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Michael  Leavitt, Secretary


Angers, Anjou, France


Monday, September 08, 2008

Remarks as Prepared for the European Union Health Minister Forum

Thank you, Madam Minister [Roselyne Bachelot-Narquin, French Minister of Health, Youth Affairs, Sports, and Associations]. This is an exceptional gathering, and it is truly a pleasure to have a chance to speak with you here in this beautiful setting.

Last fall, at the Global Health Security Initiative ministerial meeting in Washington, Minister Bachelot kindly invited me to be her guest here at this event.   I was honored by her invitation, and I was very glad to accept.

I was recently in China to see the Beijing Olympics. While there, I was reminded of the 2002 Winter Olympics in Salt Lake City, Utah.

I was Governor of Utah at the time. This was less than a year after terrorists struck the World Trade Center and the Pentagon. Then anthrax started appearing in small quantities in Florida, Washington, and New York.

On the third or fourth night of the Olympic Games, I was at the figure skating competition when I got a call from the head of the Department of Public Safety.

“Governor, we need you to come to the Command Center, now. We’ve got a problem — a positive indication of anthrax at the airport.”

I left the arena, moving as rapidly as I could toward the Command Center.

It was about 7:00 pm at night. Tens of thousands of people would be moving through airport at that time. If the readings were true, some of those people might carry the deadly anthrax spores to many more cities.

It was a frightening moment. The same monitor had registered positive for anthrax four times. But the more definitive test was at the lab, and that would take two-and-a-half hours. I waited outside the laboratory the whole time.

The reading turned out to be false. But it was a real emergency. And the fear of terrorism, and the possibility of bioterrorism, became quite real to me.

The incident taught me a lot about the threat of bioterrorism. It also impressed on me the importance of preparedness.

Preparedness is a process of learning, adapting, and growing. We’re facing new threats from new quarters. And we’ve got to respond with new ways of working together.

Tonight I want to talk with you about health security. How do we keep our citizens safe from health threats such as bioterrorism or pandemic influenza?

The keys to success in this shared endeavor are preparedness and collaboration.

Whether it’s tackling diseases that don’t know borders or ensuring the safety of products that cross our borders, we must work together. No nation can afford to go it alone.

We need collaboration both between governments and between government and the private sector.

I mentioned seeing Minister Bachelot at last fall’s Global Health Security Initiative ministerial meeting, in Washington. The GHSI has made noteworthy strides in improving global health security by stimulating information-sharing and the coordination of efforts to combat bioterrorism.

The GHSI also actively promotes development of medical countermeasures.  This is a key aspect of preparing for current and future bioterror threats or the next pandemic.

Another good example of our international collaboration is the International Partnership on Avian and Pandemic Influenza. President Bush called for the establishment of the Partnership to promote collaboration in preparing for pandemic flu, with full awareness that pandemic influenza is a threat against the entire world.

The Partnership strives for complete transparency, rapid response capabilities and cooperative surveillance. It facilitates the sharing of data and samples among nations and among international organizations such as the World Health Organization.

For 56 years, the World Health Organization’s Global Influenza Surveillance Network has been providing the world with early warnings of evolving flu viruses. Sample-sharing is essential to its efforts. All nations therefore have a responsibility to share data and virus samples. 

I want to work with all of you to ensure we coordinate our approaches to the negotiations this fall to end the impasse over virus sample sharing. We cannot afford to let global health security be held hostage any longer.

A related challenge we face in preparing for a pandemic, or a bioterror attack, is the need to develop a global market for medical countermeasures.

A key element in developing medical countermeasures is providing incentives to private companies to bring such products to market.

Within my department is an organization called the Biomedical Advanced Research and Development Authority — BARDA for short. BARDA helps fund the early-stage development of necessary vaccines, medicines, therapies, and diagnostic tools for medical emergencies. This gives companies an economic incentive to develop products we might someday need, but that the market won’t pay for now.

This is a form of collaboration between the government and the private sector: We give the companies the funding they need to make their venture worthwhile. They then bring into being a product to ensure our citizens’ safety in a future emergency.

The United States has taken the lead in these efforts. But we cannot continue to unilaterally provide such incentives for the world at large. If the governments of Europe were to join the United States in funding such development, our worldwide preparedness would be greatly improved.

Private-public collaboration is crucial to developing a global market for medical countermeasures. It is also crucial in another growing area of health security: ensuring the safety of our food, medicines, and consumer products.

Last July, President Bush asked me to chair an Interagency Working Group on Import Safety in the United States. He tasked our group with conducting an across-the-board review of products imported into the United States from around the world.

I personally visited more than two dozen cities in the United States and abroad.

I examined airports and post offices, freight hubs and fruit stands, supermarkets and seaports. I observed the processing of everything from pharmaceuticals to fish.

One thing became clear on our trips: We cannot simply inspect our way to product safety. Doing so would bring trade to a standstill. And it would divert limited resources from the goods posing the greatest risk.

Instead, we need to roll back our borders and ensure that safety and quality are built into products every step of the way. And we need to employ a risk-based process, focusing our efforts on the riskiest products.

We are saying to the world: we want you to have access to our markets. But to have access, your products must meet the high standards of safety and quality Americans expect.

I know nations in Europe are saying similar things to their suppliers as well. All of our countries are vulnerable: tainted imports can shake consumer confidence and wreak economic damage.

We know that anything that slows down the flow of goods — including unnecessary inspections — damages competitiveness.

Independent certification can go a long way toward ensuring that our expectations of safety are met.

So here is our proposition: If producers can demonstrate that they are meeting our standards, through independent certification by parties we trust, their products will have speedy entry into the United States.

Those who cannot demonstrate certification can expect increased scrutiny at our borders.

We will concentrate our resources on where the greatest risk is. We deem the greatest risk to be producers who are not demonstrating quality and safety through voluntary transparency.

To improve the safety of imported pharmaceuticals, the United States, the European Commission, and Australia recently launched a pilot project to conduct joint inspections of pharmaceutical manufacturers. We will also exchange information to help identify and inspect suppliers of pharmaceutical ingredients in other countries.

This pilot project marks the beginning of what we hope will become a new way of doing business. The principle will be collaborative information-gathering with individual decision-making.

Through this new collaboration, we can spread our inspection net wider by leveraging our respective resources. The United States will be inspecting some, the Australians others, the Europeans still others. We will then share information, so each of our regulatory agencies can make the best decision on approvals for our individual markets.

This just makes good sense. Facilities will undergo inspections more often, and we can all focus more resources on those products that present demonstrably higher risk.

This is a very exciting vision: common standards and shared inspections. Safer products. Lower costs.

Whether we are talking about ensuring the safety of imports, preparing for pandemics, or countering bioterrorism, it is clear that health security has many different components, with some important common threads. Perhaps foremost among these is that health security requires preparedness, and preparedness requires collaboration.

Thank you.

Last revised: September 09, 2008