Hi I'm Lauren Sauer, I'm an assistant professor of emergency medicine at the Johns Hopkins School of Medicine. Today, we're going to talk about International Health Regulations and the Global Health Security Agenda. The learning objectives for this session are to understand the broad concepts and history of the international health regulations, to understand the broad concepts of the Global Health Security Agenda or GHSA, to understand how the GHSA program fits within the International Health Regulations, understand what a Public Health Emergency of International Concern is, or a PHEIC, and effectively determine if an event is a possible PHEIC reportable to the WHO. So what are International Health Regulations, or IHR? The IHR are an international legal document that's binding on 194 countries across the globe, all the signatories including all member states of the WHO. They're intended to help combat the threat of disease spread across borders, and they outline the minimum requirements for a functional public health response. This allows countries to quickly detect and respond to disease outbreaks in their communities. The IHR originated in 1851 with the international sanitary regulations. These were adapted at a meeting called the International Sanitary Conference in Paris following a cholera outbreak. In 1948, almost 100 years later, the development of the World Health Organization constitution began. About 20 years later in 1969, the International Sanitary Regulations were revised and renamed the IHR. In 1995, it was determined that the IHR required significant revisions at the World Health Assembly since so many things such as travel and trade had changed across the globe. In 2005, these revised International Health Regulations entered into force, or they began to be operational. So the IHR introduces a global system for alert and response. The system includes several functions; event-based surveillance, multi hazard rapid risk assessment, and event-based risk communications. It includes critical information and communications platforms for decision support, and operations in logistics platforms for any WHO response to international public health risks or threats. The structure of the IHR is broken down by several committees. We have emergency committees such as Zika, Ebola, yellow fever, polio, Middle Eastern respiratory syndrome related coronavirus or MERS-CoV, as it's called commonly, and pandemic influenza. There are several IHR review committees that offer technical recommendations and advising to support the emergency committees, and the IHR also has several subject matter expert rosters which include these SMEs, state representatives, and advisory panel members. Now, we'll talk about potential public health emergencies of international concern. So what are these public health emergencies of international concern? Some people call them PHEICs, PHEICs, or P-H-E-I-Cs. A PHEIC is a formal declaration by the World Health Organization. This declaration is promulgated by that body's emergency committee operating under the international health regulations. So for example, in Ebola, the Ebola Emergency Committee would make a recommendation to the WHO Director General. The PHEIC is defined as an extraordinary event that may constitute a public health risk to other countries through international spread of disease so crossing borders, and may require an international coordinated response. When assessing a potential public health emergency of international concern, or a PHEIC, four decision criteria are used. The first question is, is the public health impact of this potentially serious? The second question, is this event unusual or unexpected? The third, is there potential for international spread, and the fourth question is, is there the potential for travel and trade restrictions? If two of these four questions are answered yes, countries are required to notify the WHO within 24 hours. It's important to note that if two of the four criteria are met, it doesn't mean that this is a PHEIC, but rather that this is a reportable event that should be investigated as a possible PHEIC. There's five diseases that always need to be reported to the WHO. SARS or severe acute respiratory syndrome, smallpox, new influenza viruses, wild-type polio, and Ebola virus disease. The Director General of the WHO makes a determination if an event is a PHEIC and oftentimes this is based on the recommendations of the emergency committee. The role of countries is to assess the magnitude and potential risk involved with the event, and the WHO's role is to make the decision. So the country answers those four questions, and the WHO evaluates those answers and determines if something is a PHEIC. Since the revised IHR entered into force, four PHEICs had been declared by the WHO. H1N1 influenza in 2009, polio in 2014, Ebola in 2014, and Zika virus in 2016. So with this structure in place, the WHO as the global public health authority is able to quickly assess the risk of an event and if needed, convene the resources required to mount a coordinated international response. It's important to know that the cause or the source of an outbreak is not required for reporting. Reporting can actually occur at anytime not just when the threshold of two out of four questions have been met. This primary focuses for early detection and reporting, and it's to allow for a public health response before international spread occurs, or at least to minimize the global impact of a large-scale outbreak. We're going to take a look now at an example. Looking at SARS or severe acute respiratory syndrome, which started in China in 2002, highlights the potential value of the PHEIC process. SARS occurred before the process was in place to declare PHEIC. Early on in the cases of SARS, we didn't know that the illness was caused by a coronavirus or that it likely occurred at the human-animal interface. The human animal interface is a continuum of contacts and interactions between humans, animals, and their products, and their environment, and it represents how cross-species transmission of zoonotic and emerging human and animal pathogens occur. So SARS would have met two of the assessment criteria of a public health emergency of international concern, and would've mounted additional public health resources. It has serious impact on public health. We knew the disease could kill people, but we didn't know what the disease was at the time, how it was being transmitted, how we could prevent or treat it, and who could get sick from it. It also had significant potential for international spread. We saw that disease was affecting travelers. These travelers could export the disease to other countries and we saw that happening in real time. This event would have been a prime candidate for reporting to WHO under the IHR, and would have benefited from a coordinated international response. If we'd had the current IHR structure already in place during the SARS outbreak, it's possible that the WHO could have learned sooner about the event and responded earlier. This would have enabled scientists to potentially identify the cause of the illness and potential responses sooner, and some of the significant economic impact on China because of the travel warnings may have been prevented through modified global recommendations. So let's talk a bit about IHR system operations. In order to effectively utilize the system, all countries must designate a point of contact called the National Focal Point, for communication to and from the WHO at all times. Taking the United States for example, the Secretary's Operation Center at the Department of Health and Human Services serves as our National Focal Point here in the United States. The center notifies the WHO of potential public health threats in the US that meet the assessment criteria for IHR. The assessment is largely conducted by senior scientists that the US CDC, and the CDC invites relevant state epidemiologists and representatives from the Council of State and territorial epidemiologists to join this assessment. The assessment is generally performed within 48 hours of becoming aware of an event that could merit reporting to the WHO. The US CDC becomes aware of these events through many different sources. Things like routine disease notification systems, media reports, anecdotal reports by astute public health practitioners, people who are paying close attention and notice something out of line.