South Africa Takes Landmark Step to Ensure More People Have Access to Lifesaving Medicines

Valérie Batselaere/MSF
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MSF applauds country’s leadership in global fight to increase access to affordable medicines


NEW YORK/JOHANNESBURG, JUNE 1, 2018—The government of South Africa released its new intellectual property policy this week, proposing important amendments to the country’s flawed patent law which will help ensure improved access to affordable generic medicines, said the international medical humanitarian organization Doctors Without Borders/ Médecins Sans Frontières (MSF) Friday. The landmark decision brings hope to people across South Africa who cannot afford the medicines they need to stay healthy and alive, and puts an end to current policies that reward pharmaceutical corporations with undeserved patents, said MSF. This decision follows years of pressure from a local coalition of patient and advocacy organizations through the Fix the Patent Laws (FTPL) campaign.

“South Africa’s IP policy will pave the way for a new, progressive IP law in the country by prioritizing people’s needs over corporate profits,” said Claire Waterhouse of MSF’s Access Campaign.

South African patent law currently allows pharmaceutical corporations to easily obtain multiple, undeserved patents on a single drug and charge people exorbitant prices. This means it takes longer for more affordable, generic versions to reach the market. For example, despite the fact South Africa has one of the highest burdens of tuberculosis and drug-resistant tuberculosis (DR-TB) in the world, people with DR-TB in South Africa could not afford the drug linezolid while it was under extended patent monopoly and priced at over $49 per tablet. At the same time, generic versions of this drug were available at as low as $8 in many countries, including India.

“I was one of the lucky few who managed to access linezolid for my treatment when the drug was extremely expensive in South Africa,” said Phumeza Tisile of Khayelitsha, South Africa, who survived extensively-drug-resistant TB. “I hope new patent reforms will halt the granting of multiple patents on the same medicine and increase access to affordable generic versions of lifesaving medicines that people in South Africa are desperately waiting for.”

Two key newer drugs for treating DR-TB, bedaquiline and delamanid, have also been patented multiple times in South Africa, extending their patent terms beyond 20 years. These drugs are exorbitantly priced at $900 and $1,700, respectively, for a six-month treatment course. Research has shown that realistic generic target prices for these drugs could range from $48-$102 for bedaquiline and between $30-$96 for delamanid. However, because the drugs are under extended patent monopolies, prices are not expected to fall to these levels any time soon.

Until now, South Africa had a patent registration system that allowed companies to easily get patents reviewed and approved, and patients and groups trying to prevent unnecessary patenting have seen significant delays in hearings to oppose or challenge the patents, largely due to immense pressure from multinational pharmaceutical corporations. The new policy includes explicit action points to make sure each patent application is properly examined and only granted if it meets the country’s patentability criteria. It also includes procedures to allow any interested party to challenge patent decisions and recommendations to help ensure a public-health-based approach for issuing compulsory licenses. This process allows countries to override a company’s patent and make lower-cost versions of desperately-needed medicines available while a medicine is still under patent.

For decades—unlike countries like India and Argentina that have found a balance between supporting IP and protecting public health—South Africa has failed to take advantage of the flexibilities allowed under global World Trade Organization rules, leaving the country vulnerable to abusive patenting practices by pharmaceutical companies who use the system to inflate their prices. The IP policy finally released this week is in line with the international agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), which allows countries to amend their patent laws to benefit public health.

This new IP policy could reach beyond South Africa and encourage other countries to follow suit and stop issuing unmerited patents that keep medicine prices high.

“We really believe that if South Africa legislates and implements this policy swiftly, it will not only ensure that people have the medicines they need but will also set a positive example for other countries and civil society groups in Africa involved in patent law reform processes,” Waterhouse said.

The new IP policy would not have been possible without the collective efforts of FTPL campaign, a coalition of about 40 South African groups that formed in 2011 and advocate for patent law reform and engaged with the government in many different ways— including taking to the street in protest when needed— to ensure a pro-public health approach was taken. FTPL started with just three organizations: MSF, Treatment Action Campaign, and SECTION27.