Stronger Food and Drug Regulatory Systems Abroad (2020) / Chapter Skim
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3 Global Efforts to Strengthen Regulatory Systems
3 Global Efforts to Strengthen Regulatory Systems
Pages 81-124
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From page 81... ...
. These are powerful numbers that put the public health significance of unsafe food and poor quality medicines in context.
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From page 82... ...
It also discusses how circumstances beyond the control of a single country influence local markets for food and medical products. THE ROLE OF AID As the previous chapter stated, donor assistance for health now makes up a relatively small piece of total health spending in most of the world, making the effectiveness of the remaining contribution crucial, especially to the donors.
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From page 83... ...
A valid benchmarking tool can put clear parameters on the otherwise amorphous concept of institutional capacity. There is already good consensus on the jobs regulatory authorities need to do to ensure product quality, as reflected in international assessment tools.
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Figure 3-2 gives graphical representation of a hypothetical agency's performance; the red line indicating the level three target, making it easier to visualize the agency's relative gaps. The outcome of the benchmarking assessment informs a 5-year institutional development plan wherein agencies identify how they can improve on their relative weaknesses (Khadem, 2018; Ward, 2019)
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From page 85... ...
SOURCE: Khadem, 2018. Food Safety Systems Benchmarking Assessment of the food safety system is more complicated than the analogous process for medicines, especially in low- and middle-income countries where there may be multiple systems serving different markets.
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From page 86... ...
Furthermore, because food safety touches on many different fields, there are a variety of benchmarking tools that touch on different aspects of food safety. A comprehensive food safety benchmark analogous to that provided by the WHO Global Benchmarking Tool is desirable, and may be best approximated by the WHO and the FAO Food Control System Assessment Tool.
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From page 87... ...
. The Food Control System Assessment Tool was developed in 2014, building off publicly available assessment tools from the Inter-American Institute for Cooperation on Agriculture, the World Organisation for Animal Health, and the International Plant Protection Convention (FAO, 2014; FAO and WHO, 2019b)
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88 FIGURE 3-3 Structure of the Food Control Assessment Tool.
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From page 89... ...
Assessment of animal or plant health can, when taken together, give a good picture of the food controls in a country. The World Organisation for Animal Health Performance of Veterinary Systems Tool In 2007 the World Organisation for Animal Health (known by the historical acronym OIE)
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From page 90... ...
. Broadly speaking, the tool has 13 modules, each one dealing with a different aspect of a national plant health system, including its legislative protections; resources; surveillance and reporting capacity; import regulatory system; and export, re-export, and transit systems (FAO, 2017a)
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. Less is known about the results of various food control assessment tools.
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From page 92... ...
For example, if a country was short of meeting the Global Benchmarking Tool's level three cut point in inspection and vigilance, then those functions would be the target of donor funding. Recommendation 3-1: Development partners, including multilateral and bilateral donors and private philanthropic organizations, should encourage countries' participation in regulatory benchmarking assess ments, the development of institutional development plans, and reports on progress against those plans.
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From page 93... ...
Working together toward progress on the institutional development plans also gives donors a chance to encourage their host country counterparts to publicize progress and eventually to make results public. It is in the best interest of all development partners that regulatory systems in low- and middle-income countries perform better.
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From page 94... ...
As the previous chapter explained, the WHO Prequalification Program provides assessment, inspection, and ongoing re-inspection of manufacturers and consistency testing and quality control for certain vaccines, medicines, and other medical products. As such, it can be a boon to procurement agencies, acting as a proxy regulatory approval, something especially valuable in managing the combination of limited regulatory capacity and foreign suppliers.
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From page 95... ...
. Capacity building also extends to WHO's prequalification of quality control labs, which provides technical assistance and management audits to help ensure the labs can operate to international standards (WHO, n.d.-e)
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From page 96... ...
. The most recent meeting of the International Conference of Drug Regulatory Authorities called for the same, citing the program's ability to improve access to quality-assured medicines, and its role in meeting the increasing demands of universal coverage (ICDRA, 2018)
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From page 97... ...
, as would anti-infectives since the risk of drug resistance makes the quality of these products a global public good. Expansion of the prequalification program would improve access and reduce costs of whole families of important products (e.g., antidiabetics and cancer treatments)
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From page 98... ...
One aspect of capacity building is increasing ability -- that of regulators, of manufacturers, of procurement programs -- to operate well. WHO prequalification has, by design, considerable emphasis on this aspect of capacity building, as discussed earlier in this section.
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From page 99... ...
As much as possible, they should advocate for more support for it from their agencies and from their countries' aid organizations. 5 Those performing at level four or higher on the Global Benchmarking Tool assessment.
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Advanced regulatory authorities are struggling with adjustments to their legal authority and guidelines brought about by so-called big data (EMA, 2019; Martin, 2017)
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Department of Agriculture (USDA) Global Branded Food Products Database.
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In Colombia, for example, political interest in free trade agreements translated into increased appropriations to the Invima (the food and drug regulatory agency) starting around 2012 (Guzman, 2019)
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Global Branded Food Products Database The USDA Global Branded Food Products Database provides nu trition information and ingredients from product labels. Launched in September 2016, the database runs as a public–private partnership that includes the USDA, International Life Sciences Institute (ILSI)
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From page 104... ...
Therefore, despite the potential for international food standards to improve food safety, evidence supporting such effects is limited and mixed, probably because the export and domestic food markets in low- and middleincome countries are fairly segregated (Jaffee et al., 2019; STDF, n.d.a)
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From page 105... ...
The previous chapter discussed the role of supermarket chains to compel their suppliers to meet third-party standards; the power of large procurement agencies on the medicines market is similar. Market incentives can also be used to encourage producers to invest in quality for the domestic market, as in the Twiga Foods example discussed in Box 3-3.
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From page 106... ...
Development banks and bilateral development finance organizations can lower the cost of equity and make investments in quality more profitable for businesses in low- and middle-income countries. The organizations may do this through concessional financing, meaning loans with considerably more generous terms (in interest or repayment periods or both)
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From page 107... ...
. Through its MedAccess program, CDC Group, the British development finance agency has lowered the risk to market entry for suppliers of medical products in South Asia and sub-Saharan Africa (CDC Group, n.d.)
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From page 108... ...
, though expansion potential in Africa and Latin America is less clear. Investing in these companies' expansion into underserved markets could also be a role for development finance.
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From page 109... ...
, 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. Quality laboratories will always be an essential part of any product safety system.
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From page 110... ...
. In preparing this report, the committee discussed advances in regulatory science, strategies for capacity building, the balance of work sharing among small or neighboring countries, optimal delegation of tasks from federal to local levels, and the ideal mix of revenue for an agency, all topics discussed further in Chapters 4 and 5.
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From page 111... ...
Food and Drug Administration and the U.S. Agency for International Development, should develop a network of Global Centers of Excellence in Regulatory Science for research and capacity building to identify and address the challenges of ensuring food and drug safety in low- and middle-income countries.
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is a research funder; its role as such is part of its strategic reason to invest in Global Centers of Excellence in Regulatory Science. Promoting regulatory science is a way to protect the
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The best knowledge about treating or preventing any illness will remain mostly academic without good-quality food and medical products on the market. The NIH also has some experience in promoting regulatory science.
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In implementing this recommendation, the agencies might draw valuable lessons on collaborative centers from the Joint Institute for Food Safety and Applied Nutrition, a partnership between the University of Maryland and the FDA to increase good-quality research on food safety and human, animal, and plant health (JIFSAN, n.d.-a)
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2019, FAO/WHO Food Control System Assessment Tool. Paper presented at Committee on Stronger Food and Drug Regulatory Systems Abroad, February 25, San Jose, Costa Rica.
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http://www.fao.org/neareast/news/view/en/c/1189851 (accessed July 18, 2019)
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7/1. http://www.fao.org/3/ca5334en/CA5334EN.pdf (accessed July 17, 2019)
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Paper read at 18th International Conference of Drug Regulatory Authorities, Dublin. IFC (International Finance Corporation)
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2017. A partnership for public health: USDA branded food products database.
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http://www.oecd.org/dac/financing-sustainable-development/ development-finance-standards/untied-aid.htm (accessed July 25, 2019)
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https://pharmaboardroom.com/interviews/interview-javier humberto-guzman-cruz-director-general-invima-colombia (accessed July 17, 2019)
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2017. What's new: The USDA branded food products database.
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Paper read at Committee on Stronger Food and Drug Regulatory Systems Abroad, January 8, Washington, DC. WBG (The World Bank Group)
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for evaluation of national regulatory systems. https://www.who.int/medicines/regulation/benchmarking_tool/en (accessed July 12, 2019)
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