Synthetic biology is the development of well-characterised biological components with the objective of constructing and redesigning natural biological systems. The possible uses of synthetic biology are many and include new pharmaceuticals, the generation of hydrogen for a post-petroleum economy and the detection of toxic chemicals.
However, there are also some potential risks and governance issues arising from the design of synthetic biological components. For example, there are ethical issues surrounding converting nature into market commodities and the ownership of what has previously been seen as a “public good”, as well as potential unintended harmful consequences for human health or the environment (e.g., due to accidental release) or deliberate misuse (e.g., recreation of known pathogens). Another risk may result from the fact that the technology is cheap and easy to acquire and a lot of the coding being developed and used is made public through the Internet: this could both decrease the potential for patent protection and increase the potential for an emerging hacker culture to exploit this public information.
As with several other innovative technologies a key issue concerns its definition: there are parallels with genetic engineering, but considerable differences in terms of precision (much greater). Without a precise definition, regulation will be difficult. Even with a clear definition, there is then a need to decide on the degree of novelty and, as a result, whether regulators should treat synthetic biology as path-dependent (using existing structures and processes) or path-breaking. Regulators must also decide whether synthetic biology constitutes a technology or a biological science. The regulatory pathway will depend on how these question are resolved.
Synthetic biology clearly offers opportunities to address significant needs (e.g., environmental remediation, health diagnostics and drug delivery) but the associated risk issues require resolution if it is to do so. It is also an example of another new, enabling technology for which existing governance structures and processes are ill-suited.
IRGC published a Concept Note on Synthetic Biology in spring 2008, in preparation of an exploratory workshop in June the same year. One of the conclusions of that workshop was that IRGC should conduct project work to develop policy recommendations for improving the risk governance of synthetic biology. Given the rapid development of the field, an updated and completely revised concept note was published in October 2009 to inform the workshop "Risk Governance of Synthetic Biology" in Geneva on 26 and 27 October. Both concept notes are available on our website. Taking into account the lessons learned and discussions in the workshop, IRGC will begin work on a Policy Brief to be published in early 2010.
The synthetic biology project has a budget of 60,000 CHF, and is funded by IRGC general funds. IRGC is grateful to all organisations who contribute to our work in this way. For more information about this project, contact Malin Samuelsson at malin.samuelsson@irgc.org