Practical steps to promote safe handling of high consequence pathogens

The British Medical Journal (BMJ) recently published an opinion piece on the need for a global framework for promoting safe handling of high consequence pathogens (doi: https://doi.org/10.1136/bmj.q1855 published 23 August 2024).

Indeed, emerging infectious diseases are on the rise. An active surveillance and proactive pathogen research is critical for preventing pandemics, but must be supported by rigorous safety protocols and global collaboration.

ERINHA brokers access to maximum- and high-containment laboratories in Europe facilities, facilitating research on high consequence pathogens, and fulfilling an essential role in the pre-clinical development of medical countermeasures against (re)emerging disease threats. Initially created, well before the COVID-19 pandemic, to coordinate EU maximum-containment laboratory capacity, ERINHA has become a central player in European pandemic preparedness, leading and participating in major EU-funded vaccine and antiviral drug programmes (e.g. ISIDORe, NAVIPP and CCHFVACIM). We therefore wholeheartedly agree when Karlsson et al. write, “An early understanding of microbial threats enables interventions to mitigate the risk of future pandemics. » They also lay out clearly the reasons why the use of potentially high consequence pathogens merits rigorous oversight. Here, again, we can only concur.

ERINHA’s members work within a very tight regulatory environment. They are committed to adhering to the highest standards in biosafety and biosecurity, under the scrutiny of the relevant national bodies. Through a recently initiated EU-funded programme, Interceptor, ERINHA is currently establishing a framework that would promote these standards globally. It must be recognised, however, that attempts to establish any global oversight “needed to effectively manage the risks associated with handling potentially dangerous microbes” are hampered by the fact that these are matters governed by national sovereignty. At a most basic level, there is no international alignment regarding the perceived risk for different pathogens, even within Europe. Similarly, there are multiple disparities in staff vetting and training, and few, if any, agreed legally binding common engineering standards for maximum- and high-containment design or operation. Part of ERINHA’s value is that it acts as a think-tank on biosafety and biosecurity, and promotes the exchange and implementation of best practices, especially important for countries with limited experience with high consequence pathogens.

A major question is how to translate such a voluntary system into a more binding global mechanism. Achieving international agreement would undoubtedly require the involvement of the United Nations, either directly, or through a specialized agency, most plausibly the World Health Organization (WHO). It is very encouraging to see the major efforts that the WHO has made in this area, through its technical advisory groups, and publications. Some of the issues that need to be addressed overlap with those concerning the deliberate misuse of biological agents, covered by the 1972 Biological and Toxin Weapons Convention (BWC). It is sobering, therefore, to recognise that almost half a century after the BWC entered into force, there is still no comprehensive verification mechanism. The COVID-19 pandemic fuelled intense mistrust regarding research activities among certain communities, and between some countries, with debates on the value of pathogen research becoming highly politicised. This has eroded further the possibility for global agreement on the governance of the use of high consequence pathogens.

It is ERINHA’s opinion, therefore, that for the foreseeable future, the most promising path forward will continue to be a pragmatic one, involving the promulgation of best practices established collectively by those with the most extensive direct experience, supported by dedicated biosafety and biosecurity professionals. These could then be used to inform new national regulations in states where they are lacking. ERINHA welcomes interested parties to collaborate with it in ongoing actions that will ensure that work vital for global health continues under the safest and most secure conditions.

Dr. Jonathan Ewbank, Director General
Dr. Audrey S. Richard, Head of Operations