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Indian Government rules Nexavar can be sold as generic

Posted by on March 14, 2012 in RCC News & Research - 2 Comments

NexavarThe Indian Government has established an unusual patenting precedent allowing a pharmaceutical manufacturer in India to negate Bayer Corporation’s patent on the kidney cancer drug Nexavar. The move creates a number of interesting legal, socioeconomic and medical questions. There is a question of the value of intellectual property on the international level, obviously. There is the issue of whether this is a victory for patients seeking more affordable access to cancer drugs.

The medical question is what interests — concerns may be a better word — me. I have watched very closely the process of researching and developing a cancer drug, getting FDA approval and then bringing the drug to market. It is a remarkably expensive process to develop a new drug — not only in the sense of the enormous amount of research that goes into discovering a potential new drug therapy but also the years-long process of clinical trials and navigating the drug through approval. While the federal government does engage in cancer treatment research, it pales in comparison to that of private pharmaceutical companies. Consider who produces most of the new treatments. These drug are coming from private companies. The amount of expense that goes into producing these drugs is enormous, and any company that invests in that research and development must look to recoup its expenses and, yes, make a profit. No profit, no investors in the company and no money for research. So if other countries can sidestep U.S. patents, take the intellectual property of the drug companies to create generic versions of the drug and sell them at greatly reduced prices … how does the drug company recoup its cost? How does it satisfy investors? If the drug company cannot do this, it goes out of business. Which means research and development of potential new cancer treatments shrivel. Government-run healthcare has no impact here — delivery of services or products has nothing to do with researching and developing new services and products. It isn’t likely that the government will pick up the slack; the costs are too high, and the nation is already near crisis mode in terms of debt.

So my concern is this: Will the development of new drug therapies slow if drug companies are disincentivized to continue researching and developing new therapies? Kidney cancer patients are in desperate need of more treatment options.

  • Sakyagm

     Thousands of kidney cancer patients will be thankful to the Indian government for making Nexavar available and affordable to them. On the other hand, Indian government or any other government must not do so at the cost of private companies. So, a satisfactory way must be worked out to maintain and encourage the private companies. International development agencies may be involved in evolving appropriate solutions to this life and death issues.

    • Chris Battle

      Good point, Sakyagm.

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