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South Africa May Overhaul Patent Policies

A newly mechanized pharmaceutical machine that helps pharmacists dispense medicine is loaded with ARV medication, at the U.S. sponsored Themba Lethu, HIV/AIDS Clinic, at the Helen Joseph hospital, in Johannesburg, South Africa, Nov. 15, 2012.
South Africa’s government is looking to change its National Policy on Intellectual Property - a move that activists say could make a huge difference in prices for many important medications. Critics of the current policy say it makes it too easy for companies to win patents on drugs and prevent competition.

Activists and medical experts said millions of South Africans were denied access to affordable medicines because of the nation’s intellectual property laws.

Critics said the current laws allowed pharmaceutical companies to effectively keep patents on their medicines forever by changing a tiny element -- such as a salt or another insignificant molecule -- and thus renew the patent for another two decades. Those patents kept competitors at bay and keep drug prices high.

But South Africa is now looking to change its policy, and advocates said they were encouraged by a draft that appears to seek to close some of those loopholes.

International aid group Doctors Without Borders and several South African groups said they wanted to see more scrutiny of patent applications, for third parties to be allowed to oppose patents, and -- in some cases -- for the government to grant special licenses that allowed generic versions of very expensive patented drugs.

Marcus Low, a researcher at the Cape-Town based Treatment Action Campaign, said these changes could allow production of much cheaper medicines.

“So in general, the price of the medicine comes down dramatically once there’s generic competition. In first-line AIDS treatment, the price came down from over $10,000 per patient per year to under $100 per patient per year in the last 10 years, and that’s mostly due to generic competition,” he said.

The Treatment Action Campaign is widely credited for raising the profile of HIV in South Africa and with forcing the government to make anti-retroviral drugs more widely available.

Umunyana Rugege, an attorney from Section 27, a public interest law center, said the current patent system made it too easy for pharmaceutical companies to protect their products.

“One of the key messages that we want to get across in this process is that South Africa has a system in which for every patent application that is made at the patent office, a patent is granted," she said. "That means that the patent office doesn’t actually examine each patent application to see whether or not that application meets the legal requirements of patentability …. so what we want to see is what we call an examination system, a substantive examination system. This is something that has been proposed in the policy.”

Rugege said that proposal was not without challenges -- South Africa had a lack of skilled workers and its budget was already stretched thin. But she noted that other countries that set up an examination system found it was not that hard to establish.

“An interesting thing that we’ve learned from the India example is that where resources and political commitment are there, you can establish an examination system in a relatively short amount of time," she said. "And also, what we’ve seen from India is that the examination aoffice actually generates revenue.”

Public comments will be accepted on the draft policy until October 4.