WHO releases program of work and progress report in advance of Consultative Expert Working Group on R&D (2-4 May 2016)

The World Health Organization (WHO) is convening an open-ended meeting of member states on the Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) in Geneva, Switzerland at WHO headquarters from 2 May 2016 to 4 May 2016. The WHO has published the provisional agenda, the proposed program of work and progress report. Continue Reading

Letter to HHS and NIH regarding impact of high prices on cost effectiveness of Xtandi

KEI submitted the attached letter to Secretary Burwell and Director Collins in support of the KEI/UACT petition that asked the NIH (or the Army) to use the federal government rights in the patents on the prostate cancer drug Xtandi, to remedy the excessive and discriminatory price in the United States. The letter calls attention to findings of an article from the the Journal of Oncology Pharmacy Practice, in which the authors conclude that a reduction in price would make Xtandi the most-cost effective option.

The text of the letter follows:

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KEI comment on WIPO report on patents landscape for the WHO essential medicines list

This is a comment on the WIPO- commissioned report on the patent landscape for the WHO essential medicines list, published on April 11th, 2016. The report is titled: Patent-based Analysis of the World Health Organization’s 2013 Model List of Essential Medicines, by Reed F. Beall and Amir Attaran, both at the University of Ottawa, Canada. This is is the third collaboration between WIPO’s Thomas (Tom) Bombelles (Head, Global Health, WIPO) and Attaran on the same topic — the patenting of medicines in developing countries.

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The 2016 Tufts estimates of the risk adjusted out-of-pocket costs to develop a new drug.

Draft, revised April 12, 2016.

2015:4 KEI Briefing Note: The Tufts estimates of the risk adjusted out-of-pocket costs to develop a new drug.
April 12, 2016
James Love

This is a briefing note on the 2016 Tufts study titled: Innovation in the pharmaceutical industry: New estimates of R&D costs, co-authored by three industry consultants, Joseph A. DiMasi, Henry G. Grabowski and Ronald W. Hansen. [J.A. DiMasi et al. Journal of Health Economics 47 (2016)].

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2016: Great Lakes Neuroscience and NIH exclusive license on MS/ALS patent

The following is the KEI comment to the NIH proposed exclusive license to Great Lakes Neuroscience for a patent on Multiple Sclerosis, Amyotrophic Lateral Sclerosis and certain other CNS Disorders. (PDF version here). KEI asks the NIH for certain information about the proposed license, and also asks the NIH to include provisions in the license that protect consumers in both the United States and developing countries.

For the United States, KEI asks that prices be:

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7 April 2016: Keynote address of Minister Rob Davies (South Africa) to WIPO International Conference on IP and Development

On Thursday, 7 April 2016, Dr. Rob Davies, Minister of Trade and Industry of South Africa, delivered a keynote address at the World Intellectual Property Organization’s (WIPO) International Conference on Intellectual Property and Development.

On compulsory licensing, in relation to voluntary licensing, the Minister remarked:

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