News

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.

"When we came in, we reduced the cost from coast to coast. That was our goal," Ms. Wardrop said. "... Now it's going to be treated as a brand and it's going back up to $1,000. We think that's a very unfortunate situation that affects every Canadian. It's the taxpayer's dollar that pays for cancer drugs."

In April, Mayne Pharma Canada Inc. (since taken over by Hospira Inc.) came onto the market, followed in September by Omega Laboratories Ltd.

At one point, the drug could be purchased for as little as $400 a vial.

Sanofi-aventis says it has always maintained its retail price of $1,000 for a 100-mg vial.

Cancer centres in Prince Edward Island, Nova Scotia, Ontario, Saskatchewan and Manitoba snapped up the knockoff cancer drug.

"We've been purchasing at a lower price," said Vickie Sullivan, director of the capital health cancer-care program in Nova Scotia, which provides core services to 40 per cent of that province's population. "... I would hope they would have a competitive price."

Data protection was needed for Sanofi-aventis because by the time it had completed clinical trials and found the best use of the drug oxaliplatin, its product patent was expired.

The company has a patent on the formulation of the drug, but that does not stop a generic company from bringing the same product onto the market.

"Data protection is really there to protect a drug that is not protected by its product patent," Ms. Sissmann said.

"Since it's 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 stressed that Sanofi-aventis has made sure that patients get oxaliplatin. The drug company has given away the equivalent of $33-million worth of drug to patients since December, 2001, in provinces that did not fund it.

Alberta only recently began paying for oxaliplatin and Ontario does not fund the drug, although some hospitals have picked up part of the cost.

*****

THE PROTECTION OF 'SECRET STUFF'

What data protection rules do, in the form of amendments to the Patented Medicines (Notice of Compliance) Regulations and to the Food and Drug Regulations, is prevent the telling of secrets.

"The basic idea is that because brand companies have to give a government or third party trade secret stuff, it's really theirs," said David Lee, director of the office of patented medicines and liaison in Health Canada's therapeutics products directorate. "We're in custody of somebody's trade secret information. There's an obligation on us to not disclose it in such a way that it would cause unfair commercial advantage for someone else."

The amendments, effective Oct. 5, 2006, essentially permit Canada to conform to the North American free-trade agreement and the trade-related aspects of intellectual property rights agreement, Mr. Lee said.

The new data protection rules are meant for those 25 per cent of drugs that hit the market after the standard 20-year patent has expired or not long before. Medicines covered under the new data protection rules have eight years of market exclusivity at which point no generic can enter the market.

Virtually all agree the changes are needed.

But people disagree over two issues: some are disturbed that an older drug, such as oxaliplatin, would benefit from these new changes, and more broadly, many wonder why Canada provided eight years of protection rather than the five years the United States allows.

According to E. Richard Gold, director of the Centre for Intellectual Property Policy at McGill University, five years was all that was required to fall in line with international trade agreements.

"I think it was a bad move. I find it unjustified," Dr. Gold said of the eight years of data protection. "There's no logic behind it, no market need in Canada for it. If they were hoping it would stop the pharmaceutical industry from asking for more, it won't."

And ultimately, Dr. Gold said, the cost will be borne by "provincial governments in terms of their purchase of pharmaceutical products," in addition to private insurance companies and patients.

Generic drug makers are against the decision, saying the government has given a gift to brand name pharmaceuticals, with no promise of receiving anything in return. It has launched a challenge in Federal Court, saying the eight-year rule vastly exceeds the five years necessary to comply with international trade rules.

"It will deny generics the ability to get to market," said Jim Keon, the president of the Canadian Generic Pharmaceutical Association. Had the rules been in place five years ago, it would have added $600-million to Canada's overall prescription costs, he estimated.

But Canada's Research-Based Pharmaceutical Companies (Rx&D) is pleased with the changes, saying they bring Canada within the international norm. Europe provides 10 years of data protection.

"The first main impact would be on the ability of the pharmaceutical industry to do its best work," said Philip Blake, chairman of Rx&D's board of directors. "It's bringing health improvements to Canadians. It's good strong protection for innovation."

Lisa Priest

*****

Oxaliplatin history

Known by the trade name Eloxatin, oxaliplatin is a colourless, platinum-based chemotherapy drug.

It was discovered in 1976 at Nagoya City University in Japan by professor Yoshinori Kidani, who was granted a U.S. patent in 1979.

It was then licensed by Debiopharm, a Swiss drug company, where it was developed as a treatment for advanced colorectal cancer.

Debiopharm licensed the drug to Sanofi-aventis in 1994.

It became available to patients under Health Canada's special access program in 1999. It is used on 4,000 to 5,000 Canadians a year.

Lisa Priest

*****

The distributors

Under Health Canada's special access program, patients with serious or life-threatening conditions can obtain unlicensed drugs when conventional therapies fail, are unsuitable or are unavailable. Oxaliplatin has been available under the special access program since 1999.

Here is a breakdown of the companies distributing oxaliplatin, when they began selling a new version of oxaliplatin and how many authorizations were completed by Health Canada.

Sigmacon Lifesciences Inc. came out with a competitive oxaliplatin product in February, 2006; Health Canada processed 526 authorizations for that year.

Mayne Pharma (Canada) Inc., which has since been taken over by Hospira Inc., came out with oxaliplatin in April, 2006; Health Canada processed 1,084 authorizations in 2006.

Omega Laboratories Ltd. came out with oxaliplatin in September, 2006; Health Canada processed 20 authorizations.

Sanofi-Aventis Canada Inc. launched the drug in 1999.

Health Canada processed 18 authorizations in 1999

288 authorizations in 2000

570 authorizations in 2001

1,036 authorizations in 2002

1,828 authorizations in 2003

2,329 authorizations in 2004

4,182 authorizations in 2005

4,166 authorizations in 2006

Source: Health Canada