The Spanish Association of Pharmaceutical Law (ASEDEF) organised a meeting where Industry, Administration and patient associations were able to seal a collaboration pact aimed at improving the situation and future of people with rare diseases.
Luis Cruz, president of the Spanish Association of Orphan and Ultra-Orphan Medicines Laboratories (AELMHU), took part in the conference, stating that in the field of rare diseases we barely know 10% of what we need to know and that one of the main problems is the delay in diagnosis. He also pointed out that the filters and barriers put in place by the Autonomous Regions are counterproductive and are detrimental to the equity contemplated in the law.
It is still unknown whether the new regulations on clinical trials and rare diseases will shorten the delay in diagnoses and the widespread absence of treatments. On 13 January, the Royal Decree on clinical trials 1090/2015 came into force to streamline the conduct of clinical trials in Spain, giving a greater role to patients. However, until the decree is fully implemented, only 49 orphan drugs can be marketed in Spain for a number of rare diseases that could be close to 7,000.
As a representative of the Ministry of Health, María Martínez de la Gándara explained the impossibility of paying for all therapeutic innovation without negotiation, which is why it is necessary to resort to containment tools such as expenditure ceilings and risk-sharing agreements. However, she pointed out that orphan drugs can always be considered as therapeutic innovation.
