<div dir="ltr">FroFrom: <b class="gmail_sendername">South Centre</b> <span dir="ltr"><<a href="mailto:south@southcentre.int">south@southcentre.int</a>></span><br><br><h1 style="display:block;font-family:Helvetica;font-size:40px;font-style:normal;font-weight:bold;line-height:125%;letter-spacing:-1px;margin:0px;text-align:left;color:rgb(96,96,96)!important">
<span style="color:rgb(0,0,0)">A matter of life and death</span></h1>
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<span style="color:rgb(0,0,0)">By Martin Khor</span><br>
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<span style="color:rgb(0,0,0)">Of all the
issues currently being negotiated on the Trans Pacific Partnership
Agreement, 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 agreement.</span>
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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 Trans Pacific Partnership Agreement (TPPA) negotiations, now going
on in Singapore.<br>
<br>
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.<br>
<br>
The fight for cheaper medicines has moved to cancer and other deadly
diseases, when once the controversy was over AIDS medicines.<br>
<br>
Recently, 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 patients.<br>
<br>
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.<br>
<br>
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 leukaemia.<br>
<br>
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.<br>
<br>
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.<br>
<br>
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.<br>
<br>
Multinational companies have strongly opposed compulsory licenses or the
Indian-type laws that allow for patents only for genuine innovations.<br>
<br>
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 IP.<br>
<br>
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.<br>
<br>
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.<br>
<br>
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.<br>
<br>
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 allowed to sell its medicine unless it comes up with its own
safety and clinical trial data.<br>
<br>
This goes against current practice of generic medicines and safety standards. But the US is insisting on this in the TPPA.<br>
<br>
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.<br>
<br>
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.<br>
<br>
<br>
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.<br>
<br>
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….<br>
<br>
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.<br>
<br>
<br>
Recently, 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.<br>
<br>
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.”<br>
<br>
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”.<br>
<br> <br>
India 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.<br>
<br>
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.<br>
<br>
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.<br>
<br>
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. <br>
<br>
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.<br>
<br>
Moreover, countries like Malaysia that don’t produce the generic drugs
have the option to import them from India. But if the TPPA imposes data
exclusivity rules of the type desired by the US, it would be difficult
or impossible to sell them here.<br>
<br>
Malaysians would be deprived of the much cheaper generic medicines not
only for treating cancer, hepatitis, AIDS, and many other diseases, at
least for many years. How many lives would be affected?<br>
<br>
Some countries are however 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 views.<br>
<br>
The views and positions that defend public health must prevail, for after all, it is a matter of life and death. .<br>
<br>
<br>
<b>Author: Martin Khor is the Executive Director of the South Centre. Contact: <a href="mailto:director@southcentre.int" target="_blank">director@southcentre.int</a>.</b><br></div>