Roche suspends Tamiflu delivery in Canada, to protect supplies elsewhere

Canadian Press
Oct. 27, 2005

OTTAWA (CP) - Swiss drug giant Hoffman-La Roche moved to temporarily suspend pharmacy sales of its drug Tamiflu in Canada on Tuesday to conserve stocks as flu season nears.

It also issued a companywide directive that supplies of the drug destined for the public market worldwide should be prioritized for use as treatment for seasonal flu.

The move was a response to soaring sales that threaten to drain the entire winter's allowance of the drug before the flu season actively starts - typically somewhere in the weeks before or around Christmas.

When distribution resumes in Canada, the remaining available drug will be saved for use in high-risk settings - long-term care facilities and hospitals, explained Roche Canada executive Paul Brown.

In describing the actions being taken in Canada, Brown had said the move to prioritize use of the drug was "a companywide position."

Late Tuesday, he clarified that comment to make clear he could not say how Roche affiliates in other countries would go about ensuring the remaining stocks of the drug in the public market pipeline would be reserved for treatment of seasonal flu.

"Prioritizing for the seasonal epidemic . . . is a corporatewide priority," said Brown, a company vice-president and a former global team leader for Tamiflu.

"It is impossible to say how (achieving that) will play out worldwide."

The move in Canada could put an abrupt halt to individual stockpiling of the drug, a practice that has surged as fears of a pandemic have mounted.

It comes, ironically, as Canada's Pandemic Influenza Committee has been debating whether to issue a position statement on whether individuals should or should not stockpile the drug - or whether the government should refrain from advising on a personal choice.

Tamiflu is an antiviral drug that, when taken in the first 24 to 48 hours of infection, softens the severity and length of a bout of flu. It is not a vaccine.

Brown said additional supplies for pharmacy sales in Canada may not be available until next season.

Sales of the drug have exploded. One day last week in Canada, the company sold more of the drug than it did in the entire year 2004, Brown noted.

He wouldn't say how many prescriptions were filled on that day last week. But according to data collected by IMS Health, Roche sold 22,132 packs of Tamiflu in Canada in 2004.

The decision to suspend deliveries to pharmacies won't have an impact on the company's efforts to fill Tamiflu orders from governments that are stockpiling the drug as a hedge against an influenza pandemic, Brown said.

The Canadian Pharmacists Association seized on the announcement as ammunition in its war against Internet pharmacies, saying Tamiflu meant for Canadian drug stores had been diverted to individual stockpilers outside the country.

"If there's a significant amount of that product getting diverted to another market - in this case, the United States - then clearly that can lead to supply problems in the Canadian market, and that's what we've been expressing to Health Canada for three years or more," said executive director Jeff Poston.

Brown said Roche doesn't sell to Internet pharmacy operations and doesn't know how they obtain Tamiflu.

Roche has insisted it maintains two streams of product - one destined for for government pandemic influenza stockpiles and a more modest amount distributed to pharmacies, hospitals and long-term care facilities to treat seasonal flu.

The company sets the amount for the seasonal stream based on historic usage of the drug in that market. That allocation is set nine to 12 months in advance. Before pandemic fears surged this year, that usage was low in Canada and many other countries, where the new flu drugs Tamiflu and Relenza (made by GlaxoSmithKline) have never really been embraced by consumers.

Brown said once deliveries are resumed, the remaining product in the private stream will be triaged, with the drug being given on a priority basis to institutions caring for those at greatest risk.

"What we have currently available is what we have available,"' Brown said.

Canada's chief medical officer of health described as "sensible"' the company's efforts to reserve scarce drugs for people who are actually sick.

And Dr. David Butler-Jones noted the country's stockpiles of antiviral drugs should be adequate should a pandemic strike.

"In terms of mitigating the impact from a medical standpoint, we probably have enough now," he said.

Roche's move to suspend sales will likely increase the already enormous pressure on the company to allow other drug makers to produce generic versions of the drug.

Last week, the company agreed to meet with companies that believe they have the capacity to make the complex drug and said it would issue sublicences if it is persuaded other companies have the means to make Tamiflu to Roche's quality specifications.

But Roche has long contended it would be virtually impossible for another company to gear up on short notice to make the drug from starting material to blister pack. And even if a company could, it takes about a year to make the pills, from start to finish.

Brown has said a more likely outcome of these talks would be that Roche would find companies that can perform a step or two in the process, thereby allowing it to produce more drug.

Earlier Tuesday, Butler-Jones revealed Canada will increase its stockpile of Tamiflu and other antiviral drugs.

Some provinces have intentions to buy an additional five million pills - or 500,000 treatment courses - of the drug oseltamivir, sold as Tamiflu, over the next two fiscal years, he said.

That would bring holdings in the country up to 40 million pills - enough drug to treat four million people if the current regime of two pills a day for five days is sufficient to combat the influenza strain that causes a future pandemic.

Butler-Jones said that will be augmented with Relenza, another neuraminidase inhibitor - the drug class to which Tamiflu belongs - as well as a small supply of an older, cheaper flu antiviral known as amantadine.

"We'll buy Relenza as well. What percentage, I'm not sure."

It had previously been thought that the country had 22.5 million Tamiflu pills - enough to treat 2.5 million people.

But a recent stock-taking found that figure didn't factor in previous purchases that Ontario and other provincial governments made on their own. (Most provinces and territories placed bulk orders through Public Works and Government Services Canada.)

The stock-taking showed that a combined total of 35 million pills - or 3.5 million treatment courses - are in provincial and territorial and military stockpiles as well as the federal emergency stockpile.

Butler-Jones admitted some provinces will end up having a larger per capita share of drug because of purchases they have made directly. He did not name the provinces, but said they are the ones with the highest populations and the highest needs.