We're Taking Your Medicine, Literally
By Peter Pitts
New York

Imagine that you are an inventor and the government steals your highly lucrative idea, without any warning. The next day, you are informed that the government plans to mass-produce your invention and give it away for free.
This is what happens, with increasing regularity, to the manufacturers of life-saving medicines. And self-appointed public health activists the world over are urging other governments to follow suit.
The most recent example occurred last year in Brazil, when the government confiscated the patent of an antiretroviral treatment for HIV produced by Merck, a US pharmaceutical firm.
Brazil's decision came shortly after a similar move in Thailand, where the military-appointed government issued these "compulsory licenses" to obtain two drugs.
The first, the HIV/AIDS drug Kaletra, is produced by the US-based Abbott Laboratories. The second, the heart-disease drug Plavix, is manufactured by Sanofi Aventis of France and Bristol Myers Squibb of the United States. The Thai government had already issued a compulsory license for Merck's antiretroviral.
Thailand's behavior is hardly unique. Across the world, it has been going on for years.
Last year in India, the government passed an amendment denying patents to pharmaceuticals derived from "previous knowledge," a purposefully arbitrary phrase. Also last year, India's Ranbaxy Laboratories began offering a generic form of Pfizer's cholesterol-lowering Lipitor in Denmark, despite the fact that Pfizer still holds the patent. Although Ranbaxy's version was already available in India and some other emerging markets, Denmark is the first western country to sell a copycat version of the drug.
Meanwhile, many Latin American countries have repeatedly threatened the use of patent theft to strong-arm pharmaceutical companies.
Even worse, US lawmakers are piling on. Last year, 22 members of Congress signed a letter to the U.S. Trade Representative expressing their support for the Thai government's decision.
Such action is a slap in the face to the companies whose expensive investments in drug research and technology ensure that these life-saving medicines exist in the first place.
Thankfully, however, it finally appears that those responsible for ensuring global health are taking notice of the detrimental effects such sweeping policies have on the world's poor.
Just three days after the Thai government's decision, World Health Organization (WHO) Director-General Margaret Chan laid out the key reason why communicable diseases remain such a large problem in poor countries. As she explained, "[… the pharmaceutical industry] has little incentive to develop drugs and vaccines for markets that cannot pay."
In other words, such theft discourages innovation. Drug development is an enormously expensive, time-consuming venture requiring years of effort by teams of highly-trained researchers.
In 2004 alone, according to the Government Accountability Office, the pharmaceutical industry spent $60 billion on research and development. Indeed, the average drug costs nearly $1 billion to develop.
If a company stands no chance of recouping even a portion of that investment, where is its incentive to tackle the many diseases that ravage the Third World?
Western drug companies may make good scapegoats, but in Thailand alone, they have contributed tens of millions of dollars to family planning programs and training programs for nurses and doctors treating HIV/AIDS patients. And it's doubtful that the Thai junta has the resources or the know-how to create such life-saving drugs on their own.
Furthermore, there is no guarantee that generic drugs produced overseas will even work. Quite often, copycat versions of patented drugs are manufactured in factories that do not meet WHO standards.
No one can question that activists and governments alike wish to combat these diseases in the most efficient way possible. But the greatest challenge in the world's poorest nations is healthcare infrastructure -- not pharmaceutical patents.
In the face of these larger structural challenges, patent theft is simply a cop-out -- and a deadly one at that.
(Peter Pitts is President of the Center for Medicine in the Public
Interest and a former FDA Associate Commissioner)

 



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