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: /ustr/special301).

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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: /ustr/special301).

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KEI intervention, SCCR 29, December 9, 2014

Below is a cleaned up version of the transcript, from my rambling intervention for KEI on the broadcasting treaty definitions.

Thank you, Mr. Chairman. My comments would be initially on the definitions.

It is our position that it’s more appropriate to provide protection for free services that are traditionally provided by radio and television and less appropriate for pay services,

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NIH rulemaking on transparency of clinical trials

The NIH has a notice about a proposed rule that “clarifies and expands requirements for the submission of clinical trial registration and results information to the ClinicalTrials.gov database.” Comments are due on or before February 19, 2015. We may ask the NIH to consider expanding the trials registry to include more information on the economics of clinical trials.

Here is a link to the Regulations.Gov docket for the proposed rule:

http://www.regulations.gov/#!documentDetail;D=NIH-2011-0003-0003 Continue Reading

UACT sends letter to Tufts President, Chairman of Trustees, asking questions about R&D cost study

On November 24, 2014. the Union for Affordable Cancer Treatment (UACT) sent a letter to Anthony P. Monaco, Office of the President, Tufts University, with copies to Michael Baenen, the Tufts Chief of Staff, and Peter Dolan, Chairman of the Board of Trustees for Tufts University, regarding the Tufts University press conference to announce an estimate of $2.6 billion as the R&D costs for new drugs. Continue Reading