I 
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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. FINDINGS. 
The Congress finds the following: 
(1) The World Health Organization has rec-
ommended 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 Gov-
ernment 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 manu-
facturer based in Switzerland. 
(4) Roche has insufficient manufacturing capac-
ity 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 ob-
tained 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 au-
thority to issue compulsory licenses for the produc-
tion, 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 Argen-
tina 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 compul-
sory 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’’ ac-
companying 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 prod-
ucts 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 mem-
ber’’ for the purpose of being able to import phar-
maceutical products pursuant to the Decision of the 
General Council of August 30, 2003, on ‘‘Implemen-
tation 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 relin-
quished the right to import pharmaceutical products 
manufactured under compulsory licenses. 
SEC. 3. AUTHORITY TO IMPORT PHARMACEUTICAL PROD-
UCTS 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 inad-
equate supply caused by insufficient domestic manufac-
turing 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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