James Love's blog

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.


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.

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


Diarmaid McDonald
email: accessdiarmaid@gmail.com

Susannah Markandya
email: s.markandya@gmail.com

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).

USTR provides the names of the TPP Chapters (as of September 10, 2015)

On June 4, 2015, KEI asked USTR to provide the names of the TPP Chapters. The contents of the chapters are all officially secret, but we thought the names of the chapters should be public, and made a request for the chapter names under the Freedom of Information Act (FIOA). Today, more than 3 months later, USTR has responded to that FOIA. According to USTR, as of September 10, 2015, the names of the TPP Chapters are as follows:

  1. Intial Provisions and General Definitions
  2. Trade in Goods
  3. Textiles and Apparel
  4. Rules of Orgin

KEI TPP Briefing Note: Conflicts with US legal norms and TPP provisions on IP remedies for infringement

KEI TPP Briefing Note: Conflicts with US legal norms and TPP Article QQ.H.4: {Civil Procedures and Remedies / Civil and Administrative Procedures and Remedies} (*based upon May 11, 2015 TPP negotiating text.
Draft September 9, 2015

KEI comments on MPP consultation regarding mandate to expand into HCV (and other diseases).

These were comments KEI provided to the Medicines Patent Pool (MPP), for its consultation on expanding the mandate to include drugs to treat the hepatitis C virus.

To: consultation@medicinespatentpool.org.
Date: August 28, 2015
Re: Comments by James Love on behalf of KEI for the consultation regarding the MPP mandate to expand into HCV (and other diseases).

KEI has submitted joint comments with UAEM in this consultation. Here on behalf of KEI I make a few additional points.

Five groups ask USTR to protect orphan works in TPP

Five groups, the Authors Alliance, Creative Commons, the Electronic Frontier Foundation (EFF), Knowledge Ecology International (KEI) and New Media Rights have written to Ambassador Froman at USTR, asking that the TPP not adopt measures that would prevent the Congress from enacting legislation to limit the remedies for copyright infringement that were proposed by the Register of Copyrights in June 2015, to expand access to orphan copyrighted works.

A copy of the letter is available here:

Sanders offers amendment to create compulsory licenses on medical inventions, for veterans

On Wednesday, July 22, 2015, the Senate Veterans Committee held a mark-up to consider several bills. During the mark-up, Senator Sanders offered an amendment, attached below, that would create a compulsory license mechanism in the Department of Veterans Affairs, for patents on medical inventions. (See amendment text below). The motivation for the amendment was a crisis in the VA involving access to drugs for the hepatitis C virus (HCV).

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