14 June 2019

Calls for government to allow generics of lifesaving drugs

Activists want multinational pharmaceutical company to lower over-inflated price of groundbreaking TB drug.

Activists from the Treatment Action Campaign (TAC) have called for government to scrap patent laws which prevent the generics of lifesaving drugs from entering the country.

TAC members staged a protest at the 9th SA AIDS 2019 conference in Durban demanding that Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (J&J), lower the price of tuberculosis medicine bedaquiline.

Bedaquiline is a new drug used to treat multi-drug-resistant (MDR) TB that was recommended by the World Health Organization (WHO) in 2018.

However, many high-burden TB countries have not been able to distribute it widely. The South African government pays more than R5000 for a person on a six-month course.

The price becomes even more unsustainable for patients who need 18 to 20 months’ treatment.

Tackling expenditure

The Department of Health’s Director of Drug-Resistant TB and HIV, Doctor Norbert Ndjeka, said the treatment had benefited more than 20 000 patients since last year.

"We are now giving it to virtually all patients with MDR-TB and XDR-TB. That is 10 000 per year.

We exclude children below 6 years but they form less than 1% of the cohort. Price is not an issue. We were spending R10 000 per patient for 6 months treatment, but we now spend R5400.

”But research from the University of Liverpool, the drug can be produced and sold profitably for between R120 and R240 per month. “Over-inflated price tags mean many people die without accessing lifesaving treatments.

They also force governments to divert scarce health budgets to drug procurement at the expense of broader health spending needs,” said Anele Yawa from the TAC.

The drug replaces toxic and less effective drugs, including painful injectable drugs that can have severe side effects.

Ahead of the curve

South Africa became the first country to start providing bedaquiline for all drug-resistant TB patients, ahead of the guidelines issued by the WHO.

Yawa commended the government for making sure that people with MDR-TB have access to bedaquiline.

However, he said the price should be lowered so that there can be more money for other health necessities — like employing more healthcare workers to find, diagnose and treat people with TB, and improve TB infection control in public spaces.

While bedaquiline is expected to generate $1.56-billion in sales in 2020, TAC activists say Janssen Pharmaceuticals benefited from public and philanthropic funding that went into the research and development of the drug, as well as government tax credits.

The activists also say that developing countries and international NGOs have largely provided the data for the WHO’s recommendation for the large scale adoption of bedaquiline, and have practically carried the costs of the later stage clinical development of the drug.

According to the WHO, there were more than half a million people with drug-resistant TB across the world in 2017. 

Public relations exercises

“Globally people are suffering and dying needlessly of drug-resistant TB because governments are unable to afford to procure bedaquiline to save their lives,” said Phumeza Tisile, a multi-drug-resistant TB survivor working with non-governmental organisation TB Proof.

“Instead, people with drug-resistant TB face severe pain and risk deafness taking horrendous treatments that have little value in treating this disease."

Activists have also criticised the multinational pharmaceutical company’s donations programmes, saying they are unsustainable and designed to deflect pressure.

“Donations are public relations exercises — reliance on donations not only creates dependence on a single supplier but also stifles governments' willingness to pursue more sustainable pathways, such as local production by generic manufacturers,” said Umunyana Rugege from SECTION27.

 Rugege said such donations allow J&J to divert public attention away from the company’s growing list of scandals and lawsuits in countries like India and the United States, but do little to provide TB patients with a sustainable supply of bedaquiline.

– Health-e News 

Image credit: iStock