Jan 15, 2013, First post

Early last year, when the Union government allowed the production of
Nexavar, a liver and kidney cancer drug, by an Indian company against
the wishes of multinational pharma major Bayer, the prices of several
indigenously made cancer drugs tumbled.

It was a complete game-changer in affordable healthcare in India,
which not only reduced the price of Nexavar from a prohibitive Rs. 2.8
lakh a month to Rs. 6,600, but also led to the reduction of prices of
a few other cancer drugs as well.

The step that led to this dramatic fall of prices was by an
intervention of the Union government called “compulsory licensing
(CL), by which a national government can allow somebody to produce a
patented drug without the consent of the patent owner.

After Nexavar, the government of India has begun steps to issue
compulsory license for three more cancer drugs – Trastuzumab,
Dasatinib and Ixabepilone.

Compared to Nexavar, the impact of this move is going to be
unprecedented because Trastuzumab is a wonder drug against a certain
type of breast-cancer that affects about 100,000 women in India.
Breast cancer tops the cancer burden in urban India, and an aggressive
HER+2 type of cancer is increasingly more prevalent among young women.

Indian companies don’t have a generic alternative to the breast
cancer drug yet. Reuters About 28-35 per cent of all cancers among
women in major cities is breast-cancer. Trastuzumab not only reduces
the mortality of patients with HER+2 cancer, but also is effective
against the spread of malignancy to other parts of the body.

So far, there is no other drug against HER+2 cancer with such
efficacy. It can be administered alone, along with chemotherapy and
after surgery. In many cases, it even helps avoid surgery, which many
find disfiguring.

However, majority of women with HER+2 breast cancer do not benefit
from the wonder-effect of the drug because of the prohibitive prices
by its manufacturer and patent-holder, Roche, the multinational drug
company. A full course of the drug costs anywhere between Rs six to
eight lakhs. A generic version – in this case a bio-similar product –
should not cost more than a tenth of this price.

Unlike Nexavar (chemical name Sorafenib), no Indian company has yet
started making generic versions of Trastuzumab. According to available
information , three Indian companies are currently involved in
creating this molecule, but it is a difficult process because they
have to take the biotechnological route to replicate it.

Commonly, generic versions of patented drugs are chemical copies made
by reverse engineering of the final molecule through chemical
processes. In simple terms, what it entails is taking the final
molecule (of the drug) and working backward to create the same
molecule through an alternative process.

Technical expertise, research facilities, appropriate investment and
availability of high quality human resources are important for such
processes. Endowed with all the four, India is a leader in generic
production of drugs. What it requires, however, is an enabling
environment, most of which is legal and patent-related.

In the case of Trastuzumbad, the generic version will be a biological
equivalent and not a chemical copy because this drug cannot be
replicated chemically. A biological process is trickier and more

The government decision on Trastuzumbad and the other two cancer drugs
will be significant because Indian companies are reluctant to invest
on developing a bio-equivalent, if the drug is still under patent. The
patent on this wonder drug is due to expire in 2014, but Roche has
filed several patent applications to Indian patent offices to block
any such development even beyond 2014.

Under such uncertain patent regimes, no company would risk its
investment. If the government issues a CL, the Indian drug companies
can safely invest and fast track the process. Apparently, one of the
Indian companies developing the drug is in the third stage of the
process and hence if a compulsory license comes through, the Indian
version will be out in the market sooner than later.

The latest development is yet another example of informed civil
society pressure leading to concrete results as seen in countries such
as Brazil and Thailand. In November 2012, the Campaign for Affordable
Trastuzumab, a citizens’ collective, wrote an open letter to the Prime
Minister, signed by around 200 cancer survivors, women’s groups, human
rights and health rights campaigns and treatment activists from around
the world, urging the government to make the drug affordable and
freely available to patients.

Drug companies are holding our health hostage to their greed for
profits” said Kalyani Menon-Sen, coordinator of the Campaign. “Roche
should not be allowed to get away with such predatory prices. Courts
and other authorities like the Competition Commission must take suo
moto action against Roche for abusing its dominant position in the

She also called on Indian manufacturers to expedite the production of
bio-similars of Trastuzumab.

Compulsory licensing is one of the two flexibilities provided under
the TRIPS (Trade Related Intellectual Property Rights) to allow member
countries of WTO (World Trade Organisation) to prevent the abuse of
patents. Contrary to the general belief, compulsory licenses are
issued not only by developing countries, but also by countries such as
Canada, USA, UK, France and Australia, whenever it suits them.

India joined TRIPS and complied with its rules in 2005 by amending the
patent act of 1970, which also meant giving up a lot. However, it does
have flexibilities such as CL to ensure that its citizens have access
to affordable care and multinational companies don’t get away with
predatory pricing. All that it takes for such a move is immunity from
vested interests and political will.

“Such a move will not only make healthcare more affordable, but will
also lead to domestic competition among generic manufacturers, which
in turn will lead to further fall in prices” said KM Gopa Kumar, legal
advisor and senior IPR researcher at Third World Network, a global
think tank on development issues.

The other TRIPS flexibility that WTO allows its members to protect its
citizens’s health is parallel importing, under which countries without
technical capability to produce the generics can import from other
countries. India may not be a beneficiary of this provision, but it
can help other countries. Indian generic drugs are imported by several
countries in the world.

Generic manufacture of potent MNC drugs against HIV and multi-drug
resistant TB and their dramatic price falls are the inspiring success
stories of the last decade. Cancer seems to be the new frontier. There
are also illnesses such as hepatitis-C, the treatment of which can
become affordable if a generic version of the MNC drug is available.
The MNC drug at present costs about Rs. 6 lakhs and the country has a
huge hepatitis -C burden.

In the coming years, the generic intervention and similar price cuts
will have considerable impact on treatment of cancers and other
non-communicable illnesses as well as infections such as hepatitis-C.

Without being apologetic to anybody – the MNCs and their parent
countries – the government just has to take proactive steps that are
vital for its citizens.