Stronger Food and Drug Regulatory Systems Abroad (2020) / Chapter Skim
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Pages 1-14
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These and similar problems are of special concern to the FDA Office of Global Policy and Strategy2 as it is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. This mission influenced the agency's commission of the 2012 Institute of Medicine report on regulatory systems, Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad.
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While bilateral, multilateral, and private donors deserve credit for this progress, it is also a function of increasing global prosperity and national investments in health systems and other social programs. By 2020, about half the world will live in a middle-class household.
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Recommendation 3-4: Development finance institutions such as the United States International Development Finance Corporation, the International Finance Corporation (IFC) , the UK CDC Group, and the European development finance banks should create vehicles to finance producers, distributors, and retailers in low- and middle-income countries interested in meeting regulatory standards.
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Manage- Recommendation 5-3: National regulatory authorities should take advantage of global tools to ment and support regulatory actions. Resources from United Nations agencies, including World Health collabora- Organization prequalification and Codex standards, are examples of such tools, as are the third tion party standards increasingly used in food and agriculture.
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should convene biennial meetings for food safety regulators similar to the International Conference of Drug Regulatory Authorities. The increasing complexity of regulatory work and the interconnected nature of the food supply chain make it necessary for food regulators to have a standing, formal venue for exchange and cooperation.
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Food safety involves a variety of different fields, and there are various benchmarking tools for plant and animal health, as well as a more comprehensive food system assessment from the WHO and the FAO. The institutional development plans developed out of benchmarking assessments help translate the sometimes vague job of institution building into concrete measurable steps.
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An increased demand for medical products draws attention to the essential procurement question of value for money, something that can be difficult to judge, especially when products are imported. The WHO Prequalification Program provides regulatory assessment, inspection, and ongoing quality control for certain medical products procured through UN agencies or other large donors.
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Donor funding could help minimize the technical obstacles and expense associated with this process, helping to tip the balance of tradeoffs in favor of greater openness. Recommendation 3-3: Development partners, including multilateral and bilateral donors and private philanthropic organizations, should support countries and regional organizations in pursuing greater col laboration for regulating food and medical products.
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Recommendation 3-5: The United States International Development Finance Corporation, the International Finance Corporation (IFC) , the UK CDC Group, and the European development finance banks should provide advisory services and concessional financing to manufacturers of quality and safety screening technologies to optimize manufacturing and create stronger distribution systems in low- and middle-income countries.
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Much of the regulatory agency's effectiveness, efficiency, and independence is determined by a country's political leaders, who are ultimately responsible for creating an environment conducive to product safety. Legal Protections Providing the legal framework for product safety may be the most fundamental step national political leaders can take to protect food and medical products in their countries.
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Political leaders should give regulators clear authority for international coordination and guidance on how to resolve any tension between national and shared international responsibilities. THE ROLE OF THE REGULATORY AGENCY Decision makers at the regulatory agency have the most direct, proximal control over the actions taken to mitigate product safety risks.
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Developing effective data systems to systematically identify areas of greatest risk; b. Participating in research, data sharing, technology adoption, and training activities with international partners; c.
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Recommendation 5-2: National regulatory agencies should use evidence to guide strategies to reduce the risk posed by informal markets. Strategies to consider include accreditation or licensing to formalize sellers, consumer education, and increasing competition from regulated products.
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Recommendation 5-4: National regulatory authorities should determine which functions are most effectively and efficiently carried out directly by the agency and which can be delegated to state or local authorities; collaboration and data sharing among domestic agencies should be part of any delegation plan. Efficient division of work, collaboration, and information sharing are tools that can help regulators manage the increasing challenge of protecting the safety of food and the quality of medical products in their countries.
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