Knowledge Ecology International

In 2011, the FDA told the NIH it could use enforcement discretion to permit importation and sale of unregistered drugs

In 2011, in the context of a shortage of Fabrazyme, the FDA told the NIH if they could “in theory” allow Shire to import and sell Replagal, a drug approved for sale in Europe, but not in the United States, as an unregistered biologic substitute. The remedy explored for the Fabrazyme shortage may be the best way to address a different problem, the price gouging associated with the drug Daraprim (generic name: pyrimethamine).

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Statement of KEI on announcement that there is a consensus on the Trans Pacific Partnership (TPP) trade agreement
October 5, 2015, 10am, EST

These comments by James Love, KEI Director

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On Monday, 5 October 2015, Brazil delivered the following opening statement on behalf of the Group of Latin and the Caribbean Group (GRULAC) at the World Intellectual Property Organization’s (WIPO) General Assembly.

Statement Delivered by the Delegation of Brazil on behalf of GRULAC

“Mr President,

1. I have the honor to deliver this statement on behalf of the Latin American and the Caribbean Group (GRULAC).

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October 2, 2015
FOR IMMEDIATE RELEASE
CONTACT: Zack Struver
+1 (202) 332-2670
zack.struver@keionline.org

Seven House Members Push U.S. Trade Representative to Support Indefinite Waiver on Pharmaceutical Patents for Least Developed Countries (LDCs)

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Knowledge Ecology International Press Release
28 September 2015
FOR IMMEDIATE RELEASE
CONTACT: Zack Struver
+1 (202) 332-2670
zack.struver@keionline.org

Senator Bernie Sanders asks USTR to endorse “indefinite waiver” of WTO requirements to grant drug patents for Least Developed Countries (LDCs)

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Knowledge Ecology International sent letters today (attached to this release), September 21, 2015, to the Office of the General Counsel to the United States Trade Representative (USTR) and the Office of the Inspector General for the Department of Commerce, asking that they investigate USTR and the United States Patent and Trademark Office (USPTO) for the potential violation of an Executive Order issued by Bill Clinton — which prohibits the use of trade pressures to hinder polices related to access to HIV/AIDS medicines in sub-Saharan Africa — in their attempt to stop a request by Least Develop Continue Reading →

On September 28, 2012, nearly three years ago, KEI submitted a FOIA request to USTR for “all documents relating to the World Health Organization (WHO) consideration of an agreement or treaty to support medical R&D.”

Three years later USTR has released 89 pages of documents, with some redactions. But USTR also withheld 64 documents pursuant to FOIA exemption 552(b)(5) and three documents pursuant to FOIA exemption 552(b)(1).

• USTR Cover letter

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