[Ip-health] The high price of Big Pharma greed - The Hindu, 5th March 2017

leena menghaney leenamenghaney at gmail.com
Wed Mar 8 05:51:33 PST 2017

This article is in memory of my friend and clients who have died fighting
breast cancer. Many of them are young vibrant women whose treatment
comprises of cut, slash and burn and often what gives them a hope of
survival and fighting the cancer from recurring are drugs like trastuzumab
which are priced out of reach.

*The high price of Big Pharma greed - The Hindu, 5th March 2017*

In 2014, an Indian pharmaceutical company was globally the first to receive
approval to market a biosimilar, thereby affordable version, of the breast
cancer drug Trastuzumab. Almost immediately, Swiss pharmaceutical company
Roche, innovator of the drug, filed a suit against the Indian Food & Drug
Administration (FDA) to block its sale. The action firmly put their profits
ahead of the lives of women with breast cancer.

Roche effectively embroiled India’s drug regulatory body and biosimilar
producers in a long-drawn, expensive and increasingly complex litigation to
try and prevent the marketing of potentially affordable versions of the
cancer drug from competitors. The suit was aimed at questioning the ability
of the Indian FDA to register biosimilars and made frivolous assertions
regarding copyright infringement of its package insert by competitors.

After a wait of over three years, the Delhi High Court’s decision last week
lifts some of the uncertainty surrounding the sale of the more affordable
versions of the breast cancer drug in India. The court ruled that in view
of the fact that the appropriate authority has approved the package insert
and the drug for all three indications (metastatic breast cancer, early
breast cancer and gastric cancer), the competitors should be permitted to
sell Trastuzumab.

Young women in their thirties being diagnosed with breast cancer benefit
from Trastuzumab as it reduces the risk of recurrence. Most patients
struggle to pay for their surgery and chemotherapy and Roche was charging a
staggering ₹10 lakh for 17 cycles of the medicine.

For poorer patients, this meant that despite a grant of partial treatment
costs under the Prime Minister’s National Relief Fund (PMNRF), patients
still fell short of money. Often, poor women diagnosed with breast cancer
were not even told about the treatment option. One oncologist described it
as being cruel to tell his patient that there was a drug that could
potentially save her life but priced out of reach.

In South Africa, women like Tobeka Daki, a breast cancer patient who died
fighting Roche, were denied a chance of survival, not for medical reasons
but because Roche’s charged U.S. $38,365 for Trastuzumab.

Striking a chord

Roche’s attempts to prevent price reduction or competition in different
countries has struck a chord with women, cancer groups and treatment
activists around the world. It exposes the lengths that the Swiss
corporation will go to protect its monopoly and profiteering, despite the
immense human cost. Last month, there were demonstrations in South Africa —
with patients and treatment activists chanting #RocheGreedKills — adding
their voices to the growing chorus of outrage.

Many of us who have worked on access to cancer medicines know that
competition is the most effective tool to bring down prices of essential
pharmaceuticals. Today, distributors in India are offering a vial of
Trastuzumab (440 mg) at ₹30,000, something that Roche marketed at over ₹1
lakh in 2012. Competition from other generic companies is set to enter the
market. Health economists have shown that a year’s worth of Trastuzumab can
be produced for only ₹16,000 (U.S. $240) and stiff competition among Indian
manufacturers will start bringing the prices down further.

By no means is the battle for affordable Trastuzumab over. The drug needs
to be included in the essential medicine lists (EML) of State governments
so it is procured and available to women being treated in the public sector
in hospitals like Safdarjung and AIIMS. In the private sector, hospitals
are overcharging women with breast cancer being treated in their facilities
— making over ₹10,000 on each vial administered — and not allowing them to
source the drug independently at a lower cost directly from the
distributor. Pharmaceutical companies are complicit in the malpractice as
they choose to keep the retail prices high, offering a huge cut to the
hospital for prescribing their brands.

Every day, women with breast cancer who cannot afford the drug contact me.
It is appalling that private hospitals are preying on the vulnerability of
women sick with cancer and the government does little to address the


Leena Menghaney
Mobile: 9811365412

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