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Since July 28, 2011, when Natco Pharma applied for a compulsory license to market Bayer's Nexavar (sorafenib) in India, patent and civil litigation has resulted in the grant of this license March 12, 2012. Indian law requires Natco to provide the drug free to 600 patients per year who cannot afford their $176/month price. For comparison, the price of Bayer's product is $5,600/month. Based on clinical trial data, people with renal cell carcinoma (kidney cancer) can expect to live 4-5 years with the drug; those with hepatocellular carcinoma (liver cancer), 6-8 months.
Even at $176 monthly, this drug is only affordable to India's upper middle class. The GLOBOCAN Project of the World Health Organization estimates an annual total of 30,000 new cases for all liver and kidney cancers in India, leaving untreated many more than the 600 annually who will receive free treatment for renal cell and hepatocellular carcinoma. What has so far been accomplished under Indian law is the possibility that the Indian government will be able to afford to fund treatment of its poorer population. A balance has been struck between the benefits of an Indian patent monopoly granted to Bayer in 2008, and the benefits of affordable sorafenib treatment for a larger portion of India's population.
The conflicts involved in balancing public and private interests continue, with one venue being the Trans-Pacific Free Trade Agreement presently being negotiated among Australia, Brunei, Chile, Japan, Malaysia, New Zealand, Peru, Singapore, The United States, and Vietnam. These negotiations are typically secretive, but with leaks that have made clear that protections demanded by the US pharmaceutical industry against events such as have occurred in India have contributed to a breakdown in negotiations. (See this live news feed from Brunei for many relevant links.) The TRIPS trade agreement (aka The Doha Declaration) contributed to the present reality of Indian compulsory licensing, and multinational pharmaceutical companies do not wish to see an extension of this reality to other countries.
My favorite US representative from Texas, Lloyd Doggett, has cosponsored HR 2293 with Representative Chris Van Hollen. US Senator Debbie Stabenow has sponsored matching Senate bill S. 1644. In a letter to their Congressional colleagues asking for more cosponsors, they write:
Relevant prior posts:
Proprietary Drug Patents
Compulsory Licensing of Proprietary Drugs
Indian Compulsory Licensing Case May Reveal Research Costs
Even at $176 monthly, this drug is only affordable to India's upper middle class. The GLOBOCAN Project of the World Health Organization estimates an annual total of 30,000 new cases for all liver and kidney cancers in India, leaving untreated many more than the 600 annually who will receive free treatment for renal cell and hepatocellular carcinoma. What has so far been accomplished under Indian law is the possibility that the Indian government will be able to afford to fund treatment of its poorer population. A balance has been struck between the benefits of an Indian patent monopoly granted to Bayer in 2008, and the benefits of affordable sorafenib treatment for a larger portion of India's population.
The conflicts involved in balancing public and private interests continue, with one venue being the Trans-Pacific Free Trade Agreement presently being negotiated among Australia, Brunei, Chile, Japan, Malaysia, New Zealand, Peru, Singapore, The United States, and Vietnam. These negotiations are typically secretive, but with leaks that have made clear that protections demanded by the US pharmaceutical industry against events such as have occurred in India have contributed to a breakdown in negotiations. (See this live news feed from Brunei for many relevant links.) The TRIPS trade agreement (aka The Doha Declaration) contributed to the present reality of Indian compulsory licensing, and multinational pharmaceutical companies do not wish to see an extension of this reality to other countries.
My favorite US representative from Texas, Lloyd Doggett, has cosponsored HR 2293 with Representative Chris Van Hollen. US Senator Debbie Stabenow has sponsored matching Senate bill S. 1644. In a letter to their Congressional colleagues asking for more cosponsors, they write:
"Global trade agreements increasingly affect the public's health, from the price of medicines to regulations that protect the safety of food and water supplies. The Government Accountability Office and the Center for Policy Analysis on Trade and Health (CPATH) have documented the absence of public health representation on U.S. trade advisory committees. Advisors from health-related industries including pharmaceuticals, tobacco, processed foods, alcohol beverages and health insurance have had exclusive access to government trade negotiators."This legislation is part of a larger campaign by CPATH to give public health interests a voice where only the pharmaceutical industry has thus far been heard. In summary, it is also time in the US to rebalance the interests of the pharmaceutical industry against the interests of the US population which grants them patent monopolies.
Relevant prior posts:
Proprietary Drug Patents
Compulsory Licensing of Proprietary Drugs
Indian Compulsory Licensing Case May Reveal Research Costs
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