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2 Regulatory Systems, Global Health, and Development
Pages 41-80

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From page 41...
... . The 2018 World Bank report The Safe Food Imperative pointed out the necessity of food safety for achieving at least seven of the Sustainable Development Goals, especially the goals of ending poverty, ending hunger, and promoting good health (Jaffee et al., 2019)
From page 42...
... . Subsequent UN General Assemblies have reaffirmed and supported universal coverage, both as a part of the Sustainable Development Goals and independently; creating, for example, a Universal Health Coverage Day in 2017, and convening a meeting on the topic for heads of state and policy makers in September 2019 (UHC2030, 2019; UN, 2018a)
From page 43...
... . Given this context, it is easy to miss the fact that universal coverage, as described in the Sustainable Development Goals, "include[s]
From page 44...
... Targets reflect concern with both Direct Food security requires access to safe foods; there is no productivity and market access food secuirty if the food supply is largely unsafe. Market among small-scale farmers.
From page 45...
... Improving economic growth is at the Direct Agriculture and medicines formulation are major center of this goal. Targets refer to the employers in low- and middle-income countries.
From page 46...
... rules are harmonized internationally. This goal is concerned with, among Direct The 2012 report emphasized trade as a tool to raise the other things, the use of World Trade floor on food quality in low- and middle-income countries; Organization agreements to promote it also discussed problems with meaningful participation development.
From page 47...
... Targets to advance partnerships Indirect The 2012 report suggested trade, particularly the access emphasize the importance of dialogue to lucrative markets in North America, Europe, and Japan, between the public and private as the incentive needed to raise the floor on product sectors and the need to marshal more quality in developing countries. While market access is an money for sustainable development incentive for some producers, poverty creates markets for from multiple sources.
From page 48...
... . The Global Burden of Disease study found HIV and AIDS deaths to be in decline, estimating 19 million years of life saved between 1996 and 2013, 70 percent of them in low- and middle-income countries, a success almost entirely attributable to the HIV medicines donors such as PEPFAR1 and the Global Fund have provided (Murray et al., 2014)
From page 49...
... . As the Sustainable Development Goals, with their longer list of targets, become the motivators for global progress, it is possible that health could lose its relative prominence to donors.
From page 50...
... . Safe food and good-quality medical products are a necessary precursor to improved global health and development.
From page 51...
... As a result, market incentives for safety are weak, requiring government regulatory action to balance the scales. Box 2-2 lists the essential responsibilities of the regulatory agency as relates to medical products; Box 2-3 lists the same for foods.
From page 52...
... 52 STRONGER FOOD AND DRUG REGULATORY SYSTEMS ABROAD BOX 2-2 Principal Regulatory Functions for Medical Products • Licensing of the manufacture, import, export, distribution, promotion, and advertising of medicines • Assessing the safety, efficacy, and quality of medicines, and issuing marketing authorization for individual products • Inspecting and surveillance of manufacturers, importers, wholesalers, and dispensers of medicines • Controlling and monitoring the quality of medicines on the market • Controlling promotion and advertising of medicines • Monitoring safety of marketed medicines, including collecting and analyzing adverse reaction reports • Providing independent information on medicines to professionals and the public SOURCES: Rägo and Santoso, 2008; WHO, 2003. BOX 2-3 Principal Regulatory Functions for Foods • Managing the national food control system, setting standards for safety, and implementing the national food control site • Developing an emergency response procedure • Inspecting manufacturers and suppliers, both their premises and pro cesses, including importers or exporters when necessary, and issuing, revoking, or suspending market permits when necessary • Participating in international food control activities • Sampling food during harvest, processing, storage, transport, and sale to establish compliance, identify offenders, and collect data for risk based decision making • Conducting physical, microbial, and chemical analysis, the results of which can be used to determine compliance with standards • Ensuring the food safety laboratories operate with accuracy, reliability, and repeatability of results • Integrating with the public health system to ensure reliable intelligence on the incidence of foodborne disease and its relationship to food contamination • Identifying food unfit for consumption or food deceptively sold, and taking remedial action • Providing stakeholders from farm to table with independent, unbiased information about food safety SOURCE: Adapted from FAO, 2003.
From page 53...
... As the 2012 IOM report Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad set it out, there are certain attributes that underpin most good regulatory systems (see Box 2-4)
From page 54...
... Food and Drug Administration's (FDA's) technical decisions on new chemical entities, for example, allows many agencies to use their drug regulatory staff and budget for urgent local needs, like inspection.
From page 55...
... . Because of prequalification, procurement agencies around the world can be confident they are buying quality-assured medicines, vaccines, diagnostics, and other essential medical products; generic manufacturers have the same safety net in place for their purchase of active ingredients.
From page 56...
... program also has a capacity building element. Regulators from around the world work with WHO staff to review dossiers, evaluate data, and inspect manufacturers together (WHO, 2013)
From page 57...
... SOURCE: IOM and NRC, 2010. Third-Party Certification in Food Safety Food producers may seek certification of their process by an independent, accredited organization as a way to demonstrate their safety standards, or to verify other features of production, such as animal welfare or worker protections, that might command a price premium or market access (Hatanaka et al., 2005)
From page 58...
... 58 FIGURE 2-1  A conceptual framework of important groups in food and medicines regulation. NOTE: FAO = Food and Agriculture Organization of the United Nations; NGO = nongovernmental organization; WHO = World Health Organization.
From page 59...
... Over 100,000 operations in 160 countries are certified through the Global Food Safety Initiative alone (GFSI, 2017)
From page 60...
... The European Medicines Agency (EMA) is a regional agency for the European Union and the European Economic Area; the European Food Safety Authority serves a similar role for food (EFSA, n.d.a; EMA, 2016b)
From page 61...
... Each regulatory authority has its own policies, standards, and guidelines. The different regulatory authorities did not work together until the World Bank, the New Partnership for Africa's Development, and the World Health Organization introduced the African Medicines Regulatory Harmonization initiative in 2009, leading to regional efforts to harmonize medicines regulation.
From page 62...
... In an effort to understand the extent of bilateral, regional, and global collaboration programs, the International Coalition of Medicines Regulatory Authorities undertook a mapping exercise in 2014. The project report clarifies that the network mapped in Figure 2-2 fluctuates as some organizations change their scope or membership and as new ones form.
From page 63...
... Recommendation 2-1: The Food and Agriculture Organization of the United Nations and the World Health Organization should convene biennial meetings for food safety regulators similar to the International Conference of Drug Regulatory Authorities. As the UN agencies responsible for global public health and food security, the WHO and the FAO are the best choices to convene the food regulatory meetings suggested.
From page 64...
... Figure 2-2 64 STRONGER FOOD AND DRUG REGULATORY SYSTEMS ABROAD ACRONYMS AMRH: African Medicines Regulatory Harmonization ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for APEC: Asia-Pacific Economic Cooperation Human Use ASEAN: Association of Southeast Asian Nations ICMRA MC: International Coalition of Medicines CEN SAD: Community of Sahel and Saharan States Regulatory Authorities Management Committee CIOMS: Council for International Organizations of IGAD: Intergovernmental Authority on Development Medical Sciences IGDRP: International Generic Drug Regulators Pilot CIRS: The Centre for Innovation in Regulatory IPRF: International Pharmaceutical Regulators Forum Science IRC: International Regulators Consortium Initiative DG SANTE: European Commission Health and Food Safety Directorate General OCEAC: Organization for the Coordination of the Fight against Endemic Diseases in Central Africa EAC: East African Community OECD: Organisation for Economic Co-operation and EAMI: Ibero-American Medicines Competent Development Authorities Network PAHO: Pan American Health Organization ECOWAS: Economic Community of West African States PANDRH: Pan-American Network for Drug Regulatory Harmonization EDQM: European Directorate for the Quality of Medicines PIC/S: Pharmaceutical Inspection Co-operation Scheme EMA: European Medicines Agency SADC: Southern African Development Community EMRN: European Medicines Regulatory Network GCC: Gulf Central Committee for Drug Registration Harmonisation Initiative FIGURE 2-2  Multinational medicines regulatory programs, results of the International Coalition of Medicines Regulatory Authorities' 2014–2015 mapping exercise.
From page 65...
... REGULATORY SYSTEMS, GLOBAL HEALTH, AND DEVELOPMENT 65 KEY Initiatives Organisational members Country members ICMRA members
From page 67...
... The programs shown in Table 2-2 and others like them reflect international response to various food safety problems, some existing for a century or more, others only a few years old. These programs and other, sometimes impromptu, collaborations among food regulators have great value, but an inclusive global convening at regular intervals would help ensure they operate to their maximum effectiveness.
From page 68...
... option=com_content&view=articl Safety Regional and control systems, and laboratories e&id=15241:food-safety-is-everyone-s Program business&Itemid=1926&lang=en Caribbean Agricultural Caribbean Supporting national agricultural health and https://caricom.org/about-caricom/ Health and Food Safety countries food safety systems in accordance with the who-we-are/institutions1/caribbean Agency Sanitary and Phytosanitary Agreement agricultural-health-and-food-safety agency-cahfsa International Standard Setting Bodies Codex Alimentarius Global Protecting human health from food safety http://www.fao.org/ Commission hazards and facilitating trade fao-who-codexalimentarius/en World Animal Health Global Improving animal health and facilitating http://www.oie.int Organization trade International Plant Global Improving plant health and facilitating trade https://www.ippc.int/en Protection Convention
From page 69...
... option=com_content&view=arti Caribbean cle&id=1771:food-safety-risk-analysis consortium-fsrisk&Itemid=0 JIFSAN Global Research to improve food safety and https://jifsan.umd.edu capacity building continued 69
From page 70...
... TABLE 2-2 Continued 70 Region or Countries Role Website Third-Party Auditors Global GAP Global Quality and safety standards of good https://www.globalgap.org/uk_en agricultural practices tailored to primary agricultural production Global Aquaculture Global Promote responsible aquaculture practices https://www.aquaculturealliance.org Alliance Seafood through education, advocacy, and demonstration Primus GFS Global Auditing of Good Agricultural Practices and http://www.primusgfs.com Good Manufacturing Practices, as well as Food Safety Management Systems Monitoring and Data-Sharing Efforts Emergency Prevention Global Facilitating rapid sharing of information http://www.fao.org/food/foodSystem for Food Safety during food safety emergencies through safety-quality/empres-food-safety/ the International Food Safety Authorities en Network International Food Global Collaborating among food safety https://www.who.int/activities/ Safety Authorities authorities for crisis mitigation responding-to-food-safetyNetwork (INFOSAN) emergencies-infosan PulseNet International ~86 countries Public health and food safety laboratory http://www.pulsenetinternational.org/ worldwide network international Research or Trade Associations International Individual Professional association for people working https://www.foodprotection.org/about Association for Food members from in any aspect of food safety (farming, Protection more than 50 processing, distribution, etc.)
From page 71...
... requirement for and companies with produce safety, public– edu/food-safety-modernization-act/ market access private partnership hosted by Cornell produce-safety-rule with global University implications Produce Safety Rule- U.S. Building capacity for the produce safety https://jifsan.umd.edu/training/ Produce International requirement for rule internationally international/courses/pip/description Partnership*
From page 72...
... U.S. Training sprouts producers to enhance https://www.ifsh.iit.edu/ssa requirement for understanding and implementation of best market access practices for improving sprouts safety with global implications Private Sector Initiatives SSAFE Food Promoting public–private partnerships for http://www.ssafe-food.org/about-ssafe companies food safety and standards Food Industry Asia Food Enhancing the industry's role as a partner https://foodindustry.asia/home companies in in the development of scientific food policy Asia in the region Regional Networks (including Public and Private Sector)
From page 73...
... The volume of samples coming in quickly exceeded staff capacity. With support from the International Food Safety Authorities Network and the Global Outbreak Alert and Response Network, both WHO programs, scientists eventually traced the source of the outbreak to a ready-to-eat processed meat from a factory that produced exports for 15 countries.
From page 74...
... 2015. Universal health coverage: A pro-poor pillar of sustainable development.
From page 75...
... In Financing global health 2016: Development assistance, public and private health spending for the pursuit of universal health coverage, edited by IHME. Seattle, WA.
From page 76...
... 2018. Monitoring universal health coverage within the sustainable development goals: Development and baseline data for an index of essential health services.
From page 77...
... Paper presented at Stronger Food and Drug Regulatory Systems Abroad, April 3, Washington, DC. Lagomarsino, G., A
From page 78...
... :1375–1388. UHC2030 (Universal Health Coverage)
From page 79...
... 2018a. International Universal Health Coverage Day 12 December.
From page 80...
... 2015. Tracking universal health coverage: First global monitoring report.


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