I’m delighted to join the other contributors to the Yale Journal on Regulation’s Notice and Comment Blog. My academic and professional time is more or less divided between the regulatory activities of the World Health Organization, particularly its activities under the 2005 International Health Regulations (IHR), and agencies under the U.S. Department of Health and Human Services, with emphasis on the FDA and the Centers for Medicare and Medicaid Services. Over the next few months I’ll share some of my views on critical issues facing health regulatory authorities both globally and nationally. Because it still grips headlines and the international response coordinated by the WHO remains poorly understood even by scholars of the International Health Regulations, in this post I’ll discuss the Ebola outbreak in western Africa that quickly spread to Europe and the United States, and how the international regulatory mechanisms worked (or not) in response to the outbreak. Ebola is the second major test of the International Health Regulations, the first being the 2009 H1N1 or “swine flu” pandemic of 2009-10 (there has been a third declaration of a public health emergency, wild poliovirus, but it has not tested the IHR to the extent Ebola is and H1N1 did). These preliminary tests, I argue, expose both weaknesses and strengths of the revised IHR which were generally meant to coordinate international responses to disease outbreaks but with an implicit aim of orienting global health resources toward diseases that disproportionately originate in or affect developing countries.

Certain mechanisms of the International Health Regulations are persistent like the obligation for participant countries to maintain monitoring and surveillance systems for public health risks and to inform the World Health Organization of evidence of a “public health emergency of international concern” or PHEIC. In reality many states lack the resources to ensure that their national health surveillance and response capacities meet the IHR’s functional criteria. The most important authority given WHO under the IHR is the ability of the WHO Director-General to declare a PHEIC after consultation with an Emergency Committee of external experts. That declaration triggers further authority to issue temporary recommendations for the application of appropriate health measures to prevent the international spread of disease and to avoid interference with international traffic.

The Ebola outbreak has been traced to the death of a two-year old child in Guinea in December, 2013. The outbreak remained localized until February, when a healthcare worker in a neighboring province died. Between February and April, the disease spread rapidly and by April 1, Medicins Sans Frontieres declared the outbreak “unprecedented.” Even the WHO posted a warning from the Guinea Ministry of Health on March 23 as to the outbreak of Ebola and a terrifying fatality rate. The WHO Director-General, however, did not declare a PHEIC until August 8, 2014.

So, why did the IHR mechanisms fail and, after they were triggered, what did they accomplish? That is the subject of the next post in this series.