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 smallpox.

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, Ethiopia, Lesotho, 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 and Uganda as co-sponsors.

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 in Geneva 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 US resolution. (Observers note that the UK and Denmark are each home to vaccine companies that are seeking multi-billion-dollar US government contracts to purchase smallpox vaccine.)

The US 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.

The US 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.)

The US 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.

The US 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.

The Russian 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.

Canada 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 and Ethiopia 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.)

India, 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 resolution.

Japan 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.

Nigeria, pending consensus on the timing of destruction, also supported continued retention.

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.

Iraq 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.

The Philippines 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.

Bolivia 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.

Zimbabwe 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".

China 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 remaining, China 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.

Echoing China, Thailand 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 immediately".

Peru 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.

Iran 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.

Iran 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 morning.

Following a report back of the informal working group's discussion by the Chair (India), Switzerland 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.

The US 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.

Thailand 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.

Kenya 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 the AGIES.

(* With inputs from Edward Hammond.) +