Is the legal framework by itself enough for successful WHO code implementation? A case study from Ethiopia

Abstract Since 2016, Ethiopia has passed several proclamations and directives to regulate the promotion of commercial breastmilk substitute (BMS). Ethiopia's market potential will undoubtedly be the gravitating point for international infant formula companies due to growing urbanization, purchasing power, population, and the relatively low use of BMS to‐date. The aim of this review is to assess the strengths and weaknesses of the existing laws, standards, and monitoring documents used to regulate the marketing of BMSs in Ethiopia and make future recommendations. The study findings highlighted that the regulation on marketing are comprehensive and strong to limit the promotion of infant formula. On the other hand, the regulation on marketing of follow‐up formulas, complementary foods, and growing‐up milk by manufacturers and distributors, media houses, and communication and advertisement agencies are underregulated, especially with regards to the international 69.9 regulation. The monitoring and enforcement of the existing marketing regulations remain limited in the absence of a formal coordination mechanism. Several violations of the national BMS regulations were observed. Forty‐one percent of mothers reported observing the BMS advertising and logos were detected in 36% of health facilities assessed. In 100% of cases, the infant formula labels contained violations. As the lead national authority mandated to regulate food safety, the Ethiopian Food and Drug Authority needs to update its regulations related to the marketing of BMS to fill the loopholes and revise the national law in line with the international code of marketing of BMSs to protect breastfeeding.

Unethical marketing of BMS might influence the Ethiopian social norms in urban areas by making the use of formula more fashionable than breastfeeding and exaggerate the health benefits of formula to appear comparable with breast milk as is observed in many Asian countries (Piwoz & Huffman, 2015). These unethical marketing of BMS reduces breastfeeding and increases the use of BMSs.
In response to the unethical marketing of BMS by infant formula manufacturers, the WHO developed the International Code of Marketing of Breastmilk Substitutes (WHO, 1981) and key resolutions such as the 69.9 regulation (WHO, 2016a), which explicitly include follow-up formulas and growing-up milks. This international resolution 69.9 calls on countries to implement the WHO's Guidance on Ending the Inappropriate Promotion of Foods for Infants and Young Children (WHO, 2017). As described by Pereira et al. in 2016, companies that produce follow-up formulas and growing-up milks had developed similar packaging and labelling to infant formulas and used those products to promote their brands, creating confusion among consumers (Berry, Jones, & Iverson, 2012;Cattaneo et al., 2015).
Since 2016, the Ethiopian government has adopted several directives such as the "Infant Formula and Follow-up Formula Directive No. 30/2016" and the "Food Advertisement Directive 33/2016" to support breastfeeding by restricting the promotion of BMS marketed for children less than 2 years of age. However, to date, no breaches to these directives have been reported by Food, Medicine, and Healthcare Administration and Control Authority (FMHACA) and/or other inspectors indicating lack of or poor monitoring. In many countries (Hou et al., 2019), stronger monitoring and enforcement mechanisms have been put in place to ensure that the marketing of BMSs does not undermine breastfeeding.
This study critically reviews the content of legislation, standards, and monitoring documents used to prohibit the unethical marketing of BMSs that undermine breastfeeding in Ethiopia and to identify areas of strength and areas needing improvement to ensure that the prevalence of exclusive breastfeeding can reach 70% by 2020 as stated in the National Nutrition Programme strategy (The Federal Demographic Republic of Ethiopia, 2015). This study sought to assess the exposure by mothers and health facilities to commercial advertising of BMSs in Addis Ababa.

| METHODS
To assess the current legislation and monitoring system, researchers collected data through desk reviews and structured interviews with key in 2019. The key informant interviewee was the main source of qualitative data for the situational analysis of the implementation, monitoring, and enforcement of BMS code in the country. Key informants were selected from the Federal Ministry of Health (FMOH), the Food and Medicine Authority, the Ethiopian Broadcasting Authority, UNICEF, WHO, Save the Children, Alive and Thrive, and relevant regional stakeholders. For the regional and city administration-level assessments, informants were selected from Regional Health Bureaus,

Key Messages
• Despite existence of legislation, companies are pervasively promoting breast-milk substitutes in Addis Ababa, particularly on television, as 41% of the interviewed mothers have seen breastmilk substitute advertising.
• The national laws largely exclude the International Code and Monitoring of Breastmilk Substitute (the Code)related marketing restrictions required to regulate the promotion and advertisement of follow-up formulas, complementary foods, and growing-up milks.
• A specific monitoring tool kit of approved legislation needs improvement and implementation.
• Future amendments to regulations should emphasize advertising in order to protect breastfeeding for the nutrition and health of infants and young children as the Ethiopian market becomes more favourable to international trade, including companies that manufacture infant formula.
FMHACA, and the Trade and Industry Bureau. The qualitative surveys and desk review examined the available laws, policies, the designated institutions, and available processes for BMS monitoring and enforcement at the national level and at the level of two regional states. The analysis focused on (i) legislative mandates and responsibilities of the core national and regional authorities, (ii) comparison of the international code with Ethiopia's national laws, (iii) relevant laws of national authorities outside of the core institutions, and (iv) legal tools for BMS monitoring and enforcement and their current implementation. All The sample size for this study was calculated to detect a 50% prevalence rate of exposure to advertising within the health system, with a measurement error of ±10%. Using a standard of error of 0.025, a response rate of 10%, and assuming a design effect of 1, a sample size of 107 mothers at discharge was determined. Those mothers with children aged 0-24 months were randomly selected at discharge.
Recruitment of participants and data collection were conducted on 110 mothers as no mothers refused to respond to the questionnaires from the 11 largest health facilities (of which 63% were public owned) in Addis Ababa as recommended by the Net Code Ongoing Monitoring Protocol. Sampled facilities were alerted of the data collection approximately 1 week prior to the survey. Survey supervisors worked with the health worker in-charge to identify those mothers ready for discharge and to randomly select the mothers for interviews. The survey took approximately 2 days per health facility.
In order to assess retail outlets, 11 small stores or pharmacies and 10 large stores (one from each subcity) operating in the capital were selected. As recommended (WHO & UNICEF, 2017a; WHO & UNICEF, 2017b), the 11 small stores or pharmacies were chosen in proximity to each of the 11 selected health facilities.
Small stores included corner/convenience stores and neighbourhood stores/kiosks. No pharmacies associated with the health facilities were included. The 10 large stores were selected based on prior knowledge that they would carry most of the relevant products available for sale in Addis Ababa. Large stores included national-chain grocery stores with high volume of sales. The net code checklists guided the monitoring of (a) labels and packaging of products, (b) point-ofsale promotions, and (c) health facility promotional materials and activities. The detailed checklists provided a quick snapshot in Addis Ababa of retail locations, health facilities, and package labels to identify any violation, including inspecting labels and promotional materials.
In order to conduct the assessments in health facilities operating in Addis Ababa, ethical approval was obtained from the Addis Ababa Health Bureau Ethical Review Board. Once the ethical approval was obtained, the interviewers requested the approval to conduct the assessment within the hospitals by the direction and the signed consent from the interviewed mothers.

| Legislative mandates and responsibilities
At the national level, the Ethiopian Food and Drug Administration (EFDA) and the FMOH constitute the core public health authorities (see Figure 1). FMOH has the responsibility to monitor compliance of Due to Ethiopia's federal configuration, the Regional Health Bureau and the Regional State Communications Bureau regional bureaus also have the mandate to implement the mandates around the regulation of BMS such as advertisement, marketing, promotion to health professionals, and registration of health care workers. They regulate most health workers/facilities and any advertisement and promotion that are local in nature and does not transcend regional border.

| Gaps and bottlenecks in current regulation and monitoring tools
The  Table 1 presents the key provisions of the Ethiopian legislation according to the international code of marketing of breast-milk substitutes within legal measures, whereas Table 2  EFDA, which is the leading national authority on the Code of marketing of BMS, argues that the weak coordination among federal government authorities is due to the absence of a formal monitoring mechanism. Even though platforms such as the Joint Steering Committee exists at national and regional levels, to prepare, monitor, and evaluate the implementation of the national health plan and other activities, it cannot substitute national code-specific coordinating bodies. Table 2  Institute & ICF, 2019) is an early warning of potential threat from BMS or inappropriate use of complementary feeding. As shown in our study, those practices are not constrained by any regulations. National laws do not define bottles, pacifiers, and teats as a designated product for code regulation. Unfortunately, diluted complementary food could easily become a BMS once it is given using a bottle and a nipple. The complexity of defining when a complementary food becomes a BMS was already raised in Indonesia (Soekarjo & Zehner, 2011). Even the indirect promotion of follow-up formula and growing-up milk through bottles, pacifiers, and teats is not banned in Ethiopia and should therefore be remedied with future amendments to the existing directives.

| Assessment of baby food companies' compliance
All these required amendments are presented in Table 3.

Social and financial implication No
Health hazards of inappropriate feeding No

Prohibitions of promotion to the general public
Advertising Partial restriction

Prohibitions of promotion to health workers/facilities
Provision of low-cost supplies No

Recommended age of introduction No
Message on the superiority of breastfeeding Yes Only to be used on the advice of health workers. Yes

Preparation instructions Yes
There is need to define more explicitly the following terms in order to improve the existing directives: (i) what is growing-up milk?
and (ii) what is the scope of promotion restriction to and from nonprofessional and/or unpaid personnel working in health facilities?
More than 10 bottlenecks were raised by our assessment as shown in Figure 2 and could be easily corrected through fine tuning of some articles in the existing directives (Table 3) and following the 2017 WHO guidance (WHO, 2017). Companies will use any backdoor channels to ensure that their products are being promoted and sold to the potential consumers as was observed in Nepal, Cambodia, Senegal, and Tanzania (Zehner, 2016). With a global sales of breastfeeding substitutes of US$40 billion in 2013 (Piwoz & Huffman, 2015), Ethiopia, with a population of more than 100 million, and ranked in 2015 among the top 20 fastest-growing economies in the world (Deloitte, 2015), seems to be a target market for BMSs, thus the need to strengthen the national legislation.
In addition, the promotion of many BMS within the Cambodia (Champeny et al., 2016). Even though our study did not Sales device Some restrictions Posting messages like "reduced price" and "clearance sale" at point of sales to advertise and promote infant formula and complementary food (but other product categories) is banned (see Art 9 ((2) and 12(5), Food Advertisement Directive). National laws prohibit no other sales device besides posting related messages. However, sales devices, including special displays, discount coupons, loss-leaders, and tie-in sales are not restricted for all product categories except for infant formula Sample and gift, and contact with mothers assess the capacity of inspectors from the Ministry of Health at federal and regional level, there is a need for capacity building to strengthen their ability to detect violations and enforce code-related laws as described in previous publications (Barennes, Slesak, Goyet, Aaron, & Srour, 2016;Hou et al., 2019). During a qualitative discussion implemented in parallel to our study, many of the food safety inspectors and officers at both national and regional level have limited awareness of the gaps in the relevant national laws and the Code.

| CONCLUSION
In parallel to amending the existing directives in line with the international 69.9 recommendations of the Code, Ethiopia should develop an action plan for the nationwide implementation of the monitoring and enforcement of the directives. Through the action plan, regional inspectors should have a clear understanding of their assigned roles and tasks within the monitoring and enforcement system before beginning their inspections. The monitoring system should include checklists integrated into routine activities to encourage the inspectors to complete checklists, especially as they are expected to enforce the directives. If violators remain noncompliant, Ethiopia should consider taking a stricter approach against noncompliant health centres, broadcast channels, retailers, and BMS suppliers.