Cablegate: Who: December 8-13 2008 Who Meeting On Influenza

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RUCNDT/USMISSION USUN NEW YORK 2895
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RUEAUSA/DEPT OF HHS WASHINGTON DC
RUCPDOC/DEPT OF COMMERCE WASHINGTON DC

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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

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