DECALOGUE
of Orphan Drugs
In order to raise awareness of the characteristics of orphan drugs, AELMHU has developed the “Ten Commandments of Orphan Drugs, ” which aims to highlight the value these drugs provide.
The Decalogue is summarised in the following points:
Ten points explaining, among other things, the specificity of orphan drugs, the Rare Diseases Strategy and its lines of action, the research and development process for these treatments, the role of the EMA, the Ministry and the autonomous communities, and the commitment of the pharmaceutical industry.
01
What are orphan drugs?
02
Current Legislation
03
The National Strategy on Rare Diseases
04
The challenge of research and development of orphan drugs
05
The approval of such therapies
06
Access in Spain and in the Autonomous Communities
07
Pharmaceutical spending
08
The commitment of the Pharmaceutical Industry
09
Reconciling innovation and access
10
The R&D&I process of an orphan medicinal product
