[Ip-health] Martin Khor: A matter of life and death

Thiru Balasubramaniam thiru at keionline.org
Mon Feb 24 00:58:40 PST 2014

*A matter of life and death*

*By Martin Khor*

*Of all the issues currently being negotiated in the Trans Pacific
Partnership Agreement and other similar free trade agreements, none are
more important than the ability of patients to get life-saving medicines at
affordable prices, which many fear may be a victim of the agreements.*

*Below is an expanded version of an article in the Global Trends column
published in The Star (Malaysian daily newspaper paper) on 24 Feb. 2014*

*---------   *

If you or some family members or friends suffer from cancer, hepatitis,
AIDs, asthma or other serious ailments, it's worth your while to follow the
negotiations on the Trans Pacific Partnership Agreement that are taking
place in Singapore.

It's really a matter of life and death.  For the TPPA can cut off the
potential supply of cheaper generic medicines that can save lives,
especially when the original branded products are priced so sky-high that
very few can afford them.

The fight for cheaper medicines has moved to cancer and other deadly
diseases, when once the controversy was over AIDS medicines.

Last week, a cancer specialist in New Zealand (one of the TPPA counties)
warned that the TPPA would prolong the high cost of treating breast cancer
because of new rules to protect biotechnology-based cancer drugs from
competition from generics.  And this will affect the lives of cancer

Some cancer medicines can cost a patient over US$100,000 for a year's
treatment, way above what an ordinary family can afford.  But generic
versions could be produced for a fraction, making it possible for patients
to hope for a cure and a reprieve from death.

In India, local companies are leading the fight to make medicines more
affordable to thousands of patients suffering from breast, kidney, liver
and gastro-intestinal cancer and chronic leukemia.

For example, an Indian company produced a generic drug for kidney and liver
cancer 30 times cheaper than the branded product (US$140 versus US$4,580
for a month's treatment) after it was given a compulsory license.

India has a patent law that disallows patents for a newer form of drugs or
known substances unless it improves the medicine's efficacy or
effectiveness.  Under WTO rules, countries are free to set their own
standards for novelty, or whether a product is novel enough to be eligible
for a patent.

Also, in many countries, including Malaysia, the patent law allows for
companies to obtain compulsory licenses to import or make generic versions
of original medicines. Governments grant such licenses if the branded
products are too expensive and the original companies do not offer
attractive terms for a voluntary license to other firms.

Multinational companies have strongly opposed compulsory licenses or the
Indian-type laws that allow for patents only for genuine innovations.

This is where the TPPA comes in.  Mainly at the insistence of the United
States, countries are being asked to accept "TRIPS-plus" standards of
intellectual property, that go beyond the rules of the WTO's agreement on

Especially noteworthy is the US insistence that the TPPA countries agree to
give a type of intellectual property known as "data exclusivity" for 5
years to companies producing original medicines.

This is extended to 8 or 12 years for "biologics", or medicines made with
biotechnology. Many of the new medicines for treating cancers are biologics.

This will cause immense problems for patients waiting for cheaper medicines
because "data exclusivity" prevents generic companies from relying on the
safety and clinical trial data of the original company to get safety
clearance for their generic products.

Thus, even if a generic company can prove that its medicine is
bio-equivalent to the original medicine that has already passed the safety
standard required by the health regulatory authorities, it will not be

to sell its medicine unless it comes up with its own safety and clinical
trial data.

This goes against the current practice of generic medicines and safety
standards.  But the US is insisting on this in the TPPA.

Few generic companies have the funds or technical ability to do their own
clinical trials, and thus generic medicines could well be prevented from
being used in TPPA countries for five to 12 years --  even if the medicines
are not patented.

Being deprived of affordable medicines is a matter of life and death, and
will cost many lives.  That is the most outrightly significant aspect of
the TPPA, and this is why so many groups of patients, health organisations
and independent medical experts have been outraged and outspoken in their
opposition to the TPPA.

George Laking, a cancer specialist in New Zealand, last week raised the
alarm that the TPPA could make cancer treatment unaffordable because the
data exclusivity clause would lock in the extraordinary high prices of
cancer drugs.

In an article he co-authored in the New Zealand Herald, Laking ueses the
example of Herceptin, an anti-cancer medicine which costs US$100,000 for a
year's treatment.

Once Herceptin comes off patent, it will become cheaper because generic
forms can be made, he says. Also, new medicines that have fewer side
effects and greater efficacy are being developed all the time.

That means more people will get through the treatment with less pain and
distress. But the cost of new "generic" versions of Herceptin and other
such pharmaceuticals looks likely to become a casualty of the TPPA, said

"The new drugs will stay expensive for longer, because access to generic
versions will be delayed between eight and 12 years, because of the new
data exclusivity rules in the TPPA," he remarked.

"These extended monopoly rights go far beyond existing international
norms...This would be the first time in the history of such agreements that
exclusive long-term monopoly rights over these "biologic" medicines will
have been guaranteed....

"Each additional year of exclusivity will cost consumers and taxpayers many
millions of dollars. This will be profitable for the pharmaceutical
industry, but not so good for cancer patients and their families."

According to Jamie Love of Knowledge Ecology International, an expert on
drugs and patents, the average cost of 8 biologic cancer drugs registered
with the US drug authorities in 2011-2013 is $128,000 (for a year's
treatment), with the most expensive being over $390,000.    At such prices,
hardly anyone in developing countries can afford these medicines.

In mid-February, eight prominent organisations including Medicins Sans
Frontieres, Oxfam, Public Citizen, Health Gap and Knowledge Ecology
International, issued a strong statement    on their deep concern about the
public health implications that the TPPA's measures will have for millions
of patients in need of access to affordable medicines around the whole
Asia-Pacific region.

The new US approach "not only preserves the life-threatening and
access-restricting proposals that the US has been pushing since 2011, but
also fails to provide adequate recognition of the urgent access to
medicines needs of patients living in developing countries."

Said the groups:  "The negotiations must take into account the health needs
of all patients living in TPP countries, and the US must halt its efforts
to limit countries' freedom and flexibilities, otherwise the TPPA
will  jeopardize many, if not millions, of lives".

Developments in India, which is not a TPPA country, show the
patient-friendly policies that can emerge when public health concerns are
given priority.

Two generic companies are producing generic versions of the drug Sorafenib
which treats kidney and liver cancers. The original product, named nexavar,
cost US$4,600  per patient per month.  A compulsory license was granted to
a local firm to produce a generic version of sorafenib for US$140 a month,
or 30 times cheaper.

Another Indian company is producing a generic version of the drug Gleevac,
which is used to treat a chronic form of leukemia as well as
gastrointestinal cancer, bringing the cost of treatment down from US$70,000
a year (in the USA) to US$2,500 a year in India.

This was possible because the Indian government denied the original company
a patent on Gleevac because it was not judged to be novel enough, and an
objection to that decision was rejected by the Indian Supreme Court.

India also rejected a patent application on tenofovir, a drug to treat
AIDS, after opposition to its application was filed by several
organisations. Cheaper generic versions are now available.

The Indian company Cipla has also produced a generic version of the kidney
cancer drug nexavar  (although it has been sued for doing so) and a lung
cancer drug tarceva.

Another Indian company Biocon has produced a generic version of the breast
cancer drug Herceptin.  Due to a challenge by the originator company, its
production has been stalled.  There is a citizens' campaign on affordable
trastuzumab (which is the non-proprietary name for the breast cancer drug)
to make the drug available cheaply.

Countries that join the TPPA will find it very difficult or impossible to
undertake policies and practices similar to India's, should the US
proposals in the intellectual property chapter are accepted.

Moreover, countries that don't produce the generic drugs have the option to
import them from India and other generics-producing countries.   But if the
TPPA imposes data exclusivity rules of the type desired by the US, it would
be difficult or to import and sell them.

People would be deprived of the much cheaper generic medicines for treating
cancer, hepatitis, AIDS, and many other diseases, at least for many
years.  How many lives would be affected?

Some countries are opposed to some of the US proposals.  According to a
briefing on the TPPA by the Malaysian Ministry of Trade and Industry on 20
February, the IP chapter remains the most problematic, with many differing

The views and positions that defend public health must prevail, for after
all, it is a matter of life and death.

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