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WHO Must Set Rules on H5N1 Sharing, say Indonesian authorities

Wednesday February 21, 2007

Indonesia will not share bird flu virus samples with foreign laboratories until the World Health Organization has rules in place to ensure they are not used commercially, a senior Indonesian health official said on Friday (9/2/07).

Experts say sharing H5N1 samples is crucial as it allows specialists to study the makeup of the virus and trace its evolution and the geographical spread of any particular strain. Samples are also used to prepare vaccines.

Jakarta argues that the prevailing system allows drug firms to use these samples to make vaccines that developing countries often cannot afford, reports Indonesia’s Trade and Investment News, quoting Reuters. 

Triono Soendoro, director general of the National Institute of Health Research and Development, told Reuters the WHO must help Indonesia draft a "material transfer agreement" specifying the virus samples would be used only for diagnostic purposes and not for commercial gain.

"Until it is resolved, sending specimens to WHO collaborating centers will not be resumed," Soendoro said.

The requirement for having an agreement for transferring virus samples and limited use of the samples for diagnostic purposes is also implicit under Indonesia's 1992 health law, he added.

Indonesia said last week it would only share its H5N1 samples with those agreeing not to use them commercially. The announcement came as it signed a preliminary agreement with a unit of pharmaceutical firm Baxter International Inc.

Under the pact the health ministry's research and development institute will supply the US firm with specimens of H5N1, while Baxter will provide technology to help develop a vaccine. Indonesia would have the right to produce and market the bird flu vaccine domestically. It is negotiating to export it to a number of countries.

Asked if Indonesia would share the virus strain and allow other drug makers to produce a vaccine for the rest of the world if a pandemic started in Indonesia, Soendoro said it would.

"We are not standing in the way. There's nothing exclusive with Baxter. If they want it, they just have to talk us. "If necessary, we will donate them to the poorest nations. What we don't want when the pandemic strikes, (is for) the vaccine being traded (commercially)," he added.
Soendoro said Indonesia would start a clinical trial of a human bird flu vaccine using its H5N1 strain between March and April this year. It plans to produce two million dosages of bird flu vaccine, if the vaccine-making process is successful.

Getting an affordable bird flu vaccine is of huge concern for developing countries as many life-saving medicines from HIV antiretrovirals to heart disease drugs are often inaccessible due to restrictive patent laws.

Indonesia's move struck a chord with Thailand, which recently voiced similar fears at a WHO meeting in Geneva. "The Indonesian health minister is wise, and sending a strong message that, unless developing countries which are at the epicenter of the pandemic can be assured access to potential pandemic flu vaccines, they should not cooperate by sending out the viruses to WHO," said Suwit Wibulpolprasert, a senior public health official in Thailand's Ministry of Public Health.

In the latest development, Health Minister Siti Fadillah Supari said that she would soon meet with WHO officials to clear the issue. She explained that Indonesia’s move was a "reaction" after Australia-based pharmaceutical company CSL Ltd. developed human vaccines "without Jakarta's consent" using the Indonesian strain sent to WHO centers. She called it a timely move to 'speak up' for equality and justice, reported Indonesia’s Trade and Investment News. 

Indonesia last week appointed Swiss-based Baxter Healthcare SA, a subsidiary of US drug maker Baxter International Inc., to develop human vaccines with the Indonesian strain.

The refusal to share the samples drew immediate criticism from many who said Indonesia's move could jeopardize the world's access to a pandemic vaccine, especially if Indonesia became the epicenter of a global outbreak.

According to Supari, Indonesia's decision to control its virus samples has gained support from other developing countries. "The most important thing is that we speak out. Besides, usually, we, the third world, lose the battle. But as an international organization, WHO should have been wise, fair and neutral."
Indonesia's decision was defended by the Lancet medical journal, which said the WHO must find a way to help poorer countries benefit more from medical research done by rich companies. "Indonesia fears that vaccines produced from their viruses via the WHO system will not be affordable to them," the editorial reads.

"Their concerns are forcing the world to address this inequity problem. The fairest way forward would be for WHO to seek an international agreement that would ensure that developing countries have equal access to a pandemic vaccine, at an affordable price," it said.