[Ip-health] UACT submission to Special 301 Out-of-Cycle Review of India

Manon Ress manon.ress at keionline.org
Thu Oct 30 06:10:28 PDT 2014

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 at 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

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

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.


Manon Anne Ress

ATTACHMENT:  October 29, 2014 letter from UACT to Ambassador Michael
Froman  (available at: http://cancerunion.org/actions.html)

Manon Ress, Ph.D.
Knowledge Ecology International, KEI
manon.ress at keionline.org, tel.: +1 202 332 2670
KEI needs your support. Donations to KEI are tax deductible, under
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