The Ministry of Health of Spain has launched a draft Royal Decree to update regulations on drug financing and pricing with the aim of ensuring universal access and the efficiency of the National Health System (NHS).
Public consultation open until January 15
From December 12 to January 15, a public consultation will be open to collect opinions on this new regulation. Citizens, associations and organizations can participate by sending their proposals to the following email address: participacionnormativafarmacia@sanidad.gob.es.
The new Royal Decree seeks to update a regulation in force since 2015 that has not been fully developed and that responds to the need to guarantee equal access to medicines and promote the sustainability of the SNS.
Key points of the project
The text includes measures to increase transparency in decision-making, promoting legal certainty for pharmaceutical companies. This includes clearer criteria for including, excluding or reviewing medicines in public funding.
Another important point is the promotion of competition. A reformed reference price system is proposed, which will encourage the introduction of generics and biosimilars. These measures will contribute to the economic sustainability of the Spanish health system.
Constant evaluation of medicines
The project introduces an innovative approach to ex post evaluation. This system will allow the effectiveness and efficiency of medicines to be analysed once they are on the market.
In addition, a framework for collaboration between the administration, pharmaceutical companies, healthcare professionals and patients is being established. This joint participation will facilitate more inclusive decision-making.
In line with the Pharmaceutical Strategy 2024-2028
The Royal Decree is part of the Pharmaceutical Industry Strategy 2024-2028. It is also aligned with the commitments of Spain's Recovery, Transformation and Resilience Plan.
This legislative effort seeks to improve access to medicines in Spain, promoting the efficiency of the SNS and guaranteeing the well-being of citizens.