Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 37 - Evidence - April 25, 2013
OTTAWA, Thursday, April 25, 2013
The Standing Senate Committee on Social Affairs, Science and Technology met this day, at 10:29 a.m., to study Bill S-202, An Act to establish and maintain a national registry of medical devices.
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
My name is Kelvin Ogilvie. I am a senator from Nova Scotia and chair of the committee. I would like to ask my colleagues to introduce themselves. I will start on my left.
Senator Eggleton: Art Eggleton, a senator from Toronto and deputy chair of the committee.
Senator Merchant: Good morning. I am Pana Merchant, from Saskatchewan.
Senator Harb: Mac Harb, Ontario.
Senator Enverga: Senator Enverga, from Ontario.
Senator Tannas: Senator Tannas, from Alberta.
Senator Seth: Senator Asha Seth, from Toronto, Ontario.
Senator Seidman: Judith Seidman, from Quebec.
The Chair: Thank you, colleagues. I will go over the agenda with you and remind you that the first part of the committee deals with witnesses. Is it agreed that that portion of the committee today will end no later than 11:30? It is agreed. Thank you. We will then move into the clause-by-clause phase.
With that, I would like to welcome our visitors. I will introduce them as I call them to present. By agreement, we will start with Mr. Klaus-Gerhard Stitz, Vice President of Regulatory Affairs with MEDEC.
Klaus-Gerhard Stitz, Vice President, Regulatory Affairs, MEDEC: Thank you very much, Mr. Chair and honourable senators.
MEDEC is the national trade association of the Canadian medical technology industry. I appreciate very much the opportunity to contribute to the committee's work today on behalf of our 170 member companies.
MEDEC's member companies are committed to the advancement of health outcomes for patients. This pledge includes the commitment to a rigorous post-market vigilance system through the entire product life cycle.
MEDEC has provided the Senate committee with written comments on Bill S-202. I will focus today on three points: the existing regulatory system for post-market surveillance, its relation to foreign regulators, and its challenges; Bill S- 202, its changes compared to the current system, and its challenges; and some conclusions.
Manufacturers, importers and distributors of medical devices sold in Canada who are addressed by the bill are in full compliance with the comprehensive Canadian regulations designed to protect Canadians throughout the life cycle of medical devices. The Canadian post-market vigilance system is aligned with post-market systems that regulators have put in place in other jurisdictions, such as in the U.S., Australia and EU member states. No registry for vigilance purposes exists currently anywhere or is under discussion, to the best of my knowledge.
Regulators, however, exchange information on adverse events that happen in their jurisdiction. The onus of adverse event reporting for medical devices and risk communication to medical practitioners and patients is completely on the manufacturer, which cooperates with Health Canada and health care professionals for a joint approach to maximize patient safety. Manufacturers are the ones who hold distribution records. Hospitals may have or have patient records that should contain the products used on patients, in particular when it relates to implants or life-sustaining systems. There are in development e-health records. Manufacturers also hold patient data from implant registration cards required for prescribed devices.
Manufacturers are also the ones who receive information on out-of-spec or malfunctioning products, either through their own routine production audit, which is part of the quality management systems, or via customer complaints, which can happen during service calls of manufacturers' reps to clinics and health care practitioners or by many other means, including email, phone call and mail from patients, users and retailers.
Manufacturers are the ones who assess information for health risks as they are defined by Health Canada: no or minor health risks — also, information goes into a complaint file in the quality management system of the manufacturer — or major or potential for major health risks, which require notification to Health Canada. These notifications include a host of other activities, such as the provision of sales data; stock/distribution pipeline reconciliation information; a communication strategy to be submitted to Health Canada regarding health care practitioners, patients and trade, that is, how they are to be informed and what steps the manufacturer will take; a recall strategy that defines any action that would either mitigate the situation or recall the product from the market; and how the execution of the recall will happen and how reports on its effectiveness and the number of devices sold compared to the number of patients contacted in the course of the recall will happen.
Health Canada requires all that information to investigate the successful concept that the manufacturer follows. If this is not to the satisfaction of Health Canada, then Health Canada steps in and puts itself on top of this process.
The compliance review of the entire process is done through inspections by Health Canada's Health Products and Food Branch Inspectorate, which regularly inspects importers and manufacturers.
There are challenges in this system and we should be aware of them, such as patient records; patient data on implant registry cards that might be incomplete; under-reporting of adverse events; and outreach to health care practitioners and patients, which is not an easy task. In regard to patients, there is a particular need to go to go public.
I will now discuss Bill S-202 and its challenges. The bill as it has been designed will create a special post-market surveillance process for a subset of medical devices; there is one that exists and the bill creates a different process for a subset. The patient registry is supposed to be, as defined by the bill, managed by Health Canada, but it depends completely on input from medical practitioners operating under provincial jurisdiction and on voluntary information from patients, as it is a patient registry; it is not a product registry. It is primarily a patient registry because it starts with the name of the patient who receives the device and not with the device that is put on the market.
Clause 5, the patient data submission and patient education, we consider in our industry as a requirement that is overly burdensome and time-consuming to the medical practitioner who already has many other clinical and patient advisory tasks. This is a task that always appears to come last. Other presenters have also commented that this is a very high burden that we expect to put on the practitioner. The aspect of privacy law in Canada also comes into this question.
Clause 6 is a reminder to patients to submit updates. This is a very honourable task for the registrar, but our industry doubts that patients will notify for either address changes over the lifetime of a device, which can be 20 years plus, or the removal of the device from service if not mentioned. It will not be so difficult with regard to an implant, but it will be difficult for a home-use device that has no supervision.
Therefore, clause 8, the notification of patients/medical practitioners of adverse events, will have a risk of high failure rate. As the patient data will be outdated, the medical practitioner will no longer be the person responsible for the medical care of the patient, and the patient may not be able to make a proper judgment on the action required when he receives this information. Also, other presenters have mentioned that there will be a need to have the medical practitioner in between this notification process.
In conclusion, the industry's position is that the post-market vigilance system with the national registry of medical devices as proposed in Bill S-202 will not perform better than the existing, all-encompassing and robust system that is internationally aligned. There is no visible evidence so far that this registry will save lives. It will be very expensive and resource intense. There is no record on the costing of any system that is under discussion here. The number of $207 billion per year for health care costs does not really apply to the case; it is only a subset of it.
The bill will not improve or increase the timeliness or completeness of safety corrective actions. Just to remind you, there are Canadians living in Canada who have received an implant in their country of origin and who now live here with the implant. We have no data on those patients, and this number is increasing.
The bill does not consider the possible impact of patients' e-health records in preparation, or another system in preparation, which is the unique device identifier system, which would allow the tracking of medical devices.
Further, the bill does not address the main issues of post-market vigilance systems and a low rate of adverse event reporting by patients and health care practitioners.
The Chair: I will now turn to Sholom Glouberman, President of the Patients' Association of Canada.
Sholom Glouberman, President, Patients' Association of Canada: Thank you for inviting me. I thought that the important things for me to talk about are what patients want. The Patients' Association of Canada is pretty much committed to helping patients engage in the health care system more actively because most people in Canada suffer from chronic diseases, and chronic diseases require patient engagement. We are working hard to make that happen in a positive and collaborative way.
I would like to point out that the first warning of difficulty with medical devices comes from patient experience; that patients themselves have the experience of something going wrong or of something being wrong and will often go to their doctor or to the Internet and describe the experience they are having and hear from other patients. In fact, there is a huge amount of peer-to-peer information on the Internet about implants and the side effects of implants. Google it yourselves and you will see that there are all kinds of experiences described where patients talk to other patients about their experience, and these become the early warnings that something might be wrong.
These generally go to physicians and then to the companies, and the companies wait until they find experiences that they think are serious experiences and ones that will require them to offer some kind of feedback. Sometimes there is a delay until the companies decide there is something wrong.
Peer-to-peer is the first level of defence; the second one is physicians in hospitals; and the third one seems to be the companies.
The fourth level is Health Canada and the fact that the government itself decides something is wrong and puts out a call. That is a kind of backstop. You can think of it as a backstop, but it is important to know that patients do engage in this and do report the issues, and the issues very often do result in some kind of difficulty.
In your discussions, I noticed that one of the things you were talking about as a difficulty with this registry is that patients required assent; in order to join the registry, you needed some kind of consent. There is a very simple way of getting a fairly high level of consent so that when people do consent to having an implant put in, part of that consent can be consent to have that implant registered in a registry. In that case, you get a high level of people joining the registry.
The registry serves as a tremendous backup that allows people who have not been on the Internet and who have not had a report of difficulty to hear that from a central source that is authoritative and useful. I think that is a very important part of it.
The other thing is that having this kind of registry can also provide extra benefits for patients. One of the things that would be nice is if, for example, when you registered your implant, you would get a card that said that you had an implant. That would help you get through airport security lines better, for example. You could have a card, or you could have this done in electronic form and put on phones, or you could have a chip installed that would allow people with implants to be readily identified. That can go for foreign visitors as well. We could start to introduce that. We think this would be a good thing and we think that the possibility of getting a high level of consent is probably not too difficult.
Third, we think it is very important for senators to understand that patients do not themselves purchase their implants; that most purchasing in health care is done by the physicians; and that the payment comes not from the physicians themselves but sometimes from the hospital budget and ultimately from the government. In a way, the ultimate purchaser of these implants is the government, and the government has to take some responsibility for that. That is one of the reasons Nye Bevan said that when a bedpan drops in a hospital in Cornwall, the sound of it is heard in the halls of Westminster. In fact, there are political consequences if the government does not take ultimate responsibility for the nature and quality of these implants.
We think those are all important features for you to consider, and I know that some of these things you have not thought about before.
The Chair: Thank you both very much. I will now open the committee up to questions from my colleagues.
Senator Harb: Mr. Stitz, in your presentation you spoke about existing challenges in the system. To me, there is an admission that the system as it is now is not working to the optimum level. Would you agree?
Mr. Stitz: I would not characterize it that way, Senator Harb. I would say that any system we develop will have its boundaries of perfect functioning. From there, the system will have its outliers that are very tough to reach. As my colleague Mr. Glouberman said, a registry will provide a high level of consent with patients.
When we talk about a regulatory instrument, we are not expecting a high level; we are expecting more. If I know 80 per cent of the patients who receive the device instead of 20 per cent, I very much care about them and they need to be informed. That is why, if we have a challenge to reach out to patients and to medical practitioners, we need to use the broadest vehicle possible to ensure we reach them all, and that can be television. It depends on the seriousness of the incident, of course.
Senator Harb: What happens now is that if there is a problem with a device that you or one of your companies becomes aware of, you go to the hospital or to the doctor who did the operation on the patient. What happens if that company is no longer in operation? When something goes wrong with the patient, who notifies the patient and the doctor?
Mr. Stitz: There are a couple of scenarios we have to discuss. One is that a company A exists today and is acquired by company B tomorrow.
Senator Harb: It went bankrupt, I am saying; it is no longer in business.
Mr. Stitz: That is an issue for which I have no spontaneous solution.
Senator Harb: There is a problem there.
Mr. Stitz: There is a problem that will not be resolved in an easy way. However, I would say responsibility rests with the hospital and the physician when they select a product that they want to use for therapeutic effect. If they use a company that does not have a sustainable business, they of course have to calculate or consider this with their choice. That is why many physicians choose to go with companies that are well established and do not pose that type of risk. That is an issue for which I do not think the registry will find a solution.
Senator Harb: I am sure Mr. Glouberman will disagree with you on that point, but let me ask you another question.
Mr. Stitz: If you have no one to notify or to take care, then you have no one to take care in either system.
Senator Harb: You talked about the fact that the registry does not register the device. I want to take you to clause 5 of the bill, which you mentioned. You talked about the patient only. Subclauses 5(d), (e), (f), and (g) all deal with registration of the device. The registry does not only register, although on a voluntary basis, the information about the patient; it also registers the product that your members produce, along with serial numbers and all the necessary data. I just wanted to make sure it is clear that it does that.
Mr. Stitz: It is clear, but it registers the device in combination with the patient.
Senator Harb: You said that it does not.
Mr. Stitz: It does it in combination with the patient. It does not register the device without the associated patient name. There is a distant definition in between.
Senator Harb: You spoke also about the fact that physicians will be burdened. How will that burden be any greater than it is now? The patient has to give the information to the doctor that he consents, and the doctor will pass the information to the registrar. How will that be any more challenging and difficult for a physician than it is now?
Mr. Stitz: In the current system we are not relying on the information from the physician. We are seeking the information from the physician, but if we do not get it, we go to the hospital with the information and to the patient with the information. We go beyond. If the physician is required as the anchor of the registry, we have either compliance of the physician or non-compliance, which leaves us in a difficult state.
I can refer to a current situation in which implants require implant registration cards. For most life-sustaining and supporting implants, such as cardiac pacemakers and cardiac valves listed on the medical device regulations, there is an existing device registry. However, the information that comes with the registration card from the physician or from the hospital to the manufacturers is either incomplete or fragmented. Often, it is a question under the Privacy Act, and people do not bypass that problem without the patient information data. We are using that information and archiving it in the manufacturer's database, but we have to go beyond that because we cannot rely on this being the one and only. It would never match up with the number of devices sold.
Senator Harb: Mr. Glouberman, do you have any comments?
Mr. Glouberman: Yes. In hospitals, because of the way in which records are kept, if patients give consent to having whatever is going to happen to them recorded and sent to a registry, it would happen pretty automatically and would not require any effort on the part of the doctor. That is the first thing.
Also, the idea that patients will not give consent is odd. People have to give consent in order to have the device implanted, and if part of that consent form includes consent to be registered you would have many more than 80 per cent of the patients agreeing to that. Both of those problems can be resolved. It is just a matter of how you go about doing it.
The amount of information that can be given is the amount of information in a standard admission form, so you would have quite a lot of information about the patient. Depending upon how you structure the registry, there would be all kinds of ways to keep in touch with patients over time, because patients, in the admissions process, will give not only their physical address and telephone number but also their email address and other ways in which to contact them.
Mr. Stitz: The registry covers implants and prescribed devices. If we get the consent of the patient for an implant, I have full agreement with my colleague that a procedural consent has to be given anyway, so it will not be difficult. However, a prescribed device entails a completely different process whereby consent is an add-on to the system that is currently not available.
Mr. Glouberman: That is right. It is not available now, but the consent form can add that. It is not a problem to add that.
The Chair: We understand the aspects of this.
Senator Eggleton: I want to follow up on the two kinds of devices we are talking about. We are talking about implants on the one hand and about prescribed devices or home-use medical devices on the other hand. At the committee's first meeting, the witnesses we heard from separated the two. There was much stronger support for a registry for implants than there was for prescribed devices. One group from the University Health Network was not sure that it was a major problem for home-use devices. Can you comment on the separation of the two?
Mr. Glouberman: There is a difference between them. Today we have very widespread use of medical devices such as glucometers. Trying to register glucometers would be almost impossible because they are in such widespread use as Type 2 diabetes is increasing. I do not think it would be easy to do that. The question is what range of medical devices you should look at, and I do not know the answer to that. It seems to me that some study should be done for that. Certainly, implants should be registered. That is a much more serious question. That separation is a good one to make in thinking about how far the registry would go.
Mr. Stitz: I concur, in particular when we talk about home-use devices. We have to distinguish carefully which ones are more serious, such as respirators, which are used in-home more often than before when patients were called into hospitals for that type of treatment. They have these devices at home now, but it is a challenge to include them in the registry. The discussion on separating implants from home-use devices has a valuable point, absolutely.
Senator Eggleton: Mr. Stitz, does the membership of your association do primarily home-use devices?
Mr. Stitz: They do everything from tongue depressors to cardiac pacemakers and from MRI machines to hospital beds.
Senator Eggleton: Mr. Glouberman, Mr. Stitz has indicated a concern in his presentation about how to keep the registry up to date. You may get the information right on day one, but people move and change names. How would you see that working?
Mr. Glouberman: One thing is that people's email addresses stay pretty constant. They will change when they change Internet providers, but often they will keep their old email addresses and keep them forwarded. For people who have the Internet, it will be a new way of contacting them. The same thing goes for telephones. As telephones stop being land lines and start being mobiles, people will keep the same phone number over a period of time. Contacting people will be easier in the future.
Senator Eggleton: That is a good point.
Mr. Stitz, you thought it would be overly burdensome for medical practitioners providing this information, although Mr. Glouberman thinks it is a pretty easy thing, particularly in a hospital context. In this time of trying to advance electronic recordkeeping so that much of the base data about a person is there, I would not think it would be as great a challenge.
Mr. Stitz: If the system of e-health records were used to trace these devices — and I do not think I would like to venture into whether it does or does not because it would blow us out of our time here — then the e-health record could very well have all the information.
As I mentioned in my presentation, another system is coming up with a unique device identifier. Every device in the near future, two to five years from now, will have an identifier that will allow the tracking of where the device has gone. If this identifier goes into the e-health record, the combination of the two would be extremely powerful.
Mr. Glouberman: That is the notion of the chip, to a certain extent.
Senator Seidman: Mr. Stitz, I want to clarify what you said. You made an important point in response to Senator Harb. You made it clear that he was talking about a patient registry as opposed to a device registry. Therefore, the privacy issue becomes a greater issue and the voluntary aspect of it becomes a greater issue. There is a huge difference between a registry based on the device as the primary notation in any record as opposed to the patient's name, which is the primary identifier in any record.
You also referred to jurisdictional issues. You referred to the voluntary aspect of this registry and the problems that part involves. I would like to talk about that. To my best knowledge, internationally there are no real examples of the kind of registry being proposed here, which is an all-inclusive device registry. There are examples in the U.K. and in Australia of artificial joint registries, and in fact, there is an example in England and Wales. However, I understand that the England and Wales registry will be made mandatory as opposed to voluntary and that one of the biggest issues in having these registries be useful is in exactly this aspect of it being voluntary.
One of the main points you made as to why this registry will not perform any better than what we currently have is that it will not increase the timeliness or completeness of safety corrective actions in terms of recall. It will not perform any better than what we have right now. Could you explain that a bit more for us?
Mr. Stitz: We have to go through the entire process of what the registry performs. From the discussion here, we currently have the understanding that there may be not 100 per cent compliance to the requirement to submit the data. Therefore, the registry will be, let us say, a 90 per cent complete collection of patients who have received the device. That by itself is already a performance issue when you would like to go after the patients who need to be notified or the medical practitioner who needs to be notified, because you cannot rely on the assumption that the data you have is the data that you can work from. We know from other experiences that databases compiled today are outdated three months later because there is so much moving going on that many addresses are not correct. I agree that telephone numbers and email addresses often do not change that much, but there are other circumstances that may also make this not a 100 per cent safe way of communication. That is one part.
Second, the timeliness of an evaluation of an incident is not a cut and dry situation. It is not black and white. Patient A having an incident does not mean that patient B goes through the same thing. It may be a serial product failure, okay, but many incidents or adverse events happen that relate to a patient therapy situation. You have to assess that first, and is a lot of investigation necessary?
The registry does not make that simpler. The process stays the same in its complexity. It adds facets, but it does not make it a complete picture.
Mr. Glouberman: Could I say something about that?
The Chair: Certainly, Mr. Glouberman.
Mr. Glouberman: One of the things that the British registry goes together with is a very capable complaints mechanism so that patients are encouraged to state their complaints about a particular issue with a public way to receive them, and that is on the Internet. That is really important so that the registry also gathers that information.
The first line of information is patient information. When you put this information in the hands of the provider companies, they are loathe to say that a device is defective. They need quite a lot of evidence in order to make that declaration, and it may be that the boundary is far further than the boundary that would be taken by a registry in order to provide people with information, or from a peer group.
Senator Seidman: Is the U.K.'s registry is a joint registry.
Mr. Glouberman: Yes.
Senator Seidman: It is not an all-device registry.
Mr. Glouberman: That is right.
Senator Seidman: Canada currently has a voluntary joint registry, so I am not sure what we are adding when you refer to what you are referring to. We have the current system, and we have discussed the serious complications and lack of clarity on how the proposals in this bill would achieve what they are attempting to achieve. It is a worthwhile or worthy ideal, shall we say, but the real world experience in this, all over the world, internationally, has shown this to be impractical and very costly. One has to say, from a cost-effective point of view, that there are always risk rewards, and one has to assess these things.
Senator Cordy: Canada may have a system. However, in June 2011 the Auditor General concluded that despite its best efforts, Health Canada was not able to fulfill its responsibility for medical devices as stipulated under the Food and Drugs Act and regulations. While we have it under the Food and Drugs Act and regulations, the Auditor General has said quite recently that in fact Health Canada is not doing it. Would a registry not be a start for Health Canada in terms of being responsible to acknowledge what the Auditor General has already said in terms of fulfilling its responsibilities?
Mr. Glouberman: That is certainly our view. We think the registry is an important backstop that will allow this information to pass readily and more freely and allow for a better flow of information between the various groups involved in the provision of implants. Of course, it is not only for joint implants.
Senator Cordy: A previous witness on this bill agreed with what you have also mentioned, that is, the listing of how it starts, with patients who are obviously the first ones to know, so it is peer to peer; and then physicians and hospitals; and then the companies; and lastly, unfortunately, Health Canada. At our previous hearing on this bill we heard that no one is ultimately responsible for the notification of patients. If nobody is ultimately responsible, then we know oftentimes it falls through the cracks. What happens if nobody is in charge?
Mr. Glouberman: That is right. I think that whether government wants to be ultimately responsible or not, in both the Canadian and the British system government is ultimately responsible because they are the ultimate purchaser.
Senator Cordy: The Auditor General has said they are not doing a good job.
Mr. Glouberman: That is right.
Senator Cordy: How would a national registry be helpful to Canadians? We have danced around it. I think we have had the discussion about whether it is implants or other medical devices. Let us stick to implants. How would a national registry be helpful to those who have implants?
Mr. Glouberman: I think the first thing is that it is a backstop. In general, as I said, the first level of complaint will be patient to patient. Until it is decided that there is something seriously wrong with the implant, that kind of information will be passed and decisions will be taken about whether the implant is dangerous.
It would help if a government body does that and has responsibility for that. I think it would happen earlier than through companies in general, and I do not blame anybody for that. I think the level of diligence is different in different contexts. That is one reason for having a registry.
Being able to inform people that there is something wrong and having the capacity to do that is very critical, and that is one of the things the Auditor General talked about. Having that in a registry gives you a much better capacity to do that than without a registry. It is not to say that it is 100 per cent. I agree that it will never be 100 per cent, that there will always be people who do not give full consent, but I would bet that because physicians would ask for that kind of consent, along with the consent to do the implant, you would have a much higher level than even 90 per cent. There is a good chance that you would be able to inform people. We know that the capacity to do that is increasing all the time.
Mr. Stitz: This is an interesting question, referring to the reports of the Auditor General. I have been a reader of those reports myself, and I can see a line of development from 2004 to 2011 of certain improvements that Health Canada has made. The industry has been in discussions with Health Canada about doing those, about being more vigilant and about having more information gathering so that the dialogue between Health Canada and the manufacturer can start on early signals, as we call them.
The other point, however, is that any compliance system that is being managed by the government and imposed on the industry to execute is only as good as its controls. The Auditor General was complaining that the inspectorate did not have an inspection plan of manufacturers and importers that was up to par with international standards. At the time, in 2011, manufacturers were inspected every seven years, which is, of course, a very long period. The international standard is every three years based on criteria of urgency and events that happen that make it necessary to see them faster.
That has significantly improved over the past two or three years because the inspectorate has an inspection strategy in which they have defined that some manufacturers will be seen every three years and others every five. There is action, and traction, that brings into play the weaknesses that the Auditor General was seeing.
Mr. Glouberman: We think other improvements could be made along those lines. The Patients' Association is working on ensuring that patients become part of the group that looks at those policies and at the actual case of the implants. We think that patient engagement in the system is critically important. This is another opportunity for that. If there is a registry, we believe that patient representatives should sit on the board and that they should be part of the system of inspection in order to make sure that it works reasonably well.
Senator Seth: This is a very interesting topic.
I understand that there are 60,000 medical devices. Will we register all of that? I understand it is quite an expensive a task to register all of those medical devices. We are also not paying attention to the post-market vigilance system and can address it more; that is, there is a low rate of event reporting by the patients and health care professionals.
What would the rough cost be of setting up a registry and a registrar at Health Canada? It looks quite tedious. It looks quite wide. We already have a system that is taking care of most of the things. We can improve the system. Maybe medical devices implants could be registered in a comprehensive, national, integrated medical records system to improve this area and solve a lot of problems. That could be nationwide. We could have data and monitoring of patients' data and records, which would solve more problems. I would like to know how expensive that would be. What would the cost be? After all that talking, going into a new era, what would that be?
The Chair: We did not expect you to come here with that kind of data. If any of you wishes to make a quick comment, that is fine, but I think the senator has made her point well. You could just make a quick comment, if you wish, but not get into that. That is not your role.
Mr. Stitz: Thank you very much for your understanding. I can try to give a reference.
A registry is very much comparable to what industry currently does in a clinical study because you have the name of the patient, all of the information that relates to the patient — his indications, his multi-morbidities — and the product that is being used on the patient. You then watch over that. Such a clinical study, depending on the number of patients involved, can be a million-dollar job. If you now roll this out into medical device implants in total, then you can come to a very high number.
Let me make one more point. The reason the current medical device regulations have restricted patient implant cards to mostly cardiovascular devices because they are the most critical. If one fails, a person can fall off their chair, and, until the doctor comes, it is too late. For many other devices, there are, of course, health hazards. However, they can be controlled, and we have more time and space to deal with them.
Senator Merchant: I am trying to understand. At a time when medical device mechanisms have become as important to medical care as drugs and medical devices and product breakdowns are becoming so significant, why are there privacy and expense concerns about this when we have a registry for drugs? I am trying to understand why this is such a —
Mr. Stitz: I do not understand what you mean by a drug registry.
Senator Merchant: Well, for pharmaceuticals.
Mr. Stitz: There is no registry. Drugs are registered, so they are approved. Through that, Health Canada knows what is on the market. The same applies to medical devices. However, there is no registry that relates to which patient has been prescribed which drug.
Senator Merchant: Okay, I am mistaken then.
The Chair: That is the correct answer.
Senator Enverga: As I understand it, there is an existing registry, basically on your terms. Let us say that a patient needs information and MEDEC gives the wrong information. Are you legally responsible for that?
Mr. Stitz: No, we are not. Our manufacturers would be.
Senator Enverga: Will that help legally, on your end?
Mr. Glouberman: I think that is right. One of the issues here is that of a backstop, of making sure there is some responsibility and we know where the responsibility sits.
Senator Enverga: Are you thinking that it is the government who should be dealing with this or just the practitioner who should be making the right decision here?
Mr. Glouberman: It is both. I think that you have different levels of responsibility, and I was saying that the patient has the least amount of responsibility because they do not choose the device. The doctor chooses the device but does not purchase it. Sometimes the hospital purchases it, but the ultimate purchaser is the government. The relationship between the purchaser and the provider seems quite critical. The ultimate provider is the company, so the company's interests are not exactly the same as those of the purchaser. That has to be taken into account when you do this. Having an independent registry is critical for understanding that divide.
Senator Enverga: Why will the government be responsible instead of the practitioner, the doctors or the hospital?
Mr. Glouberman: In the end, typically the individual practitioner does not take responsibility for this. That is not the way it has been in the past. As I said, when the bedpan falls in the hospital in Cornwall, it is heard in the halls of Westminster. When there is a serious defect and a serious problem, it goes to the press and the government is seen to be responsible. The Auditor General speaks of that kind of responsibility.
I think that politically it is very important that the ultimate responsibility for publicly funded health care in Canada sits on the government.
Senator Enverga: You said "seen to be responsible." Technically, it is the doctor and the practitioner who did it, right?
Mr. Glouberman: Well, technically it is not the doctor. Technically, it is everybody who is engaged. When you sue somebody, you sue the doctor, the hospital, the company — you sue everybody.
Mr. Stitz: I was thinking that if some event happens in a hospital, the outcry is, "Why did the government let this happen?"
Mr. Glouberman: That is right.
Mr. Stitz: I disagree with the temptation to make the government responsible in the first place because it is in our nature and in the nature of our media that we always need somebody who takes care of it. I do not think that it should always be the government.
Sometimes we have to go back to the roots of what really happened and who has responsibility. In those law cases where the lawyers — in order to make it really broad — put everything on the defendant's list, sure that happens, but who has responsibility will be sorted out very quickly in court.
The Chair: We could debate this one a very long time, so I will bring that to a close. I think we have had a good discussion.
Senator Seidman: I want to come back to our concern for the patient because obviously the person who has the device or the implant is the issue here. If we have a patient registry, I presume the patient finds out on the Internet or that there is some electronic way to contact the patient to inform them there is a fault in their device. Macleans published a piece that talked about the enormous stress involved for a patient when they hear that a device or an implant they have has been recalled, and the huge role the physician plays in helping a patient manage the enormous anxiety they feel when they suddenly discover that something inside their body is liable to malfunction.
The point I would like you to address, Mr. Glouberman, is the link from the manufacturer to the physician and then the physician to the patient so that the patient can be reassured immediately. That would seem to be important.
Mr. Glouberman: I agree. What Karima Velji said when she was here last is correct. However, what happens now is that the patient-to-patient peer network is usually the first to get wind of it. It then goes to the manufacturer, who sits on it for a while, and then it goes back to the doctor and the patient. Typically what happens now is the patient's inquiry starts in the peer-to-peer network, if they are aware of it.
When it goes through the process that someone has to be warned, I agree that the formal process should be that the manufacturer or the government should go back to the provider for those people who are not aware of it, and that the provider should work to reassure the patient or deal with patient anxiety. That is the provider's job. I do not deny that. I am saying you will have multiple channels of information anyway and that it is best.
I would also say that the warning does not come from the government directly to the individual, necessarily. It can go first to the provider and give the provider some responsibility for that. I see no reason not to do that.
I agree with you. Dealing with patient anxiety is something that our system does not do very well. In emergency rooms, for example, triage nurses pick out people who are sick from people who are not very sick. Those nurses in our system are not trained to deal with the anxiety of those people who are not very sick. Thinking about patient anxiety is a wonderful thing to begin to do at the Senate level.
Mr. Stitz: I would quickly refer to something that was said in this room in a previous session about an incident where a patient had a problem with a cardiac lead that was malfunctioning. What is important in that situation is that this information went very fast to the select physicians who did implants and cared for patients. In that particular incident, we saw exactly what you were describing — that patients getting the notion that there is something wrong that can kill them would drive them crazy. From there, they were insisting and imposing on their doctors that action be taken.
The quintessence of the story was that the Heart Rhythm Society concluded that it would have been better to monitor patients and increase the monitoring rate than going to re-implantation because implantation of a cardiac lead has a lethal risk as well. There were more patients in that particular case dying from re-operation than would have died from the malfunctioning of the device. That shows that these situations are so particular that a rule for all of them is hardly possible.
Mr. Glouberman: I agree.
The Chair: The final question is one that has come up, and you have referred to it either directly or indirectly. It is the theoretical electronic health record. We are talking about a theoretical registry at the moment, but the two have very similar bases in technology: the idea of a registry and an electronic health record.
Mr. Stitz, you very clearly implied that you believe a properly developed electronic health record could deal with the issues that are requested in the bill for the medical record and perhaps cover some of the other issues that you described. Did I misinterpret you?
Mr. Stitz: No.
The Chair: Mr. Glouberman, I think you touched on it more indirectly. If we had a truly functioning electronic health record, would you see that being capable of meeting the patient's needs with regard to the implant issue we are dealing with?
Mr. Glouberman: It would tremendously lower the cost of having a registry. It would allow you to create a registry electronically within the electronic health record. It would be automatic. You could do it automatically and get the feedback automatically. You would also have all the information that you need. In fact, it would be an interesting question about what kind of consent would be needed in that context.
I think one of the issues about privacy and consent is now up for debate. You have to think about the boundaries of privacy and consent in many of these cases as well. We are talking to the Privacy Commissioner of Ontario about these kinds of issues all the time because it is important to recognize that some of the privacy issues that are raised block patient capacity.
The Chair: That will be a fascinating issue in any event.
I want to thank you both for being here and answering so clearly. I think you fleshed out a great number of the issues around this bill, and I thank my colleagues for their questions.
We are now proceeding to clause-by-clause consideration of the bill. As chair I am required to ask you the following: Is it agreed that the committee proceed to clause-by-clause consideration of Bill S-202, An Act to establish and maintain a national registry of medical devices?
Senator Seth: Mr. Chair, I would like to move the following motion:
That the committee not proceed to clause-by-clause consideration of Bill S-202, An Act to establish and maintain a national registry of medical devices;
That pursuant to rule 12-23(5) the committee recommend that the Senate not proceed further with the bill;
That the committee adopt the attached draft report;
That the Steering committee be empowered to modify the report for the purpose of correcting any typographical or grammatical errors; and
The Chair be instructed to present the report to the Senate at the earliest possible opportunity but in any case no later than April 30, 2013.
The Chair: That motion is before you and I understand copies are being circulated, as well as copies of the draft report. I just wanted to make sure that I understand what is being circulated. Is that correct?
The motion is before the committee and is open to debate.
Senator Harb: Based on the presentation that we heard from the Canadian Nurses Association and other witnesses, as well as on the suggestions and presentations we have heard today, I prepared a list of amendments, first dealing with the issue of including doctors as part of the team that should be notified by Health Canada should there be a problem. I have an amendment to address those concerns.
Also, we heard about home-use devices. I have prepared a list of motions in order to remove home-use devices from inclusion as part of the registry.
All of that is to say, Mr. Chair, if the will of the committee is to really deal with matters that are of public interest, of public concern, I have genuinely, in a non-partisan fashion, prepared all of the motions and amendments as were suggested by all of the witnesses, none of whom have opposed the bill. They are either very strongly supportive of the bill or somewhat supportive of the bill. Even the gentleman who represented the organization here today was not necessarily opposed to it. He had concerns. With my amendment, I have dealt with all of those concerns.
It would be very disappointing, frankly, for the committee to not deal with an issue that is extremely important. There are many legal cases now with people suing the government. The Auditor General in a number of reports has said that something needs to be done. For us to put our heads in the sand just because someone in government has asked this committee to kill it would be disappointing.
The Chair: I take that clearly as an argument against the motion on the floor.
Before I go to Senator Eggleton, I think there is a friendly clarification to your motion, Senator Seth. You say in paragraph 4 that "the Steering committee be empowered . . ." That is what we generally refer to the group as, but its formal title for this purpose is the Subcommittee on Agenda and Procedure. I assume you would accept that substitution?
Senator Seth: Okay.
The Chair: The proper term for "steering committee" is the Subcommittee on Agenda and Procedure.
Senator Seth: Yes.
The Chair: You would consider that a friendly change and you would accept that and incorporate it?
Senator Seth: Yes.
The Chair: Thank you very much. It is understood that Senator Seth was indeed referring to the Subcommittee on Agenda and Procedure and has accepted the clarification of using the appropriate Senate title in that regard.
Senator Eggleton: This is not a very good way of proceeding. You can smile at it, but I think you should be giving a chance for him to put his motions and put his amendments. You can vote against it. It will be the same result. However, if this is an effort to circumvent his being able to raise his point, then I just think it is bad form to go in this kind of direction.
I think we have to give Senator Harb every opportunity to present his case. He wants to present a case that would separate the implants from the devices. This does not give him the opportunity to do that. He could if we were doing it on clause-by-clause in the bill. If you have determined you will vote against it in advance, even before you have heard his argument here, you have decided to put this motion. I think that is in bad faith.
The Chair: Thank you, senator. You are clearly speaking against it. I will go to Senator Seidman and Senator Cordy.
Senator Seidman: We have heard from witnesses over the past few weeks and from Senator Harb. He also questioned the witnesses, and he said to us as a committee, "Listen, on this bill we did not do a lot of research. I am open to all kinds of amendments. You can do whatever you want with it, basically."
In my opinion, that is really not the way to deal with a bill. You have witnesses here who tell us how complicated these issues are. They are very complicated issues. I have enormous trouble with a bill in front of you that needs umpteen number of amendments to try to make it something, without ever getting near the substantive things we need to talk about.
By the way, this is the third or fourth time Senator Harb has brought this bill forward, so it is not as if he has not had years to work on the substance of it. I just find it a little too light for such a serious subject, that someone brings a bill to this committee that is so general and has not dealt really in a serious way with all of the issues that have come up before us. Every witness has come here and brought forward very serious, complex issues around this subject matter. I am not making light of it myself; I am taking it extremely seriously. That is why I would have to say that I cannot possibly sit here and consider a number of amendments that try to take into account what we have heard, when what we have been presented with is a bill that is so general and does not seriously deal with the biggest issues. I just cannot see it; I am sorry.
The Chair: Senator, I will give you a chance to come in later.
Senator Cordy: I quite honestly find this most offensive that once again a Liberal member brings forward a private member's bill related to health. In both cases, my case and now Senator Harb's case, the Conservatives in the chamber of sober second thought are not even allowing the bill to go to clause-by-clause consideration. I find that, quite honestly, offensive. Perhaps what we should do is what was done in the case of my MS bill.
Senator Harb, perhaps you should put forward an access to information request and find out when this decision was actually made by the Conservatives. In the case of my bill, the decision was made in February of 2012 at a Conservative caucus meeting, where the Minister of Health attended the Conservative caucus meeting, where the head of CIHR, Dr. Beaudet, attended, which I found quite unusual, considering that CIHR is supposed to be at arm's length. Dr. Beaudet not only attended and gave a briefing to the Conservative caucus members, but he said at the time that he would give a briefing note to the minister on why they should not support a private member's bill. That was over a year ago. Perhaps you should do that and find out when this decision was made.
We are supposed to be the chamber of sober second thought. I am finding it increasingly most offensive that Liberal senators' bills are not even being allowed to go to clause-by-clause consideration. I recall a Conservative MP's bill that came before this committee dealing with Employment Insurance. Every witness we had before us, except for the member who sponsored the bill, was against it, and yet it was unanimously rubber-stamped by the Conservatives on the committee.
Perhaps that is a suggestion for you. I am quite honestly finding this more and more offensive.
Senator Eggleton: I guess the only point I am making is that what should happen here is that the proponent should have an opportunity to put his case before the committee, before the counter-case is put forth. The proponent puts it forward, and then people who oppose what he is stating then present their position. Here we have it precooked. It is being put on the table before he has had a chance to put forth his position.
I do not agree that we get into a lot of complicated situations in going the clause-by-clause route. I think we are quite capable of dealing with that, and we have before. Usually the proponent makes their case on the preamble or the first clause anyway, so you can decide at that point in time whether you want to accept them. To precook this like this is just bad faith.
Senator Seth: With due respect, it is not that we do not want to pass the bill because it comes from a Liberal. We respect that. We are here for sober thought. However, this bill has been around for a number of years, has not been changed, has not been precise and is very vague. Like a lot of things, it already exists in what we are doing presently. It goes beyond the federal role. Much of this is in the provincial and territorial area — the physicians, the hospitals and the provinces. They govern seeing the patients and implanting medical devices. There is a lot of concern about privacy, which would limit effectiveness in achieving the objective. We also have to consider the cost to taxpayers.
The other thing is that there is an alternative. We have our electronic data system, or we can make a more comprehensive, integral, national, comprehensive health record system. It could be modified more.
We keep on repeating the same thing, unfortunately. We have nothing against you.
Senator Cordy: So vote against it at clause-by-clause, but do not now allow the bill to go —
The Chair: On this particular part of the debate, under Senate regulations, the appropriate way to deal with a bill that is not going to be supported by the committee is the manner in which it is being dealt with. I just want to remind the committee of that.
Senator Eggleton: We have not heard from the proponent. They decided in advance that they will not support it.
The Chair: I am simply making an observation with regard to procedure, because procedure was under question.
Are members ready to vote on the motion?
All those in favour of the motion —
Senator Harb: I want a recorded vote.
The Chair: I will read the motion as amended with the friendly amendment:
That the committee not proceed to clause-by-clause consideration of Bill S-202, An Act to establish and maintain a national registry of medical devices;
That pursuant to rule 12-23(5), the committee recommend that the Senate not proceed further with the bill;
That the committee adopt the attached draft report;
That the Subcommittee on Agenda and Procedure be empowered to modify the report for the purpose of correcting any typographical or grammatical errors; and
That the chair be instructed to present the report to the Senate at the earliest possible opportunity but in any case no later than April 30, 2013.
The question has been called. You asked for a recorded vote.
Jessica Richardson, Clerk of the Committee: The Honourable Senator Cordy?
Senator Cordy: No.
Ms. Richarson: The Honourable Senator Eggleton, P.C.?
Senator Eggleton: Opposed.
Ms. Richardson: The Honourable Senator Enverga?
Senator Enverga: Yes.
Ms. Richardson: The Honourable Senator Harb?
Senator Harb: No.
Ms. Richardson: The Honourable Senator Martin?
Senator Martin: Yes.
Ms. Richardson: The Honourable Senator Merchant?
Senator Merchant: No.
Ms. Richardson: The Honourable Senator Seidman?
Senator Seidman: Yes.
Ms. Richardson: The Honourable Senator Seth?
Senator Seth: Yes.
Ms. Richardson: The Honourable Senator Tannas?
Senator Tannas: Yes.
[Translation]
Ms. Richardson: Honourable Senator Verner?
Senator Verner: Yes.
[English]
Ms. Richardson: For, six; against, four.
The Chair: The motion is carried, and it included the clause with regard to the report.
That concludes our business. Is there any other item to come before us? If not, I declare the meeting adjourned.
(The committee adjourned.)