TWN Info Service on Intellectual Property Issues (Feb07/02)

2 February 2007

Draft WHA resolution opposes genetic engineering of smallpox

The WHO Executive Board met from 22-30 January 2007 in Geneva and adopted a draft resolution on smallpox (variola), which will now be transmitted to the 60th World Health Assembly (WHA) in May 2007.

The Board's resolution requests the WHO Director General to ensure that any research undertaken does not involve genetic engineering of the variola virus.

This is a step in the right direction, but loopholes remain in the resolution, which threaten to undo this progress.

The two most important issues are to clarify that genetic engineering involving synthetic genes is similarly prohibited and to ensure that the current rules on smallpox DNA distribution are not relaxed.

These have to be urgently addressed, in order to ensure that the efforts to disallow genetic engineering of smallpox are effective. Moreover, largely due to opposition from the US, the resolution failed to fix a new date for destruction of the virus stocks, which means that biosafety, public health and bioweapons risks remain.

Please find below a report of the discussions, which was first published in the South-North Development Monitor (SUNS) #6180 on 31 January.

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Third World Network
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Health: WHO Board adopts draft smallpox resolution

Geneva, 30 Jan (Sangeeta Shashikant and Riaz K Tayob) -- Discussions on a draft resolution on "Smallpox eradication: destruction of variola virus stocks" (EB120/Conf. Paper No. 14) revealed continuing deep divergences among members of the World Health Organisation's Executive Board despite several drafting sessions aimed at ironing out the differences.

The Board on 27 January adopted the draft resolution, which will be transmitted to the World Health Assembly in May, at which a heated discussion can be expected.

The smallpox virus issue has divided the WHO member states in the past few years. Several developing countries want to fix a final date for destruction of the smallpox virus stocks currently held in WHO-appointed laboratories in the United States and Russia, and to have the WHO strictly regulate research that makes use of the virus. However, these two countries are resisting the destruction of the virus stocks and would like to expand the research into new areas, which biosafety experts warn would be risky.

Said Lim Li Ching, a biosafety expert at the Third World Network: "The Board's resolution requests the WHO Director General to ensure that any research undertaken does not involve genetic engineering of the variola virus". This is a step in the right direction, but loopholes remain in the resolution, which can undo this progress.

"The two most important issues are to clarify that genetic engineering involving synthetic genes is similarly prohibited and to ensure that the current rules on smallpox DNA distribution are not relaxed," said Lim.

Many developing countries, in particular, the African Group, want to set a date for the destruction of the live variola virus stocks, and pending that, to immediately undertake a major review of the results of the research undertaken, underway and being planned. They are also calling for a review of the members of the WHO Advisory Committee on Variola Virus Research (or VAC) and for measures to limit the distribution and manipulation by genetic engineering of the live variola virus.

However, the US and Russia (which hold the remaining virus stocks in WHO-authorized repositories) have refused to destroy the virus stocks despite previous WHA resolutions that have called for its destruction and have instead engaged in research involving the virus, without always sharing the outcome with other countries. In particular, the US persists in wanting to continue retaining the virus as well as distribute for certain purposes, fragments of the virus.

Some of the key points in the draft resolution (EB120. R8) are as follows:

The draft resolution decided to include a substantive item "Smallpox eradication: destruction of variola virus stocks" on the provisional agenda of the World Health Assembly.

There is however a dispute on whether the discussion on this substantive agenda item, which is understood to be a serious effort in setting a new date for destruction, should be at the 63rd or the 64th session (i. e. in 2010 or 2011). The US and other countries that are not keen to discuss destruction of the variola virus stocks, favour a later date. This date is bracketed, thus leaving it to the WHA to decide.

The Resolution broke new ground in asking the WHO Director General "to undertake a major review [in 2009/2010] of the results of the research undertaken, currently under way and the plans and requirements for further essential research for global public health purposes, taking into account the recommendations of the WHO Advisory Committee on Variola Virus Research, so that the [Sixty-third/Sixty-fourth] World Health Assembly may reach global consensus on the timing of the destruction of existing variola virus stocks".

This paragraph had been pushed by the African Group which is critical of the lack of transparency as to the kind of research that is being undertaken by the US under the oversight of the VAC. The Group initially proposed establishing a new destruction date, but was willing to compromise by accepting a major review.

They had wanted a date as early as 2008 for the major review, but were told that would simply be impossible. It is not yet entirely clear what a major review would entail and its details will need to be worked out.

The text also calls for the Director General to review the membership of the VAC, and the representation of advisers and observers at meetings of this Committee, in order to ensure balanced geographical representation, with the inclusion of experts from developing countries, and substantial representation of public health experts, and the independence of the members from any conflict of interest. It also requests the Director General to ensure that approved research proposals, research outcomes and the benefits of this research are made available to all Member States.

This is an attempt to ensure better oversight of the research, and to address the imbalances in the VAC, as there has been little developing country representation in the committee. In addition to its regional bias, the committee - particularly its advisors - has been weighted towards scientists with a personal interest in conducting smallpox research and who may wish to see restrictions relaxed.

The draft resolution also requests the Director General 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.

The text adds that the Director General is to continue to report annually on progress in the research programme, biosafety, biosecurity and related issues to the Health Assembly, through the Executive Board. However, the same paragraph suggests that the WHA may not have the opportunity to review VAC recommendations, as it only asks for an annual report on the implementation of the VAC recommendations that are already accepted by the Director General.

The resolution totally prohibits "any research" involving genetic engineering of the variola virus. However, experts point to the need to clarify that genetic engineering involving synthetic genes is similarly prohibited.

"This is very urgent, in light of recent experiments initiated by Sandia National Laboratories in the US, which have engineered synthetic variola genes into other organisms," said Lim. The variola genes obtained by Sandia were synthesized by a company and not obtained from a WHO-authorized repository.

She said it would be alarming if the US government interprets the previous WHA resolutions (which subject all smallpox research to WHO agreement and places it under WHO control) to exclude WHO control over synthetic smallpox DNA. This could easily give rise to synthesis and use of variola genes outside WHO knowledge and control.

In paragraph 4(9), the resolution asks the Director General 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 recommendations of the VAC.

Lim commented that this is very problematic, as the 2006 meeting of the VAC started a process that may modify the rules concerning possession and use of variola virus and its genes, by setting up a technical subcommittee to review the rules and propose revisions if deemed necessary.

"If this process results in a relaxation of the 1994 rules, and the US has already previously attempted to do so, this may result in a loosening of control over smallpox DNA possession," said Lim.

The current rules, drawn up in 1994 by the WHO Ad Hoc Committee on Orthopoxvirus Infections, ban genetic engineering of variola, the insertion of variola genes in other orthopoxviruses, and require that variola DNA only be provided to non-repository labs with WHO approval and even then in tightly limited quantities. They should not be modified, said Lim.

Moreover, she added that while the current rules state that the repositories cannot distribute smallpox DNA without WHO approval and that recipients of such DNA cannot send it to others, paragraph 4(9) as it stands may open the door to third parties transferring smallpox DNA to other third parties.

The draft resolution also asks the Director General to submit an annual detailed report to the Health Assembly, through the Executive Board, of the research that has been completed, the results of such research, research being undertaken, and research being planned at the two authorized repositories; 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 and to submit a report to the 61st WHA, through the Executive Board, 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, that arise out of the research.

Divergences over the continued retention of the variola virus for purposes of research were most apparent during the Executive Board meeting.

Namibia, on behalf of the Africa Group, said that the fundamental issue is the eventual destruction of the live virus stocks, adding that the previous WHA Resolution 55.10 only recognized temporary retention. It emphasized that it is clear that all essential research requiring the use of live virus is complete.

It also said that the Africa Group remained opposed to genetic engineering because of the risks posed by accidental or deliberate release, bio-terrorism and the risk posed by release of a (modified) virus. It raised issue about the composition of the VAC and proposed that this be reviewed to include public health specialists and experts from developing countries.

Namibia also found the drafting wanting in relation to setting a date for destruction despite previous WHA resolution 49.10 and WHA52.10 calling for the same.

Bahrain, on behalf of the Eastern Mediterranean Region, reiterated the African concerns and called for a certain date for destruction, adding that all essential research of the live stocks had been completed wherein the live stocks were no longer necessary. It also warned of the dangers of accidental or deliberate release of the variola virus.

Kenya similarly pointed out the dangers of continued retention, in particular the manipulation of the virus, which meant that there was a greater responsibility on the VAC, which meant that a review of the composition of the Committee was urgently needed.

It pointed out the contradiction in the positions taken, in that while there was talk about destroying the virus, at the same time others were proposing distribution of the virus which compounded further the problem of keeping track of where it is distributed to.

South Africa, (a non-member of the Executive Board) supported the statements of both the Africa Group as well as EMRO.

South Africa noted the report of the 8th VAC meeting, where it was stated that a balance was needed between sequences that may be scientifically interesting and those that were essential for public health purposes. South Africa pointed out that countries only authorized further temporary retention of the virus stocks for essential health research, not for that which might be "scientifically interesting". It called for more vigilance of some of the proposed work in this area.

It also sought clarification on the processes operating at the VAC meetings. At the 7th VAC meeting it was agreed that there is no longer any reason to retain smallpox virus for the purpose of developing vaccines. South Africa noted with surprise that the 8th meeting reported on-going work using variola virus for that purpose. It also noted that the VAC had revisited the need for further sequencing despite previously declaring that full-length sequences were no longer needed.

South Africa reiterated that it was against genetic engineering of variola and welcomed the decision of the VAC to reject the introduction of the virus into other orthopoxviruses.