109 HR 4392 IH: To provide for the importation of pharmaceutical products under a compulsory license as provided for under the World Trade Organization. U.S. House of Representatives 2005-11-18 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 109th CONGRESS 1st Session H. R. 4392 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.

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.

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.

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.