October 29, 2014 UACT submission to Docket Number USTR-2014-0020, 2014 Special 301 Out-of-Cycle Review of India Susan Wilson, Director for Intellectual Property and Innovation, Office of the United States Trade Representative, Special301@ustr.eop.gov. UACT is the Union for Affordable Cancer Treatment, an international network of people affected by cancer, who share the conviction that cancer treatment and care should be available everywhere for everyone regardless of gender, age, or nationality. More information about UACT is available at http://cancerunion.org UACT's submission to the Special 301 out-of-cycle review is an attached October 29, 2014 letter from UACT to Ambassador Froman. The UACT letter to Ambassador Froman refers to recent reports suggesting that the office of the United States Trade Representative (USTR) is pressuring the Indian government to reject a compulsory license on dasatinib, a drug for a rare form of leukemia. For UACT, the dasatinib dispute illustrates the shortcomings of US trade policy and its impact on cancer patients. UACT first points out the impact of USTR's actions on affordable treatment with dasatinib in India. The Bristol-Myers Squibb price for dasatinib is more than $100 per day, in a county with a per capita income of $4.30 per day, which makes it unreachable for the majority of leukemia patients in India. US government opposition to a compulsory license on dasatinib is a de facto endorsement of an excessive price, and will have predictably harsh consequences for leukemia patients who have developed resistance to imatinib. The UACT letter also challenges the assumption that USTR is advancing US interests by promoting stronger monopolies of medicines. The UACT argument is based upon the following facts that are discussed in more detail in the attached letter. 1. While BMS attempts to justify high cancer drug prices on the grounds that R&D is expensive, BMS in fact spent little on the R&D for dasatinib and benefited extensively from U.S. government research subsidies, including NIH funded research and clinical trials, and a 50 percent tax credit on the BMS funded trials. 2. The price of Sprycel, the BMS version of dasatinib, is excessive, everywhere. In the United States, BMS has increased the price per milligram of dasatinib by three fold since the introduction of the drug in 2006. ($77.94 per 70 mg in 2006, and $367.37 for 100 mg in 2014.) Today the average wholesale price (AWP) for dasatinib is a rapacious $367 per day, roughly twice the price in other high income countries -- and this for a drug developed with extensive US government subsidies. 3. Because of its high price dasatinib is subject to restrictive reimbursement rules, and high copayment obligations on patients. There is no alternatives to these life saving drugs, and patients cannot continue to be held hostage in a system of threats to ration drugs. 4. The United States is harmed by the high prices on cancer drugs, including dasatinib, in part because of an aging population that is more likely to require cancer related chemotherapy. The UACT letter discusses the demographic changes in the United States, and the impact of extremely high cancer drug prices on the competitiveness of the U.S. workforce, which collectively has to pay for cancer drugs that are more expensive in the United States than anywhere else. UACT opposes policies that promote high cancer drug prices throughout the world. UACT opposes policies that create an unnecessary and harmful scarcity of drugs that can save, extend and improve the lives of cancer patients. UACT suggests USTR's time and prestige would be better spent designing and advancing trade policies that allow countries to push back on high drug prices, while expanding funding for medical R&D, including for better cancer drugs and diagnostic tools. Sincerely, Manon Anne Ress UACT ATTACHMENT: October 29, 2014 letter from UACT to Ambassador Michael Froman (available at: http://cancerunion.org/actions.html)