RNNR Committee Report
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The Government of Canada’s Response to the Report of the Introduction: The unexpected outage of the National Research Universal (NRU) reactor at Atomic Energy Canada Limited’s (AECL) Chalk River Laboratories in Eastern Ontario on May 14, 2009, contributed to supply disruptions that highlighted the fragility of the supply chain that delivers medical isotopes to health care providers globally. The Government of Canada instructed AECL to make the return-to-service of the NRU its top priority and the reactor was restarted on August 17, 2010. Medical isotope production restarted on August 18, 2010 and has been continuous since then. The House of Commons Standing Committee on Natural Resources (hereafter the Committee) examined the consequences of the shutdown of the NRU in Canada and abroad. The Committee published a Report on November 24, 2010, entitled “The National Research Universal Reactor Shutdown and the Future of Medical Isotope Production and Research in Canada” in which it made 18 recommendations to the Government of Canada (hereafter “the Government”) on this important issue (see Annex A). The Government has carefully considered the recommendations of the Committee. The Government is of the view that the Committee’s Report and recommendations are generally in line with its strategy to increase the security of medical isotopes supply. The first part of this response provides background information on isotopes while the second part describes the Government’s strategy for a secure supply of medical isotopes for Canadians. 1) Medical Isotopes Production in Canada Technitium-99m (Tc-99m), which is obtained from the decay of its parent isotope molybdenum-99 (Mo-99), is the most widely used medical isotope for medical imaging and accounts for approximately 80 percent of nuclear medicine diagnostic procedures. Tc-99m performs a critical role in diagnosis and treatment decisions for some forms of heart disease, cancer, and other medical conditions. Historically, virtually all of the commercial supplies of Mo-99 have been produced via fission in nuclear reactors. Furthermore, since the United States (U.S.) does not produce Mo-99, the North American market has traditionally been heavily dependent on AECL’s NRU reactor for the production of Mo-99, as the basis for its supplies of Tc-99m. In Canada, the medical isotope supply chain has been complex and has involved a combination of both public- and private-sector organizations. The supply chain typically functions as follows. Highly enriched uranium (HEU) targets (obtained from the U.S.) are irradiated in the publicly-owned NRU reactor, and processed for Mo-99 extraction. The raw Mo-99 supplied from the NRU is then sent to Nordion, a private-sector company in Kanata, Ontario, for further processing and purification. Once Nordion has purified the Mo-99, it is then shipped toTc-99m generator manufacturers in other countries. Most of the product is shipped to U.S. private-sector Tc-99m companies that manufacture the generators and then sell to radiopharmacies and health care institutions in Canada through their Canadian subsidiaries. Although Canada is a major Mo-99 producer in the world, the supply chain is international and involves a number of other public and private sector players. A failure at any point in the supply chain can impact security of supply. Until recently, nearly all of the world’s supply of Mo-99/Tc-99m has been provided by five ageing government-owned nuclear research reactors, with the NRU reactor providing approximately 30-40 percent of that supply prior to the outage. The other major isotope-producing research reactors are located in the Netherlands, South Africa, Belgium and France. However, some small but important additions to the supply chain are currently emerging (Poland, Czech Republic, Russia and Australia). Recent planned and unplanned outages at a number of these isotope-producing research reactors have highlighted the vulnerabilities in the current global supply chain, which are likely to remain for some time. Security of supply is not a function of reactor reliability alone. It is also a function of processing capacity and availability, geographic alignment between processors and reactors, transport, handling and efficient use of the product. Historically, supply chains have been linear and somewhat independent, giving rise to the risk of complete breakdown if there is failure in one link of the supply chain (i.e. the single-point-of-failure risk). It should be noted that the relations among all players in the supply chain have been evolving since the outage of the NRU and its return-to-service, and many of the issues noted above have been examined and improved upon. 2) the Government’s Strategy for Increasing the Security of Medical Isotope Supplies for Canadians Prior to the 2009 NRU outage, the Government had foreseen the fragility of the global medical isotopes supply chain and proactively developed, in 2008, a five-point action plan to ensure consistent and reliable access to medical isotopes for Canadians over both the short and the long term. The five-point action plan included the following:
These initiatives helped to ensure that the Government was ready to respond effectively to the extended outage of the NRU in 2009. The Government has continued to work domestically and with its global partners to implement the five-point action plan to protect the health and safety of Canadians over the short and long term. In addition to this, in June 2009, the Government tasked an Expert Review Panel on Medical Isotope Production (hereafter “the Panel”) to provide guidance on the most viable options for securing supplies of Tc-99m to the Canadian health system over the medium and long term, and on the actions that may be required by governments and others to facilitate realization of the options. The Panel delivered its report to the Minister of Natural Resources on November 30, 2009, and the Government issued its response on March 31, 2010. In response to the Panel and building on its 2008 five-point action plan, the Government further refined its strategy to increase the security of medical isotope supply for Canadians in the longer term by i) pursuing the extension of the NRU’s licence until 2016, (ii) encouraging new technologies to ensure future supply, iii) supporting health care system needs, and iv) continuing international cooperation and engagement. The following Government response to the Committee’s recommendation can be described as falling under these four broad categories and is consistent with the previous response to the Expert Review Panel on Medical Isotopes. i) Pursuing the Extension of the NRU’s Licence until 2016 (Recommendations 1, 2, 4, 11, 15, 17, 18) In the short-term the Government will continue to pursue the extension of the NRU’s licence so that it can produce isotopes while work on alternatives is taking place. The Government recognizes that the NRU is critical for the short-term supply of isotopes both domestically and globally. Because the NRU’s licence will expire in 2011, the Government is investing now to re-licence the NRU to 2016. This is a key element of the Government strategy for securing the supply of medical isotopes. AECL is currently conducting a “Lessons Learned” exercise which covers the entire NRU outage focusing on lessons learned that can be used for future outages both planned and unplanned. This exercise will facilitate better planning and faster return to service times in the event of another unexpected outage. As already mentioned in the Government’s response to the Expert Review Panel on Medical Isotope Production, the Government does not intend to have the NRU produce isotopes beyond 2016. The Government’s investment in non-reactor-based production is intended to support development of supply options that will serve Canadians well beyond 2016. Accordingly, the Government appreciates that the Committee shares its commitment for the future production of medical isotopes from non-reactor based technologies. With respect to the MAPLE reactors, the Government accepted the decision of the Board of Directors of AECL to discontinue the project. As asserted by the Expert Review Panel on Medical Isotope Production, there are considerable challenges associated with the MAPLE project, including economic, technical and regulatory challenges. As stated in its response to the Expert Review Panel, the Government will remain open to considering private sector proposals that would cover full costs, liabilities and risks without further public investment. With respect to conducting a cost-benefit analysis of isotope production and evaluating future production levels of isotopes, the Nuclear Energy Agency has issued three reports on the subject for the High Level Group on the Security of Supply of Medical Radio-isotopes. There reports concluded that the onus is on all players in the isotopes supply chain, in both the public and private sectors, to work together to develop an economically sustainable model. ii) Encouraging New Technologies to Ensure Future Supply (Recommendations 3, 6, 7, 10, 12, 13, 14) The Government invested through Budget 2010, $35 million in research, development and demonstration to encourage the commercialization of non-reactor-based technologies for the production of Tc-99m in the medium and longer term. The program is aimed at advancing technologies at the leading edge of isotope technology development, and will help Canada remain a leader in the area of isotope technology. If successful, these technologies would deliver innovative solutions on a scale commensurate with Canada’s needs, and would result in reduced nuclear waste. On October 15, 2010, the Government announced the selection of four projects for funding under the Non-reactor-based Isotopes Supply Contribution Program. These projects, led by Advanced Cyclotron Systems Inc., TRIUMF, Prairie Isotope Production Enterprise and the Canadian Light Source Inc., showed the best potential to move non-reactor-based cyclotron and linear accelerator technologies to commercial viability as quickly and effectively as possible. On January 24, 2011, the Government announced the signing of the Contribution Agreements and work on these projects is underway. These four projects build on innovative work already underway in medical centers and research facilities across Canada, and exploit the expertise that Canada has developed in medical isotope technologies over the years. The projects take advantage of cyclotron and linear accelerator facilities already in place across Canada, some of which are already producing and distributing other medical isotopes. The projects will focus on scaling up the processes and understanding the safety and commercial viability of both linear accelerator and cyclotron technologies. If commercialized, these technologies would create a more distributed network of supply hubs to overcome the vulnerabilities of the current supply chain, and would largely eliminate nuclear waste from medical isotope production. This work is intended to support increased security of supply for Canadians beyond 2016, when the NRU reactor is no longer expected to produce isotopes. This program is a key part of the Government’s medical isotope strategy. The Government believes that investments in new technology will, in the long term, encourage new business development, spur collateral economic activity and provide an impetus for further technological innovation. Confident that these alternative technologies will prove successful, consideration for a new multi-purpose research reactor would be based on a thorough assessment of the possible missions, including neutron scattering and R&D for the nuclear energy industry. A requirement of such a study would be due consideration of the appropriate sharing of costs among the many users and beneficiaries of this type of infrastructure. iii) Supporting Health Care System Needs (Recommendations 8, 9, 16) In the Canadian health care system, provinces and territories have primary responsibility for the design and delivery of care, including decisions related to the use and financing of nuclear imaging technologies. The Government plays a supporting role, through measures such as fiscal transfers, regulation of health products, and investments in research and knowledge development to inform decision-making. Given the important role medical isotopes play in facilitating diagnosis and treatment, significant efforts were made by producers, suppliers, and the international community to limit the extent of supply disruptions resulting from reactor outages in 2009-2010. In Canada, complementary actions were taken to minimize health system impacts and ensure patients received needed care. The Government’s focus was on providing guidance, clear communications and rapid regulatory approval of new sources of supply and alternative isotopes, in order to support the provinces and territories and health care providers in responsive planning and effective implementation of mitigation strategies. As a result, the medical community was able to manage with the available supply of isotopes, adapting their practices, utilizing isotopes more efficiently and using alternatives for a number of procedures where clinically appropriate. While early concerns were expressed that the NRU outage would result in significant impacts, the approaches taken by provincial and territorial governments and health care providers meant that patient care was not compromised and incremental costs were manageable. Further, the response generated important learning about ways to improve efficiency and ensure the most appropriate use of radiopharmaceuticals on an ongoing basis. Moving forward, the Government will continue to exercise its regulatory role and to invest in research and knowledge. Budget 2010 provided new funding to inform the use of alternative medical isotopes and technologies and build on lessons learned from the NRU outage. On January 24, 2011, the Government announced that $3 million of this funding will be provided to the Canadian Agency for Drugs and Technologies in Health to conduct a research study which will focus on the identification and development of improved policies, protocols, and standards to help health care decision-makers optimize the use of the medical isotope technetium-99m, as well as the use of alternative medical isotopes and medical imaging equipment, such as positron emission tomography (PET). To help move research on medical isotopes and imaging technologies into clinical practice, Budget 2010 also provided $10 million for the Canadian Institutes of Health Research to establish a medical imaging Clinical Trials Network. The Network will facilitate the rapid translation of advances in medical imaging into applications useful to the health care system in patient diagnosis and treatment by creating a critical mass of international scientific expertise, coordinating Canada’s imaging research activities, and developing standardized protocols and operating procedures. iv) Continuing International Cooperation and Engagement (Recommendation 5) The Government is committed to supporting international cooperation and engagement. The medical isotope supply chain is highly complex, consisting of both public and private sector entities and comprising various processes, including irradiation, extraction, processing, purification, and generator manufacturing, that take place at different locations and in a small group of countries. In addition, the major producer countries, such as Canada, are not the major consumer countries. Canada has therefore maintained that the security of supply of medical isotopes is a global issue requiring global assessment and global solutions. As previously mentioned, the Government spearheaded action – long before the NRU outage of May, 2009 – let to the establishment of the High Level Group on the Security of Supply of Medical Radio-isotopes under the auspices of the Nuclear Energy Agency of the Organisation for Economic Cooperation and Development. The High Level Group works in close cooperation with representatives of the medical isotope supply chain including reactor operators, processors, generator manufacturers, distributors and health care professionals. This forum has been highly effective in examining the major issues affecting the short, medium and long term reliability of medical isotope supply to identify key areas of vulnerability and identify means to address them. It has also made significant progress in improving the current supply situation by such actions as increasing communications among members of the supply chain to provide timely notification of available supplies to the medical community, coordinating reactor schedules, increasing the understanding of the use of medical isotopes, as well as managing demand side issues and practices. Canada is continuing to work closely with the High Level Group on the Security of Supply of Medical Radio-isotopes and its partners. There is an ongoing need to participate in, and support an international forum for the exchange of information, monitor progress in the establishment of a properly functioning medical isotope supply chain, pursue studies of demand side and supply side issues and address other issues that may arise. 3) Conclusion: The Government is looking to transform the way medical isotopes are produced in Canada, and in particular Tc-99m, so that Canadian production is: on a sound commercial footing without government subsidization; scaled to the needs of Canadians; sustainable in terms of environmental impacts, health, safety and security, and so that Canada remains a global technological leader. We believe that this transformation will best serve the needs of Canadians for a secure supply of medical isotopes in the medium and longer term. Canada’s NRU reactor has satisfied a significant portion of world demand for Mo-99. By producing at this scale, Canadians have been left to shoulder a disproportionate amount of the nuclear waste burden associated with reactor-based isotope production. This includes the significant costs associated with longer term management of the waste. The Government favours a new paradigm in which Canadians benefit from Canadian-based isotope production, supplemented if necessary from the world market, and supply is sustainable because of reduced waste and improved economics. Annex A The House of Commons Standing Committee on Natural Resources’ Recommendations to the Government of Canada Made in its Report Entitled: “The National Research Universal Reactor Shutdown and the Future of Medical Isotope Production and Research in Canada” Recommendation 1: Considering the evidence presented to the Committee regarding the unexpected shutdown of the National Research Universal (NRU) reactor, the Committee recommends that the Government of Canada continue to support the NRU reactor and its return to service, and provide all necessary support, financial and otherwise, to ensure that the NRU reactor licence is renewed until 2016. Recommendation 2: The Committee also recommends that the Government of Canada instruct Atomic Energy of Canada Limited to produce a report on the shutdown and repair procedures in order to facilitate better planning and faster return to service times in the event of another unexpected shutdown. Recommendation 3: Considering the important role that Canada plays in the production of medical isotopes, the Committee recommends that the Government of Canada continue to support Canadian involvement in isotope production, especially through the Non-reactor-based Isotope Supply Contribution Program. Recommendation 4: In the meantime, the Committee recommends that the federal government conduct a cost-benefit analysis of isotope production, and evaluate future production levels of isotopes. Recommendation 5: Considering the integrated nature of the international isotope supply chain, the Committee also recommends that the federal government continue to support international cooperation and engagement with other isotope suppliers, and continue to improve communication protocols between stakeholders, including the public. Recommendation 6: The Committee recommends that the Government of Canada work to ensure continued isotope production in Canada as a measure to strengthen domestic supply and ensure the availability of medical isotopes to patients regardless of changes in international supply. Recommendation 7: Considering Canada’s critical role in medical isotope research, the Committee recommends that the federal government support continued research in medical isotopes. Recommendation 8: In light of this evidence, the Committee recommends that, when necessary, the Government of Canada encourage the use of alternative medical isotopes for diagnostics. Recommendation 9: Furthermore, the Committee recommends that the Government of Canada encourage the development of Position Emission Tomography (PET) technology considering the pre-clinical and clinical trials performed in Europe and in the United States. Recommendation 10: The Committee recommends that the Government of Canada study the feasibility of a new multi-purpose research reactor in order to accurately estimate construction and operating costs as well as potential sources of income and report the results to Parliament. Recommendation 11: If a private sector proposal is made for the MAPLE reactors that accepts fully the commercial risk associated with the reactors and requires no additional costs on the part of the government, the Committee recommends that the Government of Canada remain open to considering the proposal. Recommendation 12: The Committee recommends that the federal government learn from the failure of the MAPLE reactors and the impact of the NRU shutdown on medical isotope supplies in Canada, and seek to diversify and secure the supply sources of medical isotopes in the medium and long term by funding several projects out of the $35 million envelope announced in the last federal budget. Recommendation 13: Furthermore, the Committee recommends that the Government of Canada examine fully all the alternative production proposals, and continue to support the research and development of new technologies. Recommendation 14: In particular, the Committee recommends that the Government of Canada continue to fund research in accelerator technology, both linear accelerators and cyclotrons. Recommendation 15: Considering the age of the NRU reactor, the Committee recommends that the government recognize that the NRU is not a credible or sustainable long-term solution, but is critical for the short-term supply of isotopes both domestically and globally. Recommendation 16: In addition to these measures, the Committee recommends that the Government of Canada ensure that the provinces and territories are given compensation for the increased costs and additional management costs of technetium-99m incurred by health authorities as a result of the shortage of medical isotopes. Recommendation 17: Furthermore, the Committee recommends that the Government of Canada issue a public statement to clarify whether or not it intends to get out of the supply side of isotope production by 2016. Recommendation 18: If the Government of Canada intends to get out of the isotope business as stated by the Prime Minister, the Committee recommends that it issue a public statement and table a detailed exit strategy that includes its plans to keep the NRU reactor operating until 2016. |