Public Accounts Committee on March 29th, 2012

[Glenda Yeates]

Yes. Certainly, as I say, one of the things that is part of our consultation is to understand where it is we want to head. I mentioned in my opening remarks that we were looking at guidance and possibly regulatory changes if that is required to enable us to do this. I would say those are things the department—

[Gerry Byrne, Liberal, Humber—St. Barbe—Baie Verte, NL]

I appreciate that, but what you said in direct response to the Auditor General's report is that you will develop policies on enhancing public access to information on authorized clinical trials that respect privacy rights and legislation. It implies that you have already identified what those privacy rights are and what those statutory and regulatory limitations are that you have. Otherwise, you would not have replied to the Auditor General in the way that you did. Would you table to our committee your findings or your concerns—your list, as it were—of specific privacy legislation concerns and other legislative statutory concerns that restrict your ability to comply with what is being asked of you, with a view that we can potentially change those laws?

[Glenda Yeates]

I appreciate the sentiment very much, and we will give you the sense of where we are. In some cases, we are still in the process of having our legal people work through those, so when we put the language there, it's not because we have identified the precise nature in all cases. In some cases we have identified whether the law allow us to do this, or is there a way to actually do this.

We are in the process of working that through, so we will be as specific as we can be with the knowledge we have at this time.

[The Chair, NDP, David Christopherson]

Thank you. Sorry, your time has expired.

We're moving on. Mr. Aspin, you have the floor, sir.

[Jay Aspin, Conservative, Nipissing—Timiskaming, ON]

Thank you, Chair, and welcome, witnesses, to our meeting.

I'd like to focus on conflict of interest. As we all know, it's essential that our federal regulatory system be as objective and impartial as possible. Drug approval decisions should be based on what's safe for Canadians, not on any private interest, and I'm sure you're aware of the Values and Ethics Code for the Public Sector, which requires all departments to establish measures to manage conflicts of interest.

The Auditor General's report found that Health Canada's code of conduct and conflict of interest guidelines are consistent with the government's Values and Ethics Code for the Public Sector, but did note that improvements needed to be made. In his report, the Auditor General recommends that Health Canada do a better job in assessing the risks of conflicts of interest in the drug review process.

Ms. Yeates, you alluded to this in your earlier remarks. I'd like to focus on what Health Canada is doing to ensure that drug reviewers are not using confidential information about drug approvals for personal gain.

[Glenda Yeates]

I appreciate the question. I think it's a very important issue, as the Auditor General pointed out.

The department was in keeping with Treasury Board policy, but I think raised a very valid question about whether that is sufficient in this very sensitive area. We did have a mechanism in place. All employees, when they sign on, sign a conflict of interest declaration. We deal with that. We do have a code of conduct. We do have a values and ethics code we reinforce periodically with employees, but I think the answer to the question of whether we can do a better job is yes.

I think this was the Auditor General's point, and we agree. We are very confident. We have very strong professional employees in this area, so I want to reaffirm that the Auditor General did not find any situation of actual conflict of interest, nor do we want to undermine our confidence in our employees in any way. That doesn't mean that as an employer we don't think that perhaps there is a best practice here that we should reinforce and perhaps we should have some systems in place that go beyond what we do for the general department.

That's why we've undertaken, as of last November, to have all our health products and food branch employees actively reconfirm that they've looked back at the code and that they abide by it. That's why we have an outside party doing a review for us right now, to say that given the particular nature of this kind of work, certainly understanding the professionalism of our staff, what would be a best practice? Are there things we should be doing routinely to strengthen this area?

So I think it was a very helpful observation, and we agree that despite abiding by the overall code, and again, a new one will be coming out next week and that gives us a chance for the department as a whole to reinforce this for all public servants, but we want to have the best advice. Should we be doing more in this particular area? We've already gone one step beyond, but there may be other practices that we should put in place in the future. That's what we're doing in this area.

[Jay Aspin, Conservative, Nipissing—Timiskaming, ON]

Has there been a conflict of interest case?

[Glenda Yeates]

No. The Auditor General did not find one, although as they point out, that wasn't the focus of their audit, but certainly they did not identify anything. As we've gone through this process of having our staff reconfirm their commitment, we have not discovered anything in that process either.

So I think the professionalism of our staff is working very well, but I think at the same time that's not to say that we cannot strengthen our processes. So I'm very pleased to say to the committee that this is not a situation where we've had a problem and are addressing it after the fact. This is, in a sense, a preventive situation where we want to be out in front of a possible problem.

[Jay Aspin, Conservative, Nipissing—Timiskaming, ON]

In your pursuit of improving or doing better, you've alluded to developing best practices. What do you use as a source for that? Are there other health organizations in other parts of the world, or are there other health organizations in other provinces that you're looking to? What do you use as a guideline?

[Glenda Yeates]

I was a former provincial deputy minister and this is not an area wherein the provinces, although we do look to them on many other fronts, would necessarily have that kind of expertise, although they may in some regulatory areas. We certainly would look to them in many cases, but here I think it's the other international regulators. The USFDA is obviously a very well-known, well-respected institution and there's the European Medicines Agency. We have partnership agreements with a number of regulatory bodies in Australia, the U.K., and others, so that we can actually take from those who are dealing with a very similar set of challenges.

As Paul mentioned, we in fact have an ongoing regulatory dialogue with those other parties because this is a very complex and rapidly evolving world, and we want to make sure that we're learning from other regulators across the spectrum, including in this area.

[The Chair, NDP, David Christopherson]

Thank you very, Mr. Aspin.

We go over to Mr. Allen.

Sir, you have the floor.

[Malcolm Allen, NDP, Welland, ON]

Thank you, Chair.

Thank you, folks, for being with us.

Madam Yeates, you had a discussion with Mr. Aspin about transparency and conflict of interest. I think we are all in agreement, but let me ask a two-part question on the piece on conflict of interest.

In your response to the recommendation, you said that beyond the piece that you've talked about now, which quite frankly MPs have to do every year, the decision to do something—other than Treasury Board Secretariat rules and your conduct code—you said you'd have it done by March 31, 2012, which actually is Saturday.

The first question, obviously, is how far along are you?

The second piece of that is if you're far enough along, can you actually give us a sense of what it is you're hearing you ought to be doing? I would expect that you've already received the report. The deadline to receive the report is Saturday, but I don't think it's coming to you in the mail on Saturday, so it's either coming tomorrow or you already have it. Could you respond, please?

[Glenda Yeates]

I guess I will just say there are two things and I'll turn it over to my colleague to speak to the consultant's or the external report.

I would say that the first part that we did immediately was actually to do the—

[Malcolm Allen, NDP, Welland, ON]

I understand. I'm clear on that. I think you've been clear on that. I had my earpiece on and I heard.

Mr. Glover.

[Paul Glover]

Thank you.

Briefly, we will receive the report tomorrow. We have not yet received it. We will carefully consider that report, its recommendations, the feasibility of implementing those recommendations—

[Malcolm Allen, NDP, Welland, ON]

I have that, thanks.

We only get.... You see how tough this guy is over here, he cuts us off real fast.

Let me get to the point.

[Paul Glover]

September is when we'll have a plan.

[Malcolm Allen, NDP, Welland, ON]

What you're saying is that a report is coming tomorrow, and by September you'll have some sort of plan.

My request is that you table the report with us after you receive it, since you're going to get it tomorrow, and then you say your implementation plan is for September. I would expect to see also that you table the implementation plan of what you intend to do with that report at the same time, so that we know what you intend to do with that particular report. We don't want to see it collect dust. Clearly this is a huge issue for all of us. You can see on both sides of the divide here, both groups are very interested in what exactly we're going to do with this.

The Auditor General was very clear about you needing to do something. You were very clear in your response that, yes, you would. So now we are very clear about making sure you actually have an action plan and get it done. We'd appreciate you tabling that.

Let me move to the assessment and response to safety issues, on pages 22 and 23 of the Auditor General's report. It goes back to 2009 and 2010, which isn't that far removed from now. There were 99 assessments of potential safety issues, but what I would draw to your attention is that of those particular issues, 54 weren't identified by Health Canada.

Let me break down the chart for you: 25 of them came from actions by foreign regulators; 15 came from scientific literature, not yours; 9 were from adverse drug reaction reports from previous Health Canada assessments; and 5 were from safety information provided by manufacturers—so you had 54. The vast majority of them Health Canada never saw. Someone else saw them and gave them to you. That's one statement about what's happening or not happening, in my view.

The second chart, exhibit 4.5, gives a performance of how you did and whether you met your requirements or not. If it was a high rating—there were none, so you didn't have any to look at in 80 days. The medium-potential safety issues, you have 130 working days. Of the 54, you assessed 29 of them. Sixteen you managed to get done within the timeframe, and 13 you didn't. That's a significant number.

When it came to low-potential, where you had 200 working days to get it done, you had 25 assessments reviewed. You got 18 done, and 7 you missed.

Can you tell me how you're going to do better than that? Quite frankly, with those marks in school, you would fail. You wouldn't have graduated high school with those marks.

So can you tell me how you intend to make sure that, as we head to 2012, 2013, and 2014, we're not going to see this as parliamentarians, and more importantly, that Canadians aren't going to be with this sort of a standard that, quite frankly, is below standard? It's not an acceptable level—it's not even close.

Besides the fact that you have more resources and you hired 130 or 160 more folks, can you tell me what the action plan is, so that when you set a standard for yourself, when you say 29 need to be done in 180 days, you're going to get 28 done and you're going to have a reason why you didn't get the 29th done.

[Glenda Yeates]

I'll ask my colleagues to speak to the specific latter part of the question.

But I want to reassure the committee on the point that we have learned of some of these issues from elsewhere. I actually think that is a mark of the system working well. I'll just say that although we may hear of them from a foreign regulator, what we understand as a smaller country with fewer people on any given medication—some of which as my colleagues said, may have been introduced in other countries before they were actually on the market in Canada—is that we as regulators want to pool the signals. We want to pool the circumstances—

[Malcolm Allen, NDP, Welland, ON]

I hate to cut you off, Madam Yeates, but I'm going to have to because he is going to run me out of time.

[The Chair, NDP, David Christopherson]

I'm sorry, I am. You are out of time.

I'll allow you to continue, Madam Yeates.

[Glenda Yeates]

I will ask my colleague, but I would say the fact that the foreign regulators are sharing information—and much bigger populations may see more signals earlier. We may have one or two cases. They may have 20 or 30. That, in fact, is the system working well.

The fact that we're looking at the scientific literature constantly, picking up signals in the scientific literature worldwide, and then using that as the signal, I think, frankly, is the system that gives Canadians the most comfort. In fact, this is not us relying on whatever resources we will ever have in Health Canada, but this is us tapping the worldwide network and making sure that we are looking for the signals and the signs across the world. Because that way, we'll catch things much more quickly and much more effectively for Canadians.

But I'll turn to my colleague to speak to the specific—

[The Chair, NDP, David Christopherson]

No. I'm sorry. We're a minute and a half over. I've been as generous as I can be. So thank you very much. We must move along.

Madam Bateman, you have the floor.

[Joyce Bateman, Conservative, Winnipeg South Centre, MB]

Thank you very much, Mr. Chair.

I want to speak to Madam Yeates and I'm going to be focusing on transparency. First I want to clarify a few things with Mr. Maxwell.

When a department heartily agrees with all of the recommendations, this is what makes Canada wonderful. This is what makes our bureaucracy a model for the world. We listen and we work in partnership to make things better for all Canadians. I compliment the work of the Auditor General, always.

Was this your first review, Mr. Maxwell, of the responsibilities for pharmaceutical drugs in regard to transparency and consistency?

[Neil Maxwell]

We have audited almost everything in the federal government. This particular area, the regulation of pharmaceutical drugs, was something we hadn't looked at for about a decade. In my opening statement, I mentioned that we had done a similar audit of the medical devices regulation with quite similar findings. Yes, it's the first in some time.