- 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
Apparently it is now down to seven final candidates to be the new US Register of Copyrights. These include two employees of the Copyright Office (Carson and Kasunic), a lawyer in private practice (Fries), a full time professor (Brauneis), a professor/USPTO negotiator (Hughes), a trade negotiator (McCoy), and a representative of a trade association (Perlmutter). By gender, the finalists are two women, and five men.
They are, in alphabetical order:
WBU suspends participation in WIPO & EU Stakeholder discussions, pending agreement at WIPO on legal frameworkSubmitted by James Love on 27. February 2011 - 15:15
On February 26, 2011, the World Blind Union issued a statement announcing it would "suspend participation in the WIPO Stakeholder Platform and EU Stakeholder Dialogue projects, pending agreement at WIPO on a proper binding legal framework." [See full statement below]. The WBU statement is expected to dramatically change the environment for considering a new WIPO treaty for persons who are blind or have other disabilities.
Congressional Research Service reports are prepared in response to requests from members of congress. For decades, right to know groups have been asking that they be available online. The CRS describes itself as follows:
On 15 February 2011, the Co-Chairs of the WHO Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits (OEWG) held a consultation with civil society. The Co-chairs of the OEWG are Ambassador J. Gomez-Camacho, Mexico and Ambassador B. Angell-Hansen, Norway.
Four Green/EFA MEPs (from four parties and four countries) have asked a follow-up question on ACTA and the Vienna Connection, trying to get at the "is the US bound?" issue.
Greens/EFA MEPs Christian Engström, Judith Sargentini, Sandrine Beliér and Jan Albrecht have asked the European Commission this follow-up question on ACTA and Vienna Convention:
On 4 February 2011, WikiLeaks passed on to the UK newspaper, The Telegraph, a cable dated 1 November 2007 from the US Embassy in London entitled "UK AGREES WITH US APPROACH TO UPCOMING WHO INTERGOVERNMENTAL WORKING GROUP ON PUBLIC HEALTH, INNOVATION, AND IP" signed by "LEBARON".
De Gucht responds to MEP Françoise Castex. Says ACTA is binding agreement, consistent with EU 'acquis'Submitted by James Love on 7. February 2011 - 10:44
At the end of the month, Judit Rius will be leaving KEI and joining MSF in New York as U.S. Manager of MSF's Campaign for Access to Essential Medicines. Judit has been with KEI since 2006, and from the beginning, contributed greatly to nearly every aspect of KEI's work. We will miss her a lot. At MSF, Judit will work closely with another talented former KEI lawyer, Michelle Childs. We wish Judit well in her new position, and congratulate MSF on the appointment.
Today, Tibotec, a subsidiary of Johnson & Johnson, announced it has signed voluntary licensing agreements with several Indian and South African generic companies to allow generic competition on a new HIV-AIDS treatment, the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278) (rilpivirine hydrochloride), to certain developing countries.
The following is an article by Agathe Duparc which appeared on page four of the Sunday/Monday edition (23 January-24 January 2011) of Le Monde with a reference on the cover page. Below the article are two paragraphs providing readers with more background information on the World Health Assembly and the Executive Board. The third paragraph is the main quote highlighted in the print version. What is missing in this copy below is a cartoon accompanying the piece which shows a bespectacled man with a body of an octopus holding two syringes in a field of dollar signs.
After several days of negotiations, the 128th WHO Executive Board has accepted the nomination of Paul Herrling to the new WHO Consultative Expert Working Group on R&D Financing, despite the fact that Herrling is an executive of Novartis, and is the author of the IFPMA/Novartis/FRIND proposal and the co-author of the PDP Plus proposal, which will be considered by the CEWG.
Nine civil society groups write WHO Executive Board about conflict of interest on WHO R&D Financing groupSubmitted by KEI Staff on 20. January 2011 - 10:33
On January 20, 2011, 9 civil society organizations sent a letter to the WHO Executive Board registering an objection to the selection of Dr. Paul Herrling of Novartis to the WHO Consultative Expert Working Group on Research and Development: Financing and Coordination. The groups signing the letter were:
- Déclaration de Berne - Berne Declaration
- HAI Europe
- HAI Global
- Health GAP (Global Access Project)
WHO has kindly made available its conflict of interest guidelines. Apparently they are not available from the public web page. Attached are two documents:
A few of the many interesting provisions follow:
I. MEANING OF "CONFLICT OF INTEREST"