Indonesia Mulls Compulsory Licences On Three More HIV/AIDS Drugs

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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’ 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’s 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.

“They might cut the price now, but for how long?” the Indonesian doctor said. “However, 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.”

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.

“In the long term, the generic version of patented drugs will be more widely used in developing countries,” he said.

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

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