South African activists challenge state on generics

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Further confrontation between treatment activists and the South African government looks inevitable, after members of the Treatments Action Campaign (TAC) and the Congress of South African Trade Unions imported cheap generic versions of antiretrovirals from Brazil for use in HIV clinics run by international aid charity, Medecins Sans Frontiers (MSF).

The move is in defiance of international patent laws and the compromise deal worked out at the meeting of the World Trade Organisation in Qatar last November which allowed governments facing a "health emergency" to manufacture, but not import generic versions of patented medicines, most notably HIV antiretrovirals.

The drugs imported by TAC - generic versions of AZT, 3TC and nevirapine - will be used to treat severely ill patients at an MSF clinic in Khayelisha, in the Western Cape. MSF reached an agreement last year with the government of the Western Cape to conduct a pilot study to demonstrate the feasibility of providing generic anti-HIV drugs to patients. Ellen t'Hoen of MSF said the 85 people in the study were doing well, and that "A very important message is to show that the drugs can be very effective even in very poor settings and that it can be done in South Africa, with a government and particularly a president who doesn't acknowledge that HIV causes AIDS and refuses to provide antiretroviral treatment.

Glossary

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

pilot study

Small-scale, preliminary study, conducted to evaluate feasibility, time, cost, adverse events, and improve upon the design of a future full-scale research project.

 

strain

A variant characterised by a specific genotype.

 

tolerability

Term used to indicate how well a particular drug is tolerated when taken by people at the usual dosage. Good tolerability means that drug side-effects do not cause people to stop using the drug.

At $1.55 per patient per day, the imported generic drugs cost less the patented drugs being offered by pharmaceutical companies to developing country governments at heavily subsidised prices.

TAC is calling on the South African government to manufacture generic AIDS drugs as the Brazilian government has done to make treatments more affordable.

Noting that various sources have estimated that 200,000 people will die in South Africa this year from AIDS-related illness, TAC activist Zackie Achmat said: "It is clear what path our government should take - apply for compulsory licences and produce the drugs locally."

The Brazilian government has made a formal offer to help the South African government with the technology needed to produce generic Aids drugs.

Stop gap measures may harm future treatment prospects for mothers

In a separate development the national South African government has been brought into conflict with one of its own provincial administrations after the health minister of the Kwazulu-Natal province announced that the province would offer nevirapine to pregnant women to prevent mother to baby transmission of HIV. The drug could be available within six months to pregnant women in 20 state run hospitals, with 40 smaller state hospitals providing the drug as soon as possible thereafter. Lack of resources, particularly a shortage trained counsellors and nurses, have been cited by the Kwazulu Natal government as the major obstacle to making the drug immediately available. The South African national health minister, Manto Tshabalala-Msimang condemned the move, saying it was unrealistically raising expectations. Late last year the South African government was ordered by the courts to provide nevirapine to pregnant women to prevent mother to baby transmission of HIV.

However, emerging evidence that treatment with nevirapine alone may not be enough to prevent a mother infecting her baby with the virus has led some actvists to condemn the move as short sighted. Researchers reported last year that 10 per cent of babies born to mothers given nevirapine in the HIVNET 012 study not only became HIV-positive but also became resistant to nevirapine, as did 20 per cent of mothers. Resistance to nevirapine develops very quickly; mothers received only one dose in this study.

Due to their low cost of manufacture, easy dosing regimens and tolerability, non-nucleosides are likely to be a key part of any drug combinations that are offered on a large scale in countries like South Africa. To avoid resistance happening, campaigners are calling for potent combinations such as AZT and 3TC to be used in pregnant women, because these drugs are powerful enough to control HIV and will prevent resistant strains from emerging.