Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad (2012) / Chapter Skim
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5 International Action
5 International Action
Pages 165-192
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From page 165... ...
This chapter recommends specific areas for international cooperation, namely: increasing international investments in regulatory systems; encouraging open dialogue among government, industry, and academia; working toward voluntary sharing of inspection reports; and supporting surveillance. INCREASING INTERNATIONAL INVESTMENTS There is a common ground where food and medical product safety, global health, international trade, and development are mutually reinforcing (Henson and Jaffee, 2008; Horton and Wright, 2008; Maertens and Swinnen, 2009)
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From page 166... ...
Investments in international food and medical product safety should be a significant and explicitly tracked priority at development banks, regional economic communities, and public health institutions. International organizations should provide assistance to achieve mean ingful participation of developing country representatives at interna tional harmonization and standardization meetings.
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From page 167... ...
Ideally, low- and middle-income countries would use international standards in their own regulatory systems. This would protect health in places where foodborne disease and substandard drugs kill many.
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From page 168... ...
The committee recognizes that many countries do support higher safety controls on exported products and neglect to implement best practices for their domestic markets. There is reason this could change, and the committee believes the changes will be more quickly realized in the medical products industry than in the food industry.
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From page 169... ...
International food and drug safety standards promote trade and global health, but the proliferation of overlapping, often inconsistent national and private standards do not. Adoption of international food standards has been slow and, in high-income countries such as the United States, poor (Roberts and Josling, 2011)
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From page 170... ...
Global food and drug safety is well suited for the G20 agenda. The G20 development priorities include international trade, food security, investment, and job creation in low- and middle-income countries (G20, 2010)
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From page 171... ...
The United States, working with other G20 member states, should encourage and support Mexico before, during, and after the 2012 G20 meeting. Actions for the WTO, Development Banks, and Regional Economic Institutions The development banks, regional economic communities, and public health institutions need to invest more in food and medical product safety; this includes investments in the systems and processes that ensure product safety.
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From page 172... ...
It is also important that all parties should be able to modify laws if they have scientific evidence to support a change. Recommendation 5-2: In emerging economies, national regulatory authorities, regulated industry, and industry associations should engage in open and regular dialogue to exchange scientific and technical infor mation before policies are written and after they are implemented.
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From page 173... ...
Both often require political clearance at the highest government levels. This hampers efforts to promptly transmit the technical data crucial for assuring product safety.
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There are notable glimmers of improving communication in some places. In November 2011, the Indian food regulatory authority took public input from food industry associations in designing its product recall plan (FSSAI, 2011)
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From page 175... ...
, and WTO have provided similar forums and support for discussions on food and medical product regulation (FAO/WHO, 2005; GIFSL, 2010; WHO, 2011; WTO, 2011)
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From page 176... ...
Eventually, regulatory authorities in emerging economies would also be able to share inspections. Recommendation 5-3: Countries with stringent regulatory agencies3 should, within the next 18 months, convene a technical working group on sharing inspection reports with the longer-term goal of establishing a system for mutual recognition of inspection reports.
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From page 177... ...
The committee recommends that the FDA, USDA, EMA, and other technologically advanced regulatory authorities do a similar pilot study on sharing inspections of farms and food producers. The Food Safety Modernization Act increased the number of overseas inspections required of the FDA to 600 in 2011, doubling every year after that until 2016 (FDA, 2011)
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From page 178... ...
While the different regulatory laws that govern the stringent regulatory authorities will make this challenging, it is possible to agree to a set of harmonized rules for making information confidential. The committee also recognizes that, in the long run, in order to share inspection duties with other advanced regulatory authorities, the FDA will need to ask Congress to revise the terms of the inspections it mandates.
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From page 179... ...
Furthermore, the committee sees no legal barriers to joint inspections, which are useful for all parties and pave the way for future mutual recognition. SHARING INSPECTION RESULTS VOLUNTARILY As Recommendation 5-3 describes, regulatory authorities should cooperate better in inspections and work toward mutual recognition.
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From page 180... ...
The committee realizes that this raw data will not be accessible to the FDA or any regulatory agency, but it believes in the value of regulated industry sharing information and learning from formal analysis of a wide cross-section of data. Private-sector supply chains, especially in the branded food industry, are often excellent.
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From page 181... ...
Sharing information across the supply chain can help them avoid product safety lapses and thereby strengthen their brands. STRENGTHENING SURVEILLANCE SYSTEMS Surveillance is one of the main responsibilities of food and medical products regulatory authorities, and, as Chapter 3 describes, it is a major gap in regulatory systems in emerging economies.
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From page 182... ...
Developing a foodborne disease surveillance system will require improvements in laboratory infrastructure and will therefore take longer, but the committee believes meaningful improvements, such as the expansion of the CDC PulseNet program, can begin in the next 5 years. Surveillance Tools The most frequent approach to postmarket surveillance of medical products in developing countries is spontaneous or passive reporting by health workers.
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The CDC's PulseNet program has given valuable technical support
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From page 184... ...
. In the poorest countries, the lack of Internet access will prevent the reliable use of Internet-based surveillance, but the conceptually similar mobile phone surveillance shows promise (Breiman et al., 2008)
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The committee sees web-mining and event-based surveillance as potentially valuable tools for developing country regulators and believes all technical support should draw on this valuable new technology.
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From page 186... ...
In less-developed countries, mobile phone technology might be used to the same end: building a novel foodborne disease and drug postmarket surveillance system.
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From page 187... ...
The committee identified five areas where stakeholders around the world could act to improve food and medical product safety. First, the development banks, regional economic communities, and public health institutes should ensure that scientists from the least developed countries are better prepared to participate in international standard setting.
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From page 188... ...
agencies and multilaterals with appropriate expertise should support surveillance systems in developing countries. Without reliable data on postmarket surveillance of medical products and foodborne disease, risk assessment is meaningless, and risk assessment is the cornerstone of any modern regulatory agency.
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2011. Drug safety: FDA faces challenges overseeing the foreign drug manufacturing supply chain.
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. ICDRA (International Conference of Drug Regulatory Authorities)
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2006. Building PulseNet international: An interconnected system of laboratory networks to facilitate timely public health recognition and response to foodborne disesase outbreaks and emerging foodborne diseases.
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From page 192... ...
and selected National Medicines Regulatory Authorities (NMRAs) in inspection activities.
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