James Love's blog

Joint NGO Statement on TRIPS Council Decision On Extension of the Transition Period Concerning Pharmaceutical Products

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.

TPP has provision banning requirements to transfer of or access to source code of software

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.

Some parts of the TPP that deal with drug, medical device prices, reimbrusements

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:

TPP on registration of drugs, bans requirements to disclose or consider certain financial or pricing data.

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:

Despite assurances to contrary, intellectual property covered asset for TPP ISDS mechanism

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:
. . .

Copyright norms in treaties & trade agreements - what possibly can go wrong?

My presentation at IX CODAIP, Curitiba, Brazil, on Copyright norms in treaties & trade agreements - what possibly can go wrong?.

European parallel trade in pharmaceuticals, 2013

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.

EU-drug-parallel-trade-efpia-data-2013.png

What's wrong with current system of funding R&D, and what are ideas for reforms?

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, 2015

1. What is wrong with the current system for funding R&D?

Contrast in privilege: US officials working to block WTO LDC drug patent waiver, and people affected by policy

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.

Michael_Froman_official_portrait_300x.jpg
Ambassador Michael Forman. Head of USTR. Alma maters: Princeton, Oxford and Harvard Law. Formerly ran a hedge fund for Citibank.

Senator Sherrod Brown letter to USTR, supporting permanent waiver of WTO drug patent rules for LDCs

Attached 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 prices

In 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).

Statement of KEI on announcement of consensus on Trans Pacific Partnership (TPP) trade agreement

Statement of KEI on announcement that there is a consensus on the Trans Pacific Partnership (TPP) trade agreement
October 5, 2015, 10am, EST

These comments by James Love, KEI Director


Press Release: Coalition for Affordable T-DM1 Asks UK Government to grant compulsory licenses on Roche breast cancer drug

Press Release: Coalition for Affordable T-DM1 Asks the UK Government to Employ Crown Use Authority to Lower Price of Expensive Cancer Drug sold by Roche

CONTACT:

Diarmaid McDonald
email: accessdiarmaid@gmail.com
+44.7894.4557.81

Susannah Markandya
email: s.markandya@gmail.com
+44.7811.9573.12

Zack Struver
email: zack.struver@keionline.org
Cell: +1.914.582.1428
Office: +1.202.332.2670 (between 2:00 PM and 10:00 PM BST)

USTR releases documents from 2012 R&D treaty negotiations

On September 28, 2012, nearly three years ago, KEI submitted a FOIA request to USTR for "all documents relating to the World Health Organization (WHO) consideration of an agreement or treaty to support medical R&D."

Three years later USTR has released 89 pages of documents, with some redactions. But USTR also withheld 64 documents pursuant to FOIA exemption 552(b)(5) and three documents pursuant to FOIA exemption 552(b)(1).

Syndicate content