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International Health Regulations POWERPOINT PRESENTATION
July 2007

KATHRYN HARBEN, COMMUNICATIONS, COORDINATING OFFICE FOR GLOBAL HEALTH, CDC: I′d like to introduce our speakers today. Dr. Scott McNabb is director of the Division of Integrated Surveillance Systems and Services with the National Center for Public Health Informatics here at CDC.

Dr. Katrin Kohl is deputy director, Division of Global Migration and Quarantine, National Center for Preparedness, Detection and Control of Infectious Diseases, here at CDC.

And today they are going to give us an overview of the new International Health Regulations, as well as information about CDC′s role in implementing these new regulations for the U.S. government. Thank you.

SCOTT MCNABB, DIRECTOR OF DIVISION OF INTEGRATED SURVEILLANCE SYSTEMS SERVICES, NATIONAL CENTER FOR PUBLIC HEALTH INFORMATICS, CDC: Thank you, Cathy (ph). With my colleague, Dr. Katrin Kohl, we are pleased to share with you the implications and the challenges and the opportunities that are presented to the U.S. government with the adoption of the revised International Health Regulations.

The International Health Regulations are a formal code of conduct for public health emergencies of international concern. They′re a matter of responsible citizenship and collective protection. They include the commitment by the U.S. national public health effort, as well as tribal, territorial, state and local roles. And they involve all 193 World Health Organization member countries, the United States government being one of those member countries. And they take effect for the U.S. government July 17th, 2007.

As I move to the next slide, Katrin and I wanted to describe to you what the revised International Health Regulations are. They are an international agreement that gives rise to international obligations. They focus on serious public health threats with potential to spread beyond a country′s border to other parts of the world.

Such events are defined as public health emergencies of international concern, or PHEIC. The revised International Health Regulations outline the assessment, the management and the information sharing for PHEICs. As I move to the next slide, we discuss the reason why the IHRs serve a common interest.

First of all, they address serious and unusual disease events that are inevitable in our world today. They serve a common interest by recognizing that a health threat in one part of the world can threaten health anywhere, or everywhere. And they are a formal code of conduct that helps contain or prevent serious risks to public health, while discouraging unnecessary or excessive traffic or trade restrictions for, quote, "public health," purposes.

The key changes from the old IHRs, which were adopted in 1969, to the revised IHRs, include the fact that member countries must notify WHO of events meeting certain defined criteria. This is beyond a prescribed list of infectious diseases in the IHRs, that also member countries must enhance their events management, which include especially the capacity to alert and respond to these public health emergencies of international concern.

Further, member countries must meet minimum core capacities, notably in surveillance, response and at points of entry. In brief, the International Health Regulations are written in legal language, supported by guidelines to aid compliance and intended to contain public health threats and minimize economic disruption.

The International Health Regulations are not self-explanatory, recommendations for safe travel or a scientific consensus on everything possible to prevent disease spread. How will the United States accept the International Health Regulations?

In December of 2006, Secretary Leavitt released a press announcement that stated that the U.S. government had accepted the International Health Regulations with a reservation and three understandings. The deadline for registering an objection to the registration and understandings is July 17th, 2007.

The United States federal government is encouraging local and state governments to aid compliance with this federal government acceptance of the IHRs, and that includes a letter that Secretary Leavitt has mailed to the governors in the states in the United States, as well as a position statement that has been approved by the Council of State and Territorial Epidemiologists in support of the International Health Regulations.

The reservation that Secretary Leavitt placed on the U.S. government′s acceptance of the IHRs addresses the statement that the U.S. government will implement the International Health Regulations under our principles of federalism. Federalism is the system of government in which power in the United States is divided between a central authority, meaning U.S. federal government, and constituent political units, the local and state governments.

The understandings that the secretary has placed on the United States government′s acceptance of the IHR include the fact that under the IHR, incidents that involve the natural, accidental or deliberate release of chemical, biological or radiological materials must be reported.

Countries that accept the IHRs are obligated to report, to the extent possible, potential public health emergencies that occur outside their borders. And the third understanding is that the IHRs do not create any separate, private right to legal action against the federal government.

How will the United States accept the IHRs? In Washington, the Health and Human Service′s Secretary′s Operations Center, or the SOC, is the U.S. national focal point of reporting to the WHO.

The WHO will have access to IHR information on a 24/7 basis, but CDC assumes a lead role in the implementation of the IHRs, especially as it relates to human disease, and that involves the activities of detection, prevention and control. One major role for CDC is to support the existing health monitoring systems that identify and report health conditions in the United States, so that local, state and federal public health authorities need to collaborate in order to improve the ability of national health monitoring systems to report possible PHEICs under the IHR provisions.

We live in a global village. That′s become a trite term in many ways, and yet the reality is that what happens in the United States impacts the rest of the world′s community, and vice versa, and so I′d like to introduce Dr. Kohl, who will lead us through the rest of these slides.

KATRIN KOHL, DEPUTY DIRECTOR OF DIVISION OF GLOBAL MIGRATION AND QUARANTINE, NATIONAL CENTER FOR PREPAREDNESS, DETECTION AND CONTROL OF INFECTIOUS DISEASE, CDC: Thank you, Scott.

This slide shows a quote by Secretary Leavitt upon acceptance of the IHR and stresses the need for global preparedness and response to public health emergencies. So what are these public health emergencies we are talking about in this context? Over the next few slides, I am going to walk you through criteria for identifying and reporting public health emergencies of international concern to WHO.

Those criteria need to be applied by federal agencies upon notification of a potential public health emergency of international concern. There′s a list of 40 diseases in the revised IHR which are always reportable to WHO, namely smallpox, poliomyelitis, a new subtype of human influenza and SARS.

Other diseases listed include amongst them cholera, plague, yellow fever and viral hemorrhagic diseases. Those will be notifiable as long as they meet the decision criteria put forth in the next two (ph) of the IHR. All other biological, radiological or chemical events that fit the criteria in the decision algorithm that I will describe on the next slide also need to be reported.

Let me just go through these four questions here. This slide lists the four criteria listed in the decision algorithm in Annex 2 in the IHR. I will go over specific guidance for each of the four questions that you need to ask yourself when hearing about an event to assess its reportability to WHO in detail in the next two slides. But, in short, is the public health impact of the event serious? Think, for example, HIV, even early in the epidemic.

Is the event unusual or unexpected? Think back to the first cases of West Nile Virus in the U.S. Is there significant risk of international spread? Think SARS and how quickly it traveled in Asia and to North America. Is there significant risk of international travel or trade restrictions? Think to the recent diethylene glycol in toothpaste from China, which effectively stopped importation of Chinese toothpaste to the U.S., at least according to the "New York Times," yesterday.

If two of these four questions are answered with a yes, the event is reportable to WHO under the IHR. WHO then makes the final determination if a public health emergency of international concern exists.

I′m only going to read the different criteria without further explanation, but want you to think through any public health events that you′ve encountered and assess in your mind if they would have made any of these explanatory criteria to the larger question if the public health impact of the event is serious.

If any of these criteria are fulfilled, the question of seriousness would be answered as yes. Hence, there is potentially high morbidity and/or mortality: the geographic scope is large, or spreading over a large area and/or is in an area of high population density; the agent is highly transmissible or pathogenic; the event has compromised containment or control efforts; therapeutic prophylactic agents are unavailable, absent or ineffective; and cases are occurring among healthcare staff.

There′s also provision in the IHR that a country should report an event or answer this question as yes if it requires assistance for investigation and response required, which we probably think would apply less to the United States than other countries. These are the criteria for unusual or unexpected: the disease-causing agent is yet unknown or a new, emergent pathogen; the population affected is highly susceptible; the event is unusual for the season, locality or host; there′s a suspicion that this may have been an intentional act; the agent had been eliminated or never reported in the U.S.

Here are the criteria for risk of international spreads, such as is there an epidemiologic link to a single event outside the U.S., that there′s other circumstances that may predispose to international spread? For example, did cases travel internationally, or participate in international gatherings, or were they in close contact with travelers or mobile populations? Also, is there a potential cross-border movement of pathogens, agents or the host? And, finally, are there conducive transmission vehicles, such as air, water, food or the environment?

Finally, for the last question, if there is significant risk of travel or trade restrictions, the criteria are: there is a history of similar events in the past that have resulted in restrictions; the event is associated with an international gathering or tourist area; the event is, or has gained, significant government or media attention; there is a zoonotic disease or the potential for an episodic event or exported, imported food and water related.

This slide shows a simplified decision instrument from Annex 2 of the IHR to summarize the previous slides. The left box shows what the 40 diseases listed are which are always notifiable to WHO, bypassing the list of questions, while any other events, including the additional diseases specifically listed goes through the set of core questions and have to report it if two of the four questions are answered with a yes.

To further summarize, public health events need to be assessed within the local context. A decision instrument for reporting of a public health emergency of international concern is available in the IHR and WHO also assesses the reported event, and in fact we make the final determination if a public health emergency of international concern exists before any publication of the event or staging of formal response.

As mentioned before, in the U.S. the federal government has the responsibility to assess and report a potential public health emergency of international concern to WHO through its regional offices. U.S. government agencies have 48 hours to make the assessment after learning about an event and an additional 24 hours to notify WHO.

In order to fulfill our obligation of rapid assessment and reporting to allow for the fastest possible response on a global level, U.S. government agencies will in turn need to learn about events in the states as quickly as possible. And, as Scott mentioned, yesterday, on June 28th, the Council of State and Territorial Epidemiologists has voted in favor of a position to rapidly report potential public health emergencies of international concern to CDC.

In addition to the assessment and reporting of events, the IHR also prescribed globally shared responsibilities, such as core capacities to conduct surveillance and stage response, to prevent importation and spread of disease at points of entry and to develop country-specific procedures, a key element of WHO′s strategy for global health security.

I will only briefly address the framework of response and potential measures applied in response to a public health emergency of international concern. The core capacities spelled out in the IHR aim to show that an expected, robust national response effort can be undertaken, which is context specific, flexible and commits international health measures.

For example, for points of entry, these could include entrance screening of travelers for event-related health symptoms, including medical exams and interviews upon entry into the country. It could include vaccination requirements or other preventive or therapeutic public health measures, or quarantine of exposed and isolation of ill travelers. All measures potentially applied have to be by consent and with respect for human rights.

This is a very busy slide, showing the timeline for full implementation of the IHR globally. Let me go over the dates with you. One, in 2005, the World Health Assembly approved the revised IHR, which is why they′re often referred to as the IHR 2005. In 2006, the U.S. accepted the revised IHR. On June 15 of this year, the IHR entered into force, except for those countries, like the U.S., which submitted a reservation, in which case the IHR enters into force on July 17th.

In 2009, that is, within two years of entering into force, member countries have to have completed an assessment of the core capacities in their country. In 2012, that is, five years from entering into force, countries have to have achieved the core capacities, unless they are granted an extension, which can be granted for a second time under exceptional circumstances. By 2016, all countries have to be fully compliant with the IHR. In the U.S., we aim to be fully compliant by the date the IHR enters into force for us, that is, July 17.

This slide lists all the federal government partners who are actively involved in the implementation of the IHR.

Finally, here are some references for further information about the revised IHR, including the WHO Web site, with information about the IHR in all WHO languages; the Web site of the Department of Health and Human services, including also the acceptance of the IHR by the U.S. government; and an article published in the journal, "Emerging Infectious Diseases," which has the simplified decision algorithm.

Thank you.

HARBEN: Thank you, Dr. Kohl, and thank you, Dr. McNabb. I would like to ask the first question.

As you mentioned, the states will play a critical role in the U.S. government′s ability to meet its obligations under the new IHR. How will the states let us know that they have a possible public health emergency of international concern?

MCNABB: Thank you, Cathy (ph), for that question. There are generally two ways that a state health department notifies CDC of either a notifiable event or an event that would fit this criteria. One is a formal mechanism, surveillance and notification through the National Notifiable Diseases Surveillance System. But there is also an intricate, complex network of informal mechanisms, where local physicians or local health officers contact CDC directly when they are experiencing or seeing cases of unusual presentation to them.

So both of those mechanisms, both the formal and the informal mechanisms of notification at the national level are being enhanced and strengthened.

HARBEN: Thank you.

A couple of other questions have come in from the field. One of the questions that some people have is how will the IHRs impact individual travelers? Will they expect a lot of new regulations, or will this go on around them?

KOHL: We don′t expect that the IHRs, in and of themselves, will affect routine travel. The IHRs may affect travel in the event of a public health emergency of international concern, where WHO, together with its member states, may prescribe measures, as mentioned earlier, such as vaccination upon entry, medical screening upon entry, interviews about travel history and symptoms upon entry, which then may trigger other health measures, as well.

But in the absence of a public health emergency of international concern, we expect travel to continue as is currently happening.

HARBEN: This is a very general question, but how will the new IHR protect America′s health?

KOHL: We think the IHR will protect not just America′s health, but really the global health by allowing a global network of information exchange, and also by allowing a global network of staging a coordinated response. The idea is that countries will have better capacity to detect events in their countries and also to report those events within their countries and then to WHO, for WHO to then work collaboratively with those countries and the other member states to stage responses against those events.

And, ultimately, given the world that we live in, with high travel volume, high mobility of populations, this will also protect the United States from events overseas that could come to the United States.

MCNABB: I would just complement Dr. Kohl′s response by saying that all of the 193 member countries of the WHO have agreed to comply with the IHRs, which means that those countries, like the United States, which are developed countries, which are resource-rich, have a sense of obligation to help resource-poor countries, as well, raise the bar, as it were, in terms of surveillance, detection and response.

So this really provides a global view and a strategy to help elevate the capacity of member countries who may be less developed in these areas to be able to respond.

HARBEN: That′s actually a good segue to another question. I understand that the United States has some responsibility under the new IHR to also report a public health emergency of international concern if we know about it in another country.

As you know, we′re often asked to assist a country investigate an outbreak or a disease of unknown origin. What are the U.S. responsibilities with regard to notifying WHO or others about a situation we′re aware of?

KOHL: Let me maybe just clarify that this is not exclusively a U.S. obligation under the IHR. It is spread out as an understanding that we will do so to the extent possible. So this is an obligation that all countries have for other countries. And in an ideal world, this would actually not be necessary, because all countries would have sufficient capacity to detect events on their own, in their own country, and report them to WHO.

However, in a scenario that one country were to find out faster, or with more evidence, what is going on in another country, there is the obligation for the global protection to also then let WHO know about this.

HARBEN: You mentioned early on that these are international law that the 193 WHO member countries must abide by. CDC is not a regulatory agency. How will CDC and Health and Human Services ensure that our state and local partners help us report these public health emergencies of international concern?

KOHL: I think there are two points to your questions. One is how can we assure that states report to the federal government and while we legally may not have that assurance, but just as was pointed out earlier, we do have the working relationship with the states and the states have a keen interest to report to us, to also then learn what′s going on in other states. So I do not think that we need additional laws to regulate that aspect.

In terms of CDC or HHS not being a regulatory agency, we do have some regulatory responsibilities, though particularly as it comes to measures at point of entry, such as quarantine and isolation. And the ones that are spread out in the IHR are consistent with the regulatory authorities that we do have in the United States.

HARBEN: If there are other questions, I invite people to come to the microphone.

UNIDENTIFIED PARTICIPANT: Thank you. To help illustrate how this would work, I wonder if you could give us a specific example and then kind of walk us through how it might work. So let′s say that a flight arrives in New Jersey and we find that there′s an ill patient on board the plane and initial observations, initial tests, show that Rift Valley fever might be the cause. Can you take us through how this would work under the new IHR?

KOHL: Yes, it′s an interesting example, because it addresses some of the aspects we talked about earlier in terms of context specific. Rift Valley fever would not be something we would expect in the United States, hence it′s appropriate to assume that a traveler may arrive with Rift Valley fever in the United States.

It′s not highly transmissible person to person, so we wouldn′t need to be too worried about further spread within the United States. It′s typically transferred from animals to humans and specifically actually from slaughtered animals to humans.

However, then, we would want to find out where this traveler has come from and is this something that is routinely ongoing in this country, or is this something unusual for this country? Do we need to be worried that any of these animal products would be exported from this country? Would we need to worry that travelers would go to settings where it would be more likely that there could be further spread of the disease?

So I think at that point, this particular scenario would raise a lot of questions. And we could use the mechanism that′s set up under the IHR to report this to WHO, for them then to initiate the investigation in the country where the traveler came from and likely contracted Rift Valley fever.

HARBEN: Another possible example of a situation that may come up here within CDC, CDC has many laboratories and programs that are doing research. What would be the responsibility of, say, a researcher who′s working on TB and identifies something new or unusual in the course of their daily work? How would that work within CDC?

KOHL: I think every public health professional, be it at CDC or in a state, should be knowledgeable about these reporting criteria to WHO to assess in their daily work, is this something that they are not used to encountering, which is one of the reasons why I brought up this early example of HIV. What first brought us to HIV was an unusually high request for a drug to treat Kaposi′s sarcoma, which we rarely see in this country to this extent, and pulmonary infections. And so there is an art to the assessment, is something unusual, which comes with experience in your job.

So I think every scientist at CDC, and in other research agencies or public health agencies, needs to start going through this list of questions in their mind with anything they hear in their daily life to assess if this could be more serious than what we typically see as this unusual. Could this impact travel and trade? Yes.

HARBEN: And I believe you also mentioned that the regulations are not limited to infectious diseases, but any biological event, chemical event or environmental event, radiologic, could also trigger a need to report. Could you talk a little bit about that?

MCNABB: That′s a good point, because the new, revised IHRs have a new paradigm of this in reporting. It′s not just the list of the diseases that are on the left of the annex that Katrin mentioned. It includes unusual events that may be out of the box, out of our thinking right now. So working with other federal government agencies, the Department of Transportation, Department of Commerce, Department of Homeland Security, for example, are involved in the IHRs intimately.

If an event like that occurred in Santa Fe, New Mexico, for example, the appropriate federal agencies would be notified through the local and state reporting system. CDC would automatically be involved in the assessment of this, because there would be likely human illness that occurs from these events. So we would work closely with our partner federal agencies, identifying, seeing if this event fit the criteria for a PHEIC. That would be reported, then, as a potential PHEIC from the Secretary′s Operations Center to the WHO.

HARBEN: Are there other questions from the room?

UNIDENTIFIED PARTICIPANT: From a practical standpoint, how are these regulations going to impact the day-to-day work of quarantine officers?

KOHL: It is a good question. There are numerous items spread out in the IHR on the core capacities for point of entry. We are fortunate in the United States that much of what′s spread out in the IHR is work we currently address in our quarantine stations. And I′m just trying to think through a concrete example where something may be new in the IHR that we are currently not addressing.

We do work closely enough with our counterparts that would allow for screening at point of entry. However, for example, if we were obliged, through a public health emergency of international concern, to conduct extensive, 24/7 screening of travelers coming into the United States, we would not have the capacity to do this right now, even including our partners. However, we are working to build that capacity as a surge capacity through our preparedness for pandemic influenza.

UNIDENTIFIED PARTICIPANT: Thank you. My question is, you′ve mentioned earlier that there is going to be core capacities that the various countries are expected to have. How will these core capacities be assessed and what kind of obligation or role does WHO expect to have in assisting these countries, and possibly the CDC, in assisting countries?

MCNABB: That′s a great question, and, as you point out that the WHO now has an enhanced responsibility to not only provide assessment tools for the countries to use that are standardized, for example, to gather the data, to identify the gaps that exist in various countries, related to this reporting requirement and then to provide the resources or the support necessary to build the infrastructure to be able to do it.

So, as you probably know, the CDC works very closely with WHO and has been doing that for many decades. And, in fact, we work very closely, almost on a daily basis, with the WHO headquarters office, which has been tasked now as the IHR secretariat to be able to stand up and develop the capacity to assess the countries, provide them the guidance for identifying gaps, to look for resources to support those gaps. And so we work very closely with WHO in this area and anticipate even a closer relationship in the future, in that they will be looking to us for support in this effort.

KOHL: And maybe to follow up, WHO is still in the process of developing indices that would let us allow them to assess if a country has met its core capacities or not.

HARBEN: Thank you very much. This has been very helpful. There is, as we mentioned earlier, a Web site at the Department of Health and Human Services where additional information about the IHRs is available. You can reach that Web site at www.globalhealth.gov/ihr. Thank you very much.

END

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