The Convention on Biological Diversity (CBD) is a multilateral treaty with the objective to develop national strategies for the conservation and sustainable use of biological diversity. As such, it is often seen as a key document regarding sustainable development.
The CBD has two supplementary agreements, the Cartagena Protocol and Nagoya Protocol. The former deals with international shipments of genetically modified organisms. The latter provides a legal framework for the equitable sharing of benefits of utilization of genetic resources.
While the CBD is a treaty which became effective on 29th December 1993, it lead to establishment of several international bodies that continue to operate to date. The CBD Secretariat is based in Montreal, Canada and operates under the United Nations Environment Programme. Its main functions are to organize meetings, draft documents and assist member governments in the implementation of the CBD treaty. In this capacity, it has published a Technical Series note (No. 100) that I will summarize below. The topic of the note is Synthetic Biology.
The parties to the CBD have demonstrated interest in the potential impacts of synthetic biology (SynBio) on the goals of the CBD and requested to write a technical note on the subject, which updates a note on the topic published in 2015. The document was peer-reviewed within one month by one individual, seventeen countries, two intergovernmental organizations and twenty-nine other organizations. A total of 2005 comments were received during the process. The technical work underlying the document was supported by grants from the Governments of Austria and the Netherlands.
The over 200 page document comes with a great 13-point summary. I personally found some of those points overlapping or otherwise redundant, so I am providing a summary of the points that I found personally the most interesting below. If you find them relevant, you should certainly also check the original summary (references to its key points are included) and potentially the whole document.
- There is no internationally agreed definition of synthetic biology, which in turn poses challenges to its governance. (#2)
- The global synthetic biology market was estimated at US$ 6.8 billion in 2020 and is projected to grow at 23.9% compound annual growth rate through 2025 (#3)
- The majority of synthetic biology products are produced in containment (e.g. synthetic DNA, RNA and oligonucleotides) (#3)
- Research and development in SynBio mostly occurs in limited number of countries. 70.6% of synthetic biology research is funded by mere 20 agencies (6 USA, 3 China, 2 Canada, 2 Germany, 2 Japan, 2 UK, 2 EU and 1 South Korea) (#4)
- Most commercial applications of synthetic biology to date are reserved for contained industrial or laboratory settings (e.g. cosmetics and fragrances, food ingredients and flavors, fabrics). New applications are increasingly targeting (semi-)managed, urban and unmanaged settings where interaction with the biodiversity of the environment are more likely or even desired (#5, #6). There is little data to assess impact of these technologies on the environment. (#5, #6)
- Assessment of impact of new products is complex. Discussions with involved stakeholders, incl. communities, is vital and cannot be circumvented. Substitution of synthetic alternative for a natural product, while seemingly having clear net positive environmental impact, could for example displace traditional cultivation practices and aggravate fragile economic condition of small producers. (#7, #8, #9)
- While biosecurity of synthetic biology is already receiving some attention, it could be further advanced by increased transparency, communication with the public and policymakers and pro-active self-regulation (#10)
- Resources will be needed for development and update of various regulatory systems that relate to synthetic biology. It is likely that these resources will be lacking especially in countries that already have under-developed regulatory structure (incl. biosafety) (#11)
- Synthetic biology is at the moment governed by multitude of institutions at various levels, without a global overarching framework. The breadth of the field and the current regulatory structure suggest that the most effective development in international governance will be achieved by individual stakeholders engaging in consortia and broader initiatives in order to facilitate coordination and adoption of norms. (#12)
- As SynBio is young and rapidly evolving field, early foresight of upcoming technologies is important for timely development of appropriate regulation. (#13)
The Secretariat to the CBD and the Parties to the CBD recognize need to i) better integrate and coordinate governance of synthetic biology and ii) to expand the focus beyond biosafety, human health and the physical environment to include social and ethical impacts taking into account national contexts. New governance methods, integration with social sciences and engagement with involved stakeholders and communities will be required in the regulatory development, accounting for the ability to foster scientific creativity and to allow effective, yet responsible, new product development.
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