James Love's blog
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 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.
This was the release from Representative Doggett's office:
FOR IMMEDIATE RELEASE
January 11, 2016
Leslie Tisdale, (202) 225-4865
Over 50 Members of Congress to Obama Administration:
Help End Drug Price Gouging Now
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.
Attached here is a KEI submission to the US ITC for the January hearing of the
UNITED STATES INTERNATIONAL TRADE COMMISSION
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: http://keionline.org/node/2370
Under the UK's Pharmaceutical Price Regulation Scheme (PPRS), drug companies will make rebates of about £550 million in 2016, according to this story.
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.
KEI’s Initial Comments on the MPP/BMS license to patents and know-how for daclatasvir (DCV)
November 23, 2015
Knowledge Ecology International (KEI) notes the successful conclusion of negotiations between Bristol-Myers Squibb (BMS) and the Medicines Patent Pool (MPP) for a royalty-free license and technology transfer agreement on daclatasvir (DCV), an important new medicine for the treatment of the hepatitis C virus (HCV), and offers comments on the agreement.
Attached is a PDF file with my testimony this morning for the United States International Trade Commission (USITC) hearing on
"Economic Impact of Trade Agreements Implemented Under Trade Authorities Procedure”, 2016 Report. Inv. No.: 332555 November 17, 2015
Manon Ress also provided testimony at this hearing, for the Union for Affordable Cancer Treatment (UACT). A copy of her testimony is available here.
This is the tentative witness list for the November 17, 2015 United States International Trade Commission (USITC) hearing on "Economic Impact of Trade Agreements Implemented Under Trade Authorities Procedure, 2016 Report. Inv. No.: 332-555"
The August 4, 2015 USITC notice about the hearing is here.
Joint NGO Statement on TRIPS Council Decision On Extension of the Transition Period Concerning Pharmaceutical ProductsSubmitted by James Love on 6. November 2015 - 7:40
JOINT NGO STATEMENT
TRIPS Council Decision On Extension of the Transition Period Concerning Pharmaceutical Products
(PDF copy available here)
Today (6th November), the WTO-TRIPS Council adopted a decision granting Least Developed Countries (LDCs) an exemption from patents and test data protection for pharmaceutical products for a duration of 17 years.
Updated. The TPP E-Commerce chapter has a provision banning requirements to transfer or provide access to software source code. This applies to "mass market software."
Article 14.17: Source Code
1. No Party shall require the transfer of, or access to, source code of software owned by a person of another Party, as a condition for the import, distribution, sale or use of such software, or of products containing such software, in its territory.
TPP on registration of drugs, bans requirements to disclose or consider certain financial or pricing data.Submitted by James Love on 5. November 2015 - 12:37
This is from one of the 26 chapters that was never leaked before.
CHAPTER 8 TECHNICAL BARRIERS TO TRADE, ANNEX 8-C: PHARMACEUTICALS, Annex 8-E: Medical Devices (Page 25)
ANNEX 8-C: PHARMACEUTICALS
7bis. Each Party shall make its determination on whether to grant marketing authorisation for a specific pharmaceutical product on the basis of:
The negotiators have finally released, for the first time, TPP text, which is on the web here.
Despite assurances from the contrary by Australia and USTR, intellectual property is a covered asset subject to Investor State Dispute Settlement (ISDS):
Article 9.1: Definitions
For the purposes of this Chapter:
. . .