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UN Convention on Biological Diversity open-ended online forum on Synthetic Biology
Topic 7: Degree to which the existing arrangements constitute a comprehensive framework in order to address impacts of organisms, components and products resulting from synthetic biology, in particular threats of significant reduction or loss of biological diversity

Tait, J

July 2015

I am Joyce Tait, Director of the Innogen Institute in the University of Edinburgh. I am also a member of the UK Synthetic Biology Leadership Council and Chair of its Governance Subgroup. However, the opinions expressed here are my own, based on academic research on the complex interactions involved in supporting and regulating innovative developments in life sciences, including GM crops since the 1980s and, more recently, synthetic biology.
I agree with the points made in this and earlier discussions that the regulatory systems we have in place today for contained use and deliberate release will be adequate to deal with any new challenges raised by synthetic biology, or could be adapted to do so without the need for a new regulatory approach. However, no regulatory system is perfect and, by incorporating a better understanding of governance/innovation interactions, these discussions could provide an opportunity to adapt current regulatory systems (see Mike Paton, Topic 4, #7273, and Bob Friedman, #7381) to increase the opportunities for synthetic biology to meet societal needs and desires, including improved conservation of biological diversity. The current provisions of the CBD and its protocols are rather blunt instruments, well-meaning in the context of protecting bio-diversity but seriously inhibiting of innovation that could make a positive contribution towards that protection.
It is now well understood that the more time-consuming, expensive and demanding the regulatory system, the greater the dominance of the innovation system by large multinational companies as only they have the necessary resources to meet this challenge. Thus the dominant role of multinationals in developing GM crops and potentially also synthetic biology, to the regret of civil society groups, is a direct result of the regulatory systems they themselves have been so influential in creating and which they are seeking to perpetuate or amplify. In the health-related context, regulators are now well aware of the need for smarter, more adaptive approaches to regulation and are making changes that are having a dramatic impact on the cost of development of some new classes of drugs that meet specific societal needs (e.g. novel antimicrobials). In the context of biodiversity, smarter, more adaptive regulatory systems would enable small companies in developed and developing economies to produce niche applications for the smaller markets that are not attractive to multinationals but would be viable for a small company. These could, for example, deliver benefits to peasant farmers by enabling them to farm in more sustainable ways, or perhaps to grow a broader range of crops to meet local needs. Such innovations will be impossible unless our current regulatory systems are made more adaptive.
Jim Thomas (#7375) draws attention to the transformative potential of synthetic biology and makes a useful comparison with the development of information and communication technologies in the 1980s and 90s. The available evidence would suggest that if a regulatory system similar to that of the CBD and its protocols had been in operation for these technologies, the flourishing of innovation potential that we have experienced would never have happened. This is the danger faced by developers of synthetic biology if we are not able to adapt our current regulatory systems to be smarter in supporting innovations that are safe and meet societal needs and desires.
To give another innovation/regulation related example, the discussion on defining synthetic biology was inconclusive, but strongly focused on the need for such a definition. However, some participants pointed out that the robust type of definition that is required to support process-based regulation could be inhibiting of innovation by driving it towards or away from particular applications, and the importance of such biases in the early stages of development of a new technology should not be underestimated. The case for having such a technology-driving definition is considerably weakened if the regulatory system is product based (as in Canada and the USA) rather than process based (as for Europe and the CBD), as was advocated by many participants in earlier discussions.
There were frequent references in earlier discussions to the case-by-case regulatory systems currently in operation with the implication that this should be the basis for all future regulation. One could, on the other hand, point out that an adaptive regulatory system is one that would build on regulatory experience over the years and, for example, move towards a class-by-class approach as information on the behaviour of specific types of organism or product accumulates. Given the expected range and scale of applications from synthetic biology, maintaining a case-by-case approach indiscriminately may become unworkable.
Another important strand of discussion under previous topics was the extent to which the products of synthetic biology might have the unintended result of depriving small scale specialist farmers of their living, with knock-on environmental disturbances. One way of dealing with such issues is by stopping development of the technology, as advocated by several participants in these discussions. However, there are other smarter options that will allow a broader range of technologies to be developed, meeting a broader range of societal needs in numerous countries, much as has happened in the information and communication technologies. Relevant options would include: straightforward environmental protection regulation (also a potential source of jobs); government policies to support production of particular types of product; government subsidies for particular production systems that deliver societal benefits (as happens in many places for organic farming). Such approaches would enable a country to experience the broader economic and other societal benefits that might arise from synthetic biology while at the same protecting biodiversity.
The overall point being made here is that, by better understanding how innovation systems and regulatory systems interact with one another, it is possible to deliver an outcome that: (i) allows greater flexibility for a broader range of companies to develop novel, useful products that are safe; (ii) allows countries to benefit from a broader range of new products that meet societal needs and can improve economic prosperity; and (iii) at the same time protects and even improves on current levels of biodiversity.
The above comments are a selection of insights based on a major programme of academic research, further details of which are on the website of the Innogen Institute (http://www.innogen.ac.uk).

The full discussion forum on this topic is available here: CBD open-ended discussion thread