In Shortage, Should Generic Tamiflu be Imported?

The antiviral medication Tamiflu is the most commonly prescribed anti-flu medicine, and, as with the H1N1 vaccine, there may not be enough to go around.

In an effort to address anticipated shortages, federal officials released the last of their stockpile of children's Tamiflu at the end of last month, as the New York Times reported; the Centers for Disease Control and Prevention has ordered new shipments of the drug, but they're not scheduled to arrive until January. (The CDC still has millions of doses of adult Tamiflu in its stockpile.)

Tamiflu is manufactured by a Swiss company called Roche Holdings, and the company has a patent on the medicine in the United States through 2016. Kristina Becker, a spokesperson for Roche, said in an interview Tuesday that the company is "confident" that it has the resources to meet demand for the drug.

She said that while supplies of liquid Tamiflu have been spotty in some areas, there are ample supplies of the capsule form of the medication, which can be opened up and effectively turned into liquid medicine through dilution with syrup. She also said there would be more shipments of the liquid version next month.

Roche "ramped up making the capsules at the start of the pandemic because we can make enough medicine for 25 times the number children in the same time it takes to make the liquid for one person," Becker said. "We wanted to be able to make enough medicine for as many people as possible."

Deciding how much Tamiflu is no easy task for Roche; the company says it takes about six to eight months to make Tamiflu.

Enter Dr. Yusuf Hamied, the chairman of a Mumbai-based drug company called Cipla. Cipla has developed a reputation for copying drugs and selling them at cheaper prices, perhaps most notably the AIDS drugs it has sold in Africa.

Earlier this year, Cipla won a court battle in India to produce a generic version of Tamiflu, called Antiflu. The company subsequently got certification from the World Health Organization that Antiflu was as effective as Tamiflu. It began selling it in India and Mexico at a discount from the cost of Tamiflu.

Now the CDC is reportedly signaling it is open to the possibility of importing Antiflu to the United States. (Representatives for the CDC have not yet responded to a request for confirmation.) Doing so would be controversial, since patent rules prohibit a Tamiflu generic coming onto the U.S. market for years.

Hamied, Cipla's chairman, says Antiflu is identical to Tamiflu and costs 20 to 30 percent less. He told National Public Radio that the company would "keep our companies open night and day, because this is an emergency" in an effort to provide it. (According to the Times, it could take three to four months for the company to actually bring the drug to the U.S.) Antiflu has not gone through the Food and Drug Administration Approval process; to import it, the government would have to both get the approval process expedited and override patent law.

Hamied has tangled with pharmaceutical companies before; as NPR notes, the head of GlaxoSmithKline has called him a "pirate" and questioned the quality of his company's drugs. Hamied, by contrast, doesn't shy away from characterizations of himself as a modern-day Robin Hood who provides medication to those who can't afford it.

Cipla, of course, is not doing the research and development necessary to develop the medication – an expensive and time consuming process that patent law is designed to encourage. If imitators could immediately flood the market with generics soon after a drug comes out, companies would have less incentive to spend the money necessary to develop it in the first place.

Yet such considerations can fall by the wayside in a public health emergency. The H1N1 virus has resulted in more flu deaths than in past years, but they are far from widespread. Should the flu situation get much worse, and shortages grow widespread, there will likely be increasing pressure on the government to turn to Cipla.

What do you think – should the government be open to overriding patent law and bringing Antiflu into the United States? Let us know your thoughts below.

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