The Competition Commission of South Africa has decided to examine the American pharmaceutical company Johnson & Johnson for the exorbitant price it has been asking for the anti-tuberculosis medication bedaquiline, as well as for extending its 20-year patent until 2027 in order to prevent cheaper generics from entering the country.
During a media briefing held by Médecins Sans Frontières (MSF), the results of the investigation conducted by the commission were made public last week by the health department and the legal organization known as the Health Justice Initiative (HJI). When the commission has a basis to suspect that someone is acting unethically or exploitatively, it launches an investigation into the situation.
Evergreening is when pharmaceutical makers make insignificant adjustments to drugs or how they are used in order to maintain their monopoly on the market. The patent for bedaquiline compounds in South Africa was set to expire in July, but it was recently extended until 2027. This has led to charges of evergreening.
“The Competition Commission believes J&J could be in contravention of Section 8 of the Competition Act, which deals with excessive pricing and exclusionary conduct, which, in this case, refers to the practice of evergreening [because it results in excluding others from the market],” said Fatima Hassan, the founder and director of HJI. “The Competition Commission believes J&J could be in contravention of Section 8 of the Competition Act.”
“We feel that this has never happened before. Evergreening has not been investigated by the Competition Commission in any other cases involving pharmaceutical companies, as far as we are aware.
Even though tuberculosis may be treated, it remains South Africa’s leading cause of death despite the fact that the country has one of the world’s highest TB disease prevalence rates.
Bedaquiline, when combined with other medications, is an effective treatment for multidrug-resistant tuberculosis, a form of the disease for which conventional treatments are ineffective. The prior treatment consisted of up to two years of painful injections, which not only produced adverse effects such as hearing loss, but also had a high mortality rate. In contrast, the new medication is being hailed as a game-changer because of this.
In 2018, the South African Department of Health began providing bedaquiline, a medication that must be taken daily for a period of six months, to all individuals in the public health sector who required it.
At this time, the patient receives a six-month treatment plan from the health department, which costs 5,400 rand (about 232 pounds). On the other hand, countries that purchase bedaquiline through the Stop TB partnership’s Global Drug Facility will only be required to pay the equivalent of 2,446 rand (£105), as of the first of October, when a new contract with J&J will begin, the price will increase to 5,500 rand (£236).
The Global Drug Facility uses pooled procurement to negotiate payments, which enables them to fight for cheaper rates for TB drugs. This is made possible by the use of pooled procurement. However, countries such as South Africa that utilize open tender processes are unable to legally purchase medication through the use of such systems.
Candice Sehoma, a representative for MSF, stated that the organization is “enraged to witness that J&J prioritizes profit over the needs of the most vulnerable populations in a country with a high burden of drug-resistant TB.” “We call on J&J to offer the same price of 2,446 rand for bedaquiline to the South African government as they have offered to countries that are part of the Global Drug Facility deal,” which means “We call on J&J to offer the same price as they have offered to countries that are part of the Global Drug Facility deal.”
Since the beginning of this decade, people concerned about public health have been lobbying for a change in the law that would make evergreening subject to regulation. “Something for our legislators to consider is why we haven’t fixed our [patent] laws to ensure that we don’t expose ourselves to these kinds of exploitative practices,” said Russell Rensburg, the director of the Rural Health Advocacy Project at Wits University in Johannesburg. It is absolutely necessary to revise the patent laws in order to reduce health disparities.
This week at the United Nations General Assembly in New York, world leaders are participating in a high-level debate on the progress and stumbling hurdles in the fight against tuberculosis (TB), including practices such as evergreening.
Johnson & Johnson has been informed of the inquiry that is being conducted by the Competition Commission. “Johnson & Johnson is a longstanding and committed partner in South Africa’s fight against multidrug-resistant tuberculosis,” the company stated in a statement. Today, all patients in South Africa who require bedaquiline, our medicine for multidrug-resistant tuberculosis, have access to it thanks to our collaboration with the government of South Africa and other partners, which has contributed to a steady drop in the incidence of TB. Bedaquiline is one of the medicines that has contributed to the steady decline in TB incidence.