Evidence of meeting #36 for Public Accounts in the 41st Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drug.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

Neil Maxwell  Assistant Auditor General, Office of the Auditor General of Canada
Glenda Yeates  Deputy Minister, Department of Health
Paul Glover  Assistant Deputy Minister, Health Products and Food Branch, Department of Health
Marc Berthiaume  Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health

9:15 a.m.

NDP

The Chair NDP David Christopherson

Thank you.

Mr. Kramp, you have the floor, sir.

9:15 a.m.

Conservative

Daryl Kramp Conservative Prince Edward—Hastings, ON

Thank you, Chair.

Certainly, welcome to our witnesses.

Obviously, there's a recognition that the Auditor General had some concerns, and that the department has been reacting, and quite frankly, I'm pleased to see in a very favourable manner.

The one point I would make right off the bat is that I'm absolutely encouraged. Generally, this committee takes its responsibility very seriously and asks for a definitive action plan based upon the testimony of the witnesses, and of course, the response to the Auditor General. I'm very pleased to see that we have one before we've asked for one. I think that's a great step forward. Obviously, we're going to have to have some time to digest it, and quite frankly, see whether or not we find it satisfactory to this committee, but at least it's a marvellous step forward. So thank you very much for providing to the committee a response to some of the concerns that have already been registered. It shows that you're just not sitting on your fanny waiting for the committee's recommendation to move forward, and you do take these concerns seriously. So thank you very much.

My question in this is this. In moving forward, I unfortunately haven't digested this thing, but I'm concerned. What I don't want to see are abstract words like we're thinking about this, we have a desire to do this, we have a willingness to do that. I want to see absolute, concrete, definitive action. Now in this action plan here, rather than go through the whole thing with definitive action, could you at least pull out a couple of measures in the action plan that would demonstrate a concrete move forward—moves that are addressing real problems identified by the Auditor General?

Ms. Yeates.

9:15 a.m.

Deputy Minister, Department of Health

Glenda Yeates

Again, thank you very much for the question.

We agree, and I share the committee's interest in seeing concrete actions because it is an enormously complex area and we actually want to see steps. Beneath this action plan, I can assure the committee that there are many substeps. So when you have a chance to digest the plan, you may say, why is something not showing a date until, for example, March 2013? That will be, I can assure the members, because we've said, “Okay, what are the steps? How do you build this computer system to make that happen?”.

For example, on the question of timeliness, of notifying clinical trial sites of compliance ratings, the Auditor General pointed out that we did not have a standard operating procedure. We would inspect the clinical trial and we didn't actually have a benchmark for when that would occur. Now we are establishing those timeframes very specifically, so that our inspectors know that if they find something in a clinical trial site, there is a benchmark by which they are to have notified that shortfall back to the company specifically. So it's those kinds of operating procedures.

The Auditor General made a number of findings, where they said, “You tell us you're doing this according to a risk base. We don't see the absolute problems...but we don't see the documentation that can show us.” For example, on timeliness, in number 2 of our action plan, we are specifically doing that.

In terms of timeliness, the actual recommendation is that we meet our service standards. As I mentioned, we have improved our monitoring of the service standards. We now have a database. We look at them monthly at our executive committee table. As I mentioned, we can see that in most of our areas, such as new drugs, we've eliminated the backlog and we can monitor them very specifically. We have adapted the new resources and have devoted new resources to, very specifically, moving forward on the generic drugs.

I note here that there was a comment made about conflict of interest. We took immediate action. Actually, the Auditor General said that we had not documented our general conflict of interest policies. Our forms were in keeping with the policies, but we had, perhaps, to go above and beyond in an area as sensitive as drugs. So last November we actually took every person in the branch, addressed that conflict of interest very specifically, and we have those now back from the vast majority of employees in the branch. We have also hired an outside resource to advise us as to whether, more specifically, there are best practices worldwide that should take us beyond that.

So there are a number of things here. We have built quite specifically on the post-marketing side as well.

9:20 a.m.

Conservative

Daryl Kramp Conservative Prince Edward—Hastings, ON

That gives us an indication, obviously, of some solid, concrete action. All I would ask is this. I wouldn't be complacent about the fact that you have an action plan in place, though, because I can assure you that this committee will probably ask for an update and/or consistent updates on the progress along the way to ensure that the recommendations are being followed. We do appreciate your cooperation in this matter.

Thank you very kindly.

9:20 a.m.

NDP

The Chair NDP David Christopherson

I'm sorry, your time has expired. I know it goes fast when you're having fun.

Monsieur Dubé, you have the floor, sir.

9:20 a.m.

NDP

Matthew Dubé NDP Chambly—Borduas, QC

Thank you, Mr. Chair.

I'd like to thank our guests for being here today.

Drug safety is obviously an important issue for Canadians. When I think about drug safety, one aspect in particular concerns me, and that's the Sandoz matter. Sandoz is a company in Boucherville, Quebec, near my riding. This matter was raised by the mayors of the municipalities in my constituency when I had the opportunity to meet with them recently. After speaking with them and with the people of the region, I am very concerned with this matter.

I use that example because, both in the Auditor General's report and in your statements, you are asking for better language on the labels. But I have a lot of difficulty with that because, for example, a hospital in Toronto found drugs that have been improperly labelled. I have difficulty understanding that we can think about the language on labels when the drugs are not properly labelled to begin with.

What do you think about that? Is that among the improvements that you are going to undertake in applying the Auditor General's recommendations?

9:20 a.m.

Deputy Minister, Department of Health

Glenda Yeates

Thank you. There is an important point I would like to share with the committee.

There are two sides to the word "label", and it's a bit confusing. I myself was confused occasionally in the beginning.

The word “label” we often think of as the label on the bottle, which is the issue you referred to in terms of Sandoz. But the label we are talking about is a much more complex document, which is often posted on the web. It is the longer piece.

When we talk about simplifying the label, it's because we actually think physicians and Canadians need simpler language in the description of how to take the medication, what the contraindications are, what signs to look for, and the possible side effects. That is considered the label, and we think it's very important. That's why we're putting a great deal of emphasis on simplifying that information.

The actual issue we had with Sandoz—with one shipment having mislabelled vials in it—was very specific. It was a problem that was caught. There was a very significant effort, working with the company, to ensure that this was not something that actually reached Canadians or caused them any difficulty.

I would want to reassure the committee and the members that the label simplification we are talking about is so that consumers and practitioners have better information. It should not be linked in any way to the mislabelling problem that occurred at Sandoz.

9:20 a.m.

NDP

Matthew Dubé NDP Chambly—Borduas, QC

I appreciate the clarification. I wasn't aware of that distinction but, in my opinion, when we are talking about drugs, one mistake is one mistake too many. Even though we aren't talking about the same type of label, as you just explained so well, there were safety and regulatory problems in that case. The report deals with that.

In your action plan and in the steps you are taking, is that type of situation generally taken into account in finding long-term safety and regulatory solutions?

9:20 a.m.

Deputy Minister, Department of Health

Glenda Yeates

Yes, it is very important that this entire multi-step process is applied as part of the work of our investigators.

The work they do in compliance and enforcement is very important as part of this. I think it is very helpful to appreciate, as the member has noted, that it is simply not enough for us to make sure that we put the drug out into the market as safe, and then wait for the reports to come back. We actually have regular inspectors who inspect plants. They inspect for good manufacturing practices. We have, in fact, improved our ability to target those resources. We've added new resources with the new user-fee money, so we have new inspectors. We actually are able to inspect plants on a regular basis, and they inspect the ones we are a bit more worried about more frequently. For the ones that have a very strong track record, we don't have to be there as often. Those are the kinds of inspections that pick up these labelling or other issues.

We look at those on an ongoing basis.

9:25 a.m.

NDP

Matthew Dubé NDP Chambly—Borduas, QC

I'm going to have to interrupt you because I only have a little bit of time left and there is one other topic I want to bring up. My question is for the representatives from the Office of the Auditor General.

One of the beauties of the Canadian health care system is that it is public and that we are not at the mercy of large insurance companies. Could you give us more information about the issue of conflicts of interest and tell us if this concerns you, given that the role of our system is to serve the population and not the interests of large pharmaceutical companies?

9:25 a.m.

Assistant Auditor General, Office of the Auditor General of Canada

Neil Maxwell

Mr. Chair, thank you for the question.

At Health Canada, we have looked at a few aspects of conflicts of interest.

Our main concern was really the fact that we thought the department hadn't really assessed where the risks lie in terms of managing conflict of interest for its reviewers of drug submissions. And really, its processes were meeting Treasury Board requirements, but nothing more.

9:25 a.m.

NDP

The Chair NDP David Christopherson

Thank you very much. Merci.

Now Mr. Shipley, you have the floor, sir.

9:25 a.m.

Conservative

Bev Shipley Conservative Lambton—Kent—Middlesex, ON

Thank you, Mr. Chair.

Welcome to the witnesses.

First of all, I do want to say that I appreciate the fact that an action plan has been put forward, and it does see concrete movement.

But let me go back to the Auditor General's comments, and I am actually pretty concerned about this point. In number eight, Mr. Maxwell, you said that in 2004, the House of Commons committee on health recommended that the department create a public database to provide...whatever. You went on, but my time is short.

You also said that in the fall 2011 audit, you found that, despite this commitment of Health Canada, actions had not been taken.

First of all, I'll ask Madame Yeates, was there a commitment through the recommendation of the House of Commons committee on health? Was there a commitment by the department to get back to the committee with a timeline of recommendations?

Second, as my colleague has said, we can almost assure you that there will be timelines coming for a request from this committee. When I look at the report here, as of March 23, there are four completed recommendations, and 17 that are on target. Most of those seem to have started recently, not in 2004. Could you help me understand a little bit why it has taken so long?

March 29th, 2012 / 9:25 a.m.

Deputy Minister, Department of Health

Glenda Yeates

Thank you for the question.

My understanding is that in 2004 there was a recommendation from the committee, and in fact, the department took a number of steps at that time. It had some expert witnesses, I understand. It looked into the question of what was feasible, and what was reasonable in terms of clinical trials.

As was noted, for example, there was a bill that was introduced at that point, Bill C-51, which addressed some of that, so a lot of energy went into understanding whether we should do things as part of the legislation. When that legislation did not go forward, the department made a number of changes. It increased the transparency by focusing.... It actually encouraged, as we write a letter to a clinical trial site, that we ask them to put their posting on one of the WHO international sites. So we have a number of clinical trials that are now doing that.

9:25 a.m.

Conservative

Bev Shipley Conservative Lambton—Kent—Middlesex, ON

Okay. I apologize for interrupting, but we only have a few minutes.

I'm wondering could you, for this committee, give some summary of actions that had some concrete movement in terms of the concerns that the Auditor General had. I think that would help this committee in terms of our final report, if you could do that.

9:30 a.m.

Deputy Minister, Department of Health

Glenda Yeates

Certainly.

9:30 a.m.

Conservative

Bev Shipley Conservative Lambton—Kent—Middlesex, ON

Secondly, you talked in your presentation about the international connections and communications that you have. It seems that some countries seem to be able to act more quickly in terms of pulling products, and we may have a product on here that—it was mentioned—takes two years to assess, and you talked about having a priority.

I'm just wondering, do you communicate with them on the approval process, the effects, and then the withdrawal of a product? Say in the United States there's a significant pharmaceutical product that has been withdrawn from the market. There's not much difference between a person living in Ontario and in Michigan, so does it automatically come back, and do we pull that product?

9:30 a.m.

Deputy Minister, Department of Health

Glenda Yeates

I'll maybe ask my colleagues to speak to the specifics, but I would say that, in fact, we have ongoing and regular connections with our international regulatory partners. While there are some examples that are listed where we were behind the U.S. in doing something, there are times when we are, in fact, ahead of the USFDA in terms of moving. But there is very constant dialogue.

I'll ask my colleagues to speak more specifically.

9:30 a.m.

Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Paul Glover

Thank you.

Very briefly, the first is on the actual submission and approval of a product before it hits the market. We are in close collaboration with our international colleagues. There are some complexities with that where the drug companies don't always submit at the same time to different jurisdictions. So it may be in Canada before the U.S., it may be in the U.S. before Canada, and there can actually be differences between the submissions from country to country, which the companies do for their own specific reasons.

However, once that's said, when we can, we definitely do collaborate. We look at where they're the same and where they're different. Once the product is on the market, absolutely, we are collaborating on signal detection, so adverse events are shared globally to find out if there are issues. When there are problems, they are shared internationally.

As the deputy pointed out, there are numerous examples where we have gone before the U.S., where our review might actually say—to your point—the problem that the FDA found was already on the label in Canada, and there was no need to adjust the product in Canada. We have examples where we were 10 years ahead of the U.S. in terms of what our label had on it compared to what they did, and vice versa. So there are instances where we pull product, and they don't; we issue label updates, and they don't.

9:30 a.m.

NDP

The Chair NDP David Christopherson

Very good. Thank you. Sorry, time has expired, Mr. Shipley.

Over to Mr. Byrne; you have the floor, sir.

9:30 a.m.

Liberal

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

Thank you, Mr. Chair.

Health Canada has a minimum of eight years of understanding exactly what the appetite of Parliament is in terms of this issue. It has had much longer than eight years to understand the appetite of the pharmaceutical industry to want to limit disclosure and transparency. It has had much more than eight years of understanding the Canadian public's appetite to want to expand transparency.

I would like to have this included in our report, as to whether or not Health Canada's meeting what the broad objectives were originally within the Health Canada study of increased transparency.

Would you be able to explain to us or provide and maybe table to this committee not just that you have an action plan and are committed to it, but spell out to us exactly what is in the action plan? When will disclosure occur, not only for clinical trials but for marketed drugs? What information will be disclosed? How often will that information be disclosed? Can you tell us, how is it disclosed, and quite frankly, whether or not it is done in a routine and regular basis, and how inclusive it is—whether or not all drugs are being summarized or being posted or published on a regular basis, and not just whether or not intermittent inspections are being published?

Would you commit to being able to table to the committee that comprehensive form of information, providing us with exact, full details—full disclosure—of how Health Canada is going to approach this in the future?

9:30 a.m.

Deputy Minister, Department of Health

Glenda Yeates

Yes, thank you very much. We share the desire of the committee for greater transparency. In fact, as we've gone forward with our strategic thinking in terms of how we tackle this with the new resources that I've mentioned.... We have to focus first on timeliness, because we know that we had some issues. We need to focus on some of the regularization of some of the processes and making sure that we strengthen that. Transparency is very much part of our agenda. We would be pleased to give a sense to the committee of what our plan is, what we post, the progress we've made, and the progress we foresee making in the next years.

9:35 a.m.

Liberal

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

I want to be very clear. I appreciate, Deputy Minister, your forthrightness on this. I'm not looking for a sense. I'm looking for hard timelines and inclusiveness. We, as a committee, don't want a sense of what you're about to do. We need and want to know what you are going to do. What level of detail is going to be provided? When is it going to be provided? Will the public have genuine access to it or not? We will be very rigorous in assessing that to determine whether or not you are meeting the spirit and the test of what is expected of Health Canada by Canadians and by Parliament.

I'll now go into another question. I'll take that as a yes that you'll have that full disclosure. Would that be correct?

9:35 a.m.

Deputy Minister, Department of Health

Glenda Yeates

Yes. The only thing I would comment to the committee is that in some cases we are in consultations. If we're actually talking to the public, consumers, and experts, we may not be in a position to pre-empt those discussions and say precisely the outcome of those consultations. We can certainly outline, for the committee, the process we are going through and when we expect to be through that process. With that understanding, I'm happy to commit.

9:35 a.m.

Liberal

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

You are also talking to Parliament, which is providing some pretty specific instructions. I'll ask you this. You indicated that you felt there were some restrictions as to how far you could go with public disclosure because of privacy rights and legislation. Could you detail for us what specific privacy rights, and what other specific legislation beyond the Privacy Act may be inhibiting your ability to properly inform, in a transparent and lawful way, on what is expected? You sense the spirit of what is expected.

Inform us so that we as parliamentarians can be aware of this and we can potentially consider changes to those legislative mechanisms that may restrict your ability to be transparent. Would you be able to provide us with that information?