Natural pandemics have been among history's greatest health threats, from Bubonic plague, the Black Death, Smallpox, Spanish flu, Polio, HIV/AIDS, Ebola, to COVID-19. However, the fight to stop the next pandemic may well be underway in the sleek, sterile halls of a growing number of biological high-containment laboratories. As these laboratories host crucial research on deadly viruses, true biosafety and biosecurity remain elusive.
Recently, the World Health Assembly (WHA) adopted a resolution (PDF) approving the world's first Pandemic Accord to address gaps in preventing, preparing for, and responding to pandemics. Unfortunately, the resolution failed to recognize laboratory biosafety and biosecurity as serious risks to world peace and national security. The World Health Organization's (WHO) pledge barely acknowledges the threat of laboratory accidents with only two references to “laboratory biological risk management.”
Biosafety refers to measures taken “to reduce the risk of accidental release of or exposure to infectious disease agents,” whereas biosecurity refers to “systems and practices employed in legitimate facilities to reduce the risk of deliberate or malicious use of biological agents.” Given biotechnological advances, a laboratory origin remains plausible for the emergence of the SARS-CoV-2 virus that caused COVID-19. Some have suggested that the virus spread after an accidental (bioerror) or deliberate (bioterror) release, although its origin remains controversial.
The risk of laboratory accidents involving the highest consequence pathogens rises with the number of biosafety level 4 (BSL4) laboratories.
Regardless of how SARS-CoV-2 originated, the risk of laboratory accidents involving the highest consequence pathogens rises with the number of biosafety level 4 (BSL4) laboratories. These maximum containment laboratories are designed to work safely and securely with the high-risk pathogens that cause serious diseases for which no diagnostics, treatment, or vaccines exist yet. As scientists seek to better understand and address high-risk diseases, more and more BSL4 laboratories are coming online around the world.
Filippa Lentzos and Gregory Koblenz note in their work at globalbiolabs.org that there is significant room for improvement in current policies to ensure these laboratories are operated safely, securely, and responsibly. Only three countries with BSL4 laboratories have national policies for the supervision of dual-use research with legitimate scientific purpose that may be misused, and the majority do not monitor research that could have the effect of making a pathogen more dangerous, which has been a central feature in the debate about the origin of COVID-19. In addition, only a quarter of countries received high scores on the World Health Safety Index that measures the legal and institutional components of national biosafety and biosafety oversight systems.
None of the dozens of laboratories documented by Lentzos and Koblenz have signed the International Organization for Standardization's voluntary biorisk management system ISO 35001, published in 2019 to set principles, essential components, and management processes to mitigate biosafety and biosecurity risks.
Governments should strengthen standards and oversight to minimize biosafety and biosecurity threats. Here are several steps that could help:
First a Global Health Security Agenda–style international program for laboratory biosafety and biosecurity should be created. There is currently no requirement to report on BSL4 laboratories internationally, and no international entity is mandated to collect such information and provide oversight at a global level. A U.N. entity like the WHO is well poised for this role with its ability to obtain pledges of actions from its 194 member states. In the absence of this type of high-level action, expand the scope of existing biological Cooperative Threat Reduction programs (PDF) (because of their reach), beyond bioweapons and capacity building to promote “best practices” to include tallying these laboratories and developing a global oversight framework.
Next, an International Health Regulations (IHR)–style mandatory reporting requirement for laboratory accidents should be created as part of a new laboratory biosafety and biosecurity monitoring and evaluation framework. The IHR is a legally binding international code of conduct for notification of and response to disease outbreaks with pandemic potential, with the expectation that countries will build this capacity, where absent, and this proposal replicates it for laboratory accident reporting. The mandatory reporting system should be supplemented by a Joint External Evaluation (JEE)–style routine for voluntary assessments of laboratory capabilities every other year. The JEE is a tool of the IHR that assesses national preparedness capacities, providing a comprehensive picture of the capacity and preparedness of member states in the implementation of IHR core capacities. Both will require adoption by the WHA to empower the WHO.
Governments should strengthen standards and oversight to minimize biosafety and biosecurity threats.
Finally, BSL4 laboratories should be located away from major population centers as part of urban pandemic preparedness measures. Three-quarters of the laboratories mapped are in urban areas and could pose a risk to surrounding communities. While BSL4 laboratories are carefully designed to prevent the release of dangerous pathogens, the risk of further spread would be lessened if the laboratory were not located in a densely populated area should a dangerous pathogen be released or a laboratory worker be infected. Implementing this recommendation necessarily requires considering significant trade-offs involved, such as costs required to relocate existing laboratories or talent recruiting difficulties to locations that are more remote.
Laboratory biosafety and biosecurity incidents are not uncommon and they could become more so given the proliferation of dual-use research. While we may wish to dispel the risks from laboratory biosafety and biosecurity with one wave of a magic wand, only focused actions like those outlined above can truly help ensure the safety and security of the important work done in maximum containment laboratories.
