ADPIC: CUESTIONES SOBRE LOS ADPIC

Los ADPIC y la salud pública

La Declaración de Doha relativa al Acuerdo sobre los ADPIC y la Salud Pública,acordada por los Miembros de la OMC en 2001, ayudó a configurar el marco normativo del sistema de propiedad intelectual en la esfera de la salud.  En ella se recalca la necesidad de que el Acuerdo de la OMC sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio(Acuerdo sobre los ADPIC) forme parte de la acción nacional e internacional más amplia encaminada a hacer frente a los problemas de salud pública que afligen a los países en desarrollo y menos adelantados. En la Declaración se señalan algunas opciones concretas que tienen a disposición los gobiernos para atender necesidades de salud pública, denominadas también "flexibilidades". Más recientemente, la inclusión de esas flexibilidades en los Objetivos de Desarrollo Sostenible Sostenible ha puesto en evidencia la importancia que revisten.

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Compulsory licences for export of medicines

The flexibilities identified in the Doha Declaration include “the right to grant compulsory licences”.  A compulsory license is issued by a government authority or a court to make certain use of a patented invention without the consent of the patent holder. This mechanism is generally present in most patent laws, is recognized as a permissible option or flexibility under the TRIPS Agreement, and has been used by a number of WTO members in the pharmaceutical field. However, TRIPS rules originally restricted compulsory licences to serve mainly the domestic market, unless they were issued to deal with anti-competitive behaviour.

The Doha Declaration recognized that this restriction on compulsory licensing could hamper its effective use by countries with insufficient or no manufacturing capacities in the pharmaceutical sector. The amendment of the TRIPS Agreement aims at removing this difficulty by creating an additional form of compulsory licence that had not existed before: a compulsory licence especially tailored for the export of medicines to countries in need – in effect, a 'trade related' compulsory licence. This mechanism was sometimes termed the 'paragraph 6 system', from its origins in the Doha Declaration.

The new Article 31bis of the TRIPS Agreement gives full legal effect to this system and allows low cost generic medicines to be produced and exported under a compulsory licence exclusively for the purpose of serving the needs of countries that cannot manufacture those products themselves.  For the minority of WTO members yet to accept the amendment, an interim waiver will continue to apply.

 

Background information

 

Extract on special compulsory licences from the WHO-WIPO-WTO Study, “Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade

Frequently asked questions: compulsory licensing of pharmaceuticals and TRIPS

TRIPS Council annual reports on the paragraph 6 system

 

Amendment to the TRIPS Agreement

News item on entry into force of the amendment.

Video statements: some of the key players share their thoughts on the entry into force of the amendment.

Factsheet on the TRIPS amendment

Text of the 2005 decision amending the TRIPS Agreement

Amendment of the TRIPS Agreement: How many members have accepted the amendment?

How to accept the protocol amending the TRIPS Agreement: Background information for members on procedures

 

Implementing compulsory licences for export of medicines

Special compulsory licences for export of medicines: key features of WTO Members' implementing legislation: Staff Working Paper

National implementation legislation: countries implementing the system in their laws

Illustrative guide to notifying under the system

 

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