Obligations to fund R&D, under CEWG recommendation

The World Heath Organization is now debating proposal in a report form a Consultative Expert Working Group (CEWG) on R&D for a new medical R&D treaty, focusing on the special health needs of developing countries. The following table shows how much money various regions and countries would be obligated to spend on R&D, under the treaty proposal, which is .0001 of GDP, of which 20 percent would be invested through pooled funding mechanisms.

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BIO memo opposing transparency of drug development costs, sales, prices, and clinical trial outcomes

Senator Sanders has offered an amendment to the Food and Drug Administration Safety and Innovation Act of 2012 that would require drug sponsors to disclose the costs of pre-clinical research, clinical trials and related R&D, as well as grants, economic incentives that subsidize drug development costs, and also report quarterly sales and revenues, register all clinical trials at www.clinicaltrials.gov, and report detailed descriptions of each clinical trial participant’s results.

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Statement of Sen. Bernard Sanders (I-VT) on the Mark-up of FDA Reauthorization Package

This was the 3,500 word statement of Senator Bernie Sanders during Senate HELP committee markup of the PDUFA legislation. The statement covers a lot of ground, and illustrates why consumer groups love Bernie Sanders, while making one wonder why other Senators have not been more supportive of the consumer protection issues that Sanders discusses. Here are some highlights:

  • The proposal for a new extended monopoly for antibiotics and antifungal drugs is a “huge giveaway” that will lead to high prices and harm consumers.
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WTO disputes- Intellectual property dimensions of the Boeing case (WT/DS353)

“Roma locuta causa finita est” (Rome has spoken, therefore the case has been decided) was the maxim employed by medieval jurists to describe the absolute irrevocability of papal judgements in canon law. Today, in modern international trade law, the World Trade Organization’s (WTO) Appellate Body fulfills a similar function as the international trading system’s “Supreme Court”. In the words of the WTO,

[t]he Appellate Body was established in 1995 under Article 17 of the Understanding on Rules and Procedures Governing the Settlement of Disputes (DSU). Continue Reading

Is the WHO CEWG proposal for the R&D treaty “too small”?

The WHO’s Consultative Expert Working Group (CEWG) on R&D proposal for a new WHO Convention on health R&D has been widely praised by public health groups (See https://www.keionline.org/node/1399). The CEWG proposal for a treaty has also, at least so far, avoided much criticism from the pharmaceutical industry, even though it strongly embraces the notion of delinkage of R&D costs from product prices, open innovation, and technology transfer and capacity building in developing countries. Continue Reading

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5 April 2012: World Health Organization’s Consultative Expert Working Group on R&D Financing releases its Report

On Thursday, 5 April 2012, the World Health Organization released the report of the Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination entitled “Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination”. The 218 page report will take some time to fully assess.

The report can be found here: http://www.who.int/phi/CEWG_Report_5_April_2012.pdf

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KEI letter to Steve Ricchetti, asking recusal in matters that involve former clients

On March 12, 2012, Tedmund Wan posted a note on Joe Biden’s appointment of Steve Ricchetti, exploring potential conflicts of interest with the clients in a lobbying firm that he ran. On March 29, 2012, KEI formally asked Ricchetti to recuse himself in matters concerning his former clients. The letter follows.

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29 March 2012

Steve Ricchetti
Counselor to Vice President Joe Biden
The White House
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The 2012 WIPO/Library of Congress International Copyright Training symposium for developing countries

This week WIPO and the Library of Congress are holding a week long symposium on International Copyright, with title:


Emerging Issues in Copyright and Related Rights for Developing
Countries and Countries with Economies in Transition
organized by
the World Intellectual Property Organization (WIPO)
in cooperation with
the United States Copyright Office, Library of Congress
Washington D.C., March 19 to 23, 2012

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