Sunday Times (Johannesburg) - April 29, 2001

Arguably the best news ever heard for AIDS sufferers was last week's settlement between pharmaceutical manufacturers and the government which will allow cheaper drugs to be imported and made available in the public sector.

It means life-saving or -prolonging drugs will become available at much lower costs. This is a global victory in the battle against AIDS, setting a precedent which may reverberate around the world.

Drug companies decided to settle rather than to pursue their case against the government over the Medicines and Related Substances Control Amendment Act, which allows the government to import cheaper generic versions of drugs while patents are still in force.

The drug companies say they emerge from this skirmish with their patent rights intact, and government has agreed to honour international rules on intellectual property rights.

Internationally, this is seen as a watershed case, defining the limits of patent rights. Where these are seen to infringe on human rights, patent rights may no longer be deemed absolute.

South Africa is a signatory to the World Trade Organisation's Trade-Related Aspects of Intellectual Property Rights which protects intellectual property rights around the world.

But Article 31 of Trips allows countries to revoke patent rights in the event of a national emergency. An Indian drug company has invoked this clause on the grounds that AIDS is a permanent national emergency and is manufacturing generic anti-retroviral cocktails .

The latest figures suggest 4.7 million South Africans, or 12% of the population, are infected with HIV. Most of them have no medical cover and rely on the state for treatment. The settlement between government and the drug companies means they, too, may soon have access to anti-retroviral drugs capable of prolonging their lives.

One company specialising in the treatment of AIDS sufferers is LifeSense Disease Management, started in 1999 and now treating more than 2 500 patients.

While AIDS has generally been considered a death sentence, LifeSense managing director Andr van Bassen says this need not be the case. "We have two HIV-positive staff, one of whom was infected in 1985 and is still fit and healthy. The other was infected in 1991 and is equally healthy.

"HIV/AIDS need not be a death sentence," he says. "It is a chronic, manageable disease, like diabetes or hypertension."

The main reason for this is the big advance in the efficacy of anti-retroviral drugs used in the treatment of AIDS. LifeSense patients are given "triple therapy" anti-retrovirals, comprising either Viramune or Stocrin, manufactured by Boehringer Ingelheim and MSD respectively, and Combivir (a combination of AZT and 3TC). A month's triple therapy treatment costs less than R2 000.

Some drug companies have agreed to make anti-retrovirals available at a much lower cost from the beginning of 2001, reducing the cost of triple therapy by up to 50%.

Of the more than 2 000 patients being treated by LifeSense since 1999, only 23 have died and a further 39 been hospitalised.

"Without triple therapy, we would have had 10 times the number of deaths and hospitalisations," adds Van Bassen.

Not to downplay the seriousness of the disease, he emphasises that those who arrive for treatment in the late or terminal stages of the illness may be too late. "But, if they come for treatment early enough, they can add 10 to 20 years to their life."

Most LifeSense patients are covered by their medical aids, which typically allows up to R25 000 a year for AIDS treatment, as well as pathology testing.

Patients are often referred to the LifeSense treatment centre by their medical aids or they go there themselves. A confidential call centre is usually the first point of contact. A series of pathology tests are then done and, based on the results, medical advisers draw up individual treatment protocols. Patients enter a structured treatment programme with follow-ups once or twice a month.

Once placed on triple therapy, some of the results have been startling. "We've had people in wheelchairs or confined to death beds who made excellent recoveries and are back on their feet," says Van Bassen.

Last week, the Medicines Control Council registered nevirapine for pregnant mothers. It was already registered for use by adults and children with AIDS. The manufacturer, Boehringer Ingelheim, has offered the drug to the government for use in preventing mother-to-child transmission of HIV, where it has been shown to be 50% effective. But Cabinet has yet to give it the go-ahead, though approval by the council should speed this up. The company has agreed to monitor resistance to the drug, one of the issues which delayed its registration.

There is evidence suggesting indirect costs associated with AIDS - such as a member claiming for tuberculosis - are contributing to rising medical aid contributions. One solution is to allow administrators to have underwriting capabilities rather than merely performing administrative functions, says Rhys Edwards, managing director of Aon Consulting.

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