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About the Authors

Margaret Hamburg, M.D. is an internationally recognized expert in public health and medicine, who currently serves as interim Vice President for Global Biological Policy and Programs at the Nuclear Threat Initiative (NTI | bio). She previously served as Foreign Secretary of the National Academy of Medicine, as Chair of the American Association for the Advancement of Science Board, and is a former Commissioner of the U.S. Food and Drug Administration.

Jaime Yassif, Ph.D. is Senior Director and Lead Scientist for NTI | bio. Previously, she served as the inaugural Program Officer for Biosecurity and Pandemic Preparedness at Open Philanthropy.

R. Alta Charo, J.D. is Professor Emerita of law and bioethics at the University of Wisconsin and an independent consultant on biotechnology ethics and policy.  In 2021, she served as the David A. Hamburg Distinguished Fellow at the Nuclear Threat Initiative.

Hayley Severance is Deputy Vice President of NTI | bio. She previously served as a Senior Policy Advisor in the Office of the Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction in the U.S. Department of Defense.

Perspective

Taking Action to Safeguard Bioscience and Protect Against Future Global Biological Risks

With the devastating loss of life, economic disruption, and political instability it has wrought, COVID-19 has revealed that national governments and the international community are woefully unprepared to respond to pandemics—underscoring the world’s vulnerability to future catastrophic biological threats and highlighting the need for greater international collaboration and diplomacy to reduce them.

International leaders have focused considerable attention on controversies surrounding the origins of COVID-19, resulting in the World Health Organization (WHO) revisiting its initial investigation and a parallel inconclusive assessment by the U.S. intelligence community. Regardless of the outcome of these and other follow-on investigations, it is crucial that leaders now take a longer-term view and work to develop and implement steps to protect against future biological risks. Such efforts must be driven by the recognition that while naturally occurring pandemics remain a threat, the next global catastrophe could result from a laboratory accident or the deliberate misuse of bioscience and biotechnology.   

These are not new risks, but they have been exacerbated by the COVID-19 pandemic. In its wake, research into SARS-CoV-2 and other pathogens with pandemic potential has proliferated, along with the construction of new high-containment laboratories to house the work. Although the research has significant public health value, it also poses dual-use risks.1

Global biological risks also are increasing as the technical barriers to manipulating biological organisms continue to fall. Bioscience and biotechnology advances are vital to fighting disease, protecting the environment, and promoting economic development—but these innovations also exacerbate risks of deliberate or accidental misuse. For example, new technologies are making it easier to synthesize DNA and edit genes, which hold significant scientific promise, but could also enable development of dangerous pathogens. These advances could give malicious actors greater access to scientific knowledge and capabilities to create deadly biological agents, potentially manufacturing the next pandemic. To ensure that the world continues to benefit from bioscience advances, while protecting the global research and development enterprise from catastrophic accidents or deliberate misuse, stronger biosecurity and biosafety systems must be put in place at institutional, national, and international levels.

Governments play a critical role in providing oversight, but they have had difficulty keeping up with rapid advances in bioscience and biotechnology. According to the 2021 Global Health Security Index,2 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.

Bioscience governance at the international level also is weak. The WHO and the Biological Weapons Convention (BWC) each play vital roles, but this work often falls at the “seam” between efforts focused on reducing the risks of naturally occurring infectious disease and work to uphold the global norm against bioweapons development. No international entity is dedicated to strengthening biosecurity and bioscience governance and to reducing emerging biological risks associated with technology advances. Key barriers to developing globally scalable solutions include a lack of shared international norms defining adequate biosecurity measures and inadequate governance tools to incentivize adherence.

Gaps in the biosecurity architecture highlight the need for a new international entity—one that spans multiple disciplines and sectors—focused on reducing the risks of catastrophic consequences due to accidents or the deliberate abuse of bioscience and biotechnology. Working with a range of stakeholders,3  the Nuclear Threat Initiative (NTI)4 has spearheaded an effort to establish a new organization, the International Biosecurity and Biosafety Initiative for Science (IBBIS), to promote stronger global biosecurity norms and develop governance tools that meaningfully reduce risks. 

This type of international biosecurity entity should address key risk-reduction opportunities throughout the bioscience research and development lifecycle. The goal is to incorporate effective risk reduction practices at every stage—from project conceptualization and funding, through research execution, and on to publication or commercialization.

An example of the kind of work that IBBIS should lead is strengthening DNA synthesis screening practices in countries around the world, to prevent the building blocks of dangerous pathogens from falling into the hands of malicious actors. While most DNA synthesis providers voluntarily screen orders and customers, these efforts only cover an estimated 80% of global market share, leaving significant opportunities to circumvent this important biosecurity measure. The international Technical Consortium for DNA Synthesis Screening,5 jointly convened by the World Economic Forum and NTI, is working to establish a common mechanism to make screening feasible and effective for all providers, and IBBIS could play a critical role in its oversight and management.

More broadly, an international biosecurity entity could ensure that public and private stakeholders have the necessary levers to govern different points of the bioscience research and development lifecycle, as part of a layered defense. IBBIS could:

  • Support the development of biosecurity standards for use by funders, who are uniquely positioned to incentivize incorporation of biosecurity measures into grant or investment proposals.
  • Guide universities and industry in developing effective approaches to strengthen oversight of dual-use bioscience research conducted within their laboratories.
  • Partner with industry to develop biosecurity and biosafety requirements for customers who want access to materials and services to support bioscience research.
  • Work with publishers to update their guidelines regarding publication of manuscripts containing information that might be misused.
  • Develop proposals for governments to incentivize or require biosecurity practices through funding conditions, regulation, and guidance.

Now is the time for leaders from scientific research communities, industry, governments, philanthropy, and international organizations to come together with bold action to promote responsible stewardship of science and reduce preventable biological risks. Through support for IBBIS and similar initiatives, the biosciences can flourish, for the benefit of us all.

 

Endnotes

  1. Margaret A. Hamburg and Jaime Yassif, “We must take action to guard against future global biological risks,” The Hill, June 8, 2021, https://thehill.com/opinion/healthcare/557296-we-must-take-action-to-guard-against-future-global-biological-risks.
  2. Nuclear Threat Initiative and the Johns Hopkins Center for Health Security and Economist Intelligence Unit, “2021 Global Health Security Index,” accessed December 8, 2021, www.ghsindex.org.
  3. Margaret A. Hamburg, Jaime Yassif, and Hayley Severance, “NTI | bio Convenes Experts to Establish Global Entity Dedicated to Reducing Biotechnology Risks,” Nuclear Threat Initiative, May 25, 2021, www.nti.org/news/nti-bio-convenes-experts-establish-global-entity-dedicated-reducing-biotechnology-risks.
  4. The Nuclear Threat Initiative is a nonprofit, nonpartisan global security organization focused on reducing nuclear and biological threats imperiling humanity. See https://www.nti.org/
  5. Jaime Yassif, “NTI and WEF Convene Second Annual Meeting of DNA Synthesis Screening Technical Consortium,” Nuclear Threat Initiative, May 7 2021, www.nti.org/newsroom/news/nti-and-wef-convene-second-annual-meeting-dna-synthesis-screening-technical-consortium.