The new Spanish framework for Health Technology Assessment (HTA) has recently been approved by Royal Decree 415/2026. What impact will it have on rare diseases and orphan drugs? Among the possible benefits, the greater participation of patients and associations stands out, as the Royal Decree expressly mentions the need to...
The president of the Spanish Association of Orphan and Ultra-Orphan Drug Laboratories (AELMHU), Beatriz Perales, has reported that the average time for patients in Spain to access orphan drugs has been reduced to 22 months in the first four months of 2026, one month less than at the end of...
Question: Let's start by talking about the amendments that insist on protecting incentives for innovation and economic viability of orphan drugs. Do you think the current European framework sufficiently guarantees that balance or that it needs to be strengthened?Answer: Responding very directly, I believe it is necessary to reinforce it,...