Policy Options for Gene Synthesis

Gene synthesis technologies are powerful research tools used to better understand the human genome, improve therapeutics, and to design vaccines, but they can also be misused. With gene synthesis, a virus can be made “from scratch” in the laboratory, without starting from an existent virus sample; as many biosecurity regulations rely on regulating access to dangerous pathogens, gene synthesis technologies offers away around those prohibitions. This project focuses on gene synthesis and related technologies, and efforts to raise barriers against misuse. In 2010, the US Department of Health and Human Services (HHS) published guidance for providers of double stranded synthetic DNA to help screen gene synthesis orders, but recent technological advances in gene synthesis have decayed the guidelines’ biosecurity protections. There is debate about whether the 2010 HHS guidance should be updated to reflect technical advances, such as the rise of de novo synthesis and the ability to recode entire bacterial genomes. The Center team is interested in how biotechnology and market conditions affect gene synthesis biosecurity now, and how it is likely to change in the near future.

With support from the Open Philanthropy Project, the Johns Hopkins Center for Health Security hosted a one-day meeting on April 9, 2019 in Washington, DC to discuss the 2010 US Department of Health and Human Services (HHS) guidelines for providers of double stranded synthetic DNA. Invited speakers and audience members discussed potential steps that the US government and provides could take to increase biosecurity in gene synthesis. Representatives from HHS took part in the meeting, as well as other stakeholders from government, academia, and industry. The project team is working on novel policy options about how gene synthesis can be context of the current biotechnology and bioengineering landscapes.

Project team lead: Gigi Kwik Gronvall, PhD

Project team: Michael Montague, PhD; Amanda K. Mui, MPH; Rachel West

Project supported by: Open Philanthropy Project

Resources: Meeting agenda (PDF)