Opening remarks at the Meeting on Options for Increasing the Access of Developing Countries to H5N1 and other Potential Pandemic Vaccines

25 April 2007

Distinguished colleagues, directors from WHO collaborating centres, sister UN agencies, and representatives of industry,

First and foremost, I want to welcome you to this unique event. Thank you for coming to Geneva. You will be discussing some of the biggest issues and dilemmas in public health today.

You will be looking at options for increasing the access of developing countries to vaccines when the world faces the next influenza pandemic.

I am glad to see so many different parts of the world represented. Options and issues need to be debated with respect for a wide diversity of views.

The issues are complex, influenced by multiple factors. Unequal levels of resources are one problem. But equally important is the problem of finite manufacturing capacity.

For a trivalent pandemic vaccine, annual manufacturing capacity is about 500 million doses. For a monovalent vaccine, this figure increases to 1.5 billion doses.

This is still not enough for a world of well over 6 billion people.

Since resources for public health are also finite, we have to ask ourselves: how much priority should be given to a potentially devastating yet unpredictable threat?

After all, there are so many other clear and present dangers for health that are inadequately funded.

Moreover, drugs - like oseltamivir - expire. Vaccines have a limited shelf-life.

The most effective vaccine will closely match the properties of the actual pandemic virus. These properties cannot be known with certainty until the pandemic virus emerges.

We know, too, that multiple clades and sub-clades of the H5N1 virus are currently circulating. We cannot guess which one has the greatest chance of starting a pandemic.

Nor are we certain that H5N1 is the most likely candidate. Another influenza virus might take us by surprise.

Do all these uncertainties make pandemic preparedness, especially for drugs and vaccines, a luxury? Is this something to be undertaken, unilaterally, by countries with abundant resources?

Or is this something the international community should address? Does the universal nature of the pandemic threat call for universal preparedness, or at least greater fairness in preparedness? I believe it does.

Preparedness has many components, and not all are prohibitively expensive. All countries can, for example, prepare and rehearse a pandemic response plan.

Measures such as the closing of schools or encouraging employees to work from home might flatten the peak rate of infection. But we do not know if such measures would have a major impact on morbidity and mortality.

Experts have told us. They have long regarded vaccines as the most effective medical intervention for reducing morbidity and mortality during a pandemic. This assumption, which makes sense, has never been tested in practice.

A vaccine has never been available quickly enough after the start of a pandemic to test its impact on morbidity and mortality. Nonetheless, it is reasonable to assume that vaccines provide the best population-wide protection.

We know the reality: present manufacturing capacity is woefully inadequate to meet worldwide demand. Yet the issue of access to vaccines has acquired an urgency that we cannot fail to address.

Let's look at the recent history of our concern.

In early January 2004, we received information, from Viet Nam, of human infections with the H5N1 avian influenza virus. This was the first bad news in a series of events that rapidly became universally alarming.

Before that first year was over, experts from around the world were attempting to comprehend what a pandemic would mean under the unique conditions of the 21st century. You will remember the wildly different estimates of mortality, and all those headlines.

Economists attempted to calculate what a pandemic would cost the world's economy in this era of global sourcing, on-demand production, and closely connected financial markets. Even the best-case scenarios were shocking.

In the midst of all this speculation, I doubt that any influenza expert in the world would have predicted that, more than three years later, we would still be facing basically the same situation.

That is: persistent outbreaks in poultry, and sporadic human cases with uniformly high mortality.

Most experts expected one of two things to happen: either a pandemic would start fairly quickly, especially since the virus was so widespread in animals, or the virus would attenuate. It would mutate into a form less deadly for poultry, and it would lose its ability to infect and kill humans.

Neither has happened.

Instead, this H5N1 virus has given us a more protracted warning than anyone dared hope. In fact, this is the first time in history that we have been warned, in advance, that a pandemic might be imminent.

The specific options you are addressing today mark an unprecedented step forward. They have broad relevance to many other areas of public health where equitable access to interventions is needed.

This brings us back to the question of preparedness. When we talk about preparedness, and especially about fairness, we must remember our collective obligations under the revised International Health Regulations.

Public health security is a collective undertaking, a shared responsibility. Our universal vulnerability calls for global solidarity. This is the foundation of our collective defence against emerging and epidemic-prone diseases. We must also keep in mind the many distinctive features of an influenza pandemic. These events are unique public health emergencies.

First, all countries will be affected. Even before the advent of air travel, past pandemics spread to all parts of the world within six to nine months.

Second, once a pandemic is fully under way, international spread is unstoppable. Protective measures undertaken by countries may delay arrival of the virus by a few weeks, but cannot stop it.

Third, all populations are susceptible to infection. This may be unique in today's world of infectious diseases, where at least some segments of the population will be protected by pre-existing or induced immunity.

Fourth, regardless of mortality rates, all countries must expect a sudden and significant surge in the number of people requiring medical and hospital care. I doubt that any country in the world has sufficient surge capacity.

The problem will almost certainly be greatest in countries where hospital beds are already overflowing with AIDS, TB and malaria patients.

We must not forget: the next pandemic will be the first to occur since HIV/AIDS emerged. We do not know what the results of co-infection might be.

Finally, pandemics are very different from natural disasters and other international emergencies, which usually affect only limited areas or regions of the world.

In such situations, fortunate unaffected parts of the world can provide generous assistance to those in need.

This sharing of resources is not expected to take place during a pandemic, especially when protective measures are in short supply. There will be no fortunate unaffected parts of the world.

Faced with a universal threat, each country will look after itself, at least in the immediate pandemic period. This is a natural behaviour of governments: to give first priority to protecting the lives and well-being of directly threatened citizens.

I believe that developing countries are right to ask us to address the issue of more equitable access now. To date, developing countries have suffered the most from this virus.

They have slaughtered more than 200 million birds, often without sufficient funds for compensation. They have experienced by far the largest number of patients.

We can only guess at the costs in terms of laboratory tests, intensive hospital care, isolation of contacts, epidemiological investigations, and education of the public.

Developing countries know the present consequences of this virus best. This is by no means the worst disease in these countries, or even a major killer when compared with other endemic diseases.

They have been aggressive in searching for cases and open and transparent in reporting them for one main reason: their understanding, their respect that a pandemic will be a catastrophe for the entire world, and their corresponding sense of responsibility to the international community.

As you listen to various priorities and perspectives today, I hope you will keep in mind the need for global solidarity, also in preparedness. Health security is both a collective aspiration and a mutual responsibility.

As I said, now is the best time to address this issue.

At the moment, the threat is still in the future, unpredictable in timing and severity. This is the best time to invest in an insurance policy.

As you will be seeing today, the priority concerns of developing countries have been recognized. They are being addressed by a range of key players. Solutions are being offered today as options for your consideration.

I wish you a most productive meeting as you evaluate these options and work out the best way forward.