40th Anniversary Celebration of the Adoption of the International Code of Marketing of Breastmilk Substitutes Implementing the Code and relevant World Health Assembly resolutions in West and Central Africa Regional virtual event Wednesday, May 26, 2021
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40th Anniversary Celebration of the Adoption of the International Code of Marketing of Breastmilk
Substitutes
Implementing the Code and relevant World
Health Assembly resolutions
in West and Central Africa
Regional virtual event
Wednesday, May 26, 2021
About the event
▪ Simultaneous interpretation in French, English, and Portuguese.
▪ Chat box ▪ Introduction▪ to ask for help or to continue introducing yourselves.
▪ Q&A: Questions to speakers.
▪ Recording
Objectives
▪ Highlight the role of the Code and resolutions in
protecting breastfeeding
▪ Describe the state of implementation of the Code in
the region and highlight bottlenecks
▪ Introduce NetCode tools
▪ Provide country experiences in implementing
NetCode and other monitoring tools (Nigeria and
CIV).
▪ Encourage countries to develop a plan of action for
implementing the Code
About the event
Speakers and moderators
WelcomeAnne-Sophie Le DainUNICEF West & Central Africa
Opening & Closing remarks Dr Namoudou Keita West African Health Organization
Session 1: Setting the sceneManisha TharaneyAlive& Thrive
Session 2: Country experiences Cote d´Ivoire & Nigeria Hana BekeleWorld Health Organization
Q&A
Ellen SokolUNICEF West & Central Africa
Akoto OseiHellen Keller international
Edouard ZerboIBFAN
Dr. Namoudou Keita
West African Health Organization
Opening remarks
Speakers
Ellen SokolLegal consultantUNICEF West & Central Africa
Richmond Aryeetey,Associate Professor of Public HealthUniversity of Ghana
Hana BekeleSenior Nutrition SpecialistWorld Health Organization
Session 1: Setting the scene
1. The Code, related WHA resolutions,
implementation in West and Central Africa
2. Regional implementation of WHO
Guidance
3. NetCode tools for monitoring and
enforcement
The Code and implementation
in West and Central Africa
Ellen SOKOL, Legal Consultant,
UNICEF West and Central Africa
Regional Office
Outline
1. Summary of the Code and relevant
WHA resolutions
2. Legal status of the Code and WHA
resolutions
3. Implementation in West and Central
Africa
Media, billboards, special displays, free
samples, gifts, direct contact by
marketing personnel
Summary of the Code
No advertising or other form of promotion to general public
No promotion in the health care system
No posters, gadgets, gifts or incentives
to health workers, free supplies of
products or donations of equipment and
materials
Summary of the Code
Information on infant and young child feeding
Product labels
o Provide necessary information about
appropriate use
o designed so as not to discourage
breastfeeding
Product quality
Meet applicable standards recommended
by Codex Alimentarius Commission
Objective and consistent
Scope (products covered)
Companies introduce new products and
claim they are not “breastmilk substitutes”
Infant formula; other products marketed as breastmilk
substitutes; feeding bottles and teats
Scope of the Code (Article 2)
“from 6
months”
“12 months
to 3 years”
Legal status of the Code
Adopted by Resolution 34.22 of the World Health
Assembly (WHA) in 1981
A WHA resolution is an international
recommendation and NOT a binding treaty or
regulation
BUT it carries weight as a judgment on health from
the highest international body in field of health
WHA Resolution 34.22
Member States are urged to
Support implementation . . . of the provisions of the
International Code in its entirety and
Translate the International Code into national legislation,
regulations or other suitable measures.
Since 1981, WHA has adopted 18 resolutions with relevance
to the Code.
Subsequent WHA resolutions have the same status as the
Code
Relevant WHA resolutions
Six months optimal duration of exclusive breastfeeding and timely
complementary feeding
No donations of supplies of breastmilk substitutes in any part of the health
care system
Financial support for health professionals must not create conflicts of
interest
Implement WHO Guidance on ending inappropriate marketing of foods for
infants and young children
WHA Resolution 69.9 (2016)
WHA 69.9 welcomed the WHO
Guidance on Inappropriate Promotion of Foods for Infants
and Young Children
To address concern that the promotion of breastmilk substitutes and
some commercial foods for infants and young children continues to
undermine progress in optimal infant and young child feeding
Includes 7 recommendations for controlling the marketing of foods and
beverages targeted toward children under the age of 36 months
WHO Guidance: Recommendation 3
What is a breastmilk substitute
Any kind of milk specifically marketed for feeding infants and young children up to the age of 3 years (including follow-up formula and growing up milks). Recommendation 3, Guidance on ending the inappropriate promotion of foods for infants and young children, WHO 2016
Code implementation in West and Central Africa
Code implementation WCAR
www. breastmilkonly.com
Thank you!
Assessment of regional implementation of WHO guidance
on ending inappropriate promotion of foods for infants and young
children
West and Central Africa
Richmond Aryeetey,
University of Ghana School of Public Health
To assess awareness and extent to which ECOWAS and ECCAS countries have incorporated WHO Technical Guidance recommendations into national legislation, policies, strategies and plans
Objectives of analysis
• Online survey administered via email to 23 mid-level program managers
• Desk review of national legislation/regulations, policies, guidelines, and strategies/plans related to IYCF
• Using a checklist that was developed based on the 7 recommendations of the WHO Technical Guidance Document
Methods
• The Code and subsequent WHA resolutions prohibits promotion of breastmilk substitutes
• Breastmilk substitutes defined to include any milks (irrespective of form-powdered, liquid etc.) marketed for feeding infants and young children up to age of 3 years, • including follow-up formula and growing-
up milks
Recommendation 2: Breast milk Substitutes
Recommendation 2: How West and Central African countries are doing
West Africa Central Africa
Ben
in
Nig
eria
Gh
ana
Gam
bia
Co
te D
’ Ivo
ire
Cap
e V
erd
e
Sen
egal
Sier
ra L
eon
e
Togo
Bu
rkin
a Fa
so
Gu
inea
Gu
inea
B
issa
u
Lib
eria
Mal
i
Nig
er
Sao
To
me
and
Pri
nci
pe
Cam
ero
on
Ch
ad
Co
ngo
De
mo
crat
ic R
epu
blic
of
Co
ngo
Cen
tral
Afr
ican
Rep
ub
lic
Gab
on
Equ
ato
rial
Gu
inea
Part
ial
Part
ial
Part
ial
Part
ial
Litt
le
Litt
le
Litt
le
Litt
le
Litt
le
No
ne
No
ne
No
ne
No
ne
No
ne
No
ne
Part
ial
Part
ial
Part
ial
No
ne
No
ne
No
ne
No
ne
No
Info
rmat
ion
• Messages used to promote foods for infants and young children should support optimal feeding
• Inappropriate messages should not be used
• Messages should be easily understood, visible and legible to caregivers
• Messages should include:
• Importance of continued breastfeeding for up to 2 years and beyond
• Importance of not introducing complementary feeding before 6 months of age
Recommendation 4: Appropriate Messaging
• Messages SHOULD NOT :
• Include images, text or other representation that might suggest use of product for infants less than 6 months old
• Undermine or discourage breastfeeding
• Make a comparison to breastmilk
• Suggest the product is nearly equivalent or superior to breast-milk
• Recommend or promote bottle-feeding
• Convey endorsement by a professional body unless specifically approved by regulatory authorities
Recommendation 4: Appropriate Messaging
Recommendation 4: How West and Central African countries are doing
West Africa Central Africa
Cap
e V
erd
e
Gam
bia
Sen
egal
Cam
ero
on
Ben
in
Co
te D
’Ivo
ire
Gh
ana
Mal
i
Nig
eria
Sier
ra L
oen
e
Togo
Ch
ad
Gab
on
Sao
To
me
and
Pri
nci
pe
Mo
re t
han
a
littl
e
Mo
re t
han
a
littl
e
Mo
re t
han
a
littl
e
Mo
re t
han
a
littl
e
Litt
le
Litt
le
Litt
le
Litt
le
Litt
le
Litt
le
Litt
le
Litt
le
Litt
le
Litt
le
Occurs when similar packaging/labelling is used to link sale of different product lines
There should be no cross-promotion to promote breast-milk substitutes indirectly via promotion of foods for infants and young children.
Recommendation 5: Cross-promotion
Cross promotion regulation-Nigeria
CountryLegislation
mentions cross-promotion
Defines cross-promotion
Cross-promotion is prohibited
Labelling not permitted to
indicate cross-promotion
Tie-in-sales prohibited
Nigeria Yes Yes Yes No No
Senegal (Proposed in draft legislation)
Yes Yes Yes Yes No
Ghana No NoNot
indicatedNot
indicatedYes
• There is high awareness of the Code and WHO Technical guidance, albeit with limited understanding of the recommendations
• Only a few countries had included all Code provisions to effectively protect, promote and support breastfeeding.
• Relatively few countries, especially those in West Africa, had documents that had incorporated some of the seven WHO Guidance recommendations. Implementation of recommendation 5 is almost non-existent
• Survey identified opportunities for countries to build upon existing capacities
Conclusions
• Need to develop/update existing documents relevant to the WHO technical Guidance recommendations
• Advocacy, awareness creation, and capacity building regarding the WHO technical Guidance recommendations are needed.
• Technical and financial support needed for countries to develop or revise national IYCF policies, regulations, strategies, and plans
Needed Actions
Opeyemi Lasisi- University of Ghana
Akoto Osei, Marguette Beye, and Volkan Cakir - Helen Keller Intl.
Ellen Sokol- UNICEF
Acknowledgements
Monitoring and enforcement of the International Code of Marketing of
Breast-milk Substitutes
Use of the NetCode Toolkit
Hana Bekele
MO, WHO/AFRO, Zimbabwe
Outline
⚫ Why and who should monitor the Code?
⚫ NetCode toolkit – Types of monitoring
– Periodic assessment
– Ongoing monitoring system
⚫ Implementation status of the NetCode protocols
⚫ Summary
Why monitor the implementation of the Code?
⚫ Legislation to restrict marketing of breast-milk substitutes is necessary but not sufficient;
⚫ Equally important are the endorsement of implementing regulations, effective enforcement and monitoring of compliance
⚫ Monitoring compliance provides information essential for appropriate action and advocacy.
⚫ Monitoring also provides information on the quality of the legislation, including possible weaknesses and loopholes
⚫ A system of funding for regular monitoring of compliance with legislation should be explicitly developed and funded from the beginning
Who is responsible for monitoring and enforcement the implementation of the International Code ?
⚫ Primary responsibility lies with Governments according to the Article 11 of the Code
⚫ Monitoring mechanisms need to be transparent and independent
⚫ Free from commercial influence and should address labelling, all forms of advertising and commercial promotion across all media promotion and in health care, conflicts of interest, retail promotional devices, sales incentives
⚫ NGOs, institutions and individuals can draw the attention of manufacturers and distributors to activities which are incompatible with the Code, and inform the government to take action
⚫ The manufacturers and distributors of products, appropriate nongovernmental organizations, professional groups, and consumer organizations should collaborate with governments to this end
⚫ Responsible bodies should be able to impose appropriate sanctions according to existing legal systems
NetCode a monitoring framework since 2015
⚫ Network for Global Monitoring and Support for Implementation of the International Code of Marketing of Breast-milk Substitutes and Subsequent Relevant World Health Assembly Resolutions
⚫ NetCode combines the efforts of civil society organizations, academics, and selected countries to establish standards for Code monitoring
The NetCode Protocols
⚫ NetCode protocols addresses both ongoing monitoring and periodic assessment of the Code
Protocol for periodic assessment
⚫ Assess quantitatively the level of compliance with the provisions of the Code and national measures
⚫ Assess trends and changes in compliance over time
⚫ Identify priority areas for Code implementation and enforcement work
⚫ Reveal gaps and limitations of national laws to be addressed through policy and legislative measures
Modules of periodic assessment protocol
Implementation status of periodic assessment protocol
⚫ Completed studies in:– Brazil (retail only)
– Chile
– Dominican Republic (mothers only)
– Ecuador
– Mexico
– Nigeria (ATNI)
– Sri Lanka
– Thailand (ATNI)
– Uruguay
– Philippines (ATNI)
– Cote d’Ivoire
⚫ Planning started in:– Panama
– Russian Federation
– Suriname
– Zimbabwe
Protocol for ongoing monitoring system
⚫ Detect violations of the national laws and/or the Code
⚫ Document and report such violations
⚫ Investigate and validate whether the reported activities are indeed violations
⚫ Activate an enforcement mechanism that would stop such violations and deter future violations
⚫ Hold manufacturers, distributors, retail outlets, the health-care system and health-care workers to account for their breeches of national laws and/or the Code
Implementation status of ongoing monitoring systems
⚫ Working with 12 countries on developing ongoing monitoring systems
⚫ Online reporting now operative in Oman & Sri Lanka
Code status reporthttps://www.who.int/publications/i/item/9789240006010 2020 report
Implementation Manual for Guidance on Ending Inappropriate Marketing of Foods for Infants and Young Childrenhttp://www.who.int/nutrition/publications/infantfeeding/manual-ending-inappropriate-promotion-food/en/
OHCHR statement on breastfeeding and human rightshttps://www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=20871&LangID=E
IMPLEMENTING THE CODE AND RELEVANT WORLD HEALTH ASSEMBLY RESOLUTIONS IN WEST AND
CENTRAL AFRICA
EVA EDWARDS
DEPUTY DIRECTOR
NATIONAL AGENCY FOR FOOD AND DRUG
ADMINISTRATION AND CONTROL (NAFDAC)
NIGERIA
26TH MAY 2021
• Background on Nigeria and the Code (evolution of the Code instruments)
• NAFDAC (mandate for the Code/National Regulations) • The system for monitoring compliance with the Regulations• Enforcement of the Regulations• Critical success factors in establishing the system for
monitoring and enforcing the Regulations• Challenges• Lessons learned • Way forward
OUTLINE
• Nigeria voted for Code adoption in 1981
• Is expected to implement its provisions in their entirety as aminimum requirement for Code implementation throughappropriate NATIONAL MEASURES.
BACKGROUND: NIGERIA AND THE CODE
THE JOURNEY SO FAR…..TIMELINES
1981
Voted for adoption of the Code
1986
Code of Ethics & Professional Standards for Marketing of Breastmilk Substitutes
1990
Decree No. 41 of 1990 -Marketing (Breast-milk Substitutes) Decree. Now an Act - Cap. M5 Laws of the Federation of Nigeria (LFN) 2004
1999
Decree No. 22 of 1999 -Marketing (Breastmilk Substitutes) Decree (Amendment) to Cap. M5
2005
NAFDAC – Marketing of Infant and Young Children Food and other Designated Products (Registration, Sales, etc.) Regulations 2005
2019
NAFDAC – Marketing of Infant and Young Children Food and other Designated Products (Registration, Sales, etc.) Regulations 2019
NAFDAC - designated as the regulatory agency to implement, monitor and enforce the Code (National Regulations) in Nigeria. (Decree No. 22 of 1999 - Amendment)
• Coordinates activities for implementing the national regulations
• Monitors compliance with the national regulations• Enforces compliance with the national regulations and
applies stipulated sanctions for violations (as contained in the national regulations).
NAFDAC – THE MANDATE
• National Technical Committee on the Code/Regulations – anchored by NAFDAC
• BMS desk officers designated in every NAFDAC State Office (36 States + FCT)
• State Code monitoring teams set up
• Training of State Code monitoring teams:
➢ the national regulations, BMS Code
➢ the monitoring tools (developed based on NetCode protocols)
• Compliance monitoring activities conducted using the monitoring forms/tools
• Strategic Plan (2021-2025) on the implementation of the National Regulations and
the BMS Code.
SYSTEM FOR MONITORING COMPLIANCE WITH REGULATIONS
Some activities that support the monitoring system:
• Training of health workers to identify violations & report
• Training of journalists/media practitioners to identify violations & report or prevent the occurrence of violations
• Training of NAFDAC technical staff for product registration/labelling requirements to ensure compliance
• Post-registration inspection activities
SYSTEM FOR MONITORING COMPLIANCE WITH REGULATIONS
Resources developed to support the system for monitoring compliance with the
national regulations:
• Monitoring tools based on NetCode protocols
• Training manuals (in modules)
• National regulations/Code advocacy briefs for legislators & policy-makers, the
media, religious & community leaders, health professionals, mothers & families
• Key messages on Breastfeeding, TV/radio campaigns
• Strategic Plan (2021-2025) on the implementation of the National Regulations and
the BMS Code
• mobile monitoring application for real time monitoring/reporting (awaiting
finalization and deployment)
SYSTEM FOR MONITORING COMPLIANCE WITH REGULATIONS
BREASTFEEDING LEAFLETS AT HEALTH FACILITY MONITORING (LAGOS 2019)
• Reported violations are investigated and verified by NAFDAC • Violator receives official communication from NAFDAC of the contravention• Enforcement Directorate of NAFDAC is activated; violator liable on conviction to
penalties/deterrent sanctions in line with the regulations:
➢warning letters for first offenders ➢seizure of offending articles for destruction ➢hold or detention of product to allow possible corrective action➢administrative fines ➢closure of business premises ➢invalidation of Marketing License ➢confiscation of assets ➢prosecution of recalcitrant offenders, leading to fines not less than
N150, 000 – N2, 000,000 and jail term not exceeding 6 months, as appropriate.
ENFORCEMENT OF COMPLIANCE WITH THEREGULATIONS
CRITICAL SUCCESS FACTORS IN ESTABLISHING THE SYSTEM FOR MONITORING AND ENFORCEMENT
• Competent Authority - designated by law to monitor and enforce the Regulations
• Sustained Political will/commitment - leadership of NAFDAC and partners
• National Technical Committee on the Code - comprising key stakeholders
• Training/re-training - core group of Code experts, master trainers
• Existence of a strong governance structure at national and sub-national levels of
NAFDAC - all 36 States and the Federal Capital Territory
• Capacity for registration and routine inspection of BMS products by NAFDAC (post
registration)
• Sustained support from development partners - technical and financial
Inadequate budget/funding for Code activities, significant reliance on donor funding
➢ dedicated budget lines for sustainability
Inadequate numbers of trained personnel on the Code/national regulations
➢ increased training/capacity building activities
Lack of designated BMS desk officers in NAFDAC for focused coordination in the States
➢ designated BMS desk officers across the States, trained
Low/non-existent awareness of the Code/national regulations among health workers, media practitioners, mothers, the general public & infant food manufacturers/marketers
➢ training & re-training, sensitization/awareness, media campaigns, advocacy, WBW.
Ad hoc system of monitoring compliance
➢ establish monitoring system, the Strategic Plan
SOME CHALLENGES AND MITIGATION
HEALTH WORKERS SENSITIZATION ON THE CODE
BREASTFEEDING POSTER AT HEALTH FACILITY (ABUJA 2015)
We learned that we must ensure:
• Proper funding mechanisms for Code implementation
• Proper governance and coordination of the system
• Sustained training and re-training, sensitization of stakeholders for effective implementation, monitoring and enforcement of the national regulations/Code
LESSONS LEARNED
2020 CODE STATUS REPORT:
• Nigeria: 1 of 11 countries that have “enacted new Code-related
legislation or amended existing legal measures” since the last Code
Status Report.
• National regulations: “substantially aligned with the Code”.
• Close identified gaps in legal measures, improve funding mechanisms,
encourage research, intensify action on monitoring and enforcing