[Ip-health] Indonesia mulls compulsory licenses on 3 more HIV/AIDS Drugs

Sarah Rimmington srimmington@essentialinformation.org
Mon Nov 26 10:22:08 2007


http://www.ip-watch.org/weblog/index.php?p=3D841
Intellectual Property Watch

26 November 2007
Indonesia Mulls Compulsory Licences On Three More HIV/AIDS Drugs

By Sinfah Tunsarawuth for Intellectual Property Watch
BANGKOK - Indonesia is considering exercising rights under its law to
produce cheaper versions of three additional patented HIV/AIDS drugs
without the patent-holders=92 permission, after having used the measure
earlier for three similar medicines.

Three second-line antiretroviral (ARV) drugs for HIV/AIDS patients are
in need in Indonesia, and current funding for the three drugs could dry
up soon, according to Samsuridjal Djauzi, a physician who is involved in
the government=92s compulsory licensing activities. Some HIV/AIDS patients
develop resistance to their first-line drugs during the course of their
treatment and need these second-line medicines to boost their immunity,
he said.

The three under consideration are tenofovir, didanosine and lopinavir,
said Djauzi, who teaches medical science at University of Indonesia in
Jakarta and works at a clinic to help HIV/AIDS patients. Djauzi spoke in
an interview with Intellectual Property Watch on the sidelines of a
meeting on compulsory licensing in Bangkok on 21-23 November. He said
his working group is now collecting data about the three drugs in order
to make proposals to the health minister, who will make the decision.
Tenofovir, didanosine and lopinavir are the generic names of the
patented versions which are produced and marketed by Gilead Sciences,
Bristol-Myers Squibb and Abbott Laboratories, respectively.

Djauzi said currently about 10,000 Indonesian patients are on first-line
ARVs and usually less than 5 percent of the patients would develop
resistance and would need the second-line ARVs, which are more expensive.

The Global Fund to Fight AIDs, Tuberculosis and Malaria now supplies
these second-line ARVs to Indonesia, but Djauzi said the supplies might
dry up soon as the fund might decide to cut its aid to the country.

Indonesia first issued a presidential decree to use compulsory licensing
for two ARVs - lamivudine and nevirapine - in 2004. In March 2007, the
decree was renewed to cover another ARV drug efavirenz, which replaced
nevirapine as the first-line drug.

Indonesia uses lamivudine, efavirenz and zidovudine as the three
first-line ARVs for its HIV/AIDS patients. The country did not impose a
compulsory licence on zidovudine as its patent had earlier expired.
These three drugs are now produced locally by PT Kimia Farma, a
state-owned pharmaceutical company.

Djauzi said if compulsory licences are issued on the three second-line
ARVs, Indonesia might have to import the ingredients from India, but
would make the generic versions locally.

He said the prices of these second-line ARVs have come down since the
local industry started to produce the generic versions of the first-line
drugs, but he was uncertain that multinational pharmaceutical companies
would keep the prices low without the pressure of potential compulsory
licences and competition from generic drugs.

=93They might cut the price now, but for how long?=94 the Indonesian doctor
said. =93However, the society wishes for a sustainable supply of ARV drugs
with affordable price. Therefore, the option of producing them in our
own country is much desirable.=94

Djauzi said in his paper presented at the Bangkok meeting that while the
number of Indonesians affected with HIV/AIDS is estimated at 190,000 to
210,000 in 2006, patients under the ARV treatment only amount to the
current 10,000 and the number could possibly rise to 30,000 at the end
of 2008. He said later in the interview that without an effective
control programme, the number of those affected by HIV/AIDS in Indonesia
could jump to one million in 2010.

=93In the long term, the generic version of patented drugs will be wider
used in developing countries,=94 he said.

Sinfah Tunsarawuth may be reached at info@ip-watch.ch.
Intellectual Property Watch

26 November 2007
Indonesia Mulls Compulsory Licences On Three More HIV/AIDS Drugs

By Sinfah Tunsarawuth for Intellectual Property Watch
BANGKOK - Indonesia is considering exercising rights under its law to
produce cheaper versions of three additional patented HIV/AIDS drugs
without the patent-holders=92 permission, after having used the measure
earlier for three similar medicines.

Three second-line antiretroviral (ARV) drugs for HIV/AIDS patients are
in need in Indonesia, and current funding for the three drugs could dry
up soon, according to Samsuridjal Djauzi, a physician who is involved in
the government=92s compulsory licensing activities. Some HIV/AIDS patients
develop resistance to their first-line drugs during the course of their
treatment and need these second-line medicines to boost their immunity,
he said.

The three under consideration are tenofovir, didanosine and lopinavir,
said Djauzi, who teaches medical science at University of Indonesia in
Jakarta and works at a clinic to help HIV/AIDS patients. Djauzi spoke in
an interview with Intellectual Property Watch on the sidelines of a
meeting on compulsory licensing in Bangkok on 21-23 November. He said
his working group is now collecting data about the three drugs in order
to make proposals to the health minister, who will make the decision.
Tenofovir, didanosine and lopinavir are the generic names of the
patented versions which are produced and marketed by Gilead Sciences,
Bristol-Myers Squibb and Abbott Laboratories, respectively.

Djauzi said currently about 10,000 Indonesian patients are on first-line
ARVs and usually less than 5 percent of the patients would develop
resistance and would need the second-line ARVs, which are more expensive.

The Global Fund to Fight AIDs, Tuberculosis and Malaria now supplies
these second-line ARVs to Indonesia, but Djauzi said the supplies might
dry up soon as the fund might decide to cut its aid to the country.

Indonesia first issued a presidential decree to use compulsory licensing
for two ARVs - lamivudine and nevirapine - in 2004. In March 2007, the
decree was renewed to cover another ARV drug efavirenz, which replaced
nevirapine as the first-line drug.

Indonesia uses lamivudine, efavirenz and zidovudine as the three
first-line ARVs for its HIV/AIDS patients. The country did not impose a
compulsory licence on zidovudine as its patent had earlier expired.
These three drugs are now produced locally by PT Kimia Farma, a
state-owned pharmaceutical company.

Djauzi said if compulsory licences are issued on the three second-line
ARVs, Indonesia might have to import the ingredients from India, but
would make the generic versions locally.

He said the prices of these second-line ARVs have come down since the
local industry started to produce the generic versions of the first-line
drugs, but he was uncertain that multinational pharmaceutical companies
would keep the prices low without the pressure of potential compulsory
licences and competition from generic drugs.

=93They might cut the price now, but for how long?=94 the Indonesian doctor
said. =93However, the society wishes for a sustainable supply of ARV drugs
with affordable price. Therefore, the option of producing them in our
own country is much desirable.=94

Djauzi said in his paper presented at the Bangkok meeting that while the
number of Indonesians affected with HIV/AIDS is estimated at 190,000 to
210,000 in 2006, patients under the ARV treatment only amount to the
current 10,000 and the number could possibly rise to 30,000 at the end
of 2008. He said later in the interview that without an effective
control programme, the number of those affected by HIV/AIDS in Indonesia
could jump to one million in 2010.

=93In the long term, the generic version of patented drugs will be wider
used in developing countries,=94 he said.

Sinfah Tunsarawuth may be reached at info@ip-watch.ch.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/