Mark Women’s Day 2013 with a compulsory licensing of breast cancer drug Trastuzumab, so that a less expensive version of this life-saving medicine can enter the market, The Campaign for Affordable Trastuzumab has urged the Commerce Minister.

Breast cancer is now the second most common form of cancer in the country, and young women constitute the majority of those affected by the aggressive HER2+ variant of the disease.

An estimated 25,000 new cases of HER2+ breast cancer are recorded in India every year, with younger women in the majority among patients, a note from the campaign said.

Trastuzumab, from Swiss pharma giant Roche, is currently priced at Rs 6-8 lakh for a full course of 12 injections, and is out of reach for all but the most privileged, according to the campaign.

Trastuzumab has been recommended for compulsory licensing by the Health Ministry. The recommendation is currently under the consideration of the Department of Industrial Policy and Promotion under the Commerce Ministry.

Compulsory licensing

A compulsory licensing is a tool in the Government’s patent armoury that allows a third party to make a patent-protected medicine in the interest of public health. Only that, the third party would have to pay a royalty to the innovator company who owns the original rights on the said medicine.

The campaign has urged the Minister to issue a notification under Sections 92 and 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.

Other alternatives

Other alternatives negotiated by the Government such as 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 the prices down four times more than the price negotiations, the note added.

Moreover, while negotiated prices will apply only in India, Indian generics/biosimilars have the potential of increasing the access across the developing world, the campaign said.

It has further expressed its concern at the Government’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.

The first compulsory licence awarded in India — for the production of a generic competitor to the kidney and 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.