Doctors Without Borders (MSF) has warned that registration delays could hamstring the South African government’s efforts to introduce the new tuberculosis drug delamanid in the public sector.
One of only two new TB drugs to be developed in the past 50 years, it could benefit an estimated 7 000 patients in the country, according to the international humanitarian organisation.
In March, the department of health announced it would begin treating a small number of patients with multi- or extensively drug-resistant TB with delamanid as part of a pilot project, also known as a clinical access programme. Patients like these who do not respond to the two most widely used TB treatments make up about 4% of all of the almost 300 000 people diagnosed with TB in South Africa last year, according to the latest World Health Organisation global TB report.
At the time of the announcement, the department and the country’s drug regulator, the Medicines Control Council (MCC), had already begun negotiating with delamanid manufacturer Otsuka for access to the drug. According to the director of the department of health’s drug-resistant TB, TB and HIV division, Norbert Ndjeka, the department had hoped this would have been concluded by May.
More than six months later, MSF notes that the drug still hasn’t been registered. The drug has already been approved for use in countries like South Korea and Japan, as well as in the European Union.
“MSF is urging Otsuka to apply for registration and for the application to be expedited by the Medicines Control Council once filed. Given the timelines involved, we are also calling on Otsuka to outline their plan to ensure enough treatment courses will be available during the clinical access programme to meet demand,” says Jennifer Hughes, an MSF drug-resistant TB specialist, in a statement Wednesday.
MSF warns that even expedited drug registrations can take years in South Africa.
Until the drug is registered, doctors wishing to prescribe it must submit time-consuming applications to the council on a per-patient basis for access on compassionate grounds.
Delayed registration of the drug in South Africa may also stymie access to the drug in neighbouring countries such as Lesotho and Swaziland. Because of limited regulatory capacity, both countries often rely on MCC approvals to guide their own national treatment policies, the MSF says.
Hughes says: “An estimated 7 000 drug-resistant TB patients per year in South Africa could benefit from the inclusion of delamanid in their treatment regimens, but we need Otsuka to act rapidly to register the drug and provide an interim access plan if we want people who need this drug to receive it.”
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