Thank you, colleagues. I call meeting number 36 of the Standing Committee on Public Accounts to order.
Our chair is tied up on the little green bus at this particular moment. He'll be along shortly, so in the interim, out of courtesy and the opportunity to have some discussion with our witnesses, we will welcome them here and get the proceedings under way, so we'll have ample time in which to have an open conversation with them.
We have before us today Neil Maxwell, the assistant auditor general. We have Louise Dubé, a principal as well. We have, from the Department of Health, Glenda Yeates, the deputy minister; and of course, Paul Glover, the assistant deputy minister; and Marc Berthiaume, director.
Welcome to one and all.
I understand we have two opening statements, one by Mr. Maxwell and one by Glenda Yeates.
First, we will start with you, Mr. Maxwell, your opening statement, please.
Thank you for this opportunity to present the results of our audit on regulating pharmaceutical drugs at Health Canada.
With me today, as you noted, is Louise Dubé, the principal responsible for audits in the health sector.
There are about 13,000 prescription and non-prescription drugs on the Canadian market. Pharmaceutical drugs play an important role in Canada's health care system and economy. Health Canada regulates the safety, efficacy, and quality of all pharmaceutical drugs in Canada before and after the products enter the Canadian marketplace.
The department does this through a combination of scientific review, monitoring, compliance, and enforcement activities. It aims to ensure that the public has timely access to safe and effective pharmaceutical drugs, and that those who need to know of safety concerns are informed.
For our 2011 fall report, we examined whether Health Canada fulfilled its key responsibilities for pharmaceutical drugs. These responsibilities involved timeliness, consistency, transparency, conflict of interest, and risk-based post-market activities.
We found that the department had not adequately fulfilled most of these key responsibilities related to clinical trials, submission reviews, and post-market activities.
In particular, we found that Health Canada had problems with the timelines and transparency of its activities.
Health Canada is not meeting its service standards for the timely review of most of the drug submissions it receives, thus delaying Canadians' access to the health benefits of new drugs. It is also delaying access to more affordable treatments.
Health Canada has established processes to identify potential safety issues for marketed drugs, but it is slow to act. It can take the department more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information.
In 2004, the House of Commons Standing Committee on Health recommended that this department create a public database to provide information on clinical trials in progress, abandoned and completed. Health Canada committed to enhancing public access to information about clinical trials. In the fall 2011 audit, we found that, despite this commitment, Health Canada had not taken action. This lack of information increases the risk that Canadians may be unaware of new treatment options or may unknowingly participated in an unauthorized trial.
The department is also not disclosing information on drugs that it rejects, drugs that the manufacturer withdraws from the review process, or drugs with conditions.
Health care providers have the discretion to prescribe a drug for conditions that the drug has not been authorized to treat. Therefore, it is important that health care providers be informed when the department rejects a marketed drug for a new use, so they understand the department's concerns.
We reported very similar findings in our June 2011 report on the regulation of medical devices about a lack of timeliness to review submissions related to those devices. We found that Health Canada was not making use of assessment work done in other jurisdictions, as part of its own assessments of the safety and efficacy of medical devices that could lead to program efficiencies. Health Canada has recently launched an initiative to make greater use of this information for medical devices and pharmaceuticals.
We are pleased that Health Canada has agreed with our recommendations from both reports and that it has developed action plans to address them.
The regulation of pharmaceutical drugs is important to Canadians. With an aging population, the role of pharmaceuticals is expected to grow as researchers come up with new therapies to replace earlier treatments or provide new options where no treatment existed before. The committee may wish to obtain the assurance and commitment from Health Canada to implement our recommendations in a timely manner.
Mr. Chair, that concludes my opening statement. We would be pleased to answer your committee's questions.
Thank you very much, Mr. Chair, and good morning to you and members of the committee.
Thank you for the opportunity to appear before the committee to discuss chapter 4 of the Auditor General's report dealing with the regulation of pharmaceutical drugs in Canada. I am joined here today, as was noted, by Paul Glover, assistant deputy minister of the health products and food branch, and Dr. Marc Berthiaume, director of the marketed health products directorate.
Canada has one of the safest and most rigorous drug safety systems in the world. At Health Canada, we take our regulatory role in support of the drug safety system very seriously and carry it out in a scientifically rigorous and independent manner. We know, however, that there is always room for improvement.
In this spirit, I would like to thank the Auditor General for his work. As the Auditor General noted, we need to improve the timeliness of our reviews; we can better document and accelerate the process of identifying potential safety issues; and we can increase the amount of information available to Canadians about our processes.
We do, Mr. Chair, as was noted, have a detailed action plan, which has been tabled with the committee. I can assure the committee of our commitment to carry out these actions as part of our ongoing process to improve how we protect the health and safety of Canadians.
I am pleased to report that as of April 1, 2011, we have significantly more resources available to fulfill our mandate as a result of our new cost-recovery program.
As was supported by the Auditor General in a previous audit, we have now increased fees that are charged to industry in support of drug applications, thereby returning us to a more historically balanced funding model. As a result, Canada is now much more in line with comparable international regulatory agencies such as the United States Food and Drug Administration and Europe's European Medicines Agency.
These fees are expected to generate, and in fact, are already generating significant new revenues. These incremental resources have already enabled us to hire 160 new staff, strengthen our capacity to improve our processes, and upgrade things like our computer systems.
Now I would like to briefly describe some of the specific actions that either have been taken or are under way to improve the safety, transparency, and timeliness of our systems.
At Health Canada, there is no higher priority than safety. The department reviews all drugs for safety, efficacy, and quality. Canadians can be confident that the drugs approved by Health Canada have undergone a rigorous assessment against these criteria.
The Auditor General recommended that Health Canada strengthen its risk-based approach to monitoring clinical trial sites and adverse drug reaction reports during clinical trials. This past September, we introduced a risk-based approach for monitoring and assessing clinical trial adverse drug reaction reports, and we have already completed and begun to implement an updated risk-based selection process for inspection of clinical trial sites.
Moving on to transparency, Mr. Chair, we recognize that the work we do is of great interest to Canadians, and that we have a duty to make information about the safety and effectiveness of drugs available to them. As I said, we take this duty very seriously.
The department is improving transparency with respect to marketed health products with the launch of phase II of the summary basis of decision project in June. These reports will provide information in a much clearer manner so that it can be understood by Canadians.
We are improving public access to information about clinical trials by publishing summary reports about clinical trial inspections. The first of these reports was published a few days ago.
We are also making important health information more easily accessible to doctors and patients. We are working with stakeholders to make labels more understandable to Canadians, and we are posting all authorized drug labels on Health Canada's online drug product database.
We will continue to take steps through policy guidance, and if necessary, regulatory proposals to improve transparency.
We are doing a number of things to improve timeliness in our core regulatory activities.
We believe that we are making significant progress in addressing the Auditor General's concerns about the pace of assessment of potential safety issues.
We are working with the United States and some European countries to streamline our drug-submission system and share information about inspections and adverse reactions. Moving forward, we plan to expand our cooperation with other countries.
With regard to evaluating drug submissions, I am pleased to report that we are making progress. The backlog for new drug submissions was eliminated in December 2011. We do still have a challenge in meeting our performance targets for generic drug reviews and we have devoted significant new resources to tackle this area.
In summary, the Auditor General's report has been helpful in guiding some of the changes that we need to make to continue to perform our regulatory responsibilities to protect the health and safety of Canadians. We have one of the most rigorous drug safety systems in the world, and Health Canada is consistently and constantly looking for ways to strengthen it, which is why we're taking the findings of the Auditor General very seriously.
My colleagues and I would be pleased to take your questions.
This is a very important question for the committee to consider. We have a very safe and rigorous regulatory system. As was mentioned in the Auditor General's report and in the member's question, this is done in a variety of ways. It's done before the drugs ever come to market by looking at the clinical trials. It's done as the drugs are submitted for approval. It's done as we put them on the market and continue to have surveillance mechanisms to ensure that we understand all the possible consequences of these drugs.
We are the only drug regulator in the world that has established performance standards on the post-market side for completing safety assessments when a drug is already on the market. Our international partners are very interested in talking to us to see if they can adopt this practice. Most drug regulators have only timelines and benchmarks for the review of drugs.
We've strengthened the user fee proposal that was put through Parliament under the User Fees Act, which now supplies a substantially enhanced resource base to the department and rebalances the fees paid by industry in accordance with the support given by the public tax base, thus providing us with new resources. For example, we have virtually doubled the number of chemists who are able to work on the generic drug files. While we are up to date in meeting our performance standards and have eliminated the backlog for brand-name or new drugs, we are not yet meeting our performance standards for generic entities. That's why we've put these new resources in—to improve our performance in that area.
We are doing a number of things to improve our performance. We're improving the access Canadians have to identify post-market issues. We've strengthened our MedEffect database and our Canada vigilance program to make sure that whether you're a physician or a consumer, if you have an adverse event, you will be able to submit these to us easily. We have strengthened our standard operating procedures for those programs. We've taken a number of steps—I've just mentioned a few—to strengthen the process of the drug regulatory program.
Thank you, again, for the question. It is quite important.
The Auditor General's recommendations are very helpful to us. We have accepted all of them. In fact some of them that were short term are already completed, and a number more are in the medium or long term. We have long-term strategies in place and systems that are being built to address them.
We are very actively working on all 10 of the recommendations, but we have not stopped there. We would never be satisfied, nor would the Auditor General, with ever thinking we were finished with improving our performance in this area that is so critical to Canadians. There are a number of areas where we are going beyond what the Auditor General has noted.
We are, as I said, expanding our capacities in a number of areas. We're focusing on the standard operating procedures to strengthen them in many areas. We've put out some regulatory and discussion documents for consultation to discuss how we might go further in areas of transparency and others.
Perhaps because of the detailed nature of the question, I will turn to my colleagues to ask them to give additional examples of where we've gone beyond the action plan to the Auditor General's recommendations.
Mr. Chair, I thank the member for her question.
It's true that our powers are somewhat limited with respect to our ability to request a change on…
the monograph, the labels. We do have limited powers to demand or impose label updates on products as we see them. We end up working in collaboration with the companies in order to negotiate the sorts of changes we would like to see.
The process to obtain an update on instructions for a drug is now being negotiated with the industry.
We find that this works for us. Obviously we exert a fair amount of influence over industry to comply with our requests.
We have the power, if we feel that industry is not complying, to simply issue a warning saying we've asked the industry to do x and they've declined. Oftentimes that's enough to have industry come into compliance with our recommendations. We do have powers beyond just the negotiation.
In , a previous piece of legislation, there were some proposals that would have allowed us to go beyond simply working in a collaborative nature with industry, to one that would be imposing our direction upon them. Given what happened with that piece of legislation, we are taking a look at what other steps we can take to ensure the regulatory framework we have allows us to move as quickly as possible.
The one problem I would acknowledge with the current process is that it does take a bit of time in terms of negotiating rather than simply directing.
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?
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.
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?
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.
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?
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, , 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.
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.
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?
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.
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.
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?
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.
That's the magic. Nobody knows which ones you're going to follow up on. It's all good. We all have to behave.
Madam Yeates, I want to focus on the transparency issue. You've heard the passion on all sides of this committee. As parliamentarians we understand the importance of sharing information with the public. When it comes to authorized drug trials, there are a few aspects that I want your view on.
It's important for those in the trials to have access to the information. This is also important for people who end up on those drugs. I would suggest it's very important for Canadians who are making a decision about taking that drug. We are now seeing more and more that people's physicians will say to take a drug, and people will say, wait a second, and they're going to the Internet and they're verifying it. Certainly, parents do that for their children all the time. Obviously, the Auditor General focused in on your risk-based approach with regard to the inspection of clinical trials. There were a number of cases of non-compliance that you had also determined.
What actions are you taking, as a department, to disclose the information related to the clinical trial inspections in those three parts: the participants, the prospective users, and the users?
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.
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.
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.
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?
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?
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.
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.
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.
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.
Yes. Thank you to the member for his question.
I'll begin and then very quickly—I'm thoughtful of the time—hand it to my colleagues, who in fact are the experts doing this day to day.
It is very much the case that we work to make sure, right through the clinical trial approval stage, through the drug approval stage, and then in the post-market stage, that we are looking at safety at every step. We post, as my colleague mentioned, the product information on the web so that individual practitioners and Canadians can see it. We post advisories, wherever we have concerns. We have mechanisms to determine which signals might be ones we should be prioritizing.
I'll turn to my colleagues for a more complete answer.
Once a product is on the market, adverse events are the most important signal for us. We follow those up very actively. To provide the committee with some specific numbers, there were over 30,000 domestic adverse events reported to Health Canada in the last year—that is in addition to more than 300,000 international adverse events. We pool that together, we look for common safety signals, and we investigate those.
Out of those several hundred thousand safety signals and events that were reported to us, we narrow the focus down. In the last year, it was about 1,600 particular investigations that we did. That further narrows down to about 125 specific events that we felt were really worthy of further investigation.
Of those, there were between 60 and 90 risk communications, and that could be a label update, it could be a warning to the public, or it could be a withdrawal of a drug. There's a range of things in those activities. It's a case of constantly going from large volumes of data down to something very specific.
Just to respond to one of the questions earlier, for which we ran out of time, we would acknowledge that in those areas of the report card, which was mentioned by one of the members, we were not meeting performance targets. With the new fees, with the new changes in processes, we're pleased to report that we are meeting our performance targets on post-market surveillance and safety. The signals are being assessed in the timeframes that we have, they're being assigned, and the investigations are concluding.
We're very pleased that not only have we set those performance standards, but we are now able to meet them and to deal with sifting through those large amounts of data.
It's a very important question. What we would try to reassure the committee and to communicate to the committee is that when we are trying to assess the time between getting some piece of information and putting out a communication.... If we assess this to be a real and serious signal that affects the health of Canadians, obviously two years will be far too long. We don't wait. Those are prioritized and those are done immediately.
There are some signals where we would say more information needs to be gathered. We would take the time to make sure that we are confident the advice we would be giving to Canadians is, in fact, the right advice. We would say that the standard operating procedures—the clarification, which the Auditor General suggested, that we are very clear about how we prioritize that work, and set ourselves timelines.... We are meeting those timelines, as my colleague mentioned, and these signals are so unlike each other that one timeline in a sense wouldn't be appropriate for all of them. What's important is that they are done in the priority that reflects their seriousness. So for some, 24 hours would be the right timeline, and for others much longer, and different mechanisms and tools would be used.
We are comfortable that we are addressing those in a timely way, and that's, I think, the prioritization that my colleague was flagging. We always want to be making sure that we are doing a better job, though, and that's why we look to these system improvements, these process improvements, and these procedures to help us ensure that we are always catching the important ones early and that we are, in fact, setting timelines for all of them. I think that's the spirit of the way in which we're looking at this.
Yes, thank you. You read my mind.
I was hoping someone might ask that question. I have maybe three quick points, being conscious of time. I'll speak in English, since I can speak more quickly.
Concerning the two years it has taken, I listened with interest and I'm encouraged by the fact that the department is now meeting its timelines. But I would emphasize that it is a multi-step process, and there are timelines only for certain parts. So that's improvement, but we found—and it was a large number—almost 50% of the cases took more than two years, when they had to go from evaluation through to the actual communication to the medical professionals and Canadians. We found things such as breakdowns in communication between the different sections, between the people dealing with brand name and generic.
We found as well that quite often there were delays because it was easier to batch a number of label changes, if there were a number of different generics. So I think there are more structural things that will also need to be looked at with regard to that.
I have two other quick points. There's been a lot of discussion on clinical trials today, and a lot of encouraging action. Auditors always reserve judgment until they can go back and re-audit, but encouraging indeed.
The one thing that I think remains the largest gap is the question of the availability of information on specific clinical trials. As we sit here now, you could find many of those clinical trials by going to the FDA site or the European Medicines Agency. So I'm encouraged by the actions that Health Canada's taking, but a gap still exists today in terms of the information Canadians have.
Maybe I'll stop there.
That's fine, and that exhausts our time.
Thank you very much, Madame and Monsieur.
We'll now go to Mr. Byrne.
An hon. member: No. Chair....
The final thing I said was one from each. One, two, three.
Some hon. members:No. Two and two....
You're both going to go with two then? That's not what I said, but if that's your understanding, that's more important. So go ahead then....
That's fine. I stand corrected.
Mr. Kramp, then over to Mr. Byrne.
Mr. Chair, I'll try to be as clear as I possibly can, perhaps it was my miscommunication.
Sandoz has a plant in Boucherville, Quebec, and two in the U.S. The FDA inspected all of those. The FDA was concerned with what it saw in the Boucherville plant in Quebec, with respect to a product that they make there that is not sold in Canada. It is sold into the U.S. That was what the FDA found. They issued a warning letter to Sandoz saying they had this concern, and Sandoz had 30 days to respond with a plan to address that concern.
We also inspect Sandoz and its plants, just as we inspect all plants that provide product to the Canadian market, or we work with international partners to make sure they all get inspected. In the particular case of the Boucherville plant, we had been in and continue to be in it. We were in just last Friday, given the packaging mix-up. Our inspection found a number of problems, and we noted those problems and asked them to follow up with how they would respond to those observations. They were still compliant. We didn't feel the plant needed to be shut down. It could still continue operating, but we wanted to see further improvements in their operations, and that is fairly standard in terms of all our inspections.
Are you good, Mr. Byrne?
Hon. Gerry Byrne: Yes, thanks.
The Chair: Very good. Thanks.
I just want to make a couple of comments, and then we'll be on time to adjourn.
I want to underscore the importance, obviously, that everybody takes to this issue, and you can understand why. I think it's good that the action plan is giving Mr. Maxwell and his shop some comfort that you're on the right track.
It was good that you tabled this with us prior to coming here today. That is our rule, our policy. Not everybody is following it, but let it be known now that we'll be cracking down on that. You won't need to be on that list because you did meet the timeline, and it is appreciated.
I do want to underscore, and I think this is important, that this was not a good report. I think Mr. Allen commented that overall you didn't get a passing mark on something that is very close to every one of us here because of our constituents.
I will end on a positive note, but first I want to underscore that in the remarks from Mr. Maxwell this morning, he mentioned the 2011 fall report....
Now, people who have been on this committee for a while will know that nothing enrages me more than when things have been audited or looked at in the past, with recommendations made, recommendations accepted, and they go off with “Yes, sir, we'll do it”, but then, when they're brought back a couple of years later, it's not done. I have been on this committee, and Mr. Kramp too, where there have been four and five previous audits. Yours isn't quite that bad, but it's not good.
Mr. Maxwell said in his comments:
For our 2011 fall report, we examined whether Health Canada fulfilled its key responsibilities for pharmaceutical drugs....
We found that the department had not adequately fulfilled most of these key responsibilities....
We found that Health Canada had problems with the timeliness and transparency of its activities.
Health Canada is not meeting its service standards....
In paragraph 7, “but it is slow to act”, and I'll come back later to the 2004 example.
The Department is also not disclosing information....
There is a list of those, and we've talked about those.
We found that Health Canada was not making use of assessment work done in other jurisdictions....
Then there's the issue of the database back in 2004, which has been referred to by a number of members. In 2011 there was an audit where you were rapped on the knuckles for not having met your commitments in 2004, and here we are in 2012 and it's still not done.
So this is very serious. I said I'd end positive, and I will.
The action plan, I agree with Mr. Maxwell, looks very comprehensive. I think it gives us a good sense that you're on the right track.
But I do want to underscore to you, Deputy, that it will not be a pleasant day if your department returns, upon follow-up by Mr. Maxwell, and these things are not addressed. Given the assurances you're giving us—and my sense is that the committee is prepared to accept those assurances at face value—please do not come back here, upon a further review, and still have failed in all the commitments that you've made previous and made today. Please don't let that day happen. It won't be a pleasant one. Okay?
But we're feeling good. That was a good discussion. The answers were fulsome. Let's hope that going forward we can focus on being far more positive than any of the negatives, because I know you want to do the best you can for Parliament and for Canadians.
With that, I will thank you all very much. Thank you to the assistant auditor for being here today, and all of our other witnesses.
Colleagues, is there any other last-minute business to come before the committee?
Hearing none, this committee meeting now stands adjourned. Thank you.