Formula milk: RCPCH promises to review funding arrangements with industry
BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l544 (Published 04 February 2019) Cite this as: BMJ 2019;364:l544
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The World Alliance for Breastfeeding Action (WABA) celebrates annually the World Breastfeeding Week (WBW) with ‘Themes’ which focus on specific aspects/ determinants of Breastfeeding with resultant improvements in Breastfeeding Rates (BFR) and this has been recently further encouraged (WHA 71.9/ 2018). In 1994, the WBW Theme was ‘Protect Breastfeeding: Making the Code Work’. Code Implementation also results in improved BFR1. In Nigeria, the WBW Celebration in 1998 was driven by the programmatically imaginatively innovative ‘INAGOSICI Phenomenon’: ‘An Innovative Strategy For Code Implementation’2. The ‘INAGOSICI Phenomenon’ was also presented at the ‘Improvement Science Session’ of the 2011 International Forum on Quality and Safety in Healthcare in Amsterdam. The acronym ‘INAGOSICI’ derives from ‘INdustry And GOvernment Similar In Code Implementation’ and the ‘Phenomenon’ reflects: ‘The consistent inability or failure of Governments to fully Implement, and the persistent systemic and systematic failure of Industries to fully Comply with, ‘The Code’ as a ‘Minimum’ and in its ‘Entirety’’ as virtually no Country legislates on ALL the Provisions of ‘The Code’ and no Company complies fully with ‘The Code’ (The 1981 Code and ALL Subsequent Relevant WHA Resolutions) as a ‘Minimum’ and in its ‘Entirety’! The ‘INAGOSICI Phenomenon’ technicalized and grouped the ‘Stakeholders’ at the 1979 United Nations Meeting on Infant and Young Child Feeding (IYCF) as ‘Pro-Code’ (UN Systems and NGOs), ‘Anti-Code’ (Industries and Governments as the ‘Industries-Government Dyad’ or ‘Ind-Gov Dyad’) and ‘Toti-Code’ (‘Experts’ including Health Professionals!). The ‘Toti-Code’ is coined from ‘Totipotency’ of ‘Stem Cells’ implying that the ‘Experts’ have a ‘Price’ which can be paid by the Industry to dictate their ‘Tune’ (and direction of Policies, Programmes and Practices) which is obviously laden and laced with COIs2-4! For successful Code Implementation, the ‘INAGOSICI Phenomenon’ seeks strategic programmatic focus on the ‘Ind-Gov Dyad’ for effective Government legislation and complementary Industry compliance to ‘Make the Code Work’! This remains a relevant and determinant thrust for Code Implementation today as it was in 1998!!
The ‘Experts’ (including Health Professionals and, indeed, ‘Paediatricians’) have also remained a confounding determinant concern in Code Implementation with the ‘Health Professional Associations-Industry Funding’ also becoming a huge ‘Monstrosity’! Sponsorship of Health Professionals in IYCF Enterprise, under whatever guise, by Industries involved with ‘Products’ covered by ‘The Code’ begets ‘Conflicts of Interest (COI)’ which was addressed by Article 7.3 of the 1981 Code and similarly by several Subsequent Relevant WHA Resolutions (49.15/ 1996, 58.32/ 2005, 61.20/ 2008, 65.60/ 2012, 67.9/ 2014, 69.9/ 2016, 71.9/ 2018!). The ‘Framework for Engagement of Non-State Actors (FENSA)’ and the development of ‘Risks of Engagement Assessment Tools’ in 2012-2015 were explored to objectively prevent, diagnose and possibly manage COIs but to no avail and, hence in 2016, the adoption of WHA 69.9/ ‘WHO Guidance’ for ‘Ending the Inappropriate Promotion of Foods for Infants and Young Children’5. Specifically, this ‘WHO Guidance’ prohibits ‘Sponsorship of Health Professionals, their Associations and their Scientific Meetings’. Various Health Professional Associations are aggressively strategizing to eclipse or undermine this WHA 69.9! While the Royal College of Paediatrics and Child Health (RCPCH) voted at an ‘AGM Motion Debate’ on the 27th April 2016 to decline all forms of ‘Industry Funding’, the RCPCH Council laboured inappropriately, through a ‘Post-AGM Motion Debate Decision Membership Survey’ to upturn the ‘Motion Debate Decision’ and there have been reactions and counter-reactions from ‘Concerned Paediatricians’6-10. Having voted at the RCPCH AGM to decline ‘Industry Funding’, I sent a detailed critical reaction to the RCPCH President as indicated previously4!
It is salutary that the RCPCH courageously barred some Industries from its 2017 Conference11 and is currently timeously promising to review its ‘Industry Funding Agreements’12!! It is, however, very sad and disturbing to read that ‘Formula Milk Studies’ are not possible without ‘Industry Collaboration’13. This, indeed, is a disastrous stance! For such ‘Studies’, Health Professional should source their ‘Study Products/ Samples’ from Industries through normal ‘Procurement Channels’ without ‘Industry Donations, Grants, Support or Sponsorships’ as applicable to sourcing ‘Food Supplies’ for IYCF in ‘Especially Difficult Circumstances’ (WHA 39.28/ 1986, 45.34/ 1992 and several others!). Waterston (9th February 2019) drew attention to a ‘Commentary in The Lancet’ calling on International Paediatrics Association and its Members (including Paediatrics Association of Nigeria) to evolve measures to be fully ‘Code-compliant’14. In a very compelling meteoric development today 13th February 2019, the RCPCH has announced it is ending its ‘Industry Funding Agreements’15! ‘Health Professionals-Industry Funding’ must be curtailed to ‘Make The Code Work’16.
The ‘INAGOSICI Phenomenon’ should be deployed to target the ‘Ind-Gov Dyad’ so that Governments will ensure ‘Full Legislation’ on ‘The Code’ with strict enforcement to assure ‘Full Compliance’ by the Industries both of which will render the ‘Experts’ (‘Toti-Code’) programmatically of no consequence (and ‘Inert’) without COI accruing from the persistent unacceptable ‘Health Professionals-Industry Funding’. Strict ‘Code Implementation and Enforcement’ will insure ‘Industry Compliance’ with outlawed ‘Health Professionals-Industry Funding’ and ‘Code-compliant Experts’ (Not ‘Conflicted Experts’)! ‘INAGOSICI Phenomenon’ is it for ‘Making The Code Work’!! It is hoped the WABA will consider the ‘INAGOSICI Phenomenon’ and target the ‘Ind-Gov Dyad’ in the WBW Theme for 2019 or the following year!!!
The ‘Usual Marketing Practices’, which include ‘Advertisements, Promotions, Employee Incentives and such others, are unsuitable for the ‘Code Products’ which, therefore, require ‘Special Treatment’ such as No Advertisement, No Free Samples, No Low-cost Supplies, No Direct Contact of Industry Employees with Mothers and the General Public and No Sponsorships/ Funding for Health Professionals among others (WHA 34>22/ 1981)! There is, therefore, no place for ‘Code Products’ advertisement in the ‘Media’ including Biomedical Journals; The BMJ ‘Policy Rethink’ in this direction is salutary and expedient4,17! Reputable International Widely-circulated Biomedical Journals MUST stop the advertisement of these ‘Code Products’ (including ‘Foods for Special Medical Purposes (FSMP)’)!
Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education),
Professor of Child Health and Neonatology, University of Benin,
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria
UNICEF-Trained BFHI Master Trainer
ICDC-Trained in Code Implementation
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Code Implementation Project in Nigeria
*No Competing Interests.
REFERENCES
1. WHO, UNICEF, IBFAN. Marketing of Breastmilk Substitutes: National Implementation of the International Code, Status Report 2016, WHO, UNICEF and IBFAN, Geneva 2016. http://who.int/nutrition/publications/infantfeeding/code_report2016/en/ (Accessed 28 February 2017)
2. Eregie C.O. Consultancy Report for UNICEF Service Agreement for the Celebration of the 1998 World Breastfeeding Week. June-September, UNICEF Nigeria, Lagos 1998.
3. Eregie C.O. Programming the End from Before the Beginning: Juxtaposing Technology with the ‘TEA Triad’. 106th Inaugural Lecture, University of Benin, Nigeria. Uniben Press, Benin City, 17th December 2009
4. Eregie C.O. A Major Programmatic Misstep in the 2018 Revised Ten Steps to Successful Breastfeeding. https://www.bmj.com/content/363/bmj.k5146/rr-7 of 16th January 2019
5. WHO Sixty-ninth WHA. Ending inappropriate promotion of foods for infants and young children. WHA 69.9. http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_R9-en.pdf; May 28th 2016. Accessed 24th February 2017.
6. Thornton J. Paediatricians vote for college to continue accepting funds from formula companies. BMJ 2016; 355: i5827
7. Modi N. The RCPCH and funding from infant formula companies. BMJ Blogs Oct 31, 2016; http://blogs.bmj.com/bmj/2016/10/31/neena-modi-the-rcpch-and-funding-from infant-formula-companies. Accessed 24th February 2017.
8. Costello A, Branca F, Rollins N, Stahlhofer M, Grummer-Strawn L. Health Professional Associations and Industry Funding. Lancet 2017; 389 (10069): 597-598.
9. Baby Milk Action response to RCPCH relationship with formula milk companies. http://www.babymilkaction.org/archives/11135. Accessed 6th March 2017
10. Modi N, Greenough A, Viner R, Ellis J, Mash M. Health Professional Associations and Industry Funding: A Reply. Lancet 2017 Apr 29; 389 (10080): 1693-1694
11. http://www.rcpch.ac.uk/news/rcpch-and-commercial-organizations 2017
12. Mayor S. Formula Milk: RCPCH promises to review funding arrangements with Industry. BMJ 2019; 364: 1544 of 4th February 2019
13. Forsyth S. Formula Milk Studies coulldn’t exist without industry. BMJ 2019; 364: 1367 of 28th January 2019
14. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736
15. https://www.rcpch.ac.uk/news-events/news/rcpch-statement-relationship-fo...
16. Shenker NS. The resurgent influence of big formula. BMJ 2018; 362:k3577
17. Morgan SA, Waterston T, Kerac M. Formula adverts have no place in medical journals. BMJ 2019; 364: 1369.
Competing interests: No competing interests
‘HEALTH PROFESSIONAL ASSOCIATIONS-INDUSTRY FUNDING CONVERSATION’: THE RCPCH NOW TRULY LEADING THE WAY IN CHILDREN’S HEALTH
My communication of 14th February 2019 on ‘Making the Code Work’1 was sent as the RCPCH made its compelling meteoric earth-quaking announcement on the 13th February 2019: ‘It has ended its ‘Industry Funding Agreements’’2! This, indeed, is a salutary and promising development for Child Health. There are a few issues that require further attention but we will first recapitulate the ‘Historical Antecedents’ to appreciate this huge announcement by the RCPCH:
Before 2016: RCPCH received remarkable funds from the Industries involved with ‘Code Products’2.
27th April 2016: RCPCH, by its AGM Motion Debate Decision, voted to decline all forms of ‘Industry Funding’ to save its eroded reputation which the received funds cannot address or restore!
12th June 2016: Concerned RCPCH Members crystallized a ‘Position Paper’ to guide the 2016 RCPCH Council Deliberations3.
July 2016: RCPCH Council reconsidered the 2016 AGM Motion Debate Decision and commissioned the ‘Post-AGM Motion Debate Decision Membership Survey’ on ‘Industry Funding’.
August-September 2016: RCPCH-commissioned Post AGM Membership Survey conducted
October 2016: RCPCH Council, guided by the Post-AGM Survey Results, upturned the 2016 AGM Motion Debate Decision to decline all forms of ‘Industry Funding’4,5!
Early 2017: An avalanche of reactions to the RCPCH Council inappropriate conduct, modus operandi and decision with deep analyses and criticisms of the ‘Post-AGM Motion Debate Decision Membership Survey’6-14! The RCPCH Council responded to the reactions by the ‘Concerned Paediatricians’ but this was certainly not persuasive15!
Mid-2017: RCPCH barred Mead Johnson, Danone, Abbott and Nestle from its 2017 Annual Scientific Meeting Exhibitions 16! This, indeed, was salutary, complimentary and commendable; a potential pointer of the imminent courageous good!
January 2018: The Author, having voted at the 2016 RCPCH AGM to support the decline of ‘Industry Funding’, sent an analytical critique early in 2018 to the RCPCH President17.
4th February 2019: RCPCH hinted and promised to review its ‘Industry Funding Agreements’18! Also, the International Paediatrics Association and its members have been called upon to end ‘Industry Funding’19!!
13th February 2019: RCPCH announced an end to its ‘Industry Funding Agreements’2!! This is the earth-quaking and heart-warming promising development in Optimal Infant and Young Child Feeding (IYCF) Enterprise this moment!!! We hope other Paediatrics Associations and Societies will latch on this bold step by the RCPCH; Now truly leading the way in children’s health! The Paediatrics Association of Nigeria (PAN) can follow the RCPCH example and be the ‘Shining Light’ for other members of the ‘Union of National African Paediatrics Societies and Associations (UNAPSA)’!!
Now back to some issues in the ‘RCPCH Announcement’. The decision to continue engaging the Industries concerning ‘Foods For Special Medical Purposes (FSMP)’ requires critical attention. The FSMP are ‘Code Products’ and need to be monitored very closely regarding how they are marketed! They should be sourced through normal ‘Procurement Channels’ as applicable to Foods for IYCF in ‘Especially Difficult Circumstances’ (WHA 39.28/ 1986, 45.34/ 1992 and several others!)!! The issue of ‘Engagement’ comes within the ambit of the ‘Framework for Engagement of Non-State Actors (FENSA)’ which is a very rigorous and robust exercise requiring very detailed independent investigations of the potential ‘Non-State Actor’ and conduct of ‘WHO Due Diligence’ concerning ‘Past and Present’ ‘Situational Realities’ in several areas covering Public Health, Public Good, Human and Labour Matters, Business and Ethical Concerns, Environmental Protection Stance, Pervading Image and Reputation in ‘Full Code-compliance’ and Financial Integrity and Stability and ALL these are to assure that the ‘Potential Engagement’ will be completely devoid of ‘Conflicts of Interest (COIs)’! The COIs, particularly in relationships with Health Professionals and their Associations, have been the difficult focus of several World Health Assemblies (WHAs) (WHA 34.22 in Article 7.3 of the 1981 Code, 49.15/ 1996, 58.32/ 2005, 61.20/ 2008, 65.60/ 2012, 67.9/ 2014, 69.9/ 2016, 71.9/ 2018!). The FENSA and developed ‘Risks of Engagement Assessment Tools’ emerged in the WHA years 2012-2015 to Prevent, Diagnose and Manage COIs but clearly to no avail and hence the adoption of 2016 WHA 69.9/ ‘WHO Guidance’ on ‘Ending the Inappropriate Promotion of Foods for Infants and Young Children’ which unequivocally ‘Prohibits Industry Sponsorships of Health Professionals, their Associations and Scientific Meetings’! The RCPCH conjectured continued ‘Engagement’ of Industries in respect of FSMP requires an urgent re-think and needs also to be discontinued. No Company is ‘Fully Code-compliant’ and, therefore, cannot stand the ‘WHO Due Diligence’ and FENSA Requirements as ‘COI Risk-free Potential Actors’! In spite of the aggressive resistance by Industries, Health Professional Associations and some Governments (notably the United States of America), the ‘WHO Guidance’, FENSA and ‘Risks of Engagement Assessment Tools’ were not vacated at the 2018 WHA (WHA 71.9/ 2018)! The ‘RCPCH Announcement’ also needs to clearly state that FSMP should not be advertised in the RCPCH Biomedical Journal (Archives of Diseases in Childhood). This, indeed, applies to all ‘Code Products’ and also to other similar Biomedical Journals including the BMJ! The promise by the BMJ to review its ‘Advertisement Policy’ in this direction is complimentary!
The RCPCH was a Member of the ‘Baby Feeding Law Group (BFLG), a UK Body that ensures that UK Baby Feeding Laws are compliant with UN Recommendations (including ‘The Code’). As the ‘Industry Funding Pressure’ persisted, the RCPCH withdrew its membership of the BFLG20. With this inspiring ‘RCPCH Announcement’, it is fervently hoped that the RCPCH will reconsider reclaiming its desired membership of the BFLG! Its sincere continued membership would be the ‘Insurance’ for the ‘Advocacy’ for ‘Children First’ with a ‘Well-formed Conscience’!
It is pertinent to reiterate the relevance of the ‘INAGOSICI Phenomenon’ in targeting the ‘Industry-Government Dyad’ (‘Ind-Gov Dyad’) in assuring ‘Full Code Legislation’ by Governments with complementary ‘Full Code Compliance’ by Industries with the resultant ‘Forced Code Compliance’ by ‘Experts’/ ‘Health Professionals’ (including Paediatrcians)1, 21. This will significantly eclipse/ minimize the monstrosity of ‘Conflicts of Interest (COIs)’ in Optimal IYCF! The World Alliance for Breastfeeding Action (WABA) should consider a focus on the ‘INAGOSICI Phenomenon’ in the Theme for its 2020 World Breastfeeding Week (WBW) Celebrations! It is a way to go!!
REFERENCES
1. Eregie C.O. Making the Code Work for Optimal Infant and Young Child Feeding: Rekindling the ‘Health Professional Associations-Industry Funding Conversation’ and the ‘INAGOSICI Phenomenon’. https://www.bmj.com/content/364/bmj.l544/rr of 14th February 2019
2. https://www.rcpch.ac.uk/news-events/news/rcpch-statement-relationship-fo...
3. British Association for Child and Adolescent Public Health. Briefing Paper for RCPCH Members responding to the survey on sponsorship by formula manufacturers. 2016. www.bacaph.org.uk/index.php/blog/32-blog/294-blog-item1-37. Accessed 1st March 2017
4. Thornton J. Paediatricians vote for college to continue accepting funds from formula companies. BMJ 2016; 355: i5827
5. Modi N. The RCPCH and funding from infant formula companies. BMJ Blogs Oct 31, 2016; http://blogs.bmj.com/bmj/2016/10/31/neena-modi-the-rcpch-and-funding-from infant-formula-companies. Accessed 24th February 2017.
6. Costello A, Branca F, Rollins N, Stahlhofer M, Grummer-Strawn L. Health Professional Associations and Industry Funding. Lancet 2017; 389 (10069): 597-598.
7. Gulland A. Paediatricians criticize college survey on links with formula milk firms. BMJ 2016; 354:i4555
8. Waterston T and Mason E. Why the RCPCH should stop taking funds from the baby food industry.(Accessed 20th January 2018). BMJ Blogs 4 Nov 2016. http://blogs.bmj.com/bmj/2016/11/04/why-the-rcpch-should-stop-taking-fun...
9. Parry KC, Sullivan C, Stuebe AM. Health Professional Associations and Industry Funding: A Reply. Lancet 2017 Apr 29; 389 (10080): 1696. doi: 10.1016/S0140-6736 (17) 31062-0
10. Waterston T, Williams A. Retired, Wright C, Devakumer D, Kyeremateng R. Health Professional Associations and Industry Funding: A Reply. Lancet 2017 Apr 29; 389 (10080): 1695. doi: 10.1016/S0140-6736 (17) 31060-7
11. IBFAN-ICDC. Health Professional Associations and Industry Funding: A Reply.3rd April 2017; www.ibfan.icdc.org
12. Baby Milk Action response to RCPCH relationship with formula milk companies. http://www.babymilkaction.org/archives/11135. Accessed 6th March 2017
13. Kyeremateng R. Exploring the issues around sponsorship. 2017 http://www.bacaph.org.uk/blog (Accessed 21st January 2018)
14. Taludker MQ, Shahidullah M, Chowdhury A, Khatoon S, Taludker K. Health Professional Associations and Industry Funding: A Reply. Lancet 2017 Apr 29; 389 (10080): 1696-1697. doi: 10.1016/S0140-6736 (17) 31063-2
15. Modi N, Greenough A, Viner R, Ellis J, Mash M. Health Professional Associations and Industry Funding: A Reply. Lancet 2017 Apr 29; 389 (10080): 1693-1694. doi: 10.1016/S0140-6736 (17) 31057-7
16. http://www.rcpch.ac.uk/news/rcpch-and-commercial-organizations 2017
17. Eregie C.O. A Major Programmatic Misstep in the 2018 Revised Ten Steps to Successful Breastfeeding. https://www.bmj.com/content/363/bmj.k5146/rr-7 of 16th January 2019
18. Mayor S. Formula Milk: RCPCH promises to review funding arrangements with Industry. BMJ 2019; 364: 1544 of 4th February 2019
19. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736
20. Kyeremateng R. Exploring the issues around sponsorship. 2017 http://www.bacaph.org.uk/blog (Accessed 21st January 2018)
21. Eregie C.O. Adult Disease Induction and Life-course Events: Some Perspectives from a Resource-compromised Economy. Forum on Public Policy,2008 (Spring Issue On line: htp://formonpublicpolicy. Com/ papers 08sring. Html).
Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education),
Professor of Child Health and Neonatology, University of Benin,
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria
UNICEF-Trained BFHI Master Trainer
ICDC-Trained in Code Implementation
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Code Implementation Project in Nigeria
*No Competing Interests.
Competing interests: No competing interests