South Africa: How a Patent Is Blocking Access to a Life-Saving TB Medicine

ANALYSIS

Thousands of people in South Africa have drug-resistant tuberculosis (TB). Many of them will die. Death from TB can be slow and horrible.

Many of those who do survive will struggle with severe side effects and may need daily pills and injections. Some, like 23-year-old Phumeza who described her experience of TB treatment at a Treatment Action Campaign (TAC) press conference last week, will live, but lose their hearing.

Linezolid, made by the pharmaceutical company Pfizer, is one of the only drugs with some proven efficacy in treating drug resistant TB. It is currently sold in South Africa at an unaffordable R676 per pill in the private sector. The state pays R288 per pill. It must be taken daily for up to two years.

Médecins Sans Frontières (MSF) would like to treat 300 drug resistant TB patients in Khayelitsha with linezolid, but can only afford to buy the drug for little more than 20 patients. Right now, MSF doctors are in the horrible position of having to decide who gets the drug and who does not.

Linezolid is not particularly expensive to make. A generic version is available in India for a mere R25 per pill. Had South Africa been able to import the Indian generic, MSF would likely be able to treat all 300 patients in Khayelitsha who need the drug.

However, mostly because of South Africa's outdated patent laws, MSF cannot legally import the Indian generic, nor does it seem there is any workable way in which to force Pfizer to lower their price. The only option open to MSF so far has been to ask Pfizer - a request to which Pfizer has so far been indifferent.

On 4 September, the Department of Trade and Industry (DTI) released South Africa's much-anticipated Draft National Policy on Intellectual Property (IP) for public comment. This policy could in time provide us with the legal tools to deal more effectively with issues like the lack of access to linezolid.

The policy is not just about TB though, it will also impact the ability of medical schemes to pay for their members' cancer or heart disease medicines. The intricacies of patent law quickly become highly contested. Given the consequences this policy could have on healthcare in South Africa and the affordability of National Health Insurance, it is essential that this is not just a debate between industry lawyers, but between people from all sectors of the health system and broader society.