Ragini Gupta, LLM expected 2023

In Part I of this post, I discussed the law and policies governing a subset of life science research involving ‘potential pandemic pathogens’ (PPPs). This legal framework may soon be significantly modified.  Last month, the National Science Advisory Board for Biosecurity (“NSABB”) issued draft recommendations to the National Institutes of Health (“NIH”) on the effectiveness of two U.S. biosecurity policy frameworks – the Department of Health and Human Services Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (“P3CO framework”) and the Policy for Oversight of Life Sciences Dual Use Research of Concern (“DURC framework”).  The NSABB was earlier charged with providing recommendations on balancing security and public transparency in sharing of research involving enhanced transmissibility/enhanced virulence PPPs (“enhanced PPPs”) and analyzing the DURC framework in January 2020. The January 2020 charge was however deferred when the COVID-19 pandemic intensified, so that NSABB members could attend to pandemic response activities. A revised charge was issued in February 2022 and the recommendations were released in January 2023. This post will discuss the NSABB’s key recommendations.

P3CO framework

As regards the P3CO framework, the NSABB opined that the current definitions of PPP and enhanced PPP, which use the terminology “highly transmissible” and “highly virulent” are too narrow. Under the existing framework a pathogen is a PPP only if it is both likely “highly transmissible” and “highly virulent. The NSABB has recommended expanding the definition to include pathogens that are likely “moderately or highly transmissible” and/or “moderately or highly virulent” and in addition, likely to pose a severe threat to “public health, the capacity of public health systems to function or national security.” The expanded definition thus recognizes that even a moderately transmissible or virulent pathogen could result in a crisis if public health systems are overwhelmed – as with the COVID-19 pandemic when despite a relatively lower fatality rate, excess deaths were caused due to hospital strain.

The existing P3CO framework provides if transmissibility or virulence of PPPs is modified for surveillance activities and vaccine development, the resulting pathogen would not be considered a PPP for the purpose of the framework. Recommending the removal of this ‘blanket exclusion, the NSABB has instead proposed inclusion of procedures for urgent review where the PPP research is critical for public health or national security. This proposed change has been justified on the basis that blanket exclusions are not warranted and not necessary because the framework already considers risks and benefits including whether the research is critical to public health or national security.

The NSABB has urged that that the US government increase transparency in the review process and that it consider developing analogous policies that apply to pathogens that impact animals or plants (the present framework only applies to pathogens that affect humans) since such pathogens could affect food security and economic security. The NSABB has also recommended that research with PPPs at international institutions receiving funds from the US government be subject to oversight and procedures that are equivalent to domestic U.S. procedures.

DURC framework

With respect to the DURC framework, the NSABB has recommended removal of the phrase “directly misapplied” from the definition of DURC, since threats could be accidental or unintentional. A significant proposed change relates to the scope of the DURC framework – it currently applies to a list of 15 agents/toxins and 7 categories of experiments. The NSABB has recommended expanding the scope to research involving “any human, animal, or plant pathogen, toxin or agent” and that is reasonably anticipated to result in one of the 7 experimental effects – noting that the list-based approach is less adaptive.

The NSABB has also made recommendations on communication of research.  It has advised that scientific societies, publishers, journal editors, and other stakeholders encourage  (and enforce?) development of best practices for identifying material that may raise biosecurity or biosafety risks.

The NSABB observed in its findings that a “substantial percentage” of U.S. biotechnology research is supported by non-federal funding and that the potential risks associated with both DURC and PPP research justified oversight of all relevant activities, regardless of funding source – as this would enhance “federal awareness” and promote a “national culture of responsibility.” It thus recommended that research meeting the scope of the framework conducted within the U.S. or supported by the U.S. be subject to equivalent oversight.

If the NSABB’s recommendations are accepted, certain regulatory gaps in relation to life science research may be closed. However, the recommendations relate only to the DURC and P3CO frameworks, which, largely, are policies governing the federal government’s funding decisions. Thus, by design, they do not extend to research that does not receive this funding. As discussed in Part I, the result of this is that a considerable fraction of research is taking place without oversight. (except research involving the 15 select agents, as provided in the Federal Select Agent  Program (“FSAP”). The NSABB’s report, for this reason recommended “oversight of all relevant activities, regardless of funding source” but did not elaborate on how this oversight would take place. As suggested in Part I, one option would be expansion/revamping of the FSAP.  The FSAP already has procedures and structures in place for the listed select agents. These could be extended to a broader category of pathogens on the basis of attributes, in addition to a list, as well as  ‘experimental effects’ like those listed in the DURC framework. This would be a long process full of uncertainties since aspects such as expansion of oversight to non-federally funded research would require passing of new legislation.

A new area for consideration the report has opened up is its recommendation for stakeholder engagement on “responsible communication” in relation to publication of material that may involve biosecurity concerns. It however did not go into much detail about this. The dilemma between ensuring transparency and the reducing risk of misuse of published information by a sufficiently equipped malicious actor is difficult to resolve.

Response to the recommendations has been mixed, with some scientists welcoming them and others concerned that it could slow down even routine studies. While a more comprehensive policy framework and enhanced transparency could increase public confidence (which has suffered in the aftermath of the much-politicized debates on the COVID-19 “lab leak” theory), designing efficient review procedures that do not unnecessarily delay or create uncertainty around research will be crucial.

One area which the recommendations do not touch upon is scientific pursuits  outside institutions made possible by availability of cheaper alternatives to lab equipment, crowdfunding platforms and increased accessibility to information because of the internet (DIY biology, for instance). The democratization of research is full of promise and could lead to advances in science . DIYers have created a prototype for a low-cost malaria detector. They are trying develop an open source protocol for  manufacturing off-patent insulin and genetically engineer yeast to produce “real vegan cheese.” While it may be some time before a DIY biology project achieves large scale adoption, the possibilities are immense. As the capabilities of DIYers grow, a common code of conduct that addresses possible risks, while encouraging innovation, must also take form.

The NIH has said that the NIH, HHS, and the White House Office of Science and Technology Policy  will considerthe NSABB’s report.  After that, the US government will announce next steps in the review process.