- 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
United States of America Statement on Copyright Exceptions and Limitations for Persons with Print DisabilitiesSubmitted by James Love on 15. December 2009 - 9:40
World Intellectual Property Organization
Standing Committee on Copyright and Related Rights (SCCR)
December 14-18, 2009
United States of America Statement on Copyright Exceptions and Limitations for Persons with Print Disabilities
Thank you, Mr. Chairman.
The United States is proud to have a series of specific exceptions and limitations in our copyright law, including for education, libraries, and persons with print disabilities.
On Monday, December 14, the UNITAID board passed a resolution to establish a Patent Pool for AIDS medicines. The decision caped a dramatic debate on the proposal, which had been before UNITAID since 2006, and had been discussed in other fora since 2002. The following is a statement by KEI on the UNITAID decision, followed by background on the UNITAID patent pool proposal, including a copy of the UNITAID press release.
Statement of James Love, Director of KEI, on the UNITAID Patent Pool:
This is day one of a five day meeting of the WIPO SCCR, being held in Geneva. The main topic of discussion this week will be copyright limitations and exceptions.
New Ad Hoc Observers for the WIPO Standing Committee on Copyright and Related Rights (Dec.14-18, 2009)Submitted by Manon Ress on 9. December 2009 - 11:00
There will be new participants at the WIPO Standing Committee on Copyright and Related Rights (Nineteenth Session) Geneva, December 14 to 18, 2009.
Here is the lists of non-governmental organizations, which have requested to be granted observer status in sessions of the Standing Committee on Copyright and Related Rights (SCCR), according to SCCR’s Rules of Procedure (see document SCCR/1/2, paragraph 10).
- African Union of the Blind (AFUB)
- All India Confederation of the Blind (AICB)
- Asociación Civil Tiflonexos – Biblioteca Tiflolibros (Tiflolibros),
On Tuesday, December 8, 2009 at 10:42PM (EST), the site Wikileaks, posted this pithy entry on Twitter: "Big Pharma infiltrates WHO Expert Working Group process; WikiLeaks infiltrates Big Pharma".
Dec 7, 2009 letter from Ambassador Kirk to Senator Sanders and Brown on ACTA transparency, says nothing newSubmitted by James Love on 8. December 2009 - 20:44
On December 7, 2009, Ambassador Ron Kirk faxed a two page letter to Senator Bernie Sanders. (Page 1, Page 2). The letter made no concessions, and broke no new ground, as USTR continues to stonewall its critics on the transparency issue.
Kirk was responding to this November 23, 2009 letter from Senators Sanders and Brown to Kirk.
In a letter to the European Commission defending the Oracle acquisition of MySQL, Eben Moglen makes the following argument.
In a recent statement to Wired, USTR tried to justify the secrecy of the ACTA negotiations as follows:
The Administration also recognizes that confidentiality in international negotiations among sovereign entities is the standard practice to enable officials to engage in frank exchanges of views, positions, and specific negotiating proposals, and thereby facilitate the negotiation and compromise that are necessary to reach agreement on complex issues.
1 Meredith Filak
2 Malini Aisola, Knowledge Ecology International, and Meredith Filak
3 Pablo Lecuona, Tiflolibro
4 Brad Huther, U.S. Chamber of Commerce
5 Dan Pescod, Royal National Institute of Blind People
6 Nirmita Narasimhan, Centre for Internet and Society
7 Margaret Chase, Radio Reading Service
8 Robert Martinengo, Center for Accessible Publishing
9 Steven M. Rothstein, Perkins School for the Blind
10 Harold Martin, WVTF Public Radio
A KEI FOIA request for these seven documents was denied on the grounds of national security. (Links to March 2009 news storied about this here). You decide if these seven documents present a risk to the national security of the United States, or if the White House has been misusing the national security exception to avoid a public debate on public policy issues relating to the enforcement of intellectual property rights:
Sign-on Letter for Amendment 2858 Ethical Pathway for Generic Pharmaceutical Products, 111th CongressSubmitted by James Love on 5. December 2009 - 17:14
This sign-on letter has been closed
Senator Bernie Sanders (I-VT) has submitted the amendment 2858 to the health reform bill, to create an Ethical Pathway for the registration of generic medicines.
For background on the substance and rationale, I have a short blog describing the amendment here http://keionline.org/node/707.
December 4, 2009
Associate Register for Policy &
U.S. Copyright Office
Re: Notice of Inquiry and Request for Comments
on the Topic of Facilitating Access to Copyrighted
Works for the Blind and Other Persons with Disabilities
Attached are several reply comments to the Copyright Office and the USPTO regarding the WIPO draft proposal to facilitate access to copyrighted works for persons, who are blind or have other reading disabilities, in response to the Federal Register Notice of October 13, 2009.
The deadline for filing was Friday, December 4, 2009. Eventually the Copyright Office will publish all of the reply comments on the Internet, and we will provide a link.
We now have comments received from various parties, including:
In 2009, the WBU and KEI have collaborated on a new pamphlet to provide background information on the proposed WIPO treaty for persons who are blind, visually impaired or have other disabilities. A PDF of the document is available here. A version in word is available here. We also have a pdf file that is more appropriate for professional printing.
Senator Sanders Amendment 2858 would replace data exclusivity with cost sharing, if new trials violate medical ethicsSubmitted by James Love on 4. December 2009 - 9:32
Senator Bernie Sanders (I-VT) has offered an amendment to the health care reform bill that would eliminate data exclusivity in cases where duplicating clinical trials involving human subjects would violate Article 20 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human subjects. The relevant article from the Declaration of Helsinki reads as follows: