In the battle against HIV/AIDS, one of the biggest challenges for developing countries is finding a way to provide affordable, effective treatment. South Africa has decided to give free AIDS medicines to any citizen who needs them. Brazil has had a similar program for years. But the only way poor countries can afford to do that is by using cheaper generic versions of patented AIDS drugs.
The medicines in question are called anti-retroviral drugs. They can allow AIDS patients to live longer and more productive lives. But they are expensive. In the United States, a daily dose of three different anti-retrovirals can cost $10,000 a year for one person.
Multiply that by five-million, the number of South Africans with HIV, and a national treatment program seems out of reach. But generic versions of the drugs can bring the cost down to more manageable levels of less than $140 per person per year.
South Africa has joined a growing list of countries that are finding a way to give anti-retrovirals to any citizen who needs them by using generic drugs.
One of the major hurdles in getting to that point has been patent laws, and especially the TRIPS agreement, an international treaty governing intellectual property rights.
Drug companies in India started making generic anti-retrovirals years ago, but India has not yet signed the TRIPS accord, and so international patent regulations do not apply there. That meant the Indian companies could make their own versions of patented drugs, without the permission of the companies that hold the patents.
Other countries, including Brazil and Thailand, got around the TRIPS regulations by declaring AIDS a national emergency. That allowed them to waive the TRIPS patent protections and start producing generic AIDS drugs.
But South Africa, which has proportionally more HIV-positive people than any other country on earth, has never declared a state of emergency over AIDS. And South Africa is a signatory of the TRIPS accord. So, most South African drug companies stayed away from the anti-retroviral debate entirely.
One company was different. Aspen Pharmacare, the largest generic drug maker in Africa, started pursuing its own strategy for getting into the anti-retroviral business, without violating TRIPS. Aspen's chief operating officer, Linda Philip, says the company decided to go ahead, without waiting for government to lead the way.
"Remember, we were sitting with a government that said that the virus doesn't even cause AIDS. Now, if you've got a government sitting with that, they haven't even got their minds around what causes the disease, you're years off them rolling out any program," he said. "And they're only going to declare a national emergency when they have a program, they've accepted the fact that the virus causes the disease, and they're actually doing something about it. And we just figured that, if we waited till then, you would wait forever. It would happen eventually, but you'd wait too long."
Quietly and with very little publicity, Aspen Pharmacare started approaching the major international pharmaceutical companies, trying to talk them into giving Aspen what is known as a voluntary license. That means Aspen would have permission to make generic versions of the bigger companies' patented anti-retrovirals.
After years of work, the first company finally agreed. In June of this year, Aspen began making Stavudine, the first generic anti-retroviral drug to be manufactured in Africa. The company also has licenses for five other drugs, and hopes to begin making those as soon as the South African Medicines Control Council approves them.
Ms. Philip says voluntary licensing was almost unheard-of in the pharmaceutical industry before AIDS.
"People don't give up their patents. Because they've got to recoup the $800-million that they spent getting it to market. .... What you've got now is a social disease, with a lot of emotion attached to it. And they were in a new arena completely. They'd never had to do this negotiation around voluntary licensing," he said.
One of the things that helped convince the multi-national drug companies, activists say, was publicity. AIDS activists were calling the big drug makers greedy and insensitive, saying they cared more about profits than peoples' lives.
Ms. Philip says the pressure extends to Aspen and other generic manufacturers, as well. She says, from a public relations perspective, the company had to put Stavudine on the market at the lowest possible price, with minimal profit. But she says there was never really a question of giving the drugs away for free.