[Ip-health] Compulsory licensing for Trastuzumab - International Women's Day 2013 statement

Gopa Kumar kumargopakm at gmail.com
Fri Mar 8 01:17:42 PST 2013

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

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

Kalyani Menon-Sen, Campaign For Access to Affordable Trastuzumab,  +91 99
103 063 82

Leena Menghaney
Tel: 46573730/1, 9811365412

More information about the Ip-health mailing list