South Africa’s new patent law, once it is signed, will help to lower the cost of medicines and improve healthcare for all South Africans. (Image: EU Commission)
Section 27 of the South African Constitution guarantees everyone the right to access to health care. However, the government has not been able to follow the success of its antiretroviral (ARV) programme with similar programmes for other chronic diseases, especially endemic tuberculosis and hepatitis.
One of the biggest stumbling blocks to good universal health care has been the cost of patented prescription drugs. The national government has formulated a new patent law that would make it more difficult for pharmaceutical companies to be granted new patents for old drugs, but the new law has been held up for a year, in part by pressure from those companies.
Morgan Scholtz is gaunt; it sounds like he uses every ounce of strength just to speak. Even then, words escape his skeletal frame in wheezy, whispered gasps. Depending on the dosage he needs to treat his extremely drug resistant TB (XDR-TB), he spends between R12 000 and R24 000 a month on the seven different antibiotics he needs to stay alive. “I am one of the lucky few,” he whispers. “I was still covered by my parent’s medical aid when I was originally diagnosed but they can’t keep paying that. A single linezolid tablet costs R700 – the generic costs R75 but it’s not available in South Africa.”
A report released by Médecins Sans Frontières (MSF) in 2013 showed that linezolid was effective in treating XDR-TB, including in patients who were also HIV-positive. Linezolid was one of a small number of drugs that did not compromise the effectiveness of HIV treatments – a crucial factor in a country where many TB patients are co-infected with HIV, as is the case in South Africa.
For TB treatment to be effective, a patient needs to be in treatment for at least six months. The national Department of Health pays drug maker Pfizer R287 per 600mg dose; to treat one patient it costs the department R52 377. Private patients pay R589, plus mark ups, for a single dose at a cost of R123 000.
Pfizer holds multiple patents on linezolid and has renewed its patent since 2001, when the drug went on the market in Africa. It is the best antibiotic to treat drug resistant pneumonia, soft and deep tissue infections. But Pfizer has threatened to restrict use of linezolid if the country amends its patent laws to allow cheaper generics into the domestic market.
As long as you pay the filing fee with the correct paperwork you will be granted a patent in South Africa. This patent registration system allows drug companies to “evergreen” (register new patents for old drugs to which minor changes have been made or for which new uses have been found) existing drugs, and creates monopolies and drives up the price of medication in the country.
A 2013 Indian court victory could give South Africa precedent when faced with the legal threats from pharmaceutical companies. Indian law makes provision for the granting of new patents only if a drug has a new molecule and not simply a new formula for an existing drug. This has allowed India’s home-grown pharmaceutical industry to manufacture a wide range of cheaper generic alternatives to expensive life-saving drugs.
Novartis, the manufacturer of the cancer drug Gleevec, wanted to prohibit Cipla from manufacturing a generic version of the drug costing R800 per tablet by applying for a new patent on a reformulated compound. The Indian Supreme Court ruled that the country had the right to reject Novartis’s new patent as frivolous and re-affirmed the country’s right to produce cheap life-saving drugs for India as well as continue to supply 80% of the drugs used in Africa.
At the time of the ruling MSF’s Julia Hill said drug prices impoverished people with life-threatening diseases and kept life-saving drugs from the poor. “If South Africa develops a strong legal framework for its new patent law patients could have much better access to affordable life-saving medicines,” she said.
India’s patent law is not unique among South Africa’s Brics partners. Brazil, China and Russia all have legislation in place that sets a higher bar for new patents. By incorporating a patent examination system with stricter criteria and allowing for opposition to new patents, Brics partners have created home-grown pharmaceutical industries as well as given citizens access to cheaper medication.
They have also put into place research exceptions. Western pharmaceutical companies tend to search for cures for diseases from which they can profit – as in the case of Ebola, found in Africa but until recently unknown in the West, with research done by one small company. Similar issues abound with many curable diseases rampant in the developing world.
Liver cancer caused by hepatitis B is the most common cancer in men in Africa. It affects African men between the ages of 20 and 30 and causes about 1.3 million deaths a year. Treatment exists. Entecavir treats chronic hepatitis but costs R4 500 a month, and you need to take the treatment for life. The patent for Entecavir lapsed in 2001 but a new patent was granted, which also prevented the importation of an existing generic, which costs a tenth of the original.
International law allows South Africa flexibility in public health initiatives through the World Trade Organization’s Agreement on Trade Related Aspects of Intellectual Property Rights (Trips). Negotiated in 2001 in Doha, it allows countries to issue licences for life-saving drugs and to adopt stricter standards for issuing patents to older compounds filed as new drugs.
Access to cheaper generics is a public health care right. In 2001, there was a waiting list to receive ARV medication. At the time, it cost R75 000 a year to treat an HIV-positive patient. Thirty nine pharma companies banded together and sued to prevent the importation of cheaper generics.
That South Africa can now afford the world’s largest ARV programme and can treat patients for R1 500 a year became possible when that industry group backed down. It was a public relations disaster for Big Pharma, but it was the wariness over releasing pricing guidelines and profit margins that brought an end to court proceedings.
Public health activists learned lessons from that backtracking and are using them to push back against attempts to block the signing of the new National Policy on Intellectual Property. Among the many benefits of the new Act would be achieving National Development Plan objectives of a 50% reduction in TB deaths and having at least 80% of eligible patients on ARVs. It would also improve the wider health system, if resources were properly allocated.
Andaleeb Rinquist has XDR-TB. Too weak to walk, she left hospital expecting to die at home, surrounded by her family. The public health system could not afford to dispense the linezolid needed to treat her, so her husband took out personal loans of R70 000. He is now forced to work overseas to pay for ongoing treatment and to pay back the original debt.
“All I want to say is this: the government needs to prioritise people over the profits of pharmaceutical companies. Why should my family be broken up for the sake of their balance sheet?”