AVIAN INFLUENZA (AI) SAMPLE SHARING UPDATE

UNCLAS JAKARTA 000310 SIPDIS SENSITIVE SIPDIS DEPT FOR EAP/MTS, G/AIAG AND OES DEPT PASS TO USAID/ANE/CLEMENTS AND GH/CARROLL DEPT ALSO PASS TO HHS/WSTEIGER/ABHAT/MSTLOUIS AND HHS/NIH NSC FOR JMELINE E.O. 12958: N/A TAGS: TBIO AMED CASC EAGR AMGT PGOV ID SUBJECT: AVIAN INFLUENZA (AI) SAMPLE SHARING UPDATE REF: A) Jakarta 00264 B) Jakarta 00107 ¶1. (SBU) Summary. The Mission continues working to reverse the January 11 verbal directive from the Indonesian National Institute of HEALTH and Research Development (NIHRD) instructing NAMRU-2 to no longer ship AI specimens to the U.S. Centers for Disease Control and Prevention (CDC) until NAMRU-2 signs a Materials Transfer Agreement (MTA). The Ambassador briefed Senior UN System Coordinator for Avian and Human Influenza Dr. David Nabarro on the issue on February 4, and the DCM discussed the issue at length on January 31 with NIHRD Director Triono Soendoro. Visiting CDC influenza branch official Dr. Reuben Donis raised the issue with Triono and Director General for Disease Control and Environmental HEALTH Dr. Nyoman Kandun on February 2. We have also briefed the World HEALTH Organization (WHO) office in Jakarta on the issue. After more than a week of emotional reactions to the issue, Triono has floated the idea of concluding an agreement between the NIHRD and CDC to allow the flow of samples to restart, an idea we believe has merit. We accordingly recommend no additional Washington action at this time pending further discussions between the CDC and NIHRD. ¶2. (SBU) Summary, continued. A number of factors appear to be driving the Ministry of Health's (MOH) approach to the issue, including a lack of understanding about how the WHO reference laboratory system works for influenza surveillance, a lack of understanding of the capabilities of Indonesia's own laboratories, the commercial interests of Indonesia's state-owned pharmaceutical companies, frustration over Indonesia's failure so far to benefit from research into the Indonesian H5N1 strain, and concerns about Indonesia's ability to pay full retail price for the millions of AI vaccine doses it hopes to stockpile. A February 6 Financial Times report quotes Triono confirming that the GOI is withholding AI samples because it wants to keep control of the intellectual property rights of the AI virus. He reportedly added that the GOI would make a major announcement on February 7 of collaboration with Baxter International on the development of an AI vaccine. End Summary. Triono Describes Concerns during Meeting with DCM -------------- -------------- ¶3. (SBU) At their January 31 meeting, NIHRD Director Dr. Triono Soendoro explained the Ministry of Health's concerns about sample sharing to the DCM. Triono said pharmaceutical companies had developed AI vaccines using information from Indonesian AI strains without permission and that Indonesia would not benefit from use of these strains. Triono explained that the GOI planned to acquire 5 million doses of vaccines but now faced having to pay USD 15 for each dose. GOI officials and Parliamentarians are criticizing NIHRD for having openly shared samples and posted data on the Genebank, without requiring organizations receiving Indonesian samples to sign MTAs. Triono also complained about international researchers involved in AI research making uncoordinated public announcements about AI in Indonesia or publishing studies on AI without prior GOI consultation, further upsetting the GOI. ¶4. (SBU) The DCM raised concerns that stopping sample flows are preventing WHO referral labs from performing full virus characterization. Without full virus sequencing, Indonesia and the world will be blind to possible virus changes that could make a pandemic more likely. He noted our concerns that the people of Indonesia and the world would suffer the consequences of this GOI decision. At the very least, the international community will see Indonesia as jeopardizing global public HEALTH and, as a result, Indonesia would lose international standing. However, Triono dismissed these concerns and denied that Indonesian researchers are not capable of performing full virus characterization. He claimed that researchers at the Eijkman Institute in Jakarta are conducting full virus characterization of AI samples and that an Eijkman BSL-3 laboratory is almost complete. (Note: Eijkman is capable of sequencing amplicons, and has the capability to sequence from each gene of the influence of virus, but cannot yet perform full genome sequencing. Without a BSL-3 lab, it also cannot grow the virus to conduct biological tests against drug resistance.) ¶5. (SBU) Triono admitted that MOH officials face enormous pressure on the sample control and MTA issue from other GOI agencies and Parliament. He asked why the USG was reluctant to sign a MTA when other countries expressed willingness to do so, citing Korea and Singapore as examples. Triono noted other WHO collaborating centers in Australia, Japan and the United Kingdom might also be candidates for sharing samples if they are willing to sign an MTA. (Note: We understand that the WHO Reference Centers in Tokyo and Melbourne have reviewed the MOH's draft MTA and will not sign it.) Nonetheless, Triono expressed interest in resolving the current sample-sharing blockage and discussed possible ideas for doing so, including USG subsidies for the purchase of vaccine needed by Indonesian government workers, some sort of joint venture between U.S. and Indonesian pharmaceutical companies to develop a H5N1 vaccine, and a more flexible U.S. approach to the MTA. CDC Influenza Branch Official Briefs GOI Officials -------------- -------------- ¶6. (SBU) On February 1-2, visiting CDC influenza branch official Dr. Ruben Donis met Triono, Director General for Disease Control and Environmental HEALTH Dr. Nyoman Kandun, and other NIHRD and Eijkman Institute staff. Donis described the necessary research steps for full characterization of the AI virus, and explained that growing the virus requires sufficient concentrations of genetic material that will allow researchers to do full sequencing. He stressed the importance of sequencing from purified virus isolates grown in a BSL-3 facility as opposed to characterization of small fragments, or amplicons, as is currently conducted by research scientists in Indonesia. Dr. Donis also reviewed with NIHRD the added importance of studying virus binding sites and conducting anti-viral testing on isolates. (Note: Indonesian researchers cannot conduct these studies at this time.) Dr. Triono noted that the Eijkman Institute's BSL-3 laboratory would not open for another few months. With limited analyses only, Indonesian researchers cannot determine when subtle but important changes in the virus occur. ¶7. (U) Donis also explained that WHO referral labs have two main objectives for virus study: risk assessment and vaccine development. Donis clarified that as a WHO-Influenza Reference Center, CDC is not concerned with vaccine production and vaccine marketing. CDC objectives are to promote public HEALTH through promotion of vaccine development by open sharing of information. This fosters competition which then drives down the price of vaccines and allows for greater vaccination programs. During the meeting, NIHRD staff also described a partnership between state-owned pharmaceutical company BioPharma and Baxter International Laboratories that has produced what they claimed to be an effective human AI vaccine. NIHRD officials praised this partnership as a possible model for future vaccine development. ¶8. (SBU) In his meetings with Donis and the DCM, Triono praised the NIHRD's interactions with NAMRU-2 and expressed strong support for keeping collaboration going. He has emphasized the need for more time to find constructive solutions and requested that the USG not increase pressure on the issue at this time. He said he would discuss with Minister of HEALTH Dr. Fadilah Supari the possibility of the NIHRD and CDC concluding an agreement on sample sharing that would remove NAMRU-2 from the middle of the MTA issue and allow the sample flow to resume. (Comment: ONE possible approach for the NIHRD-CDC agreement would be to incorporate language from January 2007 WHO best practices documents on influenza viruses and sequence data sharing that reiterates the obligations of WHO member states to share influenza samples for risk assessment and vaccine development purposes, but also calls on the WHO Director General to "take appropriate action" if a WHO collaborating center or H5 reference laboratory misuses a virus for research or commercial purposes.) Competition with Indonesian Vaccine Developers? -------------- -- ¶9. (U) On January 30, Reuters ran a newswire about CSL, an Australian plasma products maker that has successfully developed an AI vaccine that may be ready for widespread use within six months. The next day, Minister of HEALTH Supari reportedly criticized the firm for using Indonesian virus samples for the vaccine "without Indonesia's permission" because the Indonesian H5N1 strain is "Indonesia's intellectual property." Siti also revealed that Indonesia is developing its own vaccine in cooperation with the American Pharmaceutical company Baxter International. (Note: NAMRU-2 researchers tell us that CSL produced its vaccine via reverse genetics from a DNA sequence from an Indonesian H5N1 virus isolate obtained from a website at the U.S. National Institutes of Health. On August 3, 2006, Supari gave the WHO-Influenza Reference Centers permission to post sequence information from Indonesian viruses for the purpose of additional study and vaccine production.) Press Gets in on the Story -------------- ¶10. (SBU) On February 1, we also briefed Indonesia WHO Director George Peterson on the sample sharing issue in anticipation of UN System Senior Coordinator for Avian and Human Influenza David Navarro's February 2-4 visit to Indonesia of February 4. Peterson expressed serious concern about the development and promised to immediately contact WHO Geneva and alert Navarro to the developments. The Ambassador spoke with Nabarro via telephone on the issue on February 3, emphasizing our view that this is an international issue that requires all of our attention. Nabarro said he would raise the issue in his meetings. ¶11. (SBU) A Jakarta-based Financial Times (FT) reporter questioned Nabarro aggressively on the issue at a February 4 press conference, asking Nabarro and National Committee for AI Control and Pandemic Preparedness (KOMNAS) Executive Director Bayu Krisnamurthi repeatedly if Indonesia had stopped sharing AI samples. Neither Nabarro nor Krisnamurthi answered the question directly; Krisnamurthi noted only that the issue remains "under discussion." On February 6, the FT ran a story quoting Triono confirming that the GOI is withholding AI samples because it wants to keep control of the intellectual property rights of the AI virus. He reportedly added that the GOI would make a major announcement on February 7 of collaboration with Baxter International on the development of an AI vaccine. ¶12. (SBU) Comment: We are inclined to believe Triono's claim that he is facing strong pressure on the sample sharing issue and wants to resolve it quickly, and recommend no additional Washington action at this time pending further discussions between the CDC and NIHRD. But Triono likely has little time--now that press has picked up the fact that AI sample sharing has stopped, pressure on the GOI is likely to increase, particularly if Indonesia reports another large cluster as happened in January. End Comment. PASCOE