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Updated: Sep 9, 2025

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Preparando el camino para una implementación exitosa de la Reforma de la EAT de la UE

Hans Severens1, Andrew Dillon2, Francois Meyer3

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La aplicación del Reglamento de Evaluación de las Tecnologías Sanitarias de la UE (EU HTAR) se enfrenta a desafíos como la preparación variable de los Estados miembros. La mejora de la colaboración y la participación de las partes interesadas es crucial para optimizar los procesos de evaluación de la salud y mejorar el acceso de los pacientes a los medicamentos.

Palabras clave:
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Área de la Ciencia:

  • Política de salud
  • Ciencias de la regulación
  • Economía de la salud

Sus antecedentes:

  • El Reglamento de la UE sobre la evaluación de las tecnologías sanitarias (EU HTAR) tiene por objeto armonizar los procesos de evaluación de las tecnologías sanitarias en los Estados miembros.
  • La aplicación presenta desafíos que incluyen diversos niveles de preparación nacional y preocupaciones sobre la soberanía.

Objetivo del estudio:

  • Analizar los desafíos y oportunidades asociados con la aplicación de la HTAR de la UE.
  • Identificar los factores clave para la adopción y optimización exitosas de los procesos de EAT.

Principales métodos:

  • Análisis cualitativo de los marcos regulatorios y comentarios de las partes interesadas.
  • Revisión de la preparación nacional para la EAT y de los obstáculos percibidos.

Principales resultados:

  • Los Estados miembros muestran diferentes niveles de preparación para el HTAR de la UE.
  • Existen preocupaciones con respecto a la soberanía nacional y las ineficiencias burocráticas.
  • La Consulta Científica Conjunta (CSC) es vital, pero requiere la ampliación de las franjas horarias y los criterios.

Conclusiones:

  • La preparación nacional, la reducción de la burocracia y la comunicación transparente son esenciales.
  • La expansión de la JSC y el aumento de la participación del médico/paciente fomentarán la confianza y la aplicación efectiva.
  • El fortalecimiento de la colaboración y la optimización de las vías regulatorias son fundamentales para maximizar los beneficios de la HTAR de la UE para el acceso de los pacientes a medicamentos innovadores.