S.Amdt. 650

1. Rewrites page 54, lines 7–24

   ReplacesPrinted page

   Removes page 54, lines 7–24 of the printed bill. See that page

   Inserted: medicines to treat opportunistic infections, at the lowest possible price for products of assured quality (as provided for in subparagraph (D)). Such procurement shall be made anywhere in the world notwithstanding any provision of law restricting procurement of goods to domestic sources.

   Inserted: "(B) Mechanisms for quality control and sustainable supply.--Mechanisms to ensure that such HIV/AIDS pharmaceuticals, antiviral therapies, and other appropriate medicines are quality-controlled and sustainably supplied.

   Inserted: "(C) Distribution.--The distribution of such HIV/AIDS pharmaceuticals, antiviral therapies, and other appropriate medicines (including medicines to treat opportunistic infections) to qualified national, regional, or local organizations for the treatment of individuals with HIV/AIDS in accordance with appropriate HIV/AIDS testing and monitoring requirements and treatment protocols and for the prevention of mother-to-child transmission of the HIV infection.

   Inserted: "(D) Lowest possible price and assured quality.--

   Inserted: "(i) Lowest possible price.--With respect to an HIV/AIDS pharmaceutical, an antiviral therapy, or any other appropriate medicine, including a medicine to treat opportunistic infections, the lowest possible price means the lowest price at which such medicine (which includes all products of assured quality with the same active ingredients) may be obtained in sufficient quantity in either the United States or elsewhere on the world market.

   Inserted: "(ii) Assured quality.--An HIV/AIDS pharmaceutical, an antiviral therapy, or any other appropriate medicine, including a medicine to treat opportunistic infections, shall be considered a product of assured quality if it is--

   Inserted: "(I) approved by the Food and Drug Administration;

   Inserted: "(II) authorized for marketing by the European Commission;

   Inserted: "(III) on the most recent edition of the list of HIV-related medicines prequalified for procurement by the World Health Organization's Pilot Procurement Quality and Sourcing Project; or

   Inserted: "(IV) during the period that begins on the date of enactment of this section and ending on December 31, 2004, authorized for use by the national regulatory authority of the country where the product will be used.

   Inserted: "(iii) Intellectual property protections.--An HIV/AIDS pharmaceutical, an antiviral therapy, or any other appropriate medicine, including a medicine to treat opportunistic infections, at the lowest possible price may include any product in compliance with--

   Inserted: "(I) the intellectual property laws of the country where the product is manufactured;

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   Inserted: "(II) the intellectual property laws of the country where the product will be used; and

   Inserted: "(III) applicable international obligations in the field of intellectual property, to the extent consistent with the flexibilities provided in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as interpreted in the Declaration on the TRIPS Agreement and Public Health, adopted by the World Trade Organization at the Fourth Ministerial Conference at Doha, Qatar on November 14, 2001.

   Inserted: "(iv) Prices publicly available.--Prices paid for purchases of HIV/AIDS pharmaceuticals, antiviral therapies, and other appropriate medicines, including medicines to treat opportunistic infections, of assured quality shall be made publicly available.

   Inserted: "(v) Application to appropriated funds.--Funds appropriated under title IV of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 that are used for the procurement of HIV/AIDS pharmaceuticals, antiviral therapies, and other appropriate medicines, including medicines to treat opportunistic infections, shall be used to procure products of assured quality at the lowest possible price, as determined under this subparagraph.

   Original wording

   On page 54, strike lines 7 through 24, and insert the following: “medicines to treat opportunistic infections, at the lowest possible price for products of assured quality (as provided for in subparagraph (D)). Such procurement shall be made anywhere in the world notwithstanding any provision of law restricting procurement of goods to domestic sources.

Read automatically from the Congressional Record. Check the original before relying on it.

As printed