Finance Committee on May 9th, 2017

[Greg Fergus, Liberal, Hull—Aylmer, QC]

Is it hard for you to say, or could it be there just doesn't seem to be a correlation?

[Deryck Trehearne]

I've never done a comprehensive study, but globally, it does not seem to be correlated.

[Greg Fergus, Liberal, Hull—Aylmer, QC]

Thank you.

[The Chair, Liberal, Wayne Easter]

I have one further question as well. Could you tell me what process a stakeholder would have to use to challenge these user fees under the proposed amendments? What's the process? I pay user fees in my other life, and we're never happy in the farming sector about user fees, I can tell you. What process would there be for a stakeholder to challenge these fees under this proposed amendment?

[Deryck Trehearne]

We have several. One is the consultation proper, together with discussions and negotiations about what the fee should be, in view of the impact on those sectors. I'm very glad that I'm not in the farming sector when I'm trying to set fees.

Second, we have a policy of fee mitigation for small or medium enterprises. Any small or medium enterprise can benefit from a reduction in fees, and we have excellent take-up of that process. We've done audits of it, and it's in very good shape. The people taking up the reductions in fees have a right to do so and there's good evidence to suggest that the right people are getting it. We've done audits on this.

Third, we're going to create a dispute resolution system so that stakeholders can come and discuss their situations with Health Canada. This of course will be something that we have to work on over the coming months as we develop this new regime with our stakeholders. We'll have to look at where and how that's going to work. Dispute resolution, though, is something that we're planning to do.

Fourth, we rarely have the kind of impact with stakeholders that we have with Health Canada.

[The Chair, Liberal, Wayne Easter]

Mr. Dusseault.

[Pierre-Luc Dusseault, NDP, Sherbrooke, QC]

What is the cost associated with the Health Canada approval process? For example, if a pharmaceutical company presents a new drug for approval, how much will it cost?

[Deryck Trehearne]

Are you talking about the total cost to our branch?

[Pierre-Luc Dusseault, NDP, Sherbrooke, QC]

I would like to know what it would cost in total to approve a drug.

[Deryck Trehearne]

We currently are charging about 40% of the total cost for a drug review, and that's based on 100% time-tracking. So we know the costs are quite activity based—they're not just a guess. We charge about 40% of the true cost of a drug review right now.

As to the total revenues for the department, between us and one of our counterparts that does the post-market compliance and enforcement, I believe we raise about—is it $90 million?

[Naira Minto-Saaed, Director, Strategic Planning and Accountability Division, Resource Management and Operations Directorate, Health Products and Food Branch, Department of Health]

It's $97 million.

[Deryck Trehearne]

Ninety-seven million dollars a year, which represents just under 50% of the budget of our entire branch.

[Pierre-Luc Dusseault, NDP, Sherbrooke, QC]

Thank you.

[The Chair, Liberal, Wayne Easter]

Mr. Fergus.

[Greg Fergus, Liberal, Hull—Aylmer, QC]

We now effectively authorize Health Canada to administratively determine what the user fees should be, and these fees are reflected in the full cost of the services provided. If a pharmaceutical manufacturer contests the fees being charged—they might consider them out of line, out of whack, or not reflective—that company's recourse would not be to the minister, I take it, or would the minister have the ability to overrule the department?

[Deryck Trehearne]

The minister would receive a proposal from us on the proposed fees to be changed. The minister would have the final authority here in that sense, setting them through a ministerial mandate.

[Greg Fergus, Liberal, Hull—Aylmer, QC]

Would the minister have to give her or his approval every time the fee changes?

[Deryck Trehearne]

That's correct. That is the proposal.

David wants to make a point.

[David Lee]

It may be important to note that when we establish fees now, it's under the Financial Administration Act, so it's a regulation-making process. This would be the same. It's just a different form of regulation. You're going from the Financial Administration Act over to the Food and Drugs Act, and you'd do it by order, which is still a form of regulation. It would enjoy the same gazetting process in terms of guaranteeing representations as the normal regulation-making.

[Greg Fergus, Liberal, Hull—Aylmer, QC]

I'm just trying to think back to the FAA. When decisions are made, usually ministers would say, “Thank you very much. The decision has been made by the FAA. It's been handled, and there is no more appeal to me.” That's what usually happens.

Are you saying that this would continue to happen?

[David Lee]

It would continue to happen, but it would shift from the FAA into the purview of the Minister of Health. It still has the rigour of the Statutory Instruments Act, so it behaves like a normal regulation-making process in that sense, but it doesn't go to cabinet. It's stay with—

[Greg Fergus, Liberal, Hull—Aylmer, QC]

It's out of the minister's hands.

[David Lee]

That's correct.

[Greg Fergus, Liberal, Hull—Aylmer, QC]

So there is no political recourse, then.

[David Lee]

It's the same recourse as any other regulation-making they would have.