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Standing Committee on Health



Tuesday, February 12, 2008

[Recorded by Electronic Apparatus]



     Good morning, ladies and gentlemen. Welcome to the health committee.
    We're very pleased to have some very important witnesses who are going to present before the committee today, as well as the minister, who will be joining us a little later.
    Before we go right into the testimony of the witnesses, though, I have a question for the committee—and I would ask the witnesses, if you don't mind, to indulge us for a few minutes and to be a little patient.
    First of all, I would like to ask the members if they have any objections to cancelling our meeting scheduled for February 26. That is the date the budget will be coming down. This is due, of course, to the presentation of the budget in the House that day. So what we'll do is take the whole agenda and bump it up so that it goes in the right sequence according to what we had originally planned.
    Are there any questions?
    Dr. Bennett.
    Why would we do that? Isn't our meeting from eleven to one?
    We've been advised that they need this room for the budget. We looked around for other rooms, Dr. Bennett, and there just isn't anything available that day. I also understand that, traditionally on budget day, this is common practice because of the unavailability of rooms. But thank you for that question.
    Does anybody else have a question?
    Are you all in agreement, then, that the February meeting will be cancelled in lieu of budget day?
    Thank you.
    Going on, the last item of business I want to bring before you is that there will be a very short pause—and I should tell this to the witnesses too—before the minister comes to the table at 12:15. That will allow the minister to assume his place at the witness table and it will give the witnesses a chance to remove themselves, if they don't mind. The witnesses are welcome to stay, it's just that the minister and his people will be here. That's just to let you know. I'll give you the cue when that happens.
    Pursuant to Standing Order 108(2) and the motion adopted by the committee on Tuesday, January 20, 2008, I would like to welcome the witnesses who are with us today on the subject of the supply of radioisotopes.
    We have with us Grant Malkoske, who is the vice-president of strategic technologies, and David McInnes, who is the vice-president of international relations, both of whom are from MDS Nordion; and Douglas Abrams, who is the president of the Canadian Society of Nuclear Medicine.
    I would like to remind witnesses that you have ten minutes per organization to make your presentations, and after the presentations we will proceed to questions.
     I welcome you today. We're quite anxiously looking forward to hearing what you have to say.
    Let us begin with the witnesses from MDS Nordion.


     Good morning, Madam Chair and members.
    My name is Grant Malkoske. I am vice-president of strategic technologies at MDS Nordion. Accompanying me is David McInnes, vice-president of international relations.
    MDS Nordion is an Ottawa-based life sciences company with more than 700 employees at locations in Laval, Vancouver, and Belgium.
     We welcome the opportunity to appear before you today to provide our perspective on the 2007 medical isotope supply shortage caused by the NRU reactor shutdown. This event had a significant impact on medical isotope production and our ability to supply medical isotopes to the nuclear medicine community and, in turn, that community’s ability to supply to hospitals, physicians, and patients.
    As you may be aware, we appeared before the Standing Committee on Natural Resources last week. As we stated there, there is a sequence of steps in the medical isotope supply chain that ends with hospitals. The steps involve a reactor, a processor, a radiopharmaceutical manufacturer, and a hospital and/or radiopharmacy that administer the product to the patients.
    The AECL NRU reactor is our primary source of medical isotopes. MDS Nordion is the processor of these medical isotopes at our facility in Ottawa. It is important to note that MDS Nordion is not the direct supplier of radiopharmaceuticals to hospitals. We distribute medical isotopes, which are active pharmaceutical ingredients, to our customers--radiopharmaceutical companies, all of which are based outside Canada. Our customers, in turn, manufacture radiopharmaceuticals and distribute them to hospitals and radiopharmacies in Canada and worldwide.
    Two American companies are our primary customers and supply all of Canada’s radiopharmaceutical products. Canadian-produced medical isotopes are responsible for supplying a total of more than 50% of the world’s medical isotopes, some 60,000 procedures a day, 5,000 in Canada alone.
    One important aspect in this supply picture is the global production capacity. The NRU reactor is the most reliable reactor in the world for medical isotope production. Its supply reliability exceeds 97%. There are only three other sources to call upon for backup supply: South Africa, Belgium, and the Netherlands.
    If one of these reactors goes off-line, NRU can quickly ramp up to meet 100% of the additional demand. However, the reverse is not true, as we saw last November and December. If NRU is off-line for more than seven days, no other foreign reactor or combination of foreign reactors today can fully fill the supply gap left by NRU. Even with the world’s other reactors ramping up to capacity, there was still approximately a 35% total global shortage in medical isotopes. That gap would have persisted had the NRU reactor remained off-line.
    On the evening of November 21 we were informed that NRU would not be restarting after its scheduled shutdown. We immediately initiated our contingency protocol for such emergencies. With only two days of inventory remaining, we began notifying affected customers, radiopharmaceutical manufacturers. We remained in close contact with them over the course of the outage period.
    On the morning of November 22, in a meeting with AECL, we were informed of the potential extent of the NRU outage. We advised AECL this outage would cause a shortage of global supply of approximately 30%.
    In the afternoon of November 22 we attended a regularly scheduled meeting arranged by AECL with Natural Resources Canada and ourselves. At that meeting we reiterated the estimated impact of this outage on global supply.
    On November 23 we contacted our other suppliers in South Africa, Belgium, and the Netherlands in an attempt to source backup supply. Virtually every day we remained in contact with these suppliers.


    It is important to note that at this point it was not clear when the NRU reactor would resume isotope production. The information provided by AECL was in constant flux with regard to resolution options and restart schedules. By late November, AECL advised us that it was working toward an early December restart. Based on that information, we then issued a press release.
    Starting on December 5, government officials from several departments sought regular briefings from us to update them. That led to later discussions by department officials with Natural Resources Canada and Health Canada to involve us in the development of a communication protocol, should any such supply event occur again.
    In addition to repeatedly requesting additional medical isotopes from our backup suppliers, we took a number of steps to facilitate extra supply. We obtained U.S. Food and Drug Administration approval to combine any available backup supply in any proportion. We contacted the Belgian nuclear regulator to validate the shortage crisis and enable special dispensation for increasing processing limits at the Belgian processing facility. We shipped licensed containers to all our suppliers to facilitate immediate shipments should any material become available.
    In addition to seeking the backup supply I mentioned earlier, on December 3 we also initiated a meeting with all the world's suppliers to make an unprecedented request that they share their regular supplies. They refused.
    Despite persistent attempts to source backup supply, we were only able to get a marginal amount of isotopes from abroad, about 20% of what we needed. All backup supply received by MDS Nordion prior to the time Bill C-38 was passed on December 12 came from South Africa. We were not able to get any backup supply from Europe.
    Although the medical isotope shortage turned out to be about 35%, the shortage varied from country to country. In Canada's case, it was about 65% because the NRU reactor is a primary source in our supply chain. As we have learned from the nuclear medicine community, the shortage was more acute in certain regions of the country. The reason for the geographic variation depended upon where each hospital obtained its finished radiopharmaceuticals. Our customer, U.S.-based Bristol-Myers Squibb Medical Imaging, was and still is the largest supplier of finished radiopharmaceuticals to Canada.
    We prevailed upon Bristol-Myers Squibb to ensure that Canada received its fair share of available finished radiopharmaceuticals. They informed us that in fact Canada did receive its fair share of the limited supply of medical isotopes then available over the course of the NRU outage period.
    In summary, Madam Chair, we believe we acted swiftly and worked diligently to address the medical isotope supply shortage caused by this outage. However, the reality is that there is no source of backup supply that can fulfill the worldwide gap that NRU creates as a result of an extended shutdown. Clearly, it is imperative that government, industry, and the nuclear medicine community collectively find a long-term solution for the reliable supply of isotopes from Canada.
    Thank you.
     We're available for your questions.
    Thank you, Mr. Malkoske.
     Before we entertain questions we will hear from the president of the Canadian Society of Nuclear Medicine, Mr. Douglas Abrams. Thank you.
     Thank you, Madam Chair and committee members, for allowing me the opportunity to appear before you today.
    I am a pharmacist specializing in nuclear medicine and radiopharmaceuticals and I am the director of the Edmonton Radiopharmaceutical Centre at the Cross Cancer Institute. I'm currently president of the CSNM and I am also a member of the ad hoc committee that was brought together to advise on the isotope shortage.
    I would like to provide some very brief background on nuclear medicine and radiopharmacy. I won't go into as much detail as Mr. Malkoske did, so you won't be bored twice in a row.
    Nuclear medicine uses many different isotopes for the diagnosis and treatment of a wide variety of diseases. The majority of the diagnostic tests are for heart disease and cancer, although many other disease states are impacted by a shortage. The majority of therapeutic applications are for thyroid-related diseases, but a growing number of therapies are in development and showing much promise.
    However, although the number varies with different sources, about 80% to 85% of diagnostic procedures in nuclear medicine use technetium-99m radiopharmaceuticals. This is a short-lived isotope that is conveniently derived from a much longer-lived isotope called molybdenum-99. The isotope shortage reflected the decreased supply of molybdenum-99 when the NRU reactor shutdown was extended beyond the original planned date.
    As technetium-99m has only a half-life of six hours and most radiopharmaceuticals have only a 12-hour shelf life, these products are prepared on a daily basis and cannot be stockpiled. This shortcoming is offset by the use of a generator system in which the longer-lived molybdenum-99, which has a 66-hour half-life, or about three days, can be used as the supply for the technetium-99m. These generator systems can be used for up to two weeks.
    Alberta was relatively unscathed by this crisis, as the three major centres in Edmonton, Red Deer, and Calgary all get their technetium-99m generators from Covidien, which sources most of its isotopes from Holland. However, as noted previously, the impact was very patchy and many small clinics within Alberta were using generators from BMS, which relies on the NRU reactor supply.
    My involvement was to facilitate supply to as many smaller centres as possible, which we did through discussions with Health Canada. Our major efforts were to extend the lifetime of generators after their normal expiry date, facilitate transport of used generators to smaller centres, and look into the use of alternate isotopes.
    I think I'll end there. I won't go into too much detail because I suspect I'll get questions asking me for more detail.


    Thank you very much, Mr. Adams.
    We will proceed with the questions now, starting with Ms. Fry.
    Thank you very much, Madam Chair.
    I want to thank both MDS Nordion and the president of the nuclear medicine society for coming today, because this is a very important issue. In the words of the society, it in fact had all the makings of a national medical crisis across this country.
    Now, I heard from MDS Nordion that they were aware of the problem on November 22 and that they met with Natural Resources Canada on this issue on November 22. You physicians who were going to need this were not aware until November 27, five days later. Then Dr. O'Brien said in his communiqué that he did not actually talk to anybody at all from Health Canada until probably December 5. So there was a lag time of 13 days before there was any way of talking with anybody in Health Canada to say: What is it we need to do? How can we work on this together?
    How did you know on November 22 that this was coming down? Had the nuclear medicine society been consulted? This was obviously going to impact on the nuclear medical society and the patients who see nuclear medicine physicians. Had you been aware on November 22, do you believe there were steps you could have taken, as physicians across the country, to deal with this issue in a way in which you could have triaged patients based on need and so on? Do you think you could have dealt with it over a period of maybe about a month? On the steps that were eventually taken--it was crisis management more than anything else, the shutting down of the reactor and the reopening of the reactor--do you believe your patients could have been served for about a month if you had been consulted early? Do you believe the steps that were eventually taken by the government could have been, in fact, mitigated because you would have been able to deal with it?
    Those are the questions I really want to ask you. Were there alternative routes that could have been taken to deal with this thing before it became a crisis and before shutting down and starting up had occurred?
     Thank you. That was a long question.
    The essential problem with the radiopharmaceutical supply is that it cannot be stockpiled, so it is very important for us to learn as early as possible if there is a problem. Then we can start to triage the isotope supply and the patients.
    There is very little we can do to mitigate the effect as time goes on, if the supply is not reinstated, so we can make arrangements for the patients who really need the care to maybe go into other diagnostic modalities, if that's possible. That, of course, is not always possible, depending on the waiting list for the other modalities.
    As the isotope supply diminishes there is nothing you can do to bring it back.


    How long do you think you could have lasted with some sort of interim plan that need not have gone to the kind of crisis management that eventually occurred? How long do you think you could have lasted as a medical community, with your patients, by triage?
    That answer is complicated, in that it depends upon where you were in Canada. As I stated, in Alberta in particular, the three major centres were supplied by Covidien and we were in fairly good shape. The Edmonton Radiopharmaceutical Centre obtains about 80% of its technetium from Covidien and about 20% from BMS. That 20% from BMS was off and on because BMS made a commitment that centres like our own, which would be able to most efficiently distribute the supply as need dictated, would get the supplies. So we were serviced fairly well by BMS, but not completely.
    What we did was to be in contact with a fair number of small communities outside Edmonton—Grand Prairie, Grande Cache, Medicine Hat, Lethbridge, and some nuclear medicine private clinics that did not have supply—and we were able to apportion our supply to help them out. Given the half-life and the transportation logistics, it was not possible for us to go outside of Alberta. Also, we did not have the supply to go outside of Alberta.
    So you could have done some things, if you had been informed early enough, to mitigate for a short period of time. How short?
    What we implemented required a short amount of time for us to work with Health Canada to put in place policies that would allow us to transport generators that had been used in one facility. Then if they were small enough we could ship them out to other facilities. This worked very well for a number of outlying facilities, especially farther north and farther south from us.
    The other thing was to use generators somewhat beyond their normal expiry date, implementing the appropriate safeguards for testing to make sure things had not gone awry after the expiry date.
    Those were the two things we needed to do. Health Canada responded fairly well with us by giving us process, and we made a process to allow us to do that. We needed the time to do that, but once that was in place, we were set. There wasn't much else we could do.
    The other thing we did look at, which might have helped with advance notice, was that some areas that did have cyclotrons could use fluorine 18 fluoride as a bone imaging agent, and this would help offset one of the technetium radiopharmaceuticals for bone scanning. We did not have an approved radiopharmaceutical for that in Edmonton, and in cooperation with Dr. Gulenchyn in Hamilton, we put forward a very hasty clinical trial application to use fluoride, but we never did use that. As things unfolded, we didn't need to.
    May I ask one last question?
    What will you advise should happen if this ever occurs again? What would be your advice?
    What we will be looking at in our document, as it comes through, is communication. I think that is key. We need to have communication as quickly as possible.
    The other thing we are going to need to look at is how quickly we can mobilize alternative methodology to treat the patients.
    Thank you, Mr. Abrams, for your insightful answers.
    Madame Gagnon.


    Thank you for being with us here today. I have some questions for Mr. Grant Malkoske.
    We were shocked by the lack of an emergency plan for isotope supply, and also by the lack of leadership shown by the government in the field of isotope production and supply. This is a serious responsibility.
    You told us that you asked the European suppliers to share their supplies and that they refused. I am rather surprised, because we have heard other hints that your company has trouble revealing its schedule for the production and supply of isotopes.
    How do you feel about that? Other people involved have written that you have a problem giving the Europeans an exact production schedule. We must not forget that this crisis was foreseen. It was a known fact that the Chalk River plant was not operating as it should have.
    Are you contradicting the impression you are giving?



     Thank you for the question.
    I think the important thing to reflect upon is the world-wide production capability. The fact is that if NRU goes down from a precipitous event, such as took place, there is insufficient capacity around the world to respond and replace the NRU. Frankly, there is no amount of planning in advance that would compensate for that type of an event.
    In the normal supply period when the reactors are operating without such a precipitous event, there are scheduled reactor outages around the world. Those by the Europeans are planned well in advance. In fact, through normal production, there is no conflict with regard to the availability of isotopes and the supply of medical isotopes.
    Furthermore, we do have backup supply agreements in place with some of our suppliers to make sure isotopes are available through normal outages, which would not be so eventful as one with the NRU. We have plans in place to receive material from the Europeans and South Africans.
    So in this type of an event, we do not think that planning is an issue.


    Yes, but then why do you say that the European suppliers have refused to or were unable to provide us with the required isotopes?
    Now, other sources indicate that they were indeed ready to deliver a certain quantity of isotopes. But you say that they refused outright.
    Who is right? Who is wrong? We are hearing two different stories at the same time, one of which is from a journalist who did his own investigation.


    Please let me try to clarify that.
    When the NRU event took place, we immediately started—on November 23, as I reported a moment ago—to contact our suppliers in Europe and South Africa. What we were looking for was an incremental amount of material, whatever they would have available, frankly, to fill the NRU gaps. They did increase some of their production capability. The best information we have is that they increased it by about 10% or 15%.
    We then also took a second step. We asked them if they would be prepared to look at the redistribution of the product they had in their normal production capacity, in their normal or routine capability. This is where they declined. So they had a baseload, if you will, and they were not prepared to share the baseload.
    Of the incremental 10% or 15% available from the world-wide production chain—still causing a shortfall of 35% globally—we at Nordion were only able to obtain about 20%. So of the increase of 10% to 15%, we got about 20% and distributed it as equitably as we could to our customers, the manufacturers.
    So I think there's a bit of difference between routine capability and incremental ramp-up capability to deal with shortages.


    Please answer my question. I know that you have financial interests as the sole supplier; if that played a part in your method of obtaining isotopes elsewhere, from the European suppliers, for example, what financial implications would that have had for your business?



     Really, from our point of view, price was not a factor. As I mentioned earlier, we do have backup agreements in place with the Europeans and South Africans, and those agreements have set pricing in place.
    We feel very strongly that we have an obligation to the health care system, and what we did was to proceed immediately to fulfill that obligation. So we contacted our suppliers, we contacted our customers, and we let everybody know that we needed as much medical isotope as they could supply us with to fill the gap. They stepped forward with what they could, but it was really insufficient.
    Our business is to provide reliable suppl. It wasn't a price or business issue here.


    Yes, but out of $300 million in profit, if we can call it that, $30 million goes to AECL, and that is what your business depends on. You can correct me about the exact numbers, but a large amount of money is at stake. You can tell me that it has no bearing on the matter, but I have trouble believing that.


    I'm not sure what the question really is.


    Since you are the sole supplier of isotopes in Canada, therefore, you are the only one to make a profit. You say that was not a factor. In fact, AECL has very few financial investments; MDS Nordion is the main profit-maker. You say that was not a factor in your decision to seek other suppliers. At that moment, you had a shortfall in income, did you not?


    If the inference is that we did not go to other suppliers because of the cost of those isotopes, that is not true. Price was not a factor in trying to obtain additional supply.
    Secondly, we are not the only supplier of radioisotopes. As Dr. Abrams has mentioned, there is another supplier, Covidien, who obtains medical isotopes from the Petten reactor in the Netherlands.
    Frankly, it is untrue that price was a factor.
    Thank you, Mr. Malkoske, for your insightful replies.
    Ms. Wasylycia-Leis.
    Thank you, Madame Chairperson, and thanks to all of you for appearing before us today.
    The reason we're here is to try to avoid a repeat of this whole sad and sorry state of affairs that led to Parliament being put into the terrible position of making a very difficult choice without all the facts; and to try to avoid in the future any possibility of the supply of isotopes—which is so vital for medical treatments and therapies—being hindered again; and to avoid members of Parliament having to sit down and choose between the advice of a nuclear safety commissioner, who talks about safety on the basis of expertise and knowledge, and people going without something that may be life-saving.
    I'm not sure, after all the hearings before the natural resources committee and the presentations today, that we're much closer to knowing what caused this and how we could have avoided it. I think we need to get just a little bit of clarification about the timelines, as there is ongoing confusion, and no one has really given us the proper timeframe.
    You say, Mr. Malkoske, that it was on November 22 that you heard, through a Department of Natural Resources official. Is that correct?
    What I mentioned was that it was on November 21 we were first advised by AECL that the NRU would not be restarted. There was a lot of uncertainty about the timeline.
    We met with AECL on the morning of November 22, when we were formally informed by them of the situation, and we in turn informed them of the global supply outage this would create. Then on the afternoon of November 22 AECL convened a meeting with Natural Resources Canada and Nordion. We were at that meeting, and we reiterated those points.


    The ministers of both departments suggested that they didn't really know until a full week or more after that. Do you find that hard to believe? Or do you have any sense that they may have known and didn't either connect with the information or chose not to convey it to Canadians?
    We're really not privy to the government communications, so we don't know what might have transpired or actually did transpire in that area.
    Were you, or anyone from MDS, in touch with the ministers' offices, either Natural Resources or Health Canada, about this problem?
    We thought we had taken our steps to inform government through the meeting with Natural Resources Canada. Again, not being privy to the communications, we did not go beyond that at that point in time. However, on December 5 we did receive calls from several government departments, NRCan, Industry Canada, Foreign Affairs, and Health Canada, to develop further understanding of what really was taking place.
    So you, or anyone from MDS, never initiated a contact with the ministers' offices?
    No, we did not.
    What about with the Prime Minister's Office?
    Not in those early days. No, we did not.
    So you contacted the ministers' offices at another time?
    We were contacted by a variety of officials, as Grant Malkoske mentioned, starting on December 5. That started a series of discussions with officials throughout the balance of the time until the legislation was passed, and frankly after that, because that's when we started to have conversations around the communication protocol.
    Let me ask you, Mr. Abrams, about your sense of the timelines. When did you first find out that there was a problem?
     I think it was November 27. We were contacted by BMS and Covidien that there were some problems with supply.
    So you also learned this apparently before the ministers involved did. Do you find that hard to believe?
    I didn't think much about it.
    Would you not think that if this was such a critical situation involving supply of isotopes, which is essential for life and death situations, that the Minister of Health would at least have been informed?
    The situation with radioisotopes is maybe a bit more unique than other pharmaceuticals, in that we are often subject to delays, as has been mentioned. The radioisotopes actually go out of Canada to the United States and then back into Canada, which is another discussion all by itself.
    Because they're dangerous goods, getting these isotopes back into Canada often results in customs delays. We may have production delays of a day. Frankly, we deal with this on a bi-weekly basis, maybe even more often, depending on what's going on. Seeing a communiqué that says there's going to be a disruption in generator supply puts us into a mode of how we're going to handle it, and then we start asking how long it's going to be.
    So I was not very excited by our first communications. I just said, “Here we go again; I'm going to have to look after this.” As it started to become clear that it was going to be longer, I think then it became important that other people got involved.
    I think you've tried to answer this already, but if you'd had earlier notification, would that have made the situation easier in terms of dealing with the lack of isotopes? It seems to me that you were informed a bit late in the process, given your role as physicians of nuclear medicine.
    In general, everything is easier the sooner you get the information, because then you can contact your clients and they can make arrangements. There are actually two aspects to it. Number one is to inform all of our physicians to make sure they know that there is going to be a problem, and the second one is to make sure the distribution of supply is made as efficiently as possible.
    Fair enough. I appreciate that.
     I keep asking these questions because when we're talking about a crisis of this nature, communication is essential. We have all these gaps in timelines, and not one of you has really expressed outrage at the failure of government or the bureaucracy to inform you on an expeditious basis when the pump was shut down at Chalk River. I just find that a bit hard to believe.


     I am sorry, Mrs. Wasylycia-Leis, you are over your time now.
    Dr. Abrams, if you wouldn't mind just quickly summing up Mrs. Wasylycia-Leis's statement, that would be great.
    With respect to outrage, most professionals don't run around yelling at people, because it doesn't help at all.
    You could challenge or simply express concern about the lack of notification.
    I think if you had been privy to the board meetings of the CSNM, the CANM, CARS, CCRS , and the ad hoc committee, you would know that it was made abundantly clear that we were very concerned about communication. One of the things we would like to implement in the future is a better communication line. One thing that was stated at the NRCan committee meeting was that there used to be representation from the nuclear medicine community on the CNSC advisory committee. I'm not sure exactly what the terms were, but we'd like to see that reinstated as one of the items. Having lines of communication from the different professional associations to the different government departments would be very helpful indeed.
    Thank you, Dr. Abrams.
    We'll go to Mr. Fletcher.
    A point of order, Madam Chair.
    Your time is up, Ms. Wasylycia-Leis.
    I am just wondering if it would be appropriate for us to ask for the minutes of the board meeting that was referenced.
    We certainly could do that.
     Dr. Abrams, would that be available to the public?
    I've never been asked that question before. I will go back to my board and find out.
    Can we look into it, and could you get back to us as a committee through the clerk's office?
    Thank you, Dr. Abrams.
    Thank you, Mrs. Wasylycia-Leis.
    Go ahead, Mr. Fletcher.
     I would like to thank the witnesses for coming. We certainly appreciate your professionalism. Some people around here could learn from that.
    I wonder, Dr. Abrams, if you could explain to us a little bit about the timelines. When was it that you began to see that the continued shutdown and shortage of medical isotopes was going to have an adverse effect on patient care?
    I think we were aware that there would be an adverse effect on patient care probably at the beginning of the week of December 10 or 11--that Monday--whatever day that was.
    We started getting phone calls that week from a lot of the centres that were solely supplied by Bristol-Myers Squibb. Once we got the first phone calls, we made it part of our mandate to check with the different facilities across Alberta to find out where they stood.
    Dr. Abrams, we, as parliamentarians, have been hearing conflicting information about the severity of the impact on patient health. We have some people who say that lives were not in danger as a result of the shortage of medical isotopes, and we have physicians who describe the situation as life-threatening. Based on your experience, I wonder if you could describe what the potential was for patient harm in December.
    That's a difficult question for me to answer. I'm not a physician, so it is best for me to leave the specifics of that to the physicians. But I do know, through my colleagues, that the information given by Dr. Gulenchyn , Dr. O'Brien, Dr. MacEwan, and some others we discussed it with was that essentially 10% of the nuclear medicine patient population would have been considered critical and in need of radioisotope imaging, around 40% to 50% would have been considered in need, and 40% could have been put off and done at a later date.
    With respect to the direness and the health impact, that would be better answered by a physician.


     I found Mr. Malkoske's comments interesting that planning wasn't really an issue, almost any amount of advanced planning would not necessarily have been helpful, and there weren't enough isotopes in the world to help. That's obviously a larger issue for the future, but that was the situation in which we found ourselves in December.
     Dr. Abrams, in the December 13 press release the Canadian Society of Nuclear Medicine expressed pleasure and relief that Parliament, and I quote,
has taken a strong and balanced approach in assessing the risks of operating the Chalk River facility versus the risk to Canadians of not having access to essential medical diagnostic and therapeutic services.
    I'd like to thank you for those words.
    In your opinion, what would have been the outcome if Parliament had not passed legislation to reopen the Chalk River reactor and resume supply of the much-needed medical isotopes?
    We would have seen a continued decline in services throughout Canada in the areas that could not be supplied by alternate suppliers. So everywhere in Canada that was supplied solely by Bristol-Myers Squibb would have been cut back to the levels they were able to get through Bristol-Myers Squibb, the increased supply from Europe, and what Nordion could obtain. That would have levelled off to a certain amount until the reactor was back online.
    So people would have been denied potential life-saving diagnostic services.
    If Parliament hadn't acted, the reactor could be still shut down to this day. People would have died.
    As I said, I don't know if I can restate the dire consequences of death, but I can certainly go back to what Dr. O'Brien said, and he felt unequivocally that was the case.
    I know you're not a doctor, but do you agree, support, or understand that people would be dead now if Parliament had not acted?
    I can't answer that one way or the other. It's a very complicated answer to that question, and take this from me in my current position. Most of the nuclear medicine tests are diagnostic in nature. They inform physicians what they need to do to give the best care possible for that patient. If they do not get the best diagnostic care, they may not get the best therapeutic care, and if they don't get the best therapeutic care, then what happens is up to fate.
    So based on a balance of probabilities, people would certainly not be here at present, or would soon not be here, if we had not taken action.
    Those are my questions, Madam Chair.
    Thank you, Mr. Fletcher.
    We'll now go to the second round, keeping in mind that the minister will arrive at 12:15. At that time we will suspend the round and go to our first round of questioning for the minister.
    First is Dr. Bennett, for five minutes, please.
     Thanks very much.
    I guess I'm having a little trouble believing that you couldn't predict that there would be a problem on November 27, and that you would then wait for the calls and letters to be coming in--in a panic--at the first clinical problem, instead of actually predicting it.
    Therefore I am having trouble with what Mr. Malkoske said, which is that planning is not the issue, only communication is. That means there isn't a plan B. If the only possible solution is starting up a shaky forty-year-old reactor in an earthquake zone--if that's plan B--we aren't doing very well in terms of planning. I guess I want to know where we are going on plan B in terms of what you would do again. I haven't heard that we've learned anything so far.
    Secondly, you said the problem was mainly communication. I guess I would like MDS Nordion to have a chance to answer the CMAJ allegations that a lot of the problem seems to be a lack of communication between you and AECL, in that you don't seem to be at the meetings and being able to say what each other is doing. Then there's the allegation from the Netherlands in that article that said we never get any information from the Canadians, and that you wouldn't cooperate with Europe's two large-scale isotope suppliers. Nordion is represented at our meetings, but either AECL doesn't tell Nordion or they don't allow Nordion to tell us.... The breakdown in communication, let alone the nonsense between the natural resources minister and the health minister, who don't seem to have a telephone....
    Could you help me with what plan B is? Then I would like MDS Nordion to tell me what R and D you are doing so that in the future you could use fluoride, you could use partical accelerator kinds of isotopes that do not require the high-grade enriched uranium at all, in terms of how we move forward out of this pickle of your monopoly for 50% of the world supply with no plan B.


    There were a number of questions, and I will try to address them in order.
    First of all, I wouldn't call a 50% supply a monopoly. We are a supplier. We do have--
    In Canada. You have a Canadian monopoly.
    As I mentioned, we supply to a radiopharmaceutical manufacturer. They are one of the two suppliers who supply back to Canada. Bristol-Myers Squibb and Covidien are the suppliers of radiopharmaceutical products to Canada. We supply Bristol-Myers Squibb with the medical isotopes that go into their finished products. Covidien obtains their material from the Netherlands. So there is a dual supply stream.
    On the first part, about a plan B, I agree with you that this is a tenuous situation. I think what we need is a national isotope supply strategy for Canada. At 50 years old, the NRU reactor is the most reliable reactor in the world. It has a 97% supply reliability. It stands as the pre-eminent reactor in all of the world to do that. So an investment into the NRU infrastructure to keep it operating, to keep it licensed beyond 2011, we believe is absolutely essential.
    The MAPLE reactors are solely dedicated isotope production reactors. One alone could provide the capacity that we require. The second one is a complete backup system. Bring the MAPLE reactors on line as quickly as possible.
    So we think there is a plan B. But the difficulty we all face today in the world is the eventuality of a precipitous event like NRU. It would be something like if Saudi Arabia were shut down from supplying gas or oil to the world, what would you do immediately? There would be a shortage. That's the kind of situation we were facing with NRU.
    So it's not a matter of planning for such a precipitous event. How do you do that? The global capacity was only able to fill 15% of the NRU gap. If NRU had continued on, it would still be a 15% gap. So planning three months or six months in advance would not have alleviated that situation. It is interesting to note that during this period of outage we contacted the Belgians, we contacted the people in the Netherlands, and we contacted the South Africans on November 23 to try to get any incremental amount of backup supply that we possibly could. We were very diligent; we consistently went through that.
    Interestingly, during this outage there was one European reactor that was down completely during that outage period because of a pre-planned maintenance cycle. It did not come on line until somewhere around December 18. Interestingly enough, a reactor in France shut down during that period, before Bill C-38 was passed. What kind of planning would prevent that from happening?
     There is a global capacity issue that needs to be dealt with. That is the fundamental issue in all of this.
     Thank you, Mr. Malkoske.
    I will now go to Mr. Tilson.
    Thank you, Madam Chair.
     I have a question for Dr. Abrams.
    CNSC used to have a medical advisory committee, and for some reason the former Liberal government disbanded that committee. I have two questions of you. Do you know why it was decided that this committee should be disbanded? Secondly, should we have a committee of medical experts when we have situations such as we had in December, to advise everyone, including the government?


    To answer the first question, I do not know why they disbanded the committee.
    The answer to the second one is yes, I think it would be very good for us to have an advisory committee with some nuclear medicine specialists on the CNSC to help them evaluate the medical needs. That would be useful not only in situations like this, but just to review the regulations and how they impact upon patient care.
    The next question would be to both of you, Dr. Malkoske and Mr. Abrams.
    Mr. Malkoske, I appreciate your giving us copies of your written comments. You say that government and industry and nuclear medicine should find a long-term solution.
    Mr. Abrams mentioned that communications should be better.
    Could both of you elaborate on that issue? That's one of the main reasons why we're here today, to find ways to improve the handling of such a situation, if it were to recur.
    If I may, I would address the point I mentioned in my opening remarks. I think it goes back to the national isotope supply strategy for Canada. When we take a look at the pre-eminent position Canada has in the world because of research and development in nuclear technology, Canada and we, Nordion are well-renowned internationally for everything we do.
    This goes to the heart of NRU; it goes to the heart of the MAPLE project. We need some way to ensure that NRU continues to operate until the MAPLE reactors are brought on line. I think that will give us the reliable supply of medical isotopes in Canada that is so important.
    Mr. Abrams—specifically on your comment about our need to have better communications...?
    Yes. I think the need for better communication is apparent in the way we handle the patients and how we can triage the patients. If we know in advance, we can do two things. All physicians can look at their patient workload and triage appropriately. They can speak with other modalities about triaging the most needy patients into different modalities, and from the supply distribution point of view, one can triage appropriately to make sure that everyone gets a fair share of what is needed.
    That's where communication is important, and the earlier the better, because it's much easier to make plans if you have time.
    I'd like to rephrase the question that was asked of you before, Mr. Abrams. On the issue as to whether people could have died, I understand you're saying you're not qualified to give that statement. However, the deputy leader of the Liberal Party said: “The Canadian Association of Nuclear Medicine estimates that 50,000 Canadians a month will experience delays in their medical tests.” He called it a medical crisis and also said the situation was endangering the lives of millions of Canadians. So clearly there was a situation.
    Let me ask the question in perhaps a different way. Would the lives of millions of Canadians be endangered, with this situation? In other words, if Parliament hadn't taken the action it did—if the bill hadn't been passed—would the lives of millions of Canadians have been endangered? I use the word “endangered”.
    Taking into consideration what I've said in the past about my qualifications, essentially there are a small number of patients who require nuclear medicine scans who have a 20 percent to 30-some percent risk--and I'm taking this from Dr. O'Brien--of further consequences, patients with pulmonary emboli in particular. We also use them for transplant patients in renal situations. These are very important tests, where the implications of poor diagnosis and poor treatment could result in death.
    Millions of Canadians being at imminent risk of death through this nuclear medicine shortage is probably an overstatement.


    Thank you, Dr. Abrams.
    Monsieur Malo.


    Thank you Madam Chair.
    Mr. Malkoske, can you tell us if the sale of radioisotopes is MDS Nordion's only business?


    Nordion has a couple of business lines. One of them is what we would call our isotope business, where we sell molybdenum-99 and iodine-131. We also have a line of business that includes cobalt-60 sources and radiation systems for the sterilization of health care products.


    What percentage of your revenues come from the sale of radioisotopes?


    I'm sorry, I'm not able to disclose that. Our annual revenues at Nordion are about $290 million, which is publicly stated.


    Thus, it would be correct to say that most of your income comes from the sale of radioisotopes.


    A large percentage of it does, yes.


    How can you say that the fact of acquiring supplies elsewhere would have no effect on your business and that price was not a factor in your decision?


    It's really quite simple. As I mentioned earlier, we have backup supply agreements in place with our suppliers. Those backup agreements have pricing defined. So it's already pre-defined, well in advance, what we would pay for those isotopes and that is part of our normal business evaluation.
    The critical point here is we have an obligation to the health care system. So we went out to those other suppliers and we asked them to send us more product in accordance with the agreements that we have in place.


    In your opening remarks you said that you immediately put your emergency protocol into effect on the evening of the 21st. Obviously, your emergency protocol does not work very well, because Parliament had to quickly pass a law to permit the temporary restarting of the reactor.
    What conclusions do you draw regarding the emergency protocol you had in place?


    I think it's important to understand that we are not the reactor operator; we are not the reactor licensee in the world. What we do is we receive medical isotopes from reactors around the world, including the NRU reactor. The dialogue, in terms of restarting the NRU reactor, was a dialogue between Atomic Energy of Canada and the Canadian Nuclear Safety Commission, a licensee-licensor dialogue, to which we are not privy. So what we have done is we get information from AECL, the best information that they have available, on the restart.
    As I said earlier in my opening remarks, during that first period in November--the last week of November--it was in a state of flux. It wasn't clear when the reactor would restart or what would be required to restart it. Even with that uncertainty, we took the step to contact all of our suppliers and asked them to start sending material to us. So in fact the protocol worked.
    The issue I mentioned earlier in my discussions is there is a world-wide capacity limitation that cannot replace NRU. We do not have the authority to start up another reactor in another country. Of course it's not our authority to do so.


    In the light of that, what should be done now?


     What can be done today?
    I think we've talked a lot in this and other discussions about a communication protocol. We think that is important.
    I also mentioned that I think we need a national supply strategy to ensure that the NRU reactor does not go down again on an occasion such as this and to quickly bring the MAPLE reactors online, because these will be brand new reactors solely dedicated to the production of medical isotopes. There would be two of them, one to provide a backup to the other.
    Until such time, we're in a bit of a tenuous situation globally for this.


    Thank you, Mr. Malkoske.
    We'll now go to Mr. Brown.
    Thank you, Madam Chair.
    To follow up on what my colleague Mr. Tilson was touching upon, I have a question for Dr. Abrams.
     In a press release on December 13, the Canadian Society of Nuclear Medicine expressed pleasure and relief that Parliament “has taken a strong and balanced approach in assessing the risks of operating the Chalk River facility versus the risk to Canadians of not having access to essential medical diagnostic and therapeutic services”.
    I want to get your opinion. If we didn't have that day in Parliament, what would have arisen? Do you think that was the correct approach today, as you did when the Canadian Society of Nuclear Medicine expressed that opinion on December 13?
    To answer the first question, I think that as the length of time the reactor was down progressed, we would have stabilized on the amount of technetium and molybdenum that we were able to get. I think we would have maximized what we could get from the worldwide supply, so we would have reached an equilibrium at that point. At that point there probably would have been about 30....
    BMS has about 80% of the Canadian market and Covidien has about 20% of the Canadian market. Covidien was able to ramp up a little, and that would have brought it up to maybe 35%. Let's say they could double it, to 40%; we probably would have had a 50% to 60% shortage of radioisotopes and we would have needed to make sure that our supply was as appropriate as possible.
    At the same time, we probably would have been able to look at other isotopes for some of the tests. Thallium 201 probably would have been able to take a little more of the technetium heart scans, and the use of fluoride from cyclotrons may have been able to ameliorate some of the bone scans. The problem with the fluoride would have been that there are very few cyclotrons in Canada and that it has a very short half-life of two hours. It would have been a stopgap measure. Only the larger centres in Canada could do that.
    We would probably have been able to rationalize better and better what we were doing. The number of Canadians missing their tests probably would have been around 50% to 60%. That's just looking at the numbers as I see them now.
    The communiqué was generated out of relief that something had happened. We felt that the government must have had the appropriate information to make that decision. We're not in a position to evaluate how the decision was made or why the decision was made, but once it was made, it was certainly a relief to all the nuclear medicine physicians in Canada.
    Thank you, Mr. Abrams.
    The time is 12:15 right now. I want to acknowledge that the Honourable Tony Clement is here now to take his place for our committee.
    I want to thank you very much for coming and being witnesses here at our committee. You have answered some very good questions.
    We will take 30 seconds. If the witnesses wouldn't mind vacating their seats now, we would ask the Honourable Tony Clement, Minister of Health, to join us.
    Thank you.




     I would like to call the committee to order.
    The minister has kindly joined us once again. We do see our minister here very frequently, and we thank him for taking the time to present at committee.
    What's going to happen is that the minister will make a presentation. Following that, we will go into questions. Mr. Thibault will be first, with 15 minutes.
    We will start, please, with the Minister of Health. Mr. Clement.


    Good afternoon, Madam Chair, ladies and gentlemen of the committee.


    I'm here this afternoon with my deputy minister and my assistant deputy minister on this file.


    It is my pleasure to address the health impact the Chalk River nuclear shutdown with you.
    As members of the Standing Committee on Health, you are keenly aware of the importance of correct diagnosis, especially in cases of critical illnesses such as cancer and cardiovascular disease. Radioisotopes are used in the diagnosis and treatment of cancer and cardiovascular disease.


     As members know, the Chalk River reactor is an essential source of medical isotopes in Canada and indeed world-wide. The extended shutdown of the NRU reactor significantly reduced the supply in Canada and throughout the world.
    As soon as I became aware of the situation, on December 5, my officials and I started acting immediately to stem what was quickly evolving into an urgent health crisis. We communicated with 773 health care facilities across Canada, including 245 nuclear medicine facilities, to determine initially the severity of the shortage. We found that shortages were felt in smaller rural and remote areas, particularly in Atlantic Canada, and that shortages were imminent elsewhere.
     We inquired into gaining supply from the four other medical isotope suppliers in France, Belgium, the Netherlands, and South Africa. In doing so, we found that French and South African reactors were going through routine maintenance at exactly the same moment. All in all, we found that overseas suppliers could increase their output by only 10%, or at maximum, 15%. Furthermore, overseas suppliers indicated that the earliest they could provide us with the additional supply would be December 29. Based on the information we were receiving, this would have been too little, too late, as the shortage situation would have, I'm absolutely convinced, escalated to unmanageable levels long before that.
    During this time we also established a group of experts from the fields of oncology, cardiology, and nuclear medicine, as well as representatives of the Canadian Medical Association and the Canadian Society of Nuclear Medicine. Based on the information from this group, it was clear we were in the midst of a growing health crisis, and one that needed action. One of the members of our expert group, Dr. Karen Gulenchyn, told the natural resources committee of Parliament last week that “...we believe that unmanageable shortages would have occurred within a week”. This group estimated that approximately 10% of affected patients were indeed facing life-and-death decisions.
    The group of experts also gave information that another 30% to 40% were facing the risk of under-equipped physicians making inappropriate diagnostic and treatment decisions. This message was reiterated in a letter dated December 10, 2007, to Linda Keen, and copied to me, in which Dr. Brian Day, who of course is president of the Canadian Medical Association, stated that the CMA “...joins the Canadian Society of Nuclear express our deep concern and profound disappointment with the disruption of supply of medical isotopes due to the extended shutdown of the reactor at Chalk River”.
     He goes on:
The devastating impact that this has had on patient care across Canada, and indeed around the world, has been compounded by what we perceive as a true lack of understanding of what the extended shutdown means to patients who need access to vital diagnostic procedures. For physicians it means we are increasingly being forced to make difficult clinical decisions without appropriate critical diagnostic tools.
     I'm hoping we can all agree that a faulty diagnostic or treatment decision today is the first step to a more complicated or critical situation tomorrow.
    In short, in order to serve the needs of patients in a way Canadians rightfully expect, gaining a minimal supply of medical isotopes from overseas was no substitute for a running reactor at Chalk River, which produces more than half of the world's supply. As a result, we had a responsibility to seek information from the Canadian Nuclear Safety Commission about ways to resolve the growing health crisis.
     First we wanted to see if there could be an expeditious hearing to consider the merits of AECL's safety case, without in any way directing the commission to reach a particular conclusion. Alas, such a decision was not reached.
    Second, our government issued a policy directive stipulating that the commission's decisions take into account the health of Canadians who depend on nuclear substances to meet medical needs, but that had no effect.
    So our government had to take decisive action on December 11 by proposing to Parliament Bill C-38. Of course this bill passed with all-party support, and by December 19 isotope production was returned to pre-shutdown levels, and deliveries resumed over the holidays.


     Dr. Andrew Ross, a nuclear medicine specialist at Queen Elizabeth II Health Sciences Centre in Halifax, called our action “a great Christmas present”. Indeed, he was not alone. The Canadian Medical Association and the Canadian Society of Nuclear Medicine thanked all parliamentarians of “all political stripes” for the fast legislative action.
    Now that the situation has passed, my officials are continuing to work with the expert advisory group to establish contingency plans in the event of any future supply disruption.


    This includes assessing the possibility for alternative sources, along with substitute diagnostic techniques that could be used if needed, and examining opportunities for enhancing international collaboration to coordinate supply.
    This work is also aiming to ensure timely notification of issues that may affect supply.
    As a result, we have developed a notification protocol between AECL, Natural Resources Canada and Health Canada. It provides clarity about who needs to be contacted and when. As well, it states that information will be shared immediately when it concerns Chalk River's operations and therefore the supply of medical isotopes.


    In the future, if my department receives information about a potential shortage, we will be able to draw on the best practices employed in December and the lessons learned from that experience to immediately establish contact with provinces, territories, the health care communities, and relevant experts to assess the potential impact and launch strategies to respond.
    In closing, Madam Chair, I want to underline the fact that our government acted out of necessity for the health of Canadians. Going without isotopes provided by Chalk River meant health care providers were under-equipped to meet the urgent needs of patients. As the shutdown went on longer, the potential for a health crisis grew stronger. Accordingly, our government acted decisively to stop it before it was too late. We did so with all-party support in Parliament.



    Together, all parliamentarians put aside partisanship to act as needed when lives were threatened.
    Our government did what was needed for the health of Canadians—and I thank everyone here today for your votes in December which helped achieve this result.


    Thank you, Minister Clement.
    We will begin the round of questioning with Mr. Thibault. As you know, there are 15 minutes for you, Mr. Thibault. You may share your time.


    Thank you, Madam Chair.
    Thank you, Mr. Minister.


    Minister Clement, thank you for coming, and thank you for agreeing to come to the committee on such short notice.
    First, I'd like to give you an opportunity to clarify one point in your comments. You indicated you contacted European and South African sources, and no isotopes were available for us there. We heard this morning from Mr. Malkoske that his company, Nordion, had received some from Europe and from South Africa. Is your statement that no further isotopes were available, or none?
    Thank you, honourable member.
    Our research indicated that at best the maximum number of isotopes available would be able to accommodate 10% to 15% of the demand for those isotopes within our country. In any event, those isotopes would not be made available before December 29.
    Perhaps you can seek clarification from your staff, but I believe both of those shipments to Nordion were prior to the end of December.
    I don't want to spend too much time on the decision in Parliament. We all supported it. We got to a position where we had a lack of isotopes and we had to get isotopes generated in our system. I understand it's operating normally and a Natural Resources Canada committee is looking at those questions.
    I do object, however, to the way your government handled Ms. Keen. A regulator has to follow the law and regulate. If cabinet or Parliament have to take decisions beyond that of the capability of the regulator, then that's a job for cabinet or Parliament, and Parliament exercises responsibility in that regard.
     I'd like to discuss a couple of areas with you. First, on communication--and this is coming from the presentation or in response to a question by Mr. Malkoske this morning--you didn't just deal with communications within Canada in your presentation, but international communications. Very few reactors are capable of producing these isotopes. We are the biggest producer.
    If you look at this situation, we had an extended stage shutdown. At the same time, just subsequent to our shutdown, there were two other shutdowns by reactors internationally. It seems a simple solution to have an international protocol among all producers that no shutdown be very close to another, because one of those can always be extended for one reason or another.
    Are those discussions happening internationally? Are we going to be in the position next year, in two years, or in ten years when exactly the same situation can repeat itself?
     Thank you very much, Mr. Thibault.
    I'm not privy to those particular discussions. It would probably be more appropriate in terms of Natural Resources Canada.
    In terms of our own shop here, what I wish to do, through a better protocol, is to ensure that if there is an unscheduled shutdown situation.... This is where I think there could have been, in retrospect, some improvement. We went from a scheduled shutdown situation here to a prolonged, unscheduled shutdown. Where we have that situation, you would have a better protocol.
    Yes, but you'll understand that any time you have a scheduled shutdown, you have a great risk of an extended shutdown, because you can have problems at start-up or in your regular scheduled maintenance you can find some problems that cause you not to reopen as quickly. This is a situation we had this time.
    We had two other reactors in the international chain that had scheduled shutdowns in the same timeframe. That is the huge risk. I don't know that the Government of Canada should leave it only to Natural Resources. I think it's a health issue.
    Wouldn't you have discussed that at the emergency cabinet meeting very shortly after November 22, when you saw the problem we were having here?


    As I have mentioned, we at Health Canada were first aware of the problem on December 5. That was when we were notified. At that time, we acted forcefully and quickly in order to protect the health and safety of Canadians.
     I take your point. From the point of view of making sure that there's better coordination for the health and safety of citizens world-wide, I'd certainly be in favour of having that information more widely shared as to what is in shutdown mode and when. I think that's a good idea.
    I'll accept your word that you became aware on December 5, but I don't believe your department was aware on December 5, because when I heard from Nordion this morning, when I look at the testimony of other people at Natural Resources, it seems that your department, on December 5, was ready to react.
    We looked at the cyclotron, the other products that were available. They were ready to react. They contacted all those health care institutions quite rapidly. So I think somebody in your department knew before then.
    I'll pass it over to the department, if you don't mind.
    I can affirm to you that I was informed on December 5, and I believe the department was informed on December 5 that there was this extended shutdown. We sprang into action immediately and started making calls and pulling together the advisory group.
     I know Mr. Rosenberg is an able man. I had the pleasure of serving as parliamentary secretary to the Minister of Health for 18 months, at the time Mr. Rosenberg came into his present duties.
     I became aware of the situation when you had news articles appearing by the Canadian press on December 1 and you had a CBC story from Halifax on December 4. I'm not privy now to the clippings that are collected by your department on a daily basis. Your department won't share that with opposition critics, but we find them. Your department was aware at that time. There's no way such a situation can come....
    I can't conceive that on November 22 the chairman of AECL would find out about an extended shutdown.... Mr. Burns, ironically, is in charge of nuclear energy--it reminds me a bit of The Simpsons. And he's not a Liberal hack; he's a Conservative appointee as chairman of that corporation. He says that the Minister of Natural Resources was advised at that same time.
    Now, I've been a minister before. I know that advice to the minister isn't necessarily on the minister's desk at the same time, but I can assure you it's in the minister's office on that day, or in the deputy minister's office. I can't conceive that you could have an extended shutdown at Natural Resources on November 22 and that the Minister of Natural Resources would only find out on December 3, and that the Minister of Health would only find out on December 5, or that nobody in the Department of Health.... I'm sure Nordion put out a press release on November 21, I believe.
    A voice: The thirtieth.
    Hon. Robert Thibault: On November 30 they put out a press release advising their customers. It's inconceivable to me that this information wouldn't have come to the Department of Health.
     Let me reply to that by saying that I think Minister Lunn has made it absolutely clear that he was not advised until December 3. Indeed,what was happening between November 22 and December 3 was a disagreement among the licensing agency, the safety commission, and AECL. The AECL's communications to Minister Lunn continued to be that they expected to be on line very quickly, and that only changed at the beginning of December, when it was clear that the unscheduled shutdown was going to continue for some time.
    So when you look at this, it's not as if everybody knew on November 22 that the reactor was going to be shut down for one month, two months, or three months. That, in fact, was not the case. In fact, the people who ran the reactor indicated to all concerned that they expected to be on line very quickly.
    As I said, it was only at the beginning of December—and in my case, and my department's case, December 5—that we were aware we were in a situation where the licence-granting agency was not going to be granting a licence for some time to come.


    Michael Burns says that on November 22 Minister Lunn was informed of an “extended shutdown” of the NRU reactor—an extended shutdown. Now, if I'm operating this reactor or I am responsible for this reactor that's providing half or 75% of the isotopes internationally--
    A voice: It's 50%.
    Hon. Robert Thibault: --and there's great demand in Canada, and you've pointed out in your presentation the risk from a possible extended shutdown.... I can't see how the Department of Health would not have been notified, how the minister would not have been notified, because this is a significant part of the operations of our health care system—all the diagnostic side and some of the treatment side.
    Again, I disagree with your characterization of November 22, as does the Minister of Natural Resources. The fact of the matter is that he's put it on the record since the very beginning that lower down in his department there was some communication, but it was disputed by other experts; it was disputed by other people in AECL. So the fact of the matter is, in terms of the Government of Canada knowing we were in an extended shutdown with an extended dispute with the licence-granting agency, the Canadian Nuclear Safety Commission, all of that came to a head in the early part of December, and our department was aware of the situation on December 5.
    That's all I can tell you.
    The medical practitioners knew on November 27. Those in the field knew on November 27 that they had a looming problem, that there were difficulties. The media, again, were reporting it before that.
    No, no, you see, there was a period of confusion, Monsieur Thibault.
    It remains.
    There was confusion in the industry and confusion at AECL as to how long the reactor was going to be shut down, and that's the truth of the situation. All of the people involved, whether at Nordion or AECL, or wherever, were trying to act in good faith.
    But the fact of the matter is that it was not clear that the shutdown was going to extend for a long period of time, to the extent that it was going to have an impact on the health and safety of Canadians, until the beginning of December. If you want to disagree with that, you're perfectly entitled to, but those are the facts.
    The facts between Mr. Burns and Mr. Lunn are a little bit—
    I'm not here to talk about that. You ask them that question.
    The facts between the media having reported it and your not being aware of it—
    That's not a correct characterization, Mr. Thibault, and you know it.
    But it was in the media. You can't deny that.
     A press release doesn't mean it's in the media. And in my estimation, the press release was not exactly clear on the facts.
    It was reported by Canadian Press and it was run out of Halifax by the CBC.
    A voice: December 1.
     Hon. Robert Thibault: That's the past. I want to get to something further than this. Now we're in the current situation. What are we doing on a national basis? We know we are hoping to have MAPLE 1 and MAPLE 2 come on line, and there are problems with that.
    At the Department of Health and other agencies of the federal government, are we looking at alternatives—cyclotrons, or other ways—to maximize, not only within Canada but also internationally, all of the capacity? Even when MAPLE 1 and MAPLE 2 are on line, you could have some catastrophe at Chalk River that would take them all out. Even at that point, that could happen. It's not desirable, but it could happen.
    What are we doing to minimize the effects of such events?
    Certainly that's exactly one of the mandates of the expert advisory committee I spoke about earlier. They are looking not only at the protocols used to tighten up our internal communications to ensure we know about these things as soon as possible, but also at making sure we have the right alternatives available to us—if they exist technologically—and are able to manifest those as quickly as possible.
     I'm going to let Lui Temelkovski ask the last question, please.
    Mr. Temelkovski, Mr. Thibault would like to share his time with you.
    Mr. Minister, you mentioned that first you wanted expeditious hearings to be considered in AECL's safety case, and you didn't get any positive results. Then secondly, you issued a directive and you further didn't get any satisfactory results. Then you took decisive action.
    The result of all of this is that you developed a notification protocol between AECL, Natural Resources Canada, and Health Canada. Would you agree that this is as a result of those two actions not being followed up?


    No, it was as a result of my desire—as Mr. Thibault quite correctly picks at the scar on this—to ensure that we are able to act at Health Canada as quickly as possible, if there is an unscheduled shutdown in the future. That's the desire.
    Why was the commissioner not involved in this?
    Thank you, Mr. Temelkovski; your time is just about up.
    Madame Gagnon.


    Good afternoon, Mr. Minister. Thank you for being with us today.
    In my opinion, someone was playing with fire with respect to at least two aspects of the problem: safety and the supply of isotopes for patients. Canada has lost face internationally. Indeed, 60% of our production goes to other countries. Canada has not been looking much like a leader on this file.
    Mr. Minister, I would like to ask you a question. You have told us that as soon as you were informed of the situation, on December 5, you and your officials acted promptly. Why was it that the call went out to the European suppliers on the eve of the introduction of the bill and that, during that conversation with certain suppliers, you said that it was not necessary to increase production? Also, in your testimony this morning, you said that no deliveries could be made before November 28 or November 29. Other sources, however, have informed us that Belgium and the Netherlands could have supplied us with isotopes as early as November 18, instead of November 29. I do not understand your delight in saying you acted promptly when we can see serious flaws in your diligence in this file.
    Thank you for your question.
    I have one scenario I can give to all the members of this committee to reply to this question and others. It is clear that we contacted the other nuclear companies for the first time on December 6, especially those in southern Africa. I talked to the president of AREVA in Paris, myself, on December 8. That is all in the scenario.
    I can tell you that we acted speedily in this situation. The producers of radioisotopes also responded clearly that there was no possibility the situation would improve before December 19. That was their response.
    I would certainly like to see that response, because other sources have told us that—
    I can have that scenario distributed.
    Let us go back now to some earlier dates. Just now I mentioned the 29th; that was December 29, not November 29; I got the month wrong.
    I would like to look at the Auditor General's report for 2007. The Minister of Natural Resources had already been informed. The Auditor General had even pointed out some poor management practices. There was a desire to shut down this 50-year-old reactor.
    In fact, the report could not be made public quickly because the company is not obliged to do so. Still, did the Minister of Natural Resources inform you about this problem?


    The Minister of Natural Resources publicly announced that it was important that a national examination of the future of AECL be undertaken. I support this announcement. It is important, because of all the challenges this Crown corporation faces. I support this announcement.
    You support it, but what I asked you is this: were you informed about the problem of non-compliance with respect to production?
    Of course; I am a member of cabinet.
    But I am wondering about one thing: how did you share leadership with your colleague, the Minister of Natural Resources? You also must monitor the available supply of isotopes. You told us that you are very concerned about people's health, which is a priority for you, but on December 10 it was already too late for you to be expressing your emotions on this subject. You ought to have shown leadership for your colleague in order to establish a plan and get the various stakeholders involved in a solution. You say you acted promptly, but I do not think so. You reacted because you found yourself on the brink of a catastrophe—the shutdown of the reactor and the dwindling supply of isotopes.
    Indeed, it is important for our government to take the lead in discussing and drawing conclusions about the future of AECL.
    It was your own leadership I was talking about.
    If there is a problem related to radioisotopes, I exercise my leadership by contacting the health institutions across the country and perhaps having discussions with the other radioisotope producers. I have convened a group of experts to discuss the issue. That is leadership.
    I understand that on December 10, at five minutes to midnight, you convened the experts and all that. Nevertheless, you could have started reacting the day after the report was issued, or during the weeks that followed. That was in 2007; you had some time available. You knew very well that the agency was not living up to its responsibilities regarding this licence. You knew that the operations were non-compliant.
    I trust the Minister of Natural Resources to take charge of this file and I hope it will be possible to draw conclusions about the future of AECL very soon. It is my role to support the Minister of Natural Resources in seeking other solutions.
    The president , Ms. Keen, was fired. Do you not see a conflict of interest between the developer and the regulator? Was Minister Lunn's decision not made in a conflict of interest situation involving the agency, which develops the product, and the regulator, which must monitor the developer's operations and ensure that all obligations are met? Is this not a conflict of interest that could threaten the production of isotopes?
    I support the Minister of Natural Resources, of course, and I think—
    Supporting him is all very well, but you are not answering my question. There is a problem. The Minister of Natural Resources is sure to decide to put the reactor back into operation. Similarly, the Prime Minister said there was no danger, and everything was safe. They thumbed their noses at the agency that was supposed to monitor the licence holder.


     Madame Gagnon, your time is just about up. If we could have the minister answer the question, that would be great.
    Thank you.


    The Parliament of Canada made the decision to restart the Chalk River reactor. I support that decision. It was a decision made by Parliament, not by Mr. Lunn.


    It was a hard decision for Parliament to make.


     Thank you, Madame Gagnon.
    Thank you, Minister.
    We go to Ms. Wasylycia-Leis now, please.
    Thank you, Madam Chairperson.
    Thank you, Minister, and your staff, for being here.
    I know that you felt we were in a life-threatening situation; you said so during the debate on December 11. But nothing that you did, Mr. Minister, leading up to that moment suggests that you reacted in any way that resembled reacting to a life-and-death situation. Even if you didn't know until December 5.... And I have no proof to suggest otherwise, except that it just seems incredible, unbelievable, that you wouldn't have known about this life-threatening situation before December 5, especially given our testimony from MDS Nordion, where irrefutable evidence was clearly put on record to suggest that they let your government know on November 22.
    So even if you didn't know until December 5, it seems to me that you didn't react with any haste. You didn't let the health community know publicly. You didn't let parliamentarians know. You didn't take any immediate steps to actually deal with this on a very urgent basis. Even when your deputy minister was asked if he knew if it was December 5 when he had heard, he said, “I heard on December 5, and I believe the department learned on December 5.” So clearly, he's left the door open to the fact that somebody in the department would have known. There would have been some communication somewhere if it had been as life-threatening as you talk about.
    We also know today from the testimony by MDS Nordion that on November 23 they were out making calls all around the world looking for other suppliers. For the health department not to know that strikes me as absolutely bizarre. If we accept the fact that you didn't know on December 5, that means there was a clear breakdown of communication in your government. That's what we had hoped you would address today, that you would acknowledge this problem and say how you're going to fix it. There is nothing that you have said either in the protocol or in your remarks today that suggests how you will make sure in your government that when someone in one department, like Natural Resources, hears something of a life-threatening nature, there's a mechanism for getting that information to the highest levels of government.
     Mr. Minister, you may shake your head at all of this, but I also have been a minister in a government, and I know that if I had faced a similar situation, my head would have rolled, because we operate, as you should, on the basis of ministerial responsibility. You're ultimately responsible for decisions that are made or not made, and you failed in your duties--not personally, but somewhere in your system you failed--and there wasn't a proper line of communication. That's what we haven't heard you address.
    So I would like to hear what your plan is in government for ensuring that when such life-threatening information is conveyed to government, it gets from that official to that department to that minister, to the next department that is involved, and to you as Minister of Health responsible for this life-threatening situation.
    Thank you, Ms. Wasylycia-Leis.
    I must say that is the biggest pile of nonsense I've heard in a long time. How dare you? How dare you second-guess--
    Oh, so we don't operate on ministerial responsibilities.
     I heard you out, now you hear me out.
    How dare you second-guess my department, which has made it absolutely clear that they did not know. If you have one scintilla of evidence that they knew something, you provide it. Otherwise, I suggest you keep your accusations to yourself.
    My department acted forthrightly and quickly, in lightning speed. I put it to you that they did so because they believe in the health and safety of Canadians. I'd resign the second I felt that I let Canadians down, but I can tell you I've had e-mails and letters from people around the country who said that we acted quickly. They had a friend, a relative, or a neighbour who was in dire need of radioisotopes, and we did the right thing to help the health and safety of Canadians. Those are the people I listen to, and if they told me to resign, I'd resign. But I'm not going to resign because you think you could do a better job.
    I've been through this as the Minister of Health for five years, and I can tell you that every time there's a situation like this the opposition demands the resignation of the health minister. I think it's disgusting, and you should be ashamed of yourself.


     All right.
    Madam Chairperson, if I could continue with this nonsense, the minister will know that I did not call his suggestion that he didn't hear on December 5 an untruth--
    You're calling me a liar, and you're calling my deputy a liar. You should be ashamed of yourself.
    --and I did not say that about his department except to point out that the deputy minister chose to use the words “I believe the department...”. And I then proceeded--
    Oh, come on. Is this Perry Mason land now?
    May I now ask my question, Mr. Minister?
    By all means.
    I then proceeded to ask how it was that information that went to an official in a neighbouring department that you work with closely did not get to health department officials and right through to you, the minister, on the day of this crisis. That is the question at hand.
    I am not making judgments. I am not second-guessing you. I am asking you, now that you know that you didn't hear something until December 5 that was known to your government on November 22, what you have put in place to make sure you get that information in the future. That's the question.
    I spent twenty minutes answering that question in my opening remarks.
    You have not answered that question.
    We have an expert advisory committee. We have a new protocol. That's how we're answering the question.
    Mr. Tilson.
    Point of order.
    I understand that in these committees there's always a certain amount of leeway for cross-examination, but Ms. Wasylycia-Leis is getting into badgering a minister of the government, and I don't think it's appropriate for this committee to get into that sort of conduct with a minister of the crown.
    Oh, who's badgering who?
    He has stated his position, and she continues to badger him.
    Thank you, Mr. Tilson. That's not a point of order. It's a debatable question.
     I would ask Ms. Wasylycia-Leis if you would just allow the minister to answer your questions without being interrupted.
    All right. I have a straightforward question.
    And you have a minute left.
    Yes, let me answer the question. The answer is that we formed an expert advisory group, which is continuing to advise us. And indeed, we're having another big meeting coming up at which we can move forward on this on a proactive basis.
    Also, we established a protocol for communications, so I think we've done everything that we need to do to fix what I agree should have been tighter communications within government when the situation became clear. I totally agree with that position, and I've never disagreed with that position.
    All right. Let me ask about the protocol, since we have to look at this and make a report to Parliament about the effectiveness of this strategy.
     It seems to me several things are missing. Number one, one of the big problems in this whole issue was that the physicians of nuclear medicine heard from their suppliers. They didn't hear from government. They didn't hear directly. There was no alert.
    In your protocol, you tack on your consultation with the health care community at the end of a long list of things you will do once the situation arises. It seems to me that it's not paramount there that you would ensure that you're the first means of communication to the medical community and that your alert goes out expeditiously. I think we need some explanation about the protocol.
    My last question simply is--
    You're running out of time. Could we just have the minister answer that?
    Fair enough.
    Sure, I can answer that one and assure this committee that indeed we will be contacting experts and medical practitioners simultaneously as we contact provinces and territories, the Canadian Society of Nuclear Medicine, and the CMA. So we're doing it simultaneously, not after the fact.
    Do I have time for one more question?
    Thank you.
    Ms. Bennett, you had your hand up.
    Madam Chair, I wonder if it would be possible for the committee to agree to ask the minister to table the Health Canada clippings from November 22 on, to see if indeed the Canadian Press article of December 1 and the CBC Halifax press report of December 4 were in the clippings. If they were, then someone in the department or in the minister's political office should be held responsible.
    They say the department didn't know. I cannot believe those were not in the clippings or in his office.
    I would like the Health Canada clippings tabled from November 22 until the day we passed the motion in the House.


    Mr. Fletcher.
    Madam Chair, I don't think that is an appropriate request at this time.
    We want to have our opportunity to ask the minister questions if there is time left, and if there is not time left, the meeting needs to be adjourned. It's that simple.
    If that's a motion, I'll second it, and maybe we can have a vote.
    No, we'll make it for our next meeting, but we would like to have our time to ask the minister questions if there is time.


    We can just do it as we go along.


     If there's not time, the meeting is over.
    Thank you, Mr. Fletcher.
    We have to deal with this today in a timely fashion. Please write out the motion, Dr. Bennett, and we will deal with it at the next meeting, if it is the will of the committee.


    Madam Chair, we often ask witnesses to give us information first and then answer our questions. Why not proceed that way? There is no need to make an exception for the minister. He only needs to say he will send us what we want, just as the other witnesses do. It has been done before. This is getting all blown up because it is the minister.


    Thank you, Ms. Gagnon. Yes, we could do that. We could do it that way, so we will.
    We now have a short time for Ms. Davidson. Do you have a question for the minister?
    Thank you, Madam Chair.
    Thank you, Minister, for appearing, and my thanks to the department staff.
    I think we all know that we faced a very unusual situation. I hope it will remain so. Parliament pulled together and mounted an all-party response to get this resolved.
     Today we want to look at how we're going to move forward. We heard a presentation earlier from the gentleman from MDS Nordion. These were his is words:
Clearly it is imperative that government, industry, and the nuclear medicine community collectively find a long-term solution for the reliable supply of isotopes from Canada.
    Minister, other countries have started looking at ways to reduce their reliance on isotopes being produced by the NRU reactor. Is Health Canada looking into this? Are there other types of isotopes in your approval queue? Will approvals be accelerated because of this, if there are others in the queue? Those are just a couple of brief questions. If I have more time, I'll ask you a couple more.
     In answer to the second question, I'm not aware of any. If there were, I would certainly support expediting....
    The expert advisory panel is formed to provide advice on contingency plans and to look at alternatives within the radioisotope world and beyond. You can't stockpile radioisotopes. That's the essence of the problem we face. That's why it was a crisis rather than a shortage. Some of our alternatives in this area are not great.
    That being said, the advisory panel is going to give us some advice. Certainly it would be my advice that if it's responsible and doable, we should do it.
    Thank you.
     Mrs. Davidson, our time is up.
    I want to thank Minister Clement for making himself available to the committee. We will make sure the document is tabled.
    Thank you.
    The meeting is adjourned.