Public Accounts Committee on Feb. 12th, 2007

[Morris Rosenberg]

That really goes to the last part of your earlier question on whether or not we are engaged in that kind of testing. On that, could I defer to Susan Fletcher, who can give you some information on that?

[Borys Wrzesnewskyj, Liberal, Etobicoke Centre, ON]

And please respond on Treasury Board and whether you'll be putting proposals forward.

[Susan Fletcher]

Thank you, Mr. Chair.

Yes, indeed, under the chemicals management plan that was just announced, there will be regular biomonitoring of a survey of Canadians. StatsCan will be doing it for us, and the first tranche of the survey is going to start this summer. We will know what chemicals are in people and in what quantities, and we'll be able to compare across the country. We will therefore be able to start thinking back about questions like, if this is what's there, how did it get into their bodies? We can then start looking to where the modalities or the vehicles will be for that. So that should help us a lot.

What we have to do with the Hazardous Products Act right now—and what you see reflected in this table—is react to the whole variety of products that are currently on the market and try to identify which ones may be problematic. From there, we have to do the studies and take them off if necessary. As my deputy just said, because you can get things off quicker and it's to the benefit of Canadians, our interest is to work with manufacturers rather than having to use the heavy hand of a regulation, which is lengthy and costly.

[The Chair, Liberal, Shawn Murphy]

Thank you, Ms. Fletcher.

Thank you very much, Mr. Wrzesnewskyj.

Mr. Fitzpatrick, for eight minutes.

[Brian Fitzpatrick, Conservative, Prince Albert, SK]

I want to commend you, Madam Fletcher. You're way ahead of the curve here. You're ahead of the members on the public accounts committee as far as proceeding with good policy is concerned.

On the words “command and control” and not going there, that's music to my ears, because we live in a free society. I happen to like chocolate bars even though I know they're not very good for us. We can bring in a command and control society, but I'm not exactly sure it would be compatible with a free society. Sometimes we do things that aren't always good for our health, and you can probably notice that by looking at my anatomy.

[Voices]

Oh, oh!

[Brian Fitzpatrick, Conservative, Prince Albert, SK]

I made it to 61 anyway.

I want to approach the area of prescription drugs. This is probably an area where I don't know nearly as much as I should know, but I assume that what Health Canada does on prescription drugs is work with health care professionals in the industry and with patients to provide guidelines. If there are risks involved in using prescription drugs, that knowledge is brought to the attention of people who are using prescription drugs. Is that a correct assumption?

[Morris Rosenberg]

I'll just say a word, and then I'm going to ask Mr. Yeates to comment, because it's his area.

Drugs are subject to a pre-approval process. We do an assessment of them. We share information with other regulators around the world as well. We don't allow drugs onto the market that we're not comfortable with. We allow them with conditions that we think may be appropriate.

Can I ask Mr. Yeates to respond?

[Neil Yeates]

Thank you, Chair.

Yes, that's essentially correct. We have the pre-market review process. We approve conditions for products. If we're not satisfied that the benefits outweigh the risks, we will not approve them. We approve product labels that have indications for use, and so on. That's what goes to physicians and so on across the country.

[Brian Fitzpatrick, Conservative, Prince Albert, SK]

This question is leading to another question. Mr. Rosenberg mentioned the Merck product Vioxx and the arthritis issue. I know of a person who is involved in this on the Canadian side of the border. The information being provided to me is that the information provided by doctors and health care professionals in the U.S. on the risk of using this drug was greater. There was greater knowledge, greater information about the risk of using that drug, than there was on the Canadian side.

Is there any substance to that point of view? I know the lawyers are busy with their lawsuits on this matter, but his information is that he wasn't aware of the risk. If he had been on the American side, he would have been aware of the risk because their information was more comprehensive.

[Morris Rosenberg]

Maybe I could start on this.

I can't comment specifically on that because I'm not aware, but I do know the way these things work. Canada moved at just about at the same time as the U.S. Whether the information came from that side of the border or from Europe I'm not sure, but when the red flag went up on those products, I think pretty well all drug regulators would have moved at around the same time to take them off the market.

[Brian Fitzpatrick, Conservative, Prince Albert, SK]

It isn't about it being off the market. It's about the information the patient and the doctor had when they prescribed the drug. That seemed to be their issue. The person had a heart attack, so that was his concern. His doctor and the prescription he had didn't have the same information as would have been available if he'd lived in Detroit. If there's substance to that, I'd be somewhat concerned as a Canadian.

It brings me, really, to a third area. We're 2% of the world's population and probably 2% of the world's economy. The EU and American economies and the Japanese economy are much larger than the Canadian economy. I'm sure they have agencies similar to Health Canada that deal with things like prescription drugs, and the amount they can allocate in resources in this area is gigantic compared to what a country like Canada can allocate.

My point is that I'd like to think that in this world we live in today we are sharing information, that it's seamless, that we're not trying to reinvent the wheel, and that we're not putting up barriers between other countries and ours. On the American system, we could say that maybe it doesn't go the extra mile on protecting public health, but I have extreme doubts about that. Any industry player in the United States knows darn well that if they don't go the extra mile in the American system, the American trial lawyers and the American tort system will put them out of business, so they have a strong incentive to make sure that full information is being provided to the public.

Do we have a lot of regulatory and statutory impediments to sharing information and establishing a seamless network with these other countries?

[Morris Rosenberg]

Mr. Chair, I think I'd like to ask Mr. Yeates to respond to that.

[Neil Yeates]

Thank you, Mr. Chair.

The member has hit upon a very important issue in terms of the future of food and drug regulation around the world. As you know, Vioxx was a global issue, and the action that was taken was global. We work closely with the FDA, in particular; one of our closest working relationships is with the Americans. But we also work closely with the Europeans.

We feel that we need to advance in something similar to the kind of system you describe. The term we use is work sharing. So we, as a regulatory agency, could do some of the work, the FDA could do another part, and the Europeans could do another part; we could split up the work, because all regulators around the world are having difficulty keeping up with the volume and the complexity of products coming through the front door. That's where we'd like to go. It would be very important, though, that each country retain the right to make its own final regulatory decision. Different countries have different tolerances for risk, for different cultural and historical reasons. So we feel a lot of the science work can be done in common, but countries will want to protect the right to make their own final regulatory decision.

[Brian Fitzpatrick, Conservative, Prince Albert, SK]

I do believe we should use common sense in this area. A lot of people around here accept Al Gore as the definitive thing on climate change, almost as the final chapter on the issue. I think if there are good scientists in Europe or the United States who have spent a lot of money on a drug like Vioxx, for example, have studied it inside out and know the risk inside out, I'd hate to see us pay a whole bunch of money in Canada reinventing the wheel in this area. We should use the good scientific information that's available elsewhere and maybe allocate resources to other areas where we may be able to get more bang for our dollar.

That would be my point. I have no more questions.

[The Chair, Liberal, Shawn Murphy]

Thank you very much, Mr. Fitzpatrick.

That, members, concludes the first round. We're going to go now to the second round. There's one area I just want to pursue before we do that.

This is to you, Mr. Yeates, or to the deputy.

On the regime of user fees, you indicated, Mr. Yeates, that the fees haven't been adjusted in your particular directorate for quite some time now and that it's probably time that you adjust them for inflation and other factors. We have now the User Fees Act, which gives us a whole round of consultations and other requirements that have to be met. Is this going to help your directorate or is it going to hurt your directorate? Will it allow you to charge the full...? Because I think the intent of government is to charge the actual true cost of the work that's being done by the government.

Secondly, if you are allowed to increase the fees, is there a possibility that you may be raising expectations to a level that you don't have the resources to fulfill? I'm talking about timelines and that area.

[Neil Yeates]

Mr. Chair, our intent with the new cost recovery regime--as I said, we hope to begin consultations next month--is to bring additional resources into our regulatory system. So in that respect it's very important for us. The User Fees Act requires that we establish service standards for each of the fees that we propose. In some areas that's quite easy to do, and in others it's much more complicated. I'll give you two examples.

We do inspections of manufacturing sites. That's fairly easy to measure; it's a certain amount of activity. In an area like that, we think it's likely to do full cost recovery. In post-market surveillance--looking at adverse drug reaction reports, that kind of thing--it's much more difficult to identify the receiver of the service. In many ways it's the Canadian public. So we're going to have to establish and propose what the right balance is in each area of our activity. I expect we'll end up with a mix of fees that really reflects the balance of public and private interest--100% in some, and much lower in others.

[The Chair, Liberal, Shawn Murphy]

Thank you very much.

I just have one additional question, and it goes to the auditor. This is a very important issue and I think it concerns most Canadians. Mr. Christopherson was right that the primary function of every government is to look after the security and the protection of its citizens. I haven't read the departmental reports or the report on plans and priorities of the Department of Health, for obvious reasons, but if I were to read them...would a parliamentary committee get a full grasp of the items that you've identified in your report? Would they be enumerated and elaborated upon in both those reports?

[Sheila Fraser]

I believe, Mr. Chair, there is some mention of performance measurement within the departmental performance report. Again, as we say in this report, we think the department can do a better job of explaining its performance with measurable targets. There may be objectives that have been set, but they aren't always measurable targets. As we've been trying to stress throughout this, you need that baseline data about what activities should be carried out to be able to comment on whether you have achieved all the objectives of the program.

[The Chair, Liberal, Shawn Murphy]

Thank you very much.

Just before we go to the second round, I want to remind members that five minutes goes by very quickly, so keep your questions short and to the point. I urge witnesses to keep your answers brief and focused.

Ms. Sgro, you have five minutes.

[Judy Sgro, Liberal, York West, ON]

Thank you. I don't tend to go on too long with preambles. I'm pretty short and to the point.

I've read the Auditor General's report, and you make it quite clear that for the program managers to follow their product sufficiently, there's insufficient funding there. Those things clearly are issues that will alert all of us when it comes to making sure that regulations and so on are followed through on in the enforcement activities and so on.

Is there a plan to point out some of these shortcomings in the budget, so that you ensure you've got adequate funding, or are you going to look at reallocation in your own budget process?

[Morris Rosenberg]

Mr. Chair, as I said earlier, one of the very first things we'll do as part of this internal departmental operational planning process is sit down with our program managers and make sure that we are ad idem on the diagnosis of the problem. Interviews were done with program managers for the purposes of this report. We take those very seriously. But we think we need to make sure there's a reconciliation of views and that we are talking about the same level of risk. We will do that, I assure you, as part of the ongoing work. We'll then make an assessment, and if there is a need for resources, we will first look internally at the possibility of reallocation.

Are there things we're doing that might be lower priority from which we could allocate money for issues that are a higher priority or a greater risk to the Canadian public? If the answer to that is yes, that may be the end of the story. If the answer to that is no, then we might go and speak to the Treasury Board or write a memorandum to cabinet to ask for more resources, as we did in 2003 and 2005.

[Judy Sgro, Liberal, York West, ON]

Do you not have to go to Treasury Board normally on reallocation?

[Morris Rosenberg]

It depends on whether we're within the budgets that we have, so that we could reallocate within the same program activity, or whether we might need some authority from the Treasury Board to do that.

[Judy Sgro, Liberal, York West, ON]

But the issue was pointed out in the audit, that there was reallocation with insufficient documentation?