Ecuador

Presidential Decree No. 118 (Statement of Public Access to Medicines for Human Use)

Year of Version:2009
Date of Entry into Force:October 23, 2009
Date of Text (Issued):October 23, 2009
Type of Text:IP Laws: issued by the Executive
Subject Matter:Enforcement of IP and Related Laws, IP Regulatory Body, Other, Patents (Inventions)
Notes:
This Decree declares of public interest the access to medicines used to treat diseases affecting the Ecuadorian population and are a priority for public health. May be issued compulsory licenses on patents for medicines for human use which are necessary for their treatment. Are not considered as public health priority, cosmetic medicine, cosmetic, toiletries and, in general, which will not be for the treatment of diseases.

The Ecuadorian Institute of Intellectual Property (IEPI) through the National Directorate of Industrial Property is the competent national office to grant compulsory licenses to those requesting it, provided they meet the requirements of applicable law and this decree. Authorisation of compulsory licenses shall be considered on its individual merits and must be substantiated in each case. The IEPI grant compulsory licenses in coordination with the Ministry of Public Health.

The notification by Ecuador to the WTO under article 63.2 of TRIPS states:
'The notified Decree provides that access to medicines used for the treatment of diseases which affect the Ecuadorian population and which are a public health priority is a matter of public interest, and that compulsory licences may accordingly be issued on patents of such drugs for human use as are needed for their treatment.'
Available Texts: 
English

Presidential Decree No. 118 (Statement of Public Access to Medicines for Human Use) Presidential Decree No. 118 (Statement of Public Access to Medicines for Human Use), Complete document (pdf) [68 KB]

Spanish

Decreto Presidencial N° 118 (Declaración de interés público el acceso a medicinas de uso humano) Decreto Presidencial N° 118 (Declaración de interés público el acceso a medicinas de uso humano), Complete document (pdf) [104 KB] Decreto Presidencial N° 118 (Declaración de interés público el acceso a medicinas de uso humano), Complete document (htm) [19 KB] (Version with Automatic Translation Tool)

Related Legislation:
WIPO Lex No.:EC035

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