WHA Agrees on "Major Review" of Smallpox Virus Research
By Lim Li Lin*
South-North Development Monitor #6255
May 22, 2007
Geneva, 21 May - The World Health Assembly has decided to ban genetic engineering experiments on the smallpox virus but postponed a decision on the destruction of the virus until 2010, when a "major review" of the research results on smallpox will be held.
This review is to assist the WHA in 2011 to reach a consensus on the timing of the destruction of the smallpox virus stocks.
The WHA is meeting in Geneva for its 60th session. The issue of the eradication of the smallpox variola virus stocks has been on its agenda for many years. In 1999, the remaining stocks of smallpox virus were slated for destruction.
But the two countries that still hold stocks of the virus, the US and Russia, instead decided that the virus stocks should not be destroyed and have since accelerated research on smallpox. Destruction was re-scheduled for 2002. But in 2002, the WHA agreed to an indefinite extension of the destruction order until the US and Russia complete their research agenda on the smallpox virus.
The US then submitted proposals to the WHO Advisory Committee on Variola Virus Research, which has the mandate to oversee smallpox studies in the interim period before the destruction date, to genetically engineer smallpox and to insert smallpox genes in other poxviruses. This came before the WHA in 2005.
Many countries then expressed concern about allowing genetic engineering research on the smallpox virus, and asked for a review of the proposed research. Despite taking note of the concerns and caution expressed, and the requests to revisit and review the recommendations, the WHO Secretariat issued a press release that implied that four of the five research activities proposed had been approved by the WHA members, while one activity (transferring genes from the smallpox virus and inserting them into other pox viruses) would be reviewed. The WHO Secretariat also undertook to study the issue but to date has not yet released its full report.
At the WHA last year, no agreement could be reached on setting a date for the destruction of the smallpox virus stocks, mainly because of the US refusal. Many developing countries, led by Africa, also asked for a prohibition on genetic engineering, annual substantive WHA review of the virus research, and strengthened WHO oversight.
The issue was then pushed to the WHO's Executive Board in January 2007, which produced a draft resolution. This draft had unresolved issues on the destruction date, and the major review of the research, which have now been agreed at the 60th WHA.
The smallpox resolution, which was approved by a WHA committee at the end of last week, strongly reaffirms the decisions of prior WHAs that the remaining stocks of the smallpox variola virus should be destroyed, and reaffirms the need to reach consensus on a new date for its destruction when research outcomes "crucial to an improved public-health response to an outbreak so permit".
The resolution states that a "major review" of the results of the research will be undertaken in 2010 in order for the World Health Assembly to reach global consensus on the timing of the destruction of the existing smallpox virus stocks in 2011. However, it is not clear what a "major review" entails.
Importantly, the resolution also states that any research undertaken does not involve genetic engineering of the variola virus. This would include the genetic engineering of the smallpox virus itself, and of other viruses with smallpox genes.
NGOs campaigning on the smallpox issue had called for the resolution to explicitly prohibit the insertion of smallpox genes into other poxviruses and prohibit the use of synthetic smallpox virus genes in genetic engineering experiments. However, the resolution remains silent on this.
Recently, it had come to light that Sandia National Laboratory, part of the US Department of Energy, had initiated experiments with synthetic smallpox genes engineered into other organisms.
Sandia had claimed that WHO approval for its research and experiments was not necessary because WHA resolutions do not apply to synthetic versions of the virus. The research may also be illegal as it was conducted without WHA approval, whose approval criteria is research that is essential for public health, and in any event the research involved a laboratory outside of the WHO authorized repository system.
The resolution also requested the WHO Director-General to submit a report to the 61st WHA on the legal status of the variola virus strains held at the two repositories with respect to their ownership.
The Director-General is also requested to maintain biannual inspections of the two authorized repositories "in order to ensure that conditions of storage of the virus and of research conducted in the laboratories meet the highest requirements for biosafety and biosecurity". Thailand proposed changes to the resolution that requested that the reports of those inspections be made publicly available.
The WHO Secretariat joined the fray and suggested that the US proposal that the inspection mission reports should be made available to the public after appropriate redaction, should be inserted into the text. Thailand had wanted that the report should be made public without redaction, and stressed that the report should be scientific and not political.
The Secretariat insisted that this was not possible as this may make public information that could be used by terrorists. Finally, the US and the Secretariat got its way and the text requires that the inspection mission reports be made publicly available after appropriate scientific and security redaction.
The approved research proposals, outcomes and benefits of the research are also to be made available to all Member States.
The annual reporting on progress in the research programme, biosafety, biosecurity and related issues to the WHA is to continue.
A report is to be submitted to the next WHA on measures that promote in Member states the widest and most equitable access possible to the outcomes of the research, including antiviral agents, vaccines and diagnostic tools.
The Director-General is requested to ensure that the two authorized repositories and "any other institution" that has fragments of variola virus DNA, only distribute such DNA for purposes of research on diagnostics, treatment and vaccines in accordance with the recommendations of the WHO Advisory Committee on Variola Virus Research.
This part of the resolution is worrying to the NGOs because it implies that other institutions outside of the two authorized repositories may be allowed to hold fragments of variola virus DNA, and could be allowed by the WHO Advisory Committee on Variola Virus Research to distribute it for research.
The resolution also states that membership of the WHO Advisory Committee on Variola Virus Research and the representation of advisers and observers at meetings of this Committee is to be reviewed in order to ensure balanced geographical representation, with the inclusion of experts from developing countries, and representation from public health experts, and the independence of the members of the Committee from any conflict of interest.
This is important as the Committee has in the past been severely criticized for being unbalanced because the majority of its members and advisors are from developed countries, and the composition of the Committee and its advisors is weighted towards scientists with personal interests in conducting smallpox research, and seeing restrictions relaxed.
The resolution disappointed the NGOs, particularly because it did not set a date for the destruction of the virus stocks. Nevertheless, they welcomed some good points such as the ban on genetic engineering and the report of the legal status of the virus strains held in the US and Russia.
In the debate on the draft resolution, South Africa, speaking for the Africa region, said that 26 years ago the WHA adopted a resolution declaring the global eradication of smallpox. It said that the "major review" will allow the WHA to reach global consensus on the timing of the destruction of existing variola virus stocks. It emphasized that WHO should ensure that the major review is wide ranging and covers all elements of the research being conducted, including gaining assurance that no country keeps any stocks without the knowledge of the WHO.
Kenya said that the rational for retention due to bio-terror threats does not make it safer. If we respond to those fears, it would only encourage more people to acquire more viruses, it stated.
Germany, on behalf of the European Union, welcomed the advances made in new research and said that retention of the live virus is necessary and recommended its retention.
The US said that it strongly supports research on smallpox. It said that eminent scientists are yet to exhaust the research and more work was necessary. The US said that it did not wish inspection reports on visits to authorized repositories to "fall into the wrong hands" and supported the view that the report be made public after redaction.
Lebanon, on behalf of the Eastern Mediterranean Region (EMRO), said that there has been a very broad research agenda since 1999 which has been of limited public health importance. It recalled that in its 7th meeting, the Advisory Committee on Variola Research reported that the live virus was no longer needed for sequencing, diagnostics and vaccines. It recommended that a time limit be set for the conduct of research and that a deadline for the destruction of the virus be set.
Iran said that the 52nd WHA opted for temporary retention of the stocks for research purposes and "compelling reasons" convinced the WHA to decide not to let the activity go beyond 2002.
Iran said that "there seems to be a shift, a temporary retention of almost permanent nature, has become the rule and destruction the exception; this needs to be reversed." It noted that "to make the exception become the rule, the story has tediously been dragged out by a few." It explained that the risky research agenda, despite confirmation by independent experts that all essential research has been accomplished including vaccines and diagnostic tools, "the conclusion favoured by the minority continues to dominate the agenda."
Iran challenged the WHA to revive its leadership by deciding upon a "clear, targeted and time bound road-map" for a fixed date for destruction of the virus stocks. Iran appealed to the WHA and said that nothing justifies WHO being dragged into addressing issues beyond its competencies and mandate or taken hostage to provide justification in the interest of non-health related agendas.
Iran proposed that a new destruction date for the virus stocks be fixed; all genetic engineering of the virus should be prohibited; the WHA should examine if the WHO Advisory Committee on Variola Virus Research has fulfilled its mandate; and in the interim, live virus stocks should be considered a global public good; these stocks should come under global jurisdiction; and global ownership of the research achievements should be ensured.
The Philippines said that the discussions on the destruction date of the virus must be concluded as early as 2010. It said that it did not recommend further rescheduling of the date for concluding discussions.
(* With additional reporting by Edward Hammond.)