Belinda Beresford
The Medicines Control Council has approved the use of a generic drug, Biozole, on public health grounds. The council’s acknowledgement of humanitarian arguments potentially opens the door to the mass importation of cheaper medicines to combat Aids and its side effects.
The ruling comes after the Treatment Action Campaign (TAC) illegally imported 3000 capsules of Biozole in what amounts to a test case over the distribution of cheaper drugs the government says cannot be imported legally because of patent laws.
The TAC is leading a campaign to pressure drug companies to lower the price of medicines used to treat people with HIV/Aids and to get the government to accept anti-retroviral drugs into the public health system. Biozole is a gene-ric equivalent of the anti-fungal drug fluconzole.
“This is a chink in the armour but still a significant development,” said Mark Heywood, a TAC director and legal strategist. “We’re thinking of calling a conference of generic drug producers and Mdcins Sans Frontires and possibly [the Congress of South African Trade Unions] to discuss how we can keep pushing this.”
The TAC and the Aids Law Project have been trying to pressure the government into using legal powers to allow the compulsory licensing of drugs needed to help control the HIV/Aids epidemic. The issue is expected to be taken to court.
The TAC applied to the council for Biozole to be given a Section 21 exemption to allow the drug to be used in restricted circumstances in South Africa without formal registration.
The exemption is usually given on a named patient or named doctor basis, and tends to be used where someone has been taking a drug overseas that is not registered in South Africa. But in this case the intent was to establish that a generic medicine can be prescribed even though international drug companies claim it is in breach of their patents.
The council granted the exemption solely for Biozole imported for use by the Brooklyn Clinic in Cape Town. The application was based on the grounds that the patented brand name drug, Diflucan, is “too expensive for patients to purchase”. The council made clear that it would be unwilling to allow mass distribution of Biozole, in part because legal requirements for registration have not been fulfilled and because the government has just accepted an offer of free Diflucan from the manufacturer, Pfizer. This donation will be distributed in public hospitals and clinics.
However, the TAC has pointed out that Pfizer’s offer only applies to the public health sector, and the need for cheaper generic drugs remains for those reliant on medical aid schemes or their own money. More than 300 doctors have offered to use generic drugs.
While the council’s ruling is something of a breakthrough in providing treatment for opportunistic infections to poorer people with HIV, it remains to be seen whether it will lay the ground for mass distribution of anti-retroviral drugs that attack the virus head on and not just its symptoms.
The government has so far refused to distribute anti-retrovirals within the public health system, although the announcement that the anti-retroviral Nevirapine has been authorised for use in preventing mother-to-child transmission of the virus is thought to be imminent.
The council’s ruling might allow private institutions to bring in cheaper anti-retroviral generics, but it would take a major shift in government policy and a tacit admission by President Thabo Mbeki that he was wrong to question the link between HIV and Aids before they are widely used in public hospitals.
However, the council’sexemption for Biozole could encourage the producers of generic drugs to seek registration, allowing them to become available to poorer people through the private or NGO sector.
The patented version of Biozole Diflucan is presently registered and sold in South Africa. It is used to treat some Aids-related illnesses such as a brain infection, cryptococcol meningitis and severe candidiasus (thrush). Oral and oesophageal candidiasis can be so severe that patients starve and dehydrate, unable to even open their mouths due to the pain of the infection.
The basis of the council’s submission was that Diflucan is too expensive, and providing a safe and effective generic would be in the interests of public health.
The council gave Biozole conditional approval, subject to certain criteria, including that the tablets undergo quality assessment in a South African laboratory.