TORONTO — The federal government agreed to add Tamiflu to the list of drugs that can be made generically for export because need for the drug may exceed the patent-holder's ability to produce it, an Industry Canada official said Thursday.

"Roche has taken extraordinary pains to scale up its manufacture of the drug in the past few years, especially in the last year," Doug Clark, director of patent policy, said in an interview from Ottawa.

"They've made a herculean effort to supply, but the world's a big place. And the WHO has indicated we're still many years away, even at the current rate of meeting the outstanding demand, if the world is to be safe or well prepared for an eventual pandemic."

Oseltamivir - which Roche sells under the brand name Tamiflu - was recently added to the list of about 50 drugs that the Canadian government will allow generic drug makers to produce and export to developing countries to meet pressing public health needs.

Generic drug makers who want to take advantage of the patent exemption through Canada's Access to Medicines Regime must pay a moderate royalty and agree to sell the drug for no more than 25 per cent of the cost charged by the patent-holder.

While the program is widely associated with the effort to get affordable HIV-AIDS drugs to cash-strapped African countries, it is not restricted to drugs which treat HIV-AIDS or the infections, like malaria and tuberculosis, that often go hand and hand with it.

"It's not limited to a particular country, continent or disease category. It was never meant to be," Clark said.

"This is a humanitarian regime. It should be facilitative. It should made it easy for drugs to get to these countries."

Biolyse Pharma Corp. of St. Catharines, Ont., spearheaded the bid to get Tamiflu added to the list of drugs which could be subject to what are called compulsory licences.

Executive vice-president John Fulton said Wednesday that the company has the capacity to make between 50,000 and 100,000 treatment courses of the drug a day and hopes to be in the legal position to do so soon.

"We'd like to have our first pill rolling off our encapsulator within six months," he said.

But Biolyse and any other Canadian drug maker that plans to produce generic Tamiflu has to clear a series of regulatory hurdles. Those hurdles include persuading Health Canada that they can make a safe and effective form of the medicine. They must also attempt to negotiate a reasonable royalty payment with the patent-holder.

Officials of Roche Canada did not make themselves available for comment on the decision, but the company had objected to Biolyse's bid. And Roche has recently insisted its own annual production capacity - approaching 400 million treatment courses a year - is sufficient to meet current demand for the drug.

Fulton has also said Biolyse hopes to persuade federal authorities to allow it to make generic Tamiflu for sale in Canada.

But Clark said such a development is unlikely. And he said the Access to Medicines Regime can't be used to circumvent patent protection domestically.

"If Biolyse is successful at the end of the day, that will not be a springboard, ever, to supplying the domestic market. It's a wholly different process with entirely different criteria," he said.