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Affordable drugs versus Rights of Intellectual Property
The future of
the medical bill:
Laxman Bhaskar's face looks pale, as though an inner glow has been turned off. He is a grim man in his thirties who is right now in the almost silent workshop of the Cancer Patients Aid Association (CPAA). He is printing a design on a cloth bag, a small favour to an organisation that is keeping him alive.
has a rare cancer - chronic myeloid leukemia (CML). About 30,000 Indians are
diagnosed with the disease every year. The drugs that CPAA gives him cost
Rs. 10,000 a month. And that's cheap. He takes the generic versions, the
copies, made by Indian companies. The original, usually called Glivec,
owned by Swiss pharma giant, Novartis,
would have cost him over Rs. 1,20,000 a month.
is at the moment in a battle with the CPAA and, in a way, the Indian government,
to win the exclusive marketing rights for Glivec which will result in local
companies being ordered to stop making cheaper copies of the drug. Novartis
says that it invented the base compound (imatinib) and deserves the exclusive
rights to market it. The appeal of Novartis, till recently heard by the
Madras High Court, has now been transferred to the newly created
Appellate Board (IPAB) which is expected to pass a verdict soon.
stake is a very complex issue, almost philosophical. That the poor have a
live is a truth that has no meaning if there are no life-saving drugs in
the first place. And it is not the goodness of activists that cures
diseases, but the commercial motives of big pharma companies like Novartis
which spawn multi-million dollar research.
Novartis wins the battle for Glivec, Indian generics, whom the Swiss
company's CEO Daniel Vasella had once described as "thieves",
will be wiped out and not only a cancer cure but also HIV, TB and other
treatments will become many times more expensive. The ramifications of the
Glivec battle is so important to the commerce of cure and the very meaning
of a poor person's life in a capitalistic world, that journalists from the
first world, especially Europe, have been landing in the country in the
last few weeks.
the heart of the battle, as always, is a technicality. It is called,
by Novartis, 3d. It is a section in the Indian Patents Act. The base
compound of Glivec was invented in 1993. It was only two years later that
India joined the World Trade Organisation.
said that over the next 10 years, as it moved towards a patents regime, it
consider fresh patent applications of inventions that did not exist before
1995. So the original base compound of Glivec did not qualify, but
Novartis filed for patent for a slight variation, a beta crystal
2003, Novartis was granted the exclusive marketing rights for that. But
when the Indian
Patent Law came into effect in 2005, there was a clause in section 3d that
implied that cosmetic variations, like the beta crystal form of imatinib,
cannot be considered. So, in 2006, Novartis lost its exclusive rights and
the Indian generics who were debarred from making copies rose again.
claims that it is only fighting for its rights and not for money. A spokesperson
of the company says that its Glivec International Patient Assistance
program (GIPAP) has given the drug free to 8,000 patients in India.
"Ninety-nine percent of the Indians who have been taking Glivec, have
been getting it free."
is a claim that makes Y K Sapru, the gritty chief of CPAA, a former pharma
executive himself, laugh. "What they don't tell you is that they give
the drug to patients free for one or two months, that's all. Novartis is
not here for social service. It is here to make money. Last year, Glivec
made $2.6 billion worldwide.
want to make more money. And this argument that they deserve to earn
because they invested in the research of the drug is not very good. Fifty
percent of the funding came from the US government, 30% from a US NGO and
10% from the Oregon Health and Science Institute. Only 10% came from
Novartis."(Novartis did not respond when asked for a confirmation.)
few months ago, Novartis CEO Daniel Vasella is reported to have said that
Sapru was being financed by Indian pharma companies. Sapru filed a
defamation suit for half a million dollars. Vasella eventually claimed that
he never made the statements. It is also said that Sapru is angry because
Novartis did not choose CPAA to run its free treatment programme but
instead chose an international cancer charity organisation called Max
true that we were in talks with Novartis and things didn't work out
between us, but that's all there is to it," Sapru says. He accuses
Novartis of using Max Foundation, "to promote both Glivec and to
collect clinical trial data. This has been confirmed by the founder of Max
Foundation, Pedro Rivarola. "Rivarola's son, Max had died of cancer
and so he was emotionally involved in the charity.
letter written by Rivarola to Sapru is part of the legal documents in the
Rivarola says in the letter, "I believed (being truly naďve) in the
good will of
Novartis... The relationship changed into a daily struggle to keep my
beloved foundation independent from Novartis' insatiable paws...The last
drop in the goblet made me leave. It was the situation in Thailand where
Novartis demanded that patients had to buy three months of supply before
qualifying for the program; It's time to stop this as the name of my son
is being trashed and abused just for marketing reasons."
battle beween CPAA and Novartis also has racial overtones. It is being
unofficially viewed as MNC vs India. Anand Grover, a lawyer representing
CPAA against Novartis says, "It's time the whites know that they
cannot walk into this country and expect us to be intimidated as before.
We know how to fight."He is optimistic that the future of Indian
generics is not in jeopardy. "But don't forget, they too are in it
for the money."
says that the production cost of a Glivec generic is about Rs 1,000.
"Indian companies are selling it at 10 times the price. So, they are
making huge profits. But, at least, they are cheaper than Glivec." DG
Shah, secretary general of the Indian Pharmaceutical Alliance, says
matter-of-factly, "It's true, we are not here for
charity." Indian pharma is valued at over $ 5 billion, 65% of this
coming from the export of generic drugs to developing.
revenues will help us invest in research," DG Shah says, "and in
the coming years, India will be known as not just the maker of cheap
copies but as a research hub which makes its own blockbuster
drugs. "But the future of generics and how the poor will buy their
right to stay alive is still not clear.
Discussion on the article:
MAILBOX (April 22nd, 2007)
article captioned 'The Future of the 'Medical Bill' by Manu Joseph, which appeared
in 'The Sunday Times of India' dated 15 April 2007 begins on a dramatic
note, no doubt to attract eyeballs, but is grossly misleading because as
you will note from the email response sent to him, all patients who are
prescribed Glivec for chronic myeloid leukemia (CML) or gastrointestinal
stromal tumours and cannot afford to buy the drug and are not reimbursed
or insured receive it free and this continues.
currently is given free to more than 7,000 patients and not 8,000
patients, as quoted in the article under reference. The author chose to
quote Mr. Sapru as saying that the drug is given free for one or two
article is a great disservice to the work we have been doing through The
in making sure that anyone, and I repeat anyone, who is prescribed Glivec
and .cannot afford the drug and is not reimbursed or insured receives it
absolutely free of any charge. The generic version of the drug that is
available in the market costs 4.5 times the average income in India and
could well be out of the reach for many.
Shahani, Vice Chairman & Managing Director Novartis India Limited
claim of Novartis that it supplies Glivec (priced at Rs. 1,20,000 per
month) free to
those who cannot afford it has been contested not only by the Cancer
Patients Aid Association
but also by Pedro Rivarola, the founder of Max Foundation, the NGO through
which the Novartis charity programme is being run. Also, in a
questionnaire to Mr. Shahani this correspondent specifically raised the
issue of how Glivec is being provided to India's poor but I was then told
that he was not available for comment.
Novartis claim that all poor CML patients who needed Glivec since 2002
have had an access to free Glivec through Glivec International Patient Assistance
programme (GIPAP) is not true. This is obvious from Novartis' own claim of
having given Glivec free to around 7,000 CML patients from 2002 to 2007.
Does it mean that in this five-year span, out of 30,000 CML patients
detected every year i.e. 150,000 CML patients in five years in India, only
7,000 poor CML patients needed Glivec?
reality is that Glivec is available free to only a few selected patients
recommended by doctors chosen by Novartis while thousands of others are
treated by generic
versions of Glivec manufactured by nine Indian generic manufacturing
is seeking patent and monopoly for Glivec which would mean non-availability
of generic versions of Glivec at one twelfth the price of Glivec (Rs
10,000 as against Novartis' price of Rs 1,20,000 for a month's treatment).
This means sure death for thousands of poor CML patients as NGOs will not
be able to provide the drug at affordable prices to poor CML patients.
What is more Glivec will be only the beginning which will be followed by several life-saving drugs for diseases like AIDS/HIV, cancer, tuberculosis, diabetes, etc. getting patent on similar logic as used by Novartis and then becoming unaffordable to not only the Indian population but even globally as India is the main supplier of generic drugs the world over. How serious this issue can become is realised more by the public in foreign countries, a reason why there is so much more agitations against the Glivec patent dispute in the foreign media than in India.
YKSapru, Chairman, Cancer Patients Aid Association
The "Public Eye Swiss Award 2007" for Irresponsible Corporate Behaviour goes to Novartis
On the opening day of the World Economic Forum in Davos, Switzerland, the Public Eye Swiss Award 2007 for irresponsible corporate behaviour was given to Novartis International on the basis of a nomination made by Cancer Patients Aid Association (CPAA). The Berne Declaration and Pro Natura, Switzerland, have given out this negative award for the last three years.
Novartis, a Basel based
pharmaceutical company is currently using patent lawsuits in an attempt to
limit access to affordable generic drugs in India and developing
countries. As CPAA Chairman and CEO, Y.K. Sapru said, "It's
aggressive patent policy makes Novartis responsible for the misery of
thousands of cancer patients in India today and if not restrained will
have similar effect at the global level."
Speech by Mr. Y. K.
Sapru, Chairman and CEO, CPAA India 24 January 2007 - Davos, Switzerland:
Novartis, through its actions of pricing Glivec a life saving drug for CML (Chronic Myeloid Leukemia) patients at an astronomical rate has inflicted misery, ill health, poverty and even death on thousands of sick cancer patients in India. If they are not restrained even greater misery, greater agony and widespread deaths will inflict millions of human beings at a global level.
The Glivec Story
In 2001, Novartis introduced Glivec (Imatinib Mesylate) in India - A wonder drug producing remission in over 90% of CML patients. Novartis priced Glivec at US$ 2500 for 1 month's treatment to be taken life long to keep the patient alive. In a developing country like India where there is no health insurance for a vast majority of the population, the pricing of Glivec was just out of reach for nearly everyone. Fortunately, almost simultaneously, 9 Indian companies started manufacturing its generic versions priced at an affordable US$ 180 for 1 month's treatment.
In 1998, Novartis applied in India for a patent for Glivec and was granted Exclusive Marketing Rights (EMR) in January 2003. As a result Indian courts forbade 6 out of 9 generic producers to market Imatanib Mesylate.
As a result: The 3 generic companies could not cover the entire country, CPAA and other charitable agencies could not take up the burden of supplying the drug at subsidized rates or free. Thousands of CML patients suffered and many became bankrupt as they tried to buy Glivec and many even died.
CPAA went to the Supreme Court of India against granting of EMR to Novartis.
In March 2005, the Indian Parliament passed the Indian Patent Act.
In January 2006, The Patent Controller of India rejected the patent application of Novartis for Glivec after evaluating all the points raised by CPAA. As a result once again generic versions of Glivec were available in the Indian market at affordable prices.
In May 2006, Novartis appealed against this judgment and also filed a case against the Indian Patent Act. CPAA, MSF, Oxfam & other NGOs launched a global agitation against Novartis.
In case Novartis wins both these cases in India, not only will thousands of CML patients die but 100s of life saving drugs currently available at affordable prices will get patent protection and will become unaffordable to patients suffering from life threatening diseases such as TB, Aids etc. There will be more misery - more poverty, more agony and more deaths at global level, which will be a major catastrophe.
PRESS UPDATE : CPAA SENDS DEFAMATION NOTICE TO NOVARTIS