HEAL Committee Meeting

37th PARLIAMENT, 3rd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Thursday, April 29, 2004

Á

1110

The Chair (Ms. Bonnie Brown (Oakville, Lib.))

Ms. Sheila Fraser (Auditor General of Canada)

Á

1115

The Chair

Dr. Robert Peterson (Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health)

Hon. David Kilgour (Edmonton Southeast, Lib.)

The Chair

Hon. David Kilgour

The Chair

Dr. Robert Peterson

Á

1120

Á

1125

The Chair

Mr. Rob Merrifield (Yellowhead, CPC)

Ms. Sheila Fraser

Ms. Linda Anglin (Director, Office of the Auditor General of Canada)

Mr. Rob Merrifield

Ms. Linda Anglin

Mr. Rob Merrifield

Ms. Sheila Fraser

Mr. Rob Merrifield

Dr. Robert Peterson

Á

1130

Mr. Rob Merrifield

Dr. Robert Peterson

Mr. Rob Merrifield

Á

1135

Dr. Robert Peterson

Mr. Rob Merrifield

Dr. Robert Peterson

Mr. Rob Merrifield

Dr. Robert Peterson

Mr. Rob Merrifield

Dr. Robert Peterson

Mr. Rob Merrifield

Dr. Robert Peterson

Mr. Rob Merrifield

The Chair

Ms. Sheila Fraser

The Chair

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)

Ms. Sheila Fraser

Á

1140

Mr. Réal Ménard

Ms. Sheila Fraser

The Chair

Hon. David Kilgour

Dr. Robert Peterson

Hon. David Kilgour

Á

1145

Dr. Robert Peterson

Hon. David Kilgour

Dr. Robert Peterson

Hon. David Kilgour

Dr. Robert Peterson

Hon. David Kilgour

The Chair

Mr. Rob Merrifield

Dr. Robert Peterson

Mr. Rob Merrifield

Dr. Robert Peterson

Mr. Rob Merrifield

Ms. Sheila Fraser

Á

1150

Mr. Rob Merrifield

Ms. Sheila Fraser

Mr. Rob Merrifield

Ms. Sheila Fraser

Mr. Rob Merrifield

Ms. Sheila Fraser

Dr. Robert Peterson

The Chair

Hon. Don Boudria (Glengarry—Prescott—Russell, Lib.)

Dr. Robert Peterson

Hon. Don Boudria

Dr. Robert Peterson

Hon. Don Boudria

Dr. Robert Peterson

Hon. Don Boudria

Á

1155

Ms. Sheila Fraser

Hon. Don Boudria

Ms. Sheila Fraser

Hon. Don Boudria

Ms. Sheila Fraser

Hon. Don Boudria

Ms. Sheila Fraser

Hon. Don Boudria

The Chair

Mr. Réal Ménard

Ms. Sheila Fraser

Mr. Réal Ménard

Â

1200

Ms. Sheila Fraser

Mr. Réal Ménard

Ms. Sheila Fraser

Mr. Réal Ménard

Dr. Robert Peterson

The Chair

Mr. Gilbert Barrette (Témiscamingue, Lib.)

Ms. Sheila Fraser

Â

1205

Dr. Robert Peterson

Mr. Gilbert Barrette

Dr. Robert Peterson

Mr. Gilbert Barrette

Dr. Robert Peterson

Mr. Gilbert Barrette

Ms. Sheila Fraser

Â

1210

The Chair

Dr. Robert Peterson

The Chair

Dr. Robert Peterson

The Chair

Dr. Robert Peterson

The Chair

Dr. Robert Peterson

The Chair

Ms. Sheila Fraser

The Chair

Dr. Robert Peterson

The Chair

Dr. Robert Peterson

The Chair

Ms. Sheila Fraser

Â

1215

The Chair

Dr. Robert Peterson

The Chair

Dr. Robert Peterson

The Chair

Dr. Robert Peterson

The Chair

Dr. Robert Peterson

The Chair

Mr. Rob Merrifield

Dr. Robert Peterson

Â

1220

Mr. Rob Merrifield

Dr. Robert Peterson

Mr. Rob Merrifield

Dr. Robert Peterson

Mr. Rob Merrifield

Dr. Robert Peterson

Mr. Rob Merrifield

Ms. Sheila Fraser

Mr. Rob Merrifield

The Chair

Dr. Robert Peterson

Â

1225

The Chair

Dr. Robert Peterson

The Chair

Dr. Robert Peterson

The Chair

Dr. Robert Peterson

The Chair

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CANADA

Standing Committee on Health

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NUMBER 013

l

3rd SESSION

l

37th PARLIAMENT

---

EVIDENCE

Thursday, April 29, 2004

[Recorded by Electronic Apparatus]

Á  (1110)  

[English]

    The Chair (Ms. Bonnie Brown (Oakville, Lib.)): It's my pleasure to call this meeting of the Standing Committee on Health to order and to welcome today the Auditor General of Canada, Ms. Fraser, and representatives of Health Canada in order to address Madam Fraser's report, Regulation of Medical Devices.

    I would now invite her to begin the meeting with her presentation, and that will be followed by Mr. Robert Peterson from Health Canada.

    Ms. Fraser.

    Ms. Sheila Fraser (Auditor General of Canada): Thank you, Madam Chair.

    We thank you for this opportunity to discuss the results of our audit of Health Canada's medical devices program, which was contained in chapter 2 of our March 2004 report. With me today is Linda Anglin, the director who was responsible for this audit.

    The federal government, as federal regulator, has a legislated responsibility that is outlined in the Food and Drugs Act to protect the health and safety of Canadians. Protecting Canadians from risks related to medical devices is the responsibility of Health Canada under the act as well as under the medical devices regulations.

    The goal of Health Canada's medical devices program is to ensure that medical devices available in Canada are safe, effective, and of high quality. Health Canada has developed a regulatory framework to assess the safety and effectiveness of medical devices through a balance of quality system requirements, pre-market activities, and post-market activities.

[Translation]

    Medical devices play an important role in the delivery of health care. They include diverse products such as surgical masks, blood test kits, diagnostic imaging equipment, joint implants, and heart valves. Modern health care relies more and more on these devices to diagnose, treat, mitigate, and prevent diseases and certain medical conditions. Canadians spend $5 billion on medical devices annually.

    Our audit examined how the department manages the risks and benefits related to medical devices, whether it identifies weaknesses in the program and takes action to address them, and measures and reports the results achieved by the Medical Devices Program.

    In conducting our audit, we reviewed the 1992 report issued by the Medical Devices Review Committee and the development plan for an improved medical devices regulatory program prepared by Health Canada in response to that report.

    We also reviewed documents from consultations with stakeholders that took place before the introduction of the medical devices regulations. We examined Health Canada's activities to carry out its responsibilities. We made comparisons with the medical devices programs in the United States and the United Kingdom and Health Canada's Drug Program. Finally, we considered the impact of the Medical Devices Program's human and financial resources on Health Canada's ability to adequately carry out its responsibilities.

[English]

    While Health Canada has made progress in important aspects of managing risks related to medical devices before they are authorized for sale, we concluded that it needs to better monitor the continued safety of medical devices once they're in use. We found that as a result of gaps in its medical devices program, the department does not have a comprehensive program to protect the health and safety of Canadians from risks related to medical devices, even though it committed to such a program over a decade ago. Its failure to deliver such a program compromises Health Canada's ability to protect health and safety, which could translate into growing risks, both the risk of injury and the risk of liability.

    More specifically, our audit found that Health Canada requires a more proactive inspection program to verify compliance with the medical devices regulations once products are on the market. It needs a better approach to managing risks related to the sale of unlicensed medical devices.

    Health Canada also needs to improve its post-market surveillance system to provide timely, accurate, and complete information about adverse events after devices are in use, and once safety concerns are identified, they must be better communicated to those who need this information.

    Further, the department needs to address the risks posed by the reuse of single-use medical devices.

    Health Canada also needs to ensure that Canadians have timely access to all available medical devices. While it is important that Health Canada take the necessary time to properly evaluate a device for safety and therapeutic effectiveness, delays in authorizing licences deny Canadians timely access. Therefore, Health Canada needs to ensure that devices are authorized within the performance targets. The department also needs to consider activities that would allow it to benefit from international regulatory cooperation.

[Translation]

    Although Health Canada has been aware of the gaps and weaknesses in its Medical Devices Program for some time now, it has made limited effort to address them. Limited financial and human resources and limited progress in advancing international regulatory cooperation prevent the department from addressing these gaps and weaknesses. This, in turn, prevents it from delivering the Medical Devices Program has it is designed.

    While elements of the program are acceptable, significant shortfalls indicate that the current Medical Devices Program is not sustainable over the long-term. It is expected that medical devices will become increasingly complex and that the medical devices industry will grow in size and importance. Gaps and weaknesses that exist raise concerns about how Health Canada will manage the program in the future.

    As a result, we recommended that Health Canada made a choice: either provide adequate human and financial resources to deliver the program as designed, or redesign the program and the medical devices regulations to manage risks in a way that calls for fewer resources.

Á  (1115)  

[English]

    Madam Chair, I am pleased to report that the department has accepted all of our recommendations. The committee may wish to ask the department about the specific actions it intends to take to address our recommendations as well as timelines for implementation. I would encourage your committee to review Health Canada's progress by requesting regular updates from the department and following up on any remaining gaps and weaknesses.

    That concludes my opening statement, Madam Chair. We would be pleased to answer any questions the committee may have.

    The Chair: Thank you, Ms. Fraser.

    We'll now hear Health Canada's response. While we have Mr. Borbey, the assistant deputy minister of the corporate services branch, the presentation will be made by Mr. Robert Peterson, director general, therapeutic products directorate, health products and food branch. Also accompanying these two is Ms. Kim Dix, managerof the medical devices compliance unit.

    Mr. Peterson, the floor is yours.

    Dr. Robert Peterson (Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health): Thank you, Madam Chair, and thank you for the opportunity to discuss with you the recent report of the Auditor General concerning the Health Canada medical devices program.

    As you've noted, I have with me today additional officials from Health Canada who may help in answering questions as required.

    Hon. David Kilgour (Edmonton Southeast, Lib.): On a point of order, could we not adopt this statement as read and get on with the questions?

    The Chair: We just got the paper. Did you read it prior to the meeting?

    Hon. David Kilgour: No, but we can all read it a lot faster than it can be read to us by Mr. Peterson.

    The Chair: We just got it, so I think I'd like to hear what he has to say.

    Thank you, Mr. Kilgour.

    Mr. Peterson.

    Dr. Robert Peterson: I'll try to go through this as rapidly as possible.

    The health and safety of Canadians is of paramount importance to Health Canada.

    Health Canada recognizes and accepts its role as the national regulator of medical devices in Canada. At the same time, the safety of medical devices in Canada is a shared responsibility. Health Canada works in partnership with numerous stakeholders, including provinces and territories, health professionals, and manufacturers and suppliers of medical devices to provide for access to safe, effective, and high-quality medical devices. Under the law and regulations, Health Canada has regulatory authority over the manufacture, sale, and advertising of medical devices in Canada.

    As the Auditor General's report notes, the medical devices program consists of a pre-market evaluation of the safety and effectiveness of devices and an assessment that the manufacturer adheres to quality design and manufacturing practices. Marketing authorization, once a licence is issued by Health Canada, will then ensue.

    Health Canada currently has some 16,500 active device licences, which encompass approximately 460,000 individual medical devices in Canada. It also has responsibility for post-marketing surveillance of adverse events associated with medical devices, and finally, has responsibility for compliance and enforcement activities after devices are on the market.

    These activities are administered by three directorates within the health products and food branch of Health Canada: the therapeutic products directorate; the marketed health products directorate; and the health products and food branch inspectorate.

    The Canadian regulatory program for medical devices introduced significant contemporary regulations as part of a revitalized medical devices program in 1998. The current regulatory program has improved standards for safety, effectiveness, and quality of medical devices available on the Canadian market.

    The regulations do not set out requirements to address the way medical devices are used in health care facilities. How medical devices are used is governed by provincial and territorial governments.

    The Auditor General has identified both those areas where the program is functioning well and areas where improvements can be made. Health Canada has accepted all of the Auditor General's recommendations. For some of these issues--for example cost recovery--the department had already begun to take action. For other equally complex issues, such as the reuse of single-use devices, work had already begun on the significant analysis required due to the implications for the delivery of health care by provinces and territories.

    The health products and food branch has developed a draft action plan that will address the Auditor General's recommendations, in areas such as investigational testing, timely access, post-market activities, unlicensed devices, the reuse of single-use medical devices, cost recovery, human and financial resources, and progress reports to Parliament. Health Canada will use these recommendations as it continues to look for ways to improve the medical devices program within the current branch and departmental financial framework.

    As part of our action plan, we are developing and designing a new costing model. Our approach will include extensive stakeholder consultation and the clear articulation of total program costs. This work is well underway and will be completed by next fall. Health Canada will ensure that it respects Treasury Board's external charging policy and the new User Fee Act.

    Further, Health Canada has committed to undertaking a review of the medical devices program, in consultation with stakeholders, to determine the appropriate level of program delivery, the appropriate program design, the associated resource requirements, and possible funding sources. This review will be supported by the findings and recommendations stemming from concurrent activities in such areas as the performance measurement framework. Health Canada's goal for completion of this review is the summer of 2005.

    The Health Products and Food Branch has already begun to implement its draft action plan in response to the commitments made in its responses to the Auditor General's recommendations. For example, through the therapeutic access strategy, Health Canada had begun and continues to work to address issues related to the timely access of medical devices. Through the application of project management principles, performance targets for the evaluation of licence applications for the two highest classes of medical devices--classes III and IV--are currently being met in a fashion that exceeds the performance targets. The department will continue to review its processes for this and all the other of its pre-market activities in order to find further performance efficiency gains without sacrificing quality.

Á  (1120)  

    As part of its effort to ensure continuous improvement in the program, the department is examining its post-market evaluation programs and is evaluating the tools currently being used to communicate to the public and health care professionals any identified safety concerns that may arise when medical devices are used in the health care system or by the public. As you know from your deliberations on prescription drugs, Health Canada created in April of 2002 the marketed health products directorate with a mandate to provide leadership for post-market programs. In its response to the expectations of Canadians generally for strengthened post-market programs and to an international trend towards enhanced post-marketing stewardship, it has begun to play this role.

    The marketed health products directorate is designed to leverage best practices for post-market issues for all health products within the regulatory mandate of Health Canada. The directorate is the focal point for the coordination of approaches to post-market surveillance and a crossroad for risk communications across a diverse range of product categories, which includes pharmaceuticals, biologic drugs, natural health products, and more recently, medical devices. One of the marketed health products directorate's key strategies is to develop advanced capacities for a systematic assessment of risks and benefits and the prompt detection and communication of safety signals as they concern all marketed products.

    Health Canada is also redesigning existing surveillance information systems and seeking out new collaborations with other jurisdictions. Additionally, a medical devices inspection program for importers, distributors, and class I device manufacturers was implemented by the department in late March, 2004 to complement the quality management system audits that are required as part of the device licensing requirements.

    Health Canada has been proactive in international activities, with a goal to promote and adopt mechanisms that will lead to a convergence of regulatory requirements. As a founding member of the global harmonization task force, along with its counterparts in the United States, the European Community, Australia, and Japan, Health Canada has played a strong leadership role. Health Canada is recognized by its partners as having established a classification system that is now being considered the international model for in-vitro diagnostic devices. It is also recognized in its adoption and administration of international quality systems standards for medical devices.

    Building on this previous work, most recently Health Canada officials met with both United States FDA and Australian therapeutic goods administration counterparts concerning areas of regulatory cooperation that build on existing bilateral memorandums of understanding, and these have been recently signed by our organizations.

    The discussions with the U.S. FDA also specifically address their approach to investigational testing with regard to the concerns raised by the Auditor General related to Health Canada's approach to this regulatory activity. Initial indications are that our current approaches are comparable.

    Health Canada is concerned over the potential risks of re-using single-use devices and, as already noted, is actively examining this issue. Health Canada's initial analysis of its statutory and regulatory authorities suggests that regulatory revisions are necessary. The department is in the process of finalizing arrangements for consultations with provinces and territories regarding the development of these changes to ensure patient safety.

    In conclusion, medical devices licensed for sale in Canada are subject to rigorous regulatory requirements that mitigate potential risks associated with their intended use. Our program is aligned with key international regulatory partners. Health Canada continues to look forward for ways to improve the medical devices program and welcomes the Auditor General's recommendation. The department has committed itself to action related to all of the Auditor General's recommendations, those related to investigational testing, timely access, post-market activities, unlicensed devices, the re-use of single-use medical devices, cost-recovery, and human and financial resources, and is prepared to report progress on these areas to Parliament.

    Thank you, Madam Chair.

Á  (1125)  

    The Chair: Thank you, Mr. Peterson.

    We will now move to the second part of our meeting, and we'll begin with questioning by the critic for the official opposition, Mr. Merrifield.

    Mr. Rob Merrifield (Yellowhead, CPC): Thank you for coming in. I think this is a very important area. We've seen recent newspaper articles and reports concerning individuals who have been negatively affected because of medical devices used or misused.

    The last audit of this was in 1992, correct?

    Ms. Sheila Fraser: In fact, that was a review. I don't know that we've actually done an audit previously. This was a review done by the department.

    Ms. Linda Anglin (Director, Office of the Auditor General of Canada): It was a committee chaired by Ambrose Hearn.

    Mr. Rob Merrifield: So the committee looked at it, reviewed it, and made recommendations.

    Ms. Linda Anglin: Yes. It was a report tabled with the Minister of Health.

    Mr. Rob Merrifield: Okay.

    Those recommendations you found were not followed through on, is that what you're saying?

    Ms. Sheila Fraser: We looked at the most significant of the recommendations. We didn't follow up on all of them, but many of the issues that were raised in 1992 we are raising again in this report. That's why we're saying progress has been very slow.

    Mr. Rob Merrifield: That's my frustration, that we've had a little over a decade now knowing that improper surveillance was being done. Perhaps the risks are still there, and nothing is being done. I'm wondering if the department has some response to that. Are we going to see some changes to it now? Why would we see it now, but haven't seen it in the last decade?

    Dr. Robert Peterson: I'd be pleased to respond to that, Mr. Merrifield.

    The issue with regard to progress in performance of pre-marketing activities has been addressed quite directly. As you know, to maintain contemporary scientific and medical expertise in a changing area such as this is always a challenge for regulators throughout the world. We have taken many steps. As you look at the changing environment and the increasing level of expertise that is available to us for pre-market assessment, there have been substantial changes since that time. So it's not reasonable to believe there has been no activity.

    At the present time and for the past several months following the infusion of additional resources from the dollars that came under what we refer to as the therapeutic access strategy, dating back to the Speech from the Throne 2002, where the government made a commitment to speed up the regulatory process for drug and product reviews, with additional resources provided in last year's budget to allow for that to begin, we have in fact taken control of the pre-market review program. We have a very small number of applications in backlog. From discussion with our international counterparts, I can tell you that even regulatory agencies that have greater resources than we do have applications in backlog, and they are largely in the same categories. There are problematic areas where submissions with data sets that are very preliminary or highly controversial are going to take careful consideration before they can come out.

    Nevertheless, for the higher classes of medical devices, class III medical devices, at this point in time we are exceeding performance expectations 95% of the time. For the class IV, the highest class of risk for medical devices, we're exceeding those performance standards or meeting them 90% of the time.

    There are areas, such as the surveillance of clinical trials, what we refer to as investigational testing of medical devices in Canada, that have, in a way similar to the activity in the pharmaceutical regulatory area, been the subject of relatively recent introductions of regulatory activity in Canada. We have begun for the past two years to have increasing surveillance of clinical trials that deal with pharmaceuticals. We have certainly begun to look at what will be the activity comparable to clinical trial investigation by our inspectorate in the area of medical devices.

    We specifically asked the United States FDA when we were there talking to our counterparts what percentage of clinical trial applications are reviewed in the United States, that is, investigational testing in medical devices. Their answer was 2% of trials. It is truly an audit program. We see between 100 and 120 investigational trial applications in Canada on an annual basis, so two or three investigations would have to be undertaken in Canada to have a audit program comparable to that in the United States. We are prepared to go down that path. As I said previously, investigation of clinical trial sites is a new regulatory activity within Health Canada. We have undertaken that in pharmaceuticals and believe we can do the same in respect of medical devices.

    For post-marketing surveillance of medical devices on the market, we recognize that this falls into two principle categories. One is surveillance and reporting by institutions and users of problems that exist with licensed medical devices, where we have had the opportunity to review safety and other evidence associated with the manufacture and the quality of these products in Canada. We are in a position to build in that area. It is clear that the medical device market in Canada is very small compared to other jurisdictions, so that the ability to detect the problem with a new medical device that is introduced in the Canadian market may be far overshadowed by the ability to detect that problem in the United States market, where there are considerably more devices.

    As an example, when I was in Boston in 1996, there were approximately 20 MRI instruments within two and a half miles of the classroom I was sitting in. At the same time in Canada there was one MRI device within a 100-mile radius of where we're sitting today. That has not changed substantially over the interim.

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So the ability to detect these problems is going to be highly dependent upon our access and a cooperative effort with our international partners where the market is greater and problems can be detected.

    As I have indicated, our medical devices post-marketing group has done a good deal of work to allow for the early discussions to take place with both the United States FDA, with the Therapeutic Goods Administration in Australia, and with our European counterparts. We believe we can go down that path. That does not minimize the fact that we need to strengthen our ability to collect and respond to and take a more active role in seeking out problems within Canadian institutions as well. In the past two years I've seen an increasing number of communications between Health Canada and health care providers, health care institutions, with respect to post-marketing issues.

    Mr. Rob Merrifield: When it comes to post-marketing issues, we've just gone through a study on pharmaceuticals and the problem as to not knowing what kinds of adverse reactions are out there because of their not being reported appropriately. First of all, you say there are not very many of them per capita in Canada. So a national registry should be something that is a given. Is that something you're proposing?

    Dr. Robert Peterson: I'm sorry, I don't quite understand the concept of a registry.

    Mr. Rob Merrifield: A national registry so that we know every person who actually has a medical device. Is that on a registry? Are you getting cooperation with the provinces? Are you pursuing that at all?

Á  (1135)  

    Dr. Robert Peterson: At the present time we maintain a registry of adverse reactions, so that when they are reported we are able to search that database.

    Mr. Rob Merrifield: Do we have a national registry of those who have a medical device?

    Dr. Robert Peterson: Of medical devices that are implanted? No, we do not.

    Mr. Rob Merrifield: And why would we not?

    Dr. Robert Peterson: This would be an area that would require, as you have discussed, extensive consultation with health care institutions, health care providers. As you know, the regulator at the present time does not maintain patient information with respect to individual patient health or identification of such.

    Mr. Rob Merrifield: You're saying it's an information issue, a personal ability to know an individual's record. Is that what's holding it back?

    Dr. Robert Peterson: There are several factors with this. One is that we do not presently maintain the type of personal health information that would be maintained within health care institutions or within private physicians' offices at this point. The regulator does not do that.

    Mr. Rob Merrifield: Let me put it another way then.

    Dr. Robert Peterson: There are several other aspects to that. One is those aspects related to the Privacy Act and the considerations with respect to what type of information could be maintained and, given that amount of information, whether we would be able to draw conclusions from it, and lastly, the fact that we would not be able to mandate that.

    Mr. Rob Merrifield: You answered it.

    The Chair: Ms. Fraser wants to....

    Ms. Sheila Fraser: Thank you, Madam Chair.

    I'd just like to make reference in our report to Mr. Merrifield's question.

    In exhibit 2.8 on page 22, we compare the reporting of adverse events per population of Canada, the U.S., and the U.K. You will see that the rate is much lower in Canada for reporting. The department itself has indicated that it is in part due to limited activities in the post-market. It's a question of how to get the adverse events reports.

    We also note in the report on the next page, on page 23, that there are several options that are available. A registry is one of them, but there are other techniques that are used in other countries that the department might want to consider in trying to improve the reporting of adverse events.

    The Chair: Thank you, Mr. Merrifield.

    The next questioner will be Mr. Ménard.

[Translation]

    Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): Thank you, Madam Chair.

    This is both a very sad and a very funny situation. One can't imagine that this could really be possible. Ms. Fraser, you told us that 10 years ago, the government made a commitment to monitor and follow more closely the licensing of medical devices. We're not talking about drugs. We know that Canada is one of the worst when it comes to approving drugs. We're talking about surgical devices that are used by health professionals and that can ultimately undermine people's health.

    In your report, you seem to say that there are four categories of licences or four categories of medical devices depending on the risk class. From what I understand the fourth category is the most important one. I have three questions.

    First, over the past few weeks there have been reports in the news about medical devices being recalled by hospitals. You saw this in Montreal and I believe it is also happening in Alberta. This is connected to what we're talking about. Do you think it is possible that there are class 4 medical devices that have not been audited? Are there any indications that these recalls of medical devices for clinical treatments will become more widespread in the near future?

    Ms. Sheila Fraser: Thank you, Madam Chair.

    It's very difficult to answer Mr. Ménard's questions. We looked at the current processes and systems to see if they contained any gaps or shortcomings. We do not assess and we will never be able to assess the effectiveness of these products, nor will we be able to go into hospitals to see if there are any specific cases. Perhaps Health Canada could provide more information on the cases that were reported on in the newspapers. I am not a medical expert, but I think it was more an issue of sterilization, at least in the last few cases, rather than a problem related to the medical devices or materials themselves. However you will have to take that assessment with a grain of salt.

    In terms of the recommendations that were made 10 years ago and that we followed up on, I would like to point out that the underlying cause of many of these problems may be the issue of financing and financial and human resources. Even 10 years ago the recommendations showed that the level of funding was insufficient. Costs were introduced but at the same time programs were reviewed and budgets were cut. The department has ended up with less money than it had 10 years ago, when the committee recommended that it should have more. In my opinion, the issue is one of resources and type of program. As we said, if you want to keep this program, then the situation has to be reviewed. There is an imbalance between the program and the resources available.

Á  (1140)  

    Mr. Réal Ménard: I'm very aware that governments savage and inconsiderate cuts are the direct cause of today's situation. According to your assessment, exactly how many inspectors do we need for the process to be more balanced and more worthwhile? How do you explain that no action has been taken when the Department of Health was informed about this shortcoming 10 years ago?

    So I have two very specific questions. How many inspectors do we need to correct the situation—I think you have already assessed this—and do you think that the Health Canada officials responsible for this program were surprised by your report or do you think they could have acted faster and could have understood that there were signs of what was to come? In your opinion, how much responsibility lies with Health Canada for the laxness that you described this morning?

    Ms. Sheila Fraser: Madam Chair, in paragraph 2.110 we use Health Canada's estimates. Health Canada estimated that it needs 97 persons or full-time equivalents for pre-market activities. Currently they only have 58.

    In terms of post-market activities, Health Canada estimated that it needed 73, and the department currently only has 37.5. I think that that shows you the types of problems that exist in terms of resources for the program.

[English]

    The Chair: Thank you, Mr. Ménard.

    Our next questioner will be Mr. Kilgour.

    Hon. David Kilgour: Thank you, Madam Chair.

    I wonder if Mr. Peterson could please give short answers to these questions.

    I understand that the Auditor General's findings are, first, that Health Canada does not properly monitor the clinical trials for medical devices. Does he accept that or not?

    Dr. Robert Peterson: I'll try to keep my answers short.

    We review clinical trial, investigational testing, licence applications, and review them thoroughly. We review all of those applications that come to us and we review them in a timely fashion.

    The issue that has been pointed out in the Auditor General's report relates to whether there is audit activity in order to verify the types of information that can be achieved in an audit, whether the applications are being signed in a timely fashion, whether the data is being recorded appropriately on the forms.

    We do accept the fact that this is an area we have--

    Hon. David Kilgour: Excuse me. I only have a very few minutes, and I don't think that's the short answer.

    I'll give you a number of conclusions from Ms. Fraser's report and ask you to comment briefly, please.

    The second one was that the pre-market evaluation takes too long, due partly to the staff shortage of 35%, which is 20 person-years. The same people who evaluate medical devices pre-market are also responsible for the special access program requests, which have increased by 683% in the last four years. Health Canada doesn't engage in inspection activity at the post-market phase. Health Canada only takes action when a case is brought to their attention. They have limited action to improve the way they collect and analyse data. Health Canada has never developed a communications plan. Health Canada has no position on managing the risk associated with reusing single-use medical devices.

    You can use all the words you want, but I put it to you that you're not speaking to the issues that have been raised by our highly respected Auditor General.

Á  (1145)  

    Dr. Robert Peterson: Madam Chair, I'm not certain what the question is I'm supposed to respond to.

    Hon. David Kilgour: Are you just saying everything is fine, and we're terrific, and nobody should be unhappy or concerned? It seems to me that's the long and short of what you're saying.

    Dr. Robert Peterson: I apparently missed the mark in terms of what my comments were directed toward.

    We are recognizing that there are substantial areas where there is additional work that needs to take place.

    Hon. David Kilgour: You don't sound like it, Mr. Peterson.

    Dr. Robert Peterson: I am telling you that in the issue with respect to pre-market approval, where there are statements that took place based upon the year data that was reviewed, that has been rectified.

    The medical devices pre-market assessment program today exceeds the performance standards that have been put forward.

    Hon. David Kilgour: Madam Chair, I think it's a dialogue of the deaf.

    Can we at least agree to have regular updates from the department on what they're doing, along the lines suggested by the vice-chair?

    Thank you.

    The Chair: Thank you, Mr. Kilgour.

    Mr. Merrifield.

    Mr. Rob Merrifield: I'd like to pick up on the issue of the single-use devices, both the surveillance of those when they're reused and the question of do we know what's actually happening with regard to the safety of them, but more than that, the issue of the regulations behind the sterilization of those. Should we be reusing them, or is there a protocol that is not in place or regulations that are not in place? Are they different from province to province, area to area, hospital to hospital, or is there standardization of those?

    I'm not sure where the answer lies with regard to the risks that are obvious to patients in the system.

    Dr. Robert Peterson: The guidelines for the reuse of single-use medical devices have been generated within the provincial domain, for hospitals. There have been various surveys over the years looking at the extent to which those devices that are intended for single use are being reprocessed.

    We have a difficulty here with respect to regulations. The product that would be labelled as single-use is regulated based upon its manufacture, its sale, and its advertising. Once it has been purchased by a health care facility, it is no longer being manufactured, being sold, or being advertised, and as a consequence we have for some time now been looking at what would be the necessary steps to take in this regard.

    It is only necessary to take these steps if institutions in Canada are in fact using them outside of their intended use. We recognize that this is happening.

    Mr. Rob Merrifield: That is happening. All right. So do we know how much it's happening, and are we addressing the issue? And is the issue that they shouldn't ever be reused, or is the issue that regulations are not in place to make sure that if they are reused the protocols are in place so that they're not a safety hazard?

    Dr. Robert Peterson: As I'd indicated earlier, the short answer is that we believe there will be regulatory amendments to the present medical devices regulations in order to allow for this area to be brought under regulation.

    At the present time we are not regulating the activity or the use of the devices within provincial institutions. That can be done on a voluntary basis. That can be subjected to third-party audit such as the Canadian Council on Health Services Accreditation, the group that accredits all hospitals in Canada.

    If that will not work--and this is the subject of discussions we are entering into with our provincial and territorial colleagues--if it is necessary for the government to regulate this area, we are prepared to move forward with regulations to allow for that to happen.

    Mr. Rob Merrifield: No regulations now.

    Ms. Fraser.

    Ms. Sheila Fraser: Madam Chair, just as an element of information in terms of Mr. Merrifield's question, in the report we obviously don't have data on the use, or on how much of this is used, but we have indication about a nationwide survey, done in 2001, of health care facilities. It indicates that 37% of acute care hospitals reused critical-contact single-use devices.

Á  (1150)  

    Mr. Rob Merrifield: Did you say 37% of hospitals?

    Ms. Sheila Fraser: Of acute care hospitals. And it was largely for an issue of cost.

    Mr. Rob Merrifield: We have no regulations in place, is that right?

    Ms. Sheila Fraser: That's correct.

    Mr. Rob Merrifield: So we don't know what protocol is being used on these right now. Is it different for every hospital?

    Ms. Sheila Fraser: I'm afraid I can't answer that; I don't know.

    I don't know if the department knows.

    Dr. Robert Peterson: The regulator does not know. As I say, we do not have authority in that area.

    I will venture to answer briefly that the reuse of devices is relatively complex. If a device is sold in a package that has been approved, and should that package be put onto a sterile operating table and opened because it might be used, but it is not used, then that package is recycled, re-sterilized in hospitals for use in another surgery. So although there never was patient contact, it would classify as the reuse of a single-use device, because the product was licensed in its original package.

    There are other categories where the product may actually have had contact with the patient but some of those devices are probably amenable to recycling. We know that because of the materials used, and we know that comparable devices licensed as reusable devices are perhaps indistinguishable from those.

    At the other end of the spectrum, there are devices we license as single-use devices that should be used just once. We have made that clear to institutions time and time again, that the labelled instructions with respect to the medical devices must be followed and adhered to.

    The Chair: Thank you, Mr. Merrifield.

    Mr. Boudria.

    Hon. Don Boudria (Glengarry—Prescott—Russell, Lib.): Thank you, Madam Chair.

    I'd like to ask about the reuse of medical devices. Once those regulations are complete, what would they typically contain? Would it be the standards? I mean, you can't physically walk into the ten-bed nursing care facility in my riding and walk out with the device under your arm if it's not used. That's not the role of the federal government, I would think.

    What would those regulations typically contain? Would they be limited to saying that it's an offence to reuse this, or it's against the standard to reuse this?

    Dr. Robert Peterson: In those jurisdictions where regulations have been initiated in this area, they specify those medical devices that are labelled for single use but are amenable to being re-sterilized, repackaged, and reused. They define the criteria whereby a third-party recycler or re-sterilizer would be able to obtain an establishment licence demonstrating that they are capable of doing this in an effective way.

    Hon. Don Boudria: I'm just trying to imagine this here. So somebody would go around and presumably start up some sort of an enterprise of recycling--and “recycling” may not be the right word here--those that are reusable, bringing them back to their establishment or business under strict standards, re-sterilizing them or whatever else has to be done, and then they can be reused. Is that typically how this would be done?

    Dr. Robert Peterson: That is how it works in at least one jurisdiction that has begun down that path.

    Hon. Don Boudria: Okay. When that process is used, is that included in the 37% of reuse of single devices that we heard about? Is that in those figures now, or is it 37% without using that standard? Because if there is a standard of how to redo it, how to make them so-called like new again, surely that doesn't count, does it?

    Dr. Robert Peterson: There is a guideline at the present time that is within the Canadian hospital system for the standards against which re-sterilization and repackaging should take place. But there has not been a breakdown in that survey that was reported in 2001 that would specify which devices--

    Hon. Don Boudria: So the 37% that was discussed does include, presumably, a quantity, however measured, of some of these devices that have been put to reuse using those standards, assuming they have been used properly and so on. Is there an estimate of how many? What is the 37% really, if you exclude those? Is it 10%, or half of them, or...? Is that measured somehow?

Á  (1155)  

    Ms. Sheila Fraser: Perhaps I can clarify that the 37% figure was the number of establishments, the number of acute care hospitals, that do reuse--

    Hon. Don Boudria: Oh, that doesn't mean anything, then. They could have reused one item each or some such thing. No?

    Ms. Sheila Fraser: It was an indication that there is a practice of reuse and that it is not insignificant.

    Hon. Don Boudria: But on the practice of reuse, Ms. Fraser, does that include those that have been repackaged? And I'm not sure if there's an exact term to describe this process. Is that included in there, or is this inappropriate reuse in that 37%?

    Ms. Sheila Fraser: The point we were trying to make, Madam Chair, is that there is no standard in Canada by the regulator on devices for reuse. I would perhaps encourage the committee to read our little text box on page 27, where the issue of importing reprocessed devices from the U.S. comes up. It hasn't occurred yet, but there are Canadian hospitals that are interested in it. So it is a phenomenon that's coming, and consideration needs to be given to what kind of regulatory framework is needed, if one is needed, and what it should be.

    Hon. Don Boudria: Okay. Then just one last proposition, if I may.

    I guess the Auditor General is telling us--and I'm not trying to put words in anyone's mouth here--that it's all well and good that there is a process to redo them, but there are no standards against which to measure if that is done correctly or not. Is that the idea?

    Ms. Sheila Fraser: And the whole licensing of these products, yes.

    Hon. Don Boudria: I see.

    Thank you.

    The Chair: Mr. Ménard.

[Translation]

    Mr. Réal Ménard: Ms. Fraser, I would like to come back to paragraph 12 of your brief in order to make sure that your words are fully understood. Your general comments are clear as well as your comments about how lax Health Canada has been in carrying out its responsibilities because of a lack of resources. Obviously we can't blame the public servants. The government has not provided enough resources.

    You state:

Although Health Canada has been aware of the gaps and weaknesses in its Medical Devices Program for some time, it has made limited effort to address them.

    So you seem to be saying that Health Canada was aware of the situation and that something could have been done within the framework it was working in. Is that how we should understand your statement in paragraph 12?

    Ms. Sheila Fraser: There are two elements. First, if the program continues in its current incarnation and in the way that it currently operates, it will need more resources. I think that all studies have shown that there is a lack of resources to implement the program as it stands. One part of the solution would be greater international cooperation, that is, that we accept harmonization and regulations in other countries, thereby allowing the government to become more efficient with its own regulations and making the system more efficient for manufacturers and suppliers of these devices.

    In the report, we point out that initiatives have been taken and that agreements have been signed with the European Union, for example. In paragraph 2.72, we state that a strategy has been developed but that work on harmonizing regulations is progressing slowly. We also state that mutual- recognition agreements have been reached but have never been operationalized.

    Mr. Réal Ménard: At present, there are regulatory requirements associated with public health and public safety objectives, but we have a department without the resources to fulfill its mandate. Could we come up with some way of doing things that would ensure that you, as Auditor General, would assess the exact resources each department needed to fulfill their mandates, on the basis of performance reports that the departments table each year? We, parliamentarians, see those performance reports. We have not seen this year's report yet, but we have seen last year's.

    Your work on the sponsorship file was excellent. I would like you to know that you are my idol for what you did there. And we will certainly not tolerate any lack of respect for you on the part of Mr. Guité. If you would like to answer him, I would be happy to give you 30 seconds to do so.

    Could we come up with some way of allowing you, as Auditor General, to assess the human resources every department needs to reasonably fulfill its mandate?

  (1200)  

    Ms. Sheila Fraser: The very short answer to Mr. Ménard's question is no. I am not permitted to assess programs. All I can do is conduct an audit to determine whether the department has done an assessment. I have no mandate to assess programs myself.

    Mr. Réal Ménard: However, you stated that there were only 55 employees, and that this led to the gaps that were identified. If there had been 96 employees, it would probably have been possible to... You did not report human drama. You are in a state of "alert". You say that things are not as safe as they should be, but we are not at the point where we need to decry human drama, fortunately.

    Ms. Sheila Fraser: Our role is not to raise issues of that kind. However, in our report we do note that suits have been filed against the government. There are probably some cases the department could talk to you about. But as I explained earlier, our role is to assess systems and processes, not to assess the program efficiency.

    Mr. Réal Ménard: Mr. Peterson, what would you say if we invited the Minister of Health to appear—he was here on Tuesday, in fact—and requested that plans submitted to Treasury Board for the coming year provide for 96 employees to do the work required in the branches concerned? Do you think that things might change radically, and that the additional human resources would make it possible to implement the Auditor General's recommendations?

[English]

    Dr. Robert Peterson: I'm assuming that the question you're asking is relative to resources that would be available. Would it be easier to respond to the issue if there were additional resources? The answer is unquestionably yes. A high percentage of the resources are available to us now based upon cost-recovery revenue. As you know, that has occurred as a result of an introduction of user fees government-wide. Of the more than $1 billion the government receives in external charging today, this is a very small percentage, but it is linked to the ability of the companies that are manufacturing medical devices in Canada to actually pay what would be a commensurate fee. Those fees were established in 1995. They have not been increased since that time. We believe that the revenues and the resources that should be achieved in this area would be the composite of a balance of tax-based dollars as well as cost-recovery revenues.

    The Chair: Thank you, Mr. Ménard.

    Mr. Barrette.

[Translation]

    Mr. Gilbert Barrette (Témiscamingue, Lib.): Thank you, Madam Chair.

    Thank you for taking part in this exercise, which no doubt is and will be useful, though I am sure you would like it to be even more efficient in terms of results.

    Let's come back to what we were discussing earlier, and to Quebec's recent experience with infection during surgery. If the federal government establishes regulations, could it not be accused of encroaching upon jurisdictions that are not entirely its own? I don't say these are jurisdictions that should not concern the federal government at all, but they are not entirely its own. If that were the case, who would be responsible for establishing regulations to ensure the quality of medical devices used in performing needed surgery?

    Ms. Sheila Fraser: My answer to that would be—and I'm sure the department can add something—that, under the Food and Drugs Act, the federal government is responsible for protecting the health, survival and safety of Canadians. There are also regulations on medical devices, stipulating that the federal government has obligations in that field.

  (1205)  

[English]

    Dr. Robert Peterson: Our regulatory authority at the present time is over the manufacture, sale, and advertising of this. It is truly a partnership with health care institutions as to how medical devices are used. We review the instructions that come with a medical device with regard to its appropriate use and how it would be resterilized, cleaned, or reused. Those instructions, which are explicit to the user of that device and which we review and are confident with before the licence is granted, must be followed. There must be systems in place in the institutions using these devices to be certain that takes place. Much of what we have been reading about today has not been related to the reuse of single-use devices. It has been related to difficulties associated with improper sterilization and reuse of reusable medical devices.

[Translation]

    Mr. Gilbert Barrette: Does Health Canada plan to conduct audits—perhaps it is already doing so—in Quebec and Canadian hospitals to determine the procedures and conditions under which instruments are used and reused?

[English]

    Dr. Robert Peterson: We have the opportunity through our disease surveillance programs in the public health area, the population and public health branch in particular—which has created and distributed long-standing guidelines to hospitals for appropriate use of medical devices, sterilization, etc.—to allow for infection control to be maintained. Through their surveillance systems, we maintain the transmission of infectious diseases through the use of instruments, as well as other products, such as blood, etc. That has been the basis for how this activity has had surveillance in the past.

    We recognize, and we agree with the Auditor General, that it will be important today, particularly with respect to the fact that hospitals seem to have been changing in their environment--at least there are increasingly frequent reports that there are problems with the re-use of medical devices.

    We believe we will have to work in consultation, and we are taking steps to have appropriate discussions with provinces and territories as to how that can take place. But we do believe that it is necessary to revisit that regulatory authority.

[Translation]

    Mr. Gilbert Barrette: My last question is on the time taken to inspect devices intended for the market, which, as the Auditor General pointed out, is too long due to the lack of resources. Are these delays undermining the quality of services provided, and harming the people entitled to those services?

[English]

    Dr. Robert Peterson: I believe the honest answer to that question is no. For the areas where there may be delays in having a product approved for the Canadian market—which are minimal today—we do have a special access provision within the regulations allowing any physician who believes that there is a device in the best interest of a patient to make application through the special access provisions of our programs, and to be able to obtain that particular device for use.

    We are seeing an increasing number of applications through the special access program, but I must hasten to add that the vast majority of those applications come in a single category of silicon gel breast implants. Those are devices we have serious concerns with at the present time with respect to their overall safety.

[Translation]

    Mr. Gilbert Barrette: I have a last question for the Auditor General. Are you able to determine whether these delays attributable to a lack of human resources are in fact harming people?

    Ms. Sheila Fraser: Madam Chair, as I said in answer to an earlier question, I must again say that this would be program assessment. I am not permitted to assess programs as such. My role is to determine whether the department has assessed them. This is something the department would have to do.

  (1210)  

[English]

    The Chair: Thank you, Mr. Barrette.

    With the indulgence of my colleagues, I'd like to ask a few questions as well.

    You said at the beginning that the regulation of the use of devices is actually in the hands of the provinces and the territories. That's why I don't understand why we're having all this discussion about single use, and trying to get into the regulations over that, if in fact it's clearly defined that it's provincial. Is it because we are being sued by certain people?

    Dr. Robert Peterson: No.

    The Chair: Or because you're not satisfied with the provinces' regulation of use?

    Dr. Robert Peterson: Yes, but not in respect of single-use devices. We are not looking at litigation in that area. In fact, as I say, all of the serious problems that have surfaced recently have not been in respect of the reuse of single-use devices, but rather—

    The Chair: With the sterilization of multiple-use devices.

    Dr. Robert Peterson: That's correct. And if there is a problem in that realm, then there is undoubtedly a problem across the board.

    As I had indicated, we would like to be certain that our regulatory approach is comparable to that of a principal trading partner, the United States, since our health care systems share experience and our hospitals in Canada and the United States speak about their practices. If there is a means whereby we could provide an avenue for the safe resterilization and reuse of certain medical devices, then by all means we would wish to go to there.

    The Chair: And regulate it, even though it's provincial.

    Dr. Robert Peterson: If it happens to be the reprocessing by a third party, as occurs in the United States, then that third party would come under the definition of a “manufacturer” or a “processor” and would fall under our regulatory authority. We would need to specify the issues associated with single-use devices going through that, because at the present time they are licensed for use one time, and we would therefore have to amend the regulations to allow for them, under certain circumstances, to be reused.

    The Chair: I want clarification from the Auditor General.

    In general, I think you said that the reuse of single-use devices in that 37% of hospitals that admit to doing that is usually driven as a method of saving money. Is that correct?

    Ms. Sheila Fraser: That was indicated to us as being one of the main reasons for doing that, yes.

    The Chair: Thank you.

    It seems to me we can get to the bottom of most problems when we follow the money, as the Auditor General has taught us so well.

    Mr. Peterson, on the fees associated with applying for a licence under this cost-recovery program, what percentage of your budget is dependent upon those fees?

    Dr. Robert Peterson: That varies, as you know, from year to year because these are a variable source of revenue. At the present time we are approaching approximately 60% of our revenue in medical devices being based upon fees.

    The Chair: Suppose the number of applications were cut in half next year simply because manufacturers didn't have a lot of new devices they wanted to be licensed. You would have to endure a 30% cut in your budget, if they now account for about 60% and all of a sudden the applications slowed down or dried up.

    Dr. Robert Peterson: We would have to make adjustments with respect to that. We have seen something comparable to that in the pharmaceutical area, where for the past three years there has been a reduction in the number of new drugs coming to us as a regulator. That has caused a reduction in revenue, based upon those fees. That revenue reduction has in fact been replaced by the department out of other fees.

    The Chair: What concerns me is it seems to me that you do not have predictable, stable funding.

    Perhaps Ms. Fraser would like to answer that.

    Ms. Sheila Fraser: Madam Chair, I'd like to refer you to a table that we have in the report, exhibit 2.12, which is on page 30. It shows the sources of funding for 2002-03 between the revenue from fees, special initiatives, which could be specific funding from the Treasury Board Secretariat for a specific program. What I think the committee might be interested to note is the A-based funding, which is the money that is given in parliamentary appropriations. There is no A-based funding for pre-market activities.

  (1215)  

    The Chair: Well, that's what I mean. How could it only be 60%? It looks to me like it's--

    Dr. Robert Peterson: The special initiatives, which are envelope-funding for specific purposes, are tax-based, so while we do not have stable A-based funding, we do have tax-based funding for the area.

    The Chair: Most people who are trying to do work want to know how much money they're going to have next year, and we hear complaints from people who have, say, a 5% or 10% reduction in their budget, but it seems to me your budget could be far more volatile. Have you experienced the government coming to your aid when the fees have gone down?

    Dr. Robert Peterson: I agree with you. This is a very volatile way of funding a program.

    We have seen that replaced, as I indicated, in the area of pharmaceuticals where there has been a large reduction in the revenues. In this area--

    The Chair: But you don't run that program, pharmaceuticals. You run devices.

    Dr. Robert Peterson: Actually, I have the distinctive responsibility for both pharmaceuticals and medical devices within the therapeutic products directorate.

    The Chair: Okay, I'm sorry. I guess it's just because we're talking about therapeutic products today.

    Dr. Robert Peterson: I understand, yes.

    The Chair: Mr. Merrifield.

    Mr. Rob Merrifield: I just want to put this in a nutshell. What you've identified as a problem with those multiple-use instruments that are being used or multiple-use devices that are in our hospitals is that the regulations need to be revisited because we're seeing some infections being caused. We're also seeing that the regulations need to be established if we're going to reuse single-use instruments, or we have to stop those being reused. You say 37% of the hospitals out there are reusing them; that means 63% of them are not. So something has to be done in that area.

    Also, I really find it interesting with post-market surveillance, and you talk about the registry of an automobile, that we certainly know how to recall a device in an automobile, but we have no idea how to do it when it comes to humans. Silicone breast implants are a perfect example. We have no idea how many are out there or who has had these, from my understanding. I wonder if we're moving toward a registry and if that's something you would promote.

    I want to know a timeline on the regulations, so I want you to commit to us your intentions of addressing those shortcomings, and then address the registry.

    Dr. Robert Peterson: I can commit to you the fact that we have initiated the steps to start consultation with provinces and territories around the requirements. Should we deem it necessary to move in regulations to begin to regulate an area that we are not presently regulating, there is a commitment to that. We had a teleconference with provincial counterparts at the deputy minister's level to begin to raise this as an issue for future work.

    We will pursue that as the regulator. We are aware of the fact that this is a very difficult area because it is not presently under federal jurisdiction exclusively. We are prepared to regulate an area should the health and safety of Canadians require that.

    With respect to issues associated with registries, I can only tell you that in the case that you have brought up, silicone gel breast implants, we do know every silicone gel breast implant that has been made available on the Canadian market through the special access program. They are requested by a specific physician, and the physician has in their records either the ability to fully identify that patient or has encoded that in such fashion that they can subsequently find that patient.

    In the case of silicone gel breast implants, each of which carries a serial number, we do at the present time have the ability to track that down. If we did not, then it is still the case that should there be a problem with an implant or another medical device, we can alert hospitals and health care providers to the fact that the lot number, the device serial number, or the type of device has been identified as having a problem. There is the capability, particularly for those that are surgically implanted, for the health care provider to go back and identify which patient has received those.

    We are presently looking at a recall for certain models of cardiac pacemakers, both in the United States and Canada, that allows for precisely that level of recall to take place. There is no specific registry that the regulator maintains on that. We can still see an effective recall occur.

  (1220)  

    Mr. Rob Merrifield: So you can track every device. Is that what you're saying?

    Dr. Robert Peterson: In the case of medical devices that we have talked about thus far, silicone gel breast implants, yes. We do not have specific patient information as to who has received an implant or a device, but the health care provider who has implanted that has medical records maintained within the health care facility that takes care of personal health information at the present time.

    Mr. Rob Merrifield: When it comes to the regulations, you say you're in negotiation with the provinces. We understand that there is some provincial jurisdiction here. Are you getting cooperation, or are you getting resistance?

    Dr. Robert Peterson: These are early days. I can report back that we have had very good responses from hospital associations and health care providers in the provinces. There is a very strong willingness on the part of the provincial ministries of health to enter into these discussions with us. I cannot tell you where they will lead at this point in time.

    Mr. Rob Merrifield: Will the use of Health Infoway, which many of the provinces are moving aggressively toward, help in this whole area of post-market surveillance?

    Dr. Robert Peterson: That's this network whereby we may be able to centrally identify a problem. We may be identifying the problem based upon our international contacts and agreements. We would be able to distribute that information in a very rapid fashion through the health care system should the record-keeping within the health care facilities be brought to a different level.

    Mr. Rob Merrifield: This question is for Ms. Fraser. Over $1 billion has gone into Health Infoway in the last four years. We've seen virtually nothing as far as performance is concerned. It falls outside of the access-to-information laws. Are you as nervous as I am with regard to what is happening with that $1 billion? Is there something you could recommend with regard to that?

    Ms. Sheila Fraser: Madam Chair, we have issued several reports on what we call the foundations, and Health Infoway is one of them. The federal government has transferred over $8 billion to a certain number of foundations. We're concerned about the accountability arrangements and the information that has been given to Parliament in order to ensure that these funds are being used for the purposes for which they were intended. Several audits of these have been done. The Auditor General is not the auditor of these foundations, and we do not have access to them. We have used publicly available information. Several committees have looked at the whole question of accountability arrangements and the type of information Parliament should be getting. We will continue to follow that. An audit will be done next February as a follow-up on progress that has been made.

    Mr. Rob Merrifield: Thank you.

    The Chair: The Auditor General has identified 20 unfilled positions within your branch, Mr. Peterson. You told me before the meeting that you have approval for those 20 positions but you do not have sufficient funding to acquire people to fill those posts. Do you have any idea how much money it would take? Have you figured out what your annual budget increase would have to be to accommodate those 20 persons? I know they would have varying skill levels, academic credentials, etc.

    Dr. Robert Peterson: For those 20 positions we would be looking at approximately $1.1 million. That includes the various benefits that would accrue to those positions. That is based on an average of the types of skill sets that would be available, including medical officers, scientists, and support staff. Those positions are there, as you know, in order to allow us to fill them readily should resources become available. But they are not identified as areas that currently need to have persons in them. I must re-emphasize, as you've been able to gather from the Auditor General's report, that while we're able to do the things we do extremely well at the present time, it is dependent upon a variable source of funding, and it is a fragile arrangement.

  (1225)  

    The Chair: If you had those 20 people in place because you had that $1 million that you think would cover their salaries and benefits, do you think you could respond more quickly to all of the Auditor General's suggestions, putting aside the need for cooperation with the provinces and other countries, because obviously you can only proceed on that front as quickly as the partners would agree to proceed, but even with regard to the receiving of adverse event reports, the evaluation of applications for licence, all those kinds of activities?

    Dr. Robert Peterson: Those positions are identified in the pre-market assessment area. Much of the attention we will be paying to the Auditor General's recommendations would come in the post-market and inspectorate areas. Those areas are presently being identified as far as resourcing is concerned. Again, it depends upon how many audits would be done on an annual basis as to what resources would be required. So that would accrue a resource requirement beyond what we have identified today.

    The Chair: Yet when you're evaluating these proposals, you say you are 90% there, so to me, you don't need 20 people there, you need the 20 people at the other end, on post-market surveillance and the reception of adverse event reports.

    Dr. Robert Peterson: As I say, we are there, we are meeting that performance expectation, but it is very tight, so it will be a fluctuating performance, as I believe has been recognized by the Auditor General. When they looked at the performance the year before last, it was different from what it is at present.

    The Chair: You're to be congratulated for upping that percentage, but as you can tell from our prescription drug report, we're very concerned about the number of people who are in place to receive and track and look at trends in post-market surveillance and adverse events that are happening. Have you identified and had approved some positions, even if you don't have the funding, for that area of work?

    Dr. Robert Peterson: I believe the positions have been identified. I could not quantify those for you today, but we could certainly supply additional information if you would like to have it.

    Keep in mind that the most recent funding we have had, identified in the Speech from the Throne, has been to speed up the regulatory approval process, the review process. We recognize that as we roll that out into a therapeutic access strategy across the branch, it must include the post-market follow-up and surveillance. We are just completing our first year of therapeutic access strategy additional funding and the implementation of that. That has been largely focused on the areas we have talked about pre-market today, and we have had tremendous successes. We have had substantial successes even in the pharmaceutical realm in the past year in that respect as well. We are now looking at our next phase, going into the second year of the therapeutic access strategy, how we will be able to effectively enhance the post-marketing capability in these areas.

    The Chair: We understand from meeting with bureaucrats over the last number of years the tremendous pressure you've been under to approve drugs and therapeutic devices more quickly. We aren't quite as excited about that, because we think the pressure has been put on probably for the last ten years or more. We're much more interested in the safety element in the time after approval and what we are doing to protect Canadians' health.

    It's my pleasure to thank you for coming and for answering so frankly. We thank you for the work you do every day on behalf of Canadians. We also thank those people who didn't get to answer a question but who work at Health Canada or with the Auditor General on a daily basis. Your work is meaningful, and we very much appreciate it, as do all Canadians.

    This meeting is adjourned.