Harmonizing EU Health Legislation  for New Genomic Techniques

Katarína Zajác Ševcová

doi:10.14718/NovumJus.2024.18.3.4

Enviado: 2023-12-10

Publicado: 2024-12-01

DOI: 10.14718/NovumJus.2024.18.3.4

Armonización de la legislación sanitaria de la UE para las nuevas técnicas genómicas

Katarína Zajác Ševcová

Matej Bel University Banská Bystrica

https://orcid.org/0000-0003-0530-548X

Bio

Número: Vol. 18 Núm. 3 (2024): Septiembre - Diciembre

Cómo citar

Zajác Ševcová, K. (2024). Armonización de la legislación sanitaria de la UE para las nuevas técnicas genómicas. Novum Jus, 18(3), 95–125. https://doi.org/10.14718/NovumJus.2024.18.3.4

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Resumen

Este artículo examina la regulación y aplicación de las Nuevas Técnicas Genómicas (NTG) y las pruebas genéticas en la Unión Europea (UE). Analiza los aspectos detallados de las leyes de protección de datos de la UE, subrayando su importancia para salvaguardar la privacidad de los pacientes y facilitar el intercambio de datos en los sectores de la atención sanitaria y la investigación. El artículo profundiza en las dimensiones éticas y los avances tecnológicos de la ingeniería genética, centrándose específicamente en la edición de genes y las pruebas genéticas directas al consumidor, iluminando la compleja interacción entre la tecnología, la ética y los marcos jurídicos. El análisis se extiende a los diversos entornos normativos, tanto a escala nacional como de la UE, y pone de relieve la necesidad urgente de actualizar la legislación en respuesta a los rápidos avances de las tecnologías genómicas. Esta necesidad acentúa el reto permanente de encontrar un equilibrio entre el fomento de la innovación y el respeto de las normas éticas y jurídicas. Por otra parte, el
texto aborda los esfuerzos por armonizar la normativa sobre pruebas genéticas en todos los países europeos,
teniendo en cuenta las perspectivas de las múltiples partes interesadas. El discurso presentado subraya la complejidad y la importancia crítica de formular políticas que salvaguarden los intereses públicos e impulsen los avances científicos en este ámbito que está en rápida evolución. La UE debería mejorar la regulación y la normalización de los NTG en el ámbito de la salud humana y la medicina actualizando la legislación, aplicando protocolos de evaluación de riesgos y seguridad, estableciendo directrices éticas, implicando a las distintas partes interesadas, respetando las normas mundiales, fomentando la educación pública e integrando los NTG en los sistemas sanitarios, con el fin último de promover un desarrollo seguro y ético de estos y avanzar en los objetivos de salud pública.

Palabras clave:

NTG

nuevas técnicas genómicas

legislación

Unión Europea

Citas

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