[Ip-health] Text of Indonesia compulsory license
James Love
james.love@cptech.org
Mon Dec 6 11:24:01 2004
------
Thanks to Dr. Olaf Valverde Mordt of MSF/Indonesia, for providing this
english translation of the recently issued "government use" compulsory
license for 3TC and Nevirapine. Jamie
DECREE OF THE PRESIDENT REPUBLIC OF INDONESIA
NUMBER 83 YEAR 2004
REGARDING
EXPLOITATION OF PATENT BY THE GOVERNMENT ON
ANTI RETROVIRAL DRUGS
THE PRESIDENT OF THE REPUBLIC OF INDONESIA
Considering:
a. that in line with the urgent need in the effort to control HIV/AIDS
epidemic in Indonesia, it is necessary to provide access to Anti
Retroviral Drugs that are still protected under Patent;
b. that as exploitation of Article 5 of Government
Regulation No 27 of 2004 regarding the Mechanism of
Patent Exploitation by the Government, it is
necessary to stipulate a Presidential Decree
regarding Patent Exploitation of Anti Retroviral
Drugs by the Government;
In view of:
1. Article 4 paragraph (1) of the Constitution of 1945 as
amended by the Fourth Amendment of the Constitution of 1945;
2. Law No. 23 of 1992 regarding Health (State Gazette
of 1992 No. 100, Supplementary State Gazette No.
3495);
3. Law No. 14 of 2001 regarding Patent (State Gazette
of 2001 No. 109, Supplementary State Gazette No. 4130);
4. Government Regulation No. 27 of 2004 regarding
Patent Exploitation Mechanism by the Government
(State Gazette of 2004 No. 106, Supplementary State
Gazette No. 4423);
DECIDES:
Stipulating:
DECREE OF THE PRESIDENT REGARDING PATENT EXPLOITATION OF ANTI RETROVIRAL
DRUGS BY THE GOVERNMENT.
First: The exploitation of patent of Antiretroviral Drugs
by the Government is meant to comply the urgent need of
community in the effort to control HIV/AIDS epidemic.
Secondly: The type, name of Patent Holder, Patent number
and period of Patent exploitation of the Antiretroviral
Drugs as referred to the First Dictum is attached in the
Annex of this Decree.
Thirdly: Minister of Health may appoint a Pharmaceutical
Factory as the Patent exploiter for and on behalf of the "
Government to exploit the Patent by taking into account the
recommendations from Head of National Drug and Food Control
Authority.
Fourth: The Government shall give a 0.5% compensation fee of
the net selling value of Anti Retroviral Drugs to the Patent Holder.
Fifth: This Decree shall take effect on the date of its
enactment.
Enacted in Jakarta
On 5 October 2004
THE PRESIDENT OF REPUBLIC OF INDONESIA
signed
MEGAWATI SOEKARNOPUTRI
For true copy
Deputy Cabinet Secretary
Legal and Legislation Department,
Lambock V Nahattands
ANNEX
PRESIDENTIAL DECREE OF REPUBLIC OF INDONESIA
NUMBER : 83 YEAR 2004
DATED : 5 OCTOBER 2004
TYPE, NAME OF PATENT HOLDER, PATENT NUMBER, AND PERIOD OF PATENT
EXPLOITATION OF ANTI RETROVIRAL DRUGS
NO 1
TYPE Nevirapine
NAME OF PATENT HOLDER - Boehringer Ingelheim (BI)
PATENT NUMBER - ID 0001338
PERIOD OF PATENT EXPLOITATION - 7 years
NO 2
TYPE - Lamivudine
NAME OF PATENT HOLDER - Biochem Pharma INC
PATENT NUMBER - ID 0002473
PERIOD OF PATENT EXPLOITATION -N 8 years
THE PRESIDENT OF REPUBLIC OF INDONESIA
Signed
MEGAWATI SOEKARNOPUTRI
For true copy
Deputy Cabinet Secretary
Legal and Legislation Department,
Lambock V Nahattands
--
James Love, Director, CPTech, http://www.cptech.org
Consumer Project on Technology in Washington, DC
PO Box 19367, Washington, DC 20036, USA
Tel.: 1.202.387.8030, fax: 1.202.234.5176
Consumer Project on Technology in Geneva
1 Route des Morillons, CP 2100, 1211 Geneva 2, Switzerland
Tel: +41 22 791 6727
Mobile +1.202.361.3040
james.love@cptech.org