James Love's blog

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.

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.

My testimony for Senate HELP hearing on S.1138, the Prize Fund for HIV/AIDS

This is the latest draft of my written testimony for the May 15, 2012 Senate HELP hearings on S.1138, the Prize Fund for HIV/AIDS.

Some additional relevant data are available on the following pages


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.

Senate HELP subcommittee hearings on S.1138, the HIV/AIDS prize fund

Update: the hearing web page is here: http://www.help.senate.gov/hearings/hearing/?id=2d5dda75-5056-9502-5d1a-2a40d8a92d51

On May 15, 2012, the Primary Health and Aging Subcommittee of the Senate HELP Committee will hold hearings on S.1138, the Prize Fund for HIV/AIDS.

Primary Health and Aging Subcommittee


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 http://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.

Senate HELP Committee proposes evaluation of Innovation Inducement Prizes, as alternative to product monopolies

In the United States Senate, the Committee on Health, Education, Labor and Pensions (HELP) is trying to move forward a bill titled the "Food and Drug Administration Safety and Innovation Act." Among other things, the bill would "amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, establish user-fee programs for generic drugs and biosimilars," and address a number of other topics, such as extend the legal monopoly on antibiotic drugs by 5 years.

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

KEI Statement on India's granting of compulsory license to patents on cancer drug sorafenib (NATCO Vs. BAYER)

The India Controller General Controller General of Patents, Designs & Trade Marks has just (March 12, 2012) issued an order granting a compulsory license to patents on the cancer drug sorafenib/Nexavar, in the matter of NATCO Vs. BAYER. A copy of the decision is attached below.

What's (still) wrong with ACTA, and why governments should reject the illegitimate agreement

This is a blog about the Anti-Counterfeiting Trade Agreement (ACTA). More information is available here: http://keionline.org/acta

ACTA is an attempt to bypass multilateral institutions

IIPA Special 301 complaints regarding unauthorized copying of textbooks and other educational materials

USTR asked to use trade pressure to curtail unauthorized copying of educational materials

Size Matters: PhRMA's Special 301 picks for South America.

Every year, USTR publishes the names of countries that do not adequately protect intellectual property rights. (See http://keionline.org/ustr/special301) . Among the classifications are the Priority Watch List (PWL) and the somewhat lower status Watch List (WL).

Total expenses vs reported expenditures on lobbying, six trade associations that lobby on IPR

President Obama claims to have kept "lobbyists" off the advisory boards for USTR. The Obama Administration relies upon the narrow legal definition of those persons who register to lobby the US Congress, which excludes expenditures to direct, supervise or support the lobbyists, and expenditures of many staff and consultants who are not fully engaged in lobbying the Congress. Expenditures to influence the executive branch (including USTR) has very little if any regulation, and are not counted as lobbying.

Who USTR clears to see secret text for IPR negotiations? (Such as TPPA)

In a meeting with USTR on February 15, 2012, KEI, MSF, Oxfam and Public Citizen pressed USTR to release the negotiating text for the intellectual property rights chapter in the TPPA trade agreement negotiation. USTR said the negotiation had "unprecedented" transparency, but maintained the text needed to be secret from the general public. USTR also claimed than no one on its many advisory boards, who are cleared to see the negotiating text, were lobbyists.

KEI and Essential Inventions comments to Special 301 Committee

KEI and Essential Inventions have both filed requests to testify at the public hearing on the 2012 Special 301 Report. The comments are attached here:

KEI 2012 Comments on Special 301, in PDF or ODT

Essential Inventions 2012 Comments on Special 301, in PDF

The KEI submission follows:

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