7

Conclusions and Priorities

This report is the product of the Institute of Medicine’s Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries’ deliberations. One task of this study was to identify the core elements of a functional regulatory system. The committee described these elements, and also what it sees as the minimal elements of a functional system, in Chapter 2. The core elements of regulatory systems relate to specific responsibilities that a regulatory authority takes to ensure product safety; the minimal elements include processes that are necessary to allow government to function.

From March to December 2011 the committee visited key emerging economies, spoke to representatives of the U.S. and various foreign governments, multinational and national food and medical product companies, donor organizations, development banks, and universities. These meetings informed the committee’s analysis of the main gaps in developing country regulatory and product safety systems. A literature review complemented this analysis. Table 4-1 describes how the committee used the problems identified in Chapter 3 as its targets in forming its recommendations.

Chapters 5 and 6 describe the actions the committee believes would protect the safety of the food and medical product supply and build the capacity for reliable regulation in developing countries. As the study’s statement of task (Box 1-1) points out, developing nations are a diverse group of 150 low- and middle-income countries. In its analysis the committee gave more attention to those countries that trade substantially with the United States, especially India, China, Thailand, South Africa, Mexico, and Brazil. An interest in equity led it to give some attention to the problems of the poorest countries as well.



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7 Conclusions and Priorities This report is the product of the Institute of Medicine’s Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries’ deliberations. One task of this study was to identify the core elements of a functional regulatory system. The committee described these elements, and also what it sees as the minimal elements of a functional system, in Chapter 2. The core elements of regulatory systems relate to specific responsibilities that a regulatory authority takes to ensure product safety; the minimal elements include processes that are necessary to allow government to function. From March to December 2011 the committee visited key emerging economies, spoke to representatives of the U.S. and various foreign govern- ments, multinational and national food and medical product companies, donor organizations, development banks, and universities. These meetings informed the committee’s analysis of the main gaps in developing country regulatory and product safety systems. A literature review complemented this analysis. Table 4-1 describes how the committee used the problems identified in Chapter 3 as its targets in forming its recommendations. Chapters 5 and 6 describe the actions the committee believes would protect the safety of the food and medical product supply and build the capacity for reliable regulation in developing countries. As the study’s state- ment of task (Box 1-1) points out, developing nations are a diverse group of 150 low- and middle-income countries. In its analysis the committee gave more attention to those countries that trade substantially with the United States, especially India, China, Thailand, South Africa, Mexico, and Brazil. An interest in equity led it to give some attention to the problems of the poorest countries as well. 235

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236 ENSURING SAFE FOODS AND MEDICAL PRODUCTS The committee’s recommendations are informed by a perspective that shares much with the Department of Health and Human Services’ Global Health Strategy. The committee’s strategy had four main points: the pri- macy of global public health, the importance of risk-based investments, the usefulness of market incentives, and the necessity of international coordina- tion. It recommended ways the Food and Drug Administration (FDA) can use limited resources for maximum effect. The committee was not asked to project the cost of these investments, nor did it have the proper data or suitable expertise to do so, but it recommended a path for the FDA to make the most of its limited resources and suggested other duties for other government agencies, international organizations, industry, and universities. ENTERPRISE RISK MANAGEMENT AS A TOOL TO SET PRIORITIES The value of enterprise risk management is central to the committee’s recommendations and to its strategy for strengthening the capacity of regulatory systems abroad. In order to set its priorities as an agency, the FDA needs to undertake an agency-wide risk assessment, risk analysis, and risk evaluation. This includes its capacity of building work. The committee recommends that the FDA choose which foreign offices to scale up, what topics to cover in trainings, and how to assign its staff using a scientific risk analysis. Some aspects of the FDA’s governing plan seem informed by modern risk management. The agency has, for example, responded to globalization by putting offices in India, China, Chile, and Mexico. Other agency deci- sions, such as opening offices in Europe and the Middle East, seem on the surface less grounded in scientific risk analysis. Ultimately, the committee does not have access to the data that would inform the FDA’s risk assess- ment, risk analysis, and risk evaluation framework. The FDA is in the best position to undertake this project. The committee believes that the results of a risk analysis could help Congress increase appropriations to the FDA and give the agency latitude to shift its attention more to places outside of the United States where much of the world’s food and medical products are produced. The committee is sensitive to the constraints the FDA’s limited budget puts on its work. Given the current climate in Congress and the interna- tional economic downturn it is unlikely that the FDA’s appropriations will increase dramatically in the near future. Because of its limited budget the FDA should consider working though existing networks, such as partner- ing with universities on training programs, and should use enterprise risk management to make the most of its modest budget.

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237 CONCLUSIONS AND PRIORITIES A 3- TO 5-YEAR STRATEGY FOR THE FDA The committee realizes that only the FDA has all the information nec- essary to rank its priorities, and it can best do this through enterprise risk management, dependent on quality data collected using modern information systems. Recommendations 6-1 and 6-2 address these needs. A full over- haul of the FDA informatics and information strategies will probably take a decade; reorganizing the FDA would also take a long time. However, the committee outlined steps toward these goals that can be met in the next 3 to 5 years. First among these is the use of enterprise risk management to al- locate funding and staffing to the FDA’s foreign programs. Only over time, after Congressional approval, could the agency make similar adjustments to align its domestic actions with risk management principles. Similarly, the paperless information system envisioned in Recommendation 6-2 is probably at least 8 years away. But in the next 3 to 5 years, the FDA can identify a standardized vocabulary and data collection method to use in its interna- tional activities. In general, building strong regulatory systems abroad will be a long process, and success will be incremental. However some steps of the recom- mendations put forth in Chapters 5 and 6 can be reached in the next 3 to 5 years. The committee sees these recommendations as practical steps the FDA can take to improve product safety worldwide. Therefore, in the next 3 to 5 years the FDA should: 1. Join the regulatory authorities of the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand in a working group on sharing inspections, making a plan for a sys- tem of mutual recognition of inspections to eliminate the wasteful duplication of work among similarly rigorous regulatory agencies (Recommendation 5-3). 2. Work (as one of several U.S. government agencies charged in Rec- ommendation 5-5) to strengthen pharmacovigilance and foodborne diseases surveillance systems in developing countries. The agency has technical depth in surveillance that it can channel to developing countries both directly and thorough World Health Organization (WHO) and Food and Agriculture Organization of the United Na- tions (FAO). 3. Use enterprise risk management to focus its international pro- grams, trainings, and offices (Recommendation 6-1). 4. Develop an informatics strategy that will eventually allow the FDA to move to a paperless system and articulates a standard data for- mat and vocabulary (Recommendation 6-2).

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238 ENSURING SAFE FOODS AND MEDICAL PRODUCTS 5. Revise the curriculum of the FDA staff college to better educate its employees on the international ramifications of compliance with U.S. regulations, while working through universities and existing networks to train regulators abroad (Recommendation 6-3). 6. Lead in the development and adoption of international standards for food and medical products. The committee acknowledges the leadership the United States shows in developing international standards, but it believes U.S. adoption of harmonized standards leaves something to be desired (Recommendation 6-4). 7. Give serious, public consideration to expanding the one-up, one- back, food traceability requirements to medical products (Recom- mendation 6-5). 8. Issue Cooperative Research and Development Agreements and other tools to encourage research into frugal technologies for fraud pre- vention, supply chain management, tracking, and verification that would be useful in developing counties (Recommendation 6-6). 9. Evaluate the Secure Supply Chain Pilot program in 2014 with a plan to scale up the program (Recommendation 6-7). POLITICAL WILL TO IMPLEMENT THE COMMITTEE’S RECOMMENDATIONS In their public statements over the past 2 years, the Department of Health and Human Services (HHS) and its subordinate agencies, espe- cially the FDA, have shown a commitment to responding to the challenges brought on by globalization. The department’s Global Health Strategy reflects political will for the changes the committee recommends. The strat- egy’s first objective is to enhance global surveillance for disease and health concerns (HHS, 2011). This is consistent with the committee’s recommen- dation that the FDA, Centers for Disease Control and Prevention (CDC), U.S. Department of Agriculture (USDA), and U.S. Agency for International Development (USAID) should provide technical training in pharmacovigi- lance and foodborne disease surveillance. The Global Health Strategy also gives some attention to improving the safety of the global supply chain for food and medical products (HHS, 2011). The committee believes that market incentives can strengthen the global supply chain and that access to hard-currency markets such as the United States can be that incentive. The Secure Supply Chain program, that promises speedy entry into the U.S. market to foreign producers whose products meet U.S. regulatory requirements, is an example of such a pro- gram. The elegance of the one-up, one-back, traceability requirements is also a compelling example of supply chain management. One-up, one-back was initially met with low enthusiasm by food producers, and there is ev-

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239 CONCLUSIONS AND PRIORITIES ery reason to expect that many medical product producers will resist the committee’s recommendation 6-5. Nevertheless, this is a necessary step to improve the global supply chain. Despite the FDA’s budget constraints, it can advance a serious dialogue about the medical products supply chain by immediately holding a public hearing on expanding the one-up, one-back requirement. Its Secure Supply Chain pilot program is also promising and should be evaluated, with the intent of large-scale expansion, in 2014. The fifth objective of the HHS Global Health Strategy is to strengthen and implement science-based international health and safety standards and support multilateral efforts to improve them (HHS, 2011). Recommendation 6-4 on FDA leadership in adopting standards contains steps toward achieving this objective. Aside from being good health policy, a harmonized set of standards would do much to facilitate trade and, in- directly, to improve the economic development of low- and middle-income countries that trade with the United States. Recommendation 6-3 also sup- ports the strengthening of international health and safety standards. The international, standing regulatory science training the committee recom- mends would do much to empower regulators from the poorest countries to better represent their nations at Codex and other standard setting meetings. Standards developed with wider input would better reflect the needs of all stakeholders. Facilitating an international regulatory science college would also help advance the Global Health Strategy objective of strengthening health sys- tems (HHS, 2011). Training a stronger regulatory workforce to oversee food and medical product regulatory systems is an international health and development goal. Educating students from developing countries in the new field of regulatory science would improve the technical knowledge of the regulatory workforce. A more knowledgeable, credentialed workforce would be expected to have better morale. This will take more than 10 years to realize, but the investments in training that the FDA could contribute both alone and through existing networks could improve product safety and strengthen the health system in developing countries. CONCLUSIONS This report presents the work of the IOM Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries in answer to the task given by the FDA and shown in Box 1-1. In response to this task, the committee outlined in Chapter 2 the core elements of regulatory systems. Chapter 3 responds to item B on the statement of task. Also in that chapter the committee identifies the main needs in developing country regulatory and product safety systems. Item C in the statement of task asks for areas where progress might be made in the next 3-5 years; the commit-

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240 ENSURING SAFE FOODS AND MEDICAL PRODUCTS tee outlines these in Table 4-1 and in this chapter, Chapter 7, as well as in the explanation of its recommendations in Chapters 5 and 6. In response to the statement of task items D the committee refers readers to Chapter 7. Statement of task item E, on contributions of universities, donors, and international organizations, is answered briefly in Table 4-1 and in more detail in Chapter 5. Parts of Chapter 6, particularly recommendations 6-3 and 6-6, also suggest contributions for industry and academia. Chapters 5 and 6 also address item F in the statement of task by describing how the FDA can work in partnership with other stakeholders. The committee relied on the specific questions outlined in the statement of task to guide its deliberations. Table 7-1 lists the sections of the report that respond to each question. In accordance with the statement of task’s last paragraph, the commit- tee gave the most attention to the problems of the emerging manufacturing nations that do the most trade with the United States. The committee’s TABLE 7-1 A Guide to the Statement of Task Questions and Their Answers in This Report Question Addressed in Report 1. What critical issues do developing country regulatory Chapter 3 authorities face, and how are they prioritized? 2. In what ways do they participate in standard-setting processes, Chapter 3 organizations, and harmonization e orts? 3. What issues do they face in utilizing/implementing standards Chapter 3 in a sustainable way? 4. What are the core elements of their regulatory systems, and Chapter 2 are there others that should be considered? 5. What are the major gaps in systems, institutional structures, Chapter 3 workforce, and competencies? 6. In what ways could those gaps be addressed? Chapters 4, 5, 6 7. In what ways could the U.S. FDA help address those gaps? Chapters 5, 6, 7 8. In what ways could others (as delineated above) help meet Chapters 5, 6 those gaps? 9. In what ways could the FDA partner with others to help meet Chapters 4, 5, 6 those gaps? 10. What recommendations have already been put forward to Chapter 3 strengthen regulatory systems? 11. What obstacles exist to implement those recommendations? Chapter 3 12. What steps could be taken to remove those obstacles? Chapter 4

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241 CONCLUSIONS AND PRIORITIES concern with equity also motivated it to consider the problems of the poor- est countries as well. This report identifies the main common problems in food and medical product safety across a range of countries and product lines. The committee concluded that developing countries have consistent problems with adher- ence to international standards, controlling supply chains, infrastructure deficits, laws, their workforce, institutional fragmentation, surveillance, communication, and political will. The 13 recommendations put forth in this report represent the com- mittee’s consensus view of how to best bridge the gaps in food and medical product regulatory systems in low- and middle-income countries. These are multi-sectoral recommendations that have scope for implementation by a variety of actors. The committee believes that the changes it suggests could greatly improve the safety of food and medical products around the world. REFERENCE Department of Health and Human Services (HHS). 2011. The global health strategy of the U.S. Department of Health and Human Services. Washington, DC.

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