News

An oncologist who represents Canada's cancer agencies says a spotlight needs to be shone on the drug industry now that a popular chemotherapy drug that sells for $500 a vial will soon be sold by only one company – for double that price.

“It seems to me that the spotlight needs to be shone on the drug industry and specifically on Sanofi-Aventis on how they justify a price of this nature, given the fact it has been available for 40 to 50 per cent of the cost they are proposing,” said Brent Schacter, chief executive officer of the Canadian Association of Provincial Cancer Agencies.

Friday, The Globe and Mail reported that changes to Canada's intellectual property rules will give one drug company a monopoly on a long-established cancer drug, oxaliplatin, that has a retail list price of $1,000 a 100 mg vial, the amount set by Canada's drug pricing regulator.

Regulation changes in October of 2006 will give Sanofi-Aventis Canada Inc. eight years of market exclusivity over the drug, known by the trade name Eloxatin, as soon as the firm receives its licence from Health Canada to sell it – expected as early as next month.

How this came to be is due to the complex world of patent law and Canada's need to conform to international trade agreements. Critics say the rule changes were not meant to help a long-established cancer drug, but only those medicines that are ready to hit the market just as the standard 20-year patent has expired or is about to.

For hospitals and cancer agencies, it will spell increases to their drug budgets; 4,000 to 5,000 Canadians with colorectal cancer are treated with the chemotherapy each year.

“It's going to be $500,000 more than we're paying now,” said Mark Dorreen, head of medical oncology with Capital Health in Nova Scotia., which provides core services to 40 per cent of that province's population. His institution will have to “go back to [paying] the top price. “Unless anything changes, we'll be stuck with that for the next eight years.”

That's because changes to Canada's intellectual property rules provide eight years during which no generic maker can bring the same product to market.

The rules have been in place since October of 2006.

, affect not only oxaliplatin, but 25 per cent of drugs that hit the market after their patents run out or are close to running out.

Although it is commonly referred to as a data protection act, that is a bit of a misnomer. What the new rules confer is market exclusivity. That's because the data that pharmaceutical companies use to demonstrate the effectiveness and safety of a medicine are very costly to create. The thinking is that these firms should get something back, in the form of eight years of a market all to themselves.

The drug has been available in Canada since 1999, and competing versions came on the market in 2006.

Joëlle Sissmann, vice-president of corporate affairs for Sanofi-Aventis, said data protection was needed because by the time it completed clinical trials and found the best use of the drug, its product patent had expired.

While the company has a patent on the formulation of oxaliplatin, that would not stop a generic company from bringing the same product to market. Data protection, she has said, is “really there to protect a drug that is not protected by its product patent.”

And, Ms. Sissmann said, it is not a matter of “being old or recent, it's a matter of being able to market a drug with conditions that will allow it to be protected.”

She said the list price of oxaliplatin will remain at $1,000 for a 100-milligram vial, the price agreed upon by the Patented Medicine Prices Review Board. which regulates patented medicines to ensure they are not excessive. Sanofi-Aventis, she said, has always maintained its retail price of $1,000 for a 100-mg vial, even when competitors were selling it for less.

Meanwhile, cancer centres, trying to save money by purchasing the drug at a discount, are finding their orders being cut back. This week, Health Canada began limiting the amount of the drug it would release to a six-week supply. Typically, a six-month supply of a drug is released under the special access program.

- the only place where the medication can be obtained as long as it is unlicensed.

Health Canada wants to minimize the amount of unapproved oxaliplatin on the market, pending a licensing decision on the drug, according to Health Canada spokeswoman Carole Saindon.

“They went and reduced it from six months to three months, and just reduced it to six weeks,” said Jennifer Wardrop, managing director of Sigmacon Lifesciences Inc., which sells a 100 mg vial of the drug for $500. She said 70 patients that bought her product have had their orders limited.

Cancer centres and others, she said, should be able to buy it all at a lower price, and “not be forced to pay the higher price.”

Ontario is the only province that does not fund the drug. However, many patients qualify for coverage from sanofi-adventis, which has given out $33-million worth of the drug across Canada since December, 2001.