As prepared for delivery
Let me begin by expressing my gratitude to the organizers at Chatham House for providing this opportunity to speak before an audience representing a wealth of specialized knowledge on the subject at hand: an effective global preparedness policy for pandemic influenza. Indeed, this conference is a classic example of the kind of networking that has developed -- both formally and, as here, informally -- as the international community strives to contain the spread of avian influenza, which already has appeared in some 60 countries, and to prepare for a possible human pandemic.
With that in mind, I need not belabor you with facts you already know, such as the devastating impact that a severe pandemic, similar to that of 1918, would have on the globe. Instead I have a special opportunity to share concerns and compare notes on the subject of Session One: "Pandemic Flu and Global Response."
The question of what is at stake has been addressed repeatedly by all of you but unfortunately has faded from the news headlines outside of those countries most directly affected by avian influenza in poultry. The extent to which the topic's relative disappearance from the news could affect national budgets and allocations remains to be seen, and is perhaps the subject for a separate discussion. The lowered public attention, however, also reflects to some degree the fact that we have moved beyond the "emergency" phase to one where greater attention can be paid to capacity-building, so that nationally, regionally and globally we all will be better prepared to respond to a pandemic stemming from H5N1 or any other virus as well as a broader range of emerging infectious threats.
At a series of major international conferences -- Washington (October 2005), Beijing (January 2006), Vienna (June 2006) and Bamako (December 2006) -- governments, international and regional organizations, and others have focused international attention on this global threat, which spans issues related to animal health, human health, and the broad range of economic and social consequences that would occur during a severe pandemic. The next such conference, hosted by the Government of India and sponsored by the International Partnership on Avian and Pandemic Influenza, will take place in New Delhi December 4-6. The U.S. Government delegation will go to the New Delhi ministerial conference with a new pledge of international assistance, and we hope that our partners in the international campaign against avian and pandemic influenza will join us in pledging new funds.
Our broad goals, through our international partners, remain the same: to elevate avian and pandemic influenza on national agendas, to coordinate efforts among donors and affected nations, to mobilize and leverage resources globally, to increase transparency in disease reporting and surveillance, and to build capacity for the long term.
We need to maintain our sense of urgency with respect to the pandemic threat if the momentum of preparedness and capacity-building is to be maintained. Capacity-building doesn't garner headlines. But the threat persists, and large-scale injections of resources and energy are still needed to prepare for and respond to a potential pandemic -- whether or not highly pathogenic H5N1 is the virus that becomes the next pandemic influenza.
These preparations, by necessity, must go far beyond a focus on access to pandemic vaccines. While important, such vaccines will not even be available until five or six months into a pandemic. By that time the entire world may have experienced the first wave of the pandemic. The limited quantities of anti-viral medication and H5N1 vaccines that will be available may or may not be effective against the mutated pandemic virus.
I therefore would like to discuss four elements on which the U.S. Government places great emphasis: first, rapid action to slow the spread of an incipient pandemic; second, non-pharmaceutical interventions - in particular, community mitigation measures - that governments will need to employ in the first months of a pandemic; third, planning and support for dealing with humanitarian assistance needs during a pandemic; and, finally, access to pandemic vaccines and other issues that will be discussed in November at the World Health Organization's Intergovernmental Meeting in Geneva.
In the United States, we have made extensive plans for what we call "rapid response" and what some have called "rapid containment." Our objective is to work with an affected nation and the international community to contain, or at least significantly limit, the spread of a novel human influenza virus, to reduce the impact of the outbreak and to provide everyone with additional time to prepare for the arrival of a pandemic. Although we fully recognize that the odds are against complete containment, the high payoff of a successful containment effort makes it important to try. Even a delay in the spread of the virus could reduce the eventual toll it would take. We have already deployed in Asia a portion of our strategic stockpile of anti-virals to support international containment efforts, and we continue to provide technical assistance, training and commodities to enhance the global capacity to respond.
This is an area where continual planning as well as practice through pre-pandemic exercises is required and capacity-building is critical in order to mount effective responses. Our National Strategy for Pandemic Influenza makes clear that the U.S. Government supports the leadership and coordination provided by WHO, the UN System Influenza Coordinator, and others who would lead international efforts.
We note with appreciation that WHO has just updated its Interim Protocol: Rapid Operations to Contain the Initial Emergence of Pandemic Influenza. This guidance outlines a strategic approach to contain the initial appearance of pandemic influenza. Although we understand that evolving scientific evidence requires the constant reevaluation and revision of technical guidance, we hope that this and other WHO guidance related to rapid response can soon be issued in final form. It is not enough for Member States to simply acknowledge WHO leadership on this issue. Member States must develop their own response capabilities so that they can be integrated with and supportive of international rapid response activities.
Community Mitigation Measures
Regarding non-pharmaceutical interventions, our studies have shown that the use of early, targeted, layered actions to reduce transmission of a pandemic virus in a community -- various forms of social distancing such as school closings, curtailment of public assembly, isolation, and quarantine -- can play a crucial role in reducing the impact of the pandemic. All countries, regardless of how many public health resources they have, can benefit enormously from planning and improving the ability to act in concert with community mitigation principles designed to delay the spread of disease, reduce the pandemic curve, and decrease the overall rate of infection and fatalities. Such mitigation actions are essentially methods of preventing viral transmission from the infected to the uninfected.
The United States is currently in the process of adapting for international use the Interim Pre-pandemic Planning Guidance: Community Strategy for Pandemic Influenza Mitigation in the United States that was issued by the Centers for Disease Control and Prevention, part of our Department of Health and Human Services, on February 1. We believe that its core principles can be adapted for successful use in developing countries, which are expected to suffer significant morbidity and mortality in the case of a pandemic. We will be working closely with the WHO and the international community to determine how we can best help disseminate this valuable information to all who can benefit from it.
A third area of U.S. concern regards the need to mitigate the humanitarian impact of a severe pandemic. Governments, humanitarian agencies in the United Nations System, non-governmental organizations and many others need to work together to prepare for, mitigate and respond to the humanitarian needs that would arise in WHO phases 5 and 6 of a pandemic and, by extension, other health catastrophes. The goal, in part, is to mitigate the excess mortality and profound social disruption that may take place in those countries with inadequate health infrastructure.
This effort includes establishing the means through which we will work together at operational and strategic levels as well as build the needed capacity both at the community and national level. In the U.S. Government, the Agency for International Development has taken the lead on this issue.
Sharing of Influenza Viruses and Access to Vaccines and Other Benefits
Now let me turn to some of the issues related to global preparedness and response that will be addressed at the WHO Intergovernmental Meeting in November.
For over fifty years, the Global Influenza Surveillance Network has served the world. It allows us all to maintain vigilance against our ever-changing virus foes, to develop our scientific and clinical understanding of how to combat those foes, and then to develop and produce vaccines to defeat those foes. It provides early warning of evolving influenza virus strains, both seasonal and those with pandemic potential. As we work together to increase the availability of influenza vaccines in developing countries, the world must maintain the transparent and rapid functioning of the GISN.
All nations have a responsibility to share human influenza virus samples and sample sequence data. Withholding influenza viruses from the GISN greatly threatens global public health and is inconsistent with the spirit underlying the provisions of the International Health Regulations. Not every aspect of the GISN works perfectly, and there may be room for improvement. But we must maintain the GISN - and our global vigilance -- while we discuss such proposals.
With regard to the access to pandemic vaccines and other benefits, let me be perfectly clear: the U.S. Government is strongly committed, and encourages a similar strong commitment by donor countries and private industry, to make voluntary contributions to provide benefits to developing countries for their pandemic preparedness. Such voluntary contributions could include establishing real or virtual stockpiles of vaccines and medicines, as well as providing technical assistance for developing local vaccine research and production capacity in developing countries. In fact, the U.S. Government has already contributed $10 million through the WHO Secretariat to help developing countries build their vaccine manufacturing capacity. The WHO has made six awards already to help local manufacturers in developing countries produce safe and effective influenza vaccines. With our funds, and those of other donors, WHO has been able to provide grants of up to $2.5 million apiece to Brazil, India, Indonesia, Mexico, Thailand and Vietnam.
We should also be clear that there should not be a one-to-one relationship between sharing a particular sample and accruing a specific benefit. Countries that do their duty and share information and samples should not expect to receive something concrete each and every time they share. Rather, they, and other developing countries, as members in good standing of the GISN, should be able to receive technical assistance, to have access to multilateral stockpiles of countermeasures, and to have access to other broad-based support.
We are looking forward to a discussion of multilateral stockpiles at the Intergovernmental Meeting. This will include looking at what can be done now and what could take longer. In addition to deciding how to create a stockpile, there are a number of issues about its management that we need to discuss, including what are the priorities and procedures for distribution.
What should those priorities be? We do not know where the next pandemic will begin. Many believe that the 1918 pandemic began in Kansas in the United States. A pandemic stemming from the H5N1 virus could start in Indonesia or Egypt or other countries where avian influenza is entrenched. And as soon as we know that the pandemic has begun and cannot be contained, we will need to consider the needs in every corner of the globe.
There is another problem that requires resources as well as political will: the need to increase the availability and use of seasonal and pandemic influenza vaccines around the world. The current global capacity to produce a vaccine to respond to an influenza pandemic is insufficient to meet the overall need. The WHO Global Pandemic Influenza Action Plan to Increase Vaccine Supply provides a strong foundation, but its implementation must be accelerated.
In addition, the United States has been making significant investments in vaccine research and in expanding production capacity, including over $1 billion in cell-based vaccine and adjuvant research. These investments are intended to benefit not only citizens of the United States, but citizens of the world.
At the same time, research on and the development of new drugs and vaccines is very risky, time-consuming, and extremely expensive. Intellectual property protection, including patents, is critical to ensure that vaccines will continue to be developed and made available. Ensuring the opportunity for vaccine developers to obtain patents on their vaccines is critical to preserving the incentive to develop vaccines in the first place. We cannot accept any approaches that will undermine intellectual property rights.
I trust that the issue of sharing samples with the GISN will ultimately be resolved. For our part, the U.S. Government looks forward to discussion on this subject. To the extent a set of standard, universal, pre-negotiated terms and conditions is developed, it should have at least the following key characteristics:
I look forward to discussing these and other issues over the next two days. But I would like to emphasize, again, that a full discussion of an effective global preparedness policy should not be limited to a focus on vaccines, benefit sharing, and intellectual property rights. We need to work together on our plans for rapid response and our plans for provision of humanitarian assistance. All the world's health ministers should be working within their governments to plan for non-pharmaceutical interventions to mitigate the effects of a pandemic before a pandemic vaccine becomes available.
For those of us in this room, much of our attention over the last ten months has been focused on sample sharing and access to benefits. Let us not lose sight of the broader picture as we prepare for a possible human pandemic.
Thank you for your attention.