Office of the United States Trade Representative


Fact Sheet on Access to Medicines

The United States believes that countries, under global trade rules, have and should continue to have the flexibility to have access to medicines in their fight against HIV-AIDS and other epidemics.

- The U.S. played a key role in the Doha WTO Ministerial (Nov. 2001) reaffirmation that global trade rules allow countries to decide what constitutes a health emergency and to compulsory license drugs to fight epidemics.

- At Doha, Ministers accepted a U.S. suggestion to extend the global patent rules participation period for Least Developing Countries (LDCs) from 2006 to 2016.

- Doha left unresolved how to enable poor countries without domestic production capacity to import under compulsory license from third countries drugs needed for HIV/AIDS, malaria, tuberculosis, and other infectious epidemics. When a consensus was unreachable by the end of 2002 target, the U.S. issued a unilateral moratorium on dispute settlement cases until a consensus was reached. The U.S. pledged not to challenge poor countries who override patents on drugs produced outside their countries in order to fight HIV/AIDS, malaria, tuberculosis, and other types of infectious epidemics, including those that arise in the future.

- In August of 2003, the U.S. fully supported the consensus reached that allows poor countries without domestic capacity to compulsory license the drugs needed to combat diseases such as HIV/AIDS, malaria, tuberculosis and other infectious epidemics.

Intellectual property rules provide the broad framework to protect innovation – exceptions may be appropriate for health crises but should not become the “rule.”

• Global rules on intellectual property are a relatively small part of the larger issue of developing country healthcare. To date, no WTO member has availed itself of the flexibilities under TRIPS to issue a compulsory license for drugs.

The WTO sets basic global trade rules and standards for 148 diverse economies. US FTAs are comprehensive, cutting edge agreements that “free trade” by opening markets and promoting economic development and prosperity.

• Our FTAs will not affect a country’s ability to take measures necessary to protect public health.

- By protecting IP, FTAs, like the U.S.-Jordan FTA, encourage local pharmaceutical industries. Furthermore, since the U.S.-Jordan FTA, there have been over 30 new, innovative product launches in Jordan.

- The Doha Declaration noted several flexibilities for addressing public health crises, including, for example the ability to issue compulsory licenses.

- The FTAs we have negotiated similarly contain the flexibility needed in order to address public health crises. For example, the provisions on compulsory licenses allow licenses to be issued to address national emergencies or for noncommercial public use. In fact, several of our FTAs (including Chile, CAFTA, Morocco and Bahrain) do not contain any obligations with respect to compulsory licenses.

• The United States is a leader in the global fight against HIV/AIDS and other infectious diseases.

- The President has significantly increased funding for Global HIV/AIDS, Tuberculosis and Malaria from $840 million in FY 2001 to a request of $2.8 billion in FY2005 -- more than triple the U.S. investment in 2001.

- In his 2003 State of the Union Address, President Bush announced the Emergency Plan for AIDS Relief, a five year, $15 billion initiative to turn the tide in the worldwide effort to combat HIV/AIDS. This year, the United States is spending $2.4 billion through that plan.

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