The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has just released the report by a committee set up to examine the issue of price negotiations for patented drugs. Comments are being invited from stakeholders. The report available at http://pharmaceuticals.gov.in/ can be downloaded from here too.
We note with concern that this report comes at a time when the Ministry of Health is actively exploring options such as compulsory licensing for bringing down prices of life-saving patented drugs through allowing market competition by generics and biosimilars. Trastuzumab is one of the drugs being considered for compulsory licensing.
This ill-timed move by the Department of Pharmaceuticals will benefit none other than big pharma companies whose patents on life-saving drugs are the main barrier in access to health for millions of Indians.
Global experience shows clearly that measures such as negotiated price reductions do not result in any significant expansion of access, since prices continue to remain beyond the reach of most citizens.
A case in point is Brazil, which tried to use price negotiations with multi-national pharmaceutical companies to bring down the price of patented HIV drugs. As a result, the price of Efavirenz (Merck) came down to USD 760 per person per year in 2003. In contrast, when Efavirenz was brought under compulsory license in 2007, the price came down to USD 170 per person per year, which is less than one fourth the negotiated price.
A donor-supported process of negotiated price decrease in Central America and the Caribbean in 2002 brought prices of HIV drugs down to USD 1100-1600 per patient per year. In contrast, 10 Latin American countries independently adopted an open competition-based model involving both generic manufacturers and originator companies, resulting in prices coming down from USD 5000 to USD 400 per patient per year.
The Campaign for Affordable Trastuzumab urges the Government of India to follow through on the strong political will shown by initiating the process of compulsory licensing for Trastuzumab. With 25,000 new cases of HER2+ breast cancer being recorded every year with most patients being young women, there is no time to waste. We look forward to a speedy notification and an accelerated process to bring biosimilars of Trastuzumab into the market.
Kalyani Menon, Coordinator, Campaign on Access to Affordable Trastuzumab