Stronger Food and Drug Regulatory Systems Abroad (2020) / Chapter Skim
Currently Skimming:
5 The Role of the Regulatory Agency
5 The Role of the Regulatory Agency
Pages 151-194
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 151... ...
. This chapter discusses a range of risks facing regulatory agencies, especially in low- and middle-income countries, as well as strategies to mitigate these risks.
|
From page 152... ...
This concept has worldwide support and has been applied for several decades by regulatory and public health agencies. A risk-based system employs analytical methods to rank risks based on public health impact. A risk-based system systematically ranks risks even if those risks differ in complexity and uncertainty.
|
From page 153... ...
To collect and integrate food safety data so that attribution models can be built is a critical first step in this process. A risk-based system performs all of these functions in a systematic and transparent manner with the involvement of stakeholders.
|
From page 154... ...
. Part of the challenge in collecting data is knowing how to monitor the market; not all product safety events are equally important to the regulatory agency.
|
From page 155... ...
. Over the last few years, the analysis of big data (the large amounts of data produced in digital interactions)
|
From page 156... ...
. The main obstacles to data sharing in low- and middle-income countries, especially for regulatory agencies, are not clear and may be a question for the proposed Centers of Excellence in Regulatory Science (Bezuidenhout and Chakauya, 2018)
|
From page 157... ...
Facilitating data sharing among these researchers is an important step in support of a global public good. SOURCES: EDCTP, n.d.; EDCTP Knowledge Hub, n.d.-a, n.d.-b; Hajduk et al., 2019; The Global Health Network, 2019.
|
From page 158... ...
Scarce resources are valuable, and data used to monitor food and medical product safety can be scarce, especially for regulatory agencies. Data sharing can help overcome this scarcity.
|
From page 159... ...
. Distributed ledgers have particular promise for managing complicated supply chains.
|
From page 160... ...
The proposed Centers of Excellence in Regulatory Science could take on these analyses when necessary. The regulatory agency can also facilitate good analysis by clearly stating in the goal of regulatory policy the evidence that will be evaluated and sources of this evidence, as well as indicating how the effects of a policy might influence various subpopulations (Jessup, 2013)
|
From page 161... ...
Effective medicines are not praised in stemming an outbreak any more than a restaurant critic would laud food for being uncontaminated. In the inevitable balancing against other flashier pieces of the health system, the regulatory agency stands to lose.
|
From page 162... ...
Product safety crises offer a chance to strengthen regulatory infrastructure. The distinction between the sort of crisis that undermines the agency and that which causes people to rally behind it are not always clear, but it seems that strong, effective public communication can make the difference between an embarrassing debacle and grateful support for the agency.
|
From page 163... ...
The Internet and social media are invaluable for outreach and education, both critical responsibilities of the regulatory agency. Agencies now have access to a wide range of tools to inform the public about everything from how to cook a chicken safely to where to file an adverse event report.
|
From page 164... ...
Every agency has to make different determinations about the risks confronting it; those determinations are based both on data and on an understanding of the will of society. To this end, every agency needs access to information and a strategy to communicate with government leaders, the public, and regulated industry, both to solicit their input and to convey the risks facing the agency.
|
From page 165... ...
If developments at the regulatory agency stand to grow the economy, this too should be publicized. While acknowledging that the price of medicines is influenced by many factors, the agency should be willing to comment on its contribution to economic gains.
|
From page 166... ...
SOURCES: Gostin, 2018; Instituto Nacional de Salud Pública de México, 2016; Perez Escamilla et al., 2017; WHO, 2014; Zhang et al., 2014. Finally, in considering the risks facing the regulatory agency, decision makers would do well to remember the importance of organizational culture.
|
From page 167... ...
Informal Markets for Food Informal food markets are important in low- and middle-income countries, accounting for about 80 percent of food sold, possibly more in subSaharan Africa (Jaffee et al., 2019; Roesel and Grace, 2014)
|
From page 168... ...
. The Safe Food Imperative emphasized the role for consumer engagement, including education toward understanding various food quality indicators (Jaffee et al., 2019)
|
From page 169... ...
After a series of raids on informal markets, warehouses, and shipments in the early 2000s, the Nigerian authorities concluded that the regulatory agency alone would not be able to put the informal sellers out of business (Chinwendu, 2008)
|
From page 170... ...
Strategies to consider include accreditation or licensing to formalize sellers, consumer education, and increasing competition from regulated products. In considering regulatory tools to combat informal markets, it is important to note what tools for change are realistically available to the regulatory agency.
|
From page 171... ...
Recognizing the need these sellers meet, especially in underserved areas, the Tanzania Food and Drug Authority began an accreditation program in 2003. Over 9,000 drug stores have since been accredited, making the Accredited Drug Dispensing Outlets (ADDOs)
|
From page 172... ...
. Consumer education is another invaluable tool for controlling risks of informal markets.
|
From page 173... ...
Consumer education on safe food storage, for example, will be a successful strategy only if the messages are tailored to local problems and presented in a format accessible and salient to the intended audience. Activities where attention from the regulatory agency improves the safety of products on the market beyond the baseline comparison point should be priorities for regulatory agencies in low- and middle-income countries (Ahonkhai et al., 2016; Roth et al., 2018)
|
From page 174... ...
For some, this means taking advantage of FIGURE 5-1 A continuum of tools for international regulatory cooperation. SOURCES: OECD, 2018, based on OECD, 2013.
|
From page 175... ...
. The Euro-Retailer Produce Working Group protocol on good agricultural practices and the Global Food Safety Initiative standards discussed in Chapter 2 are other prominent examples of the so-called co-regulation of food safety, meaning a hybrid regulatory model with shared government and private sector responsibilities (Garcia Martinez et al., 2007)
|
From page 176... ...
Often commercial business-to-business standards SOURCES: Adapted from Garcia Martinez et al., 2013; Henson and Humphrey, 2010.
|
From page 177... ...
. As FAO guidance on voluntary standards explained, the public sector has a responsibility to coordinate these standards so that they stimulate a market for safe foods, rather than serve as a barrier to entry, especially for small producers (UNEP and FAO, 2014)
|
From page 178... ...
The Administrative Conference of the United States recommends that, before deciding to use a third-party program to assess compliance, governments assess the capacity of the agency and the relative costs of the program, as well as the extent to which such programs may be unfair to small businesses. It encourages the regulatory agency to oversee third-party programs to ensure that they continue to advance the government's goals (as opposed to the market expansion goals of large companies)
|
From page 179... ...
Efficiency and Delegating The purpose of collaboration, co-regulation, and work sharing is to increase countries' efficiency, as well as to reduce restrictions on the movement of food and medicines internationally. Sparing resources allows agencies to attend to key local activities that others cannot perform, such as local inspections and controls on high-risk products sold in informal markets.
|
From page 180... ...
. Figure 5-3 shows core regulatory activities in the top band; those further to the left are candidates for regional regulatory cooperation or the unilateral acceptance of a trusted authority's work.
|
From page 181... ...
FIGURE 5-3 A regulatory value chain for medicines regulation. SOURCE: Adapted from Chahal et al., 2016.
|
From page 182... ...
. There is no universal blueprint for making the public sector more efficient, but communication among government agencies, both at the level of the national government and at various subnational levels, will always be crucial (Curristine et al., 2007)
|
From page 183... ...
. Recommendation 5-4: National regulatory authorities should deter mine which functions are most effectively and efficiently carried out directly by the agency and which can be delegated to state or local authorities; collaboration and data sharing among domestic agencies should be part of any delegation plan.
|
From page 184... ...
https://www.acus.gov/sites/default/files/documents/Recommendation%20 2012-7%20%28Third-Party%20Programs%20to%20Assess%20Regulatory%20Com pliance%29.pdf (accessed August 29, 2019)
|
From page 185... ...
Paper presented to Committee on Stronger Food and Drug Regulatory Systems Abroad, February 25, San Jose, Costa Rica. Cancer Research UK.
|
From page 186... ...
2015. Administrative structure and functions of drug regulatory authorities in India.
|
From page 187... ...
pdf? sfvrsn=61b890c4_2 (accessed August 21, 2019)
|
From page 188... ...
Scientific American. https://www.scientificamerican.com/article/heparin scare-deaths (accessed August 20, 2019)
|
From page 189... ...
https:// www.ibm.com/downloads/cas/8QABQBDR (accessed August 20, 2019)
|
From page 190... ...
. Harnessing public–private partner ships for data sharing to measure the impact of food safety capacity building.
|
From page 191... ...
2018. Advancing state data sharing for better economic and workforce development.
|
From page 192... ...
https://twas.org/article/big data-challenge-developing-countries (accessed August 20, 2019)
|
From page 193... ...
2019. Data management and sharing policy: The first step towards promoting data sharing.
|
From page 194... ...
2015. Big data in global health: Improving health in low- and middle-income countries.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.