A new regulatory framework is desperately needed to address emerging biotech dual-use challenges
by Christina Lin May 12, 2020
Last month the Donald Trump administration cut US National Institute of Health (NIH) funding to China’s Wuhan Institute of Virology, the laboratory now embroiled in controversy over the origin of Covid-19.
The project was run by EcoHealth Alliance, a non-profit organization that has been working with the Wuhan lab for more than a decade to study bat coronaviruses.
EcoHealth Alliance has been involved in US biodefense programs such as the US Agency for International Development’s (USAID) PREDICT for early detection of emerging pathogens.
It also received a US$3.37 million grant from the NIH’s National Institute for Allergy and Infectious Disease (NIAID), was part of the Pentagon’s GRITS (Global Rapid Identification Tool Set), and was given a $4.47 million grant in 2015 from the US Defense Threat Reduction Agency (DTRA).
The DTRA also awarded EcoHealth Alliance a $2.32 million grant from 2013-2015 for research and development in biotechnology, underscoring the increasing blurring of life science and high technology in US biodefense policy.
According to a 2018 study sponsored by the DTRA and the US Air Force Academy titled Roadmap for Biosecurity and Biodefense Policy in the United States – in which Northrop Grumman, the Bill and Melinda Gates Foundation, EcoHealth Alliance and several universities participated – biotechnology is a rapidly growing and lucrative market.
The global biotech market could reach $727.1 billion by 2025, the same study predicted.
The rapid pace of change in this industry presents opportunities to leverage new capabilities to advance medicine and health care and prevent harm. Yet because of its dual-use applications, it also faces challenges of potential bioterrorism and weaponization of these advanced technologies.
As such, the US biodefense program has also experienced commensurate growth. Before 2001, biodefense research was conducted by a small group of scientists with a mere $60 million annual budget in 1999, 2000 and 2001. At the same time, NIAID – the primary institute within the NIH that funds biodefense – had funding of just $270 million in 2001 for research on overlapping pathogens.
Shortly after the terrorist attacks of September 11, 2001, the Pentagon received an annual increase of $30 million in biodefense funding, whereas the Department of Health and Human Services (HHS) received a whopping budget of more than $1.5 billion. In fiscal year 2020, the HHS received a budget of $93.4 billion, with $42 billion and $5.89 billion allocated to the NIH and NIAID respectively.
For the past two decades, US biodefense funding has continued to rise, supporting basic research, identification and characterization of pathogens, bio-surveillance, medical countermeasures such as vaccines and microbial forensics. The NIH provides a large portion of federal grants to support these research projects, especially in university labs.
However, US government policy faced difficulties keeping pace with rapid advancements in the biotech landscape such as genetic engineering, 3D and 4D printing of biological tissues, bio-based sensors to detect radioactive molecules, and research using DNA molecules to store data, including image, video and audio information that is supported by Microsoft Corp.
Governance and oversight over these research projects is also problematic, increasing risks of theft, diversion, accidental release of pathogens and malicious use of biological material and information in bioterrorism.
Indeed, the 2018 report outlined the problematic bifurcation of US biodefense policy with one group focused on these security risks, while the other group focused on building up scientific and technical capabilities for early warning, preparedness and response to natural, accidental or deliberate biological threats.
The bifurcated model is largely reactive, and as Covid-19 has revealed, dual-use research in the biosecurity grouping often has risky consequences for the biodefense grouping. As such, there should probably be some overlapping of the two circles, for better information sharing and situational awareness from both groups in a constant feedback process.
Concerns over biosafety and biosecurity of high-containment labs have also been well documented as an ongoing problem in the US and abroad. Severe acute respiratory syndrome (SARS) escaped twice from a Beijing lab in 2004, while in 2018, the US State Department raised concerns about Wuhan lab safety violations.
In 2015, the Pentagon discovered that one of its labs had inadvertently sent live anthrax to 200 other labs worldwide over a period of 12 years. In 2009, European governments investigated US drug maker Baxter when it sent vaccines contaminated with live avian flu virus to several countries.
In 2017, the same company was fined $18 million for violating US Food and Drug Administration regulations for persistent contamination in its manufacturing facilities.
Given that Baxter has also received Pentagon and NIH contracts to develop treatments for the effects of exposure to chemical and biological agents, lab safety violations and accidental releases of pathogens and toxins give rise to harmful conspiracy theories.
Indeed, a criminal investigation was filed against Baxter for allegedly attempting to provoke the swine flu pandemic in 2009, similar to current charges of bioterrorism now being levied against China and its Wuhan lab.
There is this a risk that mounting suspicions promoted by fringe theories may provoke a dangerous biodefense arms race between great powers.
In the face of the NIH’s rising role alongside the Pentagon in US biodefense policy, the US government will likely need to consider a new framework of oversight and regulation to address these emerging challenges posed by the growing biotech industry.
Christina Lin is a California-based foreign and security policy analyst. She has extensive US government experience working on national security and economic issues and her current focus is on China-Middle East/Mediterranean relations.