The whole TPP text.
CHAPTER 8, TECHNICAL BARRIERS TO TRADE.
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:
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:
. . .
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My presentation at IX CODAIP, Curitiba, Brazil, on Copyright norms in treaties & trade agreements – what possibly can go wrong?.
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As candidates consider parallel trade in pharmaceutical drugs, a practice blocked by Obama during his presidency, here is how common it is in Europe, where it is regulated and mainstream, as reported in the EFPIA publication, the Pharmaceutical Industry in Figures. Key data, 2015.
I was recently asked by OSF to write a two page document that described “what was wrong with the current system of funding R&D?” and to offer some “important ideas for change.” This was my two page submission.
What is wrong with the current system for funding R&D? What are the most important ideas for change?
(In two pages, for OSF meeting on drug development)James Love
October 20, 20151. What is wrong with the current system for funding R&D?
On the left, the people in the Obama Administration trying to block a permanent waiver of WTO drug patent obligations for Least Developed Countries (as defined by the UN). On the right, some people living in least developed countries.
 Ambassador Michael Forman. Head of USTR. Alma maters: Princeton, Oxford and Harvard Law. Formerly ran a hedge fund for Citibank. Continue Reading Senator Sherrod Brown letter to USTR, supporting permanent waiver of WTO drug patent rules for LDCsAttached is a letter, dated October 14, 2015, from Senator Sherrod Brown to USTR’s Ambassador Michael Froman, urging USTR to support a permanent waiver of WTO drug patent rules, for Least Developed Countries. Negotiations on this issue begin formally on October 15, 2015, during a meeting of the WTO TRIPS Council. Among the money quotes: Video: Coalition for Affordable T-DM1 Crown Use Request (in UK, for patents on cancer drug Kadcyla)This is a video explaining the request by the Coalition for Affordable T-DM1 to use the Crown Use provisions in the UK patents law, in order to grant compulsory licences on the patents relating to the cancer drug T-DM1, marketed by Roche under the brand name Kadcyla. The video was produced and edited by Zack Struver for KEI, and features narration by Merith Basey from UAEM. FDA enforcement discretion to allow unregistered generic Daraprim to be imported and sold at lower pricesIn 2011, the FDA told the NIH it could use enforcement discretion to permit importation and sale of unregistered drugs In 2011, in the context of a shortage of Fabrazyme, the FDA told the NIH if they could “in theory” allow Shire to import and sell Replagal, a drug approved for sale in Europe, but not in the United States, as an unregistered biologic substitute. The remedy explored for the Fabrazyme shortage may be the best way to address a different problem, the price gouging associated with the drug Daraprim (generic name: pyrimethamine). |
