Criteria for Teletherapy Unit Exchange Prepared for National Nuclear Security Administration Office of Radiological Security David Albino Debaki Ale Asma Easa Matthew Mayeshiba Alex Straka Andrea Traverse Workshop in International Public Affairs Spring 2015 ©2015 Board of Regents of the University of Wisconsin System All rights reserved. For an online copy, see www.lafollette.wisc.edu/research-public-service/workshops-in-public-affairs publications@lafollette.wisc.edu The Robert M. La Follette School of Public Affairs is a teaching and research department of the University of Wisconsin–Madison. The school takes no stand on policy issues; opinions expressed in these pages reflect the views of the authors. The University of Wisconsin–Madison is an equal opportunity and affirmative-action educator and employer. We promote excellence through diversity in all programs. Table of Contents List of Tables ...................................................................................................................................v List of Figures ..................................................................................................................................v Foreword ........................................................................................................................................ vi Acknowledgments......................................................................................................................... vii Executive Summary ..................................................................................................................... viii 1 Introduction ..............................................................................................................................9 1.1 Radiotherapy and Cancer ..................................................................................................9 1.2 LINAC vs. Cobalt-60 Teletherapy Unit ............................................................................9 2 Stakeholders ...........................................................................................................................10 2.1 Recipient Country Identification .....................................................................................11 2.2 LINAC Identification and Donation ...............................................................................11 2.3 Site Preparation ...............................................................................................................12 2.4 Cobalt-60 Unit Disposal ..................................................................................................13 2.5 Special Role of the Private Sector ...................................................................................13 3 Criteria ...................................................................................................................................14 3.1 Framework ......................................................................................................................14 3.2 Medical Need and Cancer in Developing Countries .......................................................15 3.2.1 Cancer Incidence, Mortality, Projections.................................................................16 3.2.2 Role of Radiotherapy in Cancer Control .................................................................16 3.3 Technical Feasibility .......................................................................................................18 3.3.1 LINAC Costs ...........................................................................................................18 3.3.1.1 LINAC Unit and Operating Costs ................................................................... 19 3.3.1.2 Country Variation in LINAC Cost per Fraction .............................................. 21 3.3.1.3 LINAC Health Care Facility Costs .................................................................. 21 3.3.2 Infrastructure ............................................................................................................22 3.3.2.1 Needs Assessment and Communication .......................................................... 22 3.3.2.2 LINAC Site Infrastructure ............................................................................... 22 3.3.2.3 Human Capital ................................................................................................. 24 3.3.2.4 Disposal ........................................................................................................... 26 3.3.2.5 Country Wealth and LINAC Density as Measures of Infrastructure .............. 27 3.3.3 Policy and Regulatory Environment ........................................................................30 3.3.3.1 National Cancer Plan ....................................................................................... 30 3.3.3.2 National Regulatory Authority for Radiotherapy Machines ........................... 31 3.3.3.3 National Procurement Authority for Radiotherapy Machines ......................... 32 3.3.3.4 Donation Guidelines for Radiotherapy Machines ........................................... 32 3.4 Security............................................................................................................................33 3.4.1 Theft and Loss of Control of Radiological Material ................................................33 3.4.2 Benefits of Securing Source Material ......................................................................34 3.4.3 Protecting Cobalt-60 Radioactive Source Material .................................................35 3.4.4 Risk Environment Score ..........................................................................................36 4 Recommendations ..................................................................................................................37 Appendices .....................................................................................................................................38 Appendix A: Summary of Key Considerations .........................................................................38 Appendix B: Stakeholders .........................................................................................................40 Appendix C: Meets Medical Need Ranking ..............................................................................42 Appendix D: Technical Feasibility Ranking .............................................................................50 Appendix E: World Bank Income Region and WHO Regions .................................................57 Appendix F: Regulatory Factors ................................................................................................58 Appendix G: Security Threat Ranking ......................................................................................61 References ......................................................................................................................................66 List of Tables Table 1: Therapy Unit and Operating Costs ..................................................................................21 Table 2: LINAC Building Plans ....................................................................................................24 Table 3: World Bank Income Classes ............................................................................................28 Table 4: Radiotherapy Densities by Income ..................................................................................29 Table 5: Radiotherapy Densities by Region ..................................................................................29 Table 6: National Cancer Plans......................................................................................................31 Table 7: Risk Environment Score Components .............................................................................36 Table B1: Relevant Stakeholders by Stage of the Exchange .........................................................40 Table C1: LMIC Ranking based on Medical Need Variable .........................................................43 Table C2: Ranking of LMICs with Incomplete Medical Need Data .............................................46 Table D1: LMIC Ranking based on Technical Feasibility ............................................................50 Table D2: Area 4 LMIC Ranking based on Technical Feasibility ................................................54 Table F1: Regulatory Factors.........................................................................................................58 Table G1: LMIC Ranking based on Risk Environment Score ......................................................61 List of Figures Figure 1: Framework......................................................................................................................15 Figure 2: Cancer Deaths by Income Status ....................................................................................17 Figure 3: LMIC Cancer Deaths by Region ....................................................................................17 Figure 4: LMIC Radiotherapy Demand .........................................................................................17 Figure 5: LMIC Cancer Deaths by Type .......................................................................................17 Figure 6: LINAC Density vs. GNI per Capita (LMICs) ................................................................28 Figure 7: Incidence by Material Origin .........................................................................................34 Figure E1: World Bank Income Classification ..............................................................................57 Figure E2: World Health Organization Regions ............................................................................57 Figure G1: Risk Environment Map of LMICs with Cobalt-60 Units ............................................61 v Foreword The La Follette School of Public Affairs at the University of WisconsinMadison offers a twoyear graduate program leading to a Master of Public Affairs or a Master of International Public Affairs degree. In both programs, students develop analytical tools with which to assess policy responses to issues, evaluate implications of policies for efficiency and equity, and interpret and present data relevant to policy considerations. Students in the Master of International Public Affairs program produced this report for the National Nuclear Security Administration. The students are enrolled in the Workshop in International Public Affairs, the capstone course in their graduate program. The workshop challenges the students to improve their analytical skills by applying them to an issue with a substantial international component and to contribute useful knowledge and recommendations to their client. It provides them with practical experience applying the tools of analysis acquired during three semesters of prior coursework to actual problems clients face in the public, nongovernmental, and private sectors. Students work in teams to produce carefully crafted policy reports that meet high professional standards. The reports are research-based, analytical, evaluative, and (where relevant) prescriptive responses for real-world clients. This culminating experience is the ideal equivalent of the thesis for the La Follette School degrees in public affairs. While the acquisition of a set of analytical skills is important, it is no substitute for learning by doing. The opinions and judgments presented in the report do not represent the views, official or unofficial, of the La Follette School or of the client for which the report was prepared. Melanie Frances Manion Vilas-Jordan Professor of Public Affairs and Political Science May 2015 Madison, Wisconsin vi Acknowledgments We would like to thank the entire La Follette School faculty and administrative staff for their assistance and feedback throughout this policy report. Their dedication and support were critical to the development and publication of our policy report. Specifically, we thank Professor Melanie Manion for her invaluable counsel, support, and direction throughout this project. Her dedication was critical to the development and publication of our policy analysis. We also thank Ms. Malika Taalbi and Ms. Kristina Hatcher for the opportunity to apply our policy analysis skills to a complex and engaging real-world scenario. We would not have been able to produce this report without the support of Ms. Taalbi and the U.S. Government Office of Radiological Security. vii Executive Summary At the request of the National Nuclear Security Administration’s Office of Radiological Security, we analyze a proposal to facilitate the exchange of cobalt-60 teletherapy units in low-andmiddle-income countries for more advanced linear accelerator radiotherapy machines from United States and other high-income countries. The purpose of the exchange is to prevent theft or diversion of cobalt-60 for use in dirty bombs. Outside resources are needed to push countries towards adopting the more technologically complex and resource intensive linear accelerator unit. Our analysis delineates requirements for a viable exchange. We identify stakeholders and criteria salient to the proposed initiative and its long-term success. Stakeholders include international governmental organizations, national governments, private sector corporations, actors within the medical community, and non-governmental organizations. Stakeholders are relevant at different stages, including budgeting and planning, installation, and disposal. Our criteria to evaluate prospective recipient countries is formulated under a three-pronged framework. The overall long-term integrity of the initiative requires success in each respective prong. Weakness in one component of the framework may lead to the initiative’s reversal or collapse. The first prong considers the recipient country’s medical needs to combat cancer. Low- and middle-income countries face a cancer epidemic, but radiotherapy access and needs differ geographically. We analyze the composition of available radiotherapy services by country, which provides insights into country-level cancer control priority and need for radiotherapy treatment. If the proposed initiative does not meet the country’s medical and cancer treatment needs, it will be very difficult to find low- and middle-income countries participate in the exchange. The second prong considers technical feasibility in prospective recipient countries. Components for a viable exchange include the capacity to absorb the greater marginal costs associated with linear accelerators and country-level infrastructure requirements. Essential infrastructure include adequate human capital resources, an accommodative regulatory regime, progressive medical device procurement plans, and a regulated radioactive source disposal procedure. Without adequate technical feasibility the country may revert to cobalt-60 units. The third prong promotes prioritization of countries with a high risk of radiological material theft. The frequency and magnitude of regional radiological theft is a priority in determining prospective recipient countries; however, we defer to the NNSA’s expertise on security risks. The proposed initiative in a country with a high security risk provides a greater marginal benefit than it does in a country with a low security risk. We recommend the National Nuclear Security Administration involve a network of stakeholders to ensure the initiative’s success. The initiative must take into account the criteria in the threepronged framework. Countries will require various levels of technical support to ensure the exchange is viable. Based on our findings, we provide a list of questions to inform actual decision-making. viii 1 Introduction This report examines a National Nuclear Security Administration (NNSA) proposal to exchange cobalt-60 teletherapy units in low- and-middle-income countries (LMICs) for linear accelerators (LINACs) as part of a global campaign to prevent the theft and diversion of nuclear and radiological material. Cobalt-60 and other radiological isotopes used in medical and industrial fields can be transformed into dirty bombs that can cause widespread social and economic disruption. The NNSA proposal is based on a transfer it facilitated to replace two cobalt-60 units at the Kharkiv Institute of Physics and Technology in Ukraine in 2014 with a LINAC machine donated by the University of Minnesota Masonic Children’s Hospital. In this transfer, the NNSA also partnered with Argonne National Laboratories and Radiating Hope, which facilitated the legal and logistical aspects of transferring the donated LINACs. 1.1 Radiotherapy and Cancer Although early detection can lead to a decline in deaths from cancer, many people in developing and middle-income countries lack the financial means to seek medical consultation, and many of the countries have neither staff nor infrastructure to support treatment. Cancer places a disproportionate burden on developing countries: LMICs accounted for 57 percent of the 14 million people diagnosed with cancer worldwide in 2012, but 65 percent of deaths. Cancer is the lead killer in poor countries, where it reaches levels higher than AIDS, malaria, and tuberculosis combined (The Economist 2014). Improvements in research and increases in human capital resources in the medical field have led to advanced technology that is more effective in cancer treatment. Surgery is the biggest contributor to cancer cure rates, but the second biggest source is radiotherapy (Dodwell and Crellin 2006). While demand for radiotherapy has increased due to increased cancer incidence rates, treatment supply remains in deficit. Medical communities in developing countries seek further radiotherapy devices to address increasing cancer incidence rates (Grover et al. 2014). Radiotherapy mitigates organ destruction and is a more sustainable method to control localized cancerous tissue (Dodwell and Crellin 2006). Even though the technology exists, LMICs face numerous obstacles in treatment supply. One significant obstacle is the lack of adequate staff: many developing countries lack treatment centers and trained oncologists (Grover et al. 2014). Addressing the lack of staff requires more than simply improving technology, it requires increased education and training. Because radiotherapy is a favored option, high demand for it is not met due to the lack or shortages of radiographers, physicists, and dosimetrists (Dodwell and Crellin 2006). Even if the more effective technology is provided to LMICs, these countries still face a shortfall in who will administer the treatments and who has the training to know how to properly and effectively use the technology. 1.2 LINAC vs. Cobalt-60 Teletherapy Unit In 1951, the first cobalt-60 unit was installed for clinical use in London, Canada, and led to the rise of cobalt-60 machines being constructed and utilized all over the globe. Cobalt-60 units serve as a major cancer treatment to millions of people for many decades; they were the best 9 option available to fight cancer. The use of cobalt-60 units significantly decreased near the end of the 20th century. In the late 1950s LINAC were first installed for clinical use and overtime became the predominant cancer treatment technology in high-income countries (HINCs). LINACs’ ability to provide a superior dosimetry, the most precise calculation of the amount, rate, and distribution of radiation emitted from a source of ionizing radiation is cited as the primary reason for this transition. LINACs are also preferred to cobalt-60 units because it is believed that cobalt-60 units provide “substandard treatment” (Page et al. 2014). The inferior precision makes cobalt-60 a less attractive cancer treatment option for treatment facilities in the United States, but many developing countries cannot afford the initial capital investment and subsequent infrastructure needed to support a LINAC. Many LMICs even lack the resources to obtain a new cobalt-60 unit. As a result, many countries use cobalt-60 units well past the recommended lifespan. It was reported in 2010 that about half of the cobalt-60 units in Africa were 20 years or older and require replacement (Page et al. 2014). Cobalt-60 units are relatively more reliable, simpler to repair, easier to operate safely, lower in unit and operating costs, and easier to use to administer treatment. On the other hand, LINACs provide higher-quality dosimetry, reduced radiological security risks, and greater radiation safety. The paramount weakness of LINACs is that they require adequate infrastructure, a stable and reliable power supply, maintenance, and detailed training (Page et al. 2014). Before pairing a LINAC device with a recipient country and medical facility, the appropriate physical infrastructure to operate a LINAC needs to available. Budgeting of additional financial resources are required due to the significantly higher initial LINAC capital investment and operational costs. LINACs require infrastructure support and stable electricity supply. One requirement of LINAC technology is reliable electricity during treatment. These requirements pose a challenge for some countries. For example, after South Africa updated to a new LINAC, the unit frequently shut down due to power shortages and incompetent technical support. Even if the NNSA initiative eliminates prohibitive initial capital costs thorough the donation of a LINAC unit, the proposal does not reduce the high operational costs are include upgrades to electrical systems. LMICs face greater obstacles in operating and running LINACs than cobalt-60 units. Cobalt-60 units do not require an unwavering power supplies to generate stable and reliable radiation beams. The proposed initiative has careful consider how best to allocate resources to support LMICs throughout the transition to a LINAC-based cancer treatment regime (Page et al. 2014). 2 Stakeholders In planning this initiative, the NNSA can coordinate with expert stakeholders to ensure the initiative’s long-term success. Stakeholders include international, national, and sub-national actors with significant interest in the long-term outcome of the initiative. In addition to providing crucial buy-in to the initiative’s operation, a number of the actors outlined below can provide critical and expert advice on program implementation. This section outlines governmental, nongovernmental, and private-sector actors who can be involved in implementation including initial planning, LINAC identification, site preparation, and cobalt-60 unit disposal. An extensive list of potential stakeholders organized around the phase of the exchange is provided in Appendix B. 10 2.1 Recipient Country Identification Identifying capable and willing partners to receive the donated LINAC is an essential first step in implementation of this program. While leveraging pre-existing bilateral relationships may be sufficient for securing an initial set of partners, the expertise and connections of a variety of outside organizations can help secure the long-term viability of the project. The World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) are bolstering radiotherapy capabilities in developing nations. In addition to various independent initiatives, these two inter-governmental organizations cooperate on the Programme of Action for Cancer Therapy (PACT). This initiative works with national governments to create and improve plans to respond to the emerging cancer epidemic in LMICs. Of particular interest is the PACT advisory group, which works extensively with developing nations to coordinate the smooth and sustainable transfer of radiotherapy equipment to them. A wide array of non-governmental organizations are responding to the emerging threat of cancer in the developing world. These organizations include the Global Task Force on Expanding Access to Cancer Care and Control, the Africa Oxford Cancer Foundation, and RadiatingHope. While contacts with other non-governmental organizations can be an important part of the NNSA initiative, these three organizations were created as multi-disciplinary efforts to coordinate a wide variety of organizations. As a result, the relationships these organizations can call on and leverage during this phase of the project are of particular importance. Finally, national government organizations and health professionals in a recipient country play indispensable roles in determining whether the proposed exchange of a cobalt-60 unit for a LINAC is appropriate under particular circumstances. Of particular note are ministry of health officials, who will be able to provide the most up-to-date information on the state of the country’s health infrastructure as well as valuable personal contacts within the health system itself. This information is invaluable in determining which institutions are most suitable recipients and what sorts of accommodations will be needed to ensure long-term sustainability of an exchange. 2.2 LINAC Identification and Donation Identifying institutions willing to donate used but serviceable LINACs is a second essential part of program implementation. For this stage, the NNSA can leverage its connections with nonprofit organizations such as RadiatingHope and Argonne National Laboratories. The NNSA can build connections with other organizations that may be able to broaden the search for donated LINACs. Since 2005, an American non-governmental organization, the East Meets West Foundation, has assisted the government of Vietnam to fund two LINACs and one cobalt-60 unit (FNCA 2015). The NNSA can consider working with organizations to receive assistance in the financial aspects of LINAC identification and donation. 11 2.3 Site Preparation Readying the donated LINAC for transport to the receiving institution and preparing that institution to receive the LINAC is the largest and most complex stage of this project. Successful completion would involve extensive communication with each of the stakeholders noted above, while requiring coordination with government agencies to approve the physical transfer of the device and specialist actors to ensure the long-term sustainability of the LINAC’s operation. The LINAC is a complex and expensive piece of equipment. Transferring it would involve health officials in the receiving country and require coordination with customs, transportation, and foreign affairs officials to secure needed permits to move the device. LINAC transfers may fall under some U.S. export controls, complicating NNSA coordination with some countries. As a result, coordination with the U.S. Department of State is an essential step before any transfer takes place. Before LINAC transfer can take place, however, the device itself may require substantial repairs and upgrades to ensure it is fully operational when it arrives at the receiving institution. Through its involvement in the Ukraine project, RadiatingHope gained experience coordinating this process, which involves contracting with private companies to inspect and refurbish the donated machine, and ensuring complete records of that process are transmitted to the receiving institution in a form usable to the personnel who will operate the LINAC. The physical construction needed at the receiving site to accommodate the newly donated LINAC must be planned in coordination with local and international medical experts. The IAEA provides guidelines on proper shielding of teletherapy units. Additionally, consulting companies and local contractors are required to design or update the facility to accept the donated LINAC device, and moving companies are needed to move the unit into the facility. Education of the receiving staff to ensure they can properly operate and maintain the donated equipment is an essential part of ensuring the long-term sustainability of this project. A variety of regional intergovernmental organizations already support the education of oncology personnel, such as the African Regional Co-Operative Agreement for Research, Development, and Training Related to Nuclear Science and Technology. This organization can be useful to the NNSA in identifying a recipient country because its personnel know the region, and also, are able to assist in education and training of radiation oncologists and medical physicists (International Atomic Energy Agency 2010; International Atomic Energy Agency 2003). Other regional and multinational organizations that can be of assistance to the proposed initiative include the Regional Co-operative Arrangements for the Promotion of Nuclear Science and Technology in Latin America, the Arab Atomic Energy Agency, and the Forum of Nuclear Cooperation in Asia. RadiatingHope provides operational and peer support to radiation clinics in developing countries and shares expert knowledge on cancer cases using cloud-based collaboration platform Quentry (Brainlab 2014). The Tropical Health and Education Trust, an affiliate of UK Aid, works with structured health partnerships between the UK and LMICs to educate, train, and provide access to donated medical devices (Mullally 2013). 12 Additionally, securing buy-in and support from oncologists and technicians who have experience operating LINAC machines already in the receiving country can be an excellent source of operational knowledge to the receiving personnel. 2.4 Cobalt-60 Unit Disposal Disposal or storage of the decommissioned cobalt-60 gamma-ray source is a final major stage of the project. Disposal involves dismantling and decommissioning the cobalt-60 unit itself and transferring its radiation source to an acceptable long-term storage or disposal facility. Decommissioning the source can be a logistically and legally difficult process, given the sensitivity of the material involved. Therefore, if at all possible, partner countries should have the capacity to store or dispose of the decommissioned source. In the event that the receiving national government lacks the capacity to properly store or dispose of the cobalt-60, international organizations such as the IAEA Technical Cooperation Program may be able and willing to augment the government’s storage capacity. The Technical Cooperation Program operates a mobile hot cell program that has been used to store radioactive sources such as cobalt-60 for long periods of time in a variety of countries, and it assists member states by providing international experts to develop and implement policy and strategy for radioactive source management (International Atomic Energy Agency 2013b). The U.S. Department of Energy, under its International Radiological Threat Reduction Program and OffSite Source Recovery Project, works in identifying, recovering, securing, and storing vulnerable, high-risk radiological sources (Medalia 2011). The Arab Atomic Energy Agency, a suborganization of the Arab League, assists in setting up regulations for radiation protection, security, and safe handling of radioactive materials for its 13 member states (AAEA 2015). In the event that the partner government cannot properly dispose of this source, governments of the countries where cobalt-60 was originally produced are often legally obligated to receive the spent fuel. The technical, logistical, and legal hurdles involved in moving these materials across national borders and oceans may render such an operation difficult and costly. Almost one-third of incidents of theft and loss recorded in 2013, for example, occurred when the radioactive material was in transit (James Martin Center for Nonproliferation Studies 2015). Using the services of private companies such as CargoNet and FreightWatch International, the NNSA can help determine safe routes of cargo travel to the disposal or storage facility. 2.5 Special Role of the Private Sector In addition to providing services, private-sector corporations could play a vital role in increasing access to LINACs in the developing world. Varian Medical Systems, Elektra, Siemens, and other companies have extensive knowledge in LINAC research and development. Thus far, however, this product development has been targeted primarily at high-end health care markets in the developed world. With the increasing prevalence of cancer in LMICs, coupled with rising personal income, a market may be developing for lower-cost, lower-maintenance versions of the LINACs available in HINCs. While these machines may not be as powerful or as versatile as those in more affluent societies, the inherently greater precision and energy density of the LINAC may allow relatively simple LINACs to compete in a less affluent society. Development of a simpler product for sale specifically in developing countries is not without precedent: 13 General Electric has had success redesigning cardiograph machines for these markets. Facilitating this development may be another way to decrease the prevalence of cobalt-60 units. 3 Criteria To devise criteria for successful LINAC transfers, we develop a three-prong framework and provide recommendations to promote the likelihood of a long-term, successful LINAC donation. Section 3.1 outlines our framework. Section 3.2 focuses on the medical need in LMICs, based on cancer prevalence. Section 3.3 discusses technical feasibility, which we identify as the linchpin of a successful LINAC transfer and, for that reason, discuss in greater detail. Section 3.4 discusses the cobalt-60 security concern; here, we provide analysis, yet largely defer to the NNSA’s judgment and expertise. In the appendices, we rank LMICs according to each criterion. 3.1 Framework The Global Threat Reduction Initiative works to convert, remove, and protect radiological material in civilian sites in the United States and abroad (NNSA 2014). This proposal seeks to exchange cobalt-60 units for LINACs and is part of the initiative’s long-term goals. We argue the proposed initiative’s success is contingent the framework’s three prongs: First, the exchange must reduce the radiological security threat within the LMIC, and the regional and global communities. A recipient country with a high security threat, such as theft, provides a marginally higher security benefit if the LINAC-cobalt-60 initiative leads to a successful exchange. Second, the recipient country must have the technical capacity to support a LINAC. High technical feasibility includes adequate financial resources, supportive physical and human capital, and an accommodative regulatory environment. Third, the exchange must contribute to the LMIC’s medical needs to mitigate the cancer epidemic. The proposed initiative must assist the recipient country with combating the cancer epidemic and lack of cancer treatment services. High medical need may incentivize stakeholder engagement and the initiative’s adoption by domestic governments. Figure 1 illustrates our criteria framework. Area 1 represents ideal recipient countries, which require little additional NNSA support besides facilitation of the exchange. Area 2 countries can support LINACs and face a high security threat, yet lack a cancer epidemic. LINACs can be installed and require little additional support. However, the public health payoff is less for countries with greater medical need. Area 3 countries have a high security threat and growing cancer epidemic, yet lack the technical ability to support a LINAC machine. These countries need to develop additional capacities and receive external support for a successful exchange. Area 4 countries have high technical feasibility and a growing cancer concern; however, they lack a prevalent security threat. These countries are not a priority in the short term. 14 Figure 1: Framework Source: (Authors) All three prongs should be considered when selecting recipient countries. We rank LMICs in each of the three prongs using a proxy, which we discuss in more detail throughout the remainder of the report. Proxies are supported by research and developed using third-party indices or specific data relevant to each prong. These proxies assist and inform the NNSA in its recipient country selection. Areas 1, 2, 3, and 4 represent overlap which can be found using these proxies. We do not find a scenario where countries perfectly overlap in Area 1. The initiative’s purpose is not solely to identify criteria indicating greatest successful exchange likelihood, but also to identify stakeholders and consider how to leverage their strengths to improve a LMIC’s candidacy. For example, a country may lack full technical feasibility, yet through assistance facilitated via the proposed initiative, become a relatively ideal country in time. 3.2 Medical Need and Cancer in Developing Countries Cancer is an emerging public health crisis in the developing word and has an estimated annual cost to LMICs of $800 billion1 in 2010 (Knaul et al. 2014). As LMICs industrialize, changes in environment, lifestyle, and behavior increase cancer incidence. The changes in risk factors coupled with a relatively growing and aging population results in the prevalence of cancer in the population to increase. These societal changes in LMIC have led the WHO to predict cancer incidence and mortality rates to continually rise (World Health Organization 2014b). Cancer burden is shifting to LMICs. Based on 2012 GLOBOCAN projections, cancer accounted for 8 million cancer diagnoses and 5.3 million deaths in 2012 (Ferlay et al. 2010). These figures account for 57 percent of cancer incidence and 66 percent of cancer mortality worldwide (Torre et al. 2015) . For individuals living in less developed countries, cancer diagnosis usually occurs 1 This annual cost estimate uses a value of statistical life approach which includes, for example, the value the individuals themselves place on lost income, out-of-pocket spending on health, and a monetization of pain, and suffering. 15 at advanced stages, and access to effective treatment is limited or unavailable. Effective treatment is in stark contrast in HINCs with broad application of effective prevention measures, early detection, and access to treatment. We provide a LMIC Meets Medical Need ranking using a proxy based on cancer incidence rates from Globocan data and convert this population into an estimate of country level demand for radiotherapy machines. (See Appendix C for a discussion of calculations and complete ranking of LMICs). The top five countries based on this proxy are: Ethiopia, Uganda, Madagascar, Tanzania, and Cambodia. 3.2.1 Cancer Incidence, Mortality, Projections Cancer incidence and mortality are increasing globally. The probability of surviving cancer is 51 percent in developed countries and 16 percent in less-developed countries (Ferlay et al. 2010). Understanding which types of cancers affect which regions is crucial to determine which LMICs are most amenable to LINAC donations. The WHO collects a myriad of data on mortality. These country-level data also contain region and income identifiers. Figure 2 plots percentage of total cancer deaths over time separated by income status (World Health Organization 2015). These data illustrate the growth of the cancer epidemic in LMICs relative to HINCs. Therefore any action taken by the NNSA cannot undermine any cancer reduction effort or disrupt the cancer treatment status quo. Regional data are useful to see which LMIC areas have the greatest cancer incidence. Figure 3 plots all cancer deaths in LMICs: actual cancer deaths for 2000 and 2012, and cancer death projections for 2015 and 2030. As shown, cancer deaths are more prominent in the Western Pacific and South-East Asia. Different cancers require different treatments. Figure 4 shows LMIC cancer related deaths by type. Trachea, bronchus, lung, stomach, and liver cancer have the highest mortality rates. Highly preventable cancer deaths, including bronchus and lung, demonstrate how cancer prevention education can reduce reliance on teletherapy machines. Reducing demand increases the ability of LMIC medical professionals to switch to LINAC devices once the cobalt-60 units are demanded less. 3.2.2 Role of Radiotherapy in Cancer Control Until LMICs implement more expansive preventative cancer plans, a higher number of patients will receive late-stage cancer diagnoses. Diagnoses at advanced stage cancer means radiotherapy becomes the last resort to cure or prolong a patient’s life and an absolutely vital component of cancer treatment. In 2012, of the 8 million new cases of cancer in developing countries, 60 to 68 percent needing radiotherapy services for palliative and curative cancer treatment (Grover, Dixit, and Metz 2015; Ravichandran 2009). Health care systems in these countries are already stressed from health shocks and lack the resources and technical knowledge to obtain a radiotherapy device without international support. 16 Figure 2: Cancer Deaths by Income Status Figure 2: LMIC Cancer Deaths by Region Source: Authors using data from WHO 2015 Source: Authors using data from WHO 2015 Figure 4: LMIC Cancer Deaths by Type Figure 3: LMIC Radiotherapy Demand Source: Authors using data from WHO 2015 Source: Authors using data from: GLOBALCOM 2012 17 We conduct an analysis to determine the medical demand met for cancer patients needing radiotherapy in LMICs differentiated by region (Error! Reference source not found.). (See Appendix C for a country-level calculation and ranking.) Results show that no regions meet demand for radiotherapy units. We determine that Africa and South-East Asia have the most unmet supply for radiotherapy devices, meeting only 18 percent and 19 percent of medical need respectively. The Americas meet the most medical need, with 70 percent of supply of radiotherapy units available for treatment. 3.3 Technical Feasibility The NNSA initiative’s success is conditional on the long-term capability of the recipient country to effectively operate the donated LINAC. We discuss LINAC costs, infrastructure, and the policy and regulatory environment required to transfer, maintain, and operate a LINAC in the prospective recipient country. We offer key technical considerations for each technical feasibility criterion that the NNSA should evaluate before an exchange is initiated. (See Appendix A for these key considerations.) We define a successful recipient country as one able to support the LINAC throughout its useful life. The WHO discusses specific obstacles. We draw on WHO findings and our own to provide a technical feasibility overview. The items listed below are criteria to evaluate the technical capacity of a recipient country (World Health Organization, Department of Essential Health Technologies 2011b): high-level communication between the donor and recipient country sufficient appreciation of the challenges of the recipient’s context sufficient linkages across activities by organizations working on donations sufficient financial resources to support new medical equipment sufficient support for the long-term integration of new equipment sufficient personnel and human capital necessities accommodative regulatory environment accountability of tracking and monitoring donations and existing quantification framework for donation impact We rank LMIC infrastructure, which is one component of technical feasibility, using a country’s density of LINAC machines and gross national income (GNI) per capita. LMICs with no cobalt60 units are ranked separately to LMICs with cobalt-60 units because there is no relevant security threat. We discuss these data in Appendix D. 3.3.1 LINAC Costs LINAC costs can be prohibitively high for prospective recipient countries and vary dramatically based on geographic location. A country’s ability to absorb these additional costs indicates greater technical feasibility. We recommend the NNSA donate to countries with the adequate financial resources and requisite infrastructure to support the fixed and variable LINAC costs. In this section, we deploy a micro-level approach, focusing on the costs of a single LINAC to 18 illustrate why adequate financing is necessary. We do not incorporate the shadow costs of cobalt60 units.2 The IAEA outlines costs that countries should consider when creating a radiotherapy facility or expanding a facility. Our findings expand this list to include the following: unit costs, operating costs, long-term maintenance and servicing costs, source replacement and disposal costs (when applicable), health care facility costs, and average cost per fraction, the average cost for a single treatment dose during a LINAC’s lifespan. We recommend the NNSA ensure countries create a resource allocation plan that incorporates these cost considerations to ensure they have the financial capacity to support a LINAC. These costs vary significantly with geographic location, machine age, and supply of physical and human capital required to replace and install the LINAC (Van Der Giessen et al. 2004). We discuss costs, their variation, and their implications below. 3.3.1.1 LINAC Unit and Operating Costs The unit and operating cost of a single new LINAC are prohibitive for many LMICs. A LINAC’s unit and operating costs can be three to five times more than a cobalt-60 unit, with operating costs three to six times the cost of cobalt-60 unit (National Research Council 2008). However, low-energy LINACs, which use substantially less electricity than high-energy LINACs, are suitable for many LMICs, meaning some LMICs will have the capacity to purchase and maintain LINACs, although many countries will need financing from domestic and foreign sources. A new LINAC’s $2 million unit cost is outside the financial capacity of many LMICs (National Research Council 2008). However, a discount or donation may significantly help a country in search of a LINAC. Unit cost variation depends on age and technical specifications of the unit, including the machine’s required megavoltage. Insurance, import duties, agent fees, and supplementary services and equipment purchased add cost variation that is largely countryspecific (International Atomic Energy Agency 2010). Supplementary services and equipment include personnel training and contract servicing. Dr. Norman Coleman of the Center for Cancer Research noted in an interview that refurbished or used LINACs may come at a fraction of the cost of a new unit. However, a refurbished device comes with a trade-off of a shorter lifespan and more repairs. We recommend the NNSA require a recipient country to devise a replacement plan for the donated LINAC at the end of its lifespan to meet retirement costs. LINAC operating costs relative to the cobalt-60 unit operating costs are significantly higher. These operating costs include equipment-related costs, long-term maintenance and servicing 2 For example, a formal cost-benefit analysis would quantify additional costs of a cobalt-60 unit not considered in our analysis. A cost-benefit analysis would consider the direct cost of an actual deployment of a radiological dispersal device on human health (physical injury, psychological harm, loss of life), damage to property, contamination of buildings and property, and indirect costs of economic loss of activity (Stewart 2010; Kelly 2006; Rosoff and Winterfeldt 2007). Other indirect costs needed to prevent an attack include administrative costs and procurement of technology employed to strengthen security (Kelly 2006). Cost is involved in the training of first responders to guarantee effective disaster response to radiological contamination (Ferguson, Kazi, and Perera 2003) and insurance costs for the government and private industry (Michel-Kerjan, Raschky, and Kunreuther 2014). Costs associated with the radiological storage facility include building site construction, operation, and maintenance (Boeing Company 2007). 19 costs, and radioactive material replacement costs (applicable to cobalt-60 units only). An advantage of a LINAC is it does not require radioactive source replacement or disposal every seven years, which on average a cobalt-60 unit requires (Reddy 2013). Thus, a LINAC represents a cost saving to the recipient country in the event of an exchange. In many countries, the required cobalt-60 source replacement results in greater long-term costs. For example, in India when the cost of radioactive source replacement is included as an operating cost for 10 years, cobalt-60 units are more expensive than LINACs by 175 percent (Reddy 2013). However, a disadvantage of a LINAC is the relatively more complex and extensive long-term maintenance and servicing, excluding radioactive source replacement, which requires professionally trained staff. Health care facilities may contract with corporations such as Radiology Oncology Systems to service LINAC machines. Long-term maintenance costs are equivalent to 6.7 to 7.5 percent of the overall unit cost, depending on machine voltage. Longterm maintenance costs do not include personnel to administer treatment, such as radiotherapy technicians (National Research Council 2008). A LMIC may commit to the proposed initiative if its government understands the cost trade-offs. Additional LINAC operating burdens include a relatively greater time for corrective maintenance and calibration. LINAC’s reported down time for repairs are approximately 8 percent of operating time. This downtime is seven percentage points greater than breakdown time for cobalt-60 units (when the LINAC is in an LMIC). LINAC down time in LMICs is largely attributed to lack of financial resources, which leads to repair delay (Van Der Giessen et al. 2004). Calibrating output is crucial for effective cancer treatment and prevention of secondary cancers. Output calibration also varies by radiotherapy machine. A LINAC requires output calibrations 52 times more frequently than a cobalt-60 unit (National Research Council 2008). Machine calibrations imposes additional servicing and personnel costs on already limited health care infrastructure in LMICs. The recipient countries should plan long term for the LINAC cost premium and provide adequate financial resources to accommodate the new, high operating costs. Table 1 displays cost differentials across radiotherapy machines LINACs primarily fall into three energy categories: low, medium, and high. Low-energy LINACs, 4 to 6 megavolts, are relatively more suitable for LMICs and are comparable to cobalt-60 unit costs (Reddy 2013). The 6-megavolt LINAC, which provides superior treatment to a cobalt-60 unit, is relatively inexpensive and may prove most viable for health care systems with limited financial resources to support recurring operating expenses. The 18- megavolt LINAC is a feasible option in a country with adequate financial resources to fund ongoing maintenance and adequate power supply. 20 Table 1: Therapy Unit and Operating Costs Radiotherapy Machine Unit Cost (per unit) Operating Costs (per year) Decommission Costs (per source) Co–60 Unit 750,000 50,000 LINAC 6 megavolts 2,250,000 150,000 Not Applicable LINAC 18 megavolts 4,000,000 300,000 Not Applicable 20,000 80,000 Source: (National Research Council 2008) (Authors) Notes: Costs in U.S. dollars. Operating cost(s) include: equipment-related costs, maintenance costs, servicing costs, and source replacement; costs do not include required additional personnel costs, such as radiotherapists and operators. Modified cobalt-60 units pose a concern for the proposed NNSA initiative because they offer superior radiotherapy services relative to traditional cobalt-60 units, yet at a low cost relative to a LINAC. For example, multi-leaf collimators, dynamic wedges, and dynamic operation— traditionally LINAC-specific technology—are now available cobalt-60 unit upgrades (National Research Council 2008). These features enhance the precision and accuracy of the treatment; the cobalt-60 security risk remains, however. 3.3.1.2 Country Variation in LINAC Cost per Fraction We recommend the NSSA remain cognizant of LINAC cost per fraction variation. Cost per fraction—the average cost for a single treatment dose over the LINAC’s life span—varies by country and can be substantially more (or less) than the cost per fraction of a cobalt-60 unit. LINAC cost per fraction averages 85 percentage points more than cobalt-60 units (Van Der Giessen et al. 2004) . Cost per fraction also varies geographically and is contingent on countryspecific factors, which include the country’s cobalt-60 supplies, per-capita income, regulatory requirements, and taxes. Accounting for these different factors in the recipient country is important because they may increase or decrease the cost of treatment, relative to a cobalt-60 unit. A high cost per fraction of a cobalt-60 unit relative to a LINAC is a stronger incentive for a country to participate in the proposed initiative. LINAC median cost per fraction is $11.02 with a lower and upper bound of $3.27 and $39.59, respectively. Van Der Giessen et al. (2004) found a LINAC cost per fraction of less than $5 in Cuba, approximately $10 in Indonesia, and more than $30 in South Africa, which illustrates the cost variation among LMICs using the same technology. The variation in cost per fraction is substantially greater in countries that supply their own cobalt-60 versus countries that import. In countries that supply their own cobalt-60, LINAC cost per fraction may exceed cobalt-60 unit cost per fraction by more than 530 percentage points (Van Der Giessen et al. 2004). In LMICs that produce their own cobalt-60, political and economic vested interests make participation in the proposed initiative unlikely. 3.3.1.3 LINAC Health Care Facility Costs A LINAC requires additional physical infrastructure at the health care facility, imposing high costs and requirements on LMICs. A LINAC will not be viable in the absence of such support 21 and facility infrastructure. LMICs may need additional financial support or expertise in preparing an LINAC adequate facility. Additional physical infrastructure includes a ceiling and floor supports reinforced above and beyond what cobalt-60 unit infrastructure requires. A LINAC requires an adequate, uninterruptable power supply. The quantity of power is conditional on the megavoltage of the LINAC device, which can range from 4 to 22 megavolts. An emergency power generator is required in the event of power failure to reduce risk of lost or damaged data and injury to the patient. If a LMIC lacks radiotherapy services, it will need to construct a facility built specifically to handle radiological medical devices. New facilities can cost upward of $5 million (International Atomic Energy Agency 2010). Countries that require and cannot afford a new facility are not ideal candidates for an exchange. 3.3.2 Infrastructure Adequate country-level medical infrastructure and conditions indicate the capacity for the recipient country to participate in the exchange. While the NNSA would facilitate the initial LINAC donation, the long-term success of the program is conditional on the capacity of the recipient country to support a LINAC cancer treatment facility. In this section we discuss required and recommended country-level medical infrastructure. Presence of specific country-level infrastructure can indicate a greater likelihood of successful and sustainable exchange. Needs assessment, communication, site facilities, human capital, and cobalt-60 disposal processes are all infrastructure factors that the NNSA must consider. 3.3.2.1 Needs Assessment and Communication A high level of communication between the donor country, recipient country, and external stakeholders is vital to ensure a successful and sustainable exchange. In particular, a formal country-level needs assessment, which addresses concerns regarding adequate funding, personnel, and other support, may increase likelihood of success and enhance communication among stakeholders. A needs assessment is a starting point to ensure the country and health care facility need a machine and are aware of the obstacles and challenges (Datta, Samiei, and Bodis 2014). Additionally, a needs assessment may indicate the recipient's understanding of national capacity to support a LINAC and provide insight to the NNSA on a specific country’s or facility’s limitations (World Health Organization, Department of Essential Health Technologies 2011a). Due to the relative complexity of a LINAC versus a cobalt-60 unit, we advise the recipient country conduct a needs assessment and devise an action plan that addresses technical concerns. We speculate many LMICs do not have the capacity to fully create a thorough needs assessment. The NNSA should form partnerships with stakeholders to assess the country’s readiness and capacity to participate in the exchange. 3.3.2.2 LINAC Site Infrastructure The cancer facility receiving the donated LINAC may need structural adjustments to prepare for the permanent installation of the unit. The extent of pre-installation construction depends on 22 whether the LINAC replaces a cobalt-60 unit or is located in a new facility. To minimize liability risk exposure and maintain the integrity of the transfer, the NNSA should ensure benefits the country adheres to general construction safety procedures and manufacturer specification. Regulatory building standards ensure the structural integrity of the health care facility. The quality of construction should meet international standards. The donated LINAC device should be installed in a treatment center subject to building ordinances and safety procedures to maintain adequate amount of shielding, weight-bearing floor, support, ceiling height and floor space for a control room, treatment suite, and equipment room. Manufacturers can be consulted and site planners can evaluate the site for compliance. These standards will protect patients and staff from harmful doses of non-isotopic radiation and improve the lifetime of the facility and LINAC unit. Besides structural changes to the receiving facility, LINACs require a stable electrical infrastructure and other utilities such as information technology connections and plumbing. These technical aspects are necessary for the operation and adequate cooling of the LINAC. All LINAC models have manufacturer recommendations that outline optimal system requirements for electrical needs. These include specifications about input voltage, line voltage regulation (voltage stabilization), and electrical loads, including a mandatory ground conductor that improves the safety and useful life of the unit. Contractors must follow these electrical recommendations to protect the safety of patients, staff, and the public. Because the unit emits a substantial amount of heat, external coolant requirements are also necessary. Additional electrical requirements are needed to operate a heating, ventilating, and air conditioning system to maintain 24-hour-a-day room temperature and humidity controls. Additional plumbing is needed to operate cooling units in the equipment room. Adhering to electrical and coolant guidelines prevent operational damage, extends the life of the device, and protects the facility from fires. Table 2 lists site specifications for a CyberKnife Robotic Radiosurgery System. Radiotherapy and radiosurgery both deliver collimated beams of radiation (Accuray 2012). While, the make and the model of any donated LINAC are unknown, general specifications about the Cyberknife can provide basic information about building or remodeling a site with some possibly of error. This discrepancy is because the Cyberknife is not an exact replication of LINAC technology. When designing a building site, please defer to the actual LINAC model’s specification guidelines. 23 Table 2: LINAC Building Plans Building Permits and licensing requirements of local, state and national codes; and Regulatory Needs ordinances affecting site planning, site preparation, construction, system installation and system maintenance. Pre-installation Construction ·designate space for control room, treatment suite and equipment room. · construct new or additional shielding · modify ceiling height and floor space · provide all electrical, plumbing, fire protection, heating, ventilating, and air conditioning, lighting and power distribution · provide all information technology requirements · supply other accessories such as cabinetry, sinks and other millwork Radiation Shielding LINACs are shielded to limit the leakage of the primary beam into public areas. Primary barrier thickness is 48 to 60 inches of standard density concrete (2.3 grams per cubic centimeter) but depends on local regulations. Primary barriers adjacent to public areas use 60 inches. Secondary barriers, including the ceiling, use 42 inches. Electrical Requirements · supply 480 voltage alternating current (VAC), 3-phase, 100 amps, 55 kilovolt amps (kVA) power (200-480 VAC input power is accepted but 150 amps is required) · power conditioner (voltage stabilizer) is required if input voltage cannot be regulated to within +/- 5 percent phase to phase · uninterruptable power supply such as an emergency power generator is required in the event of power failure to reduce risk of lost or damage to data Environmental Requirements The area that houses the LINAC equipment, such as the treatment and equipment rooms, should be kept between 50-85º F(10-30º C) at all times, with 30 percent to 70 percent relative humidity. Information Technology Considerations · install device software · provide necessary Internet protocol addresses Source: (Accuray 2012) 3.3.2.3 Human Capital LMICs with sufficient staff to operate and maintain the donated LINAC have a greater likelihood of success. Technical and medical personnel with advanced training and education are required to operate radiotherapy centers. These professionals include radiation oncologists, radiation biologists, radiation therapists, radiation oncology nurses, medical physicists, and nuclear engineers. These professions require 12 years of primary school, four years of college, and two to eight years of post-graduate education. Some professions may require several additional years of residency requirements. To walk these career paths, people must have access to primary education sufficient for university attendance, and beyond. The cost of university attendance can 24 be prohibitive, even in HINCs with subsidized higher education. This expense is an additional barrier to entry, even for HINCs. A second complicating factor is the global shortage of these trained medical professionals (Hoyler et al. 2014), which results in extremely high wages that often drive professionals to relocate to HINCs where they can make more money (Hagopian et al. 2004). A tertiary factor is the lack of an international accreditation standard for the licensing and regulation of these medical professionals. Advanced training in one country may be deemed insufficient to practice the same profession in another country (Forcier, Simoens, and Giuffrida 2014). These three problems—access to education, demand for high pay, and incongruent international licensure requirements—present a daunting task for LMICs. Access to education is still a problem in the United States and other HINCs. Not all HINCs can afford to employ these medical professionals in sufficient supply. Not all trained medical professionals can practice internationally. If training, acquisition, and retention of such qualified staff still results in shortages for the HINCs, the chances of LMICs competing with HINCs for these professionals may be insurmountable. Additionally, the requirements for a national education system from primary to post-graduate education within these countries is a necessary investment, but beyond the scope of this report. LMICs must seek alternatives, if not a stop-gap. Advanced medical professionals are a requirement for the safe, effective operation and maintenance of LINACs. In contrast, the educational requirements and diversity of medical professional training is significantly less for cobalt-60 units. Because these units are operated in LMICs, we assume education systems provide for a supply of medical professionals sufficient to operate them. Furthermore, without appropriate medical staff, LMICs are significantly less likely to seek procurement of LINACs. This situation allows for two options: train existing staff or leverage existing international staff. Both options may be met through contributing financial resources to the IAEA. Through sub-units, the IAEA provides a plethora of resources for LMICs. The Division of Human Health seeks to “enhance the capabilities in Member States to address needs related to the prevention, diagnosis and treatment of diseases through the application of nuclear techniques” (International Atomic Energy Agency 2014b). The Department of Technical Cooperation “supports human resource capacity building activities, networking, knowledge sharing and partnership facilitation, as well as the procurement of equipment” (International Atomic Energy Agency 2013b). “The IAEA, through PACT (Programme of Action for Cancer Therapy), the WHO, the International Agency for Research on Cancer (IARC) and other cancerrelated organizations work together to make a coordinated global response in supporting low and middle income IAEA Member States in the implementation of comprehensive national cancer control programmes” (International Atomic Energy Agency 2013a). The magnitude of research, planning, resources, implementation, and cross-collaboration is well beyond the scope of this report. However, we recommend utilizing IAEA resources to assess cancer treatment education, and training needs required for effective and sustained LINAC implementation in LMCs. Such capacity building is in the best interest for the success of the 25 NNSA’s proposed initiative to secure cobalt-60 units in exchange for LINACs by ensuring target countries are able and willing to exchange teletherapy units. 3.3.2.4 Disposal Even at the end of its useful life, the cobalt-60 radiation source remains highly radioactive. As a result, transport to a long-term storage or disposal facility requires significant logistical planning, coordination with local authorities, and associated costs. As radioactive waste, transportation requires a specialized radioactive package to protect against radiation leakage and potential shipping accidents. Given the expense and highly specialized purpose of these packages, equipment may not be available in countries without substantial nuclear infrastructure. While these packages may be rented or borrowed from organizations such as the United States Off-site Source Recovery Project (Whitworth 2015) or the IAEA through its Mobile Hot Cell (International Atomic Energy Agency 2012), these devices are large and expensive and require substantial planning and expense to move them on site. Shortages of type-B container, which are shielded and accident-proof transportation containers, have prevented the repatriation of United States source material from Latin America. One potential solution is to wait to repatriate material until higher-level wastes are removed from nuclear reactors. The NNSA will need to coordinate extensively with national governments to secure proper permits to use transportation networks and to use national ports of entry and exit because of the sensitivity of the radioactive source. Many countries have a centralized nuclear regulatory authority that could provide expertise in coordinating such a transfer (see IAEA website for a list of nuclear regulatory authorities). Other countries, particularly those without a developed nuclear industry, may lack this central authority. Lack of a central authority would require the NNSA or the target health organization to negotiate for permits directly, which would complicate transport. Therefore, the presence of such a centralized authority should be one criterion for program participation. Long-term storage or disposal within the host country, assuming these options exist, will prove easier than international transfer of the material. Such a solution may take the form of a permanent disposal facility. However, few countries host such facilities and those that do tend to have higher national income and developed nuclear power programs (Streeper et al. 2008). A more likely possibility is a national long-term, rather than permanent, storage facility monitored and maintained by the national nuclear regulatory authority. While these facilities vary widely in their capacity to secure radiological materials, they are solely dedicated to the safe and secure storage of these materials. Long-term storage is not the optimal solution, but it is an improvement over the status quo. In the long run, the IAEA already supports programs for upgrading long-term storage facilities (IAEA, n.d. The Use of Management Sealed Radioactive Sources). Another option is the transfer of the cobalt-60 radiation source to another country for final disposition. When the host country lacks secure long-term storage, exportation may be the sole option for disposal. This process brings substantial legal and logistical complications. IAEA policies generally discourage international transfer of radioactive wastes. However, in some cases the IAEA has acknowledged such transfers are beneficial (International Atomic Energy Agency 2000). Even so, countries without vested interest in the material are unlikely to accept it for long-term storage or permanent disposition. 26 When considering possible countries to accept the material, the material source and original contract outlining the sale must be considered. For recently purchased material, the contract may contain a clause requiring the seller to accept the material once spent for recycling or disposition. This clause will require payment of a fee to cover transportation costs, which may be substantial for areas with limited health funding. For U.S.-sourced material, the Off-site Source Recovery Project may facilitate a transfer. However, the logistics of moving teletherapy radiation sources have rendered such movements cost-ineffective and never completed in some instances (Los Alamos National Laboratory 2008). Various U.S. agencies provide expertise, sharing opportunities, and resources for disposing cobalt-60 units. The Nuclear Regulatory Commission controls the use and transportation of radioactive sources. The Department of Energy’s International Radiological Threat Reduction Program and Off-Site Source Recovery Project identifies, recovers, secures, and stores radiological sources. The Department of Energy is also working on a proposal to prevent intranational source diversion and to control source imports and exports. The State Department works on strengthening border security to prevent unauthorized movement of radiological material, and the Department of Homeland Security develops and operates equipment to detect radioactive materials. The Environmental Protection Agency is involved through the Orphan Sources Initiative to retrieve, reuse, and dispose of abandoned radioactive sources from non-nuclear facilities (Medalia 2011). 3.3.2.5 Country Wealth and LINAC Density as Measures of Infrastructure Country wealth and LINAC density are measures of the country’s LINAC infrastructure and ability to absorb a LINAC. LMICs with greater wealth and LINAC density face lower marginal costs when absorbing a LINAC because these measures suggest greater human capital resources, greater public and private financial resources, adequate cobalt-60 disposal capabilities, and other infrastructure factors. Also, the government and other stakeholders in such a country have a greater capacity to adequately finance and support radiotherapy centers. Greater country wealth results in more radiotherapy machines; more radiotherapy machines create economies of scale, and absorbing an additional LINAC becomes less costly (Grau et al. 2014). Greater wealth and LINAC density suggest a country has the technical feasibility required for a successful exchange of a LINAC for a cobalt-60 unit. We measure country-wealth using GNI per capita. LINAC density is the number of LINACs per million people. To add support to this argument, we analyze the relationship between GNI per capita and LINAC density. The World Bank’s income group classifications allow us to divide LMICs into three groups according to GNI per capita. Table 3 displays the World Bank income stratification we use. 27 Table 3: World Bank Income Classes World Bank Income Class Income Range Number of Countries Low $0 – $1,045 34 Lower-Middle $1,046 – $4,125 48 Upper-Middle $4,126 – $12,745 60 Source: (World Bank 2013) Using density data from the WHO, we find a positive relationship between GNI per capita and LINAC density. As shown in Error! Reference source not found.: For each $1,000 increase in GNI per capita, LINAC density increases by 0.1419 machines per million people. Analyzing LMICs by income group, a $1,000 increase in GNI per capita there is associated with a LINAC density increase of 0.0536 in low-income countries, 0.1122 in LMICs, and 0.1890 in uppermiddle income countries (UMICs). Figure 4: LINAC Density vs. GNI per Capita (LMICs) Source: Authors using data from World Bank 2013, World Health Organization 2013c Twenty-five percent of low-income countries have a LINAC density greater than zero (of available data), compared to more than 70 percent of LMICs and UMICs. We also find that cobalt-60 units are more common in low-income countries than are LINACs. However, cobalt60 units are not specific to low-income countries. LMICs and UMICs have substantial cobalt-60 unit densities. These UMICs are relatively ideal for the proposed NNSA exchange because we argue they are better-equipped and well-financed to absorb a LINAC and support it in the long term. Table 4 displays the percentage of LMICs that have a density greater than zero. Specifically, we examine the percentage of LMICs that have a cobalt-60 unit density greater than zero, a LINAC density greater than zero, and a radiotherapy density greater than zero. 28 Radiotherapy density include LINAC density and cobalt-60 unit density. Our analysis suggests that countries with higher GNI per capita in the upper- and lower-middle income countries with LINAC infrastructure should be prioritized for the initiative (See Appendix E for a detailed global map of income stratifications and regional groupings.) Table 4: Radiotherapy Densities by Income Cobalt-60 Unit Density (Percentage of LMICs) LINAC Density (Percentage of LMICs) Radiotherapy Density (Percentage of LMICs) Low 46.15 25.00 53.85 Lower-Middle 73.68 71.79 78.57 Upper-Middle 72.55 72.55 81.13 Overall 66.96 62.28 74.38 Gross National Income Per Capita Source: (WHO Medical Device Database 2013) Note: Density is a measure of the number of machines per million people. We also suggest the NNSA focus on regions with relatively high gross national income per capita and existing quality LINAC infrastructure. Such focus can create economies of scale and lead to lower marginal costs. A regional focus allows pooling of financial and human capital resources such as health care professionals. Table 5 displays a region’s percentage of countries that have LINACs and shows that the NNSA should avoid prioritizing the Sub-Saharan Africa and the Western Pacific. These regions lack significant LINAC infrastructure and have relatively low GNI per capita. The numbers in parentheses are the number of countries within each region with a density greater than zero. Table 5: Radiotherapy Densities by Region European Mediterranean European African Cobalt-60 unit 92.31 (12/13) 89.47 (17/19) LINAC 92.31 (12/13) Radiotherapy 92.31 (12/13) Device Americas South-East Asia Western Pacific 48.57 (17/35) 73.08 (7/26) 77.78 (7/9) 38.46 (5/13) 90.00 (20/20) 28.12 (9/32) 80.00 (20/25) 77.78 (7/9) 33.33 (5/15) 100.00 (20/20) 58.33 (21/36) 81.48 (22/27) 80.00 (8/10) 46.67 (7/15) Source: (Authors) Data from: (World Health Organization 2013c) LMICs with LINAC infrastructure and high GNI per capita should be prioritized due to a greater likelihood of high technical feasibility. A regional focus may offer additional benefits. We rank LMICs’ technical feasibility by LINAC density and stratify by income group for the proposed 29 initiative. The top five countries of technical feasibility are Latvia, Lithuania, Uruguay, Bosnia and Herzegovina, and Venezuela. (We discuss the full ranking in detail in the Appendix D.)3 3.3.3 Policy and Regulatory Environment In addition to LINAC costs and infrastructure, regulatory agencies and specific regulations may enhance or reduce the technical feasibility of an exchange. In this section, we consider the impact of national cancer plans, national regulatory agencies, national procurement authorities, and donation guidelines for radiotherapy machines on the success of the proposed initiative. 3.3.3.1 National Cancer Plan Countries with operational cancer policies that allocate adequate funding are good candidates to receive a donated LINAC under the NNSA proposed initiative. The adoption of a cancer control plan indicates the government has a strong commitment to reduce cancer incidence and mortality rates, and is aware of challenges to supply treatment. Cancer programs that include mechanisms to improve data collection; implement prevention campaigns; and establish plans for early detection, diagnosis, and treatment demonstrate effective management of cancer epidemics. A country with a robust cancer policy has a higher likelihood that it has budgeted and planned for the technical requirements necessary to transfer and operate LINACs. Adequate preparation accelerates the speed at which a LMIC can receive a LINAC and would improve the success of the NNSA initiative. The WHO Non-communicable Disease Country Capacity Survey proxies the robustness of a country’s cancer policy. This survey assesses the capacity of countries to respond to noncommunicable diseases, such as cancer, through the collection of detailed information from designated individuals within the ministry of health or national institute or agency in 193 WHO member countries (World Health Organization 2012). According to a 2014 report, 85 percent of countries have adopted cancer policies, strategies, or plans; 64 percent are operational with adequate funding (Ullrich and Riley 2014). Morocco is an example of a country that has made cancer control a national priority. The Moroccan ministry of health developed a National Cancer Prevention and Control Plan for 2010 to 2019. Ratified in March 2010, the National Cancer Prevention and Control Plan focuses on prevention, early detection, diagnosis and treatment, and palliative care with 78 operational measures. From 2006 to 2012, the Lalla Salma Foundation for Cancer Prevention and Treatment conducted an independent evaluation of the country’s activities relating to cancer. The evaluators reported that 72 of the 78 measures had been initiated, with 51 in advanced stages of development. One measure in the cancer control plan involves the building and equipping of oncology centers. In the evaluation, Morocco improved from two oncology centers to nine and from two accelerators to 22 in a six year period (Bakkali 2014). The NNSA may wish to partner with countries similar to Morocco that demonstrate cancer policies that suggest institutional capacity to manage resources effectively. Europe and the Western Pacific have the highest rates of robust cancer plans with funding, whereas Africa and the Eastern Mediterranean lack funds to support cancer policies (Ullrich and 3 These countries are ranked using LINAC density. However, one could also prioritize on the number of LINACs. China, Brazil, India, Turkey, and Russian have the greatest number of LINACs. They also all have cobalt-60 units. 30 Riley 2014). Table 6 shows results from the WHO 2013 Non-communicable Disease Country Capacity Survey by region. Table 6: National Cancer Plans Percentage of countries with cancer policies, strategies, or plans Number of countries Existing policy Operational policy with funding Africa 37 73 38 Americas 31 90 65 Eastern Mediterranean 21 76 43 Europe 50 98 84 South-East Asia 10 70 70 Western Pacific 27 85 78 WHO region Source: World Health Organization 2014a; Ullrich and Riley 2014 3.3.3.2 National Regulatory Authority for Radiotherapy Machines The proposed NNSA initiative should prioritize an LMIC with a national regulatory authority that governs medical devices. A national regulatory authority would aid in safe, secure, and speedy transportation of the LINAC and streamlining of the regulatory process. A national regulatory authority reduces the administrative burden on the NNSA and other relevant government stakeholders. While most HINCs have national regulatory agencies with enforcement power, there is greater variation among LMICs. If a country lacks a national regulatory authority, the NNSA would need to communicate with subnational authorities. A national regulatory authority should increase the LINAC’s long-term security; a regional or local regulatory authority may be sufficient as long as the authority provides adequate oversight. The WHO and the IAEA recommend that a national regulatory authority should be powerful and independent from government agencies with conflicting interests. The IAEA advocates a national regulatory authority governing radiological medical devices that is independent from government departments with conflicting interests as well as any actors involved in the construction and design of radiation sources (International Atomic Energy Agency 2010). A national regulator of radiological medical devices dependent on other government departments and outside interests may pose a significant obstacle in countries that produce their own cobalt60, such as India. The WHO further recommends a national regulatory authority should have authority over pre-market approval, registration, and post-market surveillance (World Health Organization, Department of Essential Health Technologies 2011b). Appendix F lists LMICs that lack a national regulatory authority over medical devices. Most are in Africa and island nations in the Caribbean and Pacific (World Health Organization 2013b). 31 3.3.3.3 National Procurement Authority for Radiotherapy Machines The presence of a procurement authority at the national level may indicate a greater likelihood for a successful exchange. A national procurement authority is an indicator of a LMIC’s institutional capacity, which is usually accompanied by a nationally adopted procurement plan or policy coordinating the procurement process. These national authorities may help streamline and facilitate the exchange the procurement of medical devices at the country level. In particular, most LMICs have explicit national authority over the procurement of medical devices, which we argue indicate the NNSA should avoid LMICs that do not procure medical devices at the national level (World Health Organization 2013d). This authority is likely due to the necessity of a procurement plans or policy in state-run health care systems. However, government supply agencies may have legal oversight over another government agency’s medical procurement processes and could add complexity to the donation process. If procurement authority rests with the national government, the NNSA must facilitate the donation at the national level. While national medical procurement plans may help streamline communication of the exchange, it is important to solicit input and comments from the receiving health care facility. Recipient LMICs with policies mandating feedback from receiving health care facilities helps to ensure the long-term sustainability of the LINAC donation (World Health Organization, Department of Essential Health Technologies 2011b). Therefore, we advise selecting LMICs with national procurement plans that solicit and consider the receiving health care facility’s input. Appendix F lists LMICs that do not procure medical devices at the national level. Among LMICs there does not appear to be a geographic cluster. However, some of the poorest LMICs do not procure medical devices at the national level. These include Cote d’Ivoire, Guinea-Bissau, and the Democratic Republic of the Congo. 3.3.3.4 Donation Guidelines for Radiotherapy Machines We argue that a LMIC that has already enacted WHO donation guidelines for radiotherapy machines is a better candidate for the proposed initiative’s success. Inadequate national guidelines may lead to poor preparation and needs assessments, which distorts the actual need for a donation (World Health Organization, Department of Essential Health Technologies 2011b). However, exceptions may occur where the nationally approved guidelines are more robust than are WHO guidelines. We suggest an evaluation of nationally approved guidelines on a case-by-case basis, which may require significant time and research, another reason to facilitate donations with LMICs that have enacted WHO guidelines. LMICs use national or WHO donation guidelines more than HINCs do, which is attributed to fewer medical device donations to HINCs. As the NNSA’s proposed initiative notes, medical donations tend to flow from HINCs to LMICs, not the reverse. Thus, there is little need for HINCs to enact donation guidelines. For example, the only HINC on the European continent that has donation guidelines is the United Kingdom. The United States, Canada, and Japan all lack active donation guidelines (World Health Organization 2013a). 32 Appendix F lists LMICs that lack donation guidelines or have “national guidelines” for medical devices. Significant variation across LMICs exists; however, several regional trends are evident. For example, Central and South America largely have national guidelines or an absence of guidelines; Guatemala is the sole country with WHO guidelines. 3.4 Security The NNSA assists international partners to better manage and monitor radiological material with the intent to prevent a radiological attack or contamination. There are no easy solutions when managing radiological source material and waste. Many LMICs need expert advice and institutional support to reduce the risks these material pose to international security. In Ukraine, the NNSA determined that the replacement of an existing cobalt-60 unit with a LINAC was more cost effective than installing a hospital-level security system to protect source material from thief or diversion. In this section, we examine the nature of the radiological source material and waste management problems, assess the costs to society of a radiological attack or contamination, and define a proxy that differentiates across countries by security risk. The proxy uses aspects of the Nuclear Threat Initiative's Nuclear Security Index. 3.4.1 Theft and Loss of Control of Radiological Material LMICs need support to manage their radiological sources to adhere to international safety standards. Research shows three trends in LMIC radiological material: security breaches are widespread across LMIC countries, the incidence of breaches is increasing, and some countries pose more of a security threat than others. In recent years, the international media has reported a number of high-profile incidents where radiation sources from cobalt-60 units were stolen or lost, leading to death or illness for those exposed as a result. These incidents have taken place in locations as diverse as India, Mexico, and Thailand. In addition to these cases, the IAEA’s Incident and Trafficking Database reports roughly 40 cases of theft or loss of nuclear materials each year among participating nations. Of these, a “significant proportion” are related to the loss of sources used in medical diagnostic and radiotherapy applications (International Atomic Energy Agency 2014a). From 1993 to 2013, IAEA’s Incident and Trafficking Database reported 2,477 confirmed incidents related to illegal possession, criminal activities, loss, theft, and other unauthorized activities involving nuclear and radioactive materials. Almost 92 percent of the incidents were related to radioactive materials. The Database on Nuclear Smuggling, Theft, and Orphan Radiation Sources recorded 631 trafficking incidents in the Black Sea region from 1991 to 2012; of these, almost 70 percent involved radioactive materials and unauthorized shipment of radioactive and contaminated cargoes (Zaitseva and Steinhäusler 2014). Regional assessment of incidents shows that trafficking incidents of radiological materials have increased over the years. These findings indicates a substantial interest in acquiring radioactive materials for illegal usage. The Database on Nuclear Smuggling, Theft and Orphan Sources indicates that the risk of theft and loss of control is not uniform across countries. An analysis of all reported cases of nuclear and radioactive diversion in former states of the Soviet Union from 2005 to 2012 reveals that Russia, Ukraine, and Kazakhstan had the highest number of cases, as shown in Error! Reference source not found.. The analysis of trafficking incidents in the Black Sea region from 33 1991 to 2012 corroborated that Russia, Ukraine, and Turkey had the highest number of radioactive material incidents (James Martin Center for Nonproliferation Studies 2015).4 Figure 5: Incidence by Material Origin Source: Authors, using data from James Martin Center for Nonproliferation Studies 2013. The increasing volume of cases that involve diversion of, theft of, and contamination from radiological material suggests that many LMIC governments are failing their obligation to secure radiological source material, putting the global community at risk. Ineffective monitoring practices and other security problems increase the likelihood of radiological material getting into the hands of groups or individuals planning a radiological attack. Eliminating the usage of radiological source material has real benefits when weighed against the negative impacts from a radiological attack or contamination of a public space. 3.4.2 Benefits of Securing Source Material As one of the primary U.S. government agencies enforcing the country’s commitment to eliminate the threat of nuclear and radiological terrorism, the NNSA has a significant interest in working beyond U.S. borders with governments to enhance the secure handling of radiological material. Cobalt-60 teletherapy units pose a significant risk to security due to their reliance on relatively large quantities of a highly radioactive isotope for their operation. Benefits from securing cobalt-60 source material and waste is twofold: (1) protecting communities from those who intend to use radiological material for harm such as a radiological attack; and (2) protecting the radiological source material from those who don’t know the harm and accidentally 4 For a wider analysis of global incidents of theft or loss of control, unrestricted access to protected databases such as Incident and Trafficking Database and Database on Nuclear Smuggling, Theft, and Orphan Radiation Sources could provide data on trends. 34 contaminate a public or private space. These possibilities are greater at hospitals in LMICs where funding of adequate security is a challenge or where government controls on source material and waste are underdeveloped. In the event that an individual or organization gains access to a source of radiological material, it would be used to create a radiological dispersal device. A 2009 study found that if such a device were constructed, quantities as small as a few thousandths of a gram dispersed over one square kilometer would require substantial remediation (Medalia 2011). Such a device could take many forms, including dispersal from tanks mounted to a low-flying aircraft or packing the material around a high-explosive to create a “dirty bomb.” If such a device were deployed successfully, the cost in initial response, economic disruption, and remediation would be substantial. Costs would depend on factors such as the size and design of the device, the location of the incident, the weather at the time of the incident, and the required level of decontamination. Estimates of the cost of a successful attack vary from less than $1 billion to near $100 billion, depending on the parameters (Medalia 2011). A 2007 study found that the cost of a dual attack on the ports of Long Beach and Los Angeles could run in excess of $30 billion, mostly as a result of economic disruption (Rosoff and Winterfeldt 2007).5 Another possibility of harm to the public is improper disposal of radiological material. In 2010, a medical device containing cobalt-60 appeared in a scrap yard in New Delhi, India. Eight people were admitted to the hospital with acute radiation syndrome, and one died because of the exposure (Stewart 2010). Mismanagement of orphaned radiological material has also occurred in Thailand, Brazil, and Mexico. Each of these incidents indicates clear security and control vulnerabilities at the affected facility that would be eliminated through the replacement of the cobalt-60 unit with a LINAC. 3.4.3 Protecting Cobalt-60 Radioactive Source Material Effective physical protection of the cobalt-60 unit at the hospital level is the first line of defense in the effective control of the radiological source. The IAEA recommends graded security measures depending on the IAEA categorization of radioactive sources. Cobalt-60 units fall under IAEA Category 1, requiring security Level A, the highest degree of security, to prevent the unauthorized removal of the cobalt-60 source from the medical facility (IAEA, 2009). The NNSA should assess potential recipient facilities in terms of the level of on-site physical protection measures. Regardless of the site’s physical protection measures, hospitals are fundamentally for the public, and are therefore not generally designed with security as a primary concern. Robert L. Johnson (2015) from Argonne National Laboratory, who works as principle investigator for the NNSA’s Global Treat Reduction Initiative RadTrax monitoring program, states: Any facilities that use cobalt-60 teletherapy units are considered vulnerable. They are typically open facilities for public use and security is very minimal. Even hospitals within high-income countries like U.S. do not have programs to upgrade security. In fact physical security in most 5 Many technical factors limit the possibility of the deployment of a radiological dispersal device. An effective device requires careful calculations to maximize harm and full understanding of cobalt-60 source material and handling precautions (Medalia 2011). 35 hospitals in LMICs is not significant. Countries are comparable when assessed in terms of vulnerability index for such open facilities. Hospitals that lack proper security measures or have an orphaned cobalt-60 in high security risk countries are a priority for this initiative as long as they meet criteria addressed in technical feasibility. 3.4.4 Risk Environment Score National-level factors can have a significant effect on the security of radiological material within the country. Political instability, corruption, ineffective governance, and presence of groups interested in illicitly acquiring radiological materials can all undermine the security of radiological material at the national level, leading to potential thefts and loss while in use, transport, and storage. As a country demonstrates more extreme forms of these destabilizing factors, it should receive higher priority for the rapid replacement of cobalt-60 units. To categorize LMICs according to the level of threat environment, we use the Risk Environment Score of the Nuclear Threat Initiative’s 2014 Nuclear Materials Security Index. The initiative’s index is a public assessment of nuclear material security conditions around the world, prepared by the Nuclear Threat Initiative and The Economist’s Intelligence Unit (Nuclear Threat Initiative 2014). Although categories assessed in the index are related to nuclear material, the Risk Environment Score's broader focus on political and security factors makes it applicable to assessing radiological material security. Indicator and sub-indicators used to construct the Risk Environment scores in Nuclear Threat Initiative index are shown in Table 7. Table 7: Risk Environment Score Components Political stability -social unrest (large-scale demonstrations; political strikes; and inter-ethnic, racial, or religious clashes) orderly transfers of power -international disputes and tensions (armed regional conflicts, tensions with important trade or strategic partners, resulting in economic sanctions or other barriers to trade -armed conflict -violent demonstrations or violent civil or labor unrest Effective governance -effectiveness of the political system -quality of bureaucracy Pervasiveness of corruption -pervasiveness of corruption Groups interested in illicitly acquiring nuclear materials -terrorist or criminal groups interested in illicitly acquiring materials Source: Nuclear Threat Initiative 2014 The risk environmental score map and ranking of LMICs with cobalt-60 units is presented in 36 Appendix G. The five lowest-scored LMICs (and therefore the top priority countries for exchange) are Syria, Yemen, Sudan, Pakistan, and Nigeria. These low-scoring countries have the least favorable nuclear security conditions, implying a security risk for radiological sources. 4 Recommendations While the NNSA’s proposed initiative’s primary focus is to reduce the threat of theft or diversion of radiological materials, we recommend the NNSA consider a broad array of factors when matching donated LINACs with receiving countries. Our three specific recommendations follow. 1. Leverage proxies provided in this report to inform and prioritize potential candidate countries. Technical feasibility is the most limiting factor and therefore should take precedence over the medical need and security risk proxies. Once a country is chosen, the key questions posed in Appendix A can assist in additional donor prioritization. Context, time, place, and other factors will play a significant role. 2. Generate buy-in among diverse stakeholders within the global cancer control community. We identify organizations that can play an important role in the long-term success of a LINAC transfer. These organizations include private-sector corporations, actors within the medical community, international governmental organizations, national governments, and non-governmental organizations. Each has a stake in controlling cancer and can provide valuable expertise and assistance throughout the transfer process. 3. Seek to transfer relatively low-cost, low-energy LINACs. Technical requirements for individual LINACs can vary widely, so the NNSA should allocate more complicated or delicate machines to countries and institutions with greater technical capacity. Furthermore, as the market for cancer therapy in the developing world expands, the NNSA should consider working with private-sector corporations to incentivize the development of relatively simple and robust LINACs designed specifically for the developing world. LINAC producers can look to the experience of General Electric's deployment of specialized cardiograph machines as a model of successfully adapting medical equipment for effective operation in this environment. 37 Appendices Appendix A: Summary of Key Considerations We present a set of considerations and questions that summarize our criteria in the report. These considerations help to guide the selection of particular countries for the proposed initiatives. Criteria Proxy for Country Selection Throughout the report we cover numerous criteria within in our three-prong framework to prioritize countries we use three proxies. 1. Medical Need – We advise using percentage of radiotherapy demand met as a proxy. (See Appendix C for specific rankings). 2. Technical Feasibility – We advise using the presence of existing LINAC infrastructure and GNI per capita as a proxy. (See Appendix D for specific rankings.) 3. Security Risk – We advise using the Risk Environment Score as a proxy. (See Error! Reference source not found. for specific rankings.) Additional Technical Feasibility Considerations Technical feasibility is a substantial part of our report. If numerous criteria are met, we argue they suggest a greater likelihood of the proposed initiative’s success. While we recommend the NNSA rely on the proxy for prioritizing or selecting countries, the considerations below need to be addressed alongside the technical feasibility ranking. We understand this list is not fully comprehensive. However, we believe on the whole they indicate if a country can support a LINAC in the long term. LINAC Costs 1. Following the initial donation, does the receiving health care facility have adequate financial resources to support the LINAC operating costs? 2. Following the end of the donated LINAC’s lifespan, does the recipient LMIC have the necessary resources to replace the LINAC? 3. Is the recipient LMIC interested in upgrading its pre-existing Co - 60 units? LINAC Cost Per Fraction Country Variation 1. Is the LINAC cost per fraction greater than the cobalt-60 cost per fraction in the prospective recipient country? 2. Is the source of the variation because the country supplies its own cobalt-60? LINAC Health Care Facility Costs 1. Does the recipient country have a radiotherapy facility? 2. Does the receiving health care facility have adequate LINAC physical infrastructure? 3. Does the receiving health care facility have adequate and consistent power supply? 38 Country Wealth and LINAC Supply Factors 1. Does the LMIC have a LINAC device, and if so, how many? 2. Does the World Bank classify the LMIC as an UMIC? a. Prioritize the exchange with wealthier countries which have relatively higher LINAC densities. 3. Does the World Bank classify the LMIC as a lower-middle income country? a. Prioritize the exchange with wealthier countries which have relatively higher LINAC densities. 4. Does the World Bank classify the LMIC as a low-income country? a. A low-income country requires substantial infrastructure development and support before an exchange. National Cancer Plan 1. Does the country have a national cancer plan? 2. Is the plan adequately funded? Human Capital 1. Does the LMIC have access to medical professionals to operate a LINAC? 2. Where are medical professionals trained and how much are they paid? 3. Does the target facility have high staff turnover? Cobalt-60 Source Disposal 1. Does the host country have the capacity to store or dispose of the retired cobalt-60 radioactive source? 2. Will a neighboring country or the country of origination accept the cobalt-60 source? 3. Is the equipment required to move the radiation source available in the host country, or can it be easily transported to the site? 4. What permissions must be obtained from the hosting government before the cobalt-60 source can be removed and transported? National Regulatory Authority for Radiotherapy Devices 1. Does the LMIC have a national regulatory authority over medical devices? 2. Does the national regulatory authority have the power to regulate pre-market approval, registration, and post-market surveillance of radiotherapy devices? 3. Is the national regulatory authority independent from government agencies with conflicting interests? National Procurement Authority for Radiotherapy Devices 1. Does the LMIC have a national procurement authority or plan? 2. Does the national procurement authority or plan cover radiotherapy machines? 3. Does the national procurement authority or plan solicit and consider comments from the receiving health care facility? Donation Guidelines for Radiotherapy Machines 1. Does the LMIC have donation guidelines for radiotherapy machines? 2. Are the donation guidelines “national guidelines” or “WHO guidelines”? 39 Appendix B: Stakeholders Table B1: Relevant Stakeholders by Stage of the Exchange Overall planning Planning Africa Oxford Cancer Foundation Delft East Meets West Foundation Elektra Global Task Force on Expanding Access to Cancer Care and Control International Agency for Research on Cancer International Atomic Energy Agency International Campaign for Establishment and Development of Oncology Centers and Experts in Cancer without Borders RadiatingHope Siemens Varian Medical Systems World Health Organization LINAC Identification and Donation Donation Advocates for World Health American Medical Resource Foundation Brother’s Brother Foundation Medical Program Esperanca European Society for Radiotherapy & Oncology Global Hand Global Links Healing Hands International Healthcare Equipment Recycling Organization Healthcare4Africa Humatem International Aid - Medical Equipment Services International Organization for Medical Physics InterVol Medical Bridges MediSend International MedShare MedWish Project C.U.R.E. Recovered Medical Equipment for the Developing World The Afya Foundation The Partnership for Quality Medical Donations The Tropical Health and Education Trust 40 RadiatingHope The Tropical Health and Education Trust Infrastructure Requirements and Security East Meets West Foundation CargoNet FreightWatch International Local/International Police Educational Programs and Training Africa Oxford Cancer Foundation African Regional Co-Operative Agreement for Research, Development, and Training Related to Nuclear Science and Technology Health Emergencies in Large Populations Course (offered by the John Hopkins Bloomberg School of Public Health in joint collaboration with the International Committee of the Red Cross) International Atomic Energy Agency International Medical Corps Merlin, part of Save the Children Project HOPE RedR Regional Co-operative Arrangements for the Promotion of Nuclear Science and Technology in Latin America Varian Medical Systems Refurbishing Site preparation Disposal Disposal of Cobalt-60 Unit Arab Atomic Energy Agency Canada in collaboration with the Global Threat Reduction Initiative CargoNet European Union (TC Program) Forum of Nuclear Cooperation in Asia FreightWatch International International Atomic Energy Agency Nordion Inc. The Organization for Economic Co-Operation and Development (Nuclear Energy Agency) The United States Department of Energy (International Radiological Threat Reduction Program and Off-Site Source Recovery Project) 41 Appendix C: Meets Medical Need Ranking We use an estimate of country-level demand for radiotherapy machines to devise a LMIC medical need proxy. Below we discuss how we measure this proxy as well as provide a ranking of LMICs. 1. The Meets Medical Need proxy is created using data from the Globocan 2012 data set (International Association for Research on Cancer 2015) and Directory of Radiotherapy Centers (International Atomic Energy Agency 2015). It is a proxy for establishing the existing radiotherapy infrastructure, as well as need for radiotherapy infrastructure with levels of cancer incidence rates potentially treatable with radiotherapy. We assume that treating cancer in one country is as valuable as treating cancer in another. Radiotherapy units in operation = Country level estimate from Directory of Radiotherapy Centers data Radiotherapy units needed in 2012 = (Cancer incidence rate * .60) / 4506 First, we calculate the number of total radiotherapy devices needed to satisfy the country’s radiotherapy demand based on incidence rates from the Globocan dataset. Second, we divide the total number of LINAC machines in operation by the total radiotherapy devices needed to treat cancer cases. Third, we translate this calculation into a percentage. LMIC Meets Medical Need proxy = (Radiotherapy units in operation / Radiotherapy units needed) * 100 We use this percentage combined with an operational cancer plan to rank the medical need of a country. Smaller percentage points indicate the level that radiotherapy need is not being met; whereas percentages over 100 signify the medical needs of the cancer patients are being met. Error! Reference source not found. is a ranking of countries that responded to the Noncommunicable Disease Country Capacity Survey that have an operational cancer policy. Error! Reference source not found. is a ranking of those countries that responded in the survey that they do not have an operational cancer policy (World Health Organization 2014b). Data from the WHO 2014 country profiles regarding the number of radiotherapy clinics is also included in the tables (World Health Organization 2014b). Countries that meet a lower percentage of their radiotherapy treatment needs but have a relatively higher number of radiotherapy clinics may pose a more ethical and technical feasible country in terms of medical need. Choosing a transfer with a country such as Indonesia allows the NNSA to partner with a country that is meeting 11 percent of its radiotherapy treatment need. However, with 23 established clinics, the capability for Indonesia to accept an additional radiotherapy unit successfully is greater than those countries with only one clinic. 6 Calculation of the radiotherapy units needed in 2012 uses two assumptions. First, according to research, it is estimated that 60-68 percent of new cancer patient will need radiotherapy treatment (Grover, Dixit, and Metz 2015; Ravichandran 2009). In our calculation we opted for the more conservative estimate of 60 percent. Second, it estimated that approximately 450 patients can be treated on one machine annually (Grover, Dixit, and Metz 2015). 42 We do not include countries that lack data or do not have any cobalt-60 units in the ranking. Those countries that lack cobalt-60 units do not pose a security threat and should not be included for in the initial phases of the exchange proposal. They are classified as Category 4 countries in our framework as articulated in Figure 1: Framework (pg. 15). Table C1: LMIC Ranking based on Medical Need Variable Rank Country Meets Medical Need Proxy 1 Ethiopia 2 1 No Data 2 Uganda 3 1 N 3 Madagascar 4 1 Y 4 Tanzania 4 2 No Data 5 Cambodia 5 1 Y 6 DPR of Korea 5 3 Y 7 Cameroon 5 2 Y 8 Myanmar 8 4 Y 9 Nigeria 10 9 N 10 Indonesia 11 23 Y 11 Kenya 11 4 Y 12 Senegal 11 1 N 13 Bangladesh 13 14 Y 14 Yemen 13 1 N 15 Tajikistan 14 1 Y 16 Zambia 14 1 Y 17 Pakistan 16 26 N 18 Ghana 19 3 Y 19 Uzbekistan 20 13 Y 43 Number of Radiotherapy Clinics Operational Cancer Policy Meets Medical Need Proxy Number of Radiotherapy Clinics Operational Cancer Policy Rank Country 20 Papua New Guinea 20 1 N 21 Viet Nam 22 19 Y 22 Nepal 24 5 N 23 Syrian Arab Republic 24 2 Y 24 Kyrgyzstan 26 1 Y 25 Iraq 26 8 Y 26 Cuba 27 9 Y 27 Armenia 28 3 Y 28 Nicaragua 29 1 N 29 Philippines 30 34 Y 30 Serbia 32 6 N 31 Bulgaria 35 13 Y 32 Romania 35 22 Y 33 Sudan 37 2 Y 34 Algeria 38 7 Y 35 Azerbaijan 38 2 Y 36 Jamaica 39 3 N 37 India 39 314 Y 38 China 40 1,105 Y 39 Sri Lanka 41 7 Y 40 Georgia 42 5 N 41 Egypt 45 34 N 42 Paraguay 46 3 Y 44 Rank Country Meets Medical Need Proxy 43 Bolivia 47 5 Y 44 El Salvador 50 4 Y 45 Thailand 50 29 Y 46 Albania 52 5 Y 47 Mongolia 56 1 Y 48 Ukraine 56 56 N 49 Iran 58 40 Y 50 Brazil 60 222 Y 51 Ecuador 61 10 Y 52 Peru 61 18 Y 53 Russian Federation 61 129 Y 54 Libya 62 4 N 55 Belarus 62 12 No Data 56 Dominican Republic 66 9 Y 57 Honduras 71 5 Y 58 Morocco 71 17 Y 59 Mexico 71 91 N 60 Kazakhstan 72 21 Y 61 Guatemala 73 8 Y 62 Costa Rica 75 3 Y 63 Argentina 76 82 Y 64 Latvia 80 4 Y 65 South Africa 82 39 No Data 45 Number of Radiotherapy Clinics Operational Cancer Policy Meets Medical Need Proxy Number of Radiotherapy Clinics Operational Cancer Policy Rank Country 66 Mauritius 86 1 No Data 67 Lithuania 88 6 Y 68 Malaysia 90 25 Y 69 Bosnia and Herzegovina 91 5 No Data 70 Colombia 94 55 Y 71 Chile 97 27 Y 72 Tunisia 105 10 N 73 Turkey 107 96 Y 74 Namibia 112 1 Don’t Know 75 Uruguay 129 10 Y 76 Jordan 129 5 Y 77 Venezuela 154 60 Y 78 Lebanon 174 9 Don’t Know These countries either have no cobalt-60 units or lack data on cobalt-60 units and/or lack cancer incidence rates. Therefore, we are unable to classify them. Table 8: Ranking of LMICs with Incomplete Medical Need Data Meets Medical Need Proxy Number of Radiotherapy Clinics Operational Cancer Policy Rank Country 79 Afghanistan 0 No Data N 80 Belize 0 No Data N 81 Benin 0 No Data N 82 Bhutan 0 No Data N 83 Burkina Faso 0 No Data N 46 Rank Country Meets Medical Need Proxy 84 Burundi 0 No Data N 85 Cape Verde 0 No Data No Data 86 Central African Republic 0 No Data N 87 Chad 0 No Data No Data 88 Comoros 0 No Data N 89 Congo 0 No Data Y 90 Côte d'Ivoire 0 No Data Y 91 Democratic Republic of the Congo 0 No Data No Data 92 Djibouti 0 No Data N 93 Equatorial Guinea 0 No Data N 94 Eritrea 0 No Data Y 95 Fiji 0 No Data Y 96 Gabon 0 No Data N 97 Gambia 0 No Data N 98 Guinea 0 No Data Y 99 Guinea-Bissau 0 No Data N 100 Haiti 0 No Data No Data 101 Lao PDR 0 No Data N 102 Lesotho 0 No Data N 103 Liberia 0 No Data N 104 Malawi 0 No Data N 105 Maldives 0 No Data N 106 Micronesia 0 No Data Y 47 Number of Radiotherapy Clinics Operational Cancer Policy Meets Medical Need Proxy Number of Radiotherapy Clinics Operational Cancer Policy Rank Country 107 Mozambique 0 No Data Y 108 Niger 0 No Data N 109 Rwanda 0 No Data Y 110 Samoa 0 No Data Y 111 Sierra Leone 0 No Data No Data 112 Solomon Islands 0 No Data N 113 Somalia 0 No Data N 114 South Sudan 0 No Data No Data 115 Swaziland 0 No Data N 116 Timor-Leste 0 No Data No Data 117 Togo 0 No Data Y 118 Turkmenistan 0 No Data Y 119 Vanuatu 0 No Data No Data 120 Mali 8 1 Don’t Know 121 Zimbabwe 19 122 Angola 22 2 No Data 123 Mauritania 41 1 Y 124 Botswana 46 1 N 125 The FYR of Macedonia 51 1 Y 126 Montenegro 71 1 Y 127 Guyana 74 1 No Data 128 Panama 111 2 N 129 Suriname 178 1 Y 48 2 N Meets Medical Need Proxy Number of Radiotherapy Clinics Operational Cancer Policy Rank Country 130 Antigua and Barbuda No Data No Data N 131 Cook Islands No Data No Data Y 132 Dominica No Data No Data N 133 Grenada No Data No Data N 134 Kiribati No Data No Data Y 135 Marshall Islands No Data No Data Y 136 Nauru No Data No Data Y 137 Niue No Data No Data Y 138 Palau No Data No Data Y 139 Saint Lucia No Data No Data N 140 Saint Vincent and the Grenadines No Data No Data No Data 141 Sao Tome and Principe No Data No Data Y 142 Seychelles No Data No Data N 143 Tonga No Data No Data Y 144 Tuvalu No Data No Data N 49 Appendix D: Technical Feasibility Ranking We use two factors to proxy LMIC technical feasibility. These two factors include LINAC infrastructure and Gross National Income (GNI) per capita. Specifically, we use LINAC density to measure LINAC infrastructure. Below we discuss how we measure each of these as well as provide a ranking of LMICs. 1. LINAC infrastructure proxy is from the WHO. We assume LMICs with a greater LINAC density have greater institutional support, medical knowledge, commitment to superior medical services and face a lower marginal cost from adding an additional LINAC than a LMIC with a lack of infrastructure. LINAC infrastructure proxy = LINAC Density per million people 2. Gross National Income per capita data is from the World Bank (Atlas Method). GNI per capita = GNI per Capita from World Bank Note: LMI denotes Lower-middle income, not to be confused with LMIC First, we rank countries using the LINAC density proxy within World Bank income classification group (UMIC is ranked superior to lower-middle-income; lower-middle-income ranked superior to low-income). Second, we sort countries on GNI per capita. For example, this secondary ranking allows us to prioritize between two countries within the same income classification with identical LINAC densities. We do not include countries that do not have any cobalt-60 units. These are countries that do not pose a security threat due to the absence of cobalt-60 and should not be included for in the initial phases of the exchange proposal. They are classified as Area 4 countries as articulated in the framework discussion in report as articulated in Figure 1: Framework (pg. 15). Table 9: LMIC Ranking based on Technical Feasibility Rank Country LINAC Density Income Classification GNI per Capita (USD) 1 Latvia 4.39 UMIC 15,280 2 Lithuania 3.65 UMIC 14,900 3 Uruguay 2.94 UMIC 15,180 4 Bosnia and Herzegovina 2.35 UMIC 4,780 5 Venezuela 1.61 UMIC 12,550 6 Azerbaijan 1.59 UMIC 7,350 7 Brazil 1.43 UMIC 11,690 50 Rank Country LINAC Density Income Classification GNI per Capita (USD) 8 Turkey 1.43 UMIC 10,970 9 Malaysia 1.41 UMIC 10,430 10 Serbia 1.37 UMIC 6,050 11 Lebanon 1.24 UMIC 9,870 12 Costa Rica 1.23 UMIC 9,550 13 Dominican Republic 0.96 UMIC 5,770 14 Ecuador 0.83 UMIC 5,760 15 Peru 0.82 UMIC 6,270 16 Mauritius 0.8 UMIC 9,260 17 Russian Federation 0.77 UMIC 13,850 18 Colombia 0.75 UMIC 7,590 19 China 0.73 UMIC 6,560 20 Bulgaria 0.69 UMIC 7,360 21 Chile 0.68 UMIC 15,230 22 Belarus 0.64 UMIC 6,730 23 Tunisia 0.64 UMIC 4,200 24 Thailand 0.63 UMIC 5,340 25 Jordan 0.55 UMIC 4,950 26 Iran 0.54 UMIC 5,780 27 Romania 0.51 UMIC 9,060 28 Kazakhstan 0.43 UMIC 11,550 29 South Africa 0.4 UMIC 7,190 30 Jamaica 0.37 UMIC 5,220 51 Rank Country LINAC Density Income Classification GNI per Capita (USD) 31 Cuba 0.36 UMIC 5,890 32 Algeria 0.18 UMIC 5,330 33 Mexico 0.17 UMIC 9,940 34 Iraq 0.12 UMIC 6,720 35 Georgia 0.69 LMI 3,570 36 Egypt 0.52 LMI 3,140 37 Guatemala 0.45 LMI 3,340 38 Ukraine 0.44 LMI 3,960 39 Mongolia 0.35 LMI 3,770 40 Armenia 0.34 LMI 3,800 41 Morocco 0.33 LMI 3,020 42 El Salvador 0.32 LMI 3,720 43 Republic of Moldova 0.29 LMI 2,470 44 Honduras 0.25 LMI 2,180 45 Viet Nam 0.2 LMI 1,740 46 Philippines 0.18 LMI 3,270 47 Kyrgyzstan 0.18 LMI 1,210 48 Nicaragua 0.16 LMI 1,790 49 Paraguay 0.15 LMI 4,010 50 India 0.15 LMI 1,570 51 Sri Lanka 0.09 LMI 3,170 52 Bolivia 0.09 LMI 2,550 53 Indonesia 0.08 LMI 3,580 52 Rank Country LINAC Density Income Classification GNI per Capita (USD) 54 Sudan 0.08 LMI 1,550 55 Zambia 0.07 LMI 1,810 56 Nigeria 0.05 LMI 2,710 57 Ghana 0.04 LMI 1,770 58 Pakistan 0.04 LMI 1,360 59 Yemen 0.04 LMI 1,330 60 Uzbekistan 0.03 LMI 1,880 61 Nepal 0.11 LIC 730 62 Kenya 0.09 LIC 1,160 63 Bangladesh 0.04 LIC 1,010 64 Namibia 0 UMIC 5,870 65 Albania 0 UMIC 4,710 66 Papua New Guinea 0 LMI 2,010 67 Cameroon 0 LMI 1,290 68 Senegal 0 LMI 1,050 69 Tajikistan 0 LIC 990 70 Cambodia 0 LIC 950 71 Tanzania 0 LIC 630 72 Uganda 0 LIC 550 73 Ethiopia 0 LIC 470 74 Madagascar 0 LIC 440 According to our data analysis, these countries do not have any cobalt-60. They are considered Area 4 countries in our framework. 53 Table 10: Area 4 LMIC Ranking based on Technical Feasibility Rank Country LINAC Density Income Classification GNI per Capita (USD) 1 Suriname 3.71 UMIC 9,370 2 Montenegro 3.22 UMIC 7,250 3 Macedonia 2.37 UMIC 4,870 4 Panama 1.55 UMIC 10,700 5 Guyana 1.25 LMI 3,750 6 Mauritania 0.26 LMI 1,060 7 Zimbabwe 0.21 LIC 860 8 Mali 0.07 LIC 670 9 Equatorial Guinea 0 UMIC 14,320 10 Gabon 0 UMIC 10,650 11 Botswana 0 UMIC 7,770 12 Turkmenistan 0 UMIC 6,880 13 Maldives 0 UMIC 5,600 14 Angola 0 UMIC 5,170 15 Belize 0 UMIC 4,510 16 Fiji 0 UMIC 4,370 17 Samoa 0 LMI 3,970 18 Timor-Leste 0 LMI 3,940 19 Cape Verde 0 LMI 3,620 20 Micronesia 0 LMI 3,280 21 Vanuatu 0 LMI 3,130 22 Swaziland 0 LMI 2,990 23 Congo 0 LMI 2,590 24 Bhutan 0 LMI 2,330 54 LINAC Density Income Classification GNI per Capita (USD) Solomon Islands 0 LMI 1,600 26 Lesotho 0 LMI 1,500 27 Côte d'Ivoire 0 LMI 1,450 28 Laos 0 LMI 1,450 29 South Sudan 0 LMI 950 30 Chad 0 LIC 1,030 31 Comoros 0 LIC 840 32 Haiti 0 LIC 810 33 Benin 0 LIC 790 34 Afghanistan 0 LIC 690 35 Burkina Faso 0 LIC 670 36 Sierra Leone 0 LIC 660 37 Rwanda 0 LIC 630 38 Mozambique 0 LIC 610 39 Guinea-Bissau 0 LIC 590 40 Togo 0 LIC 530 41 Gambia 0 LIC 500 42 Eritrea 0 LIC 490 43 Guinea 0 LIC 460 44 D Republic of the Congo 0 LIC 430 45 Liberia 0 LIC 410 46 Niger 0 LIC 400 47 Central African Republic 0 LIC 320 48 Malawi 0 LIC 270 Rank Country 25 55 Rank Country LINAC Density Income Classification GNI per Capita (USD) 49 Burundi 0 LIC 260 56 Appendix E: World Bank Income Region and WHO Regions Figure E1: World Bank Income Classification Source: World Bank 2013 Figure E1 displays the distribution of countries by income level within the seven regions defined by the World Bank. These regions include North America, Latin America and the Caribbean, Europe and Central Asia, the Middle East and North Africa, Sub-Saharan Africa, South Asia, and East Asia and the Pacific. These regions and income level designations differ slightly from those identified by the World Health Organization, which are illustrated in the Figure E2 below. Figure E2: World Health Organization Regions 57 Source: World Health Organization 2013a Appendix F: Regulatory Factors *Denotes WHO policy or guidelines adopted Table F1: Regulatory Factors No National No National Regulatory Authority: Procurement: Donation Policy or Guidelines in Place: Afghanistan Afghanistan Albania Philippines Albania Belize Angola Russia Antigua and Barbuda Bolivia Argentina Saudi Arabia Azerbaijan Brunei Azerbaijan* Sierra Leone Bahamas Colombia Belarus* Somalia* Belize Cote d’Ivoire Bolivia South Africa* Botswana Democratic Republic of the Congo Bosnia and Herzegovina* Sri Lanka* Brunei Dominica Botswana* Sudan* Burkina Faso El Salvador Brunei* Swaziland* Burundi Haiti Cape Verde* Tajikistan* Cambodia Gabon Chad Thailand Chad Gambia China Tonga Dominica Guinea-Bissau Colombia Turkey Gabon Jordan Costa Rica Uganda Gambia Lebanon Cuba Uruguay Grenada Liberia Democratic Republic of the Congo Zambia* Guinea-Bissau Lithuania Dominican Republic* Zimbabwe* Guyana Malaysia Ecuador Jamaica Mauritius Ethiopia Kenya Micronesia Fiji Kiribati Namibia* Gabon* 58 No National No National Regulatory Authority: Procurement: Donation Policy or Guidelines in Place: Liberia Nauru Ghana Madagascar Nigeria Gambia* Mauritius Peru Guatemala* Micronesia Philippines Guinea* Mongolia Poland Haiti* Morocco Russia Honduras Mozambique Saint Lucia Indonesia* Nauru Sao Tome and Principe Kenya Niger Senegal Kiribati* Papua New Guinea Somalia Kyrgyzstan Paraguay South Africa Laos* Poland Timor-Leste Liberia* Saint Kitts and Nevis Thailand Lithuania Saint Lucia Togo Madagascar Saint Vincent Tonga Malawi Sao Tome and Principe Turkey Mexico Seychelles Moldova Suriname Montenegro* Swaziland Mozambique Timor-Leste Namibia Togo Nicaragua Yemen Oman Zimbabwe Panama Papua New Guinea Peru 59 60 Appendix G: Security Threat Ranking Figure G1: Risk Environment Map of LMICs with Cobalt-60 Units Source: Nuclear Threat Initiative 2014 The above map shows Nuclear Threat Initiative risk environment score of LMICs with cobalt-60 units. Given that the primary purpose of this initiative would be to reduce the number of cobalt60 machines in high-risk environments, efforts should be focused on those areas where security is lowest and the number of cobalt-60 machines is highest. Table G1: LMIC Ranking based on Risk Environment Score Rank Country No of Cobalt-60 Teletherapy Units Risk Environment Score 1 Syrian Arab Republic 6 16 2 Yemen 2 16 3 Sudan 6 18 4 Pakistan 31 19 5 Nigeria 5 19 61 Rank Country No of Cobalt-60 Teletherapy Units Risk Environment Score 249 21 6 Russian Federation 7 Libya 4 21 8 Iraq 2 22 9 Tajikistan 1 22 10 Azerbaijan 2 23 11 Uzbekistan 5 24 12 Republic of Moldova 2 25 13 Bangladesh 12 26 14 Kenya 2 26 15 Kyrgyzstan 2 26 16 Albania 2 27 17 Philippines 10 29 18 Bosnia and Herzegovina 2 29 19 India 335 32 20 Egypt 23 32 21 Lebanon 3 32 22 Indonesia 20 33 23 Cambodia 1 33 24 Myanmar 6 34 25 Armenia 3 34 26 Iran 24 35 27 Algeria 10 35 28 Morocco 5 36 29 Uganda 1 36 62 Rank Country No of Cobalt-60 Teletherapy Units Risk Environment Score 30 Kazakhstan 32 37 31 Honduras 4 37 32 Nicaragua 2 37 33 Georgia 1 37 34 China 548 38 35 Tanzania 2 38 36 Turkey 51 39 37 Ukraine 86 40 38 Venezuela 31 40 39 Cameroon 1 40 40 Tunisia 10 41 41 Nepal 3 41 42 Papua New Guinea 2 41 43 Dem. People's Rep. of Korea 3 42 44 Ecuador 6 43 45 Guatemala 3 44 46 Colombia 35 46 47 Bolivia 6 46 48 Jordan 1 46 49 Serbia 1 47 50 Ethiopia 2 48 51 Thailand 29 49 52 Sri Lanka 11 50 53 Paraguay 1 50 63 Rank Country No of Cobalt-60 Teletherapy Units Risk Environment Score 54 Malaysia 6 51 55 Romania 15 53 56 Dominican Republic 3 53 57 Madagascar 1 53 58 Peru 10 54 59 Viet Nam 19 55 60 Mongolia 3 55 61 El Salvador 3 56 62 Zambia 1 56 63 Mexico 60 57 64 Belarus 16 58 65 South Africa 12 58 66 Bulgaria 9 58 67 Jamaica 2 58 68 Senegal 1 58 69 Brazil 62 59 70 Argentina 36 61 71 Ghana 3 63 72 Lithuania 4 66 73 Latvia 2 67 74 Namibia 2 69 75 Cuba 10 70 76 Mauritius 2 70 77 Uruguay 8 75 64 Rank Country No of Cobalt-60 Teletherapy Units Risk Environment Score 78 Costa Rica 3 77 79 Chile 13 81 65 References Accuray. 2012. “Cyberknife System and Cyberknife VSI System: Site Planning Guide.” Sunnyvale. http://www.accuray.com/sites/default/files/vsi-site-planning-guide.pdf. 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