Thursday, August 11, 2005

The Gleevec Story: Part 1

This is the first part of an article which I wrote for Raw Nerves, our nascent college newsletter. The second part is soon to follow.

On April 17, 2001 a new drug called Gleevec was officially announced by Novartis, the second largest drug company in the world. Gleevec or imatinib which is its pharmaceutical name works by interfering with the pathways that signal the growth of tumour cells. Overnight the drug revolutionised the treatment of CML (chronic myeloid leukemia) as well as GIST (gastro intestinal stromal tumours). The scientific community was greatly excited by the development of such signal transduction inhibitors and there was hope that soon similar drugs could be used to treat various other types of cancer.

Imatinib turned out to be extremely good news for the 24000 patients who are diagnosed with CML every year in India. As per existing patent laws in India, which allowed patenting of the manufacturing process but not the final product, imatinib was soon produced by nine different generic manufactures and was made available to patients at Rs. 9000-12000 per month. This was in glaring contrast to the Rs. 1,20,000 per month which was the cost of the branded Gleevec sold by Novartis.

In 2004 things took an ugly turn when Novartis managed to secure from the Patent Controller an EMR (Exclusive Marketing Right) for Gleevec. Almost immediately the Madras High Court was forced to order six of the generic manufactures of imatinib to stop production based on a case filed by Novartis. The decision spelled death for a majority of CML patients who could not afford the Rs 1,20,000 for the branded Gleevec.

To make matters worse in December 2004 the Central Government tried to push through a piece of legislation known as the 3rd Patent Amendment Bill in order to meet India’s commitment to the World Trade Organisation’s TRIPS Agreement which required that we amend our patent laws to allow for product patenting. Such a law would make EMRs like the one granted to Novartis standard practice for any new drug and would prevent people from accessing cheaper generic versions.

Health activists around the world were quick to recognise the potentially disastrous implications of the amendment and organised themselves under the banner of the Global Campaign against the Indian Patent Amendment. Protests were organised in Europe and North America as well as throughout India.

After many modifications the final version of the Bill was finally accepted by the President on 7 April 2005. The Bill ushered in a product patent regime in India but allowed generic manufacturers like those of imantinib who had made “significant” investment to continue production after a “reasonable” royalty has been paid to the patent holder such as Novartis. Such vagueness of the terminology can be easily exploited in favour of the patent holders. In many cases generic manufacturers were reluctant to restart production fearing lawsuits from the patent holders or unreasonably high royalties.

Under the new law, if the next signal transduction inhibitor drug which works against another form of cancer was discovered, then the patent holder, in most cases a large pharmaceutical corporation will have the exclusive right to market it for the next 20 years. In the presence of such a monopoly they will be able to get away with exorbitant prices.

The story of Gleevec highlights a growing phenomenon in modern day medical practice. That the health of our patients can be adversely affected by trends in globalised trade and that in order to safeguard our patient’s health doctors will have to understand and be active participants in a worldwide movement to counter the ill effects of globalisation.

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