Drug patent theft carries high price

The Baltimore Sun

Imagine that you are an inventor and the government steals your highly lucrative idea. The next day, you are informed that the government plans to mass-produce your invention and give it away for free. If you're lucky, they'll give you a pittance for your efforts.

This is what happens, with increasing regularity, to the manufacturers of lifesaving medicines. The most recent example occurred in Thailand when the military-appointed government issued "compulsory licenses" to obtain two drugs.

The first, the HIV/AIDS drug Kaletra, is produced by a U.S. company. The second, the popular heart-disease drug Plavix, is manufactured by companies in France and the U.S. The Thai government granted itself the right to produce Kaletra for five years and Plavix indefinitely.

And in November, the Thai government issued a compulsory license for an antiretroviral treatment for HIV without even warning the manufacturer.

Thailand's behavior is hardly unique. Across the world, it has been going on for years. China, for example, produces more patent rip-offs than any other country. And in India, the government recently passed an amendment denying patents to pharmaceuticals derived from "previous knowledge," a purposefully arbitrary phrase.

Last week, an Indian company began offering a generic form of the cholesterol-lowering Lipitor in Denmark, despite the fact that the creator of Lipitor still holds the patent. Although the Indian 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, Brazil and other Latin American countries have repeatedly threatened to use patent theft to strong-arm pharmaceutical companies.

Even worse, U.S. lawmakers are piling on. Last month, 22 members of Congress signed a letter to the U.S. trade representative expressing their support for the Thai government's renegade action. This is a slap in the face to pharmaceutical companies, whose expensive investments in drug research and technology ensure that these lifesaving medicines exist in the first place.

Thankfully, however, it appears that those responsible for ensuring global health are taking notice of the detrimental effects such sweeping policies have on the world's poor.

In a speech in Thailand last week, three days after the Thai government's arbitrary decision, Dr. Margaret Chan, director-general of the World Health Organization, laid out the key reasons that communicable diseases remain such a large problem in poor countries and are often neglected by research and development. One of those reasons, she explained, is that the pharmaceutical industry "has little incentive to develop drugs and vaccines for markets that cannot pay."

First, 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, according to the Government Accountability Office, the pharmaceutical industry spent $60 billion on research and development. 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 developing world? Further, if it is acceptable for generic drug producers to make a substantial profit on the distribution of large amounts of drugs - none of which they invented - why are the companies that created the medicines not justified in turning a profit?

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.

Impoverished nations such as Thailand wish to combat diseases in the most efficient way possible. But even though it's easier for governments and activist groups to attack pharmaceutical companies and steal their patents, the greater challenge in the world's poorest nations is health care infrastructure, which is in serious need of investment.

In the face of these larger structural challenges, patent theft is simply a cop-out - and a deadly one at that.

Peter J. Pitts, a former associate commissioner at the Food and Drug Administration, is director of the Center for Medicine in the Public Interest, which accepts donations from health care corporations. His e-mail is peter.pitts@cmpi.org.

Copyright © 2021, The Baltimore Sun, a Baltimore Sun Media Group publication | Place an Ad