South Africa, Colombia and Others are Fighting Drugmakers over Access to TB and HIV Drugs

South Africa, Colombia, and other countries that fell short in the worldwide race for coronavirus vaccines are taking a more combative stance toward drugmakers and opposing policies that deny millions of people with tuberculosis and HIV access to low-cost therapy.

Experts see it as a shift in how such governments deal with pharmaceutical behemoths, and they believe it will spur additional initiatives to make crucial drugs more broadly available.

During the COVID-19 epidemic, wealthier countries purchased the majority of the world’s vaccines early, leaving few injections for poor countries and generating a disparity described by the World Health Organization as “a catastrophic moral failure.”

Activists have recently opposed Johnson & Johnson’s efforts to protect the drug’s patent. TB patients petitioned the Indian government in March, requesting cheaper generics; the government eventually agreed J&J’s patent could be breached. Belarus and Ukraine then wrote to J&J, requesting that the patents be dropped as well, but received no answer.

J&J’s patent on the medicine expired in South Africa in July, but the business had it extended until 2027, infuriating protestors who accused the company of profiteering.

After that, the South African government began looking into the company’s pricing tactics. It was spending around 5,400 rand ($282) each treatment course, more than twice as much as poor countries receiving the medication under the Stop TB Partnership.

J&J said in September, about a week after South Africa’s investigation began, that it would abandon its patent in more than 130 countries, allowing generic manufacturers to duplicate the drug.

“This addresses any misconception that access to our medicines is limited,” the company said.

J&J’s turnaround, according to Christophe Perrin, a tuberculosis expert at Doctors Without Borders, was “a big surprise” because vigorous patent protection was normally a “cornerstone” of pharmaceutical corporations’ approach.

Meanwhile, the Colombian government said last month that it will grant a mandatory license for the HIV medicine dolutegravir without seeking approval from the drug’s patent holder, Viiv Healthcare. The decision came after more than 120 organizations petitioned Colombia’s government to increase access to the WHO-recommended medicine.

“This is Colombia taking the reins after the extreme inequity of COVID and challenging a major pharmaceutical to ensure affordable AIDS treatment for its people,” said Peter Maybarduk of the Washington advocacy group Public Citizen. He noted that Brazilian activists are pushing their government to make a similar move.

Nonetheless, other experts believe that much more needs to occur before impoverished countries can manufacture their own medicines and vaccines.

According to Petro Terblanche, managing director of Afrigen Biologics, when the coronavirus pandemic struck, Africa generated less than 1% of all vaccines manufactured globally but consumed more than half of the world’s supply. The business is a partner in a WHO-backed initiative to develop a COVID vaccination utilizing the same mRNA technology as Pfizer and Moderna.

Terblanche claimed that 14 million people died of AIDS in Africa in the late 1990s and early 2000s, when governments were unable to obtain the essential medications.

President Nelson Mandela’s government in South Africa eventually suspended patents to enable for greater access to AIDS medications at the time. This prompted more than 30 pharmaceutical companies to sue in 1998 in a lawsuit dubbed “Mandela vs. Big Pharma.”

Doctors Without Borders called the incident “a public relations disaster” for the medication firms, who abandoned the lawsuit in 2001.

Terblanche stated that Africa’s previous experience with the HIV epidemic was instructive.

“It’s not acceptable for a listed company to hold intellectual property that stands in the way of saving lives and so, we will see more countries fighting back,” she said.

Terblanche believes that challenging pharmaceutical companies is only one part of ensuring that Africa has equal access to treatments and vaccines. More robust health-care systems are essential.

“If we can’t get (vaccines and medicines) to the people who need them, they aren’t useful,” she said.

However, other experts argue that South Africa’s intellectual property rules have not been properly altered, making it too easy for pharmaceutical corporations to get patents and extend their monopolies.

While many other developing nations allow legal challenges to patents or patent extensions, according to Lynette Keneilwe Mabote-Eyde, a health care activist who advises for the nonprofit Treatment Action Group, South Africa does not.

The South African Department of Health did not answer to an inquiry on drug procurement and patents.

Andy Gray, who advises the South African government on vital medications, believes J&J’s recent decision not to enforce its patent may be due to the drug’s limited potential earnings rather than bowing to activist pressure.

“Because bedaquiline is not ever going to sell in huge volumes in high-income countries, it’s the sort of product they would love to offload at some stage and perhaps earn a royalty from,” said Gray, a senior lecturer in pharmacology at the University of KwaZulu-Natal.

According to the World Health Organization’s annual report on tuberculosis, which was released earlier this month, more than 10 million people were affected by the disease last year, with 1.3 million deaths. After COVID-19, tuberculosis is the world’s deadliest infectious disease, and it is now the leading cause of death among HIV patients. According to WHO, only approximately 2 out of every 5 persons with drug-resistant tuberculosis are being treated.

Zolelwa Sifumba, a South African doctor, was diagnosed with drug-resistant tuberculosis while a medical student in 2012. She had 18 months of therapy, taking approximately 20 medications per day in addition to regular injections, which left her in “immense pain” and resulted in some hearing loss. In South Africa, bedaquiline was not made a standard treatment until 2018.

“I wanted to quit (treatment) every single day,” she said. Since her recovery, Sifumba has become an advocate for better TB treatment, saying it makes little sense to charge poor countries high prices for essential medicines.

“TB is everywhere but the burden of it is in your lower and middle-income countries,” she said. “If the lower income countries can’t get it (the drug), then what’s the point? Who are you making it for?”

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