James Love's blog
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 outcomesSubmitted by James Love on 21. May 2012 - 6:49
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.
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.
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.
COMMITTEE ON HEALTH, EDUCATION, LABOR AND PENSIONS
Primary Health and Aging Subcommittee
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 monopoliesSubmitted by James Love on 25. April 2012 - 2:48
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 countriesSubmitted by James Love on 21. March 2012 - 9:29
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
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)Submitted by James Love on 12. March 2012 - 2:40
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.
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 materialsSubmitted by James Love on 25. February 2012 - 17:54
USTR asked to use trade pressure to curtail unauthorized copying of educational materials
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).
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.
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.