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THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE 30 May 2005 RE: NGOs Call on WHO to Address Concerns, Reconsider Recommendations, and Radically Restructure its Smallpox Advisory Committee The just concluded World Health Assembly (WHA) heard many voices from governments who are concerned about and oppose the proposals to relax restrictions on smallpox virus research. While some news reports have suggested that the WHA approved the genetic engineering of smallpox, the fact remains that no consensus was reached at the WHA and it did not approve or endorse the proposed experiments. Instead, significant opposition was heard from both developed countries, such as Canada and the The Netherlands, and developing countries, such as South Africa and China. In the coming months, WHO must address those concerns through a process that will involve reconsidering recommendations and the structure and operation of the Variola Advisory Committee (VAC), a WHO advisory body given the task to temporarily oversee smallpox research in the interim before destruction of remaining live virus stocks. NGOs such as the Third World Network and the Sunshine Project urge the World Health Organisation to take the following steps in response to the concerns and objections raised about smallpox virus research at the WHA: 1. Launch a transparent and balanced process to overhaul the VAC, including its terms of reference, membership, and procedures, aimed to: a. Prevent research proponents
from reviewing their own proposals, 2. Once the VAC has been so restructured, it should reassess its prior recommendations, forwarding revised ones to the WHA for its consideration and (dis)approval. 3. In keeping with prior WHA resolutions and as requested by member states, WHO should prepare a resolution to fix a new destruction date for all remaining stocks of smallpox virus. 4. Prepare a WHO Secretariat study for the next WHA on options for how possession of live smallpox virus may be deemed a crime against humanity following destruction of remaining stocks.
Chee Yoke Heong
Item 1
NGOs Call for WHO to Address Concerns, Reconsider Recommendations, and Radically Restructure its Advisory Committee (Geneva, 25 May) -- At the 58th World Health Assembly (WHA), which ended today, the leadership of the World Health Organization (WHO) was requested by member states to reconsider proposals to expand risky smallpox research and to reassess the process by which such research recommendations are produced. WHA discussed, but did not approve, experiments to genetically engineer smallpox and other proposals that would dramatically expand risky experiments with live smallpox virus. Rather, it "noted" a report containing the proposals, after the WHO Secretariat "especially welcomed" and took "special note" of the serious cautions and criticisms made by member governments. WHO must now move to resolve the issues that governments have raised and which it has committed to address. Most of the countries speaking about smallpox research expressed serious concerns. These included calls for ongoing research to be terminated, for greater transparency, for a new destruction date for remaining virus stocks, and for strengthened WHO oversight mechanisms that are more independent and scientifically and regionally balanced. According to the Sunshine Project and Third World Network, WHO's leadership has been given a mandate to radically restructure its oversight of smallpox in the interim before destruction of the remaining stocks. This includes the terms of reference, membership, and procedures of it's Advisory Committee on Variola Virus Research (or "VAC", for Variola Advisory Committee). Once restructured, the VAC then needs to reconsider past recommendations and seek approval from the WHA before any research that goes beyond the existing limits (established in 1994) is allowed. Governments requested that WHO smallpox oversight be transformed into a stronger and more independent process that separates research proponents from those who perform reviews, that is regionally-balanced, and which incorporates heretofore neglected perspectives of public health, biosafety, and preparedness for deliberate outbreaks of disease. NGOs say that major world regions are underrepresented or entirely unrepresented on WHO's current committee. WHO should heed the calls from governments and NGOs for this problem to be addressed. Third World Network and the Sunshine Project are requesting that WHO take the following steps in response to the concerns and objections raised about smallpox virus research at the WHA: 1. Launch a transparent and balanced process to overhaul the VAC, including its terms of reference, membership, and procedures, aimed to: a. Prevent research proponents from reviewing their own proposals, b. Incorporate neglected areas of expertise, such as public health and biosafety, c. Achieve regional balance among members and advisors, d. Institute a separate, and transparent, laboratory safety review procedure e. Reform committee modalities to create greater transparency, including that of subcommittees, and to create more frequent, high quality reporting to WHA. 2. Once the VAC has been so restructured, it should reassess its prior recommendations, forwarding revised ones to the WHA for its consideration and (dis)approval. 3. In keeping with prior WHA resolutions and as requested by member states, WHO should prepare a resolution to fix a new destruction date for all remaining stocks of smallpox virus. 4. Prepare a WHO Secretariat study for the next WHA on options for how possession of live smallpox virus may be deemed a crime against humanity following destruction of remaining stocks. Item 2 Science, 27 May 2005 WHA Gives Yellow Light for Variola Studies PARIS - After the smoke had cleared, both sides declared victory last week in a debate about the most dreaded virus on the planet. Proponents of further research with variola, the virus that causes smallpox, won approval at the World Health Assembly (WHA) to expand the scope of the studies. But those opposing it- including two vocal advocacy groups-say the surprisingly lively debate showed that opposition to the work is mounting. At the meeting, the 192 member countries of the World Health Organization (WHO) rejected one study proposal, urged extra care with others, and questioned the composition of the panel overseeing the research. The meeting was the latest round of discussions, managed by WHO, about variola's fate. After its eradication in the 1970s, plans to destroy the last remaining virus stocks, now officially stored at only one Russian and one U.S. lab, have been postponed repeatedly to allow the development of new diagnostics, vaccines, and drugs to defend against bioterror attacks. Both the United States and Russia have stepped up their research programs since 9/11. Last November, WHO's Advisory Committee on Variola Virus Research recommended giving researchers more leeway by allowing, among other things, the transfer of DNA snippets of up to 500 base pairs among labs, the production of gene chips containing variola DNA, insertion of a gene for green fluorescent protein into the variola genome, and splicing variola genes into the genomes of other orthopoxviruses (Science, 19 November 2004, p. 1270). The proposal to transfer variola genes to other species ran into opposition from WHO Director-General Lee Jong-wook, who urged WHA last month to send it back to the Advisory Panel and ask for additional biosafety and biosecurity measures. During the WHA debate, on 19 and 20 May, almost a dozen countries, from South Africa to China to Tonga and the Netherlands, aired concerns about the research. Some worried about accidental escapes from the lab, others asked for a firm deadline for the final destruction of the virus; some also argued that the Advisory Committee is dominated by northern countries and by researchers with vested interests in continuing the research. Because WHA didn't vote or adopt a resolution, WHO's secretariat must interpret what exactly it decided. WHO smallpox program officer Daniel Lavanchy says the assembly agreed to ban the gene-transfer studies for now but gave the green light to the other work. To allay concerns, the Advisory Committee will scrutinize individual proposals even more exhaustively, he says. WHO will also "certainly try to address the [committee's] geographical imbalance," says Lavanchy, who agrees that the United States has been a dominant force. The debate this year was stoked by a new phenomenon: Two advocacy groups, the Sunshine Project in Austin, Texas, and the Third World Network, with headquarters in Penang, Malaysia, had campaigned aggressively against the new research. Lavanchy says the lobbying had little impact, but Jonathan Tucker of the Monterey Institute's Center for Nonproliferation Studies in Washington, D.C., says the campaign was "remarkably successful" in raising the heat. The underlying question is if-and when-work with variola will ever be completed. The goals of the research program-which include developing safer vaccines and two different smallpox drugs-give Russia and the United States an excuse to hold on to the virus almost indefinitely, says Edward Hammond, director of the Sunshine Project. Not so, says Lavanchy, who estimates that the research should take "a couple of years." D. A. Henderson, the former leader of the global eradication campaign and a long-time champion of variola destruction, also considers WHO's timetable highly unrealistic. Given the time needed to develop antiviral drugs, the added problems of working in maximum-containment labs, and the lack of a good animal model for smallpox, he says, "this could take 20, 30, or even 50 years." -MARTIN ENSERINK
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