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Governments can ration access to cancer drugs, or break patent monopolies. Why is rationing so popular?:

The new Medicines Patent Pool license with AbbVie: good news for children living with HIV

The Medicines Patent Pool (MPP) has signed a new license with AbbVie, to expand access to pediatric formulations of lopinavir (LPV) and ritonavir (r). The details of the licenses are available here:

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 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:!documentDetail;D=NIH-2011-0003-0003

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.

The Winning Bet

Leading up to the release of Professor Joe DiMasi's latest study of the cost of drug development, KEI offered $50 to the individual who could most accurately predict the new cost for drug R&D.

We received 26 guesses, ranging from $1.157 billion to $5 billion.

Joel Lexchin's estimate ($2.47 billion) was the closest to DiMasi's number ($2.558 billion). It was also the 5th largest estimate.

A complete list of submissions is below.

Name & Guess
Charles Clift - 1.157 billion
Nicole H - 1.2 billion
Ronald Rader - 1.55 billion
Wouter Deelder - 1.655 billion

KEI comment on the new Tufts Study on Drug Development Costs

The Tuft Center for Study of Drug Development (CSDD) has just concluded a press conference, and issued a press release about their new study of drug development costs. The key number is $2.558 billion.

What to look for in the new Tufts study on drug development costs. 10 issues.

When the new Tufts study on the costs of R&D for development of a new drug is released Tuesday at 10AM, here are 10 things to look for:

Research note on oncology drugs, including trial size and orphan drug status

We will be sharing some data on 2005 to 2014 oncology approvals, including the size of the trials cited in the medical review, and the orphan status.

The spreadsheet we are working on updating is published here:

KEI Research Note: Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results

A copy of the research note is also available here as a pdf file:

KEI Research Note 2014:3

Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results

Elizabeth Rajasingh
November 17, 2014


Former WTO Director-General, Pascal Lamy, mooted to chair Global Fund's Equitable Access Initiative

On 14 March 2014, KEI published "Resurrecting the Ghost of Høsbjør Past: Global Fund seeks to establish global framework on tiered pricing enforced by WTO rules" in which we provided an analysis of the Global Fund's plans to create a global framework for tiered pricing enforced by the rules of the World Trade Organization (WTO).

WIPO patent committee (SCP21): Intervention of KEI on Patents and Health

The following intervention on patents and health was delivered by KEI during the 21st session on WIPO's Standing Committee on the Law of Patents (SCP). Part 1 was delivered on 4 November 2014 during discussions of the Feasibility Study on the Disclosure of International Nonproprietary Names (INN) in Patent Applications and/or Patents. Part 2 was delivered on 5 November 2014 during general discussions on patents and health.

Statement of Knowledge Ecology International (KEI)

Item 7: Patents and health

Part 1

WIPO patent committee (SCP21): Intervention of Pakistan on Patents and Health

On Wednesday, 5 November 2014, Pakistan delivered the following intervention on patents and health.

Agenda 7 Statement on patents and health

1. General statement

Mr. Chair,

I will make this statement in national capacity,

WIPO Standing Committee on the Law of Patents (SCP 21): Intervention of Pakistan on Opposition Systems

On Tuesday, 5 November 2014, Pakistan delivered the following intervention on opposition systems.

Mr. Chairman,

The agenda item on quality of patents also include another item on "opposition systems" which was not discussed by the Committee. I want to make a small statement on opposition systems.

WIPO patent committee (SCP21) to discuss International Nonproprietary Names and Exceptions and Limitations to Patent Rights

In the words of the International Bureau of the World Intellectual Property Organization (WIPO), the WIPO Standing Committee on the Law of Patents (SCP) was created,

created in 1998 to serve as a forum to discuss issues, facilitate coordination and provide guidance concerning the progressive international development of patent law.

WTO TRIPS Council (October 2014): Statement of India on the Review of the Paragraph 6 system (compulsory licensing for export)

On 28 October 2014, India delivered the following intervention at the WTO TRIPS Council's annual review of the Paragraph 6 system (designed to facilitate compulsory licensing for export of pharmaceuticals).

In particular, India noted that

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