Pilot implementation of a monitoring and enforcement system for the International Code of Marketing of Breast‐milk Substitutes in Cambodia

Abstract Globally, monitoring and enforcement mechanisms for the World Health Organization's International Code of Marketing of Breast‐milk Substitutes are often lacking. The Cambodian government adopted the Code as the national standard in Sub‐Decree 133 on Marketing of Products for Infant and Young Child Feeding. Following the formation of a multisectoral Oversight Board and development of detailed guidance documents for the implementation and enforcement of Sub‐Decree 133, a 7‐month pilot was conducted in 2017 to trial a monitoring system in four urban areas of Cambodia. The pilot included training of monitors from the Ministries of Health and Commerce, screening for violations at retail locations and health facilities, testing reporting mechanisms, and taking actions against violators. During the pilot, 85 national‐ and subnational‐level monitors were trained, 392 site visits were made, 2,377 monitoring checklists were completed, and 11 warning letters were issued to violators. Half of the completed checklists (52.9%) indicated Code violations, yet monitors submitted zero violation reports. The pilot revealed modifications needed to the monitoring system: integrate monitor trainings into existing ministry training curricula for sustainability; enhance targeting of monitors for Sub‐Decree training; delineate clear roles and responsibilities for the national and subnational levels; simplify monitoring checklists and violation reports; and improve integration of monitoring activities into routine ministry operations. Before the Sub‐Decree 133 monitoring and enforcement system is implemented throughout Cambodia, revisions must be made to ensure the viability of this system. Challenges and lessons learned can also guide Code monitoring efforts being undertaken by other countries.


| INTRODUCTION
Scaling up of optimal breastfeeding practices could have the single largest impact on child mortality of any preventive intervention (Bhutta et al., 2013). Cambodia has made significant progress improving its rate of exclusive breastfeeding from 11% in 2000 to 74% in 2010 (National Institute of Statistics [NIS], Directorate General for Health, & ICF Macro, 2011); however, the 2014 Cambodia Demographic Health Survey found that exclusive breastfeeding and continued breastfeeding at 2 years of age declined to 65% and 37%, respectively (NIS, Directorate General for Health, & ICF International, 2015). In 2010, bottle-feeding for infants less than 6 months old increased to 14%, from 3% in 2000, and reached more than 30% for infants less than 12 months (NIS, Directorate General  (Pries et al., 2016).
Commercial promotions for BMS are increasingly prevalent in Cambodia. A 2014 survey found 86% of mothers of children less than 24 months old had observed commercial promotions for BMS and 19% observed BMS product logos on health facility equipment (Pries et al., 2016). Reviews of television advertisements airing in  (Alive & Thrive, 2016;Champeny et al., 2019). Commercial promotions of BMS products contribute to suboptimal breastfeeding practices (Piwoz & Huffman, 2015;Rollins et al., 2016). Mothers with low education or access to resources are also more susceptible to BMS promotions and the risks BMS use may pose to their children (Barennes, Slesak, Goyet, Aaron, & Srour, 2016).
In response to documented, unethical marketing activities by BMS manufacturers, the World Health Organization (WHO) developed the International Code of Marketing of Breast-milk Substitutes (the Code; WHO, 1981) and subsequent resolutions. Although the Code has been in existence for more than 35 years, WHO reports that few countries have a monitoring mechanism in place to regulate promotional practices, and of those, few are fully functional (WHO, UNICEF, & International Baby Food Action Network [IBFAN], 2016). Only 32 countries report having a formal monitoring system in place and less than a quarter of countries with a monitoring mechanism publish results of their monitoring exercises. Just six countries report having dedicated budgets or funding for monitoring and enforcement.
In 2005, the Cambodian government adopted many provisions of the Code as national policy in the Cambodian Sub-Decree on Marketing of Products for Infant and Young Child Feeding (Sub-Decree 133), to support breastfeeding by restricting the promotion of BMS marketed for children less than 2 years of age, unless approved by the Ministry of Health (MOH; Royal Government of Cambodia, 2005 yet national-and subnational-level monitors filed zero violation and monthly monitoring reports.
• The pilot exposed gaps and challenges to the designed system. Each ministry involved needs to develop a clear, detailed work plan to integrate Sub-Decree 133 monitoring into routine training, monitoring, and reporting services.
• Improved communication between stakeholders is needed to ensure that Sub-Decree 133 monitoring trainings and activities occur seamlessly, and national and subnational monitors explicitly understand their designated roles within the monitoring system.
• Training modules and checklists for Sub-Decree 133 monitoring should be revised to ensure that guidance on the monitoring process, methods, and materials is clearly explained, and ample time for teaching and activities is given.
• Clear follow-up plans should be developed to track violators that received warnings and agreement letters.
Repeat offenders should be given more stringent penalties.
After creation in 2015, the EWG recognized a need for the explicit definition of responsibilities in order to operationalize the Sub-Decree. In 2015, the EWG developed Implementation Guidelines, further detailing the roles of the four ministries at the national and subnational level for the implementation, monitoring, and enforcement of Sub-Decree 133 (MOH, 2015a). Clear Terms of Reference for the Oversight Board, EWG, and Control Committee were also developed (MOH, 2015b). Both guidance documents, endorsed by the Oversight Board in late 2015, placed an emphasis on integrating monitoring activities into the existing, routine responsibilities of the four ministries, to reduce the need for additional financial and human resources and to increase sustainability and continuity of monitoring.
To facilitate the monitoring activities of national and subnational offi-

| Pilot study design
This study was designed to trial the newly developed monitoring and enforcement system that entailed training of monitors, screening for violations, reporting mechanisms, and taking actions against violators.
The pilot focused on the monitoring process once products entered the market for sale, including monitoring promotions and product labels at points-of-sale and promotions at health facilities. The pilot did not trial the system prior to product importation/manufacture or sale. and Handicraft is called to review the labelling and packaging of locally produced IYCF products; yet, at the time of the pilot, there were no local manufacturers of IYCF products. The Sub-Decree also calls for the monitoring of product promotions on all media platforms, including television, newspaper, radio, and online; however, discussion is still ongoing as to whether this responsibility falls to the Ministry of Information or another ministry.

| Role of ministries in pilot monitoring system
The roles and responsibilities for each participating ministry and department were outlined in the joint work plan according to the Implementation Guidelines of Sub-Decree 133. Monitoring and reporting activities during the pilot were to be conducted in addition to their ongoing responsibilities and were as follows.

| Ministry of Commerce, Department of CAMCONTROL
CAMCONTROL subnational officers were responsible for monitoring during their routine activities at supermarkets, minimarts, and small shops for point-of-sale promotions and to review IYCF product labels for violations. These officers were authorized CAMCONTROL inspectors who already carried out regular ministry inspections of retail locations. The adapted checklists guided their Sub-Decree 133 monitoring, and any suspected violations were to be reported directly to the EWG by the inspector. Each month of the pilot, CAMCONTROL was responsible for submitting a summary report to the EWG of all national and subnational monitoring activities.

| Ministry of Health, Department of Drug and Food Safety
DDF's national and subnational level officers were to monitor promotional activities at pharmacies and specialty baby shops and to review product labels for violations. Similar to CAMCONTROL, DDF monitors were authorized DDF inspectors who routinely visited retail locations to ensure compliance with government regulations, and under the pilot were to integrate the use of Sub-Decree 133 checklists into their ongoing inspections. Subnational monitors were required to submit violation reports directly to the EWG as well as monthly reports on their inspection.

| Ministry of Health, National Nutrition Program
NNP was to monitor advertising and promotional activities in health facilities during routine facility visits made by their subnational Nutrition Focal Points to support nutrition-related maternal child health services. The Nutrition Focal Points were to monitor product promotions in Cambodia's health care system including the distribution of free or subsidized supplies of BMS. They were also tasked with submitting monthly reports on monitoring activities and any violation reports to the EWG. In the pilot, all national and subnational monitors finding violations during their activities were required to submit a completed form for each violation observed directly to the Secretaries of the EWG.

| Monthly monitoring reports
National and subnational monitors were to submit monthly reports summarizing their monitoring activities to their ministry's designated focal person at the national level, who then sent the reports to the EWG. Monthly reporting forms were taken from the Implementation Guidelines (MOH, 2015a) and detailed the following: (a) date of monitoring; (b) type of monitoring (e.g., point-of-sale or health facility); (c) location of monitoring, including city/district and name of site/shop/ health facility; (d) key findings from monitoring (e.g., labels not compliant); (e) list of noncompliant products; and (f) actions taken. Fifteen-question pre-tests/post-tests were administered to participants to assess mastery of the training content.

| Monitoring visits by national and subnational teams
Monitoring activities were piloted from January to August 2017. The subnational monitoring teams from CAMCONTROL, DDF, and NNP were to implement their respective monitoring procedures as part of their routine responsibilities, including completion of checklists, consolidation of checklist information into monthly reports, and submission of monthly reports to their provincial departments and EWG.

| Operation of EWG and Oversight Board
During the pilot, the EWG was to receive violation reports and the monthly monitoring reports from each ministry/department. As per the Implementation Guidelines and Terms of Reference, the EWG was to meet once a month to review monitoring activities, suspected violations, and to issue action on violations. The Oversight Board was to meet once every three months.

| Data management and analysis
With support from a WHO consultant, an Excel database system was established at DDF to track the completed checklists for all monitoring activities from the pilot period. After each round of field visits, the two ministries submitted their completed checklists to DDF for entry.
Based on the Implementation Guidelines, the checklists typically should remain at the subnational level where they are used, but to facilitate assessment for this pilot, the checklists were shared with the national level DDF and entered by the WHO consultant and DDF staff.
To assess implementation of the system during the pilot and to develop recommendations for improvement, a number of resources were reviewed and discussions held with national and subnational monitors and officials. The checklist database was analysed in Excel to calculate the number and type of monitoring visits made, checklists completed, and violations detected and reported. A WHO rapid review of the use of the checklists, which included focus group discussions with subnational monitors and key informant interviews with national ministry officials, was reviewed (Iellamo, 2017). Numerous official and unofficial meetings were held throughout the course of the pilot with EWG members, Oversight Board members, the nutrition master trainers, the national teams who carried out the spot checks, and partners including HKI, WHO, and UNICEF. A final consensus meeting was held by the Chair of the EWG in January 2018 and attended by all involved in the pilot implementation, where experiences, lessons learned, and next steps for the ministries and EWG were discussed. Table 1 displays the participant turnout from the relevant ministries at the national-and subnational-level monitor trainings. In total, 16 monitors were expected to participate from the national level and 20 from the subnational level; however, attendance was higher than expected.

| Sub-Decree 133 monitoring trainings
From the national level, 33 attended and 52 from the subnational level. The average pre-test score across the trainings was 8.0 out of 15, and the average post-test score was 12.4 out of 15. Table 2 presents the number of monitoring visits made during the pilot study. Although it was proposed that a total of 360 visits be made over the pilot, 392 visits were made in total. It was possible for a site to have been visited more than once during the pilot, as sites were   There was no evidence of subnational monitors submitting monthly reports summarizing their monitoring activities to their respective ministry nor of the ministry-designed focal person at the national level reporting to the EWG of monthly activities (Table 4).

| Monitors' adherence to Sub-Decree 133 monitoring and reporting guidelines
Additionally, no violation reports were generated and submitted to the EWG by either the subnational or national monitoring teams.

| Oversight Board, EWG, and actions taken against violators
Over the pilot period, the EWG met one time and the Oversight Board did not meet at all. By August 2017, the EWG issued a total of 11 warning and agreement letters to companies/distributors who were found to have label/package violations during the pilot monitoring (

| Training of monitoring personnel
Far more monitors attended the trainings than originally planned.
According to the ministries, the discrepancy in the turnout may have occurred because DDF and CAMCONTROL seized this opportunity to train their entire staff on the monitoring and enforcement curriculum. Positively, this reflects political commitment and interest in enforcing Sub-Decree 133 at all levels; however, the larger-thananticipated attendance resulted in staff without monitoring responsibilities being trained and having to add extra training sessions in January 2017 to fully reach the intended targets. Improved communication, coordination, and targeting is recommended to save resources.
After the national and subnational level trainings, trainers noted that significant refinement was required in the training materials, activities, and time allocation. During the pilot, subnational monitors also conveyed that they did not feel fully competent in their designated roles (Iellamo, 2017). Proposed future modifications to the training include adding more content on the detailed steps of the monitoring process, providing participants with additional time to practice filling in checklists and reporting forms, and inserting more opportunities to identify the differences between compliance and noncompliance, especially for inspectors visiting points-of-sale.
The national and subnational level trainings in the pilot were both financially and technically supported by development partners, with consideration that the government would take responsibility in providing resources when the system is eventually rolled out in other provinces. Trainings were also stand-alone, although several of the ministries have routine, scheduled trainings for their cadre of inspectors, including DDF and CAMCONTROL. To improve sustainability of monitoring, we recommend that Sub-Decree 133 training content should be fully integrated into each ministry's routine training system.

| Monitoring tools and process
Monitors made 392 visits during the pilot study; however, the implementation of these visits did not fully adhere to Sub-Decree 133's Implementation Guidelines. Monitoring activities only occurred during the spot checks by national teams. These spot checks were supported by partners, which may explain why independent, subnational monitoring did not happened as planned. Although integrating Sub-Decree monitoring into routine responsibilities should reduce the need for resources, subnational and national staff in all ministries and departments voiced concerns during the rapid review (Iellamo, 2017) and consensus meeting about the financial and human resources required to continually conduct monitoring activities. The EWG called on the ministries to reexamine and improve their integration efforts and allocation of resources, but the challenge has not yet been fully resolved.

| Reporting of monthly activities and violations
Over the pilot period, none of the monitoring teams submitted violation reports or monthly summary reports to the EWG. In informal discussions and during the rapid review, subnational monitors reported confusion over their roles and responsibilities and limited time and resources for the extra steps of reporting violations to the nationallevel monitors (Iellamo, 2017). Subnational monitors did not submit any reports because they were waiting on national monitors to followup first. More notably, subnational monitors reported that their responsibilities requiring them to directly report to the national level were at odds with the structural hierarchy of their ministries; low-level officers do not report directly to high-level officials. The integration of responsibilities must also follow the existing flow of information and reporting within the ministries. Close coordination with ministry staff at all levels is vital to understanding their operations and finding opportunities to build monitoring into their existing system.
There is evidence that a multisectoral approach to ensuring compliance with the Code can work. Through a comprehensive monitoring strategy between government, UNICEF, and non-governmental organizations, the Indian state of Assam increased exclusive breastfeeding from 29% in 1999 to 63% in 2016 (Barennes et al., 2016). Proper coordination between the government and civil society organizations is pivotal to ensure that companies are in compliance with national Code laws (Barennes et al., 2016 Warning and agreement letters were sent to 11 companies found in violation of Sub-Decree 133 during the pilot, requiring that they comply by creating proper product labels. The government's issuance of these letters was considered a "soft approach" against violators (Iellamo, 2017) and may have been taken to build awareness of Sub-Decree 133, its standards, and that the government is intent on taking action. At the time of the pilot, Cambodia did not have any punitive measures in place for violators of Sub-Decree 133. During the three rounds of spot checks, it was also observed that monitors discussed violations they found with health facility staff and shop owners.
Although this may provide an opportunity to learn and correct actions, so far, shop owners have been unwilling to remove products that are noncompliant (Iellamo, 2017

| CONCLUSION
The pilot implementation of Sub-Decree 133's monitoring and enforcement system in Cambodia presented successes, challenges, and recommendations for moving ahead. Political commitment to abiding by Sub-Decree 133's guidelines was apparent; however, changes are needed to strengthen and ensure the seamless execution of the monitoring system before it is further enacted throughout Cambodia.
Cambodia should develop an action plan for the nationwide implementation of Sub-Decree 133's monitoring and enforcement system, based on experiences and lessons learned from the pilot. This action plan needs to include a refined training system for national and subnational monitors, with improved communication and planning to allow facilitators to execute the training curricula effectively and with the appropriate staff. National and subnational monitors should have a clear understanding of their assigned roles and tasks within the monitoring and enforcement system before beginning their inspections.
Sub-Decree training should be incorporated into routine ministry operations, including booster trainings to refresh monitors' familiarity with violations.
Monitoring checklist could be shortened and refined to focus on key BMS violation indicators, enabling them to be better integrated into the ministries' routine activities or to simplify stand-alone monitoring. This will encourage subnational monitors to complete checklists, especially as they are expected to act without the supervision of national monitors. It is vital that the enforcement system's activities become a consistent part of the ministries' routine operations, either as integrated activities or with alternative approaches that account for capacity and resources, to ensure the sustainability of the system.