TWN Info Service on Biosafety / Biodiversity and Traditional Knowledge
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Calls for Precaution on "Gene Drives" at Biodiversity Meeting
The article below was published in South-North Development Monitor (SUNS) #8724, 18 July 2018.
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131 Jalan Macalister
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Calls for precaution on "gene drives" at Biodiversity meeting
London, 17 Jul (Lim Li Ching) -- Parties to the Convention on Biological Diversity (CBD), at a subsidiary meeting, have called for precaution when addressing organisms containing engineered gene drives.
Language asking Parties and other Governments to "refrain from" the release, including experimental release, of such organisms remains in square brackets, indicating disagreement on the issue.
The CBD Parties will have to resolve this issue at the next Conference of the Parties (COP) in November 2018, to be held in Sharm El-Sheikh, Egypt.
The twenty-second meeting of the CBD's Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA-22), took place from 2-7 July 2018, in Montreal, Canada.
Under the agenda item on synthetic biology, the issue of organisms containing engineered gene drives was at the forefront, due to the scientific uncertainties and potential for causing significant and irreversible adverse effects to biodiversity.
Gene drives are designed to deliberately spread transgenes and are very likely to cross national borders.
The release of a few organisms containing engineered gene drives can force the engineered trait to spread through sexual reproduction, resulting in the genetic engineering of whole populations, whether wild or domestic.
Given the serious potential adverse effects, more than 160 civil society organisations had called for a moratorium on the technology in 2016.
The rationale would be to provide time for ensuring that there are thorough and robust assessment of the risks including on ecosystems and socio-economic impacts, development of regulations specific to contained use experiments involving organisms containing engineered gene drives and mechanisms for seeking the prior informed consent of potentially affected countries before any release.
At the previous COP of the CBD held in December 2016 in Cancun, Mexico, Parties fell short of elaborating on the issue of gene drives.
Instead, the Parties reiterated a previous decision that called for a precautionary approach and establishment of effective risk assessment, risk management and regulation for synthetic biology, noting that this can also apply to some living modified organisms (LMOs) containing gene drives.
The draft recommendations considered by SBSTTA-22 drew on the outcomes of the second meeting of the Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology, which met in December 2017.
Among the issues identified by the AHTEG as important were how to address organisms containing engineered gene drives in a precautionary manner, as well as the need to prevent or minimize the exposure of the environment to organisms, components and products of synthetic biology under contained use, and for regular horizon scanning, monitoring and assessing of developments in the field of synthetic biology, given the rapid developments in the technologies.
During the discussions at SBSTTA-22, there were diverging views on several issues, particularly on organisms containing engineered gene drives.
Moldova, supported by Bolivia and Rwanda, introduced language calling on Parties and other Governments to refrain from releasing organisms containing engineered gene drives, due to the uncertainties and the high potential for transboundary movements.
On the other hand, Germany was opposed to any text that could be interpreted as a de facto moratorium, while others such as Belgium, the Netherlands and New Zealand preferred a case-by-case approach to such organisms.
On the question of the need for further research, analysis and risk assessment guidance for organisms containing engineered gene drives, the debate turned on the timing.
Parties such as Bolivia, France, Moldova, Norway and Rwanda argued that these efforts are needed before such organisms are considered for release into the environment.
Others, such as Brazil and Germany, asserted that these steps are only needed when such organisms are released into the environment.
Rwanda, supported by Bolivia, Mexico, the Philippines and Venezuela, furthermore insisted that the free, prior and informed consent of indigenous peoples and local communities is needed when considering the possible release of organisms containing engineered gene drives that may impact their traditional knowledge, innovation, practices, livelihood and use of land and water.
This was opposed by Brazil, Canada and the Netherlands, who preferred to only go as far as saying that the free, prior and informed consent of indigenous peoples and local communities "might be warranted", quoting the AHTEG report that used this phrase.
This however ignores the fact that indigenous peoples have the right to have their free, prior and informed consent sought, prior to the approval of any project affecting their lands or territories and other resources, as recognized in the UN Declaration on the Rights of Indigenous Peoples.
Another issue related to gene drives was that of conflicts of interest. Rwanda, supported by Bolivia and Moldova, called for the application of a procedure for avoiding and managing conflicts of interest to the AHTEG.
The European Union and Sweden disagreed, saying that the issue would be addressed at the second meeting of the Subsidiary Body on Implementation (SBI-2) that would follow SBSTTA-22; hence there was no need to address it in this decision.
The AHTEG had been established in 2014, but had come under scrutiny when emails obtained through freedom of information requests revealed that the integrity of the Open-ended Online Forum on Synthetic Biology, and consequently the AHTEG on Synthetic Biology, may have been compromised by external actors who sought to influence the discussions on gene drives.
There was also evidence of some AHTEG members having relevant financial interests in gene drive projects through the institutions they represent, which had not been disclosed.
As a result of these so-called "gene drive files", civil society organisations raised the issue urgently with the Executive Secretary.
She responded by assuring the Secretariat's commitment to ensure the transparency, integrity and effectiveness of all processes under the Convention and its Protocols.
It was therefore a welcome move that SBI-2, under the agenda item on "Review of the effectiveness of the processes under the Convention and its Protocols", includes a draft recommendation to approve the procedure for avoiding or managing conflicts of interest and to ensure its implementation with respect to the work of technical expert groups.
Due to the repeated clash at SBSTTA-22 between Parties on these issues, a Friends of the Chair group was established, which was open to any Party.
It met on Friday, 6 July, to consider three paragraphs on synthetic biology that were the most controversial; two of which dealt with organisms containing engineered gene drives, and the other on the issue of contained use, and detection and monitoring.
After heated discussions, a non-paper was issued by the Friends of the Chair, with only the square brackets remaining around the issue of how to treat the release of organisms containing engineered gene drives.
The relevant paragraphs related to gene drives adopted by SBSTTA-22 reads as follows:
(a) Calls upon Parties and other Governments, taking into account the current uncertainties regarding engineered gene drives, to apply a precautionary approach, in accordance with the objectives of the Convention, [with regard to][and refrain from] the release, including experimental release, of organisms containing engineered gene drives;
(b) Recognizes that, as there could be potential adverse effects arising from organisms containing engineered gene drives, before these organisms are considered for release into the environment, research and analysis are needed, and specific guidance may be useful, to support case-by-case risk assessment;
(c) Notes the conclusions of the Ad Hoc Technical Expert Group on Synthetic Biology that, given the current uncertainties regarding engineered gene drives, the free, prior and informed consent of indigenous peoples and local communities might be warranted when considering the possible release of organisms containing engineered gene drives that may impact their traditional knowledge, innovation, practices, livelihood and use of land and water.
SBSTTA-22, in a separate process, has also recommended that the Parties to the Cartagena Protocol on Biosafety consider the need for specific guidance on risk assessment of LMOs containing engineered gene drives at its tenth meeting.
Meanwhile, an attempt was made by Canada to lob a bombshell into the negotiations: it insisted that all the recommendations on synthetic biology should be suspended and no further work considered, until and unless the issue of whether synthetic biology was a "new and emerging issue" was dealt with to its satisfaction.
This attempt to hijack the progress of work on synthetic biology under the Convention was unacceptable to many Parties, including Ethiopia, France, Germany, Morocco, Sweden and Switzerland.
Nonetheless, Australia, Japan, New Zealand and South Africa continued to hark back to the fact that the AHTEG had not completed its analysis on this issue.
The EU, Norway and Switzerland however pointed out that the Secretariat had already conducted an analysis of the reports on the first and second meetings of the AHTEG against the seven criteria for the selection of new and emerging issues.
There was therefore, in their view, no need to task the AHTEG with further work on the issue.
Compromise text was eventually proposed by the Secretariat and accepted by the Parties that tasked the AHTEG to provide advice on the relationship between synthetic biology and the criteria on new and emerging issues, building on the preliminary analysis prepared by the Secretariat.
SBSTTA-22 recommended that the AHTEG on Synthetic Biology be extended with renewed membership.
In addition to providing advice on the new and emerging issues topic, its terms of reference includes stock-taking of new developments in synthetic biology in order to support a regular horizon scanning process, a review of the current state of knowledge of current and near-future applications of synthetic biology, including those applications that involve organisms containing engineered gene drives and a forward-looking report on synthetic biology applications that are in early stages of research and development.
Other recommendations include the need "to develop or implement, as appropriate, measures to prevent or minimize potential adverse effects arising from exposing the environment to organisms, components and products of synthetic biology in contained use, including measures for detection, identification and monitoring, in accordance with domestic circumstances or internationally agreed guidelines, as appropriate, with special consideration to the centres of origin and genetic diversity".
SBSTTA-22 also agreed that horizon scanning, monitoring and assessing of developments in the field of synthetic biology is needed for reviewing new information regarding the potential positive and potential negative impacts of synthetic biology vis-a-vis the three objectives of the Convention and those of its Protocols.
However, text referring to genome editing in this paragraph remains in square brackets, as does a subsequent paragraph, introduced by Rwanda, that calls for the establishment of a process and modalities for regular horizon scanning, monitoring and assessment, and a mechanism for regularly reporting the outcomes to SBSTTA and the Parties of the CBD and the Cartagena Protocol on Biosafety.
The SBSTTA-22 recommendations will now be considered by the CBD Parties at their next meeting in November 2018, to be held in Sharm El-Sheikh, Egypt.
There, the battles lines on synthetic biology, particularly on organisms containing engineered gene drives, will once again be drawn, particularly around the text that still remains in square brackets. +