Margaret A. Hamburg, M.D.
Former Commissioner of the U.S. Food and Drug Administration
Rapid advances in bioscience offer great promise but can increase risks of accidental or deliberate misuse, with potentially catastrophic consequences. Governments have not been able to provide adequate oversight.
Establish an independent organization dedicated to strengthening global biosecurity norms and developing innovative tools and incentives to uphold them.
Continued progress in developing stronger biosecurity norms and practical tools that reduce the risk of accidental misuse or deliberate abuse of modern bioscience and biotechnology.
Bioscience and biotechnology advances are vital for fighting disease, protecting the environment, and promoting economic development. However, these same innovations can also pose unique challenges—increasing the risks of accidental misuse or deliberate abuse with potentially catastrophic consequences.
These underlying risks are not new, but they have been exacerbated by COVID-19, which has led to the proliferation of research into pathogens with pandemic potential and the establishment of new high-containment labs around the world to house this work. While this research can have significant value, some of it poses dual-use risks. COVID-19 also has demonstrated that biological events have the potential to cause severe human and economic loss on a global scale, which could inspire malevolent actors to exploit pathogens and biotechnology to cause harm. This threat is of growing concern as the technical barriers to manipulating biological organisms continue to fall.
Governments are key to safeguarding the life sciences, but they have struggled to keep pace with rapid technology advances. According to the Global Health Security Index, 94% of countries have no national-level oversight measures for dual-use research, no agency responsible for such oversight, and no evidence of national assessment of dual-use research. At the same time, no international entity has dedicated its primary mission to strengthening biosecurity and bioscience governance.
To address these gaps, NTI is working with international stakeholders to establish the International Biosecurity and Biosafety Initiative for Science (IBBIS), an independent organization dedicated to reducing emerging biological risks associated with technology advances. A core element of the IBBIS mission will be to strengthen international biosecurity norms and develop innovative, practical tools and incentives to uphold them.
IBBIS has a broadly defined mission, but initially it will focus on preventing the misuse of DNA synthesis technology—with the understanding that it will expand its remit over time.
IBBIS will collaborate with stakeholders across the global bioscience and biotechnology enterprise including academia, industry, the public health community, governments and philanthropy. These activities will complement the important work of the World Health Organization, the United Nations Office of Disarmament Affairs, and other national, regional, and international organizations.
NTI’s work to establish IBBIS is rooted in the vision of a world in which bioscience and biotechnology flourish, with safeguards against deliberate or accidental misuse with potentially catastrophic consequences.
To realize this vision, NTI | bio has:
NTI plans to launch IBBIS and the international Common Mechanism for DNA synthesis screening in late 2022.
This project emerged from NTI’s Biosecurity Innovation and Risk Reduction Initiative (BIRRI).
In a new perspective penned for Science and Diplomacy, NTI | bio’s Margaret Hamburg, Jaime Yassif, Hayley Severance and former NTI David A. Hamburg Distinguished Fellow R. Alta Charo highlight the increasing risks of accidental or deliberate misuse of modern bioscience and biotechnology, and propose the establishment of a new organization.
Testimony of Jaime M. Yassif, Ph.D. before the U.S. House Foreign Affairs Subcommittee on Asia, the Pacific, Central Asia, and Nonproliferation. Hearing on “Biosecurity for the Future: Strengthening Deterrence and Detection.” Wednesday, December 8, 2021.
An interdisciplinary group of international leaders and experts came together virtually on May 21 to advance the mission and scope of a prospective global entity
Biotechnology research is essential for reducing pandemic threats and supporting the broader global health and development agendas