US trade rep is pressing Indian government to forbid production of generic cancer drug, consortium says

BMJ 2014; 349 doi: (Published 04 November 2014) Cite this as: BMJ 2014;349:g6593
  1. Deborah Cohen
  1. 1The BMJ

The US government’s opposition to the generic manufacture of a cancer drug has been described as an “endorsement of excessive pricing, a rejection of the goal of access to medicine for all, and a death sentence for leukaemia patients” in a letter from an international network of people affected by cancer.

The letter, written by the Union for Affordable Cancer Treatment to Michael Froman, the US trade representative, alleged that he is using his position to pressure the Indian government to deny patients access to affordable generic versions of dasatinib.

Made by US firm Bristol-Myers Squibb, dasatinib (marketed as Sprycel) is used to treat both Philadelphia chromosome positive acute lymphoblastic leukaemia and chronic myeloid leukaemia when patients do not respond to other treatments.

Bristol-Myers Squibb charge Rs6627 (£68; €86; $108) a day for a daily dose of 100 mg in India—a country where the average annual per capita income is $1570 and “where most patients pay for cancer drugs out of pocket,” the letter said.

“Companies seeking a compulsory license have offered to supply generic versions of dasatinib for $4 a day, and that price would likely fall if competition was permitted,” it added. The letter said that the Indian Ministry of Health had requested that the Department of Industrial Policy and Promotion issue a compulsory license for dasatinib. But the department is reportedly opposing the compulsory license, motivated primarily by concerns that it would create trade and foreign policy problems with the United States.

Moreover, it was not just the price in India that the consortium had concerns about. They said that the price was “excessive everywhere.” In the US Bristol-Myers Squibb has increased the price per milligram of dasatinib threefold since the introduction of the drug in 2006. “Today the average wholesale price for dasatinib [in the US] is a rapacious $367 per day, roughly twice the price [of the drug] in other high income countries—and this for a drug developed with extensive US government subsidies,” the letter said.

The consortium alleged that although Bristol-Myers Squibb tried to justify high cancer drug prices on the grounds that research and development was expensive, the company spent little on the research and development of dasatinib, as the funds came mainly from the public purse. “[The company] benefited extensively from US government research subsidies, including NIH [National Institutes of Health] funded research and clinical trials, and a 50% tax credit on the BMS [Bristol-Myers Squibb] funded trials,” the consortium wrote.

In England and Wales the National Institute for Health and Care Excellence did not recommend the use of dasatinib because it did not provide enough benefit to patients to justify its high cost. The Cancer Drugs Fund subsequently approved its use. The Scottish Medicines Consortium has recommended its use for people with chronic myeloid leukaemia but did not recommend it as a treatment for people with acute lymphoblastic leukaemia.

Although their letter focuses on one drug, the consortium said that “the dasatinib dispute illustrates the shortcomings of US trade policy and its impact on cancer patients.” The letter said that the US trade representative had “a simple policy regarding cancer drugs to make them as expensive as possible everywhere in the world” and that such an approach was “flawed.” Patients could not “continue to be held hostage in a system of threats” to ration life saving drugs because of the high prices charged, the consortium said.

“Are we willing to acknowledge the high cost of the current system, that returns just 8 cents per dollar of global sales in R&D [research and development], and which often wastes much of that 8% on medically unimportant R&D projects?” they asked.


Cite this as: BMJ 2014;349:g6593


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