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The future of the medical bill
[April 15, 2007]

The future of the medical bill


(The Times of India Via Thomson Dialog NewsEdge) 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.

Bhaskar has a rare cancer - chronic myeloid leukaemia (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.

Novartis 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 Intellectual Property Appellate Board (IPAB) which is expected to pass a verdict soon.

At stake is a very complex issue, almost philosophical. That the poor have a right to 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.

If 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.

At the heart of the battle, as always, is a technicality. It is called, without affection 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.

India said that over the next 10 years, as it moved towards a patents regime, it would 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 form.

In 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.

Novartis 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."

It 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. They 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.)

A 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 Foundation.

"It's 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.

A letter written by Rivarola to Sapru is part of the legal documents in the Glivec case. Rivarola says in the letter, "I believed (being truly na?ve) in the good will of Novartis The relationship changed into a daily struggle to keep my beloved foundation independent from Novartis' insatiable pawsThe 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."

The 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."

Sapru 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.

"These 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.

Copyright 2007 The Times of India. Bennett, Coleman & Co Ltd. Source : Financial Times Information Limited

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