[Ip-health] UACT submission to "2015 Special 301 Review"

Manon Ress manon.ress at keionline.org
Fri Feb 6 07:49:48 PST 2015

A pdf of the submission is available on uact.org.  If you want to file
your comments:   deadline is midnight EST. indicate "2015 Special 301
Review" at http://www.regulations.gov/
Public hearing will be February 24. See you there,


February 5, 2015

UACT submission to Docket Number USTR-2014-0025, "2015 Special 301 Review"
via http://www.regulations.gov/

TO: 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

The following, including attachments, constitutes UACT's submission to the
"2015 Special 301 Review and its notice of intent to testify at the Special
301 Public Hearing Tuesday, February 24, 2015.

UACT objects to the United States Trade Representative (USTR) pressure on
foreign governments to reject measures, including compulsory licenses,
limits of the granting of patents, cost containment and price controls and
other mechanisms to provide their population with affordable cancer drugs.

As a recent report by Oxfam indicated:[1]

According to the World Health Organization, cancer is one of the leading
causes of death around the world, with 8.2 million deaths in 2012. More
than 60 percent of the world's new cases of cancer occur in Africa, Asia,
and Central and South America and these regions account for 70 percent of
the world's cancer deaths.

In low- and middle-income countries, expensive treatments for cancer are
not widely available. Unsustainable cancer medication pricing has
increasingly become a global issue, creating access challenges in low-and
middle-income but also high-income countries.

Today, we have a handful of "game changer drugs" in the cancer treatment
field.  By game changers, we mean drugs that add time and quality to the
lives of cancer patients.

For example, let us look at dasatinib, a drug for a rare form of leukemia.
For UACT, the dasatinib dispute between the USA and India illustrated the
failing of US trade policy and its impact on cancer patients. In a previous
submission to USTR during the 2014 Special 301 Out-of-Cycle Review of India
on October 29, 2014, UACT pointed out the impact of USTR pressure on access
to treatment for the rare form of Leukemia.

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.

There are other "game changer drugs" such as Herceptin or  Kadcyla
(formerly known as T-DM1) for advanced breast cancer (HER2 positive).  Most
recently, the FDA approved the Pfizer drug Ibrance which is a life saver
for patients with the most common estrogen positive (but HER2 negative)
advanced breast cancer.  All these drugs are near or over $100,000 a year.
These treatments are not accessible to most women on earth and even hardly
available in Europe (the UK NICE has rejected Kadcyla and in some European
countries patients are not even tested because they will not get Herceptin
or Kadcyla).  In the US, to access treatment, patients have to rely on the
employers (including medicare and other government programs or agencies)
who have to pay higher and higher premiums and of course their health
insurances.  Indeed very few individuals in the US could afford to pay out
of pocket these kind of treatments.  But without these drugs, most women
with advanced breast cancer die of a premature death.  I myself have lived
the last 4 and a half years of my life thanks to access to these drugs.
However, it is heartbreaking for me to know that only a few breast cancer
patients have access to the same treatments that are keeping me alive today.

UACT is challenging the idea that USTR is advancing US interests by
promoting stronger monopolies of medicines and preventing access to these
treatments. The UACT argument is based upon the following:

1. While we recognize that developing new drugs in expensive, we know that
BMS, Roche or Pfizer in fact benefited extensively from U.S. government
research subsidies, including NIH funded research and clinical trials,
universities (public and private) and a 50 percent tax credit to fund

2. The price of these cancer drugs is excessive everywhere for everyone on
the planet especially for drugs developed with extensive US government

3. UACT believes that trade pressures to prevent other countries from using
legal mechanisms such as compulsory licensing to manufacture generics and
provide access to cancer patients in resource poor setting is immoral and
bad foreign policy.

4. USTR, this Committee, must recognize that there is no alternatives to
these life saving drugs, and cancer patients cannot continue to be held
hostage in a system of threats to ration drugs.

5. US citizens are especially harmed by the high prices on cancer drugs in
part because of an aging population that is more likely to require cancer
related chemotherapy. I would refer the Committee to the October 29, 2014
letter from UACT to Ambassador Michael Froman  (available at:
http://cancerunion.org/actions.html) which discusses in details 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.

In conclusion, UACT reaffirms its opposition to USTR trade policies that
prevent access to treatment to the majority of cancer patients on this
planet and create an unnecessary and harmful scarcity of drugs that can
save, extend and improve the lives of cancer patients around the globe.

We ask that USTR spends more time 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


Manon Anne Ress
Manon.Ress at UACT.ORG

[1] ACCESS TO CANCER TREATMENT, A study of medicine pricing issues with
recommendations for improving access to cancer medication A report prepared
for OXFAM By Ellen 't Hoen, LLM. Paris, 2 May 2014.  http://oxf.am/ZTdi

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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