[e-drug] Congress members urge USTR to respect Thai CL efavirenz

[e-drug@healthnet.org]

E-DRUG:   Congress members urge USTR to respect Thai CL efavirenz
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[from IP-health.  Thanks Dr Bala for passing it on]

Twenty-two members of the U.S. House of  Representatives yesterday sent a letter to U.S. 
Trade Representative Susan Schwab asking USTR not to interfere in Thailand's decision to issue a 
compulsory license on the AIDS drug efavirenz.

The letter states:
"We are writing to urge that the United States respect the decision of the Thai government to issue a compulsory license on the AIDS drug efavirenz. . . Unfortunately, it is our understanding that theUnited States government may be attempting to intervene in the Thai government's decision to issue and implement the compulsory license for efavirenz. As you are aware, the Trade Promotion Authority Act of 2002 mandates that United States trade policy respect other nations' public health initiatives under Doha. We therefore call on you to respect the rights of Thailand and other nations to implement important and permitted public health safeguards."
  
The letter is signed by Representatives Tom Allen, Sander Levin, Henry Waxman, Jim McDermott, 
Fortney Pete Stark, John Lewis, James Moran, Lloyd Doggett, Earl Blumenauer, Charles Gonzalez, Betty McCollum, Linda Sanchez, Carolyn Maloney, Hilda Solis, Dennis Kucinich, Barbara Lee, Michael Michaud, Loretta Sanchez, Janice Schakowsky, Maxine Waters, John Tierney, and James McGovern.

The full text of the letter follows:

The Honorable Susan C. Schwab
United States Trade Representative
600 17th Street, NW
Washington, DC 20508

Dear Ambassador Schwab:

We are writing to urge that the United States respect the decision of the Thai government to issue a compulsory license on the AIDS drug efavirenz.  Thailand's HIV/AIDS treatment initiative has been recognized as among the most successful in the developing world.  By producing 
generic first-line antiretroviral (ARV) therapies since before the medicines were patented in the 
country, Thailand's Government Pharmaceutical Organization (GPO) has made treatment widely 
accessible to tens of thousands of patients in government clinics and hospitals. 

However, increasing numbers of Thai HIV/AIDS patients need access to newer, second-line treatment options because they have developed resistance to, or severe side effects from, the 
first-line regimens. Because second-line drugs, including efavirenz, are under patent in Thailand, they are currently only available from their brand name producers.  The high price of these medicines has created a significant obstacle to the expansion and sustainability of the Thai program.  Thailand's November 29 announcement of its intent to issue a government-use compulsory license on efavirenz is a demonstration of its commitment to improve treatment options for the nearly 600,000 Thai citizens living with HIV.(1) As has been demonstrated in many other contexts, the availability of generics greatly lowers the price of HIV drugs over time and increases access to these life-savings medications.

  Further, Thailand's action is entirely consistent with internationaltrade rules.  The World Trade Organization's 1994 Agreement on Trade Related Aspects of Intellectual Property (TRIPS) specifically permits compulsory licensing, and the 2001 Doha Declaration reaffirmed eachcountry's "freedom to determine the grounds upon which such licenses are granted."(2) Under TRIPS, Thailand is not required to negotiate in advance with the patent holder because the drug will be produced in the near-term future by the GPO and distributed for non-commercial public use by Thailand's national program.(3)

Unfortunately, it is our understanding that the United States government may be attempting to 
intervene in the Thai government's decision to issue and implement the compulsory license for 
efavirenz.  As you are aware, the Trade Promotion Authority Act of 2002 mandates that United States trade policy respect other nations' public health initiatives under Doha.(4) We therefore call on you to respect the rights of Thailand and other nations to implement important and permitted 
public health safeguards.

Sincerely,

[Signed by members listed above]

(1)  Bureau of AIDS, TB, and STI, Department of 
Disease Control, Thailand Ministry of Public 
Health, www.aidsthai.org.
(2)  Paragraph 5(b), 'Declaration on the TRIPS 
Agreement and Public Health', WTO Ministerial 
Conference - Fourth Session, WT/MIN(01)/DEC/2, 20 
November (2001).
(3) World Trade Organization, Agreement on 
Trade-Related Aspects of Intellectual Property 
Rights (1994), Article 31.
(4)  U.S. Trade Promotion Authority Act (P.L. 
107-210), August 6, 2002 § 2102(b)(4)(C)