- HAI/KEI intervention at the WHA69 on the Framework of Engagement with Non-State Actors
- WHA69: Draft resolution (A69/B/CONF./7) on CEWG follow-up charts course for WHO's work on R&D
- WHO to Colombia Minister of Health: Unaffordable drug prices are a legitimate reason for issuing a compulsory license
- 28 Organizations Ask President Obama to Support Colombian Compulsory License on Expensive Leukemia Drug
- HAI/KEI intervention at the WHA69 on the negotiations on an R&D agreement
- Sens. Sherrod Brown and Bernie Sanders send letter to USTR condemning pressure on Colombia compulsory license for cancer drug
- 15 House Dems Press USTR to Clarify Position on Compulsory Licensing of cancer drug patent in Colombia
- Senator Hatch Defends Pressure on Colombia in Interview Regarding Imatinib
- WHA 69: Colombian Minister of Health Calls on WHO to Support the Regulation of Drug Monopolies
- Letter from KEI, Public Citizen, Oxfam America and Health GAP to Senator Hatch, regarding Colombia Compulsory License
Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countriesSubmitted by Zack Struver on 27. April 2016 - 14:03
On April 22, 2016, the President of Biolyse Pharma — a Canadian pharmaceutical company that specializes in the manufacture of oncology drugs — offered to supply the prostate cancer drug enzalutamide (Xtandi) to the Centers for Medicare & Medicaid Services (CMS) for $3 per pill ($12 per day; $4,383 per year). The Biolyse price for enzalutamide is 4-percent of the 2014 Medicare price, $69.41 ($277.64 per day; $101,408.01 per year), and lower than any other price in the world.
The 2016 USTR Special 301 report is now available. (copy here). The report is 77 pages of complaints about intellectual property policies around the world, plus a number of other complaints, including those related to pricing and reimbursement of pharmaceutical drugs and medical devices, restrictions on data flows, standard setting, and government procurement.
On the one hand, USTR says it is supports "access to medicine for all."
2016:1 KEI Briefing Note
Transparency of Patent Landscapes
April 25, 2016
At an April 12, 2016 WIPO seminar, Reed F. Beall and Amir Attaran presented a paper, “Patent-based Analysis of the World Health Organization’s 2013 Model List of Essential Medicines,” which includes the following odd comment:
WHO releases program of work and progress report in advance of Consultative Expert Working Group on R&D (2-4 May 2016)Submitted by thiru on 25. April 2016 - 5:07
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.
(More KEI RCEP leaks here: http://keionline.org/rcep)
Attached below is the October 16, 2015 version of the investment chapter for the proposed Regional Comprehensive Economic Partnership, known as RCEP. This text is made public for the first time by KEI.
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:
Attached here (in docx format) is the October 15, 2015 version of the draft intellectual property right chapter for the proposed Regional Comprehensive Economic Partnership (RCEP).
These estimates are published by Statista, here.
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.
Obama Administration memo: "Background on TPP Biopharma Provisions" describes how TPP will raise drug pricesSubmitted by James Love on 12. April 2016 - 9:18
[First reported by Politico] On April 9, 2016, the Obama Administration sent a document to Congress defending the TPP against criticism from the pharmaceutical industry that they did not get enough from the deal.
CDIP 17: Asia Pacific and African Group raise concerns re: WIPO's position on the UN High-Level Panel on Access to MedicinesSubmitted by thiru on 11. April 2016 - 4:04
The World Intellectual Property Organization (WIPO) is convening its 17th session of the Committee on Intellectual Property and Development (CDIP17) from 11 April 2016 to 15 April 2016. The mandate of the Committee is to "develop a work-program for implementing the 45 adopted Development Agenda recommendations" and "monitor, assess, discuss and report on the implementation of all recommendations adopted" (Source: WIPO page on the Committee on Development And Intellectual Property).
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
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)].
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:
7 April 2016: Keynote address of Minister Rob Davies (South Africa) to WIPO International Conference on IP and DevelopmentSubmitted by thiru on 7. April 2016 - 6:36
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:
The Fordham international IP conference just concluded a panel on patents for second uses of medical inventions, and the discussions illustrated once more the degree to which the patent system is poorly designed to address this issue.