The chart on page 3 shows four key messages that I'll leave with you. The overall message is that nuclear medicine is one of many imaging technologies used in medicine. It is used in addition to X-rays, CT scans, MRIs, and ultrasounds.
The largest use of nuclear medicine procedures is for cardiac imaging. That's the biggest share of the pie that you see, about 56%. These scans are used to look at the blood flow through the heart during stress tests.
The second-largest use is shown as the big blue one, bone scans, which make up about 17%. They are used to detect progression of cancers going to the bone, or even just fractures of bones as well. Then all the rest of the uses are general organ scans. As opposed to MRIs and CTs, which look at how an organ looks, these procedures actually look at how an organ functions for a range of diseases, including cancer.
We'll turn to page 4. As my colleague said, Tc-99m, or technetium-99m, which is derived from moly-99, is really the predominant isotope for about 80% of nuclear medicine procedures. It has a shelf-life of about six hours--moly-99 is 66 hours--and that's why there's a supply disruption: it can't be stockpiled like vaccines. The supply disruption right now is of significant concern to patients and to doctors across the country.
There are, however, alternatives that can be used for some of these contingency planning purposes. They can't be used for ongoing replacement, but for most procedures in cardiac imaging--which, as you saw, is the area in which nuclear medicine procedures are most used--thallium-201 is an acceptable alternative, and it is being used now across the country as part of the contingency plans that are being rolled out by the medical community and by the provinces and territories.
Another alternative is 18-F fluoride, which uses PET cameras, another imaging modality. They are being made available through clinical trials for bone scanning. We also have some that are being used by.... The alternative really is to go to MRIs and CT scanning.
There is, however, a requirement for Tc-99m. There are some procedures for which there is no viable alternative. I'm thinking specifically about kids and pediatric bone scanning for cancers. In that case, the medical community and the provinces and territories are taking the available supply and targeting it to the priority procedures and making maximum use of the available isotopes. They're using longer scans, lower dosage, and longer operating hours. They're working weekends, working 24/7 in some cases, and the hospitals and the regions are sharing the patient load and the generators as well.
:
Mr. Chair, I would like to say a few words about the global demand. We are going to focus on molybdenum and technetium.
The global demand is calculated to be about 40 million doses per year. The distribution is on page 5. You can see that the biggest user is the United States, with about 44% of the total, followed by Europe, 22%, then Japan, 14%, with the rest of the world at 16%. Canada uses 4% of the isotopes; later, we will be able to compare that figure to our share of the supply.
Let us talk about the growth in world demand. You see on page 6 that we expect a growth in world demand for this product, a product that is rare now. Demand will continue to increase as the use in present markets intensifies and as new markets start to use nuclear medicine.
Although it is a mature market, we expect that the United States will continue to lead the world demand. There are a number of key factors, but the growth is mainly because of the aging population and the increasing prevalence of heart ailments. Demand will probably increase in Asian, South American and Middle Eastern markets as new diagnostic tools are put in place.
[English]
We'll now turn to the supply side of the market on page 7. Much has been said about this over the last number of days. Moly-99 tends to be produced in nuclear research reactors—not nuclear power reactors, but smaller research reactors. There are approximately 250 such reactors around the globe, but there are only a handful that produce moly-99 in any reasonable quantity. Indeed, 95% of the moly-99 produced for export markets comes from five government-owned multi-purpose research reactors. They are the AECL's National Research Universal, which we call the NRU reactor, in Chalk River, Canada; the BR2 reactor in Belgium; the HFR reactor at Petten in the Netherlands; the OSIRIS reactor in France; and the SAFARI reactor in South Africa. There are several other smaller reactors that provide some supplies to regional or domestic markets, but not enough to really influence the global market.
The five reactors working together, or working with regular outages, can succeed in supplying the global market in the necessary quantities. However, the NRU is one of the largest, with the reactor in the Netherlands, producing roughly 30%, sometimes 40% of the global supply, and when such a reactor is down there will be an impact on global supply. Indeed, it's worth reminding ourselves that not so long ago, toward the end of the summer up to early 2009, the HFR reactor of the Netherlands was down. During that period, the NRU at Chalk River ramped up production considerably such that there was virtually no noticeable impact on Canadian demand. Now, of course, we're facing a different situation.
The slide on page 8 shows you a bit of the supply chain and how the isotopes make their way from a reactor to the patients.
First, uranium targets—we call them targets, but they're essentially bundles that go into a reactor—are irradiated. That means they're subject to the neutron beam of the reactor in the research reactor. Then, after some days in the reactor, these targets are processed. The moly-99, which is derived from this process, is extracted and it is purified. It is then incorporated into technetium-99m generators, and that is the product that is shipped to hospitals and radiopharmacies, where it's used in conjunction with drugs that allow the targeting of the radioactive materials that decay very rapidly in the body. The drugs allow targeting that to specific processes or tissues in the body.
The various steps in this process can take place at different locations and different countries, and we'll go through that. What is important is that this radioactive material decays very rapidly. The moly-99 that is produced in the reactors has a half-life of about 66 hours. That means that very quickly, if it is not shipped to the appropriate manufacturer, the product decays and is not as useful at the end of the chain. Similarly, the technetium generator that is shipped to the hospital has a limited useful life that's estimated in the range of 10 to 14 days. The longer one waits, the less effective that generator is.
This is an industry—and we'll go through the supply chain—that cannot stockpile material. It is operating every time in real time, and it has to work very efficiently at moving product through the different steps of the supply chain into the end demand. These products, of course, are subject to both nuclear and medical regulations that are necessary for producing, transporting, using the products, and approving new products, with the intent of ensuring health and safety. The various steps of the supply chain also involve costs and economic risks and rewards. Those are very critical to understanding the full complexity of the supply chain today and incentives for new or replacement technologies for the future.
The chart on page 9 depicts the global supply chain, including the reactor operators, the processors, and the technetium generators, and it shows how the process flows from left to right. If one looks at the top of the page, you'll see that the target irradiation occurs at the NRU in Chalk River for that element of the chain.
The molybdenum-99 is extracted in processing facilities at Chalk River, in what are called hot cells, or areas isolated with concrete to allow very sophisticated manipulation of radioactive material. This material is then shipped to MDS Nordion in Kanata. Nordion, you will recall, was spun out of AECL in the early 1990s. Nordion purifies the product. Importantly, it then exports this product to a number of customers in Japan and in the United States—mostly in the United States, to Lantheus, a technetium generator.
I'll come back then to show the flows of supply from Canada.
The other reactors essentially function the same way, going either through Covidien AG or the IRE, both in Europe—which can actually take supply from a number of reactors—and the South African reactor funnels the material through NTP Radioisotopes, also in South Africa, and it is shipped to different parts of the world.
Of course, the geographic alignment between reactors and processors stems from the constraints in shipping and the decay time of moly-99. While there is crossover between these chains, there is not perfect substitutability of product. It is not a trivial matter of taking something that comes out of the SAFARI reactor to be processed, for example, by Covidien in Europe, or going through MDS Nordion in Kanata. These products are not all substitutable.
If we look at the flows on page 10 as regards Canadian supply, it's important to understand again that the product from the NRU does not go directly to hospitals or clinics. It goes through a number of steps, first, through MDS Nordion in Kanata, as I just mentioned, which ships a portion of it to the rest of the world—and the largest portion to the United States, to Lantheus, and also, in some cases, to other customers in the United States—and it is only a relatively small portion that comes back into Canada. We indicated that the NRU supplies roughly 30% to 40% of global demand. It consumes roughly 4% of global supply. That means the bulk of the production of the NRU is actually exported; it is exported and in fact re-imported, because there is no technetium manufacturer in Canada.
You'll see that the end-use in the United States is at least 10 times greater than in Canada, at about 5,500 in terms of the units we've used here. The U.S. is itself supplied roughly 50% by the NRU—that is, 50% through this chain—and about 50% from other reactors globally.
We are all very keenly aware of the fact that the NRU is 50 years old. What is perhaps striking is that the other research reactors in the world that produce isotopes are essentially of similar vintage, between 42 and 47 years old. Of course, that means the costs of servicing these reactors go up—and, yes, their vulnerability also goes up—and there are also some licensing issues. As you know, the NRU is licensed by the CNSC to operate under its current licence to October 2011—and I'll come back to the work being done to extend that licence. The reactor in the Netherlands, for example, was given a one-year licence to operate in March of this year, after an extended outage it experienced.
Page 12 looks at some of the projects or proposals currently in the pipeline that could supply molybdenum-99 to the global market. The most immediate are on the left-hand side, but in fact even those are the only two that can actually produce within the next months.
The Australian reactor, called OPAL, which has been in construction basically for the last 10 years, is now commissioned to produce and to export molybdenum-99, and discussions are in place for export of that product to North America, including on the regulatory side, in both Australia as well as in Canada, with regard to the actual regulation of the health product.
Argentina has a reactor that it has been using to supply essentially to domestic and South American markets. It may supply some, albeit in modest quantities, to the North American market.
In the United States, the University of Missouri research reactor, also an older reactor, may potentially be brought onstream to produce molybdenum-99, but that is a project at this time and not a specific commitment.
The only new research reactor that is really being constructed at this time is the Jules Horowitz reactor in France, and it is expected to come onstream in roughly 2015.
There are other projects that are essentially at the conceptual stage at this time, and one would count at least five years before they come to maturity. Then there are some projects that may supply some local markets and therefore be of limited capacity or use for the global market at this time.
The proposals that have been discussed in the Canadian context include the McMaster nuclear reactor, which is also a reactor that is 50 years old and is experimental. It's a research reactor at McMaster University that has produced isotopes in the 1970s under different conditions. It has put forward a proposal to produce moly-99, and there has been engagement with McMaster to see how that could be done. But our analysis to date, the analysis of experts from AECL and from the CNSC, is that this could not be done in the short term.
UBC has also put forward a different concept, using an accelerator-based process to produce moly-99 using photo-fission. That has also been noticed as a potential process internationally, as one that merits further investigation, but again not one that is mature enough to produce at this time.
The Canadian Neutron Centre is essentially a proposal for a new research reactor in Canada, and that has been assisted by the National Research Council and would be a multi-purpose research reactor, not only producing medical isotopes.
There are, of course, additional private and public sector proposals out there. Certainly, we suspect we will have some discussion about the MAPLE reactors, which turned out to be not capable of producing and are not licensed at this time. That project was terminated in May of 2008.
The Province of Saskatchewan has indicated it is also interested in discussing with the Government of Canada possible arrangements for a research reactor and, eventually, the production of isotopes.
Perhaps I won't go through the list on page 14, Mr. Chair, not wanting to take too much of the committee's time. But the criteria that one would have to look at, looking at these various solutions, includes the technical feasibility, the readiness, the technological risks associated with the projects, and the ability to expand the technology to commercial scale.
There is business implementation and risks. The investments are very significant. Obviously, if they were to replicate in any way the production levels of the NRU, it would have to count on access to the export market for a large share of its production. This means that market has to evolve in a way that is reasonably predictable, and there has to be some ability to integrate with an existing supply chain. It does not suffice to have a reactor; you actually need to be able to work with a supply chain.
The timeliness of the solution, whether the project could be ready in five years or more, or less.... Regulatory issues have to be addressed, including the ability to handle and control nuclear materials and waste management. The United States, for example, Mr. Chair, has made it very clear that with regard to long-term solutions--not short-term, but long-term solutions--they want those reactors to function on low-enriched uranium in order to control the risk of nuclear proliferation. Currently, the NRU and most other of the reactors that produce are actually using highly enriched uranium, and this is something that the United States in particular, and indeed the international community, would want to phase out over time.
Where there are other broader benefits to Canadians, quite apart from the health care benefit, which is obvious, are the benefits to the medical industry or to the nuclear industry, and so forth.
The next steps in regard to key priorities in trying to address this challenge are threefold. It's also on the demand side, and my colleague from Health Canada may add to that later in the questions.
First of all, it remains a priority to put the NRU back into service and to extend the licence of the NRU. That is the best way right now of ensuring that there's something like the production of the NRU that comes back on stream, and obviously AECL is working very hard at ensuring that can be done as quickly as possible on a safe and reliable basis. It means as well that the work has to continue to extend the licence of the NRU. Funding was provided for that last year, reallocating from budget moneys of 2008. Budget 2009 provided funding again this year for AECL to pursue this work with the CNSC.
The second thing is international engagement so that we secure the best possible capacity out of existing capacity, that we achieve the best possible supply and the best use of that supply globally. That means, for us, engaging multilaterally, engaging bilaterally with the different producing countries, and also engaging with the United States.
Thirdly, the minister outlined last week the establishment of an expert review panel to go over the different proposals I mentioned earlier against the kind of criteria I've laid out.
I hope this is helpful. I'm more than happy to take questions from the committee.
:
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.