[Congressional Record (Bound Edition), Volume 151 (2005), Part 19]
[Extensions of Remarks]
[Pages 25481-25482]
[From the U.S. Government Publishing Office, www.gpo.gov]




  HEARING: THE NATIONAL PANDEMIC INFLUENZA PREPAREDNESS AND RESPONSE 
                 PLAN: IS THE U.S. READY FOR AVIAN FLU?

                                 ______
                                 

                        HON. DENNIS J. KUCINICH

                                of ohio

                    in the house of representatives

                       Tuesday, November 8, 2005

  Mr. KUCINICH. Mr. Speaker, is the U.S. ready for avian flu? I don't 
think there is any question that answer is a clear ``no.'' The question 
is, what are we doing about it? The administration finally released its 
plan this week under tremendous public pressure. It got underwhelming 
reviews from experts because it is deficient on several fronts that 
will be collectively necessary for us to fight this disease. It is 
especially weak on efforts to stockpile anti-virals.
  Our best anti-viral bet will be Roche's Tamiflu. It is well 
established that it will take Roche years to produce enough to satisfy 
American stockpile needs. We have enough for less than 1% of the U.S. 
population. We need at least enough for 25% of the U.S. Even after 
promised increases in production capacity, Roche's supply is far less 
than our stockpile needs. The same goes for countries around the world, 
including those where the outbreak is likely to originate if the virus 
mutates to pass easily from human to human. And yet there are plenty of 
production facilities to solve the problem. In fact, over 100 companies 
have expressed interest in ``helping (Roche) meet production 
challenges,'' according to one of Roche's own advertisements. So what 
is the problem?

[[Page 25482]]

  The problem is that Roche has a monopoly on Tamiflu. We are very 
familiar with what happens when a company has a monopoly on a product 
the world needs. They control supply. And that is exactly what Roche is 
doing.
  But choking world supply is not the only consequence of Roche's 
monopoly. If we need a reminder about the perils of concentrating 
production in the hands of a few, we only need to look to last year. 
Chiron was forced to scrap half of the U.S. flu vaccine supply when 
their manufacturing facility failed to meet safety standards. That was 
for the conventional flu. Imagine what would happen if we lost half of 
our Tamiflu supply in the middle of an avian flu outbreak. And yet, at 
the cusp of a potentially far more devastating avian flu epidemic, we 
are about to repeat our mistake. But there is a solution. Compulsory 
licensing.
  HHS has the authority to issue a compulsory license to get rid of 
this dangerous shortage by allowing other companies to make Tamiflu. 
Roche would get compensation. That authority exists specifically to 
prevent the most predictable scenario--a pharmaceutical company holding 
a drug hostage when it is needed to protect public health, in order to 
increase profits. That is exactly what we're seeing here.
  Roche revenues increased 17% last quarter. Tamiflu sales more than 
doubled to $215 million in three months. They expect to make almost $1 
billion from Tamiflu sales this year. Of course they would want to hang 
on to this monopoly. Their ultimate responsibility is to their 
shareholders, not to the public.
  We have heard a lot of promises from Roche that they are willing to 
negotiate with other companies to sublicense production, but I have not 
heard anything about a firm agreement to do so. Roche can keep fees too 
high in order to make it unprofitable for an outside company to 
manufacture Tamiflu. They can stipulate, and have indicated their 
willingness to do so, that any Tamiflu made by a company other than 
Roche would not be available for sale in the U.S. In other words, they 
can continue to restrict world supply.
  And to top it off, the administration boasts that it wants to throw a 
billion dollars into buying anti-virals. But the drugs aren't there. 
There's nothing to buy and, as it stands, there won't be anything to 
buy in the near future. We may not have that kind of time. But the 
administration is still sitting on its hands while Roche's profits 
skyrocket and Tamiflu production does not. This is a clear choice of 
profits over public health.
  As you know, Secretary Leavitt, last month nine of my colleagues and 
I sent you a letter requesting compulsory licensing. We have given 
Roche plenty of time to act appropriately and they have failed to do 
so. In order to protect public health, we must issue a compulsory 
license for Tamiflu immediately.