The patent holder of bird flu drug agrees to talk on generics
the row over licensing of avian flu drug Tamiflu, has given a glimpse of how the issue of access to drugs will be handled, in future public health emergencies.
The Swiss pharma major, Roche, which has properietory rights over the drugs, had finally agreed to talk with generic drug manufacturers about producing a cheap version of Tamiflu -- one of the two known avian flu treatments. But on October 26, 2005, secretary of the Union ministry of health revealed that Roche had never applied for a patent in India. This gives Indian generic manufacturers a green signal to produce with or without Roche. This also brings relief to many developing nations: many without the capacity to develop their own generics were looking to import it from India.
cipla's plans could have embroiled the two companies in a legal battle, if Roche had applied for a patent in India. But Roche would not disclose its patent position then. "Not disclosing patent applications is a common tactic used by these manufacturers," said D G Shah, secretary general, Indian Pharmaceutical Manufacturers Alliance. It deters generic drug manufacturers from producing cheap alternatives. Roche has also not disclosed its production capacity of the drug, and had categorically refused to talk with generic manufacturers at that point.
Tamiflu is currently in short supply. Roche plans to double its capacity by the end of the year, and again by mid-2006, but this might not prove sufficient. us- based market research firm Verispan Ltd says that 87,000 Tamiflu prescriptions were made in the two months before October 7, 2005, compared to 13,000 in the same period last year.
Though the virus has affected mostly Southeast Asia, the European Union is contemplating a complete ban on imports of wild birds after a parrot died in quarantine in the uk, of a dangerous form of the virus (h5n1). Cases of less virulent forms of bird flu have already been found in Greece, Croatia and Sweden. The us government has stockpiled more than four million doses of anti-flu drug and plans to acquire 20 million more. Avian flu deaths have also been reported from Indonesia, Thailand, Cambodia and Vietnam.
On October 18, 2005, Roche finally agreed to enter into a discussion with governments and other manufacturers to produce Tamiflu. Soon after, India's largest pharmaceutical company Ranbaxy, said it had begun talks with Roche to license Tamiflu. However, the health secretary said that there was no need for it. "The secretary's comment is wonderful news" said Shah, as it means no permission is needed to start production. Generic manufacturers still have a difficult road ahead. There are concerns that the drug is difficult to manufacture as it involves a complicated ten step process. Further, there are also supply constraints for raw materials. Roche's help might still be needed to tackle the crisis.
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