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.
I was recently asked by OSF to write a two page document that described “what was wrong with the current system of funding R&D?” and to offer some “important ideas for change.” This was my two page submission.
What is wrong with the current system for funding R&D? What are the most important ideas for change?
(In two pages, for OSF meeting on drug development)
James Love
October 20, 2015
1. What is wrong with the current system for funding R&D?
On Tuesday October 20, 2015, Representative Anna Eshoo (D-CA), one of the principal authors of the Biologic Price Competition and Innovation Act (BPCIA), sent a letter to the United States Trade Representative requesting timely clarification regarding the Trans-Pacific Partnership’s impact “on existing U.S. laws that limit damages for infringement of intellectual property (IP) rights, and on the potential ISDS ramifications for those conflicts.”
On the left, the people in the Obama Administration trying to block a permanent waiver of WTO drug patent obligations for Least Developed Countries (as defined by the UN). On the right, some people living in least developed countries.
Ambassador Michael Forman. Head of USTR. Alma maters: Princeton, Oxford and Harvard Law. Formerly ran a hedge fund for Citibank. Continue Reading →
Below you will find a collection of articles in the press and commentary by KEI relating to the request for LDC patent exemption on pharmaceutical products at the WTO.
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
Knowledge Ecology International sent letters today (attached to this release), September 21, 2015, to the Office of the General Counsel to the United States Trade Representative (USTR) and the Office of the Inspector General for the Department of Commerce, asking that they investigate USTR and the United States Patent and Trademark Office (USPTO) for the potential violation of an Executive Order issued by Bill Clinton — which prohibits the use of trade pressures to hinder polices related to access to HIV/AIDS medicines in sub-Saharan Africa — in their attempt to stop a request by Least Develop Continue Reading →
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).
