US Vice-President Al Gore's campaign for the presidency has became caught up in an escalating controversy over his opposition to a South African law aimed at providing low-cost AIDS drugs.
Gore, who officially launched his campaign last week, has actively opposed South Africa's Medicines and Related Substances Control Amendment Act. This seeks to bypass existing patents to allow the manufacture or import of expensive AIDS drugs at significantly lower costs than those currently charged by the pharmaceutical industry.
The law was approved by the country's parliament in 1997. But it has not been implemented because 41 pharmaceutical companies, led by the Pharmaceutical Manufacturers' Association of South Africa (PMASA), have challenged it in the High Court in Pretoria.
The law would allow compulsory licensing and parallel importation of medicines by South Africa. This means either that manufacturers inside the country could bypass patents and make the drugs more cheaply, paying only royalties to the patent holder; or that South Africa could import the drugs from third countries in which they are already less expensive.
The AIDS epidemic has exploded in South Africa, where recent surveys in pregnancy clinics indicate that 22 per cent of sexually active adults are infected (the figure was 14 per cent in 1997). But the latest AIDS therapy costs US$800 a month in South Africa, where the average annual income is $2,600.
“We have a Third World country that has this horrifying pandemic, and we can't afford the drugs,” says Robert Shell, a demographer at Rhodes University in Grahamstown, South Africa, who tracks the epidemic. “It is a question of life and death.”
But the South African law has riled the US government and the pharmaceutical industry. They claim that it is striking at the heart of the patent protection necessary for drug development. Led by Gore and the US trade representative, the US has pressed South African officials to rescind or rewrite the law.
A spokesman for Gore says he and Thabo Mbeki, the South African president, “are committed to working together to chart a course that will meet the medical needs of those infected with HIV or AIDS, without cutting off the commercial incentives that fuel medical research”.
Gore and Mbeki co-chair the US-South Africa Binational Commission, an economic diplomacy group. The spokesman adds that Gore “has a very strong record of efforts to fight AIDS in South Africa and his stands have been consistent with that”.
But the perception that Gore is leading an effort to deny cheap drugs to a country in a desperate plight is making its mark in the United States. International health and AIDS activists dogged Gore on the campaign trail last week, chanting “Gore's greed kills”.
“History will judge people harshly as to how they acted in this crisis. And it's going to be a harsh judgement on Gore,” says James Love, director of the Consumer Project on Technology, an advocacy organization affiliated to Ralph Nader.
Love and Nader wrote to Gore in April accusing him of using “an astonishing array of bullying tactics” to stop South Africa expanding access to AIDS drugs.
Even members of the Presidential Advisory Council on HIV/AIDS are challenging Gore. “He is wrong,” said council member Debbie Runions, a former Gore campaign volunteer, speculating whether “he's in the pockets of the pharmaceutical companies”.
Critics allege that the vice-president, who has typically embraced liberal causes such as the fight against AIDS, is being swayed by ties to the drug industry. For instance, a key lobbyist for the Pharmaceutical Research and Manufacturers of America (Pharma), Tony Podesta, is the brother of the president's chief of staff, John Podesta, and is also a Gore adviser and friend.
According to the Center for Responsive Politics, a Washington-based public-interest group, Gore's political action committee received $56,000 from individuals connected to pharmaceutical companies in 1998.
The vice-president's office denies that he has been influenced by drug makers. Officials point out that when Pharma asked the government last year to threaten South Africa with trade sanctions, it was rebuffed.
The country was merely placed on a ‘watch list’ of countries suspected of violating US intellectual property rights — a category that does not trigger sanctions. But two months later the White House announced that it was denying preferential tariff treatment for four South African imports.
South Africa's new health minister, Manto Tshabalala-Msimang, told Nature that the law is meant to address the “legacy of apartheid”. “We don't want to interfere with the patent rights, but we want to get drugs of quality at a price we can afford,” she says.
“Why would you want to buy the drug at SAR80 (US$13) when if you import it you would get it at SAR30?” she asks. “In situations of emergency, what do you do? This is the question I would pose to PMASA.”
Nonetheless, she says, she is making it “very high on my priority list” to meet the drug makers. She says the government is willing to negotiate the implementation of the law “in such a way that it meets the needs of the pharmaceutical industry”.
That will take some doing, according to the drug companies. “This is a major issue,” says Jeff Trewhitta, spokesman for Pharma. “The cost of research is very high. Patent protection is the lifeblood of the industry.”
Mirryena Deeb, chief executive officer of PMASA, says the law is so broad that it “undermines the patent law system” and allows the health minister to “just take away the patent right”.
An official at the office of the US Trade Representative (USTR), which has aggressively lobbied South Africa to reverse the law, calls it “offensive”. “They've decided that the way to solve the [AIDS] problem is to deny intellectual property rights.”
The USTR, Gore and the drug groups argue that the law breaches an important World Trade Organization (WTO) agreement on trade-related aspects of intellectual property protection, the ‘TRIPS’ agreement.
But Gore's critics read the agreement as allowing precisely the kind of action South Africa has taken. The agreement says compulsory licensing is permitted in cases of “national emergency or extreme urgency”.
Some observers say that the TRIPS language is sufficiently ambiguous for there to be honest disagreement on whether South Africa is in breach of it. What angers some, says one international health official, is that “commercial interests are leading [the US government to use] pressure tactics”, rather than using WTO dispute mechanisms.
According to a State Department report presented to Congress in February, Gore, the USTR, the Department of Commerce and the State Department have mounted an “assiduous, concerted campaign” to overturn the South African law.
Some argue that the issue goes beyond patent rights. Tom Coates, director of the AIDS Research Institute at the University of California, San Francisco, warns of the danger of drug resistant viral strains developing if the drugs are not imported in the right combinations and quantities, and administered with proper oversight.