- NIH rulemaking on transparency of clinical trials
- UACT sends letter to Tufts President, Chairman of Trustees, asking questions about R&D cost study
- The Winning Bet
- KEI comment on the new Tufts Study on Drug Development Costs
- What to look for in the new Tufts study on drug development costs. 10 issues.
- Research note on oncology drugs, including trial size and orphan drug status
- KEI Research Note: Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results
- Former WTO Director-General, Pascal Lamy, mooted to chair Global Fund's Equitable Access Initiative
- WIPO patent committee engaged in heated talks on work sharing, limitations & exceptions, client confidentiality
- WIPO patent committee (SCP21): Intervention of KEI on Patents and Health
In a somewhat unexpected and encouraging ruling, on April 12, 2011, the District Court for the District of Columbia rejected USTR claims that the release of certain documents relating to a trade negotiations can be shielded from the FOIA.
The case involves a FOIA dispute between the Center for International Environmental Law (CIEL) and the the United States Trade Representative's (USTR) over documents revealing the US negotiating position on the Investment Chapter in the proposed Free Trade Agreement of the Americas (FTAA).
Confirmation that Obama Administration was "lone hold out" for releasing bracketed ACTA text to the public in Summer of 2010.Submitted by KEI Staff on 25. April 2011 - 15:49
On July 1, 2010, William Yue, the Senior Counsel, Office of the Chief Counsel for International Commerce at the US Department of Commerce, wrote to Joel Blank and John Cobau about the ACTA negotiations. John Cobau was the Chief Counsel for International Commerce at the U.S. Department of Commerce, and Joel Blank was International Attorney-Advisor at US Department of Commerce.
A redacted version of this email was the only document released to KEI as part of a larger FOIA request concerning the Department of Commerce role in the ACTA negotiations. A copy is available here:
Ambassador Kirk's responses to Senate Finance Committee suggests enforcement of TRIPS-plus data exclusivity measuresSubmitted by Krista Cox on 25. April 2011 - 9:41
Recently, Ambassador Ron Kirk, the United States Trade Representative (USTR) responded to follow up questions from the U.S. Senate Finance Committee regarding the 2011 Trade Agenda. In addition to asserting that the U.S. Congress is not bound by ACTA, the responses suggest USTR desire to establish requirements for the implementation of data exclusivity provisions.
Six NGOs, including Knowledge Ecology International (KEI), Medecins Sans Frontieres (MSF), Oxfam, Third World Network (TWN), Universities Allied for Essential Medicines (UAEM), and Young Professionals Chronic Disease Network (YP-CDN), recently submitted recommendations to Member States to control non-communicable diseases (NCDs) in low- and middle-income countries in advance of the Moscow Ministerial conference.
A PDF of the joint statement with logos of the groups is available here:
On August 7, 2008, Stewart Baker, the Assistant Secretary for Policy at the Department of Homeland Security, sent a one page letter and a three page "Policy Position on Border Measures of the Anti-Counterfeiting Trade Agreement."
Stewart Baker was the General Counsel of the National Security Agency from 1992 to 1994, and was appointed the first Assistant Secretary for Policy at the Department of Homeland Security (DHS) by George W Bush.
KEI just received the attached letter from the Executive Office of the President's Office of the United States Trade Representative (USTR) rejecting our appeal of USTRs decision to withhold a study by the Library of Congress' Congressional Research Service on ACTA that was done for Senator Wyden.
US Congress is not bound by ACTA, according to White House answers to Senate Finance on ACTA and TPP negotiationsSubmitted by James Love on 19. April 2011 - 12:16
Ambassador Ron Kirk holds the office of United States Trade Representative (USTR) in the White House. On March 9, 2011, he testified before the US Senate Finance Committee on the 2011 Trade Agenda. Several members of the Committee provided follow up questions, and Ambassador Kirk has answered them. A full copy of the responses are available here:
15 April European Union proposal: 3 to 5 year delay in negotiations on a copyright treaty for blind personsSubmitted by James Love on 18. April 2011 - 17:22
Attached is a PDF of the proposal by the European Union that was presented at the April 15, 2011 informals in Geneva, held at the US Embassy. The European Union now proposes that WIPO adopt a soft non-binding recommendation on cross border sharing of accessible works, and then monitor progress on the issue for 3 to 5 years.
Notes from April 13, 2011 EBU/TACD/IFLA, EDA event at European Parliament on WIPO treaty for the blindSubmitted by James Love on 15. April 2011 - 11:02
Today there will be a presentation at the European Parliament on the Health Impact Fund. Below are a few earlier KEI blogs about the HIF.
April 2011 report on negotiations for a WIPO copyright treaty for persons who are blind or have other disabilitiesSubmitted by James Love on 6. April 2011 - 23:12
KEI Research Note 2011:1
April 7, 2011
Background and update on negotiations for a WIPO copyright treaty for persons who are blind or have other disabilities
Although domestic law in the US provides for certain exceptions and limitations from infringement of copyright for the production of accessible works for the visually impaired, as well as importation and exportation of these materials, the law is ambiguous and insufficient in allowing non-profit entities or government agencies to export these works.
Attached below are two PDF files that were used in my presentation today at the 1st meeting of the World Health Organization (WHO). I did not following the text that closely. The WHO is making a video of all of the presentations, which will be made available later.
On Monday, April 4, 2011, a panel of three Federal Circuit judges heard oral arguments about the patentability of the BRCA 1/2 gene claims in American Molecular Pathology, et. al, v. U.S. Patent and Trademark Office, et. al.. The panel included Judge Lourie, Judge Bryson and Judge Moore. Gregory Castanias from Jones Day argued for Myriad's position, defending the DNA claims while Chris Hansen of the ACLU argued against the patentability of the claims. The U.S.