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MINUTA MEDICAMENTOS Y TLC CON LA UNIÓN EUROPEA

En la actualidad la industria farmacéutica busca extender los períodos en los cuales tiene exclusividad de mercado para un determinado medicamento. Esto se ha concretado a través de la introducción de nuevos mecanismos que indirectamente amplían el período de patente comercial (20 años según ADPIC).

Cuando Chile suscribió el TLC con Estados Unidos fue incorporado a la legislación chilena un mecanismo que se llama Información No Divulgada por 5 años y recientemente el Tratado Trans PacíLico trata de aplicar este mismo mecanismo para nuevas indicaciones por 3 años y sumar un segundo mecanismo que es la Protección de Comercialización para medicamentos biológicos por 3
años.

Los mecanismos antes señalados podemos definirlos de la siguiente forma:

1. Información No Divulgada (o Protección de Datos de Prueba): Es un mecanismo a través del cual el Laboratorio Innovador que desarrolló e investigó el medicamento impide que otros laboratorios realicen un registro sanitario utilizando los estudios de seguridad y eficacia realizados por el laboratorio que lo desarrolló. Este mecanismo actualmente está vigente en Chile por un período de 5 años.

2. Protección de Comercialización: Es un mecanismo a través del cual el Laboratorio Innovador impide el registro sanitario de un medicamento similar (o genérico) por un período adicional aunque tenga el registro sanitario necesario.

3. Nueva indicación: El Laboratorio Innovador utilizando alguno de los mecanismos para restringir el ingreso de medicamentos similares y ante el descubrimiento de una nueva indicación puede extender el período de exclusividad de mercado. El mecanismo utilizado puede ser la Información No Divulgada para los estudios que avalan la nueva indicación o la Protección de Comercialización.

En el siguiente link puedes revisar la minuta completa realizada por Fundación Equidad:

MINUTA MEDICAMENTOS Y TLC CON LA UNIÓN EUROPEA

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