Public Accounts Committee on March 29th, 2012

[Paul Glover]

—the types of problems, the documentation, things to look for, the most common adverse events we see, safety issues to look for.

There is a wealth of information at an aggregate level—from our consultations, both participants and sponsors were looking for this—about trials, how they operate, what works, and what doesn't. It's to inform them.

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

But see, the problem here is that people don't take aggregate drugs, they take individual drugs. They take specific drugs. That, I think, is the appetite of the public, and I think that's the safety issue that the public has raised—i.e., I don't take an aggregate drug, I take a specific drug, and I want to know the specific details of that drug and what has been found of that drug.

I'll ask you this. Health Canada has moved to an industry user-fee model, which actually increases.... Can I actually get, or can I request, the amount of money that a particular firm or company has paid in user fees related to their clinical trials or their necessary Health Canada approvals? Can I get that information?

It would be kind of an interesting metric as to how much scrutiny has gone into the oversight of that particular drug.

[Paul Glover]

Mr. Chair, in response to the member's question, first and foremost, there is specific information on all of the drugs we've approved, and through MedEffect and CARN, any adverse events that are being reported to us.

While we acknowledge that people take individual drugs, we provide information on that individual drug and the types of adverse events, updates, and warnings to both health professionals and to the general public. That information is, and will continue to be, made available.

On clinical trials, we're looking to expand it, as well, in the early stages of the product development.

With respect to user fees, we are at this point posting aggregate information, but we could, obviously, provide detailed information.

I would have to pause on my answer there and just confirm exactly what level of detail our accounting system and others would be able to put forward, but we can commit to transparency on both the fees we're collecting and the performance standards we're using to meet those.

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

I appreciate it. I think Canadians want to audit Parliament in the next short while as to exactly whether or not we are helping you to be transparent and to allow full disclosure. That's why I'm really looking forward to your detailed summary of specific concerns or specific limitations that you have identified, or that the industry has identified and that they use to demand that you not disclose information. You obviously have that information as well, that feedback from the industry, saying you can't disclose this information because they have a right to have that information protected.

Perhaps you could forward to the committee all of that information about what restrictions you have in terms of not only the Privacy Act but also the other legislation that you've identified.

Mr. Maxwell or Ms. Dubé, I would ask you that same question: did you identify anything during the course of your audit that specifically restricted Health Canada's ability to disclose information through statute or regulation?

[Neil Maxwell]

Thank you.

It was really up to the department to identify those constraints. Certainly nothing came to our attention, other than the general and obvious point the member has made, which is that there are general laws of application about privacy and such in play here.

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

Mr. Chair, with that, I'll just repeat again my very strong desire to receive specific items from Health Canada in terms of further scoping down and defining. We're not getting a sense of defining the action plan. When are things going to occur? What exactly is going to be disclosed? How inclusive will it be? Will it be all-inclusive? Will it be intermittent or an occasional reporting, depending on when an inspection occurs? It's things like whether or not inspections are set over a period of time or if they're intermediate.

This is the information, I'll just suggest to you, that we're going to be looking for in our report so that we can actually gauge...so that we don't have to be eight years out, still trying to get a sense of where this is going.

Mr. Chair, I'll just leave it at that.

[The Chair, NDP, David Christopherson]

Yes, you will.

Thank you so very much.

Mr. Hayes, you have the floor, sir.

[Bryan Hayes, Conservative, Sault Ste. Marie, ON]

Thank you, Mr. Chair.

First off, I'd like to commend the assistant auditor general and staff. This is a really comprehensive audit and I learned an awful lot going through this. As members of this committee, we certainly can't know everything about every department. And I'm significantly more intelligent now about the process than I was.

I'd also like to commend the deputy minister of health and her department for their ongoing efforts to ensure that drugs sold in this country are safe. I'm a consumer of many. I've had a few problems along the way and I've never had an adverse reaction. As a matter of fact, last week I went to get a prescription and the pharmacist, who knew what other drugs I was on, advised me as to, “No, this isn't really a good mix. You need to not do this one if you're going to do this one.” So I have great confidence in the system.

My question is specifically going to focus on user fees. As the witnesses know, manufacturers of prescription drugs benefit from the regulatory services and oversight provided by Health Canada. They also benefit when consumers know that Health Canada has approved a product. We also understand the importance of cost recovery, particularly when trying to eliminate the deficit while also maintaining low taxes for individuals and businesses.

My question is this. Could the deputy explain what is meant by “increased user fees”? Obviously, at one point there were user fees, and now they have been increased. I'm trying to get a little sense of dollar value. I'm also trying to get a sense of how those increased fees have led to improved performance. You did allude to increased staffing, but I do really want a sense that you have the confidence in your human resource staffing component and their ability to fulfill your obligations that have been determined by the assistant auditor general and his staff.

[Glenda Yeates]

Thank you very much, Mr. Chair.

It's a pleasure to be able to speak to the user fee initiatives. In some ways I think it was a huge undertaking for the department and I think it is very important.

I know the user fees were set in the mid-nineties, and at that point they were about roughly half, 50%, of the cost of doing the work. In some ways that reflects the sense that there's a public interest in having drugs reviewed and an industry interest as well, and that they should bear some of the responsibility and cost for doing this work.

Over time, as the costs have increased and as the complexity and volume of submissions have increased, the fees haven't kept pace. As a result they have fallen to about 25% of the cost, in rough figures, of doing the reviews. We had fallen behind our international partners. The USFDA, for example, is at about 50% Europe, depending on the country, will be 60% to 70%. So Canada was really out of line.

With the requirements of the User Fees Act, Parliament has very clearly set out the requirements for a department that wishes to go forward with a user fee proposal. There's a great deal of due diligence that must go into a user fee proposal. We did all of that economic work, took it through the parliamentary process, and Parliament in its wisdom gave us the ability to actually increase those fees. As of April of 2011, we have been seeing a significant increase in fees.

The member asked about the magnitude. We now collect about $70 million in user fees, and that's an increase of about $34 million—not all of that is in the drug area. The assistant auditor general mentioned medical devices. It's also in the medical device area. It's across the spectrum, but a significant portion obviously is in the prescription drug area.

We think that's a significant move forward. There are a number of things we've been putting these resources to. In some cases it has allowed us to significantly increase our scientific expertise, so we've been hiring new people. We've in fact been able to hire them in different markets. We've expanded in our Toronto area to take advantage of the expertise in that labour market as well.

We've been able to hire significant new scientific experts. As I mentioned, we have new inspectors. It's across the board. We've been able to strengthen the computer system in some ways. What the Auditor General points out is that sometimes you can get a lot of these adverse reports, but you actually need to be able to prioritize, search them, go through them, so we've been able to augment our IT, information technology, capacity as well.

It's been a big time of gearing up for the department. We are not yet through all of it.

When you get new reviewers, the interesting thing is that it takes some time to train them. In the short term it actually can take some of your existing skilled reviewers, seasoned reviewers, off the files to train the new folks. It's not an immediate solution, but we are seeing now that we are getting new people on board and getting them trained up. We feel this will serve us in very good stead going forward.

[The Chair, NDP, David Christopherson]

Thank you.

Sorry, Mr. Hayes, time has expired.

Monsieur Dubé, you have the floor, sir.

[Matthew Dubé, NDP, Chambly—Borduas, QC]

Thank you, Mr. Chair.

I want to come back to the question I started to ask at the end of my last turn, about the conflict of interest. I cannot reiterate enough just how important the issue is. As I said, the beauty of our health care system is that it serves the public and not other interests. That's why conflicts of interest can be problematic.

I understand that there aren't any conflicts of interest, but you spoke about risks. Mr. Allen spoke about the proposed solution, of the report that will be tabled, and that's great. However, to fully understand the solution, it's just as important to understand the problem.

So I would like to give the representatives of the Office of the Auditor General the opportunity to speak about what is meant by the risks. Are we to understand that there may be interests other than the interest of the public or the health of Canadians?

[Neil Maxwell]

Thank you for the question.

Perhaps I could talk about two types of risk in this kind of situation.

The first is, and it's been mentioned before, that there is the potential for financial gain. The second kind of risk is probably less obvious. Having looked at certain cases over and over again from some of the same companies, there can be what we call in audit land “familiarity risk”.

There are those two types of risks. I do emphasize that we didn't go looking for cases and we didn't find a case. Our concern was that those controls have to be strengthened to ensure there was no shadow of a doubt cast over any of the employees doing this important work.

[Matthew Dubé, NDP, Chambly—Borduas, QC]

Thank you very much. I appreciate your answer.

Correct me if I'm wrong, but I thought I understood a little earlier that this wasn't the main objective of the report. That's fine; it's not a problem.

Having said that, given the importance of the issue for the reasons I mentioned—and it seems to me that I have the agreement of the people present—would you be willing to say that it's an issue that Parliament should look into, whether through an audit done by your office, a study of the legislation or a study by the Standing Committee on Health?

Do you have an opinion on that?

[Neil Maxwell]

Thank you for your question.

The Treasury Board has taken a few steps to improve the requirements relating to conflicts of interest.

Potentially, the committee might wish to focus there next, which is to understand the issue more globally. We're talking about conflict of interest in one particular department, but there is a broader story here about how conflict of interest is being managed across the government. That, I might suggest, might be one place to focus.

[Matthew Dubé, NDP, Chambly—Borduas, QC]

So it would be important for Parliament to follow this important issue in the next few months, and even over the next few years.

I would like to come back very quickly to another issue. I am very pleased to learn that there is good cooperation between Health Canada and your international colleagues. We were just talking earlier about the Sandoz issue. In that case, we saw that the FDA was the first to identify the problem.

Let's go back to what Mr. Allen said earlier, with respect to the number of times where the report points out that the problems were detected by international agencies. I am very pleased to learn that you are able to work with those agencies.

However, we need to think about our "medical sovereignty", if you'll pardon the somewhat ridiculous term. Don't you think it's important for Health Canada to be able to identify the problems on its own, without being taken hostage by other authorities in Europe or the United States?

[Paul Glover]

Thank you very much, Mr. Chair.

I'd like to begin by just underlining that Health Canada was inspecting Sandoz. We did do an inspection. We found a number of areas. We made some observations in our report to them and we're following up with them.

We made, as we do in any inspection, observations and asked for further follow-up. The FDA in their inspection of Sandoz, which includes two plants in the U.S. and one in Canada, found a particular issue. Their approach was to issue a warning letter. It was Sandoz who made a business decision about how to respond to that warning letter. So Health Canada had and continues to be inspecting the plants in Boucherville, Quebec.

We had found areas that we had already written to the company on, asking for them to take corrective action. The FDA and the product in question was a product not sold into the Canadian market. Their approach was a warning letter, and it was Sandoz that made a business decision about how to respond, not just in the Boucherville plant but the two other plants in the United States. That is important to know.

[The Chair, NDP, David Christopherson]

Sorry, the time has expired. Thank you.

Our last speaker in the full rotation is Mr. Dreeshen and you have the floor, sir.

[Earl Dreeshen, Conservative, Red Deer, AB]

Thank you very much, Mr. Chair, and thanks to our guests for being here today.

I have a bit of a health care background, at least in management. I've been a hospital board chairman for a number of years in Alberta. With regard to some of the types of things that happen, there has to be an acute awareness of health and safety needs. So I guess the things that I want to focus on are transparency and timeliness. I guess when you're taking a look at the information about health and safety that's stemming from authorized clinical trials, it's important that people are participating in these trials and that they get information back about what has taken place.

With this in mind, I would appreciate it if the deputy minister could advise the committee on how Canadians can be assured that Health Canada has taken the necessary steps to improve the amount of information that is being shared with the public?

[Glenda Yeates]

Thank you very much, Mr. Chair, and I'll begin, and then turn it over to my colleagues on the specifics of clinical trials.

But it does strike me that there are two components in the question. One is what do the people who are in the clinical trials—and again one of the things that we look to as we inspect clinical trial sites will be things like informed consent and ensuring that there are the right mechanisms between the participants in the trial and the trial site, for example. So those are things that the individual patients in the trials can be assured of. Those are things that are part of our oversight requirements at clinical trials.

Then, with regard to the question about what citizens generally can know about clinical trials, as was mentioned, we've been encouraging all of the companies who have clinical trial sites in Canada to post them on international WHO-recognized websites, so that individuals can learn of those trials. That's one of the ways that people can understand it. Again, from our consultations, this summary document that we mentioned, people said this will be very helpful to understand, and we are continuing down the path of giving more information on specific trials as well.

Maybe now I'll turn it over to my colleagues.

[Paul Glover]

Thank you very much, Mr. Chair, for the member's question.

With respect to safety, first and foremost, the design of all clinical trials is subject to a review and approval by the department to ensure that the trial both achieves its objective in its design and that the patient's safety isn't compromised throughout that.

As the Auditor General pointed out, we needed a better process to identify risks in those trials and figure out which ones to inspect. We have done that. We have instituted standard operating procedures. We have mandatory reporting of adverse events from all clinical trials. We now have a system to prioritize those adverse events so that we can figure out what the significant signals are indicating that we might have to go in to follow up with the sponsor about the design of the trial, or to inform participants or ask the sponsor to inform participants about particular health and safety issues.

We've also developed standard operating procedures that we're in the process of implementing to make sure that we inspect the right clinical trial sites to make sure that they are correctly following their own processes, as per their submission to us. We didn't have that clearly documented; it is now documented. We have a risk-based process for doing this, to identify those we think are of greatest risk, and have trained and are in the process of implementing that procedure.

So we have taken a significant number of steps to protect the health and safety of the participants in the trials and to improve reporting to us. As was noted, we started to make transparent aggregate results of clinical trials, and we won't stop there. We'll continue; that's just the first step.

[Earl Dreeshen, Conservative, Red Deer, AB]

I'd like to go back.

Madam Yeates, in your presentation you spoke about the backlog for new drug submissions and about how it had been eliminated in 2011, but you talked about the challenge in meeting performance targets for generic drug reviews.

Is there anything specific to a generic review that has caused a delay in meeting these performance targets? Or does it simply happen to be one of those situations in which you were dealing with one part and hadn't gotten around to the other?

[Glenda Yeates]

Thank you. It's a very important question in terms of the generic reviews.

We have established the targets precisely so that we can monitor to see where we're falling short, as we are in generics.

We've seen a significant increase in the volume. In some cases we've seen an increase—I think in the last year a 33% increase is the number that sticks in my mind—in the number of submissions coming in. Even as we're gearing up—as I mentioned, doubling some of the capacity in some specific areas—the increases in volume mean that we have not yet reached our targets.

We're also doing a pilot, and we'll be evaluating it, to see whether we can better integrate our reviews and collaborate with other reviewers worldwide. If there is information that we can share back and forth to make sure that a broader pool of science expertise is looking at these questions, that may speed this up for all of us. We're piloting a number of methodologies in this area, and we'll be looking to see whether that gives us some ongoing process improvements.

But we acknowledge that this is an area that still requires work, and I can reassure the committee that this is why we've put these extra resources there, and have tried to build the systems and look for the process changes that would aid those resources to move more quickly.

[The Chair, NDP, David Christopherson]

Very good.

I'm sorry, Mr. Dreeshen, that concludes your time, sir. Thank you very much.

Colleagues, we have a little more time, and I'm in the hands of the committee. We can continue—going back to the beginning of the rotation, if you wish—and go to the exhaustion of the meeting, or we can conclude matters here. I'm in your hands.

Mr. Byrne.

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

We could start with a new rotation, but maybe condense the time a little for each questioner.

[The Chair, NDP, David Christopherson]

What do you think?