MARCH 28 HIGH-LEVEL MEETING ON AVIAN INFLUENZA SAMPLE

UNCLAS SECTION 01 OF 08 JAKARTA 000933 SIPDIS SENSITIVE SIPDIS DEPT FOR EAP/MTS AND G/AIAG USAID FOR ANE/CLEMENTS AND GH/CARROLL GENEVA FOR WHO/HOHMAN E.O. 12958: N/A TAGS: TBIO AMED CASC EAGR KFLU PGOV ID SUBJECT: MARCH 28 HIGH-LEVEL MEETING ON AVIAN INFLUENZA SAMPLE SHARING ¶1. (SBU) Indonesian HEALTH Minister Dr. Fadilah Supari repeatedly pledged to resume sharing avian influenza (AI) samples with the international community during the March 29 "High Level Meeting on Responsible Practices for Sharing Avian Influenza Viruses and Resulting Benefit" in Jakarta. Supari made the same pledge at a March 27 press conference in both English and Indonesian, and repeated it the next morning in a session including President Susilo Bambang Yudhoyono (SBY). The meeting adopted a "Jakarta Declaration" that endorsed a set of technical recommendations drafted at a March 26-27 experts meeting, the most noteworthy of which is a recommendation to develop "detailed, technical Terms of Reference" (TORs) for World HEALTH Organization (WHO) collaborating centers to use when sharing viruses. In his opening address to conference participants, SBY did not mention the sample sharing issue, but instead called on participants to put "equality between countries at the center of our defense strategies" against AI. Participants welcomed March 23 and 27 statements by Secretary of Health and Human Services Mike Leavitt supporting the Government of Indonesia's (GOI) decision to resume sample sharing and committing $10 million to the WHO to expand the development and manufacturing infrastructure for influenza vaccine in developing countries. Most speakers at the March 28 meeting welcomed the GOI's decision to resume sample sharing while emphasizing the validity of Indonesia's concerns about the ability of developing countries to obtain sufficient quantities of affordable AI vaccine. Canada, the United Kingdom, and Japan also raised questions about the status of the technical recommendations, with the latter two countries noting their support for the document did not signify new financial commitments. Supari told participants at the end of the meeting that Indonesia intends to introduce a resolution at the May 2007 World HEALTH Assembly containing the Jakarta Declaration, and asked participating countries to co-sponsor it. The WHO and twenty five countries participated in the meeting (para 14); the Embassy represented the U.S. as an observer. End Summary. GOI Breaks the Sample Sharing Deadlock -------------- ¶2. (SBU) After more than three months of negotiations with the WHO, the GOI moved to end the deadlock over the sharing of Indonesian AI samples with WHO Collaborating Centers during the March 26-28 meetings on responsible practices for sharing AI viruses and resulting benefits in Jakarta. HEALTH Minister Dr. Fadilah Supari announced the decision at a March 27 press conference with Indonesian and international journalists, and repeated it the next morning in the presence of SBY. Supari explained to a skeptical media that despite her provocative rhetoric on the issue in recent weeks, Indonesia now trusts the WHO to move quickly to develop new TORs for sample sharing, and is therefore willing to begin sharing samples immediately. (Note: As of March 30, the GOI has not yet shipped any AI samples overseas.) ¶3. (U) In his remarks opening the March 28 meeting, SBY recalled the history of influenza pandemics in the 20th century, and said the economic and social consequences of an AI pandemic would be enormous. Noting that the H5N1 virus had advanced rapidly across national boundaries, SBY said it is "our responsibility to ensure that all the nations of the world are prepared to prevent and fight it." But the efforts of countries to respond to AI are very uneven depending on the capacity of countries, a discrepancy that "can be harmful to global efforts to avoid a potential pandemic...The deliberations in this High-Level Meeting must therefore focus on realizing this equality by examining together...all possible ways to JAKARTA 00000933 002 OF 008 bring countries up to par through a more altruistic approach to sample and information sharing...." SBY emphasized that the key to global pandemic preparedness is to encourage "home-grown research, laboratory, and production capabilities" in developing countries, and "assisting them in the production of their own vaccines and drugs at affordable prices." "Jakarta Declaration" and Experts Recommendations -------------- -------------- ¶4. (SBU) Under the chairmanship of Supari, the meeting adopted a seven-point "Jakarta Declaration", the text of which is contained in para 12 below. The GOI distributed the draft declaration late on the evening of March 27. The revised version differed significantly from a version the GOI had distributed in Geneva in early March. The meeting adopted the declaration with very little discussion the next day. The only difference between the March 27 draft and the version adopted the next day was the insertion of the words "and the Global Pandemic Influenza Action Plan to increase vaccine supply" in point six, done at the request of Canada. WHO representatives at the meeting clarified that although the WHO had convened the March 26-27 high-level technical meeting, it had not been a "formal technical consultation" because not all countries were invited, and the results are therefore considered only informal recommendations to the WHO Director General. ¶5. (SBU) Importantly, the "Jakarta Declaration" also contained a statement endorsing the recommendations of a high-level technical meeting held March 26-27 (see para 13). The recommendations touch on strengthening the global influenza surveillance system, capacity building for developing countries, and improving access to safe, effective, and quality H5N1 and other potential pandemic influenza vaccines. Two aspects of the recommendations proved somewhat controversial. The first is a recommendation to develop by the end of June 2007 "detailed, technical Terms of Reference" (TORs) to govern the sharing of influenza viruses with WHO Collaborating Centers. According to the recommendations, the "TORs related to virus sharing will be reflected in a standard material transfer document that will be included as part of the shipping documents sent with each specimen." The TORs should clearly define what may done with the specimens through the generation of seed viruses for future vaccine research development and production, with uses of the viruses outside the TORs requiring the prior consent of the originating country. The WHO will draft the TORs and follow "appropriate participatory processes for approval." ¶6. (SBU) The technical recommendations' call for the WHO to "seek the support of industrialized countries...for the stockpiling of safe and effective H5N1 and other potential pandemic influenza vaccines" sparked Japan and the UK to make clarifying remarks. The two countries noted they are already major donors in the fight against AI, and that neither section 4.3 of the recommendations or point 7 of the "Jakarta Declaration" should be taken to imply any additional obligations on the part of stakeholders at this stage. Japan noted in its statement that item 4 in the "Jakarta Declaration" should "not be interpreted as an actual financial commitment." ¶7. (U) At the conclusion of the meeting, Supari told participants that Indonesia intends to introduce a resolution at the May 2007 World HEALTH Assembly containing the Jakarta Declaration, and asked countries participating in the meeting to co-sponsor it. JAKARTA 00000933 003 OF 008 Broadly Supportive Statements by Participants -------------- ¶8. (SBU) Most participants, including some developed countries, were broadly supportive of Indonesia's efforts to bring the issue of equity in vaccine development and distribution to the fore. Dr. David Salisbury, Chairman of the Technical Meeting, briefed on the outcome of the technical meetings. He emphasized that getting the world prepared for pandemic influenza needs to be done on an equitable basis, but that it is also important to make seasonal viruses quickly available. The vaccine manufacturing industry is "part of our salvation," Salisbury said, given the need for vastly larger quantities of vaccine. Noting that "getting viruses into the most expert hands is the highest priority," Salisbury welcomed Indonesia's decision to resume sample sharing. In subsequent statements, the WHO, Australia, Philippines, Canada, Singapore, Japan, and the UK also congratulated Indonesia for resuming sample sharing. ¶9. (U) The WHO Representative noted his organization has initiated programs to increase the production capacity for developing countries, but they are insufficient. The WHO agrees with the importance of the three areas of actions in the technical recommendations, the representative noted, and will "do its best" to implement them. "The WHO is committed to working immediately from day ONE to translate our commitment into action," the representative concluded. ¶10. (SBU) Australian Minister of HEALTH and Aging Tony Abbott, ONE of four HEALTH ministers who attended the meeting, noted it is a "very natural and human reaction" for the GOI to try to benefit from the presence of H5N1 in Indonesia. H5N1 is potentially a global problem requiring a global solution, Abbott noted, and is a "problem too important to be stymied by unseemly haggling over property rights." Australia is "thrilled and grateful" that Indonesia will resume sample sharing, but there is also a need for "fair and reasonable access to vaccines produced from samples." Abbott suggested that the WHO consider developing a system where a portion of H5N1 vaccine be placed in a stockpile under WHO control, once they are available. He noted the WHO Secretariat has a big job to do through June 2007 in figuring out how the principles in the technical recommendations should be reflected in the new TORs. He concluded by noting the Jakarta meeting had represented an "important clearing of the air, resolution of tension, and placing on the table of legitimate concerns of countries representing billions of people." The issues are now on their way to resolution, Abbott added, and Australia stands ready to work with the WHO, APEC, ASEAN, and other groups to fight the potential scourge of AI. ¶11. (SBU) Other noteworthy statements by delegations included the following: --Canadian Ambassador John Holmes stated that the recommendations from the high-level technical meeting are an "important step forward." They build on previous documents, have established a timeline for resolving the issue, and set up a process with the WHO in the lead. "For these reasons, Canada can support the recommendations," Holmes said. --Singapore said there is a need to strengthen the global HEALTH community based on trust. Singapore doesn't want any single company or group of scientists to have a monopoly, because this would slow down vaccine development and production. The recent delay in sample JAKARTA 00000933 004 OF 008 sharing had put some people at risk, but the Jakarta meeting had initiated a global discussion about equity in vaccine development and sharing. --Japan: In addition to the concerns about resource implications noted above, Japan acknowledged the world faces a need for an updated mechanism for risk assessment and response. The Japanese representative noted his country is encouraged that HEALTH Minister Supari had declared Indonesia will immediately resume sample sharing in a spirit of trust, while the WHO puts an improved mechanism in place. --UK: Matthew Rous, DCM at the British Embassy, noted the international community, working through the WHO, has established two cornerstones of our efforts to tackle the risks of pandemic influenza - the 2005 International HEALTH Regulations and the Global Vaccine Action Plan. The effective implementation of both is essential, he said. Rous noted that the UK Government welcomes the progress reported by the WHO this week in implementing the Global Vaccine Action Plan, particularly those elements that address access for developing countries. However, he cautioned these discussions "cannot and should not be definitive" because they involve only ONE group of countries. Further technical exchanges may be needed before the World HEALTH Assembly in May, where any new policy decisions or commitments could appropriately be made. --Thailand: Dr. Morakot Kornkasem, Deputy Minister for Public Health, stated "the status quo is not acceptable. We need a new way of thinking." Thailand is happy to endorse the Jakarta Declaration, Kornkasem said, and fully supports a discussion of the issue at the May 2007 World HEALTH Assembly. Kornkasem also said the Thai Government is in the process of approving a $45 million plan for the development of an influenza vaccine production plant in Thailand. The Thai cabinet should approve the plan in the next two weeks. It had been difficult to find partners, Kornkasem said, but thanks to China and the WHO, Thailand now has sources for technology transfer. Thailand hopes to have the plant up and running within three years. It will also update its National Pandemic Preparedness Plan to included the issues raised in the Jakarta meetings. --Brunei Darussalam, Laos, Cambodia, and Burma each endorsed the Jakarta Declaration. Brunei applauded the WHO effort to develop a mechanism that could promote a more equitable distribution of vaccines, while Burma said the costs of differential pricing for H5N1 vaccines should be born by developed countries. Vaccines sold to developing countries should be priced at or near cost, the Burmese representative said. --Vietnam: The Vietnamese representative said organizations and companies that use biological materials should share the responsibilities, ask permission, and use the name of the originating countries in publications and products. Text of Jakarta Declaration -------------- ¶12. (U) Text of "Jakarta Declaration": Jakarta Declaration on Responsible Practices for Sharing Avian Influenza Viruses and Resulting Benefits High-Level Meeting on Responsible Practices for Sharing Avian Influenza Viruses and Resulting Benefits JAKARTA 00000933 005 OF 008 Jakarta Declaration ¶1. We, the HEALTH Ministers of affected and other related countries, assembled in Jakarta on 28 March 2007 to explore the modalities of a framework that strongly emphasizes the need for developing countries to share in the benefits resulting from the open and timely and equitable sharing and dissemination of information, data and biological specimens related to influenza, and especially the development and production of influenza vaccines that are accessible and affordable for all countries in order to accelerate local, regional and global preparedness and response to the threat of pandemic avian influenza; ¶2. We underline that global risk assessment and risk response to the threat of pandemic influenza including avian influenza require concerted efforts among states, international partners, including UN organizations, donor agencies, manufacturing industries, and civil society organizations; ¶3. We acknowledge the need for open, timely, and equitable sharing and dissemination of information, data and biological specimens related to influenza and their benefits; ¶4. We endorse the "Recommendation on Responsible Practices for Sharing Avian Influenza Viruses and Resulting Benefits", that was, recently developed in the High-Level Technical Meeting that took place in Jakarta, Indonesia, on 26-27 March 2007; ¶5. We urge all member states of the WHO to commit to support, strengthen and improve the Global Influenza Surveillance Network leading to a more transparent and equitable sharing of benefits from the generation of information, diagnostics, drugs, vaccines, and other technologies through the aforementioned framework; ¶6. We call upon all member states of the WHO to discuss the matters in the 60th World HEALTH Assembly in May 2007 in order to build on the WHO Best Practices for Sharing Influenza Viruses and Sequence Data, and the Global Pandemic Influenza Action Plan to increase vaccine supply, which will ultimately result in stronger global public HEALTH security; ¶7. We, the HEALTH Ministers, request the WHO to convene the necessary meetings, initiate the critical processes and obtain the essential commitment of all stakeholders to establish the mechanisms for more open virus and information sharing and accessibility to avian influenza and other potential pandemic influenza vaccines for developing countries. Jakarta, 28 March 2007 Text of Recommendations of Technical Meeting -------------- ¶13. (U) Begin text: HIGH-LEVEL TECHNICAL MEETING ON RESPONSIBLE PRACTICES FOR SHARING AVIAN INFLUENZA VIRUSES AND RESULTING BENEFITS Jakarta, Indonesia 26 - 27 March 2007 Recommendations for consideration by High Level meeting on March 28, JAKARTA 00000933 006 OF 008 2007 ¶1. Global risk assessment and risk response to the threat of pandemic influenza including avian influenza require concerted efforts among states, international partners, including UN organizations, manufacturing industry, and civil society organizations. These efforts aim to address a broad spectrum of intertwined activities that include: global influenza virus and disease surveillance, sharing of viruses and associated genetic sequence data, in-depth characterization of influenza viruses, development of updated diagnostic test and selection of vaccine strain candidates and vaccine production and distribution; ¶2. The WHO High-Level Technical Meeting on Responsible Practices for Sharing Avian Influenza Viruses and Resulting Benefits held in Jakarta, Indonesia, on 26-27 March 2007 explored the modalities of a framework that emphasizes the need for developing countries to share in the benefits resulting from sharing virus specimens. The discussions covered the need for open, timely and equitable sharing and dissemination of information, data and biological specimens related to influenza. It also underscored the need to develop and produce influenza vaccines that are accessible and affordable for all countries in order to accelerate local, regional and global response to the threat of pandemic avian influenza; ¶3. The High-Level Technical Meeting agreed to propose the establishment of a framework for affordable and equitable access to influenza vaccines, including pandemic influenza vaccines as part of pandemic preparedness. This framework should also include responsible influenza specimen and data sharing practices. ¶4. To this end, the High-Level Technical Meeting submitted these recommendations for consideration at the High Level Meeting, convened by the Ministry of HEALTH of the Republic of Indonesia in Jakarta on 28 March 2007. All member countries of WHO should commit to support, strengthen and improve the Global Influenza Surveillance Network leading to a more transparent and equitable sharing of benefits from the generation of information, diagnostics, drugs, vaccines, and other technologies. These can be accomplished by pursuing three groups of concrete actions: 4.1 The strengthening and improvement of Global Influenza Surveillance Network for sharing of biological materials Any international sharing of biological materials with WHO Collaborating Centers will be conducted in accordance with existing international and national regulations. For sharing of influenza viruses, the "Best Practices for Sharing Influenza Viruses and Sequence Data", should be followed, as well as detailed, technical Terms of Reference (TORs) for the WHO Collaborating Centres, which will be developed. The TORs related to virus sharing will be reflected in a standard material transfer document that will be included as part of the shipping documents sent with each specimen by the country sharing virus. Such detailed TORs will clearly define what may be done with the specimens and include at least: a. The identification, characterization, reporting of results, development of essential diagnostics for public HEALTH use, generation of seed viruses for future vaccine research development JAKARTA 00000933 007 OF 008 and production and monitoring of influenza viruses, including avian influenza viruses, for the purpose of assessing pandemic threats and future vaccines production; b. Any uses of the influenza viruses outside the specific TORs of WHO Collaborating Centers will require the prior consent of the originating country. However this should not hinder the development of any essential HEALTH Technologies. c. These new procedures should be drafted by the WHO Secretariat by the end of June 2007 and go through the appropriate participatory process for approval. 4.2 Capacity building for developing countries a. WHO should make its best efforts to immediately intensify its capacity building activities, appropriate to the situation in each developing country. This is particularly important in those countries affected by the H5NI viruses or those that have high risk due to geographical vicinity. This capacity building could include, but is not limited to: (1) Virus identification (2) Virus characterization (3) Identification of new strain of viruses (4) Generation and interpretation of influenza and avian influenza associated data (5) Generation of seed virus for vaccine production WHO, in consultation with countries, will make the decision on which capacity is appropriate to be strengthened or built within each specific country. b. WHO takes immediate actions to include more developing countries particularly those who have been affected by the H5N1 or are at high risk due to geographical vicinity, with additional capacity building, to better contribute to WHO's global influenza surveillance activities, and to be designated as WHO H5 influenza reference laboratories. 4.3 Actions to improve access to safe, effective and quality H5N1 and other potential pandemic influenza vaccines a. WHO should seek the support of industrialized countries, other financial partners and vaccine manufacturers, to mobilize financial and technical support for the stockpiling of safe and effective H5N1 and other potential pandemic influenza vaccines that may be used in developing countries, particularly those that have been affected by the viruses or have high risk due to geographical vicinity. For countries with the capacity and existing regulatory controls for filling and packaging of vaccines, consideration should be given to local stockpiling of vaccines in bulk. These systems of stockpiling should be accomplished and functional, either virtual or more preferably real stockpiling, and should be available as soon as possible. b. WHO should seek additional support from developed countries, funding partners and vaccine manufacturers to facilitate the transfer of technology to countries with functional regulatory agencies and vaccine manufacturers that comply with good manufacturing practices to establish influenza vaccine production. The production capacity in the committed countries should be functional as soon as possible. JAKARTA 00000933 008 OF 008 c. WHO should draft, through a participatory process, a guideline for the equitable and appropriate distribution of effective pandemic influenza vaccines, to be applied if a pandemic occurs. It should be submitted to the World HEALTH Assembly, through the Executive Board, in May 2008. It is also recommended that another meeting follow up the progress of these recommendations be convened by WHO during the time of the May 2007 World HEALTH Assembly. Meeting Participants -------------- ¶14. (U) Participants in the "High-Level Meeting on Responsible practices for sharing Avian Influenza Viruses and Resulting Benefits" included Australia, Azerbaijan, Belgium, Brunei Darussalam, Cambodia, Canada, People's Republic of China, Egypt, France, Great Britain, India, Italy, Japan, Laos, Malaysia, Myanmar, Netherlands, Philippines, Singapore, South Africa, South Korea, Thailand, Turkey, Vietnam, and the World HEALTH Organization. The Embassy represented the United States as an observer. Indonesia, Australia, Brunei Darussalam, and Laos were represented by their ministers of health. Dr. Nancy Cox, Director of the Influenza Division, Centers for Disease Control and Prevention, and Dr. Patrick Blair, Naval Medical Research Unit-2, represented the U.S. at the March 26-27 high-level technical meeting. ¶15. (U) Dr. Cox did not have an opportunity to review this report. Heffern