Stronger Food and Drug Regulatory Systems Abroad (2020) / Chapter Skim
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4 The Role of the National Government
4 The Role of the National Government
Pages 125-150
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Much of the regulatory agency's effectiveness, efficiency, and independence are determined by a country's political leaders, who are ultimately responsible for creating an environment conducive to product safety. This chapter discusses steps national governments can take to create an environment conducive to product safety.
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LEGAL PROTECTION Providing a legal framework for product safety may be the most fundamental step national political leaders can take to protect food and medical products in their country. Legal provision defining the national regulatory system is the first indictor measured in the World Health Organization (WHO)
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For the purposes of running an effective regulatory system, independence refers to a lack of political interference in scientific decision making and in the hiring and firing of technical staff. As the 2012 Institute of Medicine's report Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explained, an 1 The cited document also has model laws for multiple agency systems and integrated systems.
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medicines list/national formulary D. Drug control administration 3. Scheduling 1.
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Establishment of ing labeling National Food 30. General offenses Board 31.
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. The laws establishing regulatory agencies should protect against this kind of interference and shield technical staff from undue political influence (IOM, 2012)
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. The independence of the regulatory agency was the topic of a recent white paper from the Aspen Institute and a companion commentary in Health Affairs wherein seven former FDA commissioners called for a restructuring of the agency, removing it from the U.S.
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In Mexico and Brazil, the food and drug regulatory agency oversees products that account for 10 to 25 percent (respectively) of the gross domestic product (Arriola Penalosa et al., 2017; Moscou et al., 2016)
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. The value of the regulatory agency for health and consumer protection is clear and should be relatively straightforward to communicate to the public, a topic expanded on in Chapter 5.
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134 FIGURE 4-1 Distribution of world population across national income groups in 2000 and 2015. NOTE: HIC = high-income country; LIC = low-income country; LMIC = lower-middle-income country; UMIC = upper-middleincome country.
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. Drug regulatory authorities in Kenya, Malawi, Tanzania, Uganda, Zambia, and Zimbabwe receive minimal or no budgetary support from subvention (Ndomondo-Sigonda et al., 2017)
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The executive and legislative branches of government need therefore to revisit the regulatory agency's funding
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The drafting or revision of a country's food and drug laws is an important time to ensure these protections are in place. When done well, regulatory harmonization serves the goal of making markets for food and medical products safer and more competitive (Pombo et al., 2016)
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• Minimum revenue needs might • Relatively predictable not be met • Increases awareness of the • Risks creating a customer– cost of a service client relationship between industry and regulator • Can decrease the feeling of shared responsibility for public service Earmarked • Safeguards funding by ring- • Not easily revised or revisited; Taxes fencing it from competing can lead to inappropriate interests allocation of resources • Linking tax or revenue • Can lead to distortions in the stream closely to overall economy (e.g., if an beneficiaries may increase earmarked tax is enough to efficiency and soften public dissuade people from buying resistance to taxation the taxed product) • Increases awareness of the • Funding sensitive to market cost of a service fluctuations • Can limit coordination across sectors, encouraging fragmentation in budget • Can decrease the feeling of shared responsibility for public service SOURCES: Austin, 2019; Cashin et al., 2017; GAO, 2015.
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Another important benefit for heads of government to realize is that participation in regional regulatory programs strengthens national capacity (Kaddu et al., 2018)
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. The Pan American Network for Drug Regulatory Harmonization and the ASEAN Pharmaceutical Product Working Groups have both made good progress producing harmonized technical guidelines for their members (Pombo et al., 2016; Teo, 2016)
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Political leaders can take a meaningful step to meeting that responsibility through attention to the laws that protect the regulatory agency. Recommendation 4-1: National governments should guarantee in legis lation that national regulatory agencies be independent and financially viable, with statutes that encourage cooperation with other agencies and require a scientific basis for decision making.
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autonomous (not User fees independent agency that reports to the minister financially) India (Drug Controller General of Semi-autonomous, Subvention Minimal user fees, which are unsustainable and India, Drug Control Authority)
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Health Singapore (Health Sciences Autonomous, under Subvention Statutory board under Ministry of Health, Authoritya) Ministry of Health User fees autonomy in decision making South Africa (South African Autonomous, under Subvention Independent public entity that retains revenue Health Products Regulatory the Department of User fees generated, employs its own staff, and is Authority)
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OECD guidance on regulatory policy gives some attention to the role of core policies -- strategic statements from the government defining the underlying principles and governing of the regulatory agency (OECD, 2016a)
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. Both ASEAN and Pan American Network for Drug Regulatory Harmonization regulators have reported problems balancing subtly competing technical guidelines from their regional regulatory collaborative and FIGURE 4-3 Stepwise approach to harmonization.
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Paper presented at Committee on Stronger Food and Drug Regulatory Systems Abroad, February 25, San Jose, Costa Rica. Califf, R
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Guide lines for developing a national food law. www.fao.org/3/a-y8705e.pdf (accessed July 27, 2019)
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2012. Ensuring safe foods and medical products through stronger regulatory systems abroad.
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1999. Annex 8: National drug regulatory legislation: Guiding principles for small drug regulatory authorities.
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n.d. Global health needs global health diplomacy.
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