Support for the Delinkage of the Costs of R&D and the Price of Medicines

The concept of delinkage refers to an model of incentivizing innovation in pharmaceutical research and development wherein the price of a medical technology is not linked to the cost of R&D. The application of delinkage in the medical technologies market has been gaining broad based support from NGOs, IGOs, and governments. Below are a selection of public statements, resolutions, bills, and papers that call for the need for delinkage in ensuring global access to medicines.

Endorsements by Governments

European Union:

EU Statement at World Health Assembly on Consultative Expert Working Group Report

The EU has provided KEI with a copy of the EU statement delivered at the 65th World Health Assembly on Wed, May 23, 2012, on the WHO Consultative Expert Working Group on R&D Financing. In a nutshell, the EU position is to "generally support" the US led position, and to slow everything down. Here are some of the main points:

  • We recognise that current measures are insufficient, although we also cherish the collective efforts that have been made with respect to the issue so far.

Obama Administration Wants to Eliminate References to Doha Declaration in UN Political Declaration on Non-Communicable Diseases

The United States and the European Union are using a United Nations High Level Meeting on Non-Communicable Diseases (NCDs) to effectively renegotiate a landmark agreement on intellectual property rights and public health.

Jan 2009, Ranneberger reports on Kenya anti-counterfeit goods legislation

September 3, 2011
From KEI staff review of Wikileaks cables (

The following is a January 2009 cable written by Michael E. Ranneberger, the U.S. Ambassador to Kenya. The subject of the cable is: Kenya Passes Long Awaited Anti-counterfeit Goods Bill

Cable reference id: #09NAIROBI86

Reference id aka Wikileaks id #186907 ???
Subject Kenya Passes Long Awaited Anti-counterfeit Goods Bill
Origin Embassy Nairobi (Kenya)

Federal Circuit decision in AMP v. USPTO results in three-way split in reasoning; 2-1 decision finds isolated DNA patentable

It has been estimated that 1 out of every 8 women in the United States will develop invasive breast cancer during her lifetime. Although a diagnostic test exists to identify mutations on the BRCA1 and BRCA2 human genes, two genes associated with breast and ovarian cancer, many women are not afforded the opportunity to have testing done because Myriad Genetics holds exclusive rights over these genes.

KEI, MSF, Oxfam and PC provide follow up comments on USPTO humanitarian priority review voucher proposal

USPTO is currently considering a pilot program to grant priority review vouchers as an incentive mechanism for technologies or licensing that responds to humanitarian needs. KEI, MSF, Oxfam and PC previously submitted comments on November 19, 2010 and provided additional comments on March 4, 2011 with UAEM.

Federal Circuit hears oral arguments on patent eligibility of DNA claims

On Monday, April 4, 2011, a panel of three Federal Circuit judges heard oral arguments about the patentability of the BRCA 1/2 gene claims in American Molecular Pathology, et. al, v. U.S. Patent and Trademark Office, et. al.. The panel included Judge Lourie, Judge Bryson and Judge Moore. Gregory Castanias from Jones Day argued for Myriad's position, defending the DNA claims while Chris Hansen of the ACLU argued against the patentability of the claims. The U.S.

United States Patent and Trademark Office’s "Humanitarian Pilot Proposal." Comments by KEI, MSF, Oxfam, PC and UAEM

The USPTO is considering a pilot program to consider the benefits of providing a voucher for certain accelerated reviews of patent applications, as a reward for licensing patents for humanitarian uses. On March 2, 2011, Anne Guha provided a very useful summary of public comments on the proposal, which is available here:

Dec 9, 2009 Wikileaks documents related to the WHO EWG

On December 9, 2009, Wikileaks posted five sensitive documents related to the WHO Expert Working Group (EWG) on R&D Financing:

  • a non-public draft report of the WHO EWG
  • a non-public Comparative Analysis done by the EWG
  • the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Overview of the EWG Comparative Analysis
  • an IFPMA summary slide on the EWG Draft Report
  • Notes on the Bayh-Dole Act of 1980

    The Bayh-Dole Act (or University and Small Business Patent Procedures Act) was originally enacted in 1980 as Public Law 96-517, and was amended in 1984 by Public Law 98-620. Among other things, the Bayh-Dole Act was designed to facilitate the patenting of U.S. government funded inventions by universities, other non-profit entities and businesses.

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