National Institutes of Health Declines to Exercise Authority to Lower Xtandi Price
The National Institutes of Health will not use its rights under the Bayh-Dole Act to end the monopoly on the expensive prostate cancer drug Xtandi and allow low-priced generic versions to compete on the market.
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At the 32nd session (13 June 2016 – 1 July 2016) of the Human Rights Council, a bloc of countries known as the the Core Group (Brazil, Egypt, Indonesia, India, Senegal, South Africa and Thailand) have tabled a resolution on access to medicines “premised on the primacy of human rights over international trade, investment and intellectual property regimes.” The draft resolution complements the work of the United Nations High-Level Panel on Access to Medicines in reviewing and assessing “proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inven Continue Reading
Health Minister Alejandro Gaviria issued a declaration that it would be in the public interest for the government to lower the price of Novartis’ expensive leukemia drug, Gleevec (imatinib).
CONTACT: Andrew Goldman, +1 (202) 332-2670 or andrew.goldman@keionline.org
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Washington, DC, June 17, 2016 — Colombian Minister of Health Alejandro Gaviria today issued Resolution 2475 of 2016, declaring that it would be in the public interest for the government of Colombia to lower the price of an expensive leukemia drug. The Ministry of Health describes this resolution as unprecedented in Colombia.
The drug, imatinib, is marketed as Glivec in Colombia by the Swiss pharmaceutical company Novartis at a price of approximately $15,000 per patient per year, nearly twice the average income of a Colombian resident. Glivec has generated over $47 billion in global revenue for Novartis. Continue Reading
More on this dispute at /colombia
In response to the recent announcement from Colombia’s Ministry of Health that a public interest declaration regarding imatinib will be issued in a matter of days, Novartis issued a statement that criticized the forthcoming action, saying, “We have consistently said that Declarations of Public Interest can be important and legitimate tools to be used only in exceptional circumstances,” and saying “this is simply not the case in Colombia.” Continue Reading
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| David Hirschmann, US Chamber, claims efforts to curb high prices for cancer drugs are “a destructive course.” |
The US Chamber of Commerce might consider renaming itself the US/Swiss Chamber of Commerce, after their most recent attack on the Colombia Minister of Health (MoH) announcement that a “Declaration of Public Interest” would be issued for the patents on the cancer drug imatinib, held by the Swiss company Novartis. In the US Chamber’s defense of the Swiss drug company, they don’t mention the fact that Novartis has earned about $48 billion from sales of imatinib (sold by Novartis under the brand names Gleevec or Glivec) since the drug was put on the market, including more than $380 million per month in 2015. Continue Reading
(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) On May 18th, 2016 the NIH posted a notice on the Federal Register stating it is contemplating the grant of an exclusive license to Chimeron… Continue Reading
Alfred Engelberg and Aaron Kesselheim have published an opinion article in Nature titled:
“Use the Bayh-Dole Act to lower drug prices for government healthcare programs,” Nature Medicine 22, 576 (2016) doi:10.1038/nm0616-576, Published online 07 June 2016.
http://www.nature.com/nm/journal/v22/n6/abs/nm0616-576.html
On May 24th, 2016 the NIH posted a notice on the Federal Register stating it is contemplating the grant of an exclusive license to Dimension Therapeutics, Inc. for the development of an Adeno-Associated Virus Vectors for the Treatment of Glycogen… Continue Reading
On May 19th, 2016 the NIH posted a notice on the Federal Register stating it is contemplating the grant of an exclusive license to IntelliPanel Medical, LLC. for Anti-TNF Induced Apoptosis (ATIA) Diagnostic Markers and Therapies. Below are the comments… Continue Reading
Reports have emerged from a DNDi meeting in Rio de Janeiro, Brazil, that the Colombian Ministry of Health announced that negotiations with Novartis over the price of Glivec have failed, and that Minister Alejandro Gaviria will proceed with the formal declaration that a compulsory license for the patents on the drug is in the public interest.