Press Release: Compulsory License for anti-cancer drugs – Update from Campaign for Affordable Trastuzumab

14 January 2013, NEW DELHI

The Campaign for Affordable Trastuzumab welcomes the news that the Government of India has started the process of issuing compulsory licenses for the manufacture of  three anti-cancer drugs – trastuzumab, dasatinib and ixabepilone.

See the Indian Express news report here: Govt moves to make three key cancer drugs cheaper, 12 Jan 13, New Delhi, Indian Expres

This move will come as a huge relief to the thousands of women with HER2+ breast cancer whose lives can be saved by trastuzumab, but who are unable to access this drug because of predatory pricing by Roche, which currently controls the drug.  A full course of tratsuzumab treatment costs Rs. 6 lakhs to Rs. 8 lakhs at current prices.

Compulsory licensing for the generic production would result in significant price reductions. For instance, the price of sorafenib reduced by 97% (from Rs. 2.8 lakhs to Rs. 8,800 per month) after a compulsory licence was issued to an Indian company in March 2012.

In November 2012, the Campaign for Affordable Trastuzumab wrote an open letter to the Prime Minister, signed by over 200 cancer survivors, women’s groups, human rights and health rights campaigns and treatment activists from around the world, urging the government to make the drug affordable and freely available to patients.

See here for a copy of the letter.

“Drug companies are holding our health hostage to their greed for profits” said Kalyani Menon-Sen, campaign coordinator.  “Roche should not be allowed to get away with such a predatory pricing policy. Courts and other authorities like the Competition Commission must take suo moto action against Roche for abusing its dominant position in the market.”

Breast cancer remains one of the leading causes of cancer death in women worldwide and is now the most common form of cancer in urban areas in India. In a worrying trend, ICMR data show that younger women are showing an increasing incidence of the aggressive HER2+ type of breast cancer.  Trastuzumab, often referred to as a wonder drug, substantially reduces mortality for women with early stage HER2 positive breast cancer and increases survival time among women whose breast cancer has spread. No other cancer drug can be substituted to attain this effect.

In a related development, an international team of health activists has moved the WHO for the inclusion of trastuzumab in the WHO’s Model List of Essential Medicines (EML) for early stage breast cancer and metastatic cancers. An official submission which lays down the rationale for qualifying trastuzumab as an essential medicine is now under review. If accepted, this would be a powerful lever for making trastuzumab affordable and widely available in developing countries.

The submission by Knowledge Ecology International, University of California- San Francisco and Universities Allied for Essential Medicines is being made available on the WHO website here

Given this clear indication by the Government of India of its willingness to resist pressure from Big Pharma, the Campaign for Affordable Trastuzumab calls on the Indian pharmaceutical industry to rise to the challenge and hasten the process of developing and testing biosimilars of trastuzumab.

For further information please contact Kalyani Menon-Sen: kmenonsen [at] gmail.com, +91 9910306382.

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This entry was posted in Campaign for Affordable Trastuzumab, Compulsory Licensing, Indian Patent Law and tagged , , , . Bookmark the permalink.

One Response to Press Release: Compulsory License for anti-cancer drugs – Update from Campaign for Affordable Trastuzumab

  1. Pingback: India To Issue Compulsory Licenses On Cancer Meds | Global Regulatory Science

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