The manufacturer of the leading drug against avian flu said yesterday it was willing to discuss arrangements for other companies to produce it despite having an exclusive patent.
A spokeswoman for Roche Holding AG, a Swiss multinational company, said it might agree to allowing both governments and companies to produce the antiviral drug Tamiflu under sub-licensing agreements.
The statement came on the same day that Sen. Charles E. Schumer (D-N.Y.) called on Roche to reach an agreement within the next month to permit five American companies to manufacture Tamiflu, or face legislation that would strip the company of the patent. Schumer and others have criticized the pace of Roche's efforts to meet fast-growing world demand for its product.
"Roche is putting their own interests ahead of world health," Schumer said. "If they don't begin to actually license the patent for Tamiflu to dramatically increase worldwide production, I am going to pursue a legislative remedy a month from today."
Officials at the World Health Organization have also indicated concern over the lagging supply of Tamiflu and have referred to the right of nations under international trade treaties to break patents during health emergencies.
Also yesterday, European foreign ministers declared avian flu a global threat; it has been discovered in migrating water fowl in Greece, Romania and Turkey. The especially dangerous flu has been spreading through the bird population in Asia since 2003 and has infected 117 people, killing at least 60. Health experts fear the virus, which until now has mostly passed directly from birds to humans, could evolve in ways that would allow it to pass easily from human to human, setting the stage for a pandemic that could put millions of people at risk.
E.U. health and safety commissioner Markos Kyprianou said most European countries did not have sufficient stockpiles of antiviral drugs.
"We have not yet reached the level of preparedness that we should have," he said after an emergency meeting in Luxembourg. "This is a global threat, and there is need for international action."
Roche officials said the company planned to sharply increase production of the drug worldwide and had received approval to build a new Tamiflu manufacturing plant in the United States. They also said Roche was willing to discuss granting sub-licenses to any government or private company interested in manufacturing Tamiflu or collaborating in its production. Roche had said previously that making Tamiflu was a complex process that would take generic drug makers at least two or three years to master.
So far, only Taiwan has sent a letter to Roche asking permission to manufacture Tamiflu. But the Indian drug maker Cipla Ltd. announced yesterday that it was seeking a license from Roche to produce a generic version. A Cipla spokesman said the company believed it could begin to produce inexpensive versions of the drug by early next year. Tamiflu currently costs $60 for a course of treatment.
The government of Thailand, which is near the center of the flu epidemic in birds, has also said it was considering manufacturing its own supply of Tamiflu.
The issue of international drug patent infringement is a contentious one -- with public health advocates still angry over the slow pace at which AIDS drugs were made available to poor people in underdeveloped parts of the world, and drug makers adamant that effective patent protection is essential to the development of new drugs.
Until this year, Indian drug companies did not abide by many international patents and produced unapproved versions of many medications for distribution to poorer nations. India's entry into the World Trade Organization has largely ended that practice, leaving many nations without the resources to pay for drugs like Tamiflu.
The Bush administration has secured delivery of about 4.3 million doses of Tamiflu and has about 8 million more doses on order. The government has also signed a $100 million contract with the French company Sanofi Pasteur to develop a bird flu vaccine.
Correspondent Doug Struck in Toronto contributed to this report.