Wednesday, Jul 9, 2008
The biggest hurdle in the way of compulsory licenses are strict international intellectual property laws, which protect the patents and the bottom lines of pharmaceutical companies and thus encourage them to continue investing the millions in research required to develop new medicines. Western countries, led by the United States, have fought strenuously on the international front to protect those patents -- in effect, placing a greater value on intellectual property, in the name of spurring innovation and saving more lives in the future, than on saving lives currently at risk.
Increasingly, those battles are pitting industrialized nations against developing countries. Ninety-five percent of the world's HIV and AIDS cases are concentrated in developing nations, with the vast majority dying in Africa, but Africa comprises a minuscule 1.3 percent of the global pharmaceutical drug market. The World Health Organization estimates that only 10,000 to 25,000 of the 25 million HIV-positive or AIDS-infected people in Africa have access to the drugs they need.
Such dreadful statistics raise profound questions about how strict drug patent laws should be -- and explain Jamie Love's fixation on compulsory licensing. Compulsory licensing allows governments to suspend intellectual property laws -- either because they're impractical or because they interfere with a country's ability to deal with a health crisis. "I believe developing countries should be permitted to embrace weak levels of intellectual property protection on medicines, and specifically either exempt essential medicines from patent protection or use compulsory licensing liberally," Love recently told participants of a joint WHO/WTO meeting on intellectual property in Norway.
In fact, Love goes further: He believes pricing controls should be applied to essential drugs not just in the developing world but in the United States and other industrialized nations as well. He also calls for limiting patent protections for biomedical innovations.
It's this kind of quasi-socialist thinking that scares and angers conservatives, pharmaceutical companies and the politicians on Capitol Hill they funded to the tune of $26 million during the last election. In a recent article on the Wall Street Journal's editorial page, public health policy expert Robert Goldberg accused Love of being "more interested in eliminating profits from the pharmaceutical industry" than in eliminating AIDS. Calling Love's organization "selfish," Goldberg charged that pursuing Love's policies would "suck profits out of companies and eliminate research funding."
Not surprisingly, AIDS activists take a more positive view of the work of the fiery Love. "Jamie has played a pivotal role in establishing the framework of much of the treatment access campaign," says Kate Krause of the HealthGap Coalition and ACT-UP Philadelphia. Krause attributes the recent round of brand-name drug discounts in Africa to Love's work with Indian generic-drug manufacturer CIPLA. "He has been among the first to investigate issues that no one touches, such as drug company costs; and realizing that the stakes are so high, he makes audacious demands of the drug industry."
Journalism professor Goozner says that while Love is only one of hundreds of activists dedicated to the AIDS fight, "he's an awful important player." He notes that Love's Internet list-serv, where he posts virtually every significant news story and government report on intellectual property issues in the healthcare field, "knits that entire community together and serves as a forum for instantaneously keeping it informed of the latest and most significant developments."
"He's a tireless lobbyist in the cause," Goozner says, "traveling to all the major meetings around the globe and firing off instant e-mails to those not in attendance ... That he does it for a fraction of the pay of the hundreds of industry flacks and bureaucrats arrayed against him, yet exposes them at their own game time after time, never ceases to amaze me. I won't say that forcing the drug companies to back off in South Africa is his greatest victory, because it wasn't his alone. But it's hard to imagine it would have happened as soon as it did without him."
Love is a blue-eyed firebrand whose silver-streaked locks of brown hair are the only thing that hint at his 51 years of age. The day I visited Love's modest digs at the Carnegie Foundation offices in Washington -- Love's operation runs on a fraction of the budget of most NGOs involved in AIDS policy -- he had just returned from yet another trip to Europe, where he attended an international meeting on AIDS and intellectual property. He took me on a quick tour, through a fortress of bookshelves and metal filing cabinets, where he gave terse orders to colleagues and tried to make the world of intellectual property policy more thrilling for a reporter.
Love explained that he is pursuing a three-part strategy in his push for compulsory licensing, with South Africa as the centerpiece. First, he's working with CIPLA, the generic drug manufacturer, to demonstrate what it actually costs to manufacture AIDS drugs: Love and CIPLA claim that it costs less than $1 a day to manufacture a three-drug cocktail for one patient. Second, he's turning to the private sector, lining up the international mining company Anglo American and healthcare providers to demand compulsory licenses from the South African and other governments. Finally, if those licenses are issued, he will work with CIPLA to get drugs to the corporations and healthcare providers that want to provide them to their employees and patients.
The foundations of Love's compulsory licensing push were laid in 1997, when the South African government passed a law that would make compulsory licensing and parallel importing easier. (Parallel importing is the practice of purchasing drugs from a third party in another country instead of directly from the manufacturer. It's cheaper because pharmaceutical companies usually charge lower prices in poorer countries.) The United States, under the stewardship of then-Vice President Al Gore, pressured South Africa to abandon or revise the legislation, and the pharmaceutical companies sued. In 1998, the South African government backed off, saying it would not issue compulsory licenses. Then, in March, a month before the trial was slated to begin, it also said it would not seek to do parallel imports. A month later, the pharmaceutical companies dropped their case against South Africa.
It's been over a month since the case was dismissed. Unwilling to take on a difficult legal battle against the South African government, few companies have stepped forward to demand licenses to produce generic versions of AIDS cocktail drugs: Only CIPLA and Aspen Pharmacare, South Africa's largest generic drug manufacturer, have attempted to do so. Meanwhile, drug companies have been slashing their prices -- in order to discourage South Africa from succumbing to the temptation of compulsory licensing. But he says they haven't dropped them to rock-bottom production cost, and working with CIPLA, he has numbers to prove it.
The pharmaceutical GlaxoSmithKline, for example, announced on June 11 that it would discount Combivir -- a two-drug combination -- to $2 a day for governments, charity organizations and NGOs in Africa. CIPLA, however, has offered the same drug combination of Lamivudine and zidovine plus a third drug, nevirapine, for between 96 cents a day for nonprofits or $1.64 for governments -- at a low-end cost of $350 a year, as much as 50 percent less than Glaxo's lowest bid, according to the World Health Organization.
Given these numbers, in a situation where even pennies more in cost mean lives lost, Love keeps hammering away on the generic-licensing theme. And he's lined up some heavy hitters in the private sector to back him: The international mining company Anglo American, the largest mining company in South Africa, has proposed supplying as many as 50,000 of its HIV-positive employees with generic drugs made by CIPLA. In March, CIPLA registered a request with the South African government for a compulsory license for the key drugs it needs to produce the cocktail. The company expects a prolonged legal battle with the government.
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