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Report on the financing of innovative medicines in Spain
Last week, the Ministry of Health, through the Directorate for the Common Portfolio of Services of the National Health System and Pharmacy, published a report analysing access to innovative medicines in Spain, authorised for the period 2020-2023.
Among the conclusions reached, the following stand out:
- Significant improvements in the funding and availability of new therapies.
- Reduction of more than 170 days until the funding decision.
- More than 52% of the innovative medicines registered were available prior to their official financing through the Medicines in Special Situations (MSE) route, regulated by Royal Decree 1015/2009.
However, the Ministry of Health considers that there is still room for improvement and that the regulatory projects currently in the pipeline (Draft Law on Medicines and Medical Devices, the Royal Decree on Health Technology Assessment and the Royal Decree on the Financing and Pricing of Medicines) should consolidate the applicable framework.
EFPIA Patients W.A.I.T Indicator 2024 Survey
According to the new W.A.I.T. report published, Spain has improved in access to innovation indicators. According to the report, the figure for availability of new medicines is the highest in recent years and shows that of the 173 medicines authorised in the EU between 2020 and 2023, Spain has 123 financed (as of 25 January 2025).
The publication of this report coincides with the preparation of the Draft Law on Medicines and Medical Devices which, together with the Royal Decree on the Financing and Pricing of Medicines and the Royal Decree on Health Technology Assessment, should lay the foundations for the access model for the coming years. This package of regulations represents an opportunity to consolidate the growing trend and to comply with the maximum period of 180 days set by the regulation for making the financing decision.
Draft Royal Decree amending Royal Decree 1277/2003, of 10 October, which establishes the general basis for the authorisation of health centers, services and establishments
On 7 May, the Ministry of Health opened for public hearing and information the text of the Royal Decree amending Royal Decree 1277/2003, which establishes the general basis for the authorisation of health centers, services and establishments.
This amendment aims, on the one hand, to ensure that the patient's right to health protection is duly protected (guaranteeing and ensuring the appropriate qualifications, competences and skills of healthcare professionals). On the other hand, it updates the list of healthcare services offered in Annexes I and II of Royal Decree 1277/2003.