Bird Flu: Science and Policy

[DewDiligence]

Baxter Inks Controversial Flu ‘Understanding’ with Indonesia

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Wed Feb 7, 2007 11:45 AM ET
By Fitri Wulandari

JAKARTA, Feb 7 (Reuters) - Indonesia signed a memorandum of understanding with a unit of U.S. company Baxter International Inc. <BAX> on Wednesday to develop a human bird flu vaccine, as Jakarta came under fire for not sharing samples of the virus.

Earlier reports of the pact -- which sets a framework for future talks with Baxter -- stirred controversy because it had been linked to Indonesia's decision not to share H5N1 bird flu virus samples with foreign laboratories.

"The Indonesian government does not have an exclusive arrangement with us," said Baxter spokeswoman Deborah Spak. "Our role is in developing and producing vaccines. We are not involved in ownership issues related to virus strains."

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.

Indonesia has the highest fatalities from the disease, accounting for 63 deaths out of the global total of 166 in the past four years. Bird flu largely remains an animal disease, but it can kill people who have close contact with infected fowl.

Kim Bush, president of Baxter's vaccine unit in Switzerland, said at the signing ceremony the decision on samples was Indonesia's.

"We certainly support and endorse the best practice recommendation coming from WHO (the World Health Organization) for the sharing of viruses and sequence data," Bush said.

Medical experts criticised Indonesia's decision not to share virus samples with foreign laboratories. "This seems to be a rather perverse take on intellectual property rights. It seems perverse that they would get upset by people using this," said a virologist in Hong Kong, who declined to be identified. "If it was a Western country that did that, there would be outright condemnation. How could they be so arrogant as to put the world at risk?"

If Baxter successfully develops a vaccine, it will confer protection against the H5N1 strain now in Indonesia, but not necessarily against other H5N1 strains prevalent in Indochina, parts of Europe, the Middle East and Africa.

"This is an ethical issue. The need to know should not be confined to just Indonesia; it is a world problem," said Hong Kong infectious disease expert Lo Wing-lok.

RULES OF THE GAME

Health Minister Siti Fadillah Supari defended Indonesia's decision, saying the samples should only be used for diagnostic and not commercial purposes.

"The specimens we sent to the WHO have been forwarded to their collaborating center. There it has been used for various reasons such as vaccine development ... or research," Supari said.

"Later they sold the discovery to us. This is not fair. We are the ones who got sick. They took the sample through WHO and with WHO consent and they tried to produce it for their own use," she said at a news conference after the signing of the pact with Baxter.

Supari said Australia was producing a human bird flu vaccine using the Indonesian virus strain, but did not give details.

"I was shocked because I never gave permits to Australia to produce a vaccine using our strain," she said.

"We have been working with Baxter since the beginning and are processing intellectual property rights with them. Baxter protects our intellectual property rights," she said.

Baxter's spokeswoman said the company has not signed any formal agreement.

"What this memorandum of understanding does is provide a framework for continued discussions that may or may not lead to a formal agreement or contract," Spak said.

A Health Ministry statement said the pact called for the ministry's research and development agency to supply specimens of H5N1; Baxter will provide technology to help develop a vaccine.

Health Ministry spokeswoman Lily Sulistyowati said on Tuesday that the vaccine was to prevent poultry-to-human infection, needed for the current situation but not for a future pandemic that might involve human-to-human transmission.

Under the memorandum of understanding, 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. Production would be carried out by makers appointed by the Health Ministry.

Supari said Indonesia hoped to have the vaccine ready by the end of the year. Another senior Indonesian official said earlier this month that development of the vaccine was at a very early stage.
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