Current patent laws granted J&J monopoly status, thus preventing cheaper generics from entering the South African market.

Co-authored by Candice Sehoma, Access Campaign Advocacy Advisor and Nirvaly Mooloo, Access Campaign Intern

In South Africa, access to affordable, life-saving medication is often still a pie-in-the-sky dream due to high costs and restricted availability, enabled by patent monopolies and a lack of registration by pharmaceutical companies. 

A classic example is a cystic fibrosis medication, Trifakta, manufactured by Vertex. Cystic fibrosis is a life-threatening genetic disorder that affects the lungs and digestive system. Trifakta is currently available at a massive cost of R50 000¹ a month in South Africa but could be available at a much-reduced price. To address this, a cystic fibrosis patient (Cherrie Nel) in South Africa has filed for a compulsory license to access cheaper generic medicine (a compulsory license is a legal mechanism that allows a third party to use, produce, or sell a patented invention without the permission of the patent holder.) 

In support of this action, Doctors Without Borders (MSF) Southern Africa and the Treatment Action Campaign (TAC) have filed papers to intervene as amici curiae (friends of the court) in the compulsory licence application². The case of this cystic fibrosis medicine is not unique to what MSF has seen consistently over time. It tells the story of a perverse patent system which enables pharmaceutical companies to continue exploiting people and national health systems for their last cent. 

South Africa could learn from India 

MSF has strongly advocated access to medicines for years, particularly for Drug Resistant-TB (DR-TB) treatment. One of our key demands has been the improved availability of the revolutionary drug bedaquiline. This groundbreaking medication has shown remarkable effectiveness by shortening treatment duration and greatly enhancing patients’ chances of overcoming the disease. South Africa stands out as one of the pioneering nations to use bedaquiline, and this year marks ten years since the introduction of this transformative medicine to patients with DR-TB.

However, despite its immense benefits, the high cost of bedaquiline has always posed a significant barrier to access for the broader population, especially considering significant reductions in healthcare budgets in South Africa³. The exorbitant pricing stems from extremely stringent patent protection for the drug in South Africa. Johnson and Johnson’s (J&J) bedaquiline will hold a monopoly in South Africa until at least 2027⁴ due to the existence of secondary patents. Meanwhile, other countries like India have rejected the secondary patents to extend J&J’s monopoly, and today, 18th of July 2023, the main patent for bedaquiline is set to expire in India and many other countries. It is expected that India will, therefore, shortly be able to access cheaper generic bedaquiline because of its landmark decision not to grant J&J monopoly extension thanks to its pro-public patent system, which has allowed for the challenging and rejection of this extension by J&J. South Africa could benefit immensely if they were to adopt similar public health flexibilities such as those enshrined in Indian patent law to prevent the practice of patent evergreening. 

While a last-minute agreement has been reached between the Stop TB Partnership/Global Drug Facility (GDF) and Johnson & Johnson⁵ (J&J) to enable the GDF to provide generic versions of bedaquiline to low and middle-income nations, however, several countries with a high burden of TB may be excluded. In addition, in countries such as South Africa, where J&J remains to hold patents on bedaquiline and whose national procurement rules prevent them from procuring medicines through the GDF, National TB Programmes will not benefit from this J&J/GDF deal. Although this agreement is a positive development, it would be even more impactful if there was an additional commitment to refrain from enforcing patents in countries like South Africa to allow them to procure from generic manufacturers directly. 

Anxiously awaiting the release of the reformed patent bill 

Cherrie Nel, the cystic fibrosis patient, plans to use a critical mechanism (compulsory license) in our law to try and get access to affordable medicine to treat cystic fibrosis.

However, it is worth noting that this is still a very challenging route. 

The process of obtaining a compulsory license under the current South African laws only allows for an application to be submitted before a court of law. Going through the process requires considerable funding and can be lengthy, with potential outcomes taking several years to be determined. If South Africa were to reform its patent laws to include an administrative process for requesting a compulsory license, this would ease the process and time required, helping to ensure a speedy and effective response. The South African government must be faster in taking action to reform its existing patent laws. More than two decades since civil society organisations brought attention to the fundamental issue of the high costs of antiretroviral drugs (ARVs), the government had an opportunity to address the problem and implement legislative reforms to avoid a repeat cycle for other diseases. 

It is important to note that the South African government has never used the many crucial moments and opportunities available to undertake these reforms; the Covid-19 pandemic was one such crucial moment which could have been used to address some of the inequities encountered in accessing Covid-19 medical tools. The South African Government publicly acknowledged on global platforms how patents prevent access to medicine yet did not see it fit to expedite patent law reforms in the country.  

After all these years, we anxiously await the release of a new, reformed patent bill. It is disheartening that the Minister of Trade and Industry has shown little responsiveness to the many lives lost and will continue to be lost due to our outdated patent laws. These lives could have been saved if our patent system prioritised human well-being over pharmaceutical profits. The delay in acting raises concerns about the government’s commitment to addressing the issue and ensuring access to affordable and life-saving medicines for all. If a compulsory license is approved for cystic fibrosis medication, it will be a groundbreaking development for a country such as South Africa. Not only would this benefit cystic fibrosis patients directly, but it would also establish a significant precedent for similar situations involving TB medicine and others, and the utilisation of a compulsory license as a valuable mechanism for ensuring access to affordable medicine when no other alternatives are available. 

However, the bottom line is that the only sustainable and long-term solution to these serious issues is fixing South Africa’s patent laws. Only then will we truly have a chance at systematically accessing life-saving medicines at more affordable prices. 
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