MINISTRY OF HEALTH MALAYSIA 4 CODE OF ETHICS FORINEANT FORMULA PRODUCTSCODE OF ETHICS FOR INFANT FORMULA PRODUCTS CONTENTS: Page Foreword by the Minister of Health: iii ¥.B. Encik Chua Jui Meng Acknowledgement ¥ Preface L 1. Aim of the Code 2 2. Scope of the Code 2 3. Definitions 2 4. Ethical Practices for the Infant 4 Formula Industry 3. Ethical Practices for Medical and 6 Health Professional/Persennel 6, Guidelines for Preslucing and Vening, 7 of [oformational and Educational Materials 7. Organisation i Printed : FT Siene, [979 First Revision : F April, £982 Second Revision i F September, 1985 Third Revision : F August, 1995MINISTER OF HEALTH MALAYSIA FOREWORD BY Y.5, ENCIK CHUA JUL MENG MINISTER OF HEALTH MALAYSIA The Ministry of Health has always, for many years, emphasised (he importance of maintaining the practice of breastfeeding as a means to improve the health and nutrition of infants and young children. The Code of Ethics for Infant Formula Products in Malaysia represents one of our efforts and commitment to protect, support and promote the practice. This Cesc of Ethics first formulated in 1979, has already been revised in 1983 and 1485; and this latest edition is aur effort to keep abreast with the changing needs: and situation in the cowntry today.Among other things, the seope of the new Coste of Eahies for Infant Products has been ex 1, Spec es which prohibit the » Wid thice rchaleel feeding eqpuipme . emily hemes ind disallow any promotion of Lifamt Rarmula Products in these places. Code of Ethics also prohibits the receiving and redistribution of milk samples by medical and healih personnel and professionals both in the government and private sector. In addition, the new Code of Ethics has incorporated the labelling requirements of the Foosl Act 1983, Food Regulitions 1985 and Trade Description Act 1972, Undoubtedly, new edition of the Cody af Eilves will contribute significantly towards achieving the 0 World Samet goal for the empowerment of women to breastfeed children exch Ty For the first four to six months and to continue breastfeeding, wath complementary foods, wel the sccomd year, During the preparation of this new nev ition, we received strong supporl iid cooperation from the Infant Formal industry, Professional Rowdies and Grganisitions, International Agencies, the Universatios and the i y us. His oursincere hope that the good rapport that has beew Hished will continue to be strengthened for the sake of the h well-being of all ats and children in Malaysia. (¥.B, CHUA JUD MENG) Minister of Health MalaysiaACKNOWLEDGEMENT The prepar: Organisations, | would like to take this opportunity to express he deep appreciation of the Deparimentot Public Health, Ministry of Health Malaysia for their constructive views and suggestions. Toul aloo like to the Fellow forthe Code of Eahoes tor Infant Fe Emnenitsers of le Workings Committee ula Praelie ts; ai) Be, himdrany Ub Movin 4D) De He Keeng tin (4) De, Sham Kassim (4) Br, Paramjothi P. 43) Dr. Lim Nyok th) De. Musa Mohd. Nordin 17) Qe. Sit Noragal Audkifl 48) Dr, Narimah Avwin a Cik B (10) Puan Shamsinar Abdul Talib (11) Puan Safiah Mohd, Yusof (12) Puan Ng Soong Lek (13) Puan Rokiah Don clay Mal, Versa usial Arsheul CoM potion of the acd Code would not have been possilde wither Wout (DATO" (DR. WAN MAHMUD B, WAN OTHMAN) Deput: of Health (Public Health) Ministry of Health Malaysia DirectorGen:CODE OF ETHICS FOR [INFANT FORMULA PRODUCTS IN MALAYSIA PREFACE As Malaysia moves ahead towards becoming a developed and industrialised country by the ycar 2020, its commitment to human resource development would remain the mainstay of its thrust, Within this framework, Malaysia has expressed that duc priority will be given to development of the poor, the disadvantaged and to the vulnerable groups including women, infants and children, In this respect, infants and children that make up more than oethind af the country’s population will continue ta be the focus of the government in tenms of provision of health care, education and other basic services to enable them to attain optimal growth and development potential. While the survival and health of the infant are dependent on factors during pregnancy, mainly on the health and nutritional status of the pregnant mother, care and feeding of the newborn play a vital role in ensuring its survival and fume development, With the fostering of a caring culture and society, it is implicit that all Malaysians would want to promote practices and habits to show that we MALAYSIANS CARE, There is no better way of demonstrating this caring culture than to begin ‘by putting a baby to the mother’s breast immediately after bimh, This practice of mature nor only shows. a mother cares, but sews the foundation for the child's life and development. BREAST MILK IS THE BEST FOOD AND NUTRITION FOR THE BARY and protects the infant from diseases such as diarrhoeal and respiratory infections which could have serious effects on the child's health and growth. In addition, breastfeeding is an act of love and affection to the child, fosters bonding and nurtures a warn mother-child ship that is important for the social, emotional and psychological ment of the child. It is also through breastfeeding that family relationships can cominue to be strengthened with support from: the husband and family members. In this way, the care of the child would be a shared responsibility of all family members, thereby, creating a happy and harmonious family and a conducive environment im which the child ‘will grow and receive its fair share of affection and security.Breastfeeding is a nilural way of feeding infants and this practice » Iranscends all religigus. ictal and cultural boundarics. This practice is regarded ax a noble one in Islam and one that is advocated to all women both for the health of the child as well as the mother, his within the spirit of festering a huppy family and a caring society, as Malaysia moves towards Vision 2020, that this Code of Ethics far Infant Formula Products (1995) is pu forward for adeption and implementation by ALL to demonstrate that we MALAYSIANS are commited to the protection, prometion and support af breastfeeding for the healih and welfare of our children, 1, AIM OF THE CODE The overall aim of this Code is to uphold the supremacy of breast milk: bo assist i the salle amd adequate nutrition of infants by the protection. promotion and support of breastfeeding: and to ensure proper use of Infant Formula Products when requi ie SCOPE OF THE CODE This Code covers the basic principles of marketing and product information jor all Infant Formula Products (including feeding bottles and a idelines on ethical practices for the Infant Formula Industry and the medical and heal professional/personael inthe health care system. 3. DEFINITIONS. 4.1 ADVERTISEMENT means any represemation by any means whatsoever (written, audio or visual) for the purpose of promoting. directly of indirect sal of any Infant Formula Product. Ib releast, repa, commentar ball-point pen, poster, label, wrapper, sticker, howl catalogue, magazine, loy. cari win}, card andl letter fannouncement, immunisation, congratulation, introduction, telephone), calender, clock, diary, badge, banner, lapel pin, tie pin, dummy tin, shop signboard, motice on vehicle, billboard, corporate souvenir and any other means, 3.20 APPROPRIATE DESIGNATION means a name or description, being specific and not a generic name or description, which shall indicate 1 the prospective purchaser the true mature of the food ww which it is applied, >ad a4 3.10 COMPANY PERSONNEL mi: ny profession medical representative, s repres representative and other employee workin I! or any sent marketin, via vnlwets.. demonstrator, ve, nutritional for the [ntant 2 cornpany's OW-UP FORMULA means Infant Formula marketed for bies from six months onwards up to the age of three HEALTH CARE SYSTEM means all hospitals. clinics. at engayn health care of infants and mothers espe lactating women. ly pregnant and INFANT means a child up to twelve (12) months of age, INFANT FORMULA alternative for human product prepared from milk of eow on other ar suitable for infant feeding. ans any food described cer sul as ain for the feeding of infants. It is a imal or plant INFANT FORMULA INDUSTRY means all companies Marketing Ut t Pormuki Prodwets in Malis: INFANT FORMULA PRODL include Infant Fornuta, Fullew Lp E la, Spee ula, Ready-lo-Feed Formula aun other [nfant Formula promoted fer use by infants. LABEL means rial or other descrip ive: mutter, written, pr ar impressed on. or accompanying any Infant Feed, pumed, embossed loon dicluded in, belonging ww, or rmula Product. MARKETING means se! product publ arihvion, promotion, advertising, c felation and product information servi AND HEALTH PRO! any Ibospital alin ator, medi HIE, ETO, MTA? Bees pital nthe health care system except writs Industry. assistant and midwite work those working for the Infant PACK SILO Products eit any represemtation of the Iafiant Formula by photo or graphic or by line drawing.3.14 PROMOTION means direct or indirect forms of inducing sales. It includes cheap sale, offer, free supply, donation, redemption scheme. free gift related or unrelated to purchase. free utensil or anicle, prives, carricr-hag with pack shot or product loge, discount coupon, special display at retail outlets and other give- AWAYS, 3.15 READY-TO-FEED FORMULA means Infant Formula Products in liquid form in disposable bettie, telrapack or ather packaging. 3.16 RETAIL OUTLET imeans any phannacy. shop. supermarket medical hall and other premises (distributer, agent, importer). 3.17 SAMPLE means any Infant Formula Products provided free. 3.18 SPECLAL FORMULA means Infant Formula mutkeved for ‘oot low birthweight infants or for infants with eow's Ik hype intolerance and other metabel disorders, ETHICAL PRACTICES FOR THE INFANT FORMULA INDUSTRY The Infant Formula (Industry should: 4.10 subscribe to and abide by the Cade amd observe professional and marketing ethics and established rules of conduct imall contacts within the health care system, retail outlets and the community. 4.2 ensure that their respective company personnel invelved in sales and marketing of Infant formula Products are familiar with the Code. 4.3 not market, promote. or advertise their Infant Formula Procwers im such a way as to fa} challenge the supremacy of breast milk or ¥6) compete in any way with breast milk, 4.4 not provide sumples of Infant Formula Product to fal the health care system for use within itor for subsequent redistribution to pregnant and lactating women, parents of infants and children and members of their families and (6) the retail outlets for subsequent redistribution to the community,AS 46 47 48 49 4.10 Samples of new Infant Formula Products may, however, be provided to Medical and Health Professionals for evaluation upon approval by the Medical Research Ethical Committee. not promote of advertise their Infant Formula Products within the health care system, the retail autlets ane the mass media, However, vetted scienmific and educational materials may be distributed to hospital administrators, medical doctors, null food technologists, dietic » Pharmacists und matroms, not provide bowled water, feeding bomles, teats (pacifiers) and other related formula feeding equipment iw the medical anu health professional/personne! for use within the health care system or subsequent redistribution to the pu not be invelved in any manner with baby shows (0-36 months} ensure fisedd ancl af Infant FF tthe remuncration of company personnel be on a gulated basis, and not related in any way with sales ‘ormula Products aot give, directly or indirectly, incentives in cash or in kind to the medical and health professignalépersonnel or retail outlets as an inducement for promoting infant Formula Products, not obtain, directly or indirectly. the names and addresses of and lactating mothers for the punpese of promoting mula Products. AOL permit company personne! 1 have direct or indirect contacts with pregaant and lactating women, parents of infants and children, and members of these [ es and chikLoure providers for the purpose of promotion of Infant Formula Products and to perform educational functions related to infant formula feeding. However, they may be penmitted to investigate specific complaints related to their products. ef not allow company personnel to wear uniform which is similar to that of the government medical and health personnel. not display Infant Formula Prodvects in conferences, exhibitions ar any other similar forum, not provide mothercraft services. cither dircetly or indirectly.54 fa Aa 5. ‘7 58 54 PRA STONALSD FOR M RKSONNEL HCAL AND HEAL cvialels Health Professional /Pe crear all mothers to breast t possible but fora least the first four of breastfeeding should start duri after delive: Hiheir babies for ax long ars asia months, Management WB pregnancy and continue nat accept any Infant Formula Product, sponsorship or any ii we imcash or in kind trom whe Infant Formula Industry, of new Infant Porn Products for evaluation by amd Health Professionals as provided for under : bab is, however, permitted net allow marketing al Da! ula Products tothe public in Ihe health care system, However, hos Mministintors, medical doctors, nutritionists, fond technolagists, dietic amd matrons may accept vetted scientific and eelueation casure that company personnel do nat h conta h pega gd lactating wont and children am) members of thes system fer the punpose of promer arenis of infants: inthe bealihy ie Infant Porniuha Prose ensure that con anldresses oF not and any other sour y personnel de mut copy dhe mimes and rs from the Admission Register, Birth Register in the health care system. not request nor receive samples for themselves o9 for redistribution to pregnant and lichiting women, parents of infants and children and members oF their fanvilies. Vlntant Fermala Product Products to the very samall number of mothers wlvce a aut able wo breastfeed their babies. Such advice should be given individually and should include a clear explanation of the fina implications and consequences of the inappropriate At Formula Prodecis that supplement or replace ob5.10 not be involved in any manner with baby stows, reach af this Cos! Whespitils, clintes, mite is to be reportcd tothe Daseipliniary © for Infant Mormila Products, ity Hames are mnilee amt the Code GUIDELINES FOR PRODUCING AND VETTING OF INFORMATIONAL AND EDUCATIONAL MATERIALS. 6.1 General Principles Hula Products Milles For appre, fad Allinformation related to Infant fa the Welt ois permitted, ono the approved materials unto nd other languages is the respotsibil mma Inelustry. aw the Tnfa fd) The approval Code given by the Vetting Committee is based strictly on the scope of the Code, 62 Product Labelling ALL product lahe ik ACL DOSS, the Pood Regulations ade Deseription Act |72; 41) comply w VARS and the (ii) be in Balsa Malaysia and may include translation thereof in any other language: cy claim of superiority of rhe product to tiv Mement that the product shall be used oaly an wlvice: mw STTctiONS for COreel preparation, and a warning against the health hazards of ineorreet prepari qed” or “mate Lien; (vi) wot use the term “hum similar terms; (vil) not be used asa vehicle for advertising another product: (vii) have names and addresses of the importer and exporter: (xb have an expiry date; 7{x} ini} Guid (xiv) (xv have instructions on proper storage of the Infant Formula Product; provide the appropriate designation of major ingredients used in the Infant Formula Product in descending order of proportion by weight; not bear the words “Infant Formula with Iron” unless the Product contains no less than Img of iron (Fe) per 100 available chlor tant from which the ton the Ingredient have the name of the animal or major ingredients are derived wr List in bold characters; have the following mandatory staten display panel of the label: ots in the principal — the Approval Cocke from the Vi — “SUSU IBU ADALAH MAKANAN TERBAIK UNTUR BAYIM. These words shall be in bold letiering and not less than LU points im size for 500 eg tin. The size of the lettering shall increase proportionately with the sie of the lin, — the appropriate designation eg. INFANT FORMULA, FOLLOW-UP FORMULA, SPECIAL FORMULA, cic. These words shall be more prominent in visual emphasis and position and net ess th IP the height when compared with the brand name of the Infant Formula Product. 2 Committee — *“RUMUSAN BAYE BUKRANLAH MAKANAN TUNGGAL UNTUK BAYILEBUIE DARE ENAM BULAN™, These words shall be in bold lettering and mol tess thum 4 pwns im sive for SOQ yg tin, no label of on infant formula shall displ y graphic of infants or babies or parts of infants or babies, mothers, fecding baatles of teats, For the purpose of ing methods of preparation, graphics may be6.3) Materials Directed at Medical and Healih Professionals (hospital administrator, medical doctor, nutritionist, food technologist, dietician, pharmacist and matro fa) The aim is to provide accurate information on maternal and infant nutrition. (1) All materials on Infant Formula Products must devote at least one quarter of its content or space to positive statements on brea il (i) the importance of carly initiation of breastfeeding within one hour of delivery: Gi) the benefits of breastfeeding and superiority of breast milk: (iii) maternal nutrition and manigement of breasifeeding: (iv) the negative effects om breastfeeding of introducing partial bottle feeding; (wy) the difficulty of reversing the decision not to breastfeed: (vi) advice and support of breasticeding for working mothers; (vii) the source of the Infant Formyla Product eg. cow, goal, sOva-bean: fed Such materials should not use any picture of infant w may idealise battle feeding Gf) When such materials contain information about the use af an Infant Formula Product, such materials should contain information abo 4) the proper use of the Infant Formula Product; (ii) the social and financial implications of its usc; (iii) the health hazards of unnecessary or improper use cof the Infant Formula Product. fe) Product claims will reflect scientific integrity without implicating that any produel is superior of equal to breast milkfh it) ne the supremacy of breast milk, Il . graph, e cm topics related to infant nutrition is permitted The Feater ing: of pack seat in in fcermnation ct educational materials may be permitted upon approval by the Vetting Committee. 6.400 Materials for Vetting The procediite for submission of imatermls for vetting is as wllawes; ia} tie) fel fal) fe) fh fel The purpose ane target population nest be clearly stated iwtthe subrvission, Every request must be ace col the nye mabe med by ten (1) copies ALL vetting anatterials imust be the final draft" belore submission tothe Yeting Conmirticy, All approved materials must be printed in exactly ihe sane format, lettering, design, wording. style. display al proportionate sive as approved by ihe Veriing Commitee, Each vered maierial is approved on its own merits and no lwo or more approved materials combined together without the approval af the Vetting Committee, Accopy of the Final primed product must be semt te the Verling Committee for record purposes. The approved matenals with the labels will be valid only for from the date of approval, A abligatary after the expiry perivd Aceplion of product 107. ORGAN 1am NATIONAL COMMITTEE ON THE CODE OF ETHICS FOR INFANT FORMULA, PRODUCTS EOS TH tLNEANT: INF) MNT FORMULA, PRoDuc! Ts ORGANISATION CHART 71 NATIONAL COMMITTEE ON THE CODE OF ETHICS FOR [INFANT FORMULA PRODUCTS fo) Terms of Reference: (1) To uphold the supremacy of breast milk, consistent with the spirit and objective of the Code. (ii) To prowide a forum fer discussion on issnes related to the Code. ‘To formulate policies.on the promotion, protection and support of breasticeding. VWib) Members: Chairman: Deputy Direetor-General of Health (Public Health) Secretary: Assistant Director (Nutritiam) Members: Deputy Director-General of Health (Medical) Director of Family Health Development Director of Food Quality Control Senior Paediatrician Senior Ghstemician and Gynaccalogist Principal Assistant Director (Family Health) Director (Nutrition) Principal Matron, Nursing Division Other co-opted members Hee is assisitd by the Vetting Commitee on the je of Ethies for Infant Formula Products and the Disciplinary Commitee on the Code of Ethics for Infant Formula Products al the National Levell 22° VERCING COMMITTEE ON THE CODE OF ETHICS FOR INFANT FORMULA PRODUCT fa} Terms of Reference: (i) To vet all materials including product labelling related te Infant Formula Products, (i) To review and revise the Code of Ethics for Infant Formula Products whenever necessary. Responsible for making recommendations on amendments pertaining to the Infant Formula Products, inthe Food Act 1983 and the Food Regulations 1985, (iv) Responsible for monitoring and implementing the Code. 12(5) Members: Chairman: Director of Family Health Developmen Secretary © Assistant Director (Nutrition) Members Director of Food Quality Control Senior Paediatrician Senior Obstetrician and Gynaccologist Obstctrician and Gynaccologist froma local university Paediatrician from a local wniversity Principal Assistant Director (Family Health) Assistant Director (Nutrition) Other co-opted members: 7.3. DISCIPLINARY COMMITTEE ON THE CODE OF ETHICS: FOR INFANT FORMULA PRODUCTS. ja) Terms of Reference: G@) To coordinate investigations on specific complaints on alleged viclations of the Coxe. (ii) To assess the seriousness of the vialstions of the Coke (iit) To act on findings of the alleged violations of the Code. div) To take appropriate disciplinary actions after ‘considering all appeals (written and in person), (6) Members: Chairman: Deputy Director-General of Health (Public Health) Secretary; Assistant Director (Nutrition) 3fea fa Mlrunbre re Deputy Director General af Health (Medbcal) Director of Family Health Develapment Senior Pacdiatician Senior Obstetrician and Gynaccologist Principal Matron Representative from Mini Trade and Consumers Af ry of Domestic Any ALL appeals sthowld Ibe submitted within a peniadd af ome anonth from ate or metic te the Chairman of the Disciplinary Commitice whose decision shall be final Penalty: Any one or acombination af t be imposed depending on the se ef the vielutions of the Cade: wing penalties will ousness and Frequency (i) Waitten warning with copies tothe parent company Ja Product and Chairman of the State Committee on the Code of Ethies for lafant Formula Products (ii) Suspension of wetting of all new materials for onc lo Live years, (ii) Notification tothe World Health Organization and UNICE (iv) Notification wo othe linterna titi Food Manufacturers, ional Assancialicnt ot iv) Press release (vi) Black-listing such as omission of the relevant company from future tenders for a period of time, For non-compliance by medical doctors, the Chairman of the linary Commitice may request compliance in writing with copie Medical Council and Malaysian M:National Committed on th es for la Products in the implement Code at state and district level, (a) Terms of Reference: (i) To monitor the implementation of the Code at state and disirice level, To submit findings 6 the Disciplinary Comittee for appropriate action. tiv) To taploment appropriate actions recereenented by the Disciplinary Committee. wT celal least ange in six months or whenever necessary, fh) Members: Chinn $ State Director of Health Seereary 5 Nutrition Officer Memhers © State Deputy Director of Health (Public Healthy Stare Deputy Director of Health (Medical) State Deputy Director of Health (Pharmacy) Paediatrician Obsteir Maternal and Child Health Officer State Matronra