Natural Resources Committee on June 2nd, 2009

[Nathan Cullen, NDP, Skeena—Bulkley Valley, BC]

Does the Government of Canada have a list of critical incidences, in terms of hospitals that are in most desperate need right now? We're hearing from doctors, like Dr. Tracey and others, who have talked about running out this week, and with a cascading effect across the country of other cancer treatment centres and hospitals that will be running out. Does the Government of Canada have, essentially, a triage process, where they say where it needs to go first, what little is left?

[Meena Ballantyne]

Mr. Chair, maybe I can use this opportunity to let you know what we've been doing in the health community since 2007.

We have been working with the provinces and territories and the medical community to make sure triaging guidelines are in place, because as you may appreciate, in the practice of medicine, the doctors know their patients' needs best. They know their facilities, in terms of if they have a PET scanner or not, if they have a SPECT camera or not. Those are health care professional decisions.

We've been working with them and with the provinces and territories. And thanks to the good work of Ontario, which has been the leader in developing some contingency planning, we've issued guidance so they can triage their patients, so they can decide on which ones are the emergency cases, where the available technetium supply should be targeted.

[Nathan Cullen, NDP, Skeena—Bulkley Valley, BC]

How long does that triage list last, if we're hearing that Chalk River and the other supplies will not come on for a number of months and other supply sources may be some years? Triage only works in moments of emergency, and you apply the patches where you can to hold the fort. I look at the diagnoses that are specific to the types of isotopes we've now lost, in terms of diagnosing new cases of breast cancer, bone scans, newly diagnosed cancer patients with immediate treatment decisions.

In 2007, the minister said this was a life and death situation. We advance two years later, approximately, and we see a patchwork quilt of things to have Canadians rest assured. We also have studies in hand that there is a concern around false-positive images that are created when using thallium instead of the isotopes we currently use. If these other replacements were so fantastic and the supply of the other isotopes coming from Chalk River was so sketchy, then certainly hospitals and doctors wouldn't be using isotopes that normally come out of Chalk River; they would have used these diverse supplies.

What confuses me in this is that AECL, at the origin, was the supplier and distributor of these. The Government of Canada sells off the purchasing component to MDS Nordion, then gets sued for $25 million—successfully sued, I might add—for having hived off and then privatized this, then shutting down the MAPLE supply of reactors. Canadians are told 18 months ago it's a life and death situation, we have to override safety concerns at the nuclear facility in Chalk River. Eighteen months later, we're seeing proposed alternatives. We have a number of doctors saying that won't cut it.

[The Chair, Conservative, Leon Benoit]

Mr. Cullen, if you would like a response at all, you'd better ask the question fairly quickly.

[Nathan Cullen, NDP, Skeena—Bulkley Valley, BC]

My question is this. When talking to cancer patients right now, I have no answers from the minister yet to say that over the next weeks and months they should feel anything but concern for the diagnosis and treatment of their cancer. Can you respond to that?

[Meena Ballantyne]

Mr. Chair, our minister has been talking every week to her provincial and territorial counterparts. We're facilitating access to these alternatives; we're working with the medical community to have these available to them as soon as they need them.

Since 2007, one of the other things that's happened is that of the two supply companies, Lantheus and Covidien, one—Lantheus—has diversified its sources, so it's no longer reliant on the NRU. For example, Lantheus has ramped up its capacity to produce thallium and is making that available right away to everybody across this country, and it's being put into use. It has also signed a deal with South Africa to get supplies. So the supply is not going from 100% to zero; it's going down.

There's no question that the NRU is going to have an impact. The prolonged shutdown and shortage will have an impact; there's no question about that. But we're much better prepared than we were in 2007—the health care community, the provinces and territories, the supply chain as well, everybody—in terms of diversifying supply.

Our current supply forecasts are that Covidien, which gets its supplies from the Netherlands, is able to supply western Canada to its normal levels, because it hasn't been impacted by the shutdown. But for the Lantheus customers, Lantheus is committed to doing its best to get to 50% supply. For example, last week it was around 50%; this week it's going down. There are partnerships between Lantheus and Covidien to increase the supply for Canadian patients. So it really varies week to week. It depends upon the provinces and territories, and even provinces and territories have diversified supply sources.

Everybody has learned from 2007, and we're much better prepared this time, but there's no question that this is serious and it is going to have an impact on the health care system as it goes on.

[The Chair, Conservative, Leon Benoit]

Thank you, Mr. Cullen, and thank you, Ms. Ballantyne, for your answer.

We go now to the government side, to Mr. Trost for up to seven minutes.

[Bradley Trost, Conservative, Saskatoon—Humboldt, SK]

Thank you, Mr. Chair.

I want to pick up on those questions. As I was looking through my notes and running through the timeline, I noted that it was on May 15 that the problem really began to be observed at the NRU. It seems that fairly quickly steps were being taken. I mean that within literally hours or days, things were being moved. It was noted that May 23, about eight days later, was when AECL would essentially no longer be able to meet its scheduled production requirements for medical isotopes. I must say that compared with the chaotic nature of 2007, things seem to be running better this time.

My question is, why are things running better? We have the protocol; we have steps and communications taken. What specifically are we doing this time that we didn't do last time, and why is it working better? Could you elaborate? What has changed so much that it's made the situation more manageable?

[Serge Dupont]

The one thing we would say, and Meena may add to this, is that within hours, basically, of knowing that the NRU would be down for a prolonged period—initially it was indicated that it would be for more than one month—the information was posted on the AECL website with an explanation as to what was going on. Indeed, as this developed, as the leak materialized, the information was disclosed. As the situation progressed, there were a number of updates on the site, and within hours, as soon as it was determined that it would be at least one month, this was communicated to the medical community, and afterwards as well, through a protocol that ensures that AECL provides that information to both our department and to Health Canada.

It also provided information, as a reference point, that the supplies would be continuing during the week, because even when the reactor is down, they can still pull some rods out of the reactor and process the moly. That, of course, comes to an end after a period of roughly one week. So that period was set out. There was certainly a heads-up to the medical community that there would be difficulties ahead.

Then, as my colleague from Health Canada indicated, there were also measures in place in terms of contingency planning on the demand side, as well as rapid engagement with international partners on the supply side.

[Meena Ballantyne]

Mr. Chair, just to reinforce what my colleague has said, one of the biggest lessons learned was to have early communication and notification—this is what we heard from our medical community and from the provinces and territories—so that they could plan ahead and know how long to plan for. That was one of the biggest lessons learned. It was in the invaluable advice we got from the lessons learned report last year. The communications protocol to give virtually instantaneous notice of the fact that the NRU is going to be down for a certain length of time was instrumental in getting this contingency plan going.

We also have been working very hard over the last year with the medical professionals and with the provinces and territories to have these alternatives in place, should we need them, and all the regulatory approvals.

My job as the ADM of the health products and food branch is to make sure that whatever Canadians are using by way of health products is safe and comes from a quality place and actually does what it's supposed to do. Any time there is a new source of moly-99, or new generators, or a new condition for which you're going to use the same medication, our scientists look at it and make sure the approvals are in place. We've been working on this, and now it's unfolding and these measures are out there.

As I said concerning the supply chain, with the two main suppliers having diversified their supply chains and with the international conversations that are going on, there is real hope about boosting the supply chain this time around that wasn't there last time.

[Bradley Trost, Conservative, Saskatoon—Humboldt, SK]

It's good to hear that the steps taken by the government and the various departments over the last 18 months have paid off.

Out of curiosity, one thing I noted is that most of the nuclear medical procedures that were referred to today are diagnostic in nature. I understand, even though I'm nowhere close to being a doctor, that diagnosis is important before you get to treatment. But I want to know, for people watching, because there may be some misperceptions that people may be missing their treatments out there in Canada, that by and large it is on the diagnostic side that we will be rationing, because that's where we can do substitutions.

Would that not be a correct analysis? Even without the NRU, 60% of the world's production is still going to be there. So for 60% of procedures, we wouldn't have to ration, we wouldn't have to squeeze timelines, we wouldn't have to do anything. Am I making the correct assumption that it's going to be mostly diagnostics and the less critical diagnostics that will be the ones first substituted for?

[Meena Ballantyne]

Yes, absolutely. Again, it's the medical community who will decide, based on the needs of patients. They're already targeting the available supply of technetium to the emergency cases. If, in certain cases, delayed diagnosis means delayed treatment—

[Bradley Trost, Conservative, Saskatoon—Humboldt, SK]

So if people have relatives or friends out there, they don't have to worry; they are going to be getting their cancer treatment, and they ought not to misread something they're seeing in the newspaper.

[Meena Ballantyne]

Yes, absolutely. This does not affect radiation therapy for cancer. Radiation therapy does not rely on moly or Tc-99m. That's cobalt, so it's not coming from the NRU. There's no shortage of radiation therapy for cancer treatment at all.

[Bradley Trost, Conservative, Saskatoon—Humboldt, SK]

Okay. I just wanted to make that clear.

I think my time is up, Mr. Chair.

[The Chair, Conservative, Leon Benoit]

You have one minute.

[Bradley Trost, Conservative, Saskatoon—Humboldt, SK]

Here is the other question I have. We've talked almost exclusively about moly-99. I know there are a few other isotopes involved. Are they just not that critical? Why have we not mentioned them or gone into them? Are they much easier to substitute for? This is curiosity.

[Meena Ballantyne]

There are other isotopes, but they use different cameras. For example, for the SPECT cameras or gamma cameras, which use the technetium, the alternative is thallium, which can use the same camera for cardiac scanning. You can also use iodine-123 to image kidneys. It has a half life of 13 hours, so again timing is critical. We have gallium-67, which is used for the detection of Hodgkin's disease and lymphomas, among other types of cancers.

Using PET scanners.... This country doesn't have as many PET scanners as we have SPECT cameras, because nuclear medicine is state-of-the-art, the best there is to treat some of these things. But there is fluoride or FDG, which can be used for bone scanning for cancer, which is now made available through the clinical trials, and we know hospitals in Quebec are going to be using this. We have rubidium-82, which is used in some small heart conditions as well. We also have MRIs and CT scans that can be used.

Again, this is for contingency planning, not for ongoing management. But they are alternatives that the medical community and the provinces and territories have identified in their contingency planning.

[The Chair, Conservative, Leon Benoit]

Thank you very much.

Thank you very much, Mr. Trost, for your questions.

The time for this portion of the meeting has ended. I'd like to thank the witnesses very much for some very useful information for the committee in doing its study. From the Department of Natural Resources, Serge Dupont, associate deputy minister, and Tom Wallace, director general, electricity resources branch, thank you, gentlemen. And from the Department of Health, Ms. Ballantyne, assistant deputy minister, health products and food branch, thank you again very much.

We will suspend for a couple of minutes while the minister and others come to the table.

[The Chair, Conservative, Leon Benoit]

We will reconvene the meeting.

To continue our study of the Atomic Energy of Canada Limited facility at Chalk River and the status of the production of medical isotopes, for the second hour we have the Honourable Lisa Raitt, Minister of Natural Resources. Thank you very much for being here. And with her, from the Department of Natural Resources, are Cassie Doyle, deputy minister, and Serge Dupont, associate deputy minister. Thank you very much for being here again.

Minister, I understand you have an opening statement.

[Lisa Raitt, Conservative, Minister of Natural Resources]

I do. Thank you, Mr. Chair.

[The Chair, Conservative, Leon Benoit]

We will hear that and then go to questions.

[Lisa Raitt, Conservative, Halton, ON]

Thank you very much. Thank you for the introduction.

Ladies and gentlemen, securing a reliable supply of medical isotopes for Canadians in both the short and the long term is the focus of my department right now. It's important to underline that when we talk about security of supply, we are talking about a global industry and a global market. The issues surrounding security of isotope supply are global in nature. We are very concerned about this situation. I look forward to the committee's contribution to achieving the results that we all seek in this matter.

I would like to underscore at the outset that we are facing a situation now very different from the one we were facing in December 2007, when Parliament passed emergency legislation to overcome an impasse between the regulator and AECL and to enable the NRU to be restarted.

Last time, there was no good reason to keep the reactor in a shutdown state. The reactor was brought back online quickly and safely after Parliament heard from six witnesses and unanimously passed legislation. This time, we are faced with a significant technical problem that must be addressed before the reactor can be brought back into operation.

The last time, there were poor lines of communication between AECL, the CNSC, and the government, and significant delays in notifying the medical community as a result. This time, the medical community was informed within hours of the government's being informed that the reactor outage needed to be extended, so that necessary contingency planning could be put into effect immediately.

Last time, we were not equipped to take steps to secure alternative supplies, and officials were scrambling to understand the industry and make hurried contacts with foreign reactor owners, all to no avail. This time, we have international infrastructure in place, which will be necessary in the coming weeks and months to help the global community address a serious shortage that will persist for some months.

I will be dealing with all of the above in my opening remarks today, but let me first begin by updating on the status of the NRU.

As the committee is aware, routine monitoring uncovered a small heavy water leak at the NRU reactor on May 15. AECL has indicated that the NRU will remain shut down for a minimum of three months to identify what repairs are required and to implement the repairs. AECL has further updated concerning their process this afternoon.

I wish to take this opportunity to repeat that we are assured by both AECL and the Canadian Nuclear Safety Commission that the leak is contained and poses no risk to worker or public safety or to the environment, and an inspection program is under way. The duration of the outage will not be known until the investigations are completed and the repair options are identified.

The NRU produces some 30% to 40% of the global supply of a key isotope used in medical diagnostic procedures: molybdenum–99 and its decay product, technetium-99m. In fact, all of NRU's production is exported after further processing by MDS Nordion. About 10% of the exports are imported back into Canada by our health care providers.

As has been the case for some time, aside from NRU, only four other reactions are equipped to produce this essential medical isotope for the international market. Like the NRU, all of these are of an advanced age. This age and the maintenance requirements of all five major reactors contribute to the fragility of the global medical isotope supply chain. However, there are other factors in a highly regulated complex supply chain that relies on multiple public and private sector participants to get product to customers.

There are a limited number of processors in the chain. These are the companies that take the raw isotopes from the reactor and turn them into pharmaceutical products for use in hospitals. Due to the brief shelf life of the product and the short timeframe for delivery, it is preferable that processors be located in close proximity to the producing reactor. A further constraint is that not all processors can accept products from all reactors, for technical, contractual, and other reasons.

While assuring a reliable supply of isotopes is an important issue for Canadians, it is also very much a global issue, given the global demand's reliance on just five aging reactors. Unfortunately, it is also an issue for which there is no quick or easy solution.

That does not mean that we're simply throwing up our hands. What we can do, and what we will continue to do, is work with our partners in Canada and around the world to protect the health and safety of Canadians in both the short term and the long term.

To this end, we continue to move forward with a five-point plan. This plan includes the following: one, resuming NRU operating as quickly and safely as possible and pursuing a renewal of the NRU operating licence; two, mitigating short-term supply disruptions; three, engaging major isotope-consuming and -producing countries to coordinate short-term supply and to investigate long-term solutions; four, exploring alternatives to moly-99-based medical procedures; and five, encouraging alternative moly-99 production sources in the long term.

In terms of the NRU, AECL is working to bring the reactor back online as quickly as possible and in consistency with the highest safety standards. In addition, AECL and the CNSC have concluded a memorandum of understanding to identify the requirements for extending the NRU operating licence beyond its current expiry date of 2011. Indeed, in Budget 2009 our government allocated $47 million to AECL specifically for this work.

Second, since the last extended shutdown of the NRU, in December 2007, our government has taken concrete action to manage the impact of short-term isotope supply disruption such as we're experiencing now.

In January 2008, my department, Natural Resources Canada, together with Health Canada and AECL, concluded the protocol for notification and information sharing concerning shortages of medical isotopes. This protocol ensures that provincial and territorial health authorities and health practitioners are advised quickly of any potential or real disruption in the isotope supply chain.

With timely information, the medical community can respond quickly in order to prioritize procedures, take steps to extend and share limited isotope supplies, and utilize alternative procedures when possible. The health community has responded favourably to this initiative.

In December 2007, Health Canada struck the ad hoc working group on medical isotopes. This group reviewed the 2007 NRU outage and presented a number of recommendations to Health Canada. The working group has provided recommendations for enhancing communications, improving physician engagement, and developing best practices in triaging guidelines. Health Canada is working with the working group, as well as provincial and territorial health authorities and medical practitioners, to further this work.

The working group continues to meet and provide advice on a regular basis. It recently facilitated the sharing of guidelines that will assist the medical community to deal with the shortfalls in supply.

Government officials have also met with Canadian and U.S. private sector participants in the isotope supply chain, including MDS Nordion, Lantheus, and Covidien. These meetings are helping to ensure that the Canadian health care system continues to receive its fair share of product during periods of limited supply.

Third, the Government of Canada has been instrumental in drawing the international community together in a cooperative effort to foster global solutions. For example, at our government's request, the Nuclear Energy Agency convened an international workshop on the security of supply of medical isotopes in late January. The workshop attracted representatives from every part of the supply chain, including reactor operators, private sector isotope processors, the health industry, medical practitioners, government regulators, and policy experts.

Participants at this workshop recognized the global nature of the issue and underscored the need to deepen and develop contingency plans for supply disruptions in the near term and to share these plans as appropriate. More importantly, and at our government's urging, participants agreed to establish a high-level group to move the agenda forward.

Two weeks ago, I led a teleconference with many of those who are represented on this high-level group, including government and industry representatives from isotope-producing countries, to emphasize the importance of the international collaboration. The high-level group, consisting of representatives from key isotope-producing and -consuming countries, held its first formal discussion this morning. In acknowledgement of our international leadership on this file, Canada was today named the chair of this working group. I participated in the call and took the opportunity to underline that global cooperation will be required to maximize isotope supplies in the short term. It is also required to improve transparency in transmitting the best possible information to the medical system, and also to address impediments to the development of secure isotope supplies over the long term.

We were encouraged to learn that the Netherlands' reactor was working to increase production by 50% and the South African reactor by 20%, in the short term. Belgium indicated it has received approval to increase its processing capacity, and Australia is now producing isotopes and looking to ramp up production significantly. So we are seeing helpful developments on the supply side. But there are still challenges ahead.

The fourth point in our plan involves work being undertaken through Health Canada in concert with provincial and territorial counterparts and medical practitioners to facilitate the use of alternative medical and diagnostic procedures—alternatives that are helping to ease the demand for moly-99 in the short term while medium- and long-term alternatives are being explored.

The fifth point in our plan involves supporting efforts to develop new sources of supply for moly-99 over the long term. A number of concepts and ideas have been put forward since December of 2008. Some involve new technologies; others the enhancement of existing facilities; and still others are new facilities based on existing technologies. My department has supported feasibility studies regarding the use of an existing facility at the McMaster nuclear reactor to produce moly-99. Our government has also funded a workshop at the University of British Columbia and the TRIUMF research facility to explore the use of particle accelerators for the production of moly-99 through photo-fission.

But there are no easy or short-term solutions, and any efforts to develop new sources of moly-99 will take time and will take investment to implement. But last Thursday, our government announced the establishment of an expert panel to review proposals from the private and public sectors for new sources of key medical isotopes for Canada. The expert review panel will bring together world class expertise in the domains of health science, applied science, and public policy in order to assess the various proposals advanced, against technical, economic, and other criteria. The panel will provide its assessment in the fall.

Also on Thursday, I announced that our government is proceeding with the restructuring of AECL, now that the review of the corporation has been completed. The review concluded that a restructuring at AECL would inject strength in the nuclear industry in Canada, further strengthening its culture of growth, its culture of innovation, and its culture of leadership at a time of global expansion in the market.

Our objective through this restructuring is to position the Canadian nuclear industry to retain and create skilled jobs in designing, building, and servicing nuclear energy technology in Canada and abroad. Restructuring will not resolve issues surrounding the NRU and the supply of medical isotopes. Ensuring a reliable supply of medical isotopes is not only an issue for Canada; it is a global issue that requires a global solution.

It is also worth noting that on March 24, 2009, I introduced to Parliament Bill C-20, the Nuclear Liability and Compensation Act, a bill that will modernize the 1976 Nuclear Liability Act. I was pleased to see that this bill was sent to committee yesterday, and it is my hope that you will give the bill early consideration and return it to the House quickly.

To conclude, Mr. Chair, the Government of Canada is making every effort to minimize the impact on Canadians of the current disruption in the global supply of medical isotopes. Furthermore, we are exercising our responsibility as a major part of the global supply chain to foster the global cooperation needed to achieve a long-term solution.

I want to thank you for your time, and I look forward to any questions the committee may have.

[The Chair, Conservative, Leon Benoit]

Thank you very much, Minister, for your very pointed and helpful presentation. I appreciate it very much.

We will go now to the questioning. I think we'll have time for a seven-minute round for all parties, and then another two-minute round afterwards. So that's the way we'll proceed—if I can keep you on time—starting with Mr. Regan, from the official opposition, for up to seven minutes.

[Geoff Regan, Liberal, Halifax West, NS]

Thank you very much, Mr. Chairman, and thank you, Minister, for coming. It's nice to have you here today on what is certainly an important issue. In fact, we've heard some of the leading medical experts in Canada refer to the situation as a catastrophe.

I had a meeting a few weeks ago, in fact, before this happened, with some nuclear medicine people from Halifax, Dr. Andrew Ross, for example, who were very concerned about what might happen if this sort of thing were to occur with future supply. That was even before this occurred. And you have said in your comments today that you are very concerned about the situation.

I guess in view of that, my first question is that given that we're obviously going to be hearing from some expert witnesses in the field, people from AECL and so forth, and in view of the importance of this matter, are you willing to make time in your schedule to come back again after we hear from those witnesses?