TWN Info Service on Biodiversity/Traditional Knowledge and Biosafety
16 November 2024
Third World Network
www.twn.my
COP16: Hollowed-out assessment process for synthetic biology survives
London, 16 Nov (Eva Sirinathsinghji and Lim Li Ching) – Parties to the Convention (COP) on Biological Diversity (CBD) have adopted a decision on synthetic biology that is disappointingly hollow.
The process for broad and regular horizon-scanning, monitoring and assessment of the most recent technological developments in synthetic biology, established at COP15 in 2022, was not explicitly continued.
Nonetheless, despite concerted efforts to “de-establish” the process, the urgent assessment that is needed for synthetic biology will continue, at a reduced scale, through an expert group.
In addition, while focus has turned to capacity building and development, access to and transfer of technology and knowledge-sharing, these activities should also include the necessary capacities, technologies and knowledge on the assessment of synthetic biology.
Parties to the CBD met at their Sixteenth Conference of the Parties (COP16) in Cali, Colombia from 21 October to 1 November 2024.
In 2018, Parties had previously agreed in decision 14/19 that broad and regular horizon scanning, monitoring and assessing of the most recent technological developments is needed. They established such a process in 2022, through decision 15/31.
The decision included an agreement to start work on multidisciplinary assessments of new synthetic biology advancements. A multidisciplinary Ad Hoc Technical Expert Group (mAHTEG) was also established to support the process.
The mAHTEG assessed five prioritised topics – integration of artificial intelligence and machine learning in the context of synthetic biology; development of engineered gene drives to control vector-borne diseases and invasive species; self-limiting insect systems; self-spreading vaccines for wildlife; and inequity in the participation of developing countries in the context of synthetic biology.
Several precautionary policy proposals were made by the mAHTEG to address gaps in governance around the prioritised topics. These would require further in-depth assessments, which the mAHTEG recommended be taken up in future work.
Discussions on synthetic biology, on the basis of the mAHTEG’s outcomes, had already been contentious at the Twenty-sixth meeting of the CBD’s Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA-26), held in May 2024.
Some Parties, largely consisting of those that have adopted and export living modified organisms (LMOs), did not want to continue the horizon scanning, monitoring and assessment process. Instead, they forwarded a capacity building and development, technology transfer and knowledge sharing agenda without the necessary safeguards to protect biodiversity and human health.
Such a move would likely put developing countries at risk of receiving unsuitable or ineffective synthetic biology technologies, increasing inequities and challenging their right to a clean and healthy environment. Parties would also be ill-equipped, lacking the necessary information required to inform decision-makers on fast-moving synthetic biology developments and their potential negative impacts. (See Discussions on multidisciplinary assessments of synthetic biology falter, 31 May 2024.)
At COP16, discussions moved straight into a contact group setting. The contact group was co-chaired by Marja Ruohonen-Lehto (Finland) and Martha Kandawa-Schulz (Namibia).
Discussions were based on the draft decision from SBSTTA-26 that was heavily bracketed. They focused on two main issues: (i) development of a ‘thematic action plan’ to support capacity building, technology transfer and knowledge-sharing in the context of synthetic biology; and (ii) whether to continue with ‘multidisciplinary’ broad and regular horizon scanning, monitoring and assessment of new synthetic biology developments.
General reflections from the first contact group session highlighted that Parties still held opposing views. Following the exchange, a non-paper was produced by the co-chairs, which was then the basis for the rest of the negotiations.
With regard to the thematic action plan, many developing country Parties wanted to prioritise addressing the inequities of participation in synthetic biology within a national development context. They called for financial support, as well as capacity building for assessment and regulation of synthetic biology.
There were also some opposing views: Some developing country Parties prioritised the call for innovation and a focus on the potential benefits that are claimed to be in the pipeline. Other developing country Parties took a more cautious approach, wanting to consider also the potential adverse effects.
Parties that have biotechnology interests pushed for capacity building, technology transfer and knowledge-sharing without any concomitant capacity building for the assessment of potential impacts of synthetic biology technologies.
Yet, a capacity building agenda that omits potential biosafety as well as socio-economic, ethical and cultural impacts from its scope falls short of what is needed. Such an imbalance would lay the foundation for an inequitable action plan that risks the ‘dumping’ of unsuitable or ineffective synthetic biology technologies onto countries with limited assessment capacity.
With regard to the continuation of the horizon scanning, monitoring and assessment process, Parties that have biotechnology interests attempted to end the process entirely, despite previously agreed decisions that the process should be “broad and regular”.
Some went as far as requesting that any future process should focus solely on the potential benefits of synthetic biology, while completely ignoring the risks. They argued that the risks of LMOs are already assessed under the Cartagena Protocol on Biosafety.
This argument, however, fails to acknowledge that the horizon scanning, monitoring and assessment process asks broader scientific questions about technology failures, efficacy and suitability, as well as assesses potential socio-economic, cultural or ethical impacts. Moreover, many synthetic biology applications are not solely restricted to LMOs. (LMOs are the purview of the Cartagena Protocol).
There were also contentious discussions regarding the need to assess the current and proven benefits of synthetic biology, rather than just potential benefits that could lead to unrealistic promises and claims. Such promises and claims risk distracting decision-makers from alternative and proven interventions.
Other Parties, with a more precautionary approach to LMOs and synthetic biology technologies, prioritised the continuation of the horizon scanning, monitoring and assessment process. They stated that such a process is fundamental to understanding any impacts on the three objectives of the Convention.
They urged that the any future work follows a precautionary approach, and for assessments to continue to be multidisciplinary, taking ethical and socio-economic considerations into account.
However, the recommendations put forward by the mAHTEG to conduct further in-depth assessments on priority topics that the group deemed to warrant precautionary policy action, were eventually dropped due to strong opposition.
Following numerous contact group sessions and discussion on the conference room paper (CRP), a compromise was eventually reached and a clean L-document adopted.
The thematic action plan for capacity-building and development, access to and transfer of technology and knowledge sharing in the context of synthetic biology will take into account the identification of areas where such action is needed for research and development, and importantly, for assessment, in the field of synthetic biology.
The plan will be developed initially by collecting information from various stakeholders on their experiences, needs and priorities. The CBD’s Executive Secretary is requested to then prepare a draft thematic action plan.
A new Ad Hoc Technical Expert Group (AHTEG) is established to, inter alia, review and synthesize the compilations; consider an “independent” scientific study compiling and summarizing existing scientific studies, public research and development funding needs and priorities, and research road maps on synthetic biology applications; and taking into account the draft thematic action plan.
It should then provide advice on how capacity-building and development, access to and transfer of technology and knowledge-sharing in synthetic biology can be taken into account with respect to the draft thematic action plan.
The AHTEG is also tasked to assess both potential positive and negative impacts of synthetic biology related to the Convention and the implementation of the Kunming-Montreal Global Biodiversity Framework. Moreover, the work will also include identifying current and potential benefits of synthetic biology, paving the way for an assessment of the veracity of such claims.
The AHTEG is to report to the Subsidiary Body on Scientific, Technical and Technological Advice, while the implementation aspects of the thematic action plan will be forwarded to the Subsidiary Body on Implementation. COP17 in 2026 will then consider the subsidiary bodies’ recommendations.
With this decision, the work on synthetic biology under the CBD will continue, albeit on a scaled-down basis with regard to horizon scanning, monitoring and assessment. It will also have a different focus, largely on capacity building and development, technology transfer and knowledge sharing.
Much will depend on the submissions that will inform the work of the AHTEG, including on the capacities, technologies and knowledge on the assessment of synthetic biology. These are critical elements that are needed to ensure that Parties can still apply a precautionary approach, a central principle in the Convention, to synthetic biology. +