TWN Info Service on Biodiversity and Traditional Knowledge (May24/01)
2 May 2024
Third World Network

Dear Friends and Colleagues,

TWN Briefing Note on synthetic biology for SBSTTA-26, May 2024

Parties to the Convention on Biological Diversity will gather in Nairobi for the Twenty-sixth meeting of the Subsidiary Body on Scientific, Technical and Technological Advice from 13-18 May 2024. One of its agenda items is on synthetic biology, which the CBD has addressed over the last decade, given the potential adverse effects of the organisms, components and products of synthetic biology on the three objectives of the Convention.

In 2018, Parties agreed in Decision 14/19 that broad and regular horizon scanning, monitoring and assessing of the most recent technological developments is needed, and established such a process through Decision 15/31. A multidisciplinary Ad Hoc Technical Expert Group (mAHTEG) was also established by the same decision, to support the process, and carried out its work in 2023-2024.

This TWN Briefing Note highlights some of the outcomes of the mAHTEG’s work, and recommendations to, inter alia, continue the board and regular horizon scanning, monitoring and assessment process on a biennial basis, using the established methodology as a basis, and continue addressing the potential risks of synthetic biology in a multidisciplinary and precautionary fashion.

With best wishes,
Third World Network 

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Synthetic Biology (Agenda Item 5)
TWN Briefing Note for SBSTTA-26, May 2024

Background

The issue of synthetic biology has been on the agenda of the Convention on Biological Diversity (CBD) for the last decade, given the potential adverse effects of the organisms, components and products of synthetic biology on the three objectives of the Convention. In 2018, Parties agreed in Decision 14/19 that broad and regular horizon scanning, monitoring and assessing of the most recent technological developments is needed, and established such a process through Decision 15/31. A multidisciplinary Ad Hoc Technical Expert Group (mAHTEG) was also established by the same decision, to support the process, and carried out its work in 2023-2024.

Horizon scanning, monitoring and assessment process

The first cycle of broad and regular horizon scanning, monitoring and assessment carried out by the mAHTEG was successful in identifying numerous trends, topics and issues within the rapidly evolving field of synthetic biology.  This process thus serves to ensure that Parties can be informed of novel applications and trends that are relevant. It also functions as a platform to foster global awareness-raising.

The first cycle identified and prioritised a wide range of issues, including those: a) not covered by the Cartagena Protocol on Biosafety; b) that pose wide ranging and novel biosafety, socio-economic, ethical and cultural risks; c) applications that are now being trialled and commercialised, allowing for broader in-depth evaluations, including of efficacy and claimed benefits; and d) high-risk applications that are advancing rapidly without adequate discussion and oversight.

For example, the process identified topics that are not yet under discussion within the CBD, including the risks posed by the convergence of synthetic biology with artificial intelligence (AI), and self-spreading vaccines designed to be released into wildlife populations. The identification and assessment of these two trends in particular, were facilitated by the multidisciplinary expertise in the mAHTEG, as well as the use of multidisciplinary information.

The mAHTEG was able to assess wider overarching elements within the field of synthetic biology that are relevant to all three objectives of the Convention. Such elements include: an increase in complexity and scale of modifications across all kingdoms of life, including wild and domestic populations with multi-species applications; an increased likelihood of transboundary movements; and the permanent genetic modification and re-designing of nature.

The mAHTEG concluded that the process was successful, revealing ‘valuable information’ and recommended that it should become a broad and regular process that is conducted every biennium.

Some topics that were prioritised for assessment Self-spreading vaccines The process identified this as a technology that appears to be in advanced stages of R&D but which lacks corresponding discussions regarding risks, regulatory oversight or public awareness or participation. The assessment was able to identify that projects are advancing, noting serious biosafety and wider risks of the technology to both biodiversity and human health, including unknown evolution, altered virulence, and unintended spill-over to non-target species. The use of multidisciplinary expertise was a key component to the success of the process, including in the tracking of project pipelines. It should be noted that the scientific literature review conducted failed to pick up the issue of self-spreading vaccines. This highlights the value of the mAHTEG meeting that was successful in horizon-scanning. There are currently no processes within the Convention to sufficiently address the issue of self-spreading vaccines in wildlife, with the mAHTEG serving a valuable role in raising awareness over an issue that warrants urgent precautionary oversight. Gene drives Issues such as transboundary movements, the inability to “opt-out’ of consent due to the self-spreading nature of gene drives, as well as liability and redress concerns were highlighted by the mAHTEG as aspects of the technology that are not fully addressed by risk assessment. In addition, the ability of gene drives to achieve intended goals due to efficacy problems such as expected resistance development was also questioned. Self-limiting insects Self-limiting insects have been released in trials and have entered commercial release. This has allowed for the inclusion of efficacy assessments. The mAHTEG concluded that limitations of efficacy and entrenchment of industrialised agricultural monoculture systems are key aspects that should also be considered in decision-making processes, particularly with the current interest in developing novel forms of self-limiting LMOs.

Opportunities for improvement

As this was only the first cycle, the horizon scanning, monitoring and assessment process involved developing the process itself and assessing prioritised topics. Future rounds could improve on the choice of topics, to focus on those that are yet to be included in CBD processes, such as the current examples of the convergence of synthetic biology and AI, and self-spreading vaccines.

Future rounds could also be improved with more time allocated for the assessment step, in order to refine the outcomes of the assessment.  This could be facilitated by ensuring that assessments also include assessing the validity of claims of benefits around untested technologies, as well as by ensuring that conflicts of interest are successfully avoided or managed. In addition, as noted in Annex V of CBD/SBSSTA/26/4, which contain the recommendations of the mAHTEG, the process could be enriched through outreach to indigenous peoples and strengthening the development of relevant participatory instruments and tools.

Recommendations

• Welcome the outcomes of the broad and regular horizon scanning, monitoring and assessment process, and endorse the mAHTEG’s methodology as the continued basis for such a process. Importantly, the SBSTTA should affirm that ‘regular’ means that the process should occur biennially.
• Re-emphasize the importance of the precautionary approach and multidisciplinarity as fundamental to the horizon scanning, monitoring and assessment process, while ensuring the full and effective participation of indigenous peoples and local communities in the discussions and in the work on synthetic biology.
• Ensure proper implementation of the procedure for avoiding or and managing conflicts of interests in expert groups, adopted in decision 14/33, as a necessary safeguard.
• Adopt the recommendation of the mAHTEG to initiate policy processes and assessment, including of the ecological, socioeconomic, cultural and other impacts, of two prioritized topics: the convergence of synthetic biology and artificial intelligence; and engineered self-spreading vaccines for wildlife, with the latter including the development of mechanisms for the free, prior and informed consent of potentially affected communities.
• Adopt the recommendation of the mAHTEG to conduct a wider assessment of the socioeconomic, cultural, and ethical impacts of engineered gene drives, in particular on indigenous peoples and local communities. This would complement the current draft guidance material on risk assessment of such organisms (CBD/SBSSTA/26/5/Add.1) and could be undertaken in conjunction with a renewed mandate of the AHTEG on Socio-economic Considerations under the Cartagena Protocol.
• Continue further assessments of self-limiting insects, considering that the initial assessment found evidence of lack of efficacy and risks to biodiversity. Novel self-limiting insect technologies are on the horizon, warranting careful assessment of this approach for health and agriculture.

Emphasize the need for equitably supporting capacity-building, appropriate technology transfer and knowledge sharing efforts for developing countries for the horizon scanning, assessment and monitoring of new developments in synthetic biology, as elaborated in Annex II of CBD/SBSSA/26/4.