[Congressional Record (Bound Edition), Volume 151 (2005), Part 19]
[Extensions of Remarks]
[Page 26548]
[From the U.S. Government Publishing Office, www.gpo.gov]




                   ON COMPULSORY LICENSING OF TAMIFLU

                                 ______
                                 

                        HON. DENNIS J. KUCINICH

                                of ohio

                    in the house of representatives

                      Wednesday, November 16, 2005

  Mr. KUCINICH. Mr. Speaker, I sent the attached letter, along with my 
colleagues, in support of compulsory licensing for Tamiflu on November 
9, 2005. I submit a copy for the Record.

                                Congress of the United States,

                                 Washington, DC, November 9, 2005.
     Mike Leavitt,
     Secretary, Department of Health and Human Services, 200 
         Independence Avenue, SW, Washington, DC.
       Dear Mike: Thank you for participating in the House 
     Government Reform Committee hearing ``The National Pandemic 
     Influenza Preparedness and Response Plan: Is the U.S. Ready 
     for Avian Flu?'' on November 4, 2005. We are writing to 
     contest your stated justifications for refusing to issue a 
     compulsory license for Tamiflu and to request, again, that 
     you reconsider your stance.
       You mentioned that issuing a compulsory license would not 
     hasten the manufacture of Tamiflu because it is a complex 
     manufacturing process that incorporates a step requiring an 
     explosion hazard. There is considerable evidence showing that 
     the manufacturing process is not prohibitively complex or 
     dangerous.
       Roche's own advertisement in several periodicals has said 
     that they have ``received more than 100 requests from 
     different parties interested in helping us meet production 
     challenges.'' Indian generics manufacturer, Cipla has 
     announced that they plan to start selling enough generic 
     Tamiflu to treat 100,000 to 200,000 people by March of 2006. 
     News reports indicate that Thailand, Taiwan, Malaysia, and 
     Vietnam plan to initiate production, some as soon as February 
     2006. Taiwan appears to have made ``the drug in just 18 days, 
     not including weekends and a bank holiday, using information 
     from publicly available documents.'' They also report that 
     Roche has admitted that it exaggerated the complexity of the 
     manufacturing process. Ernie Prisbe, Vice President of 
     Tamiflu inventor, Gilead Sciences, said of the Tamiflu 
     manufacturing process, ``There's nothing that overwhelming in 
     this kind of synthesis, or that formidable, that someone 
     couldn't do it.''
       Clearly, it is feasible to ramp up production swiftly to 
     provide for the U.S. and the entire world.
       You also indicated that you did not wish to issue a 
     compulsory license for Tamiflu because it would discourage 
     pharmaceutical companies from investing in research into 
     future anti-virals or other drugs. Please be reminded that 
     whenever a government representative issues a compulsory 
     license, the licenser gets a royalty in order to insure 
     profits are not taken. Roche will undoubtedly continue to 
     make healthy profits if a compulsory license is issued.
       You further indicated that an emphasis on Tamiflu is undue 
     since it is not our strongest defense, nor is it guaranteed 
     to be relevant to the virus strain behind a pandemic. I agree 
     that Tamiflu is not a silver bullet. However, to our 
     knowledge, it is the best pharmaceutical defense we have now. 
     Our public health infrastructure is not ready and it will 
     take years to make it so. Until there is a better 
     alternative, and unless we have reason to believe the drug 
     would do more harm than good, and until our state of 
     readiness for a pandemic is stronger, we have an obligation 
     to do all we can to shore up our weak defenses now. Bear in 
     mind that the shelf life of Tamiflu is five years, which 
     means stockpiles are unlikely to go to waste.
       If you are content to wait until 2007 to fill our stockpile 
     needs, a deadline you claimed Roche would be able meet in 
     your testimony, you are gambling with public health with the 
     proceeds going to Roche. If the pandemic does not happen 
     before 2007, Roche keeps their monopoly intact and the public 
     is unharmed. If the pandemic strikes before Roche meets its 
     promised deadline, and nothing has been done to ramp up 
     production--like issuing a compulsory license--our stockpile 
     will be inadequate. History will not be kind to those who 
     could have saved lives but instead deferred to intellectual 
     property rights.
       Please reconsider your willingness to issue a compulsory 
     license for Tamiflu.
           Sincerely,
     Dennis J. Kucinich,
       Member of Congress,
     Bernard Sanders,
       Member of Congress,
     Marion Berry,
       Member of Congress.

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