India issues its first compulsory license to protect health, South Africa continues to lag behind

Early this month, India issued its first ever compulsory license, for generic manufacture and sale of Sorafenib (brand name: Nexavar). Bayer was granted a patent on Sorafenib in India in 2008. After unsuccessfully negotiating with Bayer for a voluntary license, generic pharmaceutical company Natco Pharma Ltd applied for a compulsory license in July 2011. The Indian Patent Office issued the compulsory license early this month, paving the way for generic manufacture of the medicine.

Bayer currently sells Sorafenib in India at $47 (R363) per 200 mg tablet.[1] A single 200mg tablet in South Africa is sold by Bayer at R381.00.[2] Because the drug is patent protected, no generic versions are available in the country.

Natco plans to sell Sorafenib at Rs. 8,880 per month. This amounts to approximately US$1.48 (R11.50) per tablet. Therefore South African patients will be paying 33 x more for patented Sorafenib than patients in India will pay for the generic version.

As part of our campaign to fix the patent laws, we are calling on our government to utilise compulsory licenses. The Sorafenib case in India demonstrates how compulsory licenses can be used by governments to address the often prohibitory costs of medicines under patent by issuing compulsory licenses.

It is distressing that, while South Africa faces numerous health emergencies and many medicines remain inaccessible due to cost, our government has never issued a single compulsory license for generic manufacture of medicines.

[1] Converted to rands on 22 March 2012

[2] Price sourced from medprax on 20 March 2012

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