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RUEHKO/AMEMBASSY TOKYO 6840
RUEHPH/CDC ATLANTA GA
RUEHRN/USMISSION UN ROME
RUCNDT/USMISSION USUN NEW YORK 2895
RUEHBS/USEU BRUSSELS
RUEAUSA/DEPT OF HHS WASHINGTON DC
RUCPDOC/DEPT OF COMMERCE WASHINGTON DC

UNCLAS SECTION 01 OF 03 GENEVA 001112 
 
SENSITIVE 
SIPDIS 
 
DEPT FOR G, AIAG, OES, IO, L 
COMMERCE FOR USPTO 
PASS TO USTR 
 
E.O. 12958: N/A 
TAGS: PREL EAID KFLU TBIO WHO
SUBJECT: WHO: DECEMBER 8-13 2008 WHO MEETING ON INFLUENZA 
SAMPLE/BENEFITS SHARING MAKES SUBSTANTIAL PROGRESS, BUT 
ISSUES REMAIN 
 
REF: GENEVA 2537 (2007) 
 
¶1.  (SBU) Summary:  During December 8-13 negotiations at the 
Intergovernmental Meeting (IGM) on Pandemic Influenza 
Preparedness in Geneva, delegates made substantial progress 
on complex issues -- including concrete steps to enhance the 
World Health Organization (WHO) system to assess and respond 
to pandemic threats -- but were not able to conclude 
negotiations.  With a boost from cooperation between the 
United States and Indonesia, WHO Member States agreed they 
were committed to sharing influenza viruses with human 
pandemic potential and equally committed to sharing benefits, 
such as access to pre-pandemic and pandemic vaccines.  The 
IGM will reconvene for a final time in connection with the 
May 2009 World Health Assembly (WHA).  In the meantime, 
interested governments will engage in informal consultations 
facilitated by the Australian Chair and Vice Chairs from 
other regions.  End summary. 
 
Challenges to WHO Global Influenza Surveillance Network 
 
¶2.  (SBU)  Since early 2007, Indonesia has refused to share 
human influenza virus samples (including those from human 
cases of avian H5N1 influenza) with the WHO Global Influenza 
Surveillance Network (GISN).  Indonesia insists on what some 
term "viral sovereignty" and demands benefits, such as access 
to affordable vaccines, in return for future sharing.  Some 
other developing countries, such as Brazil (with support from 
India and Thailand), have been trying to use the controversy 
to undercut intellectual property rights (IPR), and to 
require permissions for onward transfer and use of samples 
outside the network.  The United States, in coordination with 
Australia, the European Union, Canada and Japan, supports 
rapid and unencumbered sharing of samples, and provision of 
benefits to developing countries on a multilateral, voluntary 
basis, but has not accepted the Indonesian claim to 
ownership/control of a pathogen.  The World Health Assembly 
(WHA) in May 2007 set forth a process to resolve issues that 
included the IGM, which held a second meeting December 8-13, 
¶2008.  Between the first (November 2007) and second IGM 
meetings, there was an April 2008 Open-Ended Working Group 
meeting and a process of drafting chair's text as the basis 
for negotiation by drawing on previous documentation, Member 
State comments and the IGM bureau.  Concurrently, over the 
last seven months the United States and Indonesia have 
engaged in bilateral meetings, facilitated by Australia, in 
an attempt to reach agreement on principles that could 
facilitate the multilateral discussion. 
 
¶3.  (SBU)  In lead-up to the IGM, the Australia Chair shared 
with the U.S. delegation data provided by WHO that 
highlighted the continuing challenges to the WHO Network. 
Between November 2007 and November 2008, WHO received reports 
of 44 cases of H5N1 avian influenza in humans worldwide, but 
received clinical specimens from only 8 of those cases.  By 
country, the number of cases reported (specimens shared) are: 
Indonesia 20 (2), Egypt 12 (4), Vietnam 5 (0), Pakistan 3 
(1), China 3 (in process), and Bangladesh 3 (1). 
 
Pandemic Threat Persists; Joint Intervention by U.S. and 
Indonesia 
 
¶4.  (U)  On the first day of negotiations, WHO 
Director-General Margaret Chan reminded delegates of the 
pandemic threat and urged them to approach the meeting with a 
sense of urgency.  In response to a query from the USDel on 
the difficulty of maintaining preparedness in light of "flu 
 
GENEVA 00001112  002 OF 003 
 
 
fatigue" in some quarters, she told the IGM, "Pandemic 
influenza preparedness is the first priority for the 
organization." 
 
¶5.  (SBU) Given the complexity of the issues and the deep 
divisions among Member States, negotiations bogged down on 
disagreements over language on IPR; which clinical and virus 
samples should be covered by a universal, standard materials 
transfer agreement (SMTA) which would accompany samples 
throughout the system; and debate over voluntary vs. 
mandatory sharing of samples and benefits and whether there 
should be a requirement for prior informed consent for onward 
transfer.  On the fourth day, the U.S. and Indonesia, drawing 
on the mutual understanding developed during their 
consultations, jointly introduced language (originally 
suggested to Indonesia by the USG and modified based on USDel 
discussions with a few other delegations) that noted how 
sample sharing fit into a multilateral system of sample and 
benefit sharing but made clear that sharing of a sample was 
not related to receipt of a benefit.  When combined with a 
subsequent U.S. suggestion that focus be shifted from the 
never-ending debate over voluntary vs. mandatory sharing of 
samples/benefits to commitments to share samples and to share 
benefits, the meeting dynamics changed dramatically. 
Although some delegations had been critical of the 
U.S.-Indonesia discussions because they feared a separate 
bilateral agreement had been underway, at the closing session 
the Vice Chair for the African region, from Nigeria, 
specifically commended the U.S. and Indonesian delegations 
"for making everything possible." 
 
¶6.  (SBU)  Delegates also reached general agreement on 
guiding principles for development of terms of reference for 
laboratories in the WHO GISN and on terms of reference for an 
advisory group to the WHO Director-General which will focus 
on functioning of the network. 
 
IPAPI Core Group Plays Important Donor Coordination Role 
 
¶7.  (SBU)   During the negotiations, daily meetings of the 
U.S.-chaired Core Group (Australia, Canada, EU Presidency/EC, 
Japan, UK and the United States) of the International 
Partnership on Avian and Pandemic Influenza (IPAPI) proved to 
be critical for donor government coordination.  At the IGM, 
WHO presented the preliminary results of a Gates 
Foundation-supported analysis of options and related costs 
for the operation of a multilateral H5N1 pre-pandemic vaccine 
stockpile, a key benefit agreed upon at the previous IGM. 
The feedback drafted by the Core Group and presented by 
Canada at the plenary session provided further background 
information and called for a separate meeting of interested 
parties to review the policy and cost implications of various 
options.  In addition, the Core Group drafted a list of 
pandemic preparedness "milestones" (in the categories of risk 
assessment, capacity building, access to vaccines, antiviral 
stockpiles and rapid containment, technology transfer, and 
resource mobilization th 
rough international ministerial conferences) that outlined 
past and current commitments and will help guide future 
discussions. 
 
Enhanced Global Vaccine Manufacturing Capacity 
 
¶8.  (SBU)  At a side meeting, the International Federation of 
Pharmaceuticals Manufacturers and Associations (IFPMA) 
reviewed contributions manufacturers have made to pandemic 
preparedness and provided global estimates for pandemic 
 
GENEVA 00001112  003 OF 003 
 
 
vaccine production capacity.  Assuming a single strain 
pandemic vaccine, continued increase in demand for seasonal 
influenza vaccine, and antigen sparing through the use of 
adjuvants, IFPMA estimated the pandemic vaccine production 
capacity in 2007 was 3.6 billion doses per year and in 2010 
will be 18 billion doses per year. (NOTE: These estimates are 
higher than previous estimates, and if accurate represent 
substantial progress in the ability to meet vaccine demands 
in the event of a pandemic. END NOTE). 
 
International Health Regulations and Sample Sharing 
 
¶9.  (SBU)  In informal discussions prior to the IGM, WHO 
Secretariat staff shared with U.S. delegation members that 
preliminary guidance from WHO legal counselors is that 
Members States must share influenza samples with the WHO GISN 
according to the International Health Regulations (IHRs). 
The rationale is that to determine if an H5N1 influenza case 
is a public health emergency of international concern, 
samples must be shared to assess pandemic potential.  While 
the WHO staff qualified that IHR relevance to sample sharing 
remains to be discussed by the WHA, they indicated that this 
interpretation is potentially helpful, since IHR 
implementation and Member State compliance are within WHO's 
purview, in contrast to other agreements or conventions 
sometimes mentioned in the sample sharing debate such as the 
Trade Related Aspects of Intellectual Property Rights 
agreement or the Convention on Biological Diversity. 
Nevertheless, IHRs were mentioned infrequently at this IGM 
session.   To date the United States has not taken the 
position that sharing of samples is mandatory under the IHRs. 
 
Difficult Issues Remain 
 
¶10.  (SBU)  Unresolved issues generally fell into two 
categories: attempts to undercut IPR (with Brazil and India 
in the lead) and various matters related to the connection 
between virus sharing and benefit sharing (with Indonesia and 
some other developing countries trying to create linkage and 
developed countries opposing such linkage). Because the 
negotiated framework for sample and benefit sharing, when 
approved by the WHA, will be considered a non-binding 
agreement, there was strong indication that Brazil, India, 
and Indonesia intend to impose restrictions through language 
in the model SMTA that will be an annex - the SMTA being a 
legally binding contract between two parties. The IGM is 
suspended until a date to be determined around the time of 
the WHA, May 18-27. In the meantime, interested Member States 
will attempt to resolve remaining issues through informal 
consultations facilitated by the Australian Chair and Vice 
Chairs from other regions. (COMMENT: The remaining issues are 
significant and may be difficult to resolve.  The May 2009 
IGM report to WHA is likely to contain bracketed text 
reflecting those divisions.  END COMMENT). 
 
¶11.  (U) Special Representative on Avian and Pandemic 
Influenza John E. Lange has cleared this cable. 
 
TICHENOR