[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4392 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 4392

   To provide for the importation of pharmaceutical products under a 
 compulsory license as provided for under the World Trade Organization.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 18, 2005

  Mr. Allen introduced the following bill; which was referred to the 
                      Committee on Ways and Means

_______________________________________________________________________

                                 A BILL


 
   To provide for the importation of pharmaceutical products under a 
 compulsory license as provided for under the World Trade Organization.

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

SECTION 1. FINDINGS.

    The Congress finds the following:
            (1) The World Health Organization has recommended that 
        governments stockpile antiviral drugs to limit the spread of a 
        potential influenza pandemic, and the Infectious Diseases 
        Society of America has advocated that the United States 
        Government stockpile sufficient medicines to treat 25 to 40 
        percent of the Nation's population.
            (2) Currently the United States Government has stockpiled 
        only enough antiviral drugs to treat one to two percent of the 
        population in the event of a flu pandemic.
            (3) The exclusive right in the United States to manufacture 
        the antiviral drug, commonly known as Tamiflu, that is believed 
        to be most effective against the flu is owned by Roche, a 
        pharmaceutical manufacturer based in Switzerland.
            (4) Roche has insufficient manufacturing capacity in the 
        United States to produce an amount of Tamiflu in a near-term 
        time frame needed to meet the treatment goals recommended by 
        experts.
            (5) Increased quantities of Tamiflu can be obtained through 
        the voluntary or compulsory licensing to manufacturers other 
        than Roche, either domestic or foreign, to produce generic 
        versions of Tamiflu.
            (6) The United States Government has the authority to issue 
        compulsory licenses for the production, with reasonable 
        compensation to the rights holder, if any voluntary licenses 
        negotiated by Roche are insufficient to meet United States 
        public health needs.
            (7) India, China, Taiwan, Thailand, Malaysia, Vietnam, the 
        Philippines, South Korea, and Argentina are among the countries 
        considering plans to manufacture versions of Tamiflu to prepare 
        for a possible flu pandemic.
            (8) World Trade Organization rules allow for countries with 
        insufficient manufacturing capacity in the pharmaceutical 
        sector to import pharmaceutical products produced under 
        compulsory license in other countries in order to meet public 
        health needs.
            (9) The United States Government voluntarily relinquished 
        the right of the United States to import pharmaceutical 
        products produced under a compulsory license when it requested 
        that the United States be included in a list of countries 
        ineligible to import under World Trade Organization rules 
        (pursuant to the ``General Council Chairperson's Statement'' 
        accompanying the Decision of the General Council (of the World 
        Trade Organization) of August 30, 2003, on ``Implementation of 
        paragraph 6 of the Doha Declaration on the TRIPS Agreement and 
        public health'').
            (10) By reversing its decision to waive the right of the 
        United States to import pharmaceutical products produced under 
        compulsory license, the United States Government could gain 
        access to new sources of supply of Tamiflu in order to 
        stockpile sufficient quantities to prepare for a potential flu 
        pandemic.

SEC. 2. ASSERTING RIGHT TO IMPORT PHARMACEUTICALS PRODUCED UNDER 
              COMPULSORY LICENSE.

    The United States Trade Representative shall inform the General 
Council of the World Trade Organization that the United States--
            (1) declares itself an ``eligible importing member'' for 
        the purpose of being able to import pharmaceutical products 
        pursuant to the Decision of the General Council of August 30, 
        2003, on ``Implementation of paragraph 6 of the Doha 
        Declaration on the TRIPS Agreement and public heath''; and
            (2) withdraws its name from the list, contained in the 
        ``General Council Chairperson's Statement'' accompanying the 
        Decision of the General Council of August 30, 2003, of 
        countries that voluntarily relinquished the right to import 
        pharmaceutical products manufactured under compulsory licenses.

SEC. 3. AUTHORITY TO IMPORT PHARMACEUTICAL PRODUCTS MEET PUBLIC HEALTH 
              NEEDS.

     The President is authorized to import pharmaceutical products 
manufactured under a compulsory license to meet public health needs or 
to address situations of inadequate supply caused by insufficient 
domestic manufacturing capacity, in accordance with the Decision of the 
General Council of the World Trade Organization referred to in section 
2(1). Such imported pharmaceutical products shall be subject to the 
Federal Food, Drug, and Cosmetic Act.
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