Healthy Skepticism Library item: 13495

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Publication type: news

Weeks C.
New rules: life-saver or safety risk?
The Globe and Mail 2008 Apr 11
http://www.theglobeandmail.com/servlet/story/LAC.20080411.LDRUGS11//TPStory/Life

Full text:

The pharmaceutical industry, health experts and patient groups across Canada are strongly divided over whether the federal government’s proposed new system for approving and monitoring drugs will result in harm or benefit to Canadians.

Under the proposed new “progressive licensing” system, Health Canada “will shift the focus from pre-market assessment to continuous assessment” of drugs, according to an article written by departmental officials and published last June in the Canadian Medical Association Journal.

The new system will “support timely access to drugs and provide a mechanism for the continuous monitoring and reassessment of a drug’s safety” throughout its life cycle, states the article.

Some advocacy groups say the move is a much-needed development that will improve access to breakthrough, live-saving drugs or treatments for rare diseases.

“It’s a huge advancement,” said Durhane Wong-Rieger, president of the Canadian Organization for Rare Disorders. “Will it allow us to have Health Canada put an approval on a drug that it may not have previously? Absolutely. And it will in fact allow drugs to come into the market that might previously have only been available under something like a special access program or, in fact, patients would have had to go across the border to get elsewhere.”

Ms. Wong-Rieger, who said she has participated in many Health Canada consultations on the progressive licensing issue over the past few years, believes the new system is designed to provide flexibility so the department will be able to approve drugs that have limited evidence or may be novel treatments for life-threatening diseases.

Certain drugs that may have been blocked by Health Canada in the past could now have a chance to make it onto the market much faster, she said. For instance, she said, the group faced difficulty fighting for access to Revlimid, a derivative of thalidomide, which is used to treat the anemia that is common in some myelodysplastic syndromes (a group of blood cell disorders).

But others warn that flexibility could increase the likelihood that some new drugs will make it onto the market without adequate safety checks.

“My main concern is the idea that we need to get drugs to market even faster. I think it’s a problem,” said Barbara Mintzes, a health policy expert at the University of British Columbia. “We have already sped up our drug approval process. There is already research raising questions about the effect on drug safety.”

Health Canada’s concept paper on progressive licensing, published last year, states the new system will require safety checks before a drug is approved and after it’s on the market. It also states that certain drugs, such as those to treat rare diseases, or groundbreaking therapies about which data may be limited, may be able to make it to market without the evidence that’s normally required.

These exceptions could heighten the potential for risks, Dr. Mintzes said. But David Lee, a Health Canada official involved in the progressive licensing project, said the new system puts a large focus on safety and that Canadians should be assured this will improve the current system, not undermine it.

“We’re all about safety, and that’s increasing the regulatory bar,” he said.

Even so, critics charge that the government hasn’t explained how the progressive licensing system will operate. Until the details are spelled out, it will be difficult to know how consumers will be protected, Dr. Mintzes said.

The presidents of Pfizer Canada Inc., Roche Canada and BIOTECanada, as well as the vice-president and general manager of Amgen Canada Inc., a biotechnology company, are currently registered to lobby the federal government on the issue of progressive licensing.