[Ip-health] First Post: World Cancer Day: Debate on affordable drugs must focus on life or death for millions

Shailly shailly.17 at gmail.com
Mon Feb 3 22:47:42 PST 2014

by Feb 4, 2014

By Kalyani Menon-Sen


Marijn Dekkers, the Chairman of German drug MNC Bayer AG, is a powerful man
but not a name that many Indians had heard before. Things would probably
have continued that way, if not for a recent episode.

Speaking at an industry forum a few days ago, Mr Dekker characterised
India's compulsory license to Bayer's "blockbuster" cancer drug Nexavar as
"essentially theft", and added, "We did not develop this medicine for
Indians. We developed it for western patients who can afford it."

This outburst (reported in the 21 January edition of Businessweek) was
followed by an explanation. The comment, said Mr Dekkers, had been a "quick
response" to the Nexavar issue but added that he had been "particularly
frustrated" by the Indian regulator's decision, the first time a so-called
compulsory licence of a patented drug had been awarded in India. Bayer,
said Mr Dekkers, wanted "all people to share the fruits of medical progress
regardless of their origins or income".

The fact that the wolf has finally come out from under its rather
moth-eaten sheepskin disguise probably calls for a round of (slow)
clapping. But the explanation actually explains nothing. If Nexavar was not
developed for

India, why is Bayer so upset about someone else making and selling a cheap
copy to poor Indians who can't afford the real thing? Why is Bayer trying
to sell Nexavar in India anyway? Is it because the rich people it was made
for are now shopping for the next generation of drugs, and India looks like
a good place to squeeze the last drops of profit out of Nexavar before it
becomes a has-been?

Mr Dekkers and his tribe have long been ranting about India's Patent Act,
more frenzied now because many other developing countries see it as a good
model to follow. Two provisions are most often singled out for attack:
Section 84, whereby the patent controller can override a patent monopoly
and allow marketing of generic versions by a competitor when high prices
keep the drug out of reach of the majority of patients; and Section 3(d),
that disallows attempts at "evergreening" or prolonging the life of a
patent by seeking fresh protection for insignificant changes to the
original product. Both these provisions are characterised by big pharma and
its backers as unfair and unwarranted.

The fact is that compulsory licensing is perfectly legal, including under
the WTO. The Doha Declaration states that "Each member has the right to
grant compulsory licences and the freedom to determine the grounds upon
which such licences are granted." The US government has granted compulsory
licences for everything from night vision glasses to nuclear technology,
apart from hundreds of drugs and pharmaceuticals.

In contrast, the compulsory licence for Nexavar (sorafenib tosylate, a drug
used in the treatment of kidney and liver cancers), was India's first,
granted on the grounds that Bayer had failed to make the drug affordable
and available in the required quantities. This resulted in a 97 percent
drop in the price of the drug - from around $8,000 a month to less than
$200 a month.

Big pharma's standard justification for high prices is that developing a
new drug is a time¬consuming, costly and risky endeavour. According to the
Pharmaceutical Research and Manufacturers of America's 2006 Pharmaceutical
Industry Profile, developing a new drug and bringing it to the market takes
up to 10 to 15 years and on average costs $ 800 million. However, a little
digging into the arithmetic tells a different story.

The breast cancer drug Herceptin (trastuzumab) is a case in point. The drug
was developed by Genentech and approved by the FDA in 1998. The Genentech
balance sheet shows that Herceptin brought in US$ 1287 million for
Genentech in 2007, the year that it was taken over by Roche. Along with two
other cancer drugs (Avastin and Rituxan), Herceptin has accounted for 32%
of Roche's total revenue for at least five years. The money Roche has
earned from Herceptin is therefore likely to be several thousand times more
than the upper figure of $ 800 million quoted for the cost of development.

Pharma companies are also silent on the hidden public funding that goes
into drug development - for instance, clinical trials and supplementary
research are usually carried out in hospitals and laboratories that are
supported by public grants. Drug companies also enjoy significant tax
breaks in several countries, including the US and India.

In fact, the billion dollar price tag for new drugs has been recently
challenged by none other than the CEO of pharma giant Glaxo Smith Kline.
Calling it one of "the great myths of the industry", he pointed out that
the cost calculation includes the cost of failed drugs. According to him,
the rate of return on R&D investment has gone up by as much as 30 percent
in recent years because fewer drugs have flopped in late-stage testing.

Pharma companies and their backers are pushing for a patent system that
will protect their monopolies and allow them to reap extortionate profits -
regardless of the fact that this system has skewed research towards
"blockbuster" drugs for particular high-value diseases, and has cut short
the lives of millions by denying them access to life-saving drugs and

The call for decisive action by the government to regulate and control drug
prices is growing louder. There are reports that an Expert Committee set up
by the Health Ministry is going to keep a watch on patented drugs and will
recommend compulsory licensing for more cancer drugs in 2014 if necessary.
A proposal for putting a cap on foreign investment in Indian pharma
companies has been turned down by this government, but may well be revived
by its successor.

Pharma patent warriors are now pinning their hopes on the EU-India Free
Trade Agreement, which includes potentially lethal proposals such as giving
customs authorities the power to seize and destroy drugs being exported to
other countries on complaints from pharma companies claiming infringement
of intellectual property rights.

The long drawn out process of the EU-India FTA is on ice for the moment,
but will come back to life after the Lok Sabha elections. The outgoing
government may already have queered the pitch by agreeing to negotiate on
drug patent issues instead of rejecting the EU's demands outright.

The next round of the battle will be hard fought on both sides. The stakes
are high - on the one hand, unchallenged monopolies and unimaginable
profits for pharma companies; on the other, life or death for millions of
people in India and the developing world.

(Kalyani Menon-Sen is a feminist researcher and activist who coordinates
the Campaign for Affordable Trastuzumab.)


Shailly Gupta


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