PHM-Exch> The ability of patients to get life-saving medicines: A matter of life and death

[Claudio Schuftan]

FroFrom: South Centre <south at southcentre.int>

A matter of life and death
By Martin Khor
                             excerpts
      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.
   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.

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.

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.

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 leukaemia.

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
IP.

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

This goes against 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.


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.

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.


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.

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".


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.

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 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.

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?

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.

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


*Author: Martin Khor is the Executive Director of the South Centre.
Contact: director at southcentre.int <director at southcentre.int>.*
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