James Love's blog

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).

KEI letter to Register of Copyrights, USPTO and OSTP on copyright issues in TPP

On the topic of the TPP and copyright, KEI has sent a letter to Maria Pallante, the Register of Copyrights, Shira Perlmutter, Chief Policy Officer and Director for International Affairs for USPTO, and Nancy Weiss, Senior Advisor to the Chief Technology Officer, Office of Science and Technology Policy (OSTP), Executive Office of the President.

KEI asked these agencies to address certain issues in the TPP intellectual property chapter that relate to access to copyright issues, with a focus on orphan works, and uses by governments.

Mylan criticisms of the TPP provisions as regards generic medicines, warns USTR on "lazy drafting"

Attached are two documents from Mylan regarding their concerns about the TPP. The first is an April 13, 2015 10 page letter from Heather Bresch, the CEO of Mylan, to USTR head Michael Froman. (Copy here). The second is a table of inconsistencies between the TPP and US law (Copy here).

KEI letter to HHS, regarding 3 issues in the TPP

Attached below is a letter KEI sent to Emily Bleimund, Senior Policy Advisor for International Trade for the Department of Health and Human Services (HHS), and several other U.S. trade officials. The letter addresses three issues in the TPP text:

  1. There is a need for exceptions to exclusive rights in pharmaceutical and biologic drug test data.
  2. WTO standards for compulsory licenses should not be modified as part of a secret negotiation, or constrained by a 3-step test.

The failed proposed recommendations SCCR/30

The SCCR failed to adopt these recommendations. The dipcom in 2017 recommendations in Item 6 was too strong, and the exceptions recommendations for items 7 and 8 were too weak.

Also Attached as pdf

Proposed Recommendations SCCR/30

Proposed Recommendation Agenda Item 6:

Summary by the Chair, of SCCR 30

Attached is the document the chair distributed as the summary of the week long SCCR 30 meeting.

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