Publication: Impacto de los medicamentos huérfanos en el Hospital de Fuenlabrada
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2015-01
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Abstract
Las enfermedades raras tienen una baja prevalencia, si bien en su conjunto afectan a un número significativo de personas, se calcula que en la Unión Europea los afectados representan entre el 6 y 8% de la población, es decir, entre 27 y 36 millones de personas (1) .La mayoría se caracterizan por ser crónicas, debilitantes y potencialmente mortales. Por ello, la urgencia del diagnostico es una prioridad. Los medicamento huérfanos, indicados para el tratamiento de las enfermedades raras, no pueden ser desarrollados en condiciones normales de mercado, puesto que la industria farmacéutica no puede recuperar la inversión en investigación y desarrollo, debido al bajo número de personas afectadas por este tipo de patologías. Por este motivo, la Comisión Europea estableció en el año 2000 el Reglamento (CE) nº 41/2000, que fija un conjunto de incentivos con el objetivo de estimular el desarrollo de medicamentos huérfanos (2) . En términos presupuestarios, las enfermedades raras generan un gran impacto económico. Los datos de 2011 en España reflejan un gasto en medicamentos huérfanos de 420 millones de euros, que corresponde con un 2,5 % del gasto farmacéutico (3) . Este impacto se eleva considerablemente en el ámbito hospitalario donde asciende hasta el 15 % del total.
Rare diseases have a low prevalence, although as a whole affect a significant number of people, it is estimated that in the European Union affected represent between 6 and 8% of the population, ie between 27 and 36 million people. Most are characterized by chronic, debilitating and life-threatening. Hence the urgency of diagnosis is a priority. Orphan drug indicated for the treatment of rare diseases, can not be developed under normal market conditions, since the pharmaceutical industry can not recover the investment in research and development, due to the low number of people affected by such diseases. For this reason, the European Commission established in 2000 by Regulation (CE) Nº141/2000 laying down a set of incentives to stimulate the development of orphan drugs. In budgetary terms, rare diseases generate a great economic impact. Data for 2011 in Spain reflect an orphan drug spending 420 million euros, which corresponds to 2.5% of pharmaceutical expenditure.This impact is raised considerably in hospitals where it amounts to 15% of the total.
Rare diseases have a low prevalence, although as a whole affect a significant number of people, it is estimated that in the European Union affected represent between 6 and 8% of the population, ie between 27 and 36 million people. Most are characterized by chronic, debilitating and life-threatening. Hence the urgency of diagnosis is a priority. Orphan drug indicated for the treatment of rare diseases, can not be developed under normal market conditions, since the pharmaceutical industry can not recover the investment in research and development, due to the low number of people affected by such diseases. For this reason, the European Commission established in 2000 by Regulation (CE) Nº141/2000 laying down a set of incentives to stimulate the development of orphan drugs. In budgetary terms, rare diseases generate a great economic impact. Data for 2011 in Spain reflect an orphan drug spending 420 million euros, which corresponds to 2.5% of pharmaceutical expenditure.This impact is raised considerably in hospitals where it amounts to 15% of the total.