Who to Ban Genetic Engineering of Smallpox Virus

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. Read the article :