Spain has approved a new Royal Decree regulating the public financing of medical devices for non-hospitalized patients.
Scope and eligible products:
Financing will apply only to devices belonging to four defined categories: wound care, drug administration, excreta collection, and protection or reduction of internal injuries. Two contribution groups are established: a general co-payment (based on income) and a reduced contribution for patients with chronic or specific needs.
Key requirements:
Eligible products must be mass-produced, CE-marked, compliant with regulatory requirements, subject to prescription, and not advertised to the public. Financing decisions will require an express resolution by the competent Directorate-General, supported by technical and economic evaluation (clinical utility, cost-effectiveness, budget impact, and EU pricing comparison).
Main updates:
- Involvement of the Interministerial Pricing Committee in price setting
- Mandatory supply guarantees and substitution mechanisms in case of shortages
- New distribution and dispensing margin system, including fixed amounts for higher-priced products
Timeline:
The Royal Decree will enter into force on 1 July 2026, with progressive implementation between 2026 and 2028.
You can consult the full draft text here:
https://www.sanidad.gob.es/normativa/audiencia/docs/TEXTO_Y_MAIN_RD_FINANCIACION_PPSS_PARA_IP_Y_TA.pdf
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