TheCodeStory—Aparodytocelebrate25yearsoftheInternationalCode

AmericaninterferenceinthePhilippinesLatvia—RightversusMightlawsuit

culminatesinvictoryforIBFANGroup

December 2006 • Issue 8

This year marks the 25th anniversary of the International Code of Marketing of Breastmilk Substitutes. As the Code is central to ICDC’s work, it has been a commemorative year for us too – not only for celebrations but for reflection and stock-taking. In a departure from our usual style of reporting, we reproduce below a parody of the Code and key players in the field of infant and young child feeding. Written in the first person from the perspective of the Code, this piece was initiated by a couple of senior IBFANers who saw the humour in satirising the Code issue to convey hard messages where plain writing could not. Many will wonder where the Code is heading after a quarter of a century. No simple answer there and the road ahead promises to be bumpy.

It has been a packed half-year once again.

As Code Task Force Coordinator for the World Alliance for Breastfeeding Action (WABA), ICDC was busy with World Breastfeeding Week which had the Code as its theme this year. We also did our rounds as Code emissaries for breastfeeding events in Thailand and Bangladesh.

This year, the biannual meeting of the IBFAN Coordinating Council (IBCoCo) which has a rotating venue rolled into

Israel—Regulatorsinafixoversub-standardformulaandnon-compliantlabelling

Finland—RowoverFormulaResearchNewsflash—lawsadoptedintheGambia,Palau,ZambiaandBolivia

HigHligHts

From ICDC’s desk in Penang...

Yeong Joo Kean & Annelies AllainReviving Code interest in Australia

Penang so the ICDC office was host to some 20 visiting IBFANers from around the world. Soon after IBCoCo, we spent 10 days in Australia at the invitation of the Uniting Church of Australia. Our host took us far and wide through Melbourne, Canberra and

In the meantime, our co l l aborat ion wi th UNICEF cont inues. In cooperation with U N I C E F C E E / C I S and IBFAN Europe, a training course on Code implementation for Central Asia, Georgia and Turkey took place in July.

Drafting lessons for participants from the Maldives and Afghanistan

Sydney with an ambitious programme to reignite interest in the Code within the Australian community. It was a wake-up call to see how difficult it was to raise public interest on our visit but talks with leading politicians, professional associations and the NGO community already have promising outcomes, including a parliamentary inquiry.

ICDC courses are conducted in varied settings – in Baku, it was in a discotheque all wired up for simultaneous interpretation into Russian.

Another course was held in Penang end November for participants from South Asia under the auspices of the UNICEF Regional Office.

ICDC will continue to help UNICEF build capacity on the Code by conducting a series of courses at the regional level. Also in the works, before the year draws to an end is a Code monitoring course for IBFAN groups in the Arab World.

This more or less wraps up the year for ICDC. Next time you hear from Legal Update, we will be in the New Year - so, glad tidings to all.

The Code Story – a special feature to celebrate 25 years of the International Code This parody of the International Code and key players in infant and young child feeding was initiated by two individuals in different corners of the world. One wrote a paragraph, then passed it to the other for the next and so, they took turns to develop the Code Story. ICDC finds the end product thought provoking and fun, and readers will surely agree.

I'm25yearsold.Iwasbornon21May1981inGeneva,Switzerland,butI'macitizenoftheworld.Likeyou,Ihaveamother,hernameisWorldHealthOrganization,nicknameWHO.ShewasagoodmotherwhenIwasverysmall,butnowadayssheoftenforgetsthatIexist.Forexample,sheremembersmybirthdayonlyonceevery twoyearsandit’snevermuchfun.She'sboringandcomplicated.Onmybirthdayshegivesmealwaysthesamepresent,acake,wrappedinpapercalled“WHAresolution”.WhenIgetmycakeIthink:well,nowallmyproblemswillbesolved!Noway.Thetroubleisthatthecakeisbakedwithastrangerecipe,soconvolutedthatoftenIhavetolookforlegalhelptounderstandwhatkindofcakeI'mabouttoeat.Lately,thecakecomesdouble-wrapped,imagine,thesecondwrappertellshowmuchmoneyisneededtoenjoythecake.It’sliketheoldsaying:youcan’thaveyourcakeandeatit!

Unlikeyou,though,Ihaveseveralfathers.Someofthemareverygood.TheChildren'sFund,nicknameUNICEF,forexample,hasalwaysprotectedmeduringthese25stormyyears,butrecentlyheseemstothinkthatI'mgrownupandthatIdon'tneedthesamekindofsupport.Otherfathershavenotbeenaskind:someofthemfailedtorecognisemeatbirth,othershaveneglectedme,stillothershavepretended to respectmebut actually don't.Somekeepon threateningmebysaying that if I talk toomuch, thebigbadWTOdownthehillwillbeatmeup.Igetscaredandruntomyauntie,nicknameIBFAN.Sheismorelikearealmomtome,shehascaredalotforme,speaksupformeandkeepsongivingcourageandsupport.Withallthesetroublesthough,I'mstill,at25,carryingmanyofmychildhoodandadolescentproblems.

Forexample,thereistheproblemofmyscope.Thefatherwhodidn’tevenrecognisemeatbirth,nicknameIFM,isconstantly underminingme, saying that I’m only about“infant formula”.But I know that I’mmore than that!Hemakesmefeelveryinadequateandsmall,soinsignificantthatIsometimesfeellikecrying.Myauntiethenpicksmeupandcomfortsme,andsays:“Lookatyourself,you’rea universal citizen!You’ve got great potential, you cansave lives.You can stop kids fromgrowingup stunted,fromgettingcontaminatedwith...”oh,Iforget...no,nowIremember:“Enterobactersakazakii”.That’sit!Scientiststookagestoconfirmitexistedbutnowtheycan’tdenyit.Infact,IknowthatmyIFMdadisbehinditall,hedoesn’twanttorefurbishhisfactoriestogetridofintrinsicEnterobacter;hesays itcosts toomuchmoney;at thesame time,hedoesn’twanttowriteitonlabelsandbecausethatwouldalarmcustomersaboutthethehazardsofusingtheproduct.He'sverysly,thatfather!

ItremindsmeofanotherproblemthatIhadwhenIwassmallandthatwasalsodenied.Itwasabout'supplies',free

infantformulaforsmallbabiesandpeopletookalongtimetounderstandthatitwasatrap.SoundedgoodbutIknewitwasaviciouscircle:getsomefreeandyou’readdictedtothatbrand.Ittooksevenyearsandfourbirthdaypresentsfrommymomtogetthatintopeople’sheads.Solved?Notreally,itstillcomesbacktohauntmenow.Gosh,Iwishmy mother would learn to stop mumbling and write mypresentsincleartermswithoutlookingoverhershoulderatthatIFMdadallthetime.

OvertheyearsI’vewatchedhowmarketinghaschangedbut it’sstill justasharmfulasitwaswhenIwasborn.Ithasbecomemoresubtleandusesround-aboutwaysinmanydifferent typesofmedia now, including theworldwideweb. Itspromotion ishiddenforexample in theseso-called internetbabyclubs,usingmybelovedbabies,tobypassme.Butnothinghasbeenasdisturbingastheattitudeofmanypaediatriciansaround theworld.WhenIwas born, their associations said that Iwaswelcomeandbadlyneeded;butwhenitcametodefendmeintheircountries,supportnationallawsandapplyalltheprinciplestotheirownpractices,theirreactionoftenwas“wedon’tneed you, we are clever enough to accept gifts fromcompaniesandnotletitaffectourjudgementsonwhat’sbestforbabies".Manydon’tseemtohaveanyideahowmuchharmthey’redoing.Thankfullyothersarerealisingthis: some researchers, somewonderful individualsandeditorsofmedicaljournals.Andfortunatelyotherdoctorsare joiningthemandareaskingtheircolleaguestostopacceptinggiftsfromthosesneakycompanies.WhatcanIexpectinmynext25years?Willmymomstandupforme?WillIberespectedineverycountryintheworld?WhenitsmybirthdaywillIgetapresentthat’sclearandstraightforwardandhelpsmecounterthenewmarketingtacticsthataresuretocomealong?Nomorehumbugaboutspecial formulasor exceptional circumstances; excusesfromtheuncleswhomakebottlesandteatsandsaytheyweren’t told Iwas born; nomore health and nutritionclaimswhichpretendthattheseproductsmatchthegoldenstandardofbreastmilk.

Ihavealreadytravelledtomanycountries,buttherearemanyothersthatIhaven’tseenandmanymorethatI’dliketoknowbetter.AnoldauntiewholivesintheFarEastandkeepstrackofmytripstellsmethatthereare39countries(see categories 6 and 7–State of the Code by Country

My best birthday present ever – a wall size poster from my WHO mum

2 0 0 6 ) w a i t i n gfor my first visitand many morelookingforwardtoentertainmebetterthan they did thefirst time.Enoughto keepme busyfor the next 10years! Ihope thatAuntieIBFANandmy UNICEF dad

Inthegliblywordedletter,thePresidentoftheChamberofCommerce,ThomasDonohue,hadwarnedPresidentArroyoof“therisktothereputationofthePhilippinesasastableandviabledestinationforinvestment”ifshedidnot“re-examinethisregulatorydecision”.Hewasparticularlyconcernedabout theeffect of themarketing restrictionsoncompaniesandvoicedhisconcernover theway theIRR threats infant formula as a potential health hazardby requiringwarning labels. This letter has since beencounteredpointforpointbytheSecretaryofHealth.

TheletterbytheU.S.ChamberofCommercestruckarawnervewiththeinternationalbreastfeedingcommunityandthePhilippinepublic. Itwasperceivedasadirect threatto the independence of the judiciary. This should neverhappen, not in thePhilippines or in any other country.Slowlybutsteadily,petitionsandlettershavebeenpouringintosupporttheDepartmentofHealth.(seehttp://www.babymilkaction.org/CEM/cemnov06.html)Theycalluponthebusinesssectortoexerciserestraintandforthevariousarmsof theGovernment of thePhilippines – Judiciary,Executive and Legislature – to carry out their dutiesindependentlyandwithoutanyfearorfavourtofulfil therightof thechildrenofPhilippines to thebestattainablestandardofhealth.

Inthemeantime,asiftopre-emptwhateverdecisiontheSupremeCourtmakesonthecase,4newbillsrepresentingdifferent interestshavebeenpresentedtotheSenatetoreplacetheexistingMilkCode.Note: This case has given a special insight into the highly lucrative profits of formula companies. In its submission to the Supreme Court, PHAP gave an estimate of the potential cost of complying with the IRR at approximately US$128 million which is broken down as follows: • Withdrawal and destruction of non-compliant promotional

materials and samples –US$2 million• Removal of existing stock and change in packaging

–US$6 million. • Loss of sales during the shift towards compliance

–US$120 million.

These figures are probably exaggerated but are indicative of the cost and the effectiveness of promotion.

Latvia – Right versus Might law suit culminates in victory for IBFAN group The Latvian Breastfeeding Promotion and ProtectionAssociation (LKEVAB, an IBFAN group) emerged asthefinalvictor in theSupremeCourt inLatvia inacasebroughtagainstthembytheLatvianPaediatricAssociation(LPA).LegalUpdateSeptember2005first reported thisdefamationcase.Atthefirstinstance,LKEVABmanagedtodefeatLPA’scomplaintthatalettertheywroteaccusingLPA of unprofessional and illegal conduct in endorsingaNestleformulaproduct,was injurioustoLPA’shonourand reputation and that of its president. TheDistrictCourtruledinfavourofLKEVABandheldthattheirletterexpressedthetruthandthatproductendorsementisaformof advertisement which violates the International Code.LPAfiledanappealtoRegionalCourtinRigawhichwasdismissedonaproceduralpoint.LPApersistedbyfiling

Auntie IBFAN charts my travels lest people forget

will organise my journeys through these savage andmysterious lands. It’s incrediblehowsomeof thesewildcountriesthinktheyare“civilised”whileinrealitytheydon’tevenbothertotakecareoftheirsmallestcitizens.

Moreover,my friends are tellingme that older childrenarealsothreatenedbymarketing.TheytellmethatTNCs–whatafunnyname–wantkidstohavelotsofsugarydrinks,saltysnacksandfriedfoods.Junkfoods,theycallthem.SothesamebabiesthatIhelpedbringuphealthywillgrowobeseandwillbeseriouslyillwhentheygetolder.Icannotacceptthis;Iwasraisedtodefendchildren.ButIrealisedthatI’mtoolittleandatthesametimetoooldforthisnewchallenge.I’llaskmymothertoconceiveagain.Alittlebrother?Alittlesister?Idon’tmind,providedshepickstherightfathersandtheyallpromisetotakecareofhimorhereverysingledayandnotjustonbirthdays.

Itmustbesaidthatonmy25birthday,myWHOmumgavemeasurprise.ShecelebratedmybirthdaywithbannersandpostersandsheactuallysaidthatIsavelives.Itwastheproudestdayofmylife–recognitionfrommummyatlast!

American intereference in the PhilippinesA judicial storm brewed up in the Philippines when theDepartment ofHealth issued new ImplementingRulesandRegulations(IRR)torestrictmarketingpractices.TheIRRaugmentsthe1986“MilkCode”whichimplementstheInternationalCodeofMarketingofBreastmilkSubstitutes.TheMilkCodehadbecomesomewhatoutdated,inviewofchangingmarketingpracticesandthemorerecentWorldHealthAssemblyresolutions.

Inprotest over the IRR, thePharmaceutical andHealthCareAssociationofthePhilippines(PHAP)representingthethreemainUSformulacompanies–AbbottRoss,MeadJohnsonandWyeth,andotherpharmaceuticalgiantstooktheFilipino government to court, claiming amongotherthings that theDepartment ofHealth had exceeded itspowers inenacting the IRR.Atfirst, theSupremeCourtdeclinedPHAP’s application for a temporary restrainingorder(TRO)tostoptheIRRfromcomingintoeffect.

UponPHAP’sapplicationforareview,theSupremeCourtoverturned itsowndecisionbygrantingaTRO.Whileacourtcaseispending,nooneshouldcommentonitsmerits.But,aleakedletterfromtheU.S.ChamberofCommercetothePresidentofthePhilippinesshowedhowdirectpressurewasexertedontheExecutivetowithdrawtheIRR.WithindaystheTROwasgranted.

yetanotherappeal, this time to theSupremeCourt, thehighestcourtoftheland.InMaythisyear,thedecisionofthecourtbelowwasupheldbytheSupremeCourt,bringingtheanguishofLKEVABtoanend.

ThevictoryofLKEVABistingedbysadness.IevaRanka,thepresidentofLKEVABandapartytothesuitdiedwhiletheappealwasstillpending.IBFANmembersrememberIevaasapersonofcourageandintegrityandregretthatshedidnotlivetowitnessthehappyoutcome.

Legal Update notes that the International PaediatricAssociation fully supports the International Code andsubsequentWorldHealthAssemblyresolutionsanddoesnotinvolveitselfinproductendorsement.Itisunfortunatethatnotall theirmemberssubscribetothesameethicalstand.

Israel – Regulators in a fix over sub-standard formula and non-compliant labellingInDecember2003,Legal UpdatereportedontheoutbreakofthiaminedeficiencyinIsraelwhichaffected15infantsandcaused2deaths.Theoutbreakwasassociatedwiththeuseofakoshersoy-basedinfantformula—Remedia Super Soy 1.Subsequently,LegalUpdatealsoreportedthatHumana,theGermanmanufacturerofRemedia Super Soy,paidoffbetweenUS$16toUS$22milliontotheaffectedfamilies.Humana’slocalpartnerRemediaalsocametoasettlementwith3familieswhosebabiessufferedpermanentdisabilitiesbypayingareputedamountofUS$2.2milliontoeach family.But the legalwoesofRemediawere farfromover.

In September this year, the Israeli State Prosecutionannounced that three former executives of Remediawill face charges of involuntarymanslaughter, criminalnegligence, obstruction of justice, involvement in actsthatmay spread disease,misleading the public, fraudandconspiracy.FiveHealthMinistryemployeeswillalsofacechargesforfailingtoverifythattheformulasentfromGermanydidinfactcontaintheingredientslistedonthelabels.AseniorprosecutorsaidtherewerefundamentaldeficienciesintheMinistry'sregulatorymechanism.

Theindictmentofhealthofficials,inparticular,willhopefullyalert regulators everywhere that they cannot rely oncompaniestocomplywithregulatoryrequirements.InIsraelwheretheRemediadebaclestillstrikesarawnerve,theHaaretznewspapercriticisedtheMinistryofHealthforagainlettingitsguarddownbyrelyingonmanufacturerstopassonnewsafetyguidelinesonuseandstorageof formulaproducts.Apparently,thelabellingonMaternaandSimilacformulasfailedtocomplywithsafetyguidelines9monthsaftertheywereissuedbytheMinistryofHealth.

Thenewspaperlamentsthatrelianceisstillbeingplacedon compliance bymanufacturers. Meanwhile, Similac(AbbottRoss)decidedto takeontheHealthMinistrybystatingthatintheabsenceofregulationsitwillsticktotheoldlabel.Thelosersinthistug-of-warbetweenregulatorandmanufacturermaybebabiesandparentswhoareleftinthedark.

N E W S F L A S H

Whenitrains,itpours.SincethelastLegalUpdate,4newlawshavebeenadopted.Twosmallnations;theGambia andPalautookagiantleapforinfanthealthbyadoptingstronglawsreminiscentofICDC'sModelLaw.TheselawsareacredittotheregionaltrainingonCodeimplementationjointlyconductedbyICDCwithUNICEFandregionalIBFANoffices.Bothcountrieswillbelistedundercategory1ontheIBFANScale.

ZambiaandBoliviatooadoptednewlawsbutthesewereclassifiedascategory2ontheIBFANscaleduetoseveraloverarchingweaknessesinthetexts.Nonetheless,thelawsaregreatstridesforwardforbothcountries.

ICDCextendsitscongratulationstoallfourcountriesandisgladtohavemadeanimpact.

Finland - Row over formula researchIn 2004, theBreastfeedingSupportAssociationofFinland,member of IBFAN, lodged a complaint with the FinnishParliamentaryOmbudsmanaboutastudyledbytheFinnishNationalPublicHealthInstitute.Thestudyaimedatfindingoutwhetherremovalofbovineinsulinfrominfantformulawouldreduce type1diabetes(IDDM)and themechanismsof thecondition.It involvedgivinginfantformulatonewborns,andcontinuingtoprovidefreeformulaafterdischargeofmotherandchildfromthehospital.

Studies of such nature conducted at the institutional levelare allowed under Article 7.4 of the International Codebut investigation by theOmbudsman discovered that thestudyproceededforsixmonthsbeforeethicsapprovalwassought. More and more irregular practices were disclosedas investigations continued. It was recently revealed thatparticipantswerenottoldthatthestudywasfundedentirelybyValio,aFinnishbabyfoodmanufacturer.Orthefactthattheprincipal investigatorof thestudywas the inventorandbeneficiaryof thepatent for the formula. Participantswerealsonottoldthattheywereinaproductdevelopmentstudyfor a private company.Norwere theyadequately informedabout thebenefitsofbreastfeedingasopposed to formula-feeding.TheresearchershavebeenrequestedtorespondtotheOmbudsmanfindingsbeforearulingismade.

TheHeadoftheNationalHealthInstitute,PekkaPuska,hadapprovedthestudy.Heassuredthatitcomplieswiththelawonmedicalresearchandthatthedistributionofinfantformuladoesnotdeviatefromlegalnorms.Mr.Puskawasaleadingcandidate for theposition ofDirector-General of theWorldHealthOrganization, since filled byDr.MargaretChan ofHongKong.