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Governments can ration access to cancer drugs, or break patent monopolies. Why is rationing so popular?:

WIPO General Assembly 2014: Opening statement of the United States broaches IGC, broadcasting treaty and copyright L&Es

On Monday, 22 September 2014, Ambassador Pamela Hamamoto delivered this opening statement on behalf of the United States at the 2014 WIPO General Assembly.

Ten years on from the launch of the Development Agenda by Argentina and Brazil in 2004, the Obama administration expressed the following views on the Development Agenda:

WIPO General Assembly 2014: Asia Pacific Group charts its position on Broadcast Treaty, Design Law Treaty and copyright L&Es

On Monday, 22 September 2014, Bangladesh delivered the following statement on behalf of the Asia Pacific Group. Here below is the Group's position on WIPO's normative work including copyright limitations and exceptions for libraries and archives, copyright limitations and exceptions for educational and research institutions and persons with other disabilities, the proposed Design Law Treaty, the proposed broadcasting treaty and proposed instruments for the protection of genetic resources, traditional knowledge and traditional cultural expressions.

Biden presses Colombia to block biosimilar drugs

vp_portrait.jpegOn September 8, 2014, Vice President Joe Biden wrote to Juan Manuel Santos Calderón, the President of Colombia. In the letter, Biden registered a complaint about the regulations in Colombia to register biosimilar drugs. A copy of the letter from Vice President Joe Biden is available here, and includes this quote:

WIPO's new Senior Management Team: New faces for Copyright, Development, Global Issues and Patents

A long standing parlor game for WIPO insiders and observers during the summer of 2014 involved guessing the composition of WIPO's new Senior Management Team (the team of deputy director generals and assistant director generals who form WIPO's cabinet). On 16 September 2014, the WIPO secretariat laid this to rest by revealing the composition of the new WIPO Senior Management Team of deputy director generals and assistant director generals. New faces in the cabinet include: Mr.

The Gilead HCV license: Glass half empty, or half full?

On Monday, September 15, 2014, Gilead announced licensing agreements with 7 generic drug manufacturers, for two of its HCV drugs, including sofosbuvir, which is currently the most important HCV drug, and the basis for Gilead’s value to shareholders. KEI's statement from Monday, and links to other NGO comments are here:

KEI welcomes the Gilead HCV licenses, as a step to expand access to treatments. Notes challenges that remain

Today Gilead announced it will provide seven generic drug manufacturers licenses to make and sell two drugs that are used in combination to treat the Hepatitis C Virus (HCV) in 91 developing countries.

Senator Wyden in 2012, on access to the TPP text

In 2012, as a member of the Senate Finance Committee, Senator Ron Wyden was a strong advocate for providing the public with access to the TPP negotiating text. Now, as Chairman, the Senator has been silent on the public's right to the text. This is an example of Wyden in 2012. Has his position changed?

Timestamp and notes on Wyden comments on need for transparency in TPP

WIPO General Assembly 2014: Hard Decisions on the Broadcast Treaty and work program on copyright limitations and exceptions

In the piece, WIPO General Assembly 2014: Hard Decisions on the Design Law Treaty and Treaty for Protection of Genetic Resources (22 July 2014), KEI highlighted the hard decisions awaiting the WIPO General Assembly (22 September 2014 to 30 September 2014) with respect to the Design Law Treaty, the imminent revision of the Lisbon Agreement to include geographical indications and WIPO's work to conclude an instrument for the protection of genetic resources, traditional knowledge and folklore.

13 May 2014: WHO Technical Consultation on Innovative Models for New Antibiotics’ Development and Preservation

In a concerted bid to contain the emerging threat posed by antibiotic resistance, in May 2014, the World Health Organization's (WHO) 67th World Health Assembly (WHA) passed WHA resolution 67.25 on "Antimicrobial resistance" instructing the WHO to "develop a global action plan to combat antimicrobial resistance" by May 2015 (Source: WHO page on Draft Global action plan on antimicrobial resistance).

TDR and the Pooled Fund for R&D: WHO demonstration projects and CEWG follow-up

In May 2014, the World Health Organization's (WHO) 67th World Health Assembly (WHA67) passed decision WHA67(15) setting the stage for the creation of a new pooled funding mechanism for R&D.

OMB's Revised Guidance on Appointment of Lobbyists to Federal Advisory Committees, Boards, and Commissions

Following litigation by several lobbyists, OMB is revising its guidance on the appointment of lobbyists to federal advisory committees, boards, and commissions. Now, lobbyists can serve on these committees, including the USTR advisory boards. Money quote:

CPTech's 2003 reports for the RSA Competition Commission, in Hazel Tau et al.v GSK, Boehringer, et al

On August 13, 2014, the Republic of South Africa (RSA) Competition Commission (CC) released the redacted versions of the reports provided to the CC by CPTech in 2003 in the TAC competition case involving GSK and Boehringer Ingelheim. A complete set of the documents is available here, and links to individual documents are listed below.

Gilead's US patient access programs for Sovaldi

This is a note on Gilead run or funded programs that are available for patients residing in the United States.

Recently, Gilead's new hepatitis C drug, Sovaldi, has received much attention and criticism for its high price of $1000 a day.

Some recent cancer drug prices

Attached are two annexes from our 2014 USTR Special 301 comments

Money speaks: USTR releases letters from Congress backing PhRMA on exclusive rights biologic test data in TPP

As part of a partial response to FOIA request, USTR has provided KEI with copies of 13 letters sent by members of Congress, from July 27, 2011 to August 8, 2013, on the topic of biologic drug test data provisions in the TPP negotiation. We had obtained several but not all of these letters earlier from a variety of sources, including from PhRMA's web page -- where some had been proudly displayed. (See link below).

Were there letters on the other side? Yes, three. (see below).

With the FOIA request, we have also obtained the responses to the letters.

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