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Info Service on Intellectual Property Issues (Mar13/02) 8 March 2013, New Delhi: The Campaign for Affordable Trastuzumab has called on the Commerce Minister to mark International Women's Day 2013 with an announcement of compulsory licensing for Trastuzumab, a life-saving drug for women with HER2+ breast cancer. Trastuzumab, the patent for which is held by Swiss pharma giant Roche, is currently priced at Rs.6-8 lakhs for a full course of 12 injections, and is out of reach for all but the most privileged. An estimated 25,000 new cases of HER2+ breast cancer are recorded in India every year, with younger women in the majority among patients. Trastuzumab has been recommended for compulsory licensing by an Expert Committee set up by the Health Ministry. The recommendation is currently under the consideration of the Department of Industrial Policy and Promotion in the Ministry of Commerce. The Campaign has urged the Minister to issue a notification under Sections 92 or 100 of the Indian Patents Act, which will end Roche's monopoly and open the door for local manufacturers to enter the market with affordable biosimilar versions that can compete with Roche's product. The letter cites evidence to show that Roche's pricing policy is irrational and unethical, reflecting its strategy of pushing the pricing envelope to the maximum extent possible. The Campaign has also cited compelling evidence to show that measures such as negotiated price reductions and voluntary licensing floated by the Ministry of Chemicals and Fertilisers are weak in comparison to the option of compulsory licensing, which can bring prices down four times more than price negotiations. Moreover, while negotiated prices will apply only in India, Indian generics/biosimilars have the potential of increasing access across the developing world. The letter expresses concern at the Government of India's apparent reluctance to use the compulsory licensing option to ensure access, even though this measure is available under the Indian Patents At which was amended in 2005 to make it TRIPS-compliant. The first compulsory licence awarded in India - for production of a generic competitor to the liver cancer drug Sorafenib - has been recently upheld by the Intellectual Property Appellate Board. The Campaign is endorsed by more than 150 Indian and global groups of cancer survivors, health rights activists, women's groups, treatment activists and public interest organisations. The full text of the letter is available at http://donttradeourlivesaway.files.wordpress.com/2013/03/final-why-no-action_-letter_8-march-2013.pdf Kalyani Menon-Sen, Campaign For Access to Affordable Trastuzumab, +91 99 103 063 82
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