Spain: Controversia en la propuesta de la Comisión Europea de excepción de fabricación al Certificado Complementario de Protección (CCP)

Last Updated: 6 June 2018
Article by Fátima Mateos

La Unión europea abrió una consulta pública a finales de 2017 para modificar la regulación de la propiedad intelectual de los medicamentos.

La consulta tenía como objetivo explorar una recalibración de ciertos aspectos de la protección mediante patente y certificado de protección suplementaria (CCP), y anunció que esta recalibración podría comprender los siguientes 3 puntos:

  • la creación de un título europeo de CCP,
  • una actualización del alcance de las exenciones de investigación de patentes de la UE,
  • la introducción de una exención de fabricación al CCP.

Los CCPs son un derecho de propiedad intelectual único que constituye una extensión (de hasta 5 años) del plazo de un derecho de patente (de 20 años). Los CCPs se aplican a productos farmacéuticos y fitosanitarios innovadores que han sido autorizados por las autoridades reguladoras. Su objetivo es compensar la pérdida de protección efectiva de patentes que se produce debido a las pruebas obligatorias y prolongadas y los ensayos clínicos que los productos requieren antes de obtener la aprobación regulatoria de comercialización.

Con esta consulta se pretende actualizar los CCPs, y también todo lo referente a la cláusula Bolar, una exención legislativa que permite a las compañías de genéricos producir medicamentos todavía bajo protección siempre y cuando no se vayan a comercializar en la Unión Europea.

La consulta sobre la exención de fabricación de CCP es quizás la cuestión que ha generado más debate en el sector. La patronal de los genéricos de la Unión Europea "Medicines for Europe" emitió un comunicado el pasado 28 de Mayo de 2018, en que ha pedido una exención de los CCPs para la fabricación de medicamentos y que se amplíe la definición de la cláusula Bolar.

La autorización inicial de comercialización de nuevos medicamentos a menudo se otorga en diferentes momentos para diferentes mercados. Como resultado, los períodos de protección caducan en diferentes momentos, por ejemplo, en los Estados Unidos y Europa. En la mayoría de los casos, la protección total es más larga en Europa que en cualquier otra región del mundo.

El actual reglamento europeo CCP deja la industria de medicamentos genéricos y biosimilares en la Unión Europea en desventaja competitiva. Los fabricantes genéricos y biosimilares basados en la UE no pueden producir medicamentos para exportar a regiones donde los períodos de protección ya han expirado o para su lanzamiento inmediato en Europa después de que expiren los CCPs mientras el medicamento de referencia esté protegido por un certificado de protección complementario en el UE.

Según estimaciones de la Comisión Europea, los genéricos y los biosimilares podrían representar hasta el 80 por ciento del volumen de medicamentos para 2020. Sin embargo, la falta de incentivos para invertir como resultado de la normativa actual significa que la industria europea no podrá realizar todo su potencial en el mercado único de la Unión Europea a largo plazo.

Los fabricantes de medicamentos genéricos y biosimilares ubicados en otros países sin protección de CCP (por ejemplo, Canadá, Brasil, Rusia, India, China, etc.) o con períodos de protección más cortos pueden ingresar a mercados de exportación o UE sin protección hasta cinco años antes que sus competidores europeos.

Además, las PYMEs a menudo no tienen recursos para establecer plantas de fabricación en el exterior. Por lo tanto, renuncian a la producción durante el período del CCP, perdiendo competitividad frente a otras empresas del sector en Europa y en el extranjero o se ven obligados a subcontratar la producción a terceros fabricantes en países que no pertenecen a la Unión Europea.

La situación actual otorga a los fabricantes no comunitarios una ventaja de tiempo de entrega, es decir, les permite ingresar al mercado genérico y biosimilar en EE. UU. tan pronto como caduque el período similar al de CCP.

"Medicines for Europe" asegura que con la aprobación de esta normativa hasta 2025 se crearían entre 20.000 y 25.000 nuevos puestos de trabajo. Además, se incrementarían las ventas netas de la industria farmacéutica en Europa entre 7.300 millones y 9.500 millones, y se garantizaría una entrada más rápida de competencia genérica y biosimilar, lo que generaría ahorros en el gasto farmacéutico de 1.600 millones a 3.100 millones de euros. El sector europeo de los fabricantes de principios activos también se beneficiaría, ascendiendo sus ventas de 211,8 millones a 254,3 millones para 2030, creando 2000 empleos adicionales en ese sector.

Sin embargo, la Federación Europea de Industrias y Asociaciones Farmacéuticas (EFPIA) considera que la propuesta de la Comisión reduce los derechos de propiedad industrial y podría condicionar el desarrollo de medicamentos innovadores y mermar el acceso a éstos por parte de los pacientes. Además, envía la señal de que Europa debilita su compromiso con la propiedad industrial poniendo en riesgo la inversión en innovación de la industria farmacéutica (35.000 millones de euros al año) y su capacidad de generación de empleo (700.000 empleados en todo el continente, 118.000 de ellos dedicados a actividades de I+D) y su aportación tanto al crecimiento económico como al avance en el cuidado de los pacientes.

La industria farmacéutica innovadora teme que esta propuesta de devaluación del sistema de protección de la propiedad industrial, además de ser perjudicial para el desarrollo de fármacos innovadores en Europa, pueda causar el traslado de buena parte de la actividad de innovación biomédica que ahora mismo se desarrolla en el continente a otros lugares del mundo que valoren y potencien la economía basada en el conocimiento.

Ahora sólo queda esperar a las nuevas medidas que adoptará la Comisión Europea con el fin de equilibrar los intereses de la industria farmacéutica con respecto a sus derechos de propiedad industrial frente a la industria de los genéricos y biosimilares.


Clarke, Modet & Co - SPAIN


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