The Campaign for Access to Affordable Trastuzumab (CAAT), a platform working in the health sector to make Trastuzumab affordable, has called upon the Union commerce minister Anand Sharma to announce compulsory licensing (CL) for Trastuzumab, a life-saving drug for breast cancer, to mark the International Women's Day.

Trastuzumab has been recommended for compulsory licensing by an expert committee set up by the Union health ministry. The recommendation is currently under the consideration of the department of industrial policy and promotion (DIPP) in the union ministry of commerce.

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.

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 Campaign's  letter to the minister 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 over 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 Act which was amended in 2005 to make it TRIPS-compliant.