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Wednesday, April 19, 2006

Terrorism, Pfizer Style

James Love doesn't pull any punches with this story about Pfizer.

"Recently Pfizer sued the head of the drug regulatory agency in the Philippines, personally, asking for 1.4 million pesos in damages. Pfizer also sued another government official, the regulatory agency itself, and a government-owned trading company...

In the Philippines, Pfizer charges from $.88 to $1.46 per day for Norvasc (more for the larger dose). In 2004, the average per capita income in the Philippines was $3.20 per day. Eighty percent of the population lives on less than $2 per day. Pfizer knows this. They have calculated that they can make greater profits selling Norvasc at a high price to a small number of the wealthiest Filipinos (less than 5 percent of the population can afford the drug), than a larger number of people with lower incomes.

The Philippine government is trying to undertake some extremely modest measures to lower the price of this drug. They want to import versions of the drug that Pfizer sells in other countries. Pfizer charges much lower prices for the same drug in Thailand, Indonesia, India and other countries in the region. And, the Philippines government says it won't even do this until June 2007, when the Pfizer patent on Norvasc expires.

In other words, the Philippines government is allowing Pfizer to price Norvasc out of reach for 95 percent of the population of the country for the entire term of the patent, but they want the cheaper prices foreigners pay, when the patent expires.

But this isn't good enough for Pfizer. Pfizer is suing the government, and government officials personally, so it can stop the process of testing the imports. Pfizer figures this might delay the imports of the cheaper drugs for 18 months. And Pfizer also hopes they can stop the Philippines government from reducing the prices of other Pfizer products, including Lipitor, Zithromax and Unasyn, which are in a similar situation.

The legal issues are described briefly in this blog by my colleague Judit Rius.

Pfizer seems to be succeeding in bullying the Philippine government. Apparently the Philippine government has stopped efforts to register the cheaper imported products.

This is only the latest installment in a long history of pressure on the Philippines government. For example, check out this astonishing report by Jennifer Ellen Mattson on a 1999 Collaboration between the US government and pharmaceutical industry to oppose Philippine government efforts to promote expanded use of generics for off-patented drugs."

If you have the time Jennifer Ellen Mattson's timeline referred to by Love as 'astonishing' is well worth a read. It's a classic and not very appetising case study in how the international politics of intellectual property work.

Kim Weatherhall says:

"To introduce a generic (or even an imported version of a drug) to the market, regulatory approval must be obtained from the TGA (our equivalent of the US FDA). That means demonstrating 'bioequivalence' - to prove the drug is the same as the approved version sold by an innovator company...

Australia already has springboarding provisions that that allows activity by generics manufacturers during the patent period to enable them to collect the information required to obtain regulatory approval...

I just can't believe that Pfizer would have the nerve to sue for this kind of activity, perfectly legal in most places around the world. The patent will be respected, they get the patent term. Actually, that's not hard to believe - that is use of existing law. The Phillippines should be supported to amend its law to allow springboarding. I find it harder to believe Pfizer would sue government officials in their personal capacity - that is just unconscionable additional pressure to add to the equation, and just plain inappropriate."

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