Public Accounts Committee on Feb. 12th, 2007

[Morris Rosenberg]

Yes, and we have undertaken to provide sufficient documentation. We have also undertaken, under our new budgeting framework, to ensure that people understand the conditions under which money for special initiative programs was provided, and to respect those conditions. We recognize that we have a responsibility as well, within Health Canada, to engage with the central agencies to make sure that the planning and budgeting frameworks are robust and flexible enough to take into account the fact that there is a constant change in what's going on in the environment out there, and that we need to be able to react to that in order to fulfill our mandate to protect the health and safety of Canadians.

[Judy Sgro, Liberal, York West, ON]

Numerous industries have complained about the costs they currently have to pay for getting the approval process through. But more importantly to them, and to Canadians, was the length of time it takes to get drug approvals through. And that's not full cost recovery. So I gather, under this, there's going to be a significant increase in the costs that the industry is going to pay to get that process through. But has there been any intent here to beef up the process so that it doesn't drag on for such a long period of time, given the fact that they're going to be asked for additional dollars to ensure that the funding process goes through?

[Morris Rosenberg]

First of all, in the therapeutic access strategy put in place in 2003, significant new funds were provided to the department in the budget of that year to specifically deal with the question of backlog. We have cleared the backlogs, and this is without having done anything on the fee side. In putting a new fee structure together, one of the things that we will do, and we are in fact required to do by the User Fees Act, is to develop a set of service standards that are commensurate with the level of fees that we'd be looking for. There would be consultations with the industry, and indeed with Parliament, on any proposal to increase fees, and then on what those service standards would be.

[Judy Sgro, Liberal, York West, ON]

Okay. Thank you.

[The Chair, Liberal, Shawn Murphy]

Thank you, Ms. Sgro.

Mr. Sweet, you have five minutes.

[David Sweet, Conservative, Ancaster—Dundas—Flamborough—Westdale, ON]

Mr. Rosenberg, I've heard your answer on a couple of occasions. Basically you're saying, when members of the committee ask whether you'll go back to the Treasury Board for funds, that you're not convinced. It's not management's concern right now, and you need to make that investigation. Is that basically it?

[Morris Rosenberg]

Let's say we're not talking about cataclysmic events. We're not talking about Hurricane Katrina or something like that, when it's obvious that there isn't going to be sufficient money. You're talking about kind of normal risk.

[David Sweet, Conservative, Ancaster—Dundas—Flamborough—Westdale, ON]

Day to day.

[Morris Rosenberg]

The first thing you would do in any program, I think, is ask yourself whether you have the flexibility within that program, within other programs in the same branch, and then within the same department to manage, before you go to the Treasury Board. Because if you didn't do that, the Treasury Board would send you back to look at your own--

[David Sweet, Conservative, Ancaster—Dundas—Flamborough—Westdale, ON]

That's sufficient for me.

Madam Fraser, do you feel comfortable and confident right now that this department is now on track with these recommendations and is beginning to move in the right direction expeditiously?

[Sheila Fraser]

Well, we've certainly seen, I think, a commitment on the part of departmental management to move in this area. They've indicated to us, in their operational planning exercise, that they're going to be putting it in. They've indicated, as well, that they will be establishing a list of activities, I think, by the end of 2008, the current year, which seems reasonable. These things cannot all be established overnight.

So yes, I think there's some indication of commitment there. Obviously every auditor will tell you that they'll hold judgment until they actually see it in place, so we may come back at some point in the future to do a follow-up, but--

[David Sweet, Conservative, Ancaster—Dundas—Flamborough—Westdale, ON]

At this point, all the positive indicators....

[Sheila Fraser]

--the responses are very positive, yes.

[David Sweet, Conservative, Ancaster—Dundas—Flamborough—Westdale, ON]

I have two more questions.

First, Mr. Rosenberg, just for our committee, can you make a statement today, in thorough confidence--because there are dates of 2007 and 2008 when you're going to comply with these recommendations--that you're on track with these responses to the recommendations and with the actions you're taking?

[Morris Rosenberg]

I can make a statement that we are on track and that we will monitor throughout, on a regular basis, the implementation of them. I think one of the benefits of an Auditor General's report is that it does tend to focus the mind. That's reality. So we will be monitoring on a regular basis our ability to comply with these management improvements we're putting in place.

If something were to change, we would talk to a number of people, including the Auditor General, about that. But right now, we're aiming for the dates we have and that you'll see in the action plan we put forward.

[David Sweet, Conservative, Ancaster—Dundas—Flamborough—Westdale, ON]

Right.

My last question is whether you can give the committee an overview of the relationship between Health Canada and the Public Health Agency.

[Morris Rosenberg]

Yes. You get into the concept of portfolio management. The Public Health Agency's origins, I guess, were around the SARS crisis and the report that was done that reflected that there ought to be a stand-alone agency to deal not only with infectious disease matters but with other public health matters, and that there should be a chief public health officer for Canada in charge of that agency.

The evolution is that this was a branch within Health Canada before that. It was the population and public health branch. So the chief public health officer, the head of that branch, is a deputy head, with all the authorities--financial, administrative, and so on--that I would have, and he reports directly to the Minister of Health.

Within the portfolio, there are a number of organizations, including the Canadian Institutes of Health Research, the Public Health Agency, us, the Hazardous Materials Information Review Commission, and the Patented Medicine Prices Review Board. That's the portfolio. We try to do some portfolio coordination, such as coordination of policy and, where possible, some coordination of financial requests, because we tend to be looked at as a portfolio and as an envelope.

So there's a need for that. Health Canada will play a kind of leadership role, if you wish, within the portfolio, as first among equals or something like that. That might even be too strong a phrase. It's very collaborative. We don't want to be working at cross-purposes for the same minister, so there is coordination that takes place in that regard.

[David Sweet, Conservative, Ancaster—Dundas—Flamborough—Westdale, ON]

Thank you.

[The Chair, Liberal, Shawn Murphy]

Thank you very much, Mr. Sweet.

Madam Brunelle, cinq minutes.

[Paule Brunelle, Bloc, Trois-Rivières, QC]

Good afternoon, ladies and gentlemen.

I am somewhat disturbed by certain things that I read in your reports.

Mr. Rosenberg, you gave us a very good explanation of the responsibilities of Health Canada. I see that you are dealing with a range of files that involve drugs, medical equipment and other health products, food, pesticides, hazardous substances in the workplace, the quality of air and water, and so forth. This is enormous. It touches on every area of our lives. We know that there are old problems that still persist while new problems come up that involve environmental issues. Moreover, we are exposed to various viruses from abroad.

However, as Ms. Fraser said in her presentation, the audit showed that the core funding budgets had been substantially cut over the past three years. For instance, the Product Safety Program was cut by 10%, the Drug Products Program was cut by 32%, and the Medical Devices Program by 50%.

In addition, Ms. Fraser's report states the following:

8.22 The Product Safety Program has requested additional funding, but it received very little funds for special initiatives in 2005-06 to address the shortfalls presented above. Program managers indicated that their inability to carry out these responsibilities could have consequences for the health and safety of Canadians, such as exposure by consumers to non-compliant hazardous products. There is also a risk of liability to the Crown.

Please, reassure me. I am thinking of contaminated blood and of C. difficile and a tendency to imitate the United States by taking everything to court. I must confess that I am confused. The people concerned by this should have many questions to ask.

[Morris Rosenberg]

I think that the report shows that even if the core funding was cut, the funding from all other sources has generally remained the same. On the other hand, the report raised the following question that we are dealing with in our departmental planning. We want to know whether a specific activity is sufficiently funded by budgets from all sources and if we are carrying out our responsibilities adequately.

As I said, we are not starting from scratch. Every day, we carry out an entire range of activities to evaluate the risks that products can pose to Canadian consumers. That is what we are doing for hazardous products. Management is applying an entire range of methods like inspections, monitoring, following up on consumers' complaints, discussions with the regulatory authorities of other countries, to be really sure that we can carry out our mandate.

As I said and as we read in the Auditor General's report, the management framework could be improved in order to do this, and this is the objective that we are currently seeking to attain.

[Paule Brunelle, Bloc, Trois-Rivières, QC]

Ms. Fraser, I see that the issue is becoming increasingly complicated. You suggested that we should ask Health Canada to give us an action plan with a specific schedule for implementation, etc. From what I hear, I think it would be useful.

In your opinion, what should this action plan contain?

[Sheila Fraser]

I suggest that the committee refer to our recommendations, with which the department has agreed. You need to see the specific measures that they intend to take in view of our recommendations, as well as who is responsible and what timetable they have. In some cases, resources will have to be allocated. In fact, activities like these studies need funding.

This is the kind of action that I would envisage. I gather that it will be ready for tabling with the committee by the end of this month.

[Paule Brunelle, Bloc, Trois-Rivières, QC]

Mr. Rosenberg, what items would you choose to include in this action plan?

[Morris Rosenberg]

I would choose to improve operational planning and to provide a budget planning framework that would give our managers clear directives regarding the principles and rules to follow in determining priorities and carrying out audits, including documentation relative to decisions.