Public Accounts Committee on March 29th, 2012

[The Vice-Chair, Conservative, Daryl Kramp]

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.

[Neil Maxwell, Assistant Auditor General, Office of the Auditor General of Canada]

Thank you, Mr. Chair.

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.

[The Vice-Chair, Conservative, Daryl Kramp]

Thank you very much, Mr. Maxwell.

Please go ahead, Ms. Yeates.

[Glenda Yeates, Deputy Minister, Department of Health]

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.

Thank you.

My colleagues and I would be pleased to take your questions.

[The Chair, NDP, David Christopherson]

Thank you very much.

I assume everything that needs to be done to this point has been done, so all of the statements that are going to be made have been made.

Very good.

In that case, we will start with Mr. Saxton. You have the floor, sir.

[Andrew Saxton, Conservative, North Vancouver, BC]

Thank you, Mr. Chair, and my thanks to our witnesses for being here today to discuss the Auditor General's report on regulating pharmaceutical drugs.

I was pleased to note that the Auditor General examined many important areas of regulating pharmaceutical drugs, including transparency and timeliness in communicating information about clinical drug trials, conflicts of interest, timeliness of safety assessment recommendations for marketed drugs, and how Health Canada applies risk-based standard operating procedures. Along with Health Canada's other drug regulation activities, these are all important areas to Canadians and to Canadian drug manufacturers and suppliers.

In this context, could the deputy minister provide this committee with some additional details on how Health Canada regulates prescription drugs to ensure that it is putting the health and safety of Canadians first?

[Glenda Yeates]

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.

[Andrew Saxton, Conservative, North Vancouver, BC]

It appears from your remarks and opening statement this morning that Heath Canada is treating the Auditor General's recommendation as a priority and taking his concerns seriously. It also appears that Health Canada is taking steps to address each of the 10 recommendations from the Auditor General's report. Could the deputy minister, or one of her officials, confirm that the department is going beyond the recommendations of the Auditor General in order to ensure the safety of Canadians?

[Glenda Yeates]

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.

[The Chair, NDP, David Christopherson]

Very briefly, please.

[Paul Glover, Assistant Deputy Minister, Health Products and Food Branch, Department of Health]

If I may then, Mr. Chair, very quickly, as was pointed out on transparency, we're looking at what we can do to accelerate and go beyond the recommendations of the Auditor General.

We're looking at issues like the labels and how readable they are, plain language information for Canadians, and the product monographs, which are quite large and sometimes difficult for physicians to digest quickly—so easier and more accessible summaries.

We're taking a look at a range of things beyond what the Auditor General pointed out.

[The Chair, NDP, David Christopherson]

Thank you, Mr. Saxton.

Moving along to Madame Blanchette-Lamothe.

You have the floor.

[Lysane Blanchette-Lamothe, NDP, Pierrefonds—Dollard, QC]

Thank you very much.

The Auditor General's report indicates that the department has limited regulatory power when it comes to modifying the labelling of drugs after they have been authorized for sale.

I would like you to explain a little about why this power is limited, what that means exactly. Would it be better for the department to have more power in that respect?

[Paul Glover]

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 Bill C-51, 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.

[The Chair, NDP, David Christopherson]

Thank you. Could you keep the answers brief, please?

[Lysane Blanchette-Lamothe, NDP, Pierrefonds—Dollard, QC]

Thank you.

Let's talk about the response time once a drug is on the market. We've been told that it can sometimes take more than two years before a safety issue with a drug is identified.

Fairly briefly, if you can, could you explain why it can take so long. Would it be important for improvements to be made to these timelines?

[Dr. Marc Berthiaume, Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health]

We need to take into account an important factor. We must not forget that we always deal with the most urgent things first. Health Canada's priority remains the safety of Canadians. We will grant priority to the various issues related to drugs. Some of them may take longer because of that prioritization.

It is important to understand that, when we identify an issue with a product that is on the market, we have to investigate that issue, which can take some time. We generally start by gathering information on the product itself, on how it is used in Canada. Then, we talk to our international colleagues to see what information they can provide. Sometimes, we get information from the industry…

[Lysane Blanchette-Lamothe, NDP, Pierrefonds—Dollard, QC]

I'm sorry for interrupting you, but I understand why this may take so long: it's a complicated process.

Would it be better for the process to be quicker? Would it be beneficial for the safety of Canadians to have a quicker safety issue assessment process?

[Dr. Marc Berthiaume]

Actually, what's important is dealt with as a priority. Of course, we always want to do things as quickly as possible. However, when there is a significant risk for Canadians, we act as quickly as we can.

[Lysane Blanchette-Lamothe, NDP, Pierrefonds—Dollard, QC]

I'm not trying to corner you, but I would like you to tell me whether, in your opinion, it would be relevant to be more efficient when it comes to identifying safety issues.

[Dr. Marc Berthiaume]

I think that, in the past few years, the department has made considerable progress with respect to its ability to tackle the drug safety issues that arise. The department has increased its ability to respond; it has improved its response time; it has increased the number of issues that are analyzed. There are more resources. Everything has been done to be more and more efficient with respect to the department's response time to health issues that emerge when products are put on the market.

[Lysane Blanchette-Lamothe, NDP, Pierrefonds—Dollard, QC]

I'll ask my question one last time. Please answer with a "yes" or a "no".

I fully understand that there have been improvements, but would it be relevant to increase the efficiency with respect to identifying safety issues?

[Dr. Marc Berthiaume]

As I just said, all of our actions show our commitment…

[Lysane Blanchette-Lamothe, NDP, Pierrefonds—Dollard, QC]

I'm not questioning your commitment.

Answer "yes" or "no": would it be relevant to increase this efficiency?

Perhaps the answer is "no", since you are saying that anything urgent is already made a priority. I want to know whether or not it would be relevant to increase the efficiency.

[Dr. Marc Berthiaume]

I think all of our actions indicate that this is what we're currently doing.