A growing number of drugs in Canada are receiving conditional approval designed to speed promising drugs to market. But concern has been raised about Health Canada's ability to compel drugmakers to provide safety information. AP Photo

In his fall update to Parliament, interim auditor general John Weirsema expressed concern over Health Canada's lack of legal authority to demand regular safety updates from drug companies.

A drug regulator without the legal authority to demand drug safety information is bad enough. But what makes it more problematic is that he was talking about drugs that have only received conditional approval, and are awaiting more information before being fully approved.

What's more, the department knew it had this problem, among several others, many years ago.

Go back to the late 1990s.

It was a time when AIDS groups were putting pressure on then-health minister Allan Rock to speed up the approval of a drug called Viramume. Though the drugmaker, Boehringer Ingelheim Canada Ltd., hadn't produced enough clinical trial information during the drug's approval process, Health Canada scientists felt pressure to fast-track the drug, despite their safety concerns.

Health Canada, AIDS groups and other supporters of this new conditional approval argued the measure was necessary in order to get life-saving drugs to the people who needed them.

That argument didn't work as well when it came to Relenza, a flu drug that Health Canada at the time determined to be only of "modest" benefit.

It received full approval in the summer of 2003, though there are very few — if any — provincial drug formularies that carry the drug.

These two drugs were among the first to be given conditional approval under a new Health Canada policy that came into effect on May 30, 1998. It was hard to argue against the rationale: if a life-saving drug shows promise, get it to market as soon as possible, continue testing for safety, and submit the information to Health Canada as quickly as possible.

But there were weaknesses in the policy — including the fact the department lacked the legal authority to grant the approvals.

After CBC News aired stories on this and other problems, Health Canada's then director general of the therapeutic products program issued a directive:

"Recent media attention has focused on the legal status of this policy and the process by which drugs receive (a notice of compliance with conditions). The Bureau of Policy and Coordination has been tasked with the undertaking to review the policy… to identify lessons learned. In addition, the review should determine the existing tracking/surveillance and enforcement mechanisms and propose recommendations to strengthen these functions."

The directive resulted in a report called Notice of Compliance with Conditions Policy Evaluation (view a draft of the report, obtained through Access to Information).

The department's review was extensive and contained good recommendations that led to important changes. For instance, Health Canada now possesses the legal authority to issue conditional approval. It posts information online when one is granted and the website allows users with a bit of knowledge of databases to download information.

Most conditional approvals for cancer drugs

As the data with the chart above indicates, the drugs receiving the highest number of conditional approvals are cancer drugs. In fact, they make up about two thirds of all the products that are fast-tracked onto the market. And among cancer drugs, those treating breast cancer comprise about half.

The other emerging category is drugs to treat Alzheimers.

It's easy to see why Alzheimers or breast cancer patients should have access to medicine that could save their lives or slow the disease's progression. However, as in the case of Avastin, a drug that had been conditionally on the market for the treatment of breast cancer since Feb. 6, 2009, there are dangers that could end up producing more harm than the illnesses itself.

This week, Health Canada pulled approval for Avastin in treating breast cancer, concluding "Avastin does not significantly reduce tumour size or extend lives, while it may cause serious and potentially life-threatening risks, such as heart attacks, severe high blood pressure, bleeding, and the development of small tears in parts of the body such as the nose, stomach or intestines."

Making promises after conditional approval

Companies that receive conditional approval are obliged to sign "letters of undertaking," in which they pledge to conduct the necessary research in order to satisfy Health Canada's ultimate safety demands.

Most of these companies also submit what's called a "qualifying notice" that spells out what information they plan to submit.

Health Canada lacks the legal authority to compel them to produce regular safety updates.

It's hard to know what effects this lack of legal muscle - or lack of staff to pursue the companies — has on the speed with which companies submit additional safety information. Viramune and Relenza were on the market for four and six years, respectively, before receiving final approval. On average, the companies that did submit more safety data to Health Canada to win permanent approval took four years. Is this average too long? Given Health Canada's lack of legal authority to compel information, it's a question worth asking.

"There's a problem with approvals based on conditional data," says Barbara Mintzes, a drug safety expert at the University of British Columbia. "Health Canada should be able to force the companies to carry out the studies within a specific period of time, or have another mechanism for the studies to be done, either the company putting money into a fund or having them done publicly."

Asked why his department lacks the legal authority to compel safety information from drug companies, Marc Berthiaume, the departmental official in charge of drug safety could only say that they're still studying the matter.

When pressed for further details, the department responded in an email. "Health Canada is working to modernize Canada's regulatory system for pharmaceuticals, medical devices and biologics, in order to improve authorization requirements and post-market monitoring.

"As part of this Health Canada hosted technical discussions between October 2010 and January 2011 to explore technical regulatory issues, test and validate proposed activities, and identify areas needing further policy work.”

So, the department is still talking and studying.

Back in 2002, when Health Canada completed its review of the conditional approval policy, an official sent out a congratulatory note to her staff for a job well done.

Given the problems outlined in the interim auditor general's report, it seems those congratulations were premature.

If you have specific information about this topic you’d like to share, contact David McKie at david_mckie@cbc.ca