Ecuador: Regime for mandatory licences for medicines
Description
The Presidency of the Republic issued Executive Decree # 118 regarding the licensing, including the mandatory licensing, of medicines. That decree, issued on 23 October 2009, contained the following articles:
ARTICLE 1.- To declare of public interest the access to medicines used for treatment of illnesses that affect to the Ecuadorian population that are priority to public health.
ARTICLE 2.- The Ecuadorian Institute of Intellectual Property ( IEPI), will grant mandatory licenses in coordination with the Public Health Ministry.
ARTICLE 3.- The National Institute of Hygiene and Tropical Medicine,"Leopoldo Izquieta Pérez", will grant the sanitary records to medicines produced or imported under the mandatory licenses.
ARTICLE 4.- The Ecuadorian Institute of Intellectual Property (IEPI) will establish the scope, object and and terms by which the license is granted as well as the amount and conditions of payment of the royalties of such licenses.
The objective of this measure is "[...] to assure the universal access to essential medicines, to consolidate the authority and sovereignty of the state in the managing of medicines and physioterapeutical resources, by means of the utilization of mandatory licenses as instruments to reduce the costs of the medicines."
Any Evidence-Based Deliberation:
| Question | Result |
|---|---|
| Is there anything in the public record to suggest that evidence of the effectiveness of the proposed measure was considered during official deliberations? | Don't know |
| Is there any evidence that alternatives to the proposed measure were considered? | Don't Know |
| Is there anything in the public record that suggests that empirical evidence informed the comparison across the alternatives available to government? | Don't Know |
| Was such evidence identified? | Don't Know |
| Is such evidence publicly available? | Don't Know |
| Did the official decision-maker in question provide an explanation as to why a chosen measure was favoured over alternatives? | Don't Know |
| Is there any evidence to suggest that potentially affected trading partners were consulted before the measures were taken? | Don't Know |
| Is there any evidence that safeguards have been put in place to ensure that implementation of the initiative is transparent and non-discriminatory? | Don't Know |
| Did the government state its intention to review the measure within one year of implementation? | Don't Know |
Date Discovered: 24/10/2009
Implemented: Yes
Date of inception: 23 Oct 2009
GTA Evaluation: Red
Source:
Presidency of the Republic, Executive Decree # 118
Government Response: .
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