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REGULATION / SCIENCE: WHO to ban genetic engineering of smallpoxvirus

------------------------------- GENET-news -------------------------------
TITLE:  WHO to ban genetic engineering of smallpox virus
SOURCE: Third World Network Biosafety Information Centre, Malaysia
AUTHOR: South-North Development Monitor, Switzerland, by Lim Li Lin
DATE:   22.05.2007

WHO to ban genetic engineering of smallpox virus

Geneva, 21 May (Lim Li Lin*) -- 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  

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  

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  

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.)

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