Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad (2012) / Chapter Skim
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4 A Strategy to Building Food and Medical Product Regulatory Systems
4 A Strategy to Building Food and Medical Product Regulatory Systems
Pages 147-164
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From page 147... ...
The department's new health strategy emphasizes the importance of improving global disease surveillance, increasing the integrity of the food and medical product supply chain, implementing scientifically rigorous international health and safety 147
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From page 148... ...
. Food and Medical Product Safety and Global Health Rich and poor countries alike feel the costs of unsafe food and medical products.
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. International manufacturing and modern distribution systems have made food and medical products truly global industries.
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An explanation of the four pieces of this strategy follows. Emphasis on Global Public Health The cornerstone of this strategy is its recognition that adequate regulation of food and medical products is essential for public health, improved well-being, and long lifespan.
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Their prevention and treatment depend on national regulatory authorities as much as they depend on the primary health care system, but donor investments in health favor disease-specific programming and improving primary health care to the exclusion of developing the food and medical products regulatory system. This is ultimately a short-sighted donor strategy.
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From page 152... ...
Suitable Market Incentives The committee's strategy includes building incentives that encourage strong national regulatory authorities and higher compliance with international standards. The United States and the EU are examples of markets with much stricter controls than in low- and middle-income countries (Euro Consultants, 2010)
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. The committee sees value in encouraging retailers and manufacturers to improve oversight of their suppliers by increasing liability for the importation of unsafe food and medical products.
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The World Bank funded a project on building capacity for food and drug safety in India that contributed to the development of the 2006 Indian Integrated Food Law (World Bank, 2009)
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The Group of Twenty (G20) international forum is a venue that brings leaders of these countries together to advance an agenda of a strong, sustainable, and balanced global economy; it would be a useful venue to elevate the priority of food and medical product safety for global health, development, and trade.
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One exemplary partnership was between Chile and the International Atomic Energy Agency (IAEA)
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government including USAID, the CDC, and USDA. Meaningful change in product safety systems will take time, and success will be measured in increments.
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TABLE 4-1 158 Recommended Actions to Address the Nine Main Problems in Developing Country Product Safety Systems Critical Issue Recommendations Timeframe Action Adherence to 5-1: Increasing international investments 1 year Bring regulatory capacity building to the 2012 G20 meeting agenda international 3-5 years Track investments in regulatory systems and training standards 5-3: Working toward shared inspections 18 months Share inspection reports among stringent regulatory agencies ≈10 years Establish a system for mutual recognition of inspection reports 5-4: Sharing inspection results voluntarily 3 years Share industry inspection results among members 6-5: Expanding one-up, one-back track 1 year Convene a public workshop on expanding one-up, one-back and trace 6-7: Giving market incentives for supply 2 years Evaluate the Secure Supply Chain program in 2014 chain management 3-5 years Scale up the Secure Supply Chain program based on evaluation Controlling 5-4: Sharing inspection results voluntarily 3 years Share industry inspection results among members supply chains 6-2: Using information technology 3-5 years Articulate a standard data format and vocabulary ≈10 years Develop an informatics strategy that moves to paperless systems 6-5: Expanding one-up, one-back track 1 year Convene a public workshop on expanding one-up, one-back and trace 6-6: Researching inexpensive technology 2 years Issue CRADAs that benefit producers and regulators abroad 3-5 years Stimulate industry and academic research on behalf of small producers 6-7: Giving market incentives for supply 2 years Evaluate the Secure Supply Chain program in 2014 chain management 3-5 years Scale up the Secure Supply Chain program based on evaluation
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From page 159... ...
foreign policy 6-8: Increasing civil liability ≈10 years Hold producers and importers liable for unsafe products Workforce 5-2: Encouraging open dialogue among 3-5 years Identify neutral venues to bring together government, industry, government, industry, and academia in and academia emerging economies Ongoing Regular, open dialogue on regulatory science and policy 5-3: Working toward shared inspections 18 months Share inspection reports among stringent regulatory agencies ≈10 years Establish a system for mutual recognition of inspection reports 5-5: Strengthening surveillance systems 3 years Develop pharmacovigilance plans 5 years Improve the foodborne disease surveillance systems ≈10 years Build a cadre of trained epidemiologists 159 continued
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foreign policy 6-6: Researching inexpensive technology 2 years Issue CRADAs that benefit producers and regulators abroad 3-5 years Stimulate industry and academic research on behalf of small producers
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From page 161... ...
Critical Issue Recommendations Timeframe Action Communication 5-2: Encouraging open dialogue among 3-5 years Identify neutral venues to bring together government, industry, government, industry, and academia in and academia emerging economies Ongoing Regular, open dialogue on regulatory science and policy 5-3: Working toward shared inspections 18 months Share inspection reports among stringent regulatory agencies ≈10 years Establish a system for mutual recognition of inspection reports 5-4: Sharing inspection results voluntarily 3 years Establish a protocol for sharing anonymous internal inspection results Ongoing Publish these results in association newsletters and other publications 6-2: Using information technology 3-5 years Articulate a standard data format and vocabulary ≈10 years Develop an informatics strategy that moves to paperless systems 6-6: Researching inexpensive technology 2 years Issue CRADAs that benefit producers and regulators abroad 3-5 years Stimulate industry and academic research on behalf of small producers Political will 5-1: Increasing international investments 1 year Bring regulatory capacity building to the 2012 G20 meeting agenda 3-5 years Track investments in regulatory systems and training 5-2: Encouraging open dialogue among 3-5 years Identify neutral venues to bring together government, industry, government, industry, and academia in and academia emerging economies Ongoing Regular, open dialogue on regulatory science and policy 6-4: Leadership in adopting standards 3-5 years Adopt international standards in the United States ≈10 years Fully integrate product safety into U.S. foreign policy 6-7: Market incentives for supply 2 years Evaluate the Secure Supply Chain program in 2014 chain management 3-5 years Scale up the Secure Supply Chain program based on evaluation 6-1: Using enterprise risk management to rank priorities 3-5 years Choose priorities for FDA foreign operations 161 ≈10 years Lobby Congress to reorganize FDA operations based on risk
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2006. Private regulation of food safety by supermarkets.
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2009. Public-private partnerships and collective action in high value fruit and vegetable supply chains.
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2010. FAO/WHO framework for developing national food safety emergency response plans.
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