in the Spanish healthcare system

The Spanish healthcare system offers near-universal healthcare throughout Spain. This is mostly paid for by taxpayers through social security. The regional ministries of health are responsible for the territorial organisation of health services within their jurisdiction.

Health technology assessment in the Spain

Spain primarily follows a regional HTA approach, with 17 regions having complete control of their own health budget.

At a central level, once a medicine is licensed by the Spanish Agency of Medicines and Medical Devices (AEMPS), the Ministry of Health (Ministerio de Sanidad, MISAN),  decides on its reimbursement and pricing. This is based primarily on an assessment of therapeutic value. A positive recommendation by the MISAN implies that the medicine is approved for regional use.

At the regional level, different regions may then conduct their own assessments, though some regions organise to perform joint drug evaluations.

For medical devices, there are two main pathways to national reimbursement:

• Introduction of a new medical device through price and reimbursement (outpatient route)
  • Manufacturers of eligible medical devices may submit evidence to the Inter-Ministerial Pricing Commission for Pharmaceuticals (CIPM) who are responsible for setting prices for drugs and medical devices within the National Health System
  • Once the CIPM have approved the medical device for reimbursement, the device is provided with a national product code, allowing the product to be sold within a pharmacy setting. The reimbursement status of the product is communicated to the autonomous regions, which allows the product to be prescribed in regional community pharmacies within Spain. However, since 2016, this method of reimbursement for outpatient medical devices has been blocked, and a new method is currently being created
• Introduction of a new health technology as a public health service
  • This pathway is specific to innovative health technologies that have the potential to improve the Spanish health system. In order to gain reimbursement via this method, cost-effectiveness and clinical study data must be submitted to the HTA agency (national HTA body). The MISAN will then determine the reimbursement status of the technology. If a positive opinion is provided, the technology can be listed on the New Technology list of the National Health Public Service
  • Medical devices and technologies that are not reimbursed through the National Health System have the opportunity to be reimbursed by a tender procedure in each autonomous region (who will likely conduct their own assessments)

Spanish payers’ primary focus:

Spain is an evolving market, with budget impact remaining relevant, and cost effectiveness gaining momentum.