TWN Info Service on Health Issues (May11/07)
27 May 2011
Third World Network
WHA defers to 2014 decision on smallpox
virus stocks destruction
Published in the SUNS #7158
dated 26 May 2011
Geneva, 25 May (Lim Li Ching*) -- Attempts by
the United States to prolong the retention of variola (smallpox) virus
stocks have been thwarted at the World Health Assembly (WHA) that met
from 16 to 24 May.
The WHA instead decided on Tuesday 24 May to put
aside the US proposal in
favour of resuming the discussion at the 67th WHA in 2014.
The decision followed contentious discussions
on a draft resolution, proposed by the US
and several co-sponsors, that would have allowed continued retention
of the existing virus stocks, with a report on progress of research
only in five years' time (2017), at the 69th WHA. Despite an informal
working group meeting to deliberate the issue, there was no consensus
and a decision was then made to defer the discussion on the draft resolution.
In the final decision adopted on 24 May, the WHA
decided to strongly reaffirm the decisions of previous WHA sessions
that the remaining stocks of variola virus should be destroyed. It also
reaffirmed the need to reach consensus on a proposed new date for the
destruction of variola virus stocks when research outcomes critical
to an improved public health response to an outbreak so permit.
It further decided to include a substantive item
"Smallpox eradication: Destruction of variola virus stocks"
on the provisional agenda of the 67th WHA session.
According to various sources, enormous bilateral
pressure, up to ministerial and head-of-state levels, was applied by
the US on many capitals, urging support for the US position on
The just-ended 64th WHA was meant to have considered
the results of a major review of smallpox research. While smallpox was
eradicated in the wild more than 30 years ago, live virus stocks are
still held in two World Health Organization (WHO) repositories in the
US and Russia. Despite previous experts' recommendations and WHA resolutions
setting a date for destruction of the stocks, the two countries continue
to insist on retaining the stocks. Retention is only temporarily authorized
in order to conduct research essential to global public health.
The outcome of a major review mandated by the
WHA at its 60th session found no compelling scientific or public health
reason to continue to retain the virus. This review comprises a scientific
review and a public health review, the latter carried out by the Advisory
Group of Independent Experts to review the smallpox research programme
(AGIES). (See SUNS #7150 dated 16 May 2011.)
At the Monday discussion, developing countries
that spoke strongly in support of the prompt destruction of the virus
stocks and who reiterated that there is no justification for continued
retention, included the 22 countries of the Eastern Mediterranean region
(a WHO configuration), the Gulf Cooperation Council member states, Zimbabwe,
China, Thailand, the Philippines, Malaysia and Bolivia.
In the debate that ensued, Iran
(speaking for the Eastern Mediterranean region) pointed out that the
draft resolution (initiated by the US
and issued on 16 May, the first day of the WHA) had ignored the fundamental
element - the question of destruction and that even those who supported
the resolution have said that retention is temporary. After 30 years
of accepting this, a definite time for destruction is needed at this
juncture, it emphasised.
The draft resolution was first officially proposed
on 16 May by Australia,
New Zealand, the
Russian Federation and the US. A revised
draft resolution issued four days later added Barbados,
Canada Colombia, the Democratic Republic of Congo, Mexico
Observers were surprised that this new configuration
of virus retention proponents included countries from the African region,
which historically had been among the most vocal supporters for setting
a new date for the destruction of the stocks. (It was such calls by
the African region in 2007 that had led to the commissioning of the
major review of smallpox research.)
Thus, developing countries were not as united
as in previous WHA meetings in their call for prompt virus destruction.
After numerous postponements, the smallpox agenda
item finally opened on the penultimate day of the WHA, Monday 23 May.
Observers noted that the delayed consideration of the smallpox issue
was advantageous to the US,
as it afforded the US more time to
continue its lobbying efforts for its position. Various sources confirmed
that there was enormous bilateral pressure up to the highest political
level in several capitals, urging support for the US position.
That the issue was important to the US was also underscored by the press conference
held by the Secretary of Health and Human Services, Kathleen Sebelius,
on the second day of the WHA. Smallpox was one of the three issues highlighted
at the US press conference,
as issues that the US
has "been focussing on".
When the Chair of the WHA Committee A, which considers
technical and health matters, opened the official discussion on smallpox,
he informed the room that Denmark,
Italy and the United Kingdom were now also co-sponsors of the
(Observers note that the UK and Denmark are each home to vaccine companies
that are seeking multi-billion-dollar US government contracts to purchase
made the first intervention, stressing that it believes that now is
not the appropriate time for destruction of the virus stocks, as it
would leave the world vulnerable to a smallpox outbreak. It raised the
issue of "undisclosed stocks" (allegations of which have never
been actually substantiated). It called for the WHA to continue to authorise
smallpox research and to allow retention of the stocks.
cited the scientific review as supporting their position. (A reading
of the scientific review report shows that every chapter of the review
was authored or co-authored by variola scientists working with either
the US or Russia.)
also referred to the AGIES report, giving the impression that the report
stated that work with live variola "may be indispensable for the
development and approval of antiviral drugs against smallpox".
Observers were surprised by this apparent misrepresentation, as the
report had merely said that this was what the scientific review had
argued. In fact, in the AGIES' view, regulatory approval could be achieved
without the use of live variola virus.
then read out a list of countries now supporting the draft resolution
- Armenia, Australia,
Barbados, Belarus, Canada,
Colombia, Denmark, Democratic Republic of Congo, Estonia, Ethiopia,
Fiji, Italy, Jamaica,
Japan, Kazakhstan, Lesotho,
Malawi, Mexico, Mozambique,
New Zealand, Russian Federation, Samoa,
Uganda, United Kingdom, United
States of America and Tanzania - bringing the total number
of co-sponsors to twenty-six. During the discussions, Israel and Monaco indicated that they would also
join as co-sponsors.
Federation reiterated that it needed
time to continue the research and that there should be caution in destruction
of live variola strains, as this would be an irreversible event. It
maintained that its containment facilities are safe.
held the firm view that the stocks must be retained for public health
purposes and that setting a date for destruction was premature. It felt
that a review of the issue in five years' time, as called for by the
resolution, was an appropriate time line.
Other countries spoke to merely state that they
were supporting the US
resolution, without providing any justifications for their positions.
A technical expert following the discussion said
that regrettably, some of these countries made statements that were
technically questionable, which perhaps reflected a lack of clear understanding
of the issue. For example, one developing country raised the threat
of a pandemic and the need to develop a vaccine, perhaps unaware that
these vaccines already exist (and were used to wipe out smallpox in
the first place) and do not require live variola, as the vaccines are
made from vaccinia, a related but less dangerous virus.
Some African countries such as Tanzania
raised the prospect of monkeypox. (It was not clear how this issue,
a concern in its own right, was related to the issue of smallpox.)
despite pointing out that the draft resolution strongly reaffirms previous
WHA decisions that the remaining stocks should be destroyed, supported
the adoption of the US
also supported the US
resolution and thanked the US
for drafting the resolution. It however, also reiterated that the final
goal was destruction of the stocks.
Hungary, speaking for the European Union, Turkey,
Croatia, Macedonia, Montenegro, Iceland, Bosnia and Herzegovina, Serbia,
Moldova, Norway and Switzerland, supported continued temporary retention
of the virus at the current locations (in the US and Russia), for the
purposes of enabling further results-oriented and periodically reviewed
research. It suggested that once the approved research was concluded,
the WHA should research consensus on the date of destruction.
pending consensus on the timing of destruction, also supported continued
On the other hand, Iran,
speaking on behalf of the Eastern Mediterranean
region, comprising 22 countries, traced the history of the smallpox
discussion following its eradication in the wild, pointing to the two
specific deadlines for destruction, which were unfortunately not met.
It reminded delegates that the research activities were approved only
as long as they were outcome-oriented, time-limited and periodically
reviewed. Iran said that the time-line for conducting
such research had been extended and exhausted.
The Eastern Mediterranean
region therefore did not think that further research required access
to the live virus, and that on the contrary, destruction of the stocks
would end the threat of the emergence of an accidental or deliberate
release. It called for a date for destruction to be set by the WHA,
as "enough is enough".
In its view, a resolution should set a prompt
and fixed date for destruction, terminate authorization of research
involving live variola, ensure global ownership of the research results,
ensure equitable access to the research outcomes, fully prohibit genetic
engineering of smallpox, and allow for effective verification and monitoring.
As such, the draft resolution as proposed by the US and co-sponsors was not acceptable
to the region; "drastic changes" were needed instead.
supported the Iranian statement on behalf of the Eastern
Mediterranean region and called for a date for destruction
to be set. At a minimum, it said, a timetable for the research conclusion
was needed, leading to destruction of the stocks.
reaffirmed that for eradication to be realized, no trace of the live
virus should be kept, as it poses a public health risk. It called for
the WHA to fix a date for destruction of the stocks and to not authorize
variola research that was not essential to public health. It also requested
the Director-General to improve the transparency of the Advisory Committee
on Variola Virus Research, to make the research results available to
all, and to enforce strict biosafety and laboratory containment, in
the interim before destruction.
Saudi Arabia, with support from the United Arab
Emirates, Kuwait, Qatar, as well as Yemen, forwarded the Gulf Cooperation
Council's view that there was no reason to continue research with smallpox
virus and that a date for destruction should be set. Bahrain associated
itself with the statements made by Saudi Arabia and Iran on behalf of
the Eastern Mediterranean region and supported a resolution for destruction
of the stocks. The United Arab Emirates
similarly supported the Saudi Arabian intervention.
also reaffirmed the consensus for destruction. It reiterated that the
research's public health goals have been reached, and that therefore
it was necessary to move forward on destruction.
highlighted the point that as long as the two WHO repositories retain
virus stocks, there remains a potential global threat of the resurgence
of the disease. On the US-sponsored resolution, it was concerned that
despite consensus in previous years on destruction of the remaining
stocks, the US and Russia continue to retain the stocks.
This is also despite the major review concluding that the essential
research requiring live variola has been completed. Zimbabwe was concerned by the US resolution,
that among other things, authorizes further temporary retention of the
virus stocks and requires confirmation by member states that they do
not have stocks within their borders.
It said that what the US is proposing "is taking us
two decades back". It also stressed that there was no documented
evidence of any other stocks besides the authorized ones. Zimbabwe called for immediate destruction
of the virus stocks, as "any further prevarication will only increase
the potential threat of a resurgence of smallpox".
lauded the great progress made in smallpox research, noting that diagnostics
and vaccines already developed provide the necessary "technical
guarantees" to enable response to a future outbreak. The key problem
said, is how to effectively prevent the recurrence of smallpox. In China's view,
the destruction of variola virus stocks and the strict prohibition on
synthetic variola are the most important ways. China
therefore supported the termination of use of live variola virus in
research and urged a clear time-line for destruction. It also proposed
that the WHO make timely reports and notifications of the research progress
and that member states had access to the relevant research results.
reiterated that the world already has the vaccines and diagnostic tools
to deal with any potential smallpox outbreak, and there was no longer
adequate scientific justification for retention of live variola virus
stocks. Continuing to do so would not serve global security but would
pose a threat to humanity. It reminded the WHA that the stocks of virus
are the property of the WHO and not of individual states such as the
US or Russia. Thailand said that it could not accept
the draft resolution and called for the stocks to be "destroyed
pointed to the importance of the public health goals of the research
and reaffirmed the need for destruction. Malaysia also recognized the major
progress made on antivirals, improved and safer vaccines and diagnostics.
It urged the WHA to fix a definite date for destruction for the remaining
stocks. Bangladesh called for consensus on
destruction "sooner rather than later". Indonesia recalled previous resolutions
setting the date for destruction, and that the global consensus was
for destruction. It called for a new date for destruction to be set.
After the interventions, the US responded by underlining that it
clearly and unequivocally supports the eventual destruction of the virus
stocks, but only when the programme of research is complete, and that
time had not yet come. It pledged to be open in its research, and to
make the results fully available to the global community.
A statement was made on behalf of CMC-Churches
in Action and 43 civil society organizations calling on the WHA to unequivocally
terminate research with smallpox virus and to fix a prompt and irrevocable
date for the destruction of the virus stocks.
After all the interventions were made, the Chair
noted that while there were several reservations, no concrete proposals
for amendment had been forwarded. He then asked if the Committee was
ready to adopt the draft resolution.
pointed out that there were strong reservations and statements made
which indicated that some member states could not accept the resolution.
It said that the draft resolution had ignored the fundamental element
- the question of destruction - and effectively prolonged retention
for an unlimited time. It said that even those who supported the resolution
have said that retention is temporary; after 30 years of accepting this,
a definite time for destruction is needed at this juncture.
then highlighted that the position of the Eastern
Mediterranean region was that since this is a serious and
sensitive issue, according to rule 76 of the rules of procedure, any
vote on the issue should be done by a secret ballot. It later clarified
that they would be willing to first exhaust avenues in obtaining a consensus
draft resolution, before considering a vote. The meeting was suspended
for about 20 minutes, as countries considered the issue of a vote.
The Chair then convened an informal working group
to work on the draft resolution to try to come to a consensus. Closed
sessions of the group met from 12 noon till 2.30pm, and then again from
5.30pm till 8.30pm on Monday, 23 May. Fifty member states participated
in the working group's discussions.
The informal working group was however unable
to come to consensus on the draft resolution. Given that there was no
consensus, the matter was then brought back to Committee A the next
Following a report back of the informal working
group's discussion by the Chair (India),
proposed that the WHA defer the consideration of the item and discuss
it again at the 67th session. In the meantime, it reiterated, previous
WHA resolutions would remain valid and continue to apply. It felt that
three years would be an adequate timeframe to work towards reaching
a consensus on the issue.
Iran responded that while it does not have a problem
with the Swiss suggestion, deferment to the 67th WHA was "not acceptable",
as that was too far from now, given that this WHA had actually been
mandated to make a decision on this important question.
then took the floor reiterating its belief that there was strong support
for the resolution as set forth, with 27 co-sponsors from both developed
and developing countries. However, based on the discussions of the working
group, there did not seem to be a possibility of finding full consensus.
Hence, the US viewed the
Swiss suggestion as "potentially constructive" but maintained
that merely pushing the issue from one WHA to the next may not be in
the best interest of the WHO.
agreed on the need for the WHA to work by consensus and supported the
principle of deferring the issue. It proposed that at the WHA in which
the issue would be considered, that a drafting group be convened from
day one, in order to give enough time to work through the issues. Thailand then suggested a compromise
date, calling for deferment to the 66th WHA.
went further by proposing deferment to the 65th WHA, and called for
the text of discussion in the working group, which had not been agreed
on, to form the basis of the discussions then. Zimbabwe
observed that time was needed to reach agreement, and supported the
Swiss proposal for consideration of the item at the 67th WHA. Morocco agreed
with this as well.
The meeting was then suspended for almost an hour
and a half, during which WHO Director-General Dr. Margaret Chan informally
facilitated discussions that led to the final decision that was adopted
by the WHA.
Meanwhile, the Director-General will continue
the mandate of the Advisory Committee on Variola Virus Research and
(* With inputs from Edward Hammond.) +
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