[Congressional Record (Bound Edition), Volume 151 (2005), Part 20]
[Extensions of Remarks]
[Pages 27523-27524]
[From the U.S. Government Publishing Office, www.gpo.gov]




  LEGISLATION TO PROMOTE AN ADEQUATE STOCKPILE OF ANTI-AVIAN FLU DRUGS

                                 ______
                                 

                          HON. THOMAS H. ALLEN

                                of maine

                    in the house of representatives

                       Friday, November 18, 2005

  Mr. ALLEN. Mr. Speaker, today I am introducing legislation to ensure 
that the United States has a sufficient supply of drugs to combat avian 
flu in the event of a pandemic. My bill authorizes the importation of 
generic medicines when the U.S. patent holder cannot make enough 
medicine to meet domestic public health needs, and removes a trade 
policy barrier to such imports.
  The prospect of an avian flu pandemic has gripped health officials 
around the world. Part of the response would involve treating victims 
with drugs to lessen the spread of the flu virus. The World Health 
Organization has urged all nations to stockpile reserves of antiviral 
flu drugs, and the Infectious Diseases Society of America has 
recommended that the United States stockpile enough drugs to treat 25 
to 40 percent of the population.

[[Page 27524]]

  The drug believed to be most effective against the flu is Tamiflu. 
The exclusive right in the United States to manufacture Tamilfu is 
owned by Roche, a pharmaceutical manufacturer based in Switzerland.
  As Health and Human Services Secretary Michael Leavitt testified 
before the Energy and Commerce Committee on November 8, Roche has 
insufficient manufacturing capacity in the U.S. to meet the stockpile 
needs. At its maximum production, Roche could only produce 13 million 
treatment courses by the end of this year, far short of the 75 million 
we need to treat 25 percent of the population.
  If Roche does not voluntarily license other companies to produce 
Tamiflu, the U.S. government has the authority to issue compulsory 
licenses to gain access to other sources of production of the drug. 
India, Taiwan, China, Thailand, Malaysia, Vietnam, the Phillipines, 
South Korea and Argentina are among the countries considering plans to 
manufacture versions of Tamiflu to prepare for a possible flu pandemic.
  However, Americans facing a pandemic today could not get anti-flu 
drugs from those countries, because in 2003 the U.S. Trade 
Representative agreed to make the U.S. ineligible to import drugs 
produced abroad under compulsory licenses.
  World Trade Organization rules allow for countries with 
``insufficient'' manufacturing capacity in the pharmaceutical sector to 
import pharmaceutical products produced under a compulsory license in 
other countries in order to meet public health needs. This authority is 
contained in paragraph 6 of the 2001 ``Doha Declaration'' on Trade 
Related Aspects of Intellectual Property Rights (TRIPS) and public 
health. The August 30, 2003, decision of the WTO TRIPS Council spelled 
out implementation of this authority.
  At the urging of U.S. negotiators, the August 30 decision created an 
``opt out'' list, whereby countries could voluntarily agree not to use 
the import authority. The U.S. is on the ``opt out'' list. Therefore, 
we find ourselves in a situation where the United States government 
voluntarily restricted its access to critical drugs to fight a 
pandemic. That makes no sense.
  The solution is simple. We can ``opt in'' to the system. That is what 
my bill does. It directs the U.S. Trade Representative to notify the 
WTO that the U.S. declares itself an ``opt in'' country and thus 
eligible to import drugs made under compulsory licenses in order to 
meet public health needs. It also affirms that the President has the 
authority to import such drugs in such cases, as long as the drugs are 
approved by the Food and Drug Administration.
  Americans should have the comfort of knowing that if the public needs 
a particular drug to stop an avian flu pandemic, the U.S. government 
will have access to all available production sources for the drug. My 
bill would make sure that our government can do what it takes to combat 
an avian flu pandemic or other health emergency.

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