Month: May 2012

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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During the week of 14 May 2012, the Republic of Kenya submitted a resolution to the 65th session of the World Health Assembly entitled, “WHO Convention on Research and Development Financing and Coordination”. The resolution will be published by the World Health Organization (WHO) as a conference paper for discussion in Committee A under agenda item 13.14 Consultative Expert Working Group on Research and Development: Financing and Coordination. It is expected that this agenda item on the CEWG will be brought forward for early discussion at the Assembly.

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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

/prizes
/hiv
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The World Intellectual Property Organization (WIPO) will convene the 18th session of the WIPO Standing Committee on the Law of Patents (SCP) from 21 May 2012 to 25 May 2012 (during the same week as the 65th session of the World Health Assembly). The agenda of the SCP is reproduced below.

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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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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

HEARING NOTICE

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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 →

The USTR’s 2012 Special 301 list was published on April 30, 2012. Below are some comments about certain portions of the Special 301 Report that concern access to knowledge and access to medicines.

USTR cites the “TEAM” approach to access to medicines
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