A chemotherapy medicine that sells for $500 a vial is about to be marketed for double that amount due to changes in Canada's intellectual property rules that, unwittingly, will leave one pharmaceutical company with a monopoly on a long-established cancer drug.
The regulation changes will give Sanofi-aventis Canada eight years of market exclusivity over the colorectal cancer drug oxaliplatin as soon as the firm receives its licence from Health Canada to sell it - expected as early as next month.
That means that three other companies will have to stop selling versions of oxaliplatin to cancer centres, hospitals and patients at deep discounts.
While changes to Canada's intellectual property rules last fall were necessary to conform to international trade agreements, Toronto-based pharmaceutical litigator Tim Gilbert said they were really meant for new drugs coming onto the market.
Although the changes are referred to as data protection, this is a bit of a misnomer. What the new rules confer is market exclusivity.
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 during which no generic maker can bring the same product to market.
"That law was never intended to protect a product this old," said Mr. Gilbert, a lawyer who represents Sigmacon Lifesciences Inc., a company that sells a cheaper version of oxaliplatin.
Oxaliplatin was first used in Canada for colorectal cancer in 1999. Malcolm Moore, chairman of the National Cancer Institute of Canada's gastrointestinal cancer group, estimates 4,000 to 5,000 Canadians currently receive that type of chemotherapy each year.
But the intellectual property rules affect more than one drug and thousands of patients.
The new rules will cover about 25 per cent of drugs that hit the market after the standard, 20-year patent has expired or not long before. Those rules provide eight years of market exclusivity for companies in this situation during which no generic can enter the market.
Very few drugs, however, are like oxaliplatin.
Despite being the standard of care for colorectal cancer patients, the drug-maker Sanofi-aventis only recently sought a licence from Health Canada to market the chemotherapy drug.
It has been distributed since 1999 under Health Canada's special access program, which provides unlicensed drugs to those with serious or life-threatening conditions when conventional therapies fail, are unsuitable or are unavailable - so long as no licensed alternative is available.
"[Data protection] was meant to encourage brand-new drugs to come on the market and for companies to spend the money to get them on the market," Mr. Gilbert said of the new changes. "This is old money spent a long time ago and they're going to get a windfall in Canada."
Jennifer Wardrop, managing director of Sigmacon Lifesciences Inc., which sells a 100 mg vial of the drug for $500, estimates that once Sanofi-aventis formally launches the drug, it will reap at least $50-million a year in retail sales.
It will add hundreds of thousands, if not millions, to the drug budgets of some cancer agencies.
Dhali Dhaliwal, president and chief executive officer of Cancer Care Manitoba, whose institution bought the less-costly oxaliplatin, predicted the impact will be considerable.
According to Joëlle Sissmann, vice-president of corporate affairs for Sanofi-aventis Canada Inc., the list price of oxaliplatin, known by the trade name Eloxatin, will remain at $1,000 for a 100-milligram vial. She said that is the price agreed upon by the Patented Medicine Prices Review Board, which regulates patented medicines to ensure they are not excessive.
In February, 2006, Ms. Wardrop's company became the first to sell a competitive version of the drug under Health Canada's special access program. Sigmacon set its price at $650 a vial, but by that March, had reduced it to $500.
