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Synthetic biology (SynBio) in simple terms, refers to artificially developing or imitating a natural process or system. The complexity and novelty of synthetic biology, however, have created a level of difficulty to define it due to the continuously fast track evolution of the technology and the broadening of its context in the past decade. SynBio’s current and potential impact is multidisciplinary, with an estimated applicability and impact of over US$30 trillion by 2030, which further intensifies the need to understand and govern this exponentially evolving subsector.

The topic of SynBio and its regulatory and governance framework have been gaining more traction, especially after several key recent events, such as the fast track development and adoption of the mRNA vaccines during the COVID-19 pandemic. This event alone has left open many unanswered questions, from scientific, legal, governance, ethical, social, and economic perspectives. The fact that we are daily interacting with SynBio knowingly or unknowingly – from food to environment, along with the development of designer babies, creating a new form of life like AI Xenobots from a single cell from a frog, and efforts of de-extinction, have made it critical for the scientist and policy makers to act immediately. While this sector took years to decode the human genome, it now takes days to design a vaccine against a new deadly virus, at a fraction of the cost.

Thus, this report has delved into several SynBio scenarios, through a multidisciplinary lens, while surveying the global governance framework, and the current and potential risks associated with this sector and technologies, in the absence of a collective consensus on the legal and ethical frameworks, at minimum, to regulate the use and development of SynBio. This policy paper provides an overall prospective of the magnitude and complexity of the sector, and the policy options for governing SynBio on the national and global levels. These policy recommendations take into consideration the continuously evolving and multi-sectoral technologies, utilizing the expertise of geneticists, health care providers, researchers, policy experts, legal experts, and pharmaceutical experts.