Schedule for the March 1, 2016 USTR Special 301 Hearing
KEI is one of the non-government entities speaking at the USTR Special 301 hearing on Tuesday. We each get 7 minutes of testimony and 3 minutes of questions. (The schedule is here).
Author: James Love
Equitable Access Initiative (EAI), 1st intervention
I am in a meeting of the Equitable Access Initiative (EAI), which is considering new ways of measuring development and/or health needs, in the context of the priority setting by donors. I am a member of the Expert Panel, and this was my intervention in the morning session:
The presentations by John McArthur and Dominik Zotti were excellent, and the work of the four expert groups is a very useful contribution for those struggling with the challenge of setting priorities for aid.
5 questions about NIH licenses to patents on Production of Attenuated Respiratory Syncytial Virus Vaccines
The NIH has a notice for comments on proposed licenses of several patents relating to the “Production of Attenuated Respiratory Syncytial Virus Vaccines”. See: https://federalregister.gov/a/2016-03486
We asked Peter Soukas, a Senior Technology Licensing Specialist in the Technology Transfer and Intellectual Property Office, at the National Institute of Allergy and Infectious Diseases (NIAID), these questions:
- What provisions exist in the license to protect US residents against excessive or unreasonable pricing?
Obama asks the Senate to ratify the Marrakesh treaty for the blind
This is the announcement.
For Immediate Release February 10, 2016
TO THE SENATE OF THE UNITED STATES:
With a view to receiving the advice and consent of the Senate to ratification, I transmit herewith the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired, or Otherwise Print Disabled, done at Marrakesh on June 27, 2013 (Marrakesh Treaty). I also transmit, for the information of the Senate, a report of the Secretary of State with respect to the Marrakesh Treaty that includes a summary of its provisions.
Xtandi 2016 March-In Request
Today Knowledge Ecology International and the Union for Affordable Cancer Treatment (UACT) petitioned the Department of Health and Human Services, the Department of Defense, and the National Institutes of Health, asking that they exercise either their royalty-free, non-exclusive license or federal “march-in” rights to end the monopoly on an expensive prostate cancer drug, enzalutamide, marketed as Xtandi by Astellas, a Japanese pharmaceutical company.
Xtandi was invented at UCLA on federal grants from the NIH and DoD.
2016: 51 members of Congress have asked the NIH to use March-In rights to rein in high drug prices
This was the release from Representative Doggett’s office:
FOR IMMEDIATE RELEASE
January 11, 2016Contact:
Leslie Tisdale, (202) 225-4865
Over 50 Members of Congress to Obama Administration:
Help End Drug Price Gouging Now
FDA approves 45 new drugs. 47 percent qualify for 50 percent Orphan Drug tax credit
In calendar year 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel drugs, approved as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs). This is a large number of approvals.
KEI’s December 19, 2015 submission to the US ITC regarding the TPP
Attached here is a KEI submission to the US ITC for the January hearing of the
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, DC
Investigation No. TPA-105-001
Trans-Pacific Partnership Agreement: Likely Impact on the U.S. Economy and on Specific Industry Sectors
Our earlier, related testimony on trade agreements was here: /node/2370
The UK’s rebates on drug sales, and introducing the budget constraint into pricing models
Under the UK’s Pharmaceutical Price Regulation Scheme (PPRS), drug companies will make rebates of about £550 million in 2016, according to this story.
KEI intervention on definition of broadcasting
WIPO SCCR 31 is having a text based discussion of the language for a proposed broadcasting treaty. The meeting is open to NGOs, instant transcripts are streamed over the Internet, and the proceedings are webcast. I was allowed to make to technical interventions this afternoon on the definitions. This is a slightly edited version of my second intervention, on the question of whether or not to have separate definitions for broadcasting and cable casting.