WHA: No agreement on smallpox virus stocks

Edward Hammond

28 May 2006
Governments meeting at the World Health Assembly (WHA), which ended on 27 May, failed to come to agreement on a proposed resolution on the destruction of smallpox virus stocks.

Contentious issues included the establishment of a destruction date for virus stocks (held in the US and Russia), a ban on genetic engineering experiments with the virus, and withdrawal of authorization for types of research that have already fulfilled their public health goals.
The WHA decided to transmit a draft resolution (of the working group formed to resolve the issue) for further consideration by the World Health Organization's Executive Board at its meeting in January 2007.
Many developing countries and several NGOs following the issue were disappointed that greater progress was not made at the meeting. However, as a result of the efforts of many countries, led by South Africa on behalf of the Africa Group, a destruction date for the virus, a prohibition on genetic engineering, and other important issues have been highlighted and remain in play.
The smallpox issue emerged as the most controversial issue at the WHA, with many developing countries advocating a firm date for destroying the virus stocks and stricter WHO controls and oversight over the stocks and the research undertaken using them.
The United States put serious negotiating capacity into the issue, with many of the leading officials of its delegation personally involved in the smaller working group talks that went into the night. It was adamant in wanting to block most of the proposals of the developing countries, to provide it with the maximum freedom possible to maintain the virus stocks and conduct research.
At the WHA, delegates first discussed the smallpox virus stocks issue at Committee level on 25 May evening. More than two dozen countries made interventions. The debate was led off by Namibia, who spoke on behalf of WHO's African Region.
Namibia said that the Ministers of Health of Africa at their meeting had expressed concerns over safety and security of the smallpox virus stocks. The Ministers remained opposed to research involving genetic engineering of the smallpox virus due to the risks of accidental or deliberate release of engineered smallpox.
The Ministers also expressed concern on the composition of the WHO Advisory Committee on Variola Virus Research (or the VAC) as the committee lacks broad representation. It should be reviewed to assure balanced composition and comprise public health specialists, and must be independent from the scientists from the two laboratories.
Namibia said it was key to eliminate the virus stocks instead of expanding research. The original idea was that research results would be time-limited and to be reviewed. It must be considered if the costs of research using the live virus far outweigh the benefits.
The time had come to decide on a date to eliminate the stocks, said Namibia, citing several previous WHA resolutions on elimination of the stocks. The Africa group proposed 30 June 2010 as the new date for destroying the stocks, which would allow time for the remaining research needed.
South Africa and Cameroon supported Namibia. Iran was also supportive. Others endorsed parts of Namibia's plan, such as Jordan, speaking on behalf of WHO's Eastern Mediterranean region, which noted that sufficient sequences and diagnostics exist and that no more smallpox virus research was needed in those areas. Thailand asked for resolution text to withdraw WHA authorization for smallpox virus research for the purposes of genetic sequences, diagnostics, and vaccines, as these goals have been satisfied.
The US and Russia voiced the most direct opposition to the African proposal, particularly to a new destruction date, although the US did accept the need for some reforms of the VAC and said it was prepared to negotiate.
The Marshall Islands, Canada, and Israel were most closely aligned with the US, particularly with respect to not establishing a new destruction date. Australia offered more qualified support, noting that smallpox research for research's sake should not be the objective. Japan also stressed the aim of destroying the stocks, and the need for WHO oversight of research, and the sharing of research findings.
France and the UK suggested that the WHA examine the unexplored question of the legal status of the virus stocks, by which was meant the ownership and other issues.
[The virus stocks were deposited with US and Russian laboratories in the 1970s and 80s. Several European countries, among others, sent stocks of smallpox virus to the WHO repositories, and the several hundred strains held in Russia and the US include virus types collected in most regions of the world. Thus, there are a variety of possible claims.
Underlying the discussion of strain ownership are questions related to control of the stocks, as well as access to the benefits of research utilizing the stocks. For example, what would happen if an EU member, or another country, requested its stocks back so that it could conduct its own research? Or, much like the present debate over bird flu (H5N1) strains and vaccine access, if benefits of research are to be available to WHO Member States, and African smallpox strains were used to help develop a smallpox antiviral drug, would not Africa have rights to that drug?]
Other countries made brief statements in the Committee. None questioned the need to destroy smallpox virus stocks. Most said that they favoured temporary retention of virus stocks, but many did not significantly further elaborate their position.
Austria, (speaking on behalf of the European Union, Bulgaria, Romania, Turkey, and Bosnia Herzegovina) simply said that research should be within WHA-approved parameters and that consensus should be achieved on a destruction date. Brazil seemed to have a similar position, although it also noted the need for VAC reform.
Given the lack of consensus, a working group was formed to discuss the draft resolution. Chaired by Thailand, it first met on 26 May afternoon. While the Group was initially successful in removing some of the brackets from the preambular paragraphs, discussions became tense and progress slower as it moved into the operative portion of the resolution.
A second meeting followed on 26 May night and a final attempt was made to reach agreement on 27 May morning, a few hours before the meeting's closing plenary session.
The mood in the working group had turned "ugly" during some phases, according to some diplomats. Several items proved to be contentious. The US refused to consider a new date for destruction of the virus stocks. Instead, it offered to have a "major review" of variola virus research in 2010.
Other countries tried to work with the US by agreeing to such a review, but at an earlier date. In return for possibly relaxing their demand for a destruction date, the Africa group, supported by some developing countries in other regions, sought tighter WHO and WHA research controls and oversight over the research.
According to diplomatic sources, these included an annual substantive WHA assessment to determine what need, if any, remains for the variola stocks, a ban on genetic engineering experiments and DNA distribution, much-improved reporting to the WHA on research, and reporting on ownership and equitable access to research benefits.
However, these demands were not acceptable to the US. The US also resisted efforts to withdraw WHA authorization for smallpox virus stocks to be retained for the already-accomplished purposes of obtaining DNA sequences and developing diagnostics tests and new vaccines. Although the VAC has concluded that there is no scientific need for variola virus stocks for these purposes, the US (and Russia) are resisting the withdrawal of WHA authorization to keep the virus for these purposes.
In defending its position, the US was aided by a last-minute intervention through a note from the WHO Director-General, who asked the VAC to keep talking about the issue only three days before the WHA opened. The Director-General thus could have pre-empted WHO Member States' discussion.
Not surprisingly, when the Working Group came to discuss Africa's proposal to end WHA authorization for retaining the virus for those purposes, the US reportedly said the Director-General's request that the VAC continue discussing the issue stood in the way of WHO Member States from coming to their own conclusion.
More progress was made to reform the VAC to create better geographic balance and to include a broader range of expertise. The most debated point in this item was the African proposal that scientists from the virus repositories, where smallpox virus research is conducted, not be allowed to serve on the VAC.
The Africans argued that the scientists who conduct research should not judge the necessity, scientific merit, and safety aspects of their own proposals. Although Africa identified a serious VAC conflict of interest problem, the US negotiating team (including the Director of the US Centers for Disease Control, where smallpox stocks are held) resisted Africa's proposal.
By late on 26 May it was clear that significant differences remained. Participants termed the discussions "very tough" and said "it got quite ugly" as members tried to move through the most important issues. Over the course of the evening, the US not only clashed with Africa and other developing countries, it had disagreements with European countries that spilled into the hallways outside the meeting room.
Ultimately, the US would not move beyond its proposal to have a "major review" in 2010, and refused to accept any additional constraints on research in return for Africa dropping its insistence on a new destruction date being set this year.
A final working group meeting was held on Saturday morning, but when no progress was made, Thailand (the chair of the working group) proposed to the Committee that the WHA decide to submit the text of the draft resolution as proposed by the working group (on smallpox) be submitted to the 119th session of the Executive Board (in January 2007) for its consideration.
At the closing plenary of the WHA, this proposal was adopted. After its adoption, the Health Minister of South Africa, Dr M.E. Tshabalala-Msimang, made a statement.
She said that when the African region proposed that a date for the destruction of the smallpox virus should be set, some Member States indicated that research in this area would not have been concluded by the time envisaged and that the live variola virus would still be required.
She said that she concurred with the need to conclude approved research before destroying the live virus. "We expect that once the research is concluded the virus will be destroyed. We will monitor with interest, the progress in this regard," she added.
She said that during Committee discussions, Member States recognized that the use of the live virus in research does pose some serious risks to public health. "It is critical therefore to ensure that the research is conducted in an absolutely safe and secure environment," she said.
"It is not unusual for medical research to be audited by an independent panel to ensure that the methodology and laboratory practices are appropriate given the level of risk that the virus poses to public health. Research ethics committees are a case in point for medical research. So, monitoring and transparency requirements in research projects are usually a norm.
"The African group had initially proposed a destruction date of 30 June 2010. Having considered views from a number of delegations, we were prepared to accept, as a compromise, a set of measures that would assist this Assembly in reaching consensus on the date of destruction of the live variola virus.
"These measures include a major review of the research that has been completed, research being undertaken and research being planned at the two official repositories as well as to submit a detailed report of such a review and research results to the Health Assembly."
The Minister said "sadly, we have to report that despite the efforts of the African group to introduce reasonable monitoring and transparency requirements, we could not reach consensus. We trust that all members are still committed to the goal of eventual destruction of the live variola virus stocks in keeping with previous decisions of this Assembly."
South Africa added that it wished to have the resolution adopted by consensus and thus believed there should be sufficient time for delegations to carry out necessary consultations and obtain mandates. It is in this spirit that it supported the decision to refer the draft resolution in its entirety to the 119th session of the Executive Board in January 2007 for its consideration.
(The author is Director of the Sunshine Project, a research organization specialising in biosafety and bio-security issues based in the United States.)

Edward Hammond
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