[Congressional Record Volume 150, Number 127 (Friday, October 8, 2004)]
[Senate]
[Pages S10847-S10848]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. WYDEN:
  S. 2944. A bill to provide that no funds may be expended by the 
United States Trade Representative to negotiate data exclusivity 
provisions for certain pharmaceutical products; to the Committee on 
Finance.
  Mr. WYDEN. Mr. President, today I am introducing legislation 
regarding the way the trade policies of the United States affect the 
ability of developing countries to access to generic drugs.
  The bill addresses concerns that this Administration, through the 
United States Trade Representative, is pursuing policies that will make 
it even more difficult for developing countries to gain access to the 
drugs they need, particularly generics, to treat their public health 
problems like TB, HIV/AIDS and malaria. This is just wrong.
  The policies the Administration seeks to put in place are data 
exclusivity provisions. Such provisions tend to benefit drug 
manufacturers. As reported in The Wall Street Journal and elsewhere, 
when these provisions are included trade agreements they essentially 
bar countries from being able to get more affordable generic drugs for 
a period of time, usually five years.
  Trade agreements should be about promoting trade. People in 
developing

[[Page S10848]]

nations who are suffering from such epidemic diseases should not be 
denied access to affordable medicines because of trade agreements.
  The purpose of what is known as the Doha Declaration was to clarify 
that trade rules on intellectual property would not interfere with the 
ability of developing countries to take measures to protect public 
health. The legislation I am introducing today would prohibit USTR from 
spending any funds in order to impose data exclusivity for drugs used 
to treat HIV/AIDS, tuberculosis, or other epidemics, or needed in 
circumstances of extreme urgency, or national emergency.
  I am not one to trample on the need to protect trade secrets, but I 
cannot condone policies that inhibit developing countries from being 
able to address their own public health needs. In today's world, it is 
shortsighted to think that infectious diseases cannot cross borders. By 
allowing developing countries access to generic drugs, we not only help 
improve health in those nations, we also help ourselves control these 
debilitating and often deadly diseases.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2944

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. LIMITATION.

       (a) In General.--Notwithstanding any other provision of 
     law, funds appropriated or otherwise obligated to the United 
     States Trade Representative may not be expended to negotiate 
     data exclusivity provisions with any country with respect to 
     public health pharmaceutical products or to require actions 
     of another country which interfere with a country's access to 
     public health pharmaceutical products.
       (b) Definitions.--In this section:
       (1) Data exclusivity provision.--The term ``data 
     exclusivity provision'' means a provision that restricts for 
     a set period of time a country from approving for sale 
     generic public health pharmaceutical products based on 
     original clinical data of public health pharmaceutical 
     products previously approved for sale.
       (2) Public health pharmaceutical products.--The term 
     ``public health pharmaceutical products'' means any patented 
     pharmaceutical product, or pharmaceutical product 
     manufactured through a patented process, needed to treat HIV/
     AIDS, tuberculosis, malaria, or other epidemics, or needed in 
     circumstances of extreme urgency or national emergency in 
     accordance with the Decision of the General Council of 30 
     August 2003 on the Implementation of Paragraph Six of the 
     DOHA Declaration on the TRIPS Agreement and Public Health and 
     the WTO General Council Chairman's statement accompanying the 
     Decision (JOB(03)/177, WT/GC/M/82) (collectively known as the 
     ``TRIPS/health solution'').
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