James Love's blog

KEI comments to DHHS on WHA agenda 17.4, the Consultative Expert Working Group on Research and Development

Re: 17.4 Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination Document A68/34

My name is James Love, from Knowledge Ecology International. I wanted to discuss the negotiations on new approaches to funding medical R&D.

I will begin with the much delayed discussions about a WHO R&D treaty, which are supposed to resume in 2016.

We have suggestions for some changes in the discussion, to move things forward.

USTR's 2015 Special 301 List

Every year USTR issues a list of countries targeted to be subjected to trade pressures over their policies on intellectual property rights. This year's list was published on April 30, 2015. KEI has a copy of every version of the Special 301 list here: http://www.keionline.org/ustr/special301

USTR describes the list as follows:

The Special 301 Process

OCR version of leaked EU document on : "A digital single market strategy for Europe"

Yesterday, Politico published this story:

Leaked digital single market’s ‘evidence file’ reveals Commission’s ambitions. Documents show policy came before evidence for cybersecurity measures.
By ZOYA SHEFTALOVICH 20/4/15, 1:29 PM CET Updated 21/4/15, 11:33 AM CET
(http://www.politico.eu/article/leaked-digital-single-market-strategy-evidence/)

The CA State Assembly Health Committee staff analysis of AB463; includes who supports and opposes

The California Assembly Health Committee has published an analysis of AB463, the Pharmaceutical Cost Transparency Act of 2015. The bill will be marked up by the committee on Tuesday (April 21). The analysis was written by Dharia McGrew. It recommends three amendments to the bill, and provides a discussion of the benefits of the required disclosures, with context, and describes the support and opposition. The staff report is attached, and below is a list of 33 groups supporting and 22 opposing the bill.

State of California considers AB463, a bill to require disclosure of drug development costs, and more economic data

This is a bill that will see legislative action next week in California, and the bill has some momentum. This is the first time I have seen any government make an effort to have useful data on the economics drug drug development and pricing, and it provides a model that other governments may want to built upon.

A mark-up on the bill has been scheduled for Tuesday, April 21, 2015, in the Assembly Health Committee.

BILL NUMBER: AB 463
INTRODUCED BILL TEXT

INTRODUCED BY Assembly Member Chiu

FEBRUARY 23, 2015

Sony complains fundraiser: "smells a little bit like a Disney play regarding corp. tax reform"

This from the Wikileaks Sony Archive:

An email from Keith Weaver, the "Executive Vice President, Worldwide Government Affairs at Sony Pictures Entertainment, provide an illustration the practical art of doing "Government Affairs," meeting "goals" for fundraisers, trying to avoid making "personal" contributions, and wondering if the donations were to much focused on another company's purchase of policy" "smells a little bit like a Disney play regarding corp. tax reform".

Jamie

From: Weaver, Keith
Sent: Tuesday, August 26, 2014 5:23 PM
To: Weil, Leah

KEI and Public Citizen ask the NIH for safeguards in patent license for HCV drug

The following attached letter [PDF ], from KEI and Public Citizen, asks the NIH to impose certain conditions on an exclusive license on NIH owned patents for a drug to treat the hepatitis C virus (HCV). The NIH wants to license the patents to Virotas Biopharmaceuticals, LLC, a company having a place of business in California. Other than the patents involved, the NIH requires people to sign a non-disclosure to know more about the deal.

Twenty groups write Congress, no fast track without public access to trade agreement negotiating texts

Twenty groups, including KEI, have written Congress, asking the Congress to provide public access to draft trade agreement texts and U.S. proposals throughout negotiations, and to specific that only agreements developed through such processes should obtain any expedited congressional consideration.

Among other things, the groups said:

St Jude's influenza patents, with US government rights

St Jude holds 24 patents with influenza in the specification, that also disclose US government rights. Some of these were discussed here: http://keionline.org/node/2188

PAT. NO. Title
1 8,574,592 Modified influenza virus for monitoring and improving vaccine efficiency
2 8,551,481 Anti-cancer vaccine composition comprising an anti-CD223 antibody and kit comprising an anti-cancer vaccine and an anti-CD223 antibody
3 8,309,099 DNA transfection system for the generation of negative strand RNA virus

CDC FOIA regarding intellectual property on avian flu intellectual property rights

Our 2009 FOIA request, and 42 pages of CDC emails debating what to give us.

http://keionline.org/misc-docs/FOIA/14-01041-cdc-foia-frequest-2009.pdf

The February 17, 2015 cover letter from CDC.
http://keionline.org/sites/default/files/CDC_17feb2015_FOIA_CoverLetter.pdf

The 184 page CDC foia response, which we received in February 2015. Note that we were particularly interested in the patent issues related to reverse genetics.

KEI Special 301 supplemental comments: Compulsory Licensing not restricted to "Emergencies" or "Measure of Last Resort"

At the February 24, 2015 USTR hearing on Special 301, KEI asked to provide supplemental comments on R&D for the record, and KEI was separately asked by USTR to provide comments on online pharmacies, and by DHHS to comment on the relationship between emergencies and compulsory licensing. (The KEI page on Special 301 is here: http://keionline.org/ustr/special301).

KEI's supplemental comments in USTR 301: Online pharmacies, parallel trade and counterfeit drugs

At the February 24, 2015 USTR hearing on Special 301, KEI asked to provide supplemental comments on R&D for the record, and KEI was separately asked by USTR to provide comments on online pharmacies, and by DHHS to comment on the relationship between emergencies and compulsory licensing. (The KEI page on Special 301 is here: http://keionline.org/ustr/special301).

KEI's Feb 27, 2015 Supplemental Comments to USTR Regarding Research and Development

At the February 24, 2015 USTR hearing on Special 301, KEI asked to provide supplemental comments on R&D for the record, and KEI was separately asked by USTR to provide comments on online pharmacies, and by DHHS to comment on the relationship between emergencies and compulsory licensing. (The KEI page on Special 301 is here: http://keionline.org/ustr/special301).

KEI 2015 Special 301 Comments (filed February 6, 2015)

Attached are KEI's February 6 comments to USTR on the 2015 Special 301.

Our 7 page submission begins with this:

KEI comments on India IP strategy

Attached are KEI's January 30, 2015 comments on the India IP Policy.

http://keionline.org/sites/default/files/KEI_30Jan2015_Comments_India_IPR_Policy.pdf

This is how the comments begin:

Knowledge Ecology International (KEI) has reviewed the document entitled “National IPR Policy” prepared by the IPR Think Tank. The document is surprisingly lacking in several key areas. In particular:

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