Thank you very much for the opportunity to speak to the committee today.
I am a legislative lawyer in private practice here in Ottawa. I have been writing legislation for governments in Canada and outside Canada for over 20 years in private practice, and a few years before that with the Government of the Northwest Territories in Yellowknife. I am also consulting counsel on a number of class action lawsuits against Health Canada for regulatory negligence in relation to illegal and harmful medical devices allowed on the market. I should make it quite clear that I am a critic of Health Canada, and that will come clear in my presentation. These court cases also involve serious allegations of negligent post-market surveillance.
After the thalidomide disaster, the role of Health Canada was legislatively strengthened to protect the public from harmful drugs. People think this disaster cannot happen again. Recently, in a CBS report on Trasylol, they reckoned there are 1,000 deaths per month from that drug in the United States. I don't think we are in a position where we've learned many lessons from the past.
There's much I could speak about, but I understand this committee's focus is on post-market surveillance, so I'll restrict my comments to that.
The purpose of post-market surveillance is to protect the public. Health Canada's new commitment to reducing protection of the public through progressive licensing means that more dangerous products will be allowed on the market earlier. This means that post-market surveillance will be even more essential to protect the public.
In my view, post-market surveillance requires four essential things to work. I say this as a lawyer who designs regulatory systems for government. I do it for the Government of Canada, governments in the north, and provinces, as well as foreign governments. The first is that a legislative scheme has to be created to require it. Second, politicians and departmental management have to have the will to actually do it. Third, there has to be adequate staff and budget to do it. Fourth, the involvement of physicians, hospitals, and the public have to be included in the scheme.
In my view, none of these things are present today. Post-market surveillance is an illusion, and unfortunately a very sad illusion, for the public that is relying on it. I make no apology for being a bit gloomy on this, but I will explain my comments one by one.
First, on the legislative scheme, there is no legislative obligation for Health Canada to conduct post-market surveillance. There should be. I understand that a bill has just been introduced, or is about to be introduced today, requiring greater product safety recall powers. We'll have to see what it is, but this could be the beginning of a solution to this problem. I will speak about what I think should be in such legislation for proper post-market surveillance.
At a minimum, the legislation should define an adverse reaction as follows. An adverse reaction occurs when a drug, including its inactive or non-active ingredients, is suspected of causing any of the following: no therapeutic benefit; no diagnostic benefit; no prophylactic benefit; no effect at all; and finally, any injury to the patient. We are hearing about antidepressants that have no effect at all, not even a placebo effect. That should be an adverse report.
There should be mandatory reporting of adverse incidents, both within Canada and outside. There should be mandatory recall of adverse drug products, and mandatory public notice of adverse drug products should be required.
I have spoken with Dr. Ed Napke, who is a physician who was formerly in Health Canada, and he established the original adverse reaction reporting system in Canada. It's one of the first in the world. He insists that drugs must be defined as consisting of both active and inactive ingredients.
There is no obligation to label the inactive ingredients, even though these chemicals will affect the efficacy and safety of the drug product. This committee may not be aware, but Parliament unanimously passed a motion in 1989 asking the government to require complete labelling of all active and inactive ingredients in drugs, but no action has been taken 19 years later.
One example currently in Ottawa is Flomax, a prostate drug. The inactive ingredients in its formulation were changed to allow time release. It now swells up into a hard, glutinous substance about the size of a walnut. If it gets stuck in your esophagus, you can die. And those aren't the active ingredients; they're the “inactive” ingredients.
In my view, the current food and drug regulations are not adequate for post-market surveillance. It's only mandatory for industry to report a serious, unexpected adverse drug reaction, which means a serious adverse drug reaction that is not identified in nature, severity, or frequency in the risk information set out on the label of the drug. If the manufacturer says 5% of the people who take this will be seriously harmed, and in fact 5% of the people are harmed, the industry has no obligation to report that 5%.
There is no mandatory recall of drugs by industry. If a drug starts killing people, the industry is not obliged to recall the product. There is no power for government to order the recall of a drug. It seems very Canadian to just rely on the word “please”--“Please recall the drug. Take it off the market.”
There is no mandatory public notice of harmful or ineffective drugs. Instead, we have self-inspection by industry. There is even no need for industry to report any complaints they receive or investigation about drugs to Health Canada. If people are complaining directly to the drug companies, they do not have to report this to Health Canada. They are expected to keep a record of the complaint, but only for one year after the expiry of the drug lot.
Next I'd like to speak about political and management will. Even if there's a good legislative scheme, there must be will, of course, in the government to act to protect the public. In my view, the department has lost its way on this point.
The department is developing a corporate risk profile to identify management challenges, and I'll quote the following from the department:
The department is developing its corporate risk profile to identify management challenges with respect to the potential corporate risks--e.g. financial, technology, property, etc.--that may impact the realization of its corporate objectives.
So for the department, risk protection is not protection of Canadians from risk, but protection of the department from risk of the public.
The priority of the department is to improve access to drugs and medical devices. Look at their therapeutics access strategy. This is a complete about-face from the original purpose of the department, which was to protect the public.
The 2002 Speech from the Throne advocated speeding up the regulatory process for drug approvals to ensure Canadians have faster access to the safe drugs they need. In my view, this means that more dangerous products will get on the market, requiring even better need for post-market surveillance.
Health Canada refers in its literature to the drug industry as its client. In my own experience with litigation over a temporomandibular joint implant, Health Canada argued in court repeatedly that it owes no duty of care to the public. I repeat, it owes no duty of care to the public. And lawyers for Health Canada argue that if there is gross negligence in the department, even admitted gross negligence, there is no remedy except to vote out the politician. So the only remedy for bureaucratic negligence, lawyers for the department argue, is voting out the minister. I cannot stress too much the profound shift in the philosophy of the department.
I've been working with governments for a long time. I know that no government likes enforcement inspectors who go in and cause trouble, who raise problems with stakeholders. So there's a very strong tendency in government--and it's natural--to reduce inspections because they just cause problems. The inspector goes in, says, “You have this illegal product, take it off the market, or do something about it”, the minister or the deputy minister gets a call, and everyone's life is miserable. We have to take steps to deal with that.
In my own TMJ case, the department has resisted for nine years advising the public of a catastrophic medical device allowed on the market by Health Canada. Nine years it's fought us in court, saying it has no obligation to inform the public on this device.
Last week we finally, after repeated motions, got the court to order Health Canada to do a public notice campaign to advise the public that there's a catastrophic.... Now, this is a medical device, but this is the philosophy of the department--they owe no duty to inform the public.
I see that my time--