To facilitate a gathering of additional  information, participants are asked to consider the following points in relation to this topic:
1. Review the potential impacts on the three objectives of the Convention that may  in the context of synthetic biology. Please use specific examples when possible.

2. What are the potential gaps or challenges for risk assessment, risk management and regulation that may arise or need to be addressed in the context of developing countries ? What is the availability of tools to detect, identify and monitor the organisms, components and products of synthetic biology?

3. Review the potential social, economic, cultural, ethical, political, human health and/other relevant impacts that may arise from this trend and issue. What are the relevant considerations for IPLCs, women and youth?

4. What lessons can be learned from other domains? How might those lessons from elsewhere be relevant or shed insight in assessing this topic in the context of the aims of the Convention on Biological Diversity?

Dear colleagues,

It is my pleasure to welcome you to the Open-ended Online Forum on Synthetic Biology. The forum will be open from 6 to 15 November at 17.00 EST. I will be moderating the discussion and will provide support should the need arise. Please also bear in mind the forum guidelines that you can find on the website.

Thank you in advance for your engagement and I am looking forward to productive discussions!

Kind regards,
Florian Rabitz

Greetings colleagues!

Leocris Batucan, a fellow for the National Committee on Biosafety of the Philippines.

I would like to start with #2 (availability of tools to detect, identify and monitor the organisms, components and products of synthetic biology) in the context of our country, the Philippines which is a developing economy.

The tools and the knowhow to detect, identify, and monitor components and products are available to a degree however due to the archipelagic nature of the state (i.e. multiple entry points, seaports) and growing economy (i.e. increasing volume), trained personnel are lacking. There is a need for more capacity building and training. The logistics of reagents and products  remains an issue. Likewise, continuity of efforts is needed as some ports of entry are less able than others.

Activities to improve the situation is present and continuing. NCBP, with its international and local partners, is exerting effort in establishing detection laboratories, and training personnel.

A couple of points from one perspective in South Africa (a developing country):
1. Local Innovation capacity/capability is essential to support/develop.
At present our maize (corn), soya & cotton in SA are very largely GM.  All of these are multinational products.  As climate change increases, it is imperative that we have local capability to adapt our other (orphan) crops to drought/new pests, etc.  The latter is not of interest to multinationals because the markets are (usually) very small. Good to have our staples getting world class technology adaptation, but we need capability for other crops.
2. Building the innovation system
Relying on multinationals means that the research & innovation is not local, and therefore jobs and skills are not local. Part of the premium developing countries must pay for GM crops is to continue support for skills and jobs located in the developed world. This inequality makes sense for business, but it is entrenching inequality for the developing countries.
3. Regulation requires science skills
In my view, regulation - particularly the risk assessment components - is best conducted by people who are intimately familiar with the technology and its applications. In some developing countries, this scientific familiarity may just be theoretical or there is a stronger focus on administrative/ political justifications.  For a sustainably defendable system, science based skills must continually be developed.

Dear colleagues,

Aiming to address the guiding questions, I would like to share pertinent information on the topic of Inequity in the participation of developing countries in the context of synthetic biology.

The advancements in synthetic biology can result in both direct and indirect impacts on biodiversity, leading to either positive or negative outcomes (McFarlane et al., 2022). However, the limited access to this technology in developing countries hinders their ability to benefit from potential positive impacts and to adequately evaluate potential negative consequences. The high rate of biodiversity loss, as highlighted in the Global Assessment Report on Biodiversity and Ecosystem Services, is primarily driven by land use changes, pollution, direct exploitation, and climate change manifestations (Brondizio et al., 2019).

Changes in land use impact different regions disproportionately, while afforestation and cropland abandonment are common in the Global North, deforestation and agricultural expansion happen in the Global South (Winkler et al., 2021). Consequently, agriculture, one of the focal areas for synthetic biology research in developed countries, is a key contributor to biodiversity loss in developing countries. The application of synthetic biology in agriculture addresses critical challenges like climate change, soil fertility, plant microbiomes, photosynthesis, and nutrient content in crops (Abberton et al., 2016; Bender et al., 2016; Borel, 2017; Bourzac, 2017; De Steur et al., 2017). The potential positive impacts of synthetic biology on biodiversity in developing countries lie in its ability to address agricultural challenges more sustainably. By creating crops that are more resilient to climate change, enhancing soil fertility through bioengineered solutions, or even developing pest-resistant plants, synthetic biology has the potential to reduce the ecological impact of traditional farming practices.

Moreover, direct exploitation of natural resources is one of the main sources of income in developing countries.  Although degraded ecosystems may be slow to recover or may not recover naturally even after their exploitation stops (Moreno-Mateos et al., 2017), a transition to knowledge-based industries is needed for a sustainable economic growth (Nathaniel et al., 2021). According to Precedence Research (2023), the current market value of synthetic biology is 16.35 billion U.S. dollars and will reach 72 billion by 2030. This report shows that the collective global market share contributed by Latin America, the Middle East, and Africa is only 7%, emphasizing an opportunity for these regions to tap into and contribute significantly to the synthetic biology industry. Increasing participation of developing countries in synthetic biology not only aligns with the imperative for sustainable economic practices but also positions these regions to harness the benefits of a growing and transformative market.

Article 401 of the Ecuadorian constitution from 2008 asserts the nation's status as free from transgenic crops. This law prohibits farmers from cultivating transgenic crops but permits the consumption of products derived from transgenics. Despite the explicit prohibition on the use of transgenic crops being in effect for 15 years, there is still a lack of adequate facilities and resources for their detection (Intriago-Barreno, & Bravo-Velásquez, 2016). This limitation is likely to extend to products of synthetic biology as well.

In an era of high throughput sequencing and rapid DNA synthesis, genetic resources can easily trespass frontiers as digital sequences. Although including the use of digital sequences under the CBD is contested (Lyal, 2022), access to sequencing technologies is fundamental for developing countries seeking to catalog their genetic resources and aspire to fair and equitable sharing of benefits derived from them. In compliance with the Convention on Biological Diversity, Ecuador implemented a framework contract to access genetic resources, aiming to promote the sustainable use of biological and genetic resources within its national borders (Gobierno del Ecuador, 2011). This contract, along with an export permit, is a prerequisite for scientists sending genetic material abroad for sequencing. However, the bureaucratic process involved in obtaining the contract is cumbersome, often taking more than a year. This delay hampers the potential discovery of genetic resources that could be used sustainably, given the lack of local sequencing facilities. It is important to learn from this experience, recognizing that constraining the progress of synthetic biology in developing countries is likely to impede the achievement of the objectives of the Convention on Biological Diversity.

The ethical, regulatory, and socio-economic dimensions of deploying synthetic biology in developing countries need careful consideration. While there are environmental risks, which may parallel those associated with living modified organisms, leaving the countries behind would perpetuate their dependency on developed nations for technology and widen the economic gap between them. The limited access to synthetic biology technology in developing countries also prevents their active participation in discussions on the subject. Closing this technological gap is crucial for fostering global collaboration and ensuring a more inclusive approach to biodiversity conservation.

In an era of high throughput sequencing and rapid DNA synthesis, genetic resources can easily trespass frontiers as digital sequences. Although including the use of digital sequences under the CBD is contested (Lyal, 2022), access to sequencing technologies is fundamental for developing countries seeking to catalog their genetic resources and aspire to fair and equitable sharing of benefits derived from them. In compliance with the Convention on Biological Diversity, Ecuador implemented a framework contract to access genetic resources, aiming to promote the sustainable use of biological and genetic resources within its national borders (Gobierno del Ecuador, 2011). This contract, along with an export permit, is a prerequisite for scientists sending genetic material abroad for sequencing. However, the bureaucratic process involved in obtaining the contract is cumbersome, often taking more than a year. This delay hampers the potential discovery of genetic resources that could be used sustainably, given the lack of local sequencing facilities. It is important to learn from this experience, recognizing that constraining the progress of synthetic biology in developing countries is likely to impede the achievement of the objectives of the Convention on Biological Diversity.

Abberton, M., Batley, J., Bentley, A., Bryant, J., Cai, H., Cockram, J., ... & Yano, M. (2016). Global agricultural intensification during climate change: a role for genomics. Plant biotechnology journal, 14(4), 1095-1098.
Bender, S. F., Wagg, C., & van der Heijden, M. G. (2016). An underground revolution: biodiversity and soil ecological engineering for agricultural sustainability. Trends in ecology & evolution, 31(6), 440-452.
Borel, B. (2017). CRISPR, microbes and more are joining the war against crop killers. Nature, 543(7645).
Bourzac, K. (2017). Bioengineering: solar upgrade. Nature, 544(7651), S11-S13.
Brondizio, E. S., Settele, J., Diaz, S., & Ngo, H. T. (2019). Global assessment report on biodiversity and ecosystem services of the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services.
De Steur, H., Mehta, S., Gellynck, X., & Finkelstein, J. L. (2017). GM biofortified crops: potential effects on targeting the micronutrient intake gap in human populations. Current opinion in Biotechnology, 44, 181-188.
Gobierno del Ecuador (2011). Reglamento al Régimen Común Sobre Acceso a los Recursos Genéticos. Decreto Ejecutivo 905.
Intriago-Barreno, R., & Bravo-Velásquez, E. (2016). Primera detección de Soya transgénica (Glycinemax) cultivada en la Costa ecuatoriana usando métodos de monitoreo participativo. Cienciamérica, 5(1), 75-82.
Lyal, C. H. (2022). Digital sequence information on genetic resources and the convention on biological diversity. In Global Transformations in the Use of Biodiversity for Research and Development: Post Nagoya Protocol Implementation Amid Unresolved and Arising Issues (pp. 589-619). Cham: Springer International Publishing.
Macfarlane, N. B., Adams, J., Bennett, E. L., Brooks, T. M., Delborne, J. A., Eggermont, H., ... & Redford, K. H. (2022). Direct and indirect impacts of synthetic biology on biodiversity conservation. Iscience.
Moreno-Mateos, D., Barbier, E. B., Jones, P. C., Jones, H. P., Aronson, J., López-López, J. A., ... & Rey Benayas, J. M. (2017). Anthropogenic ecosystem disturbance and the recovery debt. Nature communications, 8(1), 14163.
Nathaniel, S. P., Nwulu, N., & Bekun, F. (2021). Natural resource, globalization, urbanization, human capital, and environmental degradation in Latin American and Caribbean countries. Environmental Science and Pollution Research, 28, 6207-6221.
Precedence Research. (2023). Synthetic Biology Market. Retrieved from https://www.precedenceresearch.com/synthetic-biology-market. Accessed November 10, 2023.
Winkler, K., Fuchs, R., Rounsevell, M., & Herold, M. (2021). Global land use changes are four times greater than previously estimated. Nature communications, 12(1), 2501.

Dear Colleagues,
There is a huge gap between the north (developed countries) and the south (developing) countries in terms of modern research techniques employed in synthetic biology. In order to bridge this gap, urgent and deliberate steps and initiatives ought to be undertaken. The longer the wait the wider the gap. Relevant organizations need to organize training courses on synthetic biology with practical approach for scientists from developing countries. Also, some universities can consider giving scholarships to students from developing countries to study for their masters and PhD in synthetic biology and related fields. University researchers in Ghana can also be given the opportunity to attend further training as part of staff development, capacity building and career progression.

The African continent and Ghana for that matter has great research potential that is highly underutilized. I strongly believe that this platform can be used as a stepping stone to utilize the research potential in Africa and Ghana for that matter.

Developed countries therefore need to lend a helping hand to developed countries in order to bridge the gap of inequity. Scientists in developing countries can be given "return home grant" where they can be given synthetic biology training to return to their home countries with a grant to carry out the research work.

More importantly, all the helping hand initiatives should be carried out in collaboration with the relevant government agencies in order to gradually persuade the African and Ghana governments to get involved and eventually take over the initiative of funding synthetic biology research in Ghana and Africa at large.

Thank you for your attention.
Francis Dajnkpa - Ghana

Synthetic biology is an approach predominantly led by wealthier nations, and it seems to be overlooking the potential role that developing and emerging economies, rich in biodiversity, could play. The limited geographical diversity in synthetic biology publications and underrepresentation in iGEM participation are some of the signals to the need for greater inclusivity. This is vital for unlocking access to a broader spectrum of talent, fostering innovative ideas, and inspiring nature-inspired products. Developing countries, struggling with challenges like infectious diseases, agriculture, socio-economic, and environmental issues, could significantly benefit from increased participation. Addressing the participation gap in synthetic biology would not only facilitate tailored solutions for specific needs but also promote the effective management of potential risks, responsible research and innovation, and the advancement of sustainable development goals. Simultaneously, it could bring benefits to wealthier nations and contribute to achieving the three core objectives of the Convention on Biological Diversity (CBD).

Conservation of Biological Diversity:
Increased participation can foster the development of technologies dedicated to preserving ecosystems. Synthetic biology can play a pivotal role in habitat restoration, biodiversity monitoring, and sustainable agriculture, alleviating pressure on natural habitats. It can lead to the creation of more sustainable solutions for issues like pollution, waste management, and conservation, contributing to global environmental goals.

Sustainable Use of Biological Components:
Inclusive participation empowers developing countries to harness synthetic biology for sustainable use. For instance, from crops with enhanced resilience and nutritional content to resistance against climate change, pests, and diseases, these advances can contribute to food security, reduce harmful pesticides, and promote environmentally friendly agriculture.

Fair and Equitable Sharing of Benefits:
Diminishing inequity can improves fair and equitable benefit-sharing, a core CBD objective. Joint research projects, technology transfer, and capacity-building initiatives can empower developing countries to actively participate and benefit. Additionally, it can contribute to addressing global challenges, such as rapid vaccine development and diagnostic tools, efficiently tackling pressing global health issues.

My name is Luciana Ambrozevicius and I have been working for the Brazilian Ministry of Agriculture and Livestock for the past decade. I am also currently a member of the Brazilian National Biosafety Commission and I have been a member of the AHTEG on Risk Assessment in 2023, as well as I am a former member of the previous Synbio AHTEG. Thank you for the moderator and for the Secretariat for the opportunity to share some ideas.

I agree with #3085: “There is a huge gap between the north (developed countries) and the south (developing) countries in terms of modern research techniques employed in synthetic biology” and I also agree with one of the practical solutions mentioned: “Relevant organizations need to organize training courses on synthetic biology with practical approach for scientists from developing countries.”

Also important to mention the role of global south (#3114) “Synthetic biology is an approach predominantly led by wealthier nations, and it seems to be overlooking the potential role that developing and emerging economies, rich in biodiversity, could play. “

About the specific questions presented by the moderator:
1. Review the potential impacts on the three objectives of the Convention that may  in the context of synthetic biology. Please use specific examples when possible.
The majority of synthetic biology applications for use in the environment are intended to enhance the conservation and/or sustainable use of biodiversity and to help achieve GBF commitments and Sustainable Development Goals. Each application must be evaluated on a case-by-case basis in a transparent and iterative process.  A characteristic of synthetic biology applications is that it follows steps related with “design, build, test, learn and repeat” and throughout the development process, potential positive and negative impacts are evaluated and compared to possible alternatives.  The environmental crises and food insecurity presents a huge challenge for humanity and all the opportunities and available tools have to be considered to achieve sustainable solutions. 

There are examples of national authorities interested on the capacity of synthetic biology to develop useful applications:

https://webarchive.nationalarchives.gov.uk/ukgwa/20130221185318/www.innovateuk.org/_assets/tsb_syntheticbiologyroadmap.pdf

https://www.csiro.au/en/work-with-us/services/consultancy-strategic-advice-services/csiro-futures/future-industries/synthetic-biology-roadmap

2. What are the potential gaps or challenges for risk assessment, risk management and regulation that may arise or need to be addressed in the context of developing countries ? What is the availability of tools to detect, identify and monitor the organisms, components and products of synthetic biology?
The examples above show that most of the studies elaborating a Road Map focused on a strategic view of how synthetic biology could underpin a thriving economy are elaborated by developed countries. In my opinion this is the gap for developing Parties. Those studies could help developing countries to focus their efforts in a more sustainable way towards their economical and social development and eradication of poverty while adopting more biodiversity-friendly solutions. 

In my opinion there are no potential gaps or challenges for risk assessment, risk management and regulation at this moment. Based on the operational definition of synthetic biology adopted by CBD Parties and the definition of LMO in the Cartagena Protocol on Biosafety, it can be considered that all living organisms developed through synthetic biology so far will fall under the definition of an LMO. In this case the general principles of risk assessment in the Annex III of the Cartagena Protocol, include a scientifically sound, transparent and comparative approach, remain applicable to the risk assessment of LMOs developed through Synbio.

For those organisms developed using synthetic biology methods that are so similar to those found in nature, meaning they are virtually indistinguishable from those that might occur through traditional breeding, they should follow the same procedures applicable to the conventional organism.

3. Review the potential social, economic, cultural, ethical, political, human health and/other relevant impacts that may arise from this trend and issue. What are the relevant considerations for IPLCs, women and youth?
Although all the mentioned considerations are relevant, they are part of decision making process where the risks and benefit of the technologies have to be considered according with national circumstances. Those considerations are not part of the risk assessment process that should be always science-driven. 

4. What lessons can be learned from other domains? How might those lessons from elsewhere be relevant or shed insight in assessing this topic in the context of the aims of the Convention on Biological Diversity?
I consider that is necessary to promote research in areas such as modelling, establishment of scenarios and to use a step-wise approach with information collected during different phases of product development. It is also important to use and to adapt the experience gained in other areas of risk assessment such as management of pests and invasive alien species and decades of experience with RA of LMOs released in the environment.

Best regards,
Luciana

General intervention for all topics

Dear members of the ATHEG,

All the trends and issues proposed here are relevant. Although the others don´t prioritized are too. The point is that synthetic Biology understood as the combination of Systems Biology and Molecular Biology represents the opportunity to create new bio-elements similar to or inclusive unsimilar to the nature has. Synbio is a huge door that transgresses the natural barriers, rules, and limitations. This door opens the possibility to play with imagination and scientific creativity, but this game needs rules because when the biological systems are intentionally altered, we need to be sure we know how that system functions and how our objective can be reached without losing the play.

Symple, all products of Synbio need to be evaluated, and evaluated case by case and step by step but not all the criteria applied to assess the living modified organisms in the Cartagena Protocol context are useful, because of the current Synbio products include ones that pretend to do changes in biology systems without have enough knowledge and comprehension on how this systems work and the ecological interactions of these systems.
At this moment, we need to generate general rules or criteria for the developers with the aim of product design will incorporate some scientific parameters, ethical criteria, and a previous risk assessment or risk prospection analysis to ensure these products have environmental and health responsibility.

About the use of AI in product design, its important that the information that feeds that AI is from confident sources with the up mentioned criteria.

On the other hand, the inequity in the participation of developing countries in the context of synthetic biology should be addressed with the recognition of the importance of biotechnology for life solutions and with the acceptance and promotion of synthetic biology research and development, accompanied by technology transfer and building capacity in biotechnology risk assessment and risk management.

Best regards.

Dear Participants of the Open-ended Online Forum on Synthetic Biology,

Thank you for your interventions and active engagement.
The forum is now closed for comments.

Thank you,
The Secretariat