Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countries
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:
(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 prices
[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 Medicines
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 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:
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.
These were my notes from my talk on Thursday morning at the annual Fordham International IP conference, which is organized by Professor Hugh Hansen. The panel was titled "Examination of TPP & TTIP."What is wrong with the TransPacific Partnership (TPP)?
The TPP was negotiated with asymmetric secrecy. Not from industry, but from the public. Nearly all of the real experts in IP policy were in the dark over the actual language of the texts. We delegated too much power to government trade negotiators and to lobbyists.
BIO, PhRMA and US Chamber of Commerce express fear of UN High-Level Panel on Access to Medicines in letter to Senator Hatch
In a sternly worded letter dated 18 February 2016, the Biotechnology Innovation Organization (BIO), the National Association of Manufacturers (NAM), the National Foreign Trade Council (NFTC), the Pharmaceutical Research and Manufacturers of America (PhRMA), the U.S. Chamber of Commerce (the Chamber) and the United States Council for International Business (USCIB) wrote Senator Orrin Hatch (Republican - Utah) expressing serious reservations with the United Nations High-Level Panel on Access to Medicines (UN HLP).
GSK has made a major announcement of new policies to expand access to its patented medicines. A copy of the press statement is here.
This was the Wall Street Journal's take on the Doha Declaration on TRIPS and Public Health, two days after the agreement was reached:
11 Groups Urge NIH to Lower Price of Xtandi, NIH/Army-Funded Prostate Cancer Drug With $129k/Year Price Tag
+1 (914) 582-1428
FOR RELEASE: MARCH 21, 2016
Non-Profit Groups Urge Obama Administration, NIH to Lower Price of Government-Funded, $129,000 Per Year Prostate Cancer Drug
The groups asked the National Institutes of Health to “take this opportunity to act” to lower the price of the prostate cancer drug Xtandi and show leadership on deterring discriminatory pricing practices.
TDR releases report on a Health Product Research & Development Fund: A Proposal for Financing and Operation
On 17 March 2016, the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) released a 76-page report entitled, Health Product Research & Development Fund: A Proposal for Financing and Operation.