pharma v duque

7/25/2019 Pharma v Duque

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Republic of the PhilippinesSUPREME COURT

ManilaEN BANC

G.R. No. 173034 October 9, 2007PHARMACEUTICA AN! HEATH CARE ASSOCIATION O" THE PHIIPPINES, petitioner,vs.HEATH SECRETAR# "RANCISCO T. !U$UE III% HEATH UN!ER SECRETARIES !R. ETHE#N P. NIETO, !R. MARGARITAM. GAON, ATT#. AE&AN!ER A. PA!IA, ' !R. (A!E ". !E MUN!O% )*+ ASSISTANT SECRETARIES !R. MARIO C.IAER!E, !R. !AI! (. O-A!A, AN! !R. NEMESIO T. GAO, respondents.

! E C I S I O NAUSTRIA/MARTINE-, J.The Court and all parties involved are in agreement that the best nourishment for an infant is mother's milk. There is nothinggreater than for a mother to nurture her beloved child straight from her bosom. The ideal is, of course, for each and every Filipinochild to enoy the une!ualed benefits of breastmilk. "ut ho# should this end be attained$"efore the Court is a petition for certiorariunder Rule %& of the Rules of Court, seeking to nullify dministrative (rder ).(.* +o.--%--/ entitled, Revised Implementing Rules and Regulations of Executive Order No. 51, Otherwise nown as !he"#il$ %ode," Relevant International &greements, 'enali(ing )iolations !hereof, and for Other 'urposes)R0RR*. Petitionerposits that the R0RR is not valid as it contains provisions that are not constitutional and go beyond the la# it is supposed toimplement.+amed as respondents are the 1ealth 2ecretary, 3ndersecretaries, and ssistant 2ecretaries of the 4epartment of 1ealth )4(1*.For purposes of herein petition, the 4(1 is deemed impleaded as a corespondent since respondents issued the !uestioned R0RRin their capacity as officials of said e5ecutive agency./

65ecutive (rder +o. &/ )Milk Code* #as issued by President Cora7on !uino on (ctober 8, /98% by virtue of the legislativepo#ers granted to the president under the Freedom Constitution. (ne of the preambular clauses of the Milk Code states that thela# seeks to give effect to rticle //of the 0nternational Code of Marketing of "reastmilk 2ubstitutes )0CM"2*, a code adopted bythe :orld 1ealth ssembly ):1* in /98/. From /98 to --%, the :1 adopted several Resolutions to the effect thatbreastfeeding should be supported, promoted and protected, hence, it should be ensured that nutrition and health claims are notpermitted for breastmilk substitutes.0n /99-, the Philippines ratified the 0nternational Convention on the Rights of the Child. rticle ; of said instrument provides that2tate Parties should take appropriate measures to diminish infant and child mortality, and ensure that all segments of society,specially parents and children, are informed of the advantages of breastfeeding.(n May /&, --%, the 4(1 issued herein assailed R0RR #hich #as to take effect on of the R0RR on Total 6ffect provides sufficient standards.

BBBBBBBBBBBBB/ )/* 3nited +ations Convention on the Rights of the ChildA )* the :1( and 3nicef -- ?lobal 2trategy on 0nfant andDoung Child FeedingA and )>* various :orld 1ealth ssembly ):1* Resolutions.

The parties filed their respective memoranda.The petition is partly imbued #ith merit.On the issue of petitioner's standing:ith regard to the issue of #hether petitioner may prosecute this case as the real partyininterest, the Court adopts the vie#enunciated in 65ecutive 2ecretary v. Court of ppeals,;to #it@

The modern vie# is that an association has standing to complain of inuries to its members. This vie# fuses the legalidentity of an association #ith that of its members. A* )oc)to* ) t)*+* to 56e t 5or t 8orer +e:te t6)c o5 +rect *teret 5 t ;e;ber )re )55ecte+ b< te )cto*. A* or)*=)to* ) t)*+* to )ert teco*cer* o5 t co*tte*t.5 5 5 55 5 5 :e note that, under its rticles of 0ncorporation, the respondent #as organi7ed 5 5 5 to act as the representative ofany individual, company, entity or association on matters related to the manpo#er recruitment industry, and to perform

other acts and activities necessary to accomplish the purposes embodied therein. The re:o*+e*t , t, te)::ro:r)te :)rt< to )ert te rt o5 t ;e;ber, bec)e t )*+ t ;e;ber )re * e>er< :r)ctc)6 e*e+e*tc)6. 5 5 5 Te re:o*+e*t ?)oc)to*@ bt te ;e+; tro 8c t *+>+)6 ;e;ber ee to;)e ;ore e55ect>e te e:reo* o5 ter >oce )*+ te re+re o5 ter re>)*ce.&)6mphasis supplied*

#hich #as reasserted in Purok Bagong Silang Association, Inc. v. Yuipco,%#here the Court ruled that an association has the legalpersonality to represent its members because the results of the case #ill affect their vital interests.=
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1erein petitioner's mended rticles of 0ncorporation contains a similar provision ust like in 65ecutive 2ecretary, that theassociation is formed to represent directly or through approved representatives the pharmaceutical and health care industry beforethe Philippine ?overnment and any of its agencies, the medical professions and the general public.8Thus, as an organi7ation,petitioner definitely has an interest in fulfilling its avo#ed purpose of representing members #ho are part of the pharmaceutical andhealth care industry. Petitioner is duly authori7ed9to take the appropriate course of action to bring to the attention of governmentagencies and the courts any grievance suffered by its members #hich are directly affected by the R0RR. Petitioner, #hich ismandated by its mended rticles of 0ncorporation to represent the entire industry, #ould be remiss in its duties if it fails to act ongovernmental action that #ould affect any of its industry members, no matter ho# fe# or numerous they are. 1ence, petitioner,#hose legal identity is deemed fused #ith its members, should be considered as a real partyininterest #hich stands to bebenefited or inured by any udgment in the present action.

On the constitutionality of the provisions of the I"rt, the Court #ill determine if pertinent international instruments adverted to by respondents are part of the la# of the land.Petitioner assails the R0RR for allegedly going beyond the provisions of the Milk Code, thereby amending and e5panding thecoverage of said la#. The defense of the 4(1 is that the R0RR implements not only the Milk Code but also various internationalinstruments/-regarding infant and young child nutrition. 0t is respondents' position that said international instruments are deemedpart of the la# of the land and therefore the 4(1 may implement them through the R0RR.The Court notes that the follo#ing international instruments invoked by respondents, namely@ )/* The 3nited +ations Convention onthe Rights of the ChildA )* The 0nternational Covenant on 6conomic, 2ocial and Cultural RightsA and )>* the Convention on the6limination of ll Forms of 4iscrimination gainst :omen, only provide in general terms that steps must be taken by 2tate Partiesto diminish infant and child mortality and inform society of the advantages of breastfeeding, ensure the health and #ellbeing offamilies, and ensure that #omen are provided #ith services and nutrition in connection #ith pregnancy and lactation. 2aidinstruments do not contain specific provisions regarding the use or marketing of breastmilk substitutes.The international instruments that do have specific provisions regarding breastmilk substitutes are the 0CM"2 and various :1Resolutions.3nder the /98= Constitution, international la# can become part of the sphere of domestic la# either

bytr)*5or;)to*or *cor:or)to*.//The transformation method re!uires that an international la# be transformed into a domesticla# through a constitutional mechanism such as local legislation. The incorporation method applies #hen, by mere constitutionaldeclaration, international la# is deemed to have the force of domestic la#./

Treaties become part of the la# of the land through tr)*5or;)to*pursuant to rticle E00, 2ection / of the Constitution #hichprovides that nGo treaty or international agreement shall be valid and effective unless concurred in by at least t#othirds of all themembers of the 2enate. Thus, treaties or conventional international la# must go through a process prescribed by the Constitutionfor it to be transformed into municipal la# that can be applied to domestic conflicts./>

The 0CM"2 and :1 Resolutions are not treaties as they have not been concurred in by at least t#othirds of all members of the2enate as re!uired under 2ection /, rticle E00 of the /98= Constitution.1o#ever, the 0CM"2 #hich #as adopted by the :1 in /98/ had been transformed into domestic la# through local legislation, theMilk Code. Conse!uently, it is the Milk Code that has the force and effect of la# in this urisdiction and not the 0CM"2per se.The Milk Code is almost a verbatim reproduction of the 0CM"2, but it is #ell to emphasi7e at this point that the Code did not adoptthe provision in the ICMBS )bo6te6< :robt* )+>ert*or other forms of promotion to the general public of products #ithinthe scope of the 0CM"2. 0nstead, te M6 Co+e e:re6< :ro>+e t)t )+>ert*, :ro;oto*, or oter ;)ret* ;)ter)6

;)< be )66o8e+ 5 c ;)ter)6 )re +6< )tor=e+ )*+ )::ro>e+ b< te I*ter/Ae*c< Co;;ttee IAC.(n the other hand, 2ection , rticle 00 of the /98= Constitution, to #it@

26CT0(+ . The Philippines renounces #ar as an instrument of national policy, adopts the generall* acceptedprinciples of international law as part of the law of the landand adheres to the policy of peace, e!uality, ustice,freedom, cooperation and amity #ith all nations. )6mphasis supplied*

embodies the *cor:or)to*method./;

0n !i"ares v. anada,/&the Court held thus@?Generally accepted principles of international la#, by virtue of the incorporation clause of the Constitution, form part ofthe la#s of the land even if they do not derive from treaty obligations. The classical formulation in international la# seesthose customary rules accepted as binding result from the combination ofG t#o elements@ the established, #idespread,and consistent practice on the part of 2tatesA and a psychological element kno#n as the opinion uris >e*ecet)te )opinion as to la# or necessity*. 0mplicit in the latter element is a belief that the practice in !uestion isrendered obligatory by the e5istence of a rule of la# re!uiring it./%)6mphasis supplied*

?enerally accepted principles of international la# refers to norms of general or customary international la# #hich are binding on

all states,

/=

i.e., renunciation of #ar as an instrument of national policy, the principle of sovereign immunity,

/8

a person's right to life,liberty and due process,/9andpacta sunt servanda,-among others. The concept of generally accepted principles of la# has alsobeen depicted in this #ise@2ome legal scholars and udges look upon certain general principles of la# as a primary source of international la# because tee te Dc)r)cter o5 r)to*)6eD )*+ )re D>)6+ tro )66 *+ o5 ;)* ocete.D)


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4uration therefore is not the most important element. More important is the consistency and the generality of the practice.5 5 55 5 5 5(nce the e5istence of state practice has been established, it becomes necessary to determine #hy states behave the #aythey do. 4o states behave the #ay they do because te< co*+er t ob6)tor&of the 3+ Charter. 3nder the /9;% :1( Constitution, it is the :1 #hich determines thepolicies of the :1(,%and has the po#er to adopt regulations concerning advertising and labeling of biological, pharmaceuticaland similar products moving in international commerce,=and to make recommendations to members #ith respect to any matter#ithin the competence of the (rgani7ation.8The legal effect of its regulations, as opposed to recommendations, is !uite different.Regulations, along #ith conventions and agreements, duly adopted by the :1 b*+ ;e;ber t)te thus@

rticle /9. The 1ealth ssembly shall have authority to adopt conventions or agreements #ith respect to any matter #ithinthe competence of the (rgani7ation. t#othirds vote of the 1ealth ssembly shall be re!uired for the adoption ofsuch co*>e*to* or )ree;e*t, #hich )66 co;e *to 5orce 5or e)c Me;ber 8e* )cce:te+ b< t * )ccor+)*ce8t t co*ttto*)6 :rocee.rticle -. E)c Me;ber *+ert)e t)t t 866, #ithin eighteen months after the adoption by the 1ealth ssembly of aconvention or agreement, t)e )cto* re6)t>e to te )cce:t)*ce o5 c co*>e*to* or )ree;e*t. 6ach Membershall notify the 4irector?eneral of the action taken, and if it does not accept such convention or agreement #ithin the timelimit, it #ill furnish a statement of the reasons for nonacceptance. 0n case of acceptance, each Member agrees to makean annual report to the 4irector?eneral in accordance #ith Chapter H0E.

rticle /. The 1ealth ssembly shall have authority to adopt regulations concerning@ )a* sanitary and !uarantinere!uirements and other procedures designed to prevent the international spread of diseaseA )b* nomenclatures #ithrespect to diseases, causes of death and public health practicesA )c* standards #ith respect to diagnostic procedures forinternational useA )d* standards #ith respect to the safety, purity and potency of biological, pharmaceutical and similarproducts moving in international commerceA )e* advertising and labeling of biological, pharmaceutical and similar productsmoving in international commerce.rticle . egulations adopted pursuant to Article #$ shall co%e into force for all !e%&ers after due notice has &eengiven of their adoption &y the ealth Asse%&ly e(cept for such !e%&ers as %ay notify the )irector*+eneral of re"ection orreservations ithin the period stated in the notice. )6mphasis supplied*

(n the other hand, *+er Artc6e 23, reco;;e*+)to* o5 te FHA +o *ot co;e *to 5orce 5or ;e;ber,in the same #ay thatconventions or agreements under rticle /9 and re6)to* *+er Artc6e 21come into force. rticle > of the :1( Constitutionreads@

rticle >. The 1ealth ssembly shall have authorit* to ma$e recommendationsto Members #ith respect to any matter#ithin the competence of the (rgani7ation. )6mphasis supplied*

The absence of a provision in rticle > of any mechanism by #hich the recommendation #ould come into force for member statesis conspicuous.The former 2enior Iegal (fficer of :1(, 2ami 2hubber, stated that :1 recommendations are generally not binding, but theycarry moral and political #eight, as they constitute the udgment on a health issue of the collective membership of the highestinternational body in the field of health.96ven the 0CM"2 itself #as adopted as a mere recommendation, as :1 Resolution +o.>;. states@

The ThirtyFourth :orld 1ealth ssembly 5 5 5 adopts, * te e*e o5 Artc6e 23 o5 te Co*ttto*, the 0nternationalCode of Marketing of "reastmilk 2ubstitutes anne5ed to the present resolution. )6mphasis supplied*

The 0ntroduction to the 0CM"2 also reads as follo#s@0n %!i"ares v. a-ada>=and Shangri*la International otel

!anage%ent, td. v. )evelopers +roup of Co%panies, Inc..>8

The :orld 0ntellectual Property (rgani7ation ):0P(*, a speciali7ed agency attached to the 3+ #ith the mandate to promote andprotect intellectual property #orld#ide, has resorted to soft la# as a rapid means of norm creation, in order to reflect and respondto the changing needs and demands of its constituents.>9(ther international organi7ations #hich have resorted to soft la# includethe 0nternational Iabor (rgani7ation and the Food and griculture (rgani7ation )in the form of the Code( Ali%entarius*.;-
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:1( has resorted to soft la#. This #as most evident at the time of the 2evere cute Respiratory 2yndrome )2R2* and vian fluoutbreaks.

&lthough the I-R Resolution does not create new international law +inding on -O mem+er states, it providesan excellent example of the power of "soft law" in international relations. International law*ers t*picall*distinguish +inding rules of international law/"hard law"/from non/+inding norms, principles, and practices thatinfluence state +ehavior/"soft law." -O has during its existence generated man* soft law norms, creating a"soft law regime" in international governance for pu+lic health.The soft la# 2R2 and 01R Resolutions represent significant steps in laying the political ground#ork for improvedinternational cooperation on infectious diseases. These resolutions clearly define :1( member states' normative duty tocooperate fully #ith other countries and #ith :1( in connection #ith infectious disease surveillance and response to

outbreaks.!his dut* is neither +inding nor enforcea+le, +ut, in the wa$e of the 0&R0 epidemic, the dut* is powerfulpoliticall*for t#o reasons. First, the 2R2 outbreak has taught the lesson that participating in, and enhancing,international cooperation on infectious disease controls is in a country's selfinterest 5 5 5 if this #arning is heeded, thesoft la# in the 2R2 and 01R Resolution could inform the development of general and consistent state practice oninfectious disease surveillance and outbreak response, perhaps crystalli7ing eventually into customary international la# oninfectious disease prevention and control.;/

0n the Philippines, the e5ecutive department implemented certain measures recommended by :1( to address the outbreaks of2R2 and vian flu by issuing 65ecutive (rder )6.(.* +o. -/ on pril %, --> and 6.(. +o. 8- on February , --;, delegatingto various departments broad po#ers to close do#n schoolsJestablishments, conduct health surveillance and monitoring, and banimportation of poultry and agricultural products.0t must be emphasi7ed that even under such an international emergency, the duty of a state to implement the 01R Resolution #asstill considered not binding or enforceable, although said resolutions had great political influence.s previously discussed, for an international rule to be considered as customary la#, it must be established that such rule is beingfollo#ed by states because they co*+er t ob6)tor* micronutrient supplementationA );* universal saltiodi7ationA )&* the e5ercise of other feeding optionsA and )%* feeding in e5ceptionally difficult circumstances. 0ndeed, the primacy ofbreastfeeding for children is emphasi7ed as a national health policy. Ho8e>er, *o8ere * A.O. No. 200/0014 t +ec6)re+ t)t) :)rt o5 c e)6t :o6certe;e*t or :ro;oto* o5 bre)t;6 bttte o6+ be )bo6te6< :robte+.The national policy of protection, promotion and support of breastfeeding cannot automatically be e!uated #ith a total ban onadvertising for breastmilk substitutes.0n vie# of the enactment of the Milk Code #hich does not contain a total ban on the advertising and promotion of breastmilksubstitutes, but instead, specifically creates an 0C #hich #ill regulate said advertising and promotion, it follo#s that a total banpolicy could be implemented only :r)*t to ) 6)8amending the Milk Code passed by the constitutionally authori7ed branch ofgovernment, the legislature.

Thus, only the provisions of the Milk Code, but *ot toe o5 bee*t FHA Reo6to*, can be validly implemented by the4(1 through the subect R0RR.Tr+, the Court #ill no# determine #hether the provisions of the R0RR are in accordance #ith those of the Milk Code.0n support of its claim that the R0RR is inconsistent #ith the Milk Code, petitioner alleges the follo#ing@

/. The Milk Code limits its coverage to children -/ months old, but the R0RR e5tended its coverage to young childrenor those from ages t#o years old and beyond@

MI CO!E RIRR

FHEREAS, in order to ensure that safe and ade!uatenutrition for infants is provided, there is a need toprotect and promote breastfeeding and to inform thepublic about the proper use of breastmilk substitutesand supplements and related products throughade!uate, consistent and obective information andappropriate regulation of the marketing and distributionof the said substitutes, supplements and relatedproductsASECTION 4e. 0nfant means a person falling #ithinthe age bracket of -/ months.

Secto* 2. Pr:oe J These Revised Rules andRegulations are hereby promulgated to ensure theprovision of safe and ade!uate nutrition for infants andyoung children by the promotion, protection andsupport of breastfeeding and by ensuring the properuse of breastmilk substitutes, breastmilk supplementsand related products #hen these are medicallyindicated and only #hen necessary, on the basis ofade!uate information and through appropriatemarketing and distribution.Secto* 55. Doung Child means a person from theage of more than t#elve )/* months up to the age ofthree )>* years )>% months*.
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. The Milk Code recogni7es that infant formula may be a proper and possible substitute for breastmilk in certaininstancesA but the R0RR provides e5clusive breastfeeding for infants from -% months and declares that there is nosubstitute nor replacement for breastmilk@

MI CO!E RIRR

FHEREAS, in order to ensure that safe and ade!uatenutrition for infants is provided, there is a need toprotect and promote breastfeeding and to inform thepublic about the proper use of breastmilk substitutesand supplements and related products throughade!uate, consistent and obective information and

appropriate regulation of the marketing and distributionof the said substitutes, supplements and relatedproductsA

Secto* 4. !ec6)r)to* o5 Pr*c:6e J The follo#ingare the underlying principles from #hich the revisedrules and regulations are premised upon@a. 65clusive breastfeeding is for infants from - to si5)%* months.b. There is no substitute or replacement for breastmilk.

>. The Milk Code only regulates and does not impose unreasonable re!uirements for advertising and promotionA R0RRimposes an absolute ban on such activities for breastmilk substitutes intended for infants from -; months old or beyond,and forbids the use of health and nutritional claims. 2ection /> of the R0RR, #hich provides for a total effect in thepromotion of products #ithin the scope of the Code, is vague@

MI CO!E RIRR

SECTION . Te Ge*er)6 Pb6c )*+ Moter. J)a* +o advertising, promotion or other marketingmaterials, #hether #ritten, audio or visual, for products#ithin the scope of this Code shall be printed,published, distributed, e5hibited and broadcast unlesssuch materials are duly authori7ed and approved by an

interagency committee created herein pursuant to theapplicable standards provided for in this Code.

Secto* 4. !ec6)r)to* o5 Pr*c:6e J The follo#ingare the underlying principles from #hich the revisedrules and regulations are premised upon@5 5 5 5f. dvertising, promotions, or sponsorships of infantformula, breastmilk substitutes and other related

products are prohibited.Secto* 11. Probto* J +o advertising, promotions,sponsorships, or marketing materials and activities forbreastmilk substitutes intended for infants and youngchildren up to t#entyfour );* months, shall beallo#ed, because they tend to convey or givesubliminal messages or impressions that underminebreastmilk and breastfeeding or other#ise e5aggeratebreastmilk substitutes andJor replacements, as #ell asrelated products covered #ithin the scope of this Code.Secto* 13. DTot)6 E55ectD Promotion of products#ithin the scope of this Code must be obective andshould not e!uate or make the product appear to be asgood or e!ual to breastmilk or breastfeeding in theadvertising concept. 0t must not in any case underminebreastmilk or breastfeeding. The total effect shouldnot directly or indirectly suggest that buying theirproduct #ould produce better individuals, or resulting ingreater love, intelligence, ability, harmony or in anymanner bring better health to the baby or other suche5aggerated and unsubstantiated claim.Secto* 1. Co*te*t o5 M)ter)6. The follo#ingshall not be included in advertising, promotional andmarketing materials@a. Te5ts, pictures, illustrations or information #hichdiscourage or tend to undermine the benefits orsuperiority of breastfeeding or #hich ideali7e the use ofbreastmilk substitutes and milk supplements. 0n thisconnection, no pictures of babies and children together

#ith their mothers, fathers, siblings, grandparents,other relatives or caregivers )or yayas* shall be used inany advertisements for infant formula and breastmilksupplementsAb. The term humani7ed, maternali7ed, close tomother's milk or similar #ords in describing breastmilksubstitutes or milk supplementsAc. Pictures or te5ts that ideali7e the use of infant andmilk formula.Secto* 1. ll health and nutrition claims for products#ithin the scope of the Code are absolutely prohibited.For this purpose, any phrase or #ords that connotes toincrease emotional, intellectual abilities of the infantand young child and other like phrases shall not be

allo#ed.;. The R0RR imposes additional labeling re!uirements not found in the Milk Code@

MI CO!E RIRR

SECTION 10. Co*t)*erK)be6. J)a* Containers andJor labels shall be designed toprovide the necessary information about the

Secto* 2. Co*te*t J 6ach containerJlabel shallcontain such message, in both Filipino and 6nglishlanguages, and #hich message cannot be readily


6/18

appropriate use of the products, and in such a #ay asnot to discourage breastfeeding.)b* 6ach container shall have a clear, conspicuous andeasily readable and understandable message inPilipino or 6nglish printed on it, or on a label, #hichmessage can not readily become separated from it,and #hich shall include the follo#ing points@)i* the #ords 0mportant +otice or their e!uivalentA)ii* a statement of the superiority of breastfeedingA)iii* a statement that the product shall be used only on

the advice of a health #orker as to the need for its useand the proper methods of useA and)iv* instructions for appropriate preparation, and a#arning against the health ha7ards of inappropriatepreparation.

separated therefrom, relative the follo#ing points@)a* The #ords or phrase 0mportant +otice or?overnment :arning or their e!uivalentA)b* statement of the superiority of breastfeedingA)c* statement that there is no substitute forbreastmilkA)d* statement that the product shall be used only onthe advice of a health #orker as to the need for its useand the proper methods of useA)e* 0nstructions for appropriate preparation, and a

#arning against the health ha7ards of inappropriatepreparationA and)f* The health ha7ards of unnecessary or improper useof infant formula and other related products includinginformation that po#dered infant formula may containpathogenic microorganisms and must be prepared andused appropriately.

&. The Milk Code allo#s dissemination of information on infant formula to health professionalsA the R0RR totally prohibitssuch activity@

MI CO!E RIRR

SECTION 7. He)6t C)re Sere+ b< t Co+e. 4onations of products,e!uipments, and the like, not other#ise falling #ithinthe scope of this Code or these Rules, given by milkcompanies and their agents, representatives, #hetherin kind or in cash, may only be coursed through the


7/18

0nter gency Committee )0C*, #hich shall determine#hether such donation be accepted or other#ise.

8. The R0RR provides for administrative sanctions not imposed by the Milk Code.

MI CO!E RIRR

Secto* 4. A+;*tr)t>e S)*cto*. J Thefollo#ing administrative sanctions shall be imposedupon any person, uridical or natural, found to haveviolated the provisions of the Code and itsimplementing Rules and Regulations@a* /stviolation K :arningA

b* ndviolation K dministrative fine of a minimum ofTen Thousand )P/-,---.--* to Fifty Thousand)P&-,---.--* Pesos, depending on the gravity ande5tent of the violation, including the recall of theoffending productAc* >rdviolation K dministrative Fine of a minimum of2i5ty Thousand )P%-,---.--* to (ne 1undred FiftyThousand )P/&-,---.--* Pesos, depending on thegravity and e5tent of the violation, and in additionthereto, the recall of the offending product, andsuspension of the Certificate of Product Registration)CPR*Ad* ;thviolation Kdministrative Fine of a minimum ofT#o 1undred Thousand )P--,---.--* to Five

1undred )P&--,---.--* Thousand Pesos, dependingon the gravity and e5tent of the violationA and inaddition thereto, the recall of the product, revocation ofthe CPR, suspension of the Iicense to (perate )IT(*for one yearAe* &thand succeeding repeated violations Kdministrative Fine of (ne Million )P/,---,---.--*Pesos, the recall of the offending product, cancellationof the CPR, revocation of the Iicense to (perate )IT(*of the company concerned, including the blacklisting ofthe company to be furnished the 4epartment of "udgetand Management )4"M* and the 4epartment of Tradeand 0ndustry )4T0*Af* n additional penalty of T#o Thousand Five1undred )P,&--.--* Pesos per day shall be made for

every day the violation continues after having receivedthe order from the 0C or other such appropriate body,notifying and penali7ing the company for the infraction.For purposes of determining #hether or not there isrepeated violation, each product violation belongingor o#ned by a company, including those of theirsubsidiaries, are deemed to be violations of theconcerned milk company and shall not be based on thespecific violating product alone.

9. The R0RR provides for repeal of e5isting la#s to the contrary.The Court shall resolve the merits of the allegations of petitioner seriati%./. Petitioner is mistaken in its claim that the Milk Code's coverage is l imited only to children -/ months old. 2ection > of the MilkCode states@

26CT0(+ >. Scope of the CodeK The Code applies to the marketing, and practices related thereto, of the follo#ing

products@ breastmilk substitutes, including infant formulaA other milk products, foods and beverages, including bottlefedcomplementary foods, #hen marketed or other#ise represented to be suitable, #ith or #ithout modification, for use as apartial or total replacement of breastmilkA feeding bottles and teats. 0t also applies to their !uality and availability, and toinformation concerning their use.

Clearly, the coverage of the Milk Code is not dependent on the age of the child but on the *+ o5 :ro+ctbeing marketed to thepublic. The la# treats infant formula, bottlefed complementary food, and breastmilk substitute as separate and distinct productcategories.2ection ;)h* of the Milk Code defines infant formula as a breastmilk substitute 5 5 5 to satisfy the normal nutritional re!uirements ofinfants up to bet#een four to si5 months of age, and adapted to their physiological characteristicsA #hile under 2ection ;)b*, bottlefed complementary food refers to any food, #hether manufactured or locally prepared, suitable as a complement to breastmilk orinfant formula, #hen either becomes insufficient to satisfy the nutritional re!uirements of the infant. n infant under 2ection ;)e* isa person falling #ithin the age bracket -/ months. 0t is the nourishment of this group of infants or children aged -/ months thatis sought to be promoted and protected by the Milk Code."ut there is another target group. "reastmilk substitute is defined under 2ection ;)a* as any food being marketed or other#ise

presented as a partial or total replacement for breastmilk, #hether or not suitable for that purpose. T ecto* co*:co6o* o5 te M6 Co+e c)**ot be co*+ere+ec6>e 5or c6+re* )e+ 0/12 ;o*t. 0n other #ords, breastmilk substitutes may also be intended for young children morethan / months of age. Therefore, by regulating breastmilk substitutes, the Milk Code also intends to protect and promote thenourishment of children more than / months old.


8/18

6vidently, as long as #hat is being marketed falls #ithin the scope of the Milk Code as provided in 2ection >, then it can be subectto regulation pursuant to said la#, even if the product is to be used by children aged over / months.There is, therefore, nothing obectionable #ith 2ections ;and &)ff*;>of the R0RR.. 0t is also incorrect for petitioner to say that the R0RR, unlike the Milk Code, does not recogni7e that breastmilk substitutes may bea proper and possible substitute for breastmilk.The entirety of the R0RR, not merely truncated portions thereof, must be considered and construed together. s held in )e una v.Pascual,;;tGhe particular #ords, clauses and phrases in the Rule should not be studied as detached and isolated e5pressions, butthe #hole and every part thereof must be considered in fi5ing the meaning of any of its parts and in order to produce a harmonious#hole.2ection = of the R0RR provides that #hen medically indicated and only #hen necessary, te e o5 bre)t;6 bttte

:ro:erif based on complete and updated information. 2ection 8 of the R0RR also states that information and educationalmaterials should include information on the proper use of infant formula #hen the use thereof is needed.1ence, te RIRR, t 6e te M6 Co+e, )6o reco*=e t)t * cert)* c)e, te e o5 bre)t;6 bttte ;)< be:ro:er.>. The Court shall ascertain the merits of allegations >;&and ;;%together as they are interlinked #ith each other.To resolve the !uestion of #hether the labeling re!uirements and advertising regulations under the R0RR are valid, it is important todeal first #ith the nature, purpose, and depth of the regulatory po#ers of the 4(1, as defined in general under the /98=dministrative Code,;=and as delegated in particular under the Milk Code.1ealth is a legitimate subect matter for regulation by the 4(1 )and certain other administrative agencies* in e5ercise of policepo#ers delegated to it. The sheer span of urisprudence on that matter precludes the need to further discuss it..;81o#ever, healthinformation, particularly advertising materials on apparently nonto5ic products like breastmilk substitutes and supplements, is arelatively ne# area for regulation by the 4(1.;9

s early as the /9/= Revised dministrative Code of the Philippine 0slands,&-health information #as already #ithin the ambit of theregulatory po#ers of the predecessor of 4(1.&/2ection 9>8 thereof charged it #ith the duty to protect the health of the people, andvested it #ith such po#ers as )g* the dissemination of hygienic information among the people and especiall* the inculcation of

$nowledge as to the proper care of infantsand the methods of preventing and combating dangerous communicable diseases.2eventy years later, the /98= dministrative Code tasked respondent 4(1 to carry out the state policy pronounced under 2ection/&, rticle 00 of the /98= Constitution, #hich is to protect and promote the right to health of the people and instill healthconsciousnessamong them.&To that end, it #as granted under 2ection > of the dministrative Code the po#er to )%* propagatehealth information and educate the populationon important health, medical and environmental matters #hich have healthimplications.&>

:hen it comes to information regarding nutrition of infants and young children, ho#ever, the Milk Code specifically delegated to theMinistry of 1ealth )hereinafter referred to as 4(1* the po#er to ensure that there is ade!uate, consistent and obective informationon breastfeeding and use of breastmilk substitutes, supplements and related productsA and the po#er to co*tro6such information.These are e5pressly provided for in 2ections / and &)a*, to #it@

26CT0(+ /. I%ple%entation and !onitoringK5 5 5 5)b* The Ministry of 1ealth shall be principally responsible for the implementation and enforcement of the provisions of thisCode. For this purpose, the Ministry of 1ealth shall have the follo#ing po#ers and functions@

)/* To promulgate such rules and regulations as are necessary or proper for the implementation of this Code andthe accomplishment of its purposes and obectives.5 5 5 5);* To e5ercise such other po#ers and functions as may be necessary for or incidental to the attainment of thepurposes and obectives of this Code.

26CT0(+ &. Infor%ation and /ducationK)a* The government shall ensure that obect>e )*+ co*te*t information is provided on infant feeding, for use byfamilies and those involved in the field of infant nutrition. This responsibility shall cover the planning, provision, design anddissemination of information, and the control thereof, on infant nutrition. )6mphasis supplied*

Further, 4(1 is authori7ed by the Milk Code to co*tro6 the content of any information on breastmilk vis*0*visbreastmilk substitutes,supplement and related products, in the follo#ing manner@

26CT0(+ &. 5 5 5)b* 0nformational and educational materials, #hether #ritten, audio, or visual, dealing #ith the feeding of infants andintended to reach pregnant #omen and mothers of infants, shall include clear information on all the follo#ing points@ )/*

the benefits and superiority of breastfeedingA )* maternal nutrition, and the preparation for and maintenance ofbreastfeedingA )>* the negative effect on breastfeeding of introducing partial bottlefeedingA );* the difficulty of reversing thedecision not to breastfeedA and )&* #here needed, the proper use of infant formula, #hether manufactured industrially orhomeprepared. hen such materials contain information a+out the use of infant formula, the* shall include thesocial and financial implications of its use the health ha(ards of inappropriate foods or feeding methods and, inparticular, the health ha(ards of unnecessar* or improper use of infant formula and other +reastmil$ su+stitutes.0uch materials shall not use an* picture or text which ma* ideali(e the use of +reastmil$ su+stitutes.S/C1IO2 3. ealth 4orkers 55 5 5 5)b* 0nformation provided by manufacturers and distributors to health professionals regarding products #ithin the scope ofthis Code )66 be retrcte+ to ce*t5c )*+ 5)ct)6 ;)tter, )*+ c *5or;)to* )66 *ot ;:6< or cre)te )be6e5 t)t bott6e5ee+* e>)6e*t or :eror to bre)t5ee+*. It )66 )6o *c6+e te *5or;)to* :ec5e+* Secto* b.S/C1IO2 $6. Containers7a&el 5)a* Containers andJor labels shall be designed to provide the necessary information about the appropriate use of the

products, and * c ) 8)< ) *ot to +cor)e bre)t5ee+*.5 5 5 5)d* The term humani7ed, maternali7ed or similar terms shall not be used. )6mphasis supplied*

The 4(1 is also authori7ed to control the purpose of the information and to #hom such information may be disseminated under2ections % through 9 of the Milk Code&;to ensure that the information that #ould reach pregnant #omen, mothers of infants, and
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health professionals and #orkers in the health care system is restricted to scientific and factual matters and shall *otimply orcreate a belief that bottlefeeding is e!uivalent or superior to breastfeeding.0t bears emphasis, ho#ever, that the 4(1's po#er under the Milk Code toco*tro6information regarding breastmilkvis*a*visbreastmilk substitutes *ot )bo6teas the po#er to control does not encompass the po#er to absolutely prohibit theadvertising, marketing, and promotion of breastmilk substitutes.The follo#ing are the provisions of the Milk Code that une!uivocally indicate that the control over information given to the 4(1 isnot absolute and that absolute prohibition is not contemplated by the Code@

a* 2ection #hich re!uires ade!uate information and appropriate marketing and distribution of breastmilk substitutes, to#it@

26CT0(+ .Ai% of the Code 5 The aim of the Code is to contribute to the provision of safe and ade!uate

nutrition for infants by the protection and promotion of breastfeeding and by ensuring the proper use of breastmilksubstitutes and breastmilk supplements #hen these are necessary, on the basis of ade!uate information andthrough appropriate marketing and distribution.

b* 2ection > #hich specifically states that the Code applies to the marketing of and practices related to breastmilksubstitutes, including infant formula, and to information concerning their useAc* 2ection &)a* #hich provides that the government shall ensure that obective and consistent information is provided oninfant feedingAd* 2ection &)b* #hich provides that #ritten, audio or visual informational and educational materials shall not use anypicture or te5t #hich may ideali7e the use of breastmilk substitutes and should include information on the health ha7ardsof unnecessary or improper use of said productAe* 2ection %)a* in relation to 2ection /)a* #hich creates and empo#ers the 0C to revie# and e5amine advertising,promotion, and other marketing materialsAf* 2ection 8)b* #hich states that milk companies may provide information to health professionals but such informationshould be restricted to factual and scientific matters and shall not imply or create a belief that bottlefeeding is e!uivalent orsuperior to breastfeedingA and

g* 2ection /- #hich provides that containers or labels should not contain information that #ould discourage breastfeedingand ideali7e the use of infant formula.

0t is in this conte5t that the Court no# e5amines the assailed provisions of the R0RR regarding labeling and advertising.2ections />&&on total effect and %&%of Rule E00 of the R0RR contain some labeling re!uirements, specifically@ a* that there be astatement that there is no substitute to breastmilkA and b* that there be a statement that po#dered infant formula may containpathogenic microorganisms and must be prepared and used appropriately. 2ection /%&=of the R0RR prohibits all health and nutritionclaims for products #ithin the scope of the Milk Code, such as claims of increased emotional and intellectual abilities of the infantand young child.These re!uirements and limitations are consistent #ith the provisions of 2ection 8 of the Milk Code, to #it@

26CT0(+ 8. ealth orkers 5 5 5 5)b* 0nformation provided by manufacturers and distributors to health professionals regarding products #ithin the scope ofthis Code shall be retrcte+ to ce*t5c )*+ 5)ct)6 ;)tter, and such information )66 *otimply or create a beliefthat bottlefeeding is e2uivalentor :erorto breastfeeding. 0t shall also include the information specified in 2ection

&.&8)6mphasis supplied*and 2ection /-)d*&9#hich bars the use on containers and labels of the terms humani7ed, maternali7ed, or similar terms.These provisions of the Milk Code e5pressly forbid information that #ould imply or create a belief that there is any milk producte!uivalent to breastmilk or #hich is humani7ed or maternali7ed, as such information #ould be inconsistent #ith the superiority ofbreastfeeding.0t may be argued that 2ection 8 of the Milk Code refers only to information given to health #orkers regarding breastmilk substitutes,not to containers and labels thereof. 1o#ever, such restrictive application of 2ection 8)b* #ill result in the absurd situation in #hichmilk companies and distributors are forbidden to claim to health #orkers that their products are substitutes or e!uivalents ofbreastmilk, and yet be allo#ed to display on the containers and labels of their products the e5act opposite message. That aske#edinterpretation of the Milk Code is precisely #hat 2ection &)a* thereof seeks to avoid by mandating that all information regardingbreastmilk vis*a*visbreastmilk substitutes be consistent, at the same time giving the government control over planning, provision,design, and dissemination of information on infant feeding.Thus, 2ection %)c* of the R0RR #hich re!uires containers and labels to state that the product offered is not a substitute forbreastmilk, is a reasonable means of enforcing 2ection 8)b* of the Milk Code and deterring circumvention of the protection and

promotion of breastfeeding as embodied in 2ection

%-

of the Milk Code.2ection %)f*%/of the R0RR is an e!ually reasonable labeling re!uirement. 0t implements 2ection &)b* of the Milk Code #hich reads@26CT0(+ &. 5 5 55 5 5 5)b* 0nformational and educational materials, #hether #ritten, audio, or visual, dealing #ith the feeding of infants andintended to reach pregnant #omen and mothers of infants, shall include clear information on all the follo#ing points@ 5 5 5)&* #here needed, the proper use of infant formula, #hether manufactured industrially or homeprepared. :hen suchmaterials contain information about the use of infant formula, they shall include the social and financial implications of itsuseAthe health ha(ards of inappropriate foods or feeding methods and, in particular, the health ha(ards ofunnecessar* or improper use of infant formula and other +reastmil$ su+stitutes. 2uch materials shall not use anypicture or te5t #hich may ideali7e the use of breastmilk substitutes. )6mphasis supplied*

The label of a product contains *5or;)to*about said product intended for the buyers thereof. The buyers of breastmilksubstitutes are mothers of infants, and 2ection % of the R0RR merely adds a fair #arning about the likelihood of pathogenicmicroorganisms being present in infant formula and other related products #hen these are prepared and used inappropriately.PetitionerLs counsel has admitted during the hearing on


10/18

0n furtherance of 2ection %)a* of the Milk Code, to #it@26CT0(+ %. 1he +eneral Pu&lic and !others.K)a* +o advertising, promotion or other marketing materials, #hether #ritten, audio or visual, for products #ithin the scopeof this Code shall be printed, published, distributed, e5hibited and broadcast unless such materials are duly authori7edand approved by an interagency committee created herein pursuant to the applicable standards provided for in this Code.

the Milk Code invested regulatory authority over advertising, promotional and marketing materials to an 0C, thus@26CT0(+ /. I%ple%entation and !onitoring )a* For purposes of 2ection %)a* of this Code, an interagency committee composed of the follo#ing members is herebycreated@

Minister of 1ealth Chairman

Minister of Trade and 0ndustry Member

Minister of * To prescribe the internal and operational procedure for the e5ercise of its po#ers and functions as #ell as theperformance of its duties and responsibilitiesA and);* To :ro;6)te c r6e )*+ re6)to* ) )re *ece)r< or :ro:er 5or te ;:6e;e*t)to* o5Secto* ) o5 t Co+e. 5 5 5 )6mphasis supplied*

1o#ever, 2ection // of the R0RR, to #it@26CT0(+ //. Prohi&itionJ +o advertising, promotions, sponsorships, or marketing materials and activities for breastmilksubstitutes intended for infants and young children up to t#entyfour );* months, shall be allo#ed, because they tend toconvey or give subliminal messages or impressions that undermine breastmilk and breastfeeding or other#ise e5aggeratebreastmilk substitutes andJor replacements, as #ell as related products covered #ithin the scope of this Code.

prohibits advertising, promotions, sponsorships or marketing materials and activities for breastmilk substitutes in line #ith theR0RRLs declaration of principle under 2ection ;)f*, to #it@

26CT0(+ ;. )eclaration of Principles 55 5 5 5)f* dvertising, promotions, or sponsorships of infant formula, breastmilk substitutes and other related products areprohibited.

The 4(1, through its corespondents, evidently arrogated to itself not only the regulatory authority given to the 0C but alsoimposed absolute prohibition on advertising, promotion, and marketing.Det, oddly enough, 2ection / of the R0RR reiterated the re!uirement of the Milk Code in 2ection % thereof for prior approval by 0Cof all advertising, marketing and promotional materials prior to dissemination.6ven respondents, through the (2?, ackno#ledged the authority of 0C, and repeatedly insisted, during the oral arguments on


11/18

2(I0C0T(R ?6+6RI 46E+46R@Dour 1onor, please, first #e #ould like to stress that there is no total absolute ban. 2econd, the 0ntergency Committee isunder the 4epartment of 1ealth, Dour 1onor.5 5 5 522(C0T6


12/18

any case undermine breastmilk or breastfeeding. The total effect should not directly or indirectly suggest that buying theirproduct #ould produce better individuals, or resulting in greater love, intell igence, ability, harmony or in any manner bringbetter health to the baby or other such e5aggerated and unsubstantiated claim.

2uch standards bind the 0C in formulating its rules and regulations on advertising, promotion, and marketing. Through that singleprovision, the 4(1 e5ercises control over the information content of advertising, promotional and marketing materials onbreastmilk vis*a*visbreastmilk substitutes, supplements and other related products. 0t also sets a viable standard against #hich the0C may screen such materials before they are made public.0n /9ui*Asia Place%ent, Inc. vs. )epart%ent of :oreign Affairs,%;the Court held@

5 5 5 TGhis Court had, in the past, accepted as sufficient standards the follo#ing@ public interest, ustice and e!uity,public convenience and #elfare, and simplicity, economy and #elfare.%&

0n this case, correct information as to infant feeding and nutrition is infused #ith public interest and #elfare.;. :ith regard to activities for dissemination of information to health professionals, the Court also finds that there is noinconsistency bet#een the provisions of the Milk Code and the R0RR. 2ection =)b*%%of the Milk Code, in relation to 2ection 8)b*%=ofthe same Code, allo#s dissemination of information to health professionals but such*5or;)to* retrcte+ to ce*t5c )*+5)ct)6 ;)tter.Contrary to petitioner's claim, 2ection of the R0RR does not prohibit the >* o5 *5or;)to* to e)6t :ro5eo*)6o*ce*t5c )*+ 5)ct)6 ;)tter. :hat it prohibits is the involvement of the manufacturer and distributor of the products covered bythe Code in activities for the promotion, education and production of 0nformation, 6ducation and Communication )06C* materialsregarding breastfeeding that are *te*+e+ 5or 8o;e* )*+ c6+re*. 2aid provision cannot be construed to encompass eventhe +e;*)to* o5 *5or;)to* to e)6t :ro5eo*)6, ) retrcte+ by the Milk Code.&. +e5t, petitioner alleges that 2ection 8)e*%8of the Milk Code permits milk manufacturers and distributors to e5tend assistance inresearch and in the continuing education of health professionals, #hile 2ections and > of the R0RR absolutely forbid the same.Petitioner also assails 2ection ;)i*%9of the R0RR prohibiting milk manufacturers' and distributors' participation in any policymakingbody in relation to the advancement of breastfeeding.2ection ;)i* of the R0RR provides that milk companies and their representatives should not form part of any policymaking body or

entity in relation to the advancement of breastfeeding. The Court finds nothing in said provisions #hich contravenes the Milk Code.+ote that under 2ection /)b* of the Milk Code, it is te !OH 8c )66 be :r*c:)66< re:o*b6efor the implementation andenforcement of the provisions of said Code. 0t is entirely up to the 4(1 to decide #hich entities to call upon or allo# to be part ofpolicymaking bodies on breastfeeding. Therefore, the R0RR's prohibition on milk companiesL participation in any policymaking bodyin relation to the advancement of breastfeeding is in accord #ith the Milk Code.Petitioner is also mistaken in arguing that 2ection of the R0RR prohibits milk companies from giving reasearch assistance andcontinuing education to health professionals. Secto* 22=-o5 te RIRR +oe *ot :ert)* to ree)rc )t)*ce to or teco*t** e+c)to* o5 e)6t :ro5eo*)6A rather, it deals #ith breastfeeding promotion and e+c)to* 5or 8o;e* )*+c6+re*. +othing in 2ection of the R0RR prohibits milk companies from giving assistance for research or continuing educationto health professionalsA hence, petitioner's argument against this particular provision must be struck do#n.0t is 2ections 9=/and /-=of the R0RR #hich govern research assistance. 2aid sections of the R0RR provide thatree)rc)t)*ce 5or e)6t 8orer )*+ ree)rcer ;)< be )66o8e+ :o* )::ro>)6 o5 )* etc co;;ttee, )*+ 8t cert)*+c6ore rere;e*t ;:oe+ o* te ;6 co;:)*< )*+ o* te rec:e*t o5 te ree)rc )8)r+.The Milk Code endo#s the 4(1 #ith the po#er to determine ho# such research or educational assistance may be given by milk

companies or under #hat conditions health #orkers may accept the assistance. Thus, 2ections 9 and /- of the R0RR imposinglimitations on the kind of research done or e5tent of assistance given by milk companies are completely in accord #ith the MilkCode.Petitioner complains that 2ection >=>of the R0RR prohibits milk companies from giving assistance, support, logistics or training tohealth #orkers. This provision is #ithin the prerogative given to the 4(1 under 2ection 8)e*=;of the Milk Code, #hich provides thatmanufacturers and distributors of breastmilk substitutes may assist in researches, scholarships and the continuing education, ofhealth professionals in accordance #ith the rules and regulations promulgated by the Ministry of 1ealth, no# 4(1.%. s to the R0RR's prohibition on donations, said provisions are also consistent #ith the Milk Code. 2ection %)f* of the Milk Codeprovides that donations ;))6 o5 te !OH. The la# does not proscribe the refusal of donations. The Milk Code leaves it purely to the discretion of the4(1 #hether to re!uest or accept such donations. The 4(1 then appropriately e5ercised its discretion through 2ection &/=&of theR0RR #hich sets forth its policy not to re!uest or approve donations from manufacturers and distributors of breastmilk substitutes.0t #as #ithin the discretion of the 4(1 #hen it provided in 2ection & of the R0RR that any donation from milk companies notcovered by the Code should be coursed through the 0C #hich shall determine #hether such donation should be accepted or

refused. s reasoned out by respondents, the 4(1 is not mandated by the Milk Code to accept donations. For that matter, noperson or entity can be forced to accept a donation. There is, therefore, no real inconsistency bet#een the R0RR and the la#because the Milk Code does not prohibit the 4(1 from refusing donations.=. :ith regard to 2ection ;% of the R0RR providing for administrative sanctions that are not found in the Milk Code, the Courtupholds petitioner's obection thereto.Respondent's reliance on Civil Aeronautics Board v. Philippine Air ines, Inc.=%is misplaced. The glaring difference in said case andthe present case before the Court is that, in the Civil Aeronautics Board, the Civil eronautics dministration )C* #as e:re6>. The circular provided for fines for the commission ofprohibited acts. The Court found that nothing in the circular contravened the la# because the 4(6 #as e5pressly authori7ed by".P. Blg.>> and R.. +o. =%>8 to impose fines or penalties.

0n the present case, neither the Milk Code nor the Revised dministrative Code grants the 4(1 the authority to fi5 or imposeadministrative fines. Thus, #ithout any e5press grant of po#er to fi5 or impose such fines, the 4(1 cannot provide for those fines inthe R0RR. 0n this regard, the 4(1 again e5ceeded its authority by providing for such fines or sanctions in 2ection ;% of the R0RR.2aid provision is, therefore, null and void.The 4(1 is not left #ithout any means to enforce its rules and regulations. 2ection /)b* )>* of the Milk Code authori7es the 4(1to cause the prosecution of the violators of this Code and other pertinent la#s on products covered by this Code. 2ection /> of
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the Milk Code provides for the penalties to be imposed on violators of the provision of the Milk Code or the rules and regulationsissued pursuant to it, to #it@

26CT0(+ />. Sanctions 5)a* ny person #ho violates the provisions of this Code or te r6e )*+ re6)to* e+ :r)*t to tCo+eshall, upon conviction, be punished by a penalty of t#o )* months to one )/* year imprisonment or a fine of not lessthan (ne Thousand Pesos )P/,---.--* nor more than Thirty Thousand Pesos )P>-,---.--* or both. 2hould the offensebe committed by a uridical person, the chairman of the "oard of 4irectors, the president, general manager, or the partnersandJor the persons directly responsible therefor, shall be penali7ed.)b* ny license, permit or authority issued by any government agency to any health #orker, distributor, manufacturer, ormarketing firm or personnel for the practice of their profession or occupation, or for the pursuit of their business, may,

upon recommendation of the Ministry of 1ealth, be suspended or revoked in the event of repeated violations of this Code,or of the rules and regulations issued pursuant to this Code. )6mphasis supplied*8. PetitionerLs claim that 2ection &= of the R0RR repeals e5isting la#s that are contrary to the R0RR is frivolous.2ection &= reads@

26CT0(+ &=. epealing Clause ll orders, issuances, and rules and regulations or parts thereof inconsistent #ith theserevised rules and implementing regulations are hereby repealed or modified accordingly.

2ection &= of the R0RR does not provide for the repeal of la#s but only orders, issuances and rules and regulations. Thus, saidprovision is valid as it is #ithin the 4(1's rulemaking po#er.n administrative agency like respondent possesses !uasilegislative or rulemaking po#er or the po#er to make rules andregulations #hich results in delegated legislation that is #ithin the confines of the granting statute and the Constitution, and subectto the doctrine of nondelegability and separability of po#ers.=82uch e5press grant of rulemaking po#er necessarily includes thepo#er to amend, revise, alter, or repeal the same.=9This is to allo# administrative agencies fle5ibility in formulating and adustingthe details and manner by #hich they are to implement the provisions of a la#,8-in order to make it more responsive to the times.1ence, it is a standard provision in administrative rules that prior issuances of administrative agencies that are inconsistentthere#ith are declared repealed or modified.

0n fine, only 2ections ;)f*, // and ;% are ultra vires, beyond the authority of the 4(1 to promulgate and in contravention of the MilkCode and, therefore, null and void. The rest of the provisions of the R0RR are in consonance #ith the Milk Code.Iastly, petitioner makes a catchall allegation that@

5 5 5 TGhe !uestioned R0RR sought to be implemented by the Respondents is **ece)r< )*+ o::re>e, )*+ o55e*>e to te +e :roce c6)e o5 te Co*ttto*, *o5)r ) te );e * retr)*t o5 tr)+eand because aprovision therein is inade!uate to provide the public #ith a comprehensible basis to determine #hether or not they havecommitted a violation.8/)6mphasis supplied*

Petitioner refers to 2ections ;)f*,8;)i*,8>&)#*,8;//,8&,8%>,8=;%,88and &89as the provisions that suppress the trade of milk and,thus, violate the due process clause of the Constitution.The framers of the constitution #ere #ell a#are that trade must be subected to some form of regulation for the public good. Publicinterest must be upheld over business interests.9-0n Pest !anage%ent Association of the Philippines v. :ertili8er and PesticideAuthority,9/it #as held thus@

5 5 5 Furthermore, as held in ssociation of Philippine Coconut 4esiccators v. Philippine Coconut uthority,+e:te te5)ct t)t Dor :ree*t Co*ttto* e*r*e 5ree e*ter:re ) ) :o6ce to te

o>er*;e*t te :o8er to *ter>e*e 8e*e>er *ece)r< to :ro;ote te e*er)6 8e65)re. There can be no !uestionthat the unregulated use or proliferation of pesticides #ould be ha7ardous to our environment. Thus, in the aforecitedcase, the Court declared that 5ree e*ter:re +oe *ot c)66 5or re;o>)6 o5 :rotect>e re6)to*. 5 5 5 It ;t bec6e)r6< e:6)*e+ )*+ :ro>e* b< co;:ete*t e>+e*ce t e)ct6< o8 c :rotect>e re6)to* 8o6+ re6t *te retr)*t o5 tr)+e. 6mphasis and underscoring suppliedG

0n this case, petitioner failed to sho# that the proscription of milk manufacturersL participation in any policymaking body )2ection;)i**, classes and seminars for #omen and children )2ection *A the giving of assistance, support and logistics or training )2ection>*A and the giving of donations )2ection &* #ould unreasonably hamper the trade of breastmilk substitutes. Petitioner has notestablished that the proscribed activities are indispensable to the trade of breastmilk substitutes. Petitioner failed to demonstratethat the aforementioned provisions of the R0RR are unreasonable and oppressive for being in restraint of trade.Petitioner also failed to convince the Court that 2ection &)#* of the R0RR is unreasonable and oppressive. 2aid section provides forthe definition of the term milk company, to #it@

26CT0(+ & 5 5 5. )#* Milk Company shall refer to the o#ner, manufacturer, distributor of infant formula, follo#up milk,milk formula, milk supplement, breastmilk substitute or replacement, or by any other description of such nature, including

their representatives #ho promote or other#ise advance their commercial interests in marketing those productsA(n the other hand, 2ection ; of the Milk Code provides@)d* 4istributor means a person, corporation or any other entity in the public or private sector engaged in the business)#hether directly or indirectly* of marketing at the #holesale or retail level a product #ithin the scope of this Code. primary distributor is a manufacturer's sales agent, representative, national distributor or broker.5 5 5 5)* Manufacturer means a corporation or other entity in the public or private sector engaged in the business or function)#hether directly or indirectly or through an agent or and entity controlled by or under contract #ith it* of manufacturing aproducts #ithin the scope of this Code.

+otably, the definition in the R0RR merely merged together under the term milk company the entities defined separately under theMilk Code as distributor and manufacturer. The R0RR also enumerated in 2ection &)#* the products manufactured or distributedby an entity that #ould !ualify it as a milk company, #hereas in the Milk Code, #hat is used is the phrase products #ithin thescope of this Code. Those are the only differences bet#een the definitions given in the Milk Code and the definition as restated inthe R0RR.2ince all the regulatory provisions under the Milk Code apply e!ually to both manufacturers and distributors, the Court sees no

harm in the R0RR providing for ust one term to encompass both entities. The definition of milk company in the R0RR and thedefinitions of distributor and manufacturer provided for under the Milk Code are practically the same.The Court is not convinced that the definition of milk company provided in the R0RR #ould bring about any change in thetreatment or regulation of distributors and manufacturers of breastmilk substitutes, as defined under the Milk Code.
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65cept 2ections ;)f*, // and ;%, the rest of the provisions of the R0RR are in consonance #ith the obective, purpose and intent ofthe Milk Code, constituting reasonable regulation of an industry #hich affects public health and #elfare and, as such, the rest of theR0RR do not constitute illegal restraint of trade nor are they violative of the due process clause of the Constitution.FHERE"ORE,the petition is PARTIA#GRANTE!. 2ections ;)f*, // and ;% of dministrative (rder +o. --%--/ dated May/, --% are declared NUand OI!for being ultra vires. The 4epartment of 1ealth and respondents are PROHIBITE!fromimplementing said provisions.The Temporary Restraining (rder issued on ugust /&, --% is I"TE!insofar as the rest of the provisions of dministrative (rder+o. --%--/ is concerned.SO OR!ERE!.Puno, ;Chief uisu%&ing, Ynares*Santiago, Sandoval*+utierre8, Carpio, Corona, Carpio*!orales, A8cuna, 1inga, Chico*

2a8ario, +arcia, ?elasco,


15/18

)b* 0n Reo6to* No. 39.2L )May /%, /98%*, the :1 re!uested the :1( 4irector ?eneral to direct theattention of member states to the fact that any food or drink given before complementary feeding is nutritionallyre!uired may interfere #ith the initiation or maintenance of breastfeeding and therefore should neither bepromoted nor encouraged for us by infants during this period.)c* 0n Reo6to* No. 43.3)May /;, /99-*, the :1 urged member states to protect and promote breastfeedingas an essential component of nutrition policies so as to enable infants to be e5clusively breastfed during the f irstfour to si5 months of life.)d* 0n Reo6to* No. 4.34 )May /;, /99*, the :1 urged member states to implement the targets of the0nnocenti 4eclaration specifically, to give effect to the 0CM"2.)e* 0n Reo6to* No. 4.7)May /-, /99>*, the :1 urged member states to strive to eliminate undernutrition,

malnutrition and nutritional deficiency among children.)f* 0n Reo6to* No. 47.)May 9, /99;*, the :1 urged member states to ensure that there are no donations ofsupplies of breastmilk substitutes and other products covered by the 0CM"2 in any part of the health caresystem.)g* 0n Reo6to* No. 49.1)May &, /99%*, the :1 urged member states to ensure that complementary foodsare not marketed for or used in #ays that undermine e5clusive and sustained breastfeeding.)h* 0n Reo6to* No. 4.2)May --*, the :1, noting that despite the fact that the 0nternational Code ofMarketing of "reastmilk 2ubstitutes and relevant subse!uent :orld 1ealth ssembly resolutions state that thereshould be no advertising or other forms of promotion of products #ithin its scope, ne# modern communicationmethods including electronic means, are currently increasingly being used to promote such productsA andconscious of the need for the Code5 limentarius Commission to take the 0nternational Code and subse!uentrelevant 1ealth ssembly resolutions into consideration in dealing #ith health claims in the development of foodstandards and guidelines 5 5 5, urged member states to develop ne# approaches to protect, promote andsupport e5clusive breastfeeding for si5 months as a global public health recommendation.)i* 0n Reo6to* No. .2)May /&, --*, the :1 re!uested the Code5 limentarius Commission to ensure

that labelling of processed foods for infants and young children be consistent #ith the :1( policy under the0C"M2.)* 0n Reo6to* No. L.32)May &, --&*, the :1 urged member states to continue to protect and promotee5clusive breastfeeding for si5 months.)k* 0n Reo6to* No. 9.21)May =, --%*, the :1 reiterated its support for the ?obal strategy for 0nfant andDoung Child Feeding.

>/4avid Fidler, supra note 9.>rticle >8. /. The Court, #hose function is to decide in accordance #ith international la# such disputes as are submittedto it, shall apply@ a* international conventions, #hether general or particular, establishing rules e5pressly recogni7ed by thecontesting statesA b* international custom, as evidence of a general practice accepted as la#A c* the general principles ofla# recogni7ed by civili7ed nationsA d* subect to the provisions of rticle &9, udicial decisions and the teachings of themost highly !ualified publicists of the various nations, as subsidiary means for the determination of rules of la#.>>2upra note 9.>;Iouis 1enkin, et al., 0nternational Ia#, Cases and Materials, nd6d., supra note /, at //;/>%.

>&2upra note /9.>%9- Phil. =- )/9&/*.>=2upra note /&.>8?.R. +o. /&99>8,March >/, --%, ;8% 2CR ;-&.>96d#ard N#ak#a, 2ome Comments on Rulemaking at the :orld 0ntellectual Property(rgani7ation,###.la#.duke.eduJshellJcite A 2eptember />, --=, /@>>, citing the /999 :0P( Resolution ConcerningProvisions on the Protection of :ellNno#n Marks, --- :0P( Recommendation Concerning Trademark Iicenses, and--/ :0P( Recommendation Concerning Provisions on the Protection of Marks and other 0ndustrial Property Rights in2igns on the 0nternet.;-0d.;/2upra note 9.;2ection . PurposeJ These Revised Rules and Regulations are hereby promulgated to ensure the provision of safe andade!uate nutrition for infants and young children by the promotion, protection and support of breastfeeding and byensuring the proper use of breastmilk substitutes, breastmilk supplements and related products #hen these are medically

indicated and only #hen necessary, on the basis of ade!uate information and through appropriate marketing anddistribution. )3nderscoring supplied*;>2ection &)ff*. Doung Child means a person from the age of more than t#elve )/* months up to the age of three )>*years )>% months*. )3nderscoring supplied*;;?.R. +o. /;;/8, , /989 by Proclamation +o. ;9&.;8>%;-, +ovember &, --&,;=% 2CR /%8, /9%A St. ukesFs !edical Center /%ployees Association* A:4 v.2ational a&or elations Co%%ission,?.R. +o. /%-&>, March =, --=A 1a&larin v. +utierre8, +.. 2o.I=8/%;, /, /98=, /& 2CR =>-, =;/A PollutionAd"udication Board v. Court of Appeals, ?.R. +o. 9>89/, March //, /99/, /9& 2CR //, />/;A ivera v. Ca%p&ell, EPhil. E3, EE*E ;$D$=G oren8o v. )irector of ealth, 6 Phil. D, DH ;$D#H=.;9s early as People v. Po%ar, ;% Phil. ;;-, ;;& )/9;*, #e already noted that advancing civili(ation is +ringingwithin the scope of police power of the state toda* things which were not thought of as +eing with in such power

*esterda*.The development of civili7ation, the rapidly increasing population, the gro#th of public opinion, #ith anincreasingG desire on the part of the masses and of the government to look after and care for the interests of theindividuals of the state, have brought #ithin the police po#er of the state many !uestions for regulation #hich formerly#ere not so considered.&-ct +o. =//, approved on March /-, /9/=.&/Nno#n then as Public 1ealth 2ervice
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16/18

&2ection /, Chapter 0, Title 0H, 65ecutive (rder +o. 9.&>0d. at 2ection >.&;26CT0(+ %. 1he +eneral Pu&lic and !othersK

)a* +o advertising, promotion or other marketing materials, #hether #ritten, audio or visual, for products #ithinthe scope of this Code shall be printed, published, distributed, e5hibited and broadcast unless such materials areduly authori7ed and approved by an interagency committee created herein pursuant to the applicable standardsprovided for in this Code.)b* Manufacturers and distributors shall not be permitted to give, directly or indirectly, samples and supplies ofproducts #ithin the scope of this Code or gifts of any sort to any member of the general public, includingmembers of their families, to hospitals and other health institutions, as #ell as to personnel #ithin the health care

system, save as other#ise provided in this Code.)c* There shall be no pointofsale advertising, giving of samples or any other promotion devices to induce salesdirectly to the consumers at the retail level, such as special displays, discount coupons, premiums, special sales,bonus and tiein sales for the products #ithin the scope of this Code. This provision shall not restrict theestablishment of pricing policies and practices intended to provide products at lo#er prices on a longterm basis.)d* Manufactures and distributors shall not distribute to pregnant #omen or mothers of infants any gifts or articlesor utensils #hich may promote the use of breastmilk substitutes or bottlefeeding, nor shall any other groups,institutions or individuals distribute such gifts, utensils or products to the general public and mothers.)e* Marketing personnel shall be prohibited from advertising or promoting in any other manner the productscovered by this Code, either directly or indirectly, to pregnant #omen or #ith mother of infants, e5cept asother#ise provided by this Code.)f* +othing herein contained shall prevent donations from manufacturers and distributors or products #ithin thescope of this Code upon re!uest by or #ith the approval of the Ministry of 1ealth.

26CT0(+ =

pharma v duque

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