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Cheap HIV drugs are more important than patents

In January, the Thai government gave its domestic drug manufacturers carte blanche to effectively copy the formula for Abbot Laboratories' AIDS drug, Kaletra, and reproduce it in Thailand at a fraction of the cost.

A storm of protest ensued. The U.S. placed Thailand on a "priority watch list" of badly behaved countries. The European Union followed suit with a sharply worded letter from Trade Commissioner Peter Mandelson lamenting Thailand's outrageous disregard for Abbot's intellectual property.

Yet, contrary to common perception, Thailand's move was, and remains, in perfect observance of international law. The Doha Agreement on Trade-related Aspects of Intellectual Property Rights, signed by all members of the World Trade Organization, stipulates that "every country has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted."

"Compulsory" licenses essentially allow governments to revoke patents when they are deemed to work against the public good, either by stifling competition or unreasonably restricting access to a product. Once a royalty fee is negotiated and a time limit set, governments are free to compel the original patent holder to hand over its intellectual property.

The U.S. government routinely grants compulsory licenses for purely commercial reasons, largely to streamline production of consumer electronics and military hardware. Five such licenses were issued in the last year alone, one of them specifically to Abbott. To no one's horror or, frankly, interest, Italy recently issued a compulsory license for a drug that treats enlarged prostates.

Thailand's compulsory license addresses a far starker reality -- in a country of 65 million, 650,000 people (one in every 100) is infected by the AIDS virus. With soaring temperatures -- and refrigeration the exception rather than the rule -- heat-stable drugs such as Kaletra are crucial. Kaletra also has the advantage of low toxicity; for people whose livers have withstood years of harsh antiretroviral treatment, Kaletra is a gentler, but prohibitively priced, passport to life.

Why, then, has the Thai government's attempt to acquire a lifesaving drug run into a wall of corporate indignation and government censure?

The standard answer is that pharmaceutical advances are based on the respect of intellectual property. Without the protective role of patents, the argument goes, drug makers would fail to recover their research-and-development costs and consequently shy away from pursuing new drugs.

The truth is that more than half of all antiretroviral drugs were researched entirely on U.S. government grants. Both lopinavir and ritonavir, the two antiretroviral agents in Kaletra, were researched with public money. "Heck, we paid for them," said James Love, director of the Washington-based Consumer Project on Technology.

The pharmaceutical industry lives in fear of a cheap-drug domino effect. Thailand's compulsory license could inspire the entire continent of Africa -- where 70% of the world's 40 million HIV/AIDS cases are found -- to issue licenses for a series of drugs.

Countries such as Kenya and Uganda, not to mention South Africa, have not only the manufacturing base needed to copy and reproduce drugs for a fraction of their cost, they also have the right. So what's stopping them? "There is a history of trade pressures," Love said. "Very few countries are willing to face such pressures."

Despite death on an unimaginable scale, talk of compulsory licensing remains anathema in most of Africa, so millions of lives are left in the hands of a well-meaning yet ineffectual group of international donors, whose solution to the problem has been to purchase and distribute generic AIDS drugs made in India and Brazil. It's a noble effort, but with pitiful results. Fifteen years after the invention of antiretrovirals, only one in four Africans has access to them.

But it gets worse. For many of those who survived thanks to first-line treatments, the time has come to switch to newer, less-toxic drugs -- all of them patented, none of them even remotely available. "We're starting from zero again," said Buddhima Lokuge, U.S. manager of Doctors Without Borders' "campaign for access to essential medicines." By the time generic competition kicks in for the newer drugs, millions of people will have died unnecessarily.

The AIDS epidemic will constitute the single greatest loss of life in modern history. It is impossible for us in the West to conceive of death on such a scale. Far more difficult to understand, however, is the arbitrary nature of this holocaust: The drugs exist, why can't people have them?

African countries should find the resolve to follow Thailand's example and grant compulsory licenses when they see fit. In so doing, they would put an end to a drug monopoly whose human cost brings shame to us all.

Lara Santoro worked as a journalist in Africa from 1997 to 2004.

Copyright © 2015, Los Angeles Times
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