Associated Press
TORONTO — The federal government has added the flu antiviral oseltamivir – better known as Tamiflu – to the list of patented medications that generic drug manufacturers in this country can apply to make and export to developing countries.
Douglas Clark, Industry Canada’s director of patent policy, confirmed in an e-mail late Wednesday that oseltamivir has been added to the list of drugs covered by the program called Canada’s Access to Medicines Regime, formerly known as the Jean Chretien Pledge to Africa Act.
The executive vice-president of Biolyse Pharma Corp., the Ontario company that has been lobbying for the right to make generic Tamiflu, said it will begin immediately the process of trying to get a licence to produce and export the drug.
And John Fulton suggested developing countries aren’t the only potential clients for the generic Tamiflu that Biolyse hopes to make.
"I’ll tell you straight up, there’s definitely an interest to investigate the possibility of a compulsory licence for domestic product," he said, referring to a legal instrument that would allow the company to sell generic Tamiflu on the Canadian market as well. That permission could not be granted through the Access to Medicines Regime.
"We definitely have that interest and we’re already researching that."
Fulton said the privately held company, located in St. Catharines, Ont., has the capacity to make between 500,000 and one million oseltamivir pills – or 50,000 to 100,000 treatment courses – a day.
"We’d like to have our first pill rolling off our encapsulator within six months," he said.
That could be optimistic. The two-year old legislation, hailed as an international breakthrough when it was brought into force, has not yet led to the exportation of a single pill.
Critics say the cumbersome legislation, which requires companies to attempt first to negotiate a sublicence, allows patent holders to drag out the negotiations. The new federal government has pledged to find a fix.
The legislation requires that generics be sold for no more than 25 per cent of the cost of the patented version. Tamiflu is made by Swiss drug maker Hoffman-La Roche, which already sells the drug at a reduced cost to poorer countries.
Roche holds the rights to Tamiflu, the flu drug countries around the world have rushed to stockpile in the face of fears an influenza pandemic may be pending. Tamiflu’s patent is owned by Gilead Sciences, which developed the drug.
Under pressure last fall to markedly increase production of the drug, Roche agreed to allow several manufacturers in poorer countries to make a generic version of Tamiflu.
As well, it expanded output by bringing the services of 16 external contractors into its own production line. By the end of this year, the company will be able to make 400 million treatment courses a year.
Biolyse asked Roche for the right to make Tamiflu last fall, but was not among the companies selected, Fulton said.
Roche formally objected to Biolyse’s bid to add Tamiflu to the list of drugs available through the Access to Medicines Regime. A spokesperson for Roche Canada did not return calls Wednesday evening.
Fonte: http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20060928/tamiflu_drugs_060928?s_name=&no_ads
Data de acesso: 28/11/2006