Belinda Beresford
Free anti-fungal drugs widely needed by people with HIV/Aids may be distributed within a few weeks, in line with an agreement signed two months ago by the Department of Health and the donor, drug company Pfizer.
The Medicines Control Council has said it will decide next week whether to register the anti-fungal agent fluconozol. If the registration is approved, the manufacturer of the drug, multinational Pfizer, says distribution could start within five weeks.
The agreement between Pfizer and the South African government provides for free fluconozol to be distributed through the public health system. The Memorandum of Understanding signed by Pfizer and the Department of Health on December 1 last year predicts there will be 620?000 clinical Aids cases in South Africa next year, with 80% being treated at public hospitals.
Fluconozol is used to treat cryptococcal meningitis, an infection of the brain. The memorandum estimates it will affect 12 000 people this year, and 22 000 next year.
Fluconozol is also used to treat oesophageal candidiasis, a yeast infection that affects approximately 17% of HIV/Aids patients. In its severe form, the infection can spread from the mouth through the patient’s body to the anus. People with the infection have difficulties eating because of the pain, and endure severe diarrhoea. If untreated, they can starve to death.
Pfizer estimates that approximately 160 000 patients will receive medication under the donation programme. The government will be given the commercial paediatric version free to treat children in the state system.
The restricted access to fluconozol, caused by its high cost, has led to high-profile action by the Treatment Action Campaign (TAC), which is campaigning for cheap or free drugs for everyone with HIV/Aids, and for the provision of generic drugs if necessary.
In an attempt to put pressure on the government, TAC bought 3 000 tablets of Biozol, a generic form of fluconozol manufactured in Thailand, into South Africa.
According to TAC the action was not only to put pressure on the government and drug companies directly about prices, but also to speed up the implementation of the Pfizer donation. The drug costs R80 to R100 a capsule, but R28 to the government.
Pfizer confirmed this week that it had submitted an application for fast-track registration of the tablet form of fluconozol on July 17 last year the week after the international Aids 2000 conference in Durban.
The donation programme will also provide training for health-care professionals.
This week generic drug manufacturer Cipla offered to provide triple therapy a three-drug anti-retroviral regime generally regarded as a gold standard of HIV care to international aid agency Mdcins sans Frontires for $350 (about R2?730) a year.
A local representative of the company said the offer was part of a three-tiered package. The $350 was designed to help the “totally poor”, those who could not even get to state hospitals. The government tender offer was $600 (about R4?680), and commercially the drugs would be offered for $1 200 (about R9?360).
The offer is subject to patent laws Cipla says it is not willing to have a legal battle over patents with pharmaceutical companies.