Regulating the Unknown: the Interactions Between Risk Regulation and Uncertainties in the Context of Covid-19 Pandemic

Regulating the Unknown: the Interactions Between Risk Regulation and Uncertainties in the Context of Covid-19 Pandemic
2020-05-01

“the risk problems confronting contemporary society are trans-scientific in character – that is, …while they can be posed by science, they cannot be solved by science alone”-John Paterson.[1]

Early this year when the Global Risk Report was released, climate change topped the list of the most severe global risks. Little did we know that at the same time, the world was being plagued by the novel coronavirus (Covid-19), a pandemic that has infected almost three million people and killed almost two hundred thousand globally and the figures continue to rise.  In all of this, the human, economic, and social risks are quite evident. Such an event does so much to reveal fragile and vulnerable risk governance systems in not just the United Kingdom but across the world, particularly from a public health perspective. We saw systems that appeared ill-prepared and fractured, struggling not just to mitigate the risks and contain the virus but also to communicate the challenges in a time of great uncertainty. We saw systems shift between complacent self-regulatory risk governance models to some of the harshest prescriptive regimes.

While the answer to Covid-19 remains more of a scientific issue, it is hard to ignore the role of regulation in providing a robust risk governance regime that not only mitigates the present disaster but equally anticipates and prepares for the future. This blogpost offers answers to two main questions. Firstly, is there a global proactively designed risk governance regime to anticipate and mitigate against pandemics like the Covid-19? If the answer is in the affirmative, then the second and most important question is, in the context of the coronavirus pandemic, did such a regime perform as it was designed to? Well, I can easily tell you that if it did, I would certainly not have written this blog post. What that means is that while the World Health Organisation has designed quite a sophisticated and somewhat robust risk governance regime under the International Health Regulation 2005 through its surveillance and comprehensive risk assessment model, its interaction and implementation by state parties have been somewhat prescriptive, ad-hoc, fragmented and a clear failure of global cooperation.  

THE GLOBAL HEALTH RISK GOVERNANCE REGIME

Law as an instrument of social engineering has for centuries through the instrumentality of regulation governed human behaviour and through interactions with other disciplines it has contributed to solving some of society’s most complex challenges and risks – and a global health crisis is, in principle, no different. Following several experiences with Public Health Emergencies, the World Health Organisation under Article 21 of its Constitution approved the International Health Regulation 2005 (IHR) which entered into force in 2007 and is binding on 194 WHO Member States. The objective of the IHR is "to prevent, protect against, control and provide a public health response to the international spread of diseases in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interfaces with international traffic and trade". While the said objective captures principles of an objective-based regulatory regime, it appears to suggest some potential conflict between risk and international trade without clarity on where the priority would lie. It will be essential to examine the IHR further to determine how it aligns with established robust risk governance principles.

In regulating risks, high and major risk regimes have experimented with several regulatory models, but there is a consensus amongst risk regulatory theorists that meta-regulation is the most sophisticated and robust in the anticipation and mitigation of risk in high-major industries and the IHR is designed as such. The IHR is designed to anticipate and prepare for public health emergencies. This is achieved through its global surveillance and comprehensive risk assessment system. Baker and Fidler explain that it is an "ongoing systematic collection, analysis, and interpretation of outcome-specific data for use in the planning, implementation, and evaluation of public health practice" . These bio-surveillance and risk assessment models were designed to assess health-related events that could metamorphose into global Public Health Emergencies of International Concern (PHEIC). It then becomes the responsibility of the state party under article 6.1 of the IHR 2005 to notify the WHO within 24hrs of such an event that could constitute a PHEIC as well as health measures implemented to respond to these events. It must be noted that under article 7, the responsibility to report applies both to events that are within or outside that state party’s territory.

In determining if an event is a PHEIC, the IHR in annex 2 provides a "decision instrument" that identifies the "seriousness of the public health impact and the likelihood of international spread". Unlike the 1969 IHR which limited the scope of application to just 3 communicable diseases, the 2005 IHR rightfully defines diseases as "an illness or medical condition that does or could threaten human health regardless of its source of origin" therefore providing a more encompassing application to both communicable and non-communicable diseases, whether naturally occurring, accidentally caused, or intentionally created. But for automatic notification to WHO, the IHR prescriptively provides a list of diseases for which a single case may constitute a PHEIC and must be reported to the WHO immediately. This list includes smallpox, poliomyelitis, human influenza caused by new subtypes, and severe acute respiratory syndrome (SARS). This means that although Covid-19 is covered under SARS, in the future, if a disease is not on the list, it may not be reported immediately. There is a second list of diseases, but notification is determined by the assessment and there is no requirement to report automatic. Thirdly, even where a disease does not meet the requirement for formal notification, state parties are expected to consult with the WHO as the disease may still be of public health concern.

Through the surveillance and risk assessment regime under the IHR 2005, it is expected that diseases or "infections that have newly appeared in a population or have existed but are rapidly increasing in incidence or geographic range"  could be detected and public health responses are taken to limit its spread, especially at an international level (Article 2).  Therefore, state parties are required under the IHR 2005 to "develop, strengthen, and maintain core surveillance capacities" (Article 5.1). Also, state parties are required to have a national IHR focal point to coordinate responses and liaise with the WHO. (Article 4) Then there is the emergency committee.  I am sure you must be wondering how we got ourselves into such a precarious and helpless situation with COVID-19 when the WHO has such a supposedly robust international risk governance regime that is designed to anticipate, prevent and prepare against the sort of pandemic that has killed over a hundred and ninety thousand people. We will look at that now. 

HOW WELL HAS IT FARED?

From the above analysis of WHO’s public health risk governance regime under the IHR 2005, it becomes apparent that developing such a comprehensive surveillance and risk assessment regime will require both significant technical and financial resources which state parties may not necessarily possess, especially in developing countries. Even those who have, are wondering why they should spend so much on something they may never need, especially when there are more demanding issues. Perhaps, this may be one reason over “80 percent have not fully implemented their IHR obligations”. Although article 44 of the IHR requires both state parties and WHO to collaborate in mobilising financial resources, such an obligation can be viewed as weak (David and Fidler). Another concern is that the governance and political systems in certain jurisdictions make even the sharing of data remarkably challenging, especially where there are concerns regarding transparency. There is also concern that required responses may interfere with the trade and economy of state parties and therefore creating a conflict. There are also inherent concerns with designing a risk governance regime with so much uncertainty and the Coronavirus has been nothing but a learning curve.

The Covid-19 pandemic and the IHR 2005 has once again revealed the interactions between law and science in mitigating public health risks. While the IHR is designed with clear objectives using meta-regulatory principles, its health surveillance and risk assessment regime may have been ignored by even the most advanced public health systems. Countries struggled with assessing the complexity and gravity of the risks, not to mention the insufficient testing, contact tracing, and the much-needed PPE. The situation is worsened by politicization and withdrawal of funding to the WHO by the United States which happens to be its biggest contributor. While countries have passed emergency regulations to deal with the coronavirus pandemic, these emergency regulations do not provide long-term risk governance regimes to prevent future outbreaks. At a time of considerable uncertainty, we are left with science, regulation, and everything in between, yet the answers seem ever so elusive. I want to end on an optimistic note, but I lack the words. Hopefully, we have now come to understand that mother nature is all we have and we may have to treat her with a greater sense of respect.

 


[1] John Paterson “Trans-Science, Trans-Law and Proceduralization” (2003) 12 (4) Social and Legal Studies 525.

Published by School of Law, University of Aberdeen

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