[Ip-health] Ecuador: Unofficial translation of President Correa's decree no. 118

[peter maybarduk]

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[ Picked text/plain from multipart/alternative ]
This is an unofficial translation =96 I'm afraid, not quite so eloquent
as the original =96 of Ecuadorean President Rafael Correa's declaration
on access to medicines and compulsory licensing (decree no. 118).
The original is available here: http://www.sigob.gov.ec/decretos/. -
peter

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No. 118

RAFAEL CORREA DELGADO


CONSTITUTIONAL PRESIDENT OF THE REPUBLIC

WHEREAS:


Article 32 of the Constitution of the Republic establishes that
health is a right ensured by the State, the fulfillment of which is
linked to the exercise of other rights sustaining well being;

Article 3.1 of the Constitution of the Republic provides that it is
an essential duty of the State to ensure without any discrimination
whatsoever the effective enjoyment of the rights provided in the
Constitution and in international instruments, particularly,
constitutionally recognized rights, such as health;

Article 363 No. 7 of the Constitution of the Republic provides that,
for the fulfillment of a regimen of well being, it is the obligation
of the State, in matters of health, to =93ensure availability and
access to quality, safe and effective medicine, regulate the
commercialization thereof and promote domestic production and use of
generic drugs that meet the epidemiological needs of the population.
In access to medicines, public health interests shall take precedence
over economic and commercial interests.=94

Article 31 of the World Trade Organization=92s Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPS) recognizes
the right of countries to issue compulsory licenses for drug patents
to combat and mitigate diseases of public interest;

The Doha declaration on the TRIPS Agreement and Public Health,
adopted unanimously by the Member States of the World Trade
Organization, specifies that each Member State =93has the right to
grant compulsory licenses and the freedom to determine the grounds
upon which such licenses are granted.=94  Additionally, the declaration
specifically states that the TRIPS Agreement should be interpreted
and applied to =93promote access to medicines for all;=94

The global strategy and plan of action on =93public health, innovation
and intellectual property=94 of the World Health Assembly, WHA 61.21,
paragraph 20,  states, =93Intellectual Property rights do not prevent
nor should they prevent Member States from taking measures to protect
public health.=94

Objective No. 3 of the 2007-2010 National Development Plan, enacted
under Executive Decree 745 of April 7, 2008, is: =93To raise the life
expectancy and the quality of life of the population;=94

The Andean Norm set forth in Decision 486, establishing a Common
Industrial Property Regime, contemplates compulsory licensing, as
does the Ecuadorean Law of Intellectual Property;

For fulfillment of this objective, the aforementioned National
Development Plan establishes policy 3.3 =93To ensure universal access
to essential medicines, consolidate authority and sovereignty of the
State in management of medicines and phyto-therapeutic resources,=94
with one of the strategies being the use of compulsory licenses as an
instrument for lowering the cost of medicines;

It is an interest of the State in the field of public health to
safeguard the equitable access to health care and, consequently, to
medicine, especially of the most vulnerable socio-economic classes.

In exercising the powers vested under sections 1 and 3 of Article 147
of the Constitution of the Republic and as provided under Article 65
of Decision 486 of the Andean Community of Nations:

DECREES:


Article 1.- Hereby declares of public interest access to medicines
used for the treatment of diseases that affect the Ecuadorean
population and are priorities for public health, for which compulsory
licenses may be granted for patents on any human use medicine that
may be necessary for treatment.  Cosmetic, esthetic, personal
hygienic medicines and, in general, those that are not used for the
treatment of disease, shall not be considered public health priorities.

Article 2.- The Ecuadorean Institute of Intellectual Property (IEPI),
through the National Directorate of Industrial Property, is the
Competent National Office to grant compulsory licenses to those who
apply for them, provided that such persons fulfill the requirements
set forth in applicable legislation and this decree.  Authorization
of Compulsory Licenses shall be considered in light of their
particular circumstances and shall be supported by a factual basis in
each case.  IEPI shall grant compulsory licenses in coordination with
the Ministry of Public Health.

Article 3.- The =93Leopoldo Izquieta Perez=94 National Institute of
Hygiene and Tropical Medicine shall take the steps necessary to
register medicines that may be produced or imported under the rules
of compulsory licensing, within a maximum period of thirty days
counted from the date of filing of the application, provided the
legal requirements are satisfied and the necessary procedures
followed to verify the quality, safety and efficacy of the medicines.

Article 4.- The Ecuadorian Institute of Intellectual Property,
through the National Directorate of Industrial Property, shall
establish the scope, purpose and time period for which licenses shall
be granted; as well as the amount and conditions of royalty payments,
and other requirements set forth in applicable law.

Article 5.- The Ecuadorean Institute of Intellectual Property,
through the National Directorate of Industrial Property, in
accordance with applicable legislation, shall notify patent holders
who are subject to the rules of compulsory licensing.

Article 6.- The time period of the compulsory license shall be set by
the competent body of the Ecuadorean Institute of Intellectual
Property.  This period may be declared terminated by said authority,
without prejudice to adequate protection of the legitimate interests
of persons who have received authorization for them, should the
circumstances giving rise to the license cease to exist and are
unlikely to recur.

General provision. =96 The Ministry of Public Health and the Ecuadorean
Institute of Intellectual Property are charged to execute this
decree, according to their fields of competence.

Final provision.- This Decree shall enter into force as of the time
of signing, without prejudice to the publication thereof in the
Official Record.

Signed in San Francisco de Quito, on October 23 of 2009.

[Signature]

RAFAEL CORREA DELGADO

CONSTITUTIONAL PRESIDENT OF THE REPUBLIC