Major victory on affordable drugs

By Anso Thom Time of article published Apr 4, 2013

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Johannesburg - A landmark decision by the Indian Supreme Court to uphold India’s Patents Act in the face of a challenge by pharmaceutical company Novartis has been hailed across the world as a major victory for affordable medicines.

The ruling, announced on Monday in Delhi, has great significance for South Africa and other countries with high prevalence of HIV and TB, where access to newer and affordable drugs is crucial.

In Khayelitsha, almost one in five people (17.4 percent) on ARV treatment for five years has had to switch to second-line regimen, which costs the government over five times more than the first-line combination. The only reason for this price difference is that most second-line drugs are still available only from originator companies holding patents. Had Novartis succeeded in India, there would have been no alternatives to brand drugs, and drug prices would inevitably go up.

India began granting patents on medicines to comply with international trade rules, but designed its law with safeguards – including a clause known as Section 3(d) – that prevent companies from abusing the patent system. Section 3(d) prevents companies from gaining patents on modifications to existing drugs, in order to extend monopolies.

The Novartis ruling is critically important for South Africa because the Department of Trade and Industry is currently drafting amendments to the country’s outdated patent laws. South Africa’s patent system does not include protections like India’s Section 3(d) at all.

Instead, South Africa allows companies to easily register patents and extend monopolies through minor drug modifications.

“South Africans are missing out on affordable versions of life-saving medicines because generic competition is blocked by frivolous patents that prevent or delay generic competition,” said Julia Hill of Médecins Sans Frontières Access Campaign in Joburg.

While India, for example, avoided patenting the cancer medicine imatinib (Gleevec), South Africa granted Novartis an initial patent on imatinib in 1993, which expires this month. However, secondary patents granted by South Africa, including one on imatinib mesylate salts, extend Novartis’ monopoly until 2022. As a result, treating a patient with imatinib for a year in South Africa costs $33 896 (R312 234) – 259 times more expensive than the least expensive Indian generic alternative.

Médecins Sans Frontières said South Africa could implement similar rules to India without violating international trade rules. – Health-e News Service

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