DOH Admin Order No.2010-0013

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Republic of rhe Phil ippincs Department oI Heallh OF'FICE OF THE SECRETARY 12 r4ay 20I0 ADMINISTR.ATI\,8 ORDER No.2010 - /0/? SIIBJEC'I: RtrOUIRING GRAPHIC IIEALTII INFORMATION ON TOBACCO PRODUCT PACKAGES, ANOPTING IVIEASURES TO ENSURE THAT TOBACCO PRODUCT PACKAGING AND LABELLING DO NOT PROMOTE TOBACCO BY ANY MEANS TIAAT ARE FALSE. MISLEADING. DECEPTI\'E OR LIKELY TO CREATE AN ERRONEOUS IMPRESSION. AND MATTERS RNLATtrD TIIDRETO I. RATIONALE/BACKGROTINI) The right to health is one ol lhe lindamental rights enshrined in Afiicle ll of the Constitution. Section 15 stales that "the State shall prolect and promote the righl to health ofthe people and instilt health consoiousness among them." Likewise, under Repubiic Act No. 7394 or the ConsLrmer Protection Act, llilipinos have the tight to obtain accurate infornation as k) lhe naturc, qualily and quantity of the contents of consumer products, as well as the dghl lo be protccied lrom deceptive, unfair and unconscionable sales acts or practices. As a State-Party lo the International Covenant on Economic, Social and Cullural Rights, the Philippines recognized the right of everyone lo the enjoyment of the highesl attainable standard of physical and mental health. . The right to health in'cludes the right to health-teitted e.lucation and information. Access to information, including the right to seek, receive and impart information arrd ideas conceming health issues is considered an integral componellt of the right Lo health. There is unequivocal scientific evidence establishing lhat dealh, disease and disability result fiom tobacco consurnplion and exposurc to tobacco smoke. At present, thete are about 5 million deaths a year worldwide dircctly related to tobacco and WHO estimates this to double by 2020' if present trends continue unchecked. By then, 70% of mortaLity would be taking place in a.os r. rd,ao(o. o.J n/.v J1001 lturr 'e r'3 01 r l " ': .r {.oJ , r'l-30.. Pl ; ro' ro.nl ' dl 'L 4 o e '

description

DOH Administrative Order required graphic health information on tobacco product packages

Transcript of DOH Admin Order No.2010-0013

Page 1: DOH Admin Order No.2010-0013

Republic of rhe Phil ippincs

Department oI HeallhOF'FICE OF THE SECRETARY

12 r4ay 20I0

ADMINISTR.ATI\,8 ORDERNo.2010 - /0/?

SIIBJEC'I: RtrOUIRING GRAPHIC IIEALTII INFORMATION ON TOBACCOPRODUCT PACKAGES, ANOPTING IVIEASURES TO ENSURETHAT TOBACCO PRODUCT PACKAGING AND LABELLING DONOT PROMOTE TOBACCO BY ANY MEANS TIAAT ARE FALSE.MISLEADING. DECEPTI\'E OR LIKELY TO CREATE ANERRONEOUS IMPRESSION. AND MATTERS RNLATtrD TIIDRETO

I. RATIONALE/BACKGROTINI)

The right to health is one ol lhe lindamental rights enshrined in Afiicle ll of the Constitution.

Section 15 stales that "the State shall prolect and promote the righl to health ofthe people and

instilt health consoiousness among them." Likewise, under Repubiic Act No. 7394 or the

ConsLrmer Protection Act, llilipinos have the tight to obtain accurate infornation as k) lhe naturc,

qualily and quantity of the contents of consumer products, as well as the dghl lo be protccied

lrom deceptive, unfair and unconscionable sales acts or practices.

As a State-Party lo the International Covenant on Economic, Social and Cullural Rights, the

Philippines recognized the right of everyone lo the enjoyment of the highesl attainable standard

of physical and mental health. . The right to health in'cludes the right to health-teitted e.lucation

and information. Access to information, including the right to seek, receive and impart

information arrd ideas conceming health issues is considered an integral componellt of the right

Lo health.

There is unequivocal scientific evidence establishing lhat dealh, disease and disability result

fiom tobacco consurnplion and exposurc to tobacco smoke. At present, thete are about 5 million

deaths a year worldwide dircctly related to tobacco and WHO estimates this to double by 2020'

if present trends continue unchecked. By then, 70% of mortaLity would be taking place in

a.os r. rd,ao(o. o.J n/.v J1001 lturr 'e r'3 01 r l " ':.r {.oJ , r'l-30.. Pl ; ro' ro.nl ' dl 'L 4 o e '

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developing counfties. In the Philippines, 240 Filipinos die cveryday or over 87,000 a year ltomwhat is clearly a preventable disease. Tobacco products contain toxic compounds and over fonycarcinoggns, including carbon monoxide, arsenic, benzene, butane, lormaldchyde, lead, toluene,

and nicotine, among others. Nicotine, a by-ploduct uniqLre only to tobacco, is tltc substance thateventually leads the smoker to addiction.

Recogrizing the magnitude of the lobacco €pidemic. the Philippines. along wrth other States,

signed the Framework Convention on Tobacoo Control (FCTC) - the only public health treaty

initiated by the World Health Organization (WHO), The FCIC requires State parties to adopt a

comprehensive range ol measures designed to reduce the devaslating health ard economic

impacts oftobacco.

On 4 September 2005, follou'ing its ratitication through the conou(ence of twolhirds of the

Philippine Senate in accordance with the Constitution, the FCTC was lransformed into municipallaw. As such, the FCTC became legally binding upon state organs.

As a State Party to thc FCTC, the Phiiippines is duly-bound 10 comply with FCTC provisions in

good lbith, in observance of the principle of pacta sullt serJan.la, srch tha1, the failure of the

Philippines to perform its treaty obligations unde. the FCTC constitutes an intemationally

$'rongflrl act under the doctrine of state rcsponsibility, a norln of EeDeral international law lhatevery internatjonally wrongful act of a Siate entails lnternational lcsponsibility ofthat State.

Articlc I I ofthe FCTCI provides that Parties shall, within three years after cntry into fbrce oflhctreaty, adopt, and implement eflective measures lo ensure that €ach unit packet and package oftobacco products and any outside packaging and labelling of such products (i) catay rolatirrg

health warnings that shall, among othets, cover 500/n or mote but no less than 30u% of the

principal display area, placed in the principal janguage or languuges and may be in the lorm ofpictures or pictograms, and approved by the competent national authority: and (ii) do not

promolg tobacco products by means that are false, misleading, deceptive or likely to create an

erroneous imprcssioll abollt its characteristics, health efl'ects, hazards, or emissions. The

inclusion of a speoific timelrame of three years in Afiicle li underscores the mandatory ahd

prescriptive nature, as well as the exigency. of the Philippines' obligation to adopt ond

implement effective measures in compliance with said provision.

Article 5.2 of the ICTC mandates Pa ies to adopt and implement not just effective legislative,

but also executive, administrative and/or other measll.es in developing appropriate policies lbr

preventing and reducing tobacco consumption, nicotine addiction and cxposure to tobacco

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Under the Constitution and the Administrative Code of 1987, the Depaftnenl of lleallll(Department) is the compctent national authority mandated to ensure the propagation of heahhinformation. In its disoussion ofthe Department's power to regulale pdvate indusfies in the area

of health information, the Supreme Court held that "lh]ealth is a legitimdte subject matter forregulation by the DOll (and certain otber adminislrative agencics) in exercisc of police powers

delegated to it. The sheer span ofjurisprudence on that matter precludes the need to further

discuss it." The Supreme Cou , in its examination of the naturc, puqose, and depth of the

regulatory powers ef the Department, cited the Administrative Codc, which tasked the

Department to carry oul the state policy pronounced under Section 15, Afiicle II olthe 1987

Constitution, which is "to protect and promote the right to health olthe people and instill heallh

oonsciousness among them." To this end, the Department was "granted under Section 3 of tlreAdmhistrative Code the porver to propagate health information and educate the poplllation or1

important health, medical and environmental matters which have heallh implications."

The Department is likewise mandated, under the Consumer Protection Act, to protect the

interests of the consumgr, promote his general welfare, and establish standards of conduct forbusiness and industry. To this end, the Department has the duty to implcment measures that

ensure the provision of inlormation necessary for the protection of public health alld the

protection of consumers against deceptive pmcticas.

Evidcnce shows that health infonnation with picturos communioates health risks better especially

to children and young people as well as the illitsrate, and inctease the motivation ol lobacco

users to quit and to decrcase their tobacco consumltion.

Pursuant 10 DepartmeDt Order 2009-01 16, th€ Depaftment may promulgale an Administrative

Order (Ordcr) lhat prescdbes policies, tules and regulations, and procedtrres in accordance with

or pursuant to la\4, 10 supplemenf plovisions ol the law or provides means lol carlying thenl out,

and is primarily applicable to individuals and organizations ouiside the Department.

Through this Order, tlre Philippines, through the l)epartment, is laking a definitive step towards

complying with its binding inlernational obligations under the FC'fC

Through this Ordet thc Depaftment underscorcs the Primacy of public health and al'firms its

primary function to pl omote, prolect, preserve, and restore the heahh olthe people

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. OBJtrCTI\'ES

It is the policy ofthe State to promote the right ro bealth ofall the people and instill healthconscior.isness among them. TIle State affirms this as one of the fimdarnental rights of a humanbeihg. Towards this end, the State shall implement effective measures to achieye the followingobjcctives:

a. irovide necessary information abou! the health consequences, addictivenature, and mortal threat posed by tobacco consumption and exposure totobacco smoke through measurcs that aLe scientifioally pfoven to be elfectivein iroreasing public awareness of the hgalth eflects of tobacco use and inreducinS tobacco consumption;

b. Protect consumers from deceptjve labels, packaging, descriptions andprdclices related to tobacco use;

c. lmplement measures to prohibit means that are lalse, misleading, deceptive orlikely (o creatc an erroneous impression about $e characteristics of tobaoco,

its heahh effects, hazards or emissions, so as to promote tobacco producls inlohacco product pilckages.

To achieve these objeolivcs, the Depattmcnt shall ensure that effective, distincf, and highly

visible graphic health information is placed on tobacco product packages.

MoLeovcr, the DepaftmeDt shall ensute that tobacco product packaging and labelling do nol

promole a tobacco product by any mcans that are false, mislcading, deceptive, or likely to create

an erroneous impression abont the product and its characteristics, health effects, hazards ot

enrissions.

IN. SCOPE AND COVERAGE

lhese policies and guidelines shall apply to all tobacco products and to all tobacco

manufacture$, importers, exporters, wholesalers, distributors, retailers, concessionaires, and

other sellers oftobacco products, as well as thejr'agents and representatives, which are operating,

existing, and/or found rvithin the Republio ofthe Philippincs,

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tv. DEFINITION OF ]'ERMS

"Gtttphlc Health Infomatio " means statements, and/or other information,accompanied by related fuli-color pictures or pictograms, which inform about thecontenls and subst4nces, in descriptive form, of tobacco products as rvell as informagainst health dangers and other problems lelated to tobacco producls, tobaccoconsumption, exposure to lobacco smoke, or other effects oftobacco use,

"Tobacco Proaluct Pocrtdge" means the packet and package oftobacco products and anyoutside packagiDg and labelliDg of tobacco prodlrcts for sale, distribution, exportation,importation, tmde, exchange, or exhibition, srch as, but not limited to, packs, tins, boxes,pouches, flip.lops, slide and shcll packages, cadons, transparclt wrappers: clcarpackaging, packages containing one product unit, master cases, ot olher containels oF

tobacco products.

c,

b.

"Tabucco Ptoducts" means prodLlcts entitely or pafily made of leaf tobacco as tawhaterial, lvhich are nanufhctured to be used for smoking, sucking, chewing or snulting,or by an1 other means ofconsLllnption.

d. "Irr.sel" means any communication inside an individual packagc and/or carton purchased

at ejther lvholesale or retajl by consumcrs, such as a leaflet or broohure.

e. "Onse " means any commLrnication affixed to the outside of an individual packag€

and/or carton prrchased at either wlrolesale or rctail by consumers, such as a brochure

benealh the outer cellophane wrapping or glued to the olLtside ofthe cigarette package.

v. ipncrnc pnovrsloNs

The Departmeht hereby promulgates the fbllowing rules and regulations govcrning packaging

and labelling of tobacco products:

A. Gyaphic Health Irfotmation

1. Scope of Graphic llealth Infoftdtioh. - Each unit packet and package of tobacco

products, ilrcluding paokage insefts and onserls, and any outside packaging and

labellilg of such products for sale, distribulion or importation wifiin the country,

shall bear large, clear, visible, and legible full color graphic heallh information, :ls

attached in ,4nhex l.

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2.

3.

5.

6.

Size oni Posltion qfG tphic Hednh lttfotmfltion. -1he gtaphic health infonrationshall occupy the upper portions oi each tobacco product packet or package and nolgss than thidy perceni (30olo) of the front pane! and sixty peroent (600lo) of the backpanel (or all coresponding panels of the unit packet or package if in non-standard

packaging) in a manner that ensures maxirnum visibility.

nohtioa. - lhere shall be a minimum of eight (8) variations of graphic health

information that shall appear concurrently within a twenty four (24) month period.

The variations shall appear on an equal number of l etaiL tob.Lcco product packages loreach brand and tbr each paokage sizc and t5,pe.

4, Transilioas. - During transition periods, when an old sct of graphic health

iuformation is being replaced by a new set, there shall be a phase-in pe(iod of sixty(60) days between sets of graphic health information, during which time both sets

may be used concurrently.

Tehpldes. - The templates of graphic health intbrmation, which conlain specilic

printing and othet requircmenls, shall be issucd by the Department on its own, or

upon consultation with organizations with established track record of, and expertise in

public health policies and duly recognized by the Depaltment as such. The

template(s) shalL be approved by the Secretary within thi(y (30) days lrom itssubmission and shall be deemcd automatically apprcved ifnol acted upon thereafter.

These templates shall be issued by the Depadment e!eD, two (2) years ot as the need

for it a ses.

Slrict A.lhercttce. - The tobacco manufaclurers, imponers. exporters, wholcsalers.

clistributors, retailers, concessionaires, and other sellers, sball sfictly lbllow lhe

templates and shall submit theil packagings and iabclings for approval to the

Department no later than three (3) months bcfore they are to be used- The Department

shall act on the packaging and labeling of the unit packet and package of tobacco

prodlLcts within thjriy (30) days from its submission and shall be deemed

automatically approved if not acted upon thercalier.

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B. Misleading Descriptors

l. Genelal Prohibitior. - Each unit packel and package of tobacco prodncts, including' package inserts and onsefis, and any outside packagirg and labelling ofsuch products

for sale, distribution or importation wilhin the country shall not promote a lobacco

product by any means that are false, misleading, deceptive or likety to create an

erron€ous imp.ession about the product's characteristics, health effects, hazards or. emissior,s, including any term, descriptor, tradenark, figurative or any olher sign

(including colors, imagcs, or nunhers) or any package or product design t'eature that

directLy or indirectLy create or are liksly to create the false inpression that a particular

iobacco product or brand is less hamlt'll thall any otLler tobacco prodrlct or brand.

Usc of nrisleading descriptors on tobacoo produot packages such as, but not iirnited

to, "low tar", "light", "ultra-1ight," 'l11ild," "extra," "ullm," and similar terms in any

language that might mislead consumers, is prohibited. Use olcorresponding synbols

ol colors sigrifying the same is also pmhibitcd. No misleadirlg descriptor shall be

used as part of a brand name ot rmdemark for tobacco products introduced afler the

efl'ectivity of this Order-

Z. Prohibition o Mislea.ling Infomation. - Irfomation that may imply that one

variant or brand is safer than the other is prollibited, such as statements indicating that

the tobacco product contains "leduced levels" ofcontenls, substances, and cm;ssirnrs.

Figures lor emission yi€lds, such as for tar, nicotine end carbon monoxide, shall be

prohibited, including when used Bs part ofa brand name or trademark

VI. COMMON PROVISIONS

L Compliance. - Tobacco prodrrcL facluges tl\at do not comply lvitb this Order shall be

frohibited after ninety (90 days) ftom the elfectivity o[ t]ris Order' Non-compliant

products must be withdrawn no later than such date Absolutely no extcnsions of time to

cornply with the provisions oftlris Order slrall be gEnted to tobacco manufactuters or any

other aflected parly.

Imported tobacco products mealt to be sold in the Philippines, even ifthey are iD product

packages thal carry graphic health infolnration compliant \!ith the country ofo gin shall

comply with this Order within thirty (30) days from lhis order's effectivity-

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2. DutJ) Not to SelyDispla! Non-cohplianl Prcducts, - Manufacturers, importers,exporters, wholesalers, distlibrLtor.s, retaiiers, concessionaires and other sellers shall notsgli and,/or display iobacco products that do not comply with this Order.

1. Bunleh of Costs oh Tobacco Companier, - All costs relative to the packaging andlabelling of tobacco products shall be borne by the respective tobacco manufacturers,importers, and/or exporters responsible forpackaging and labelliog ofthe products.

4. Monltoting Te.rns. - Therc shall be Monitoring Teams at the national, rcgional,provincial, city, municipal, and barangay levels (in coordinatiou with respective LocalGovernhent Uoits), as well as in civil society, to ensure compliance with, andimplementation of, this Ordcr.

Monitoring Tdams shall be coftposed oi

a, National Level:

i, National Center for Healih Promolion (NCllP)ii. Non-Govemment Organizations (NGOS) as deputized by thc Department.

iii, Any other office/agency designated by the Departrnent.

b, Ilegional/Provincial/City/Municipal/Barangay Level:

i. Centers for Health Developmcnt (CllDs)ii. Provincial Health OfTlces

iii. City l{ealfi Offices

iv. Municipal Health Offices/ Rural llealth Unitsv. Bamngay Health Oflicesvi, NGOS as deputized by the Department

vii. Any other office/agency designated by the Departmcnt.

5. Moniloring Teqmt; Fanclions ond Resaonsibililies, - Monitoring teams shall have the

following responsibilities:

a. Monitor compliance with, as $'ell as problems encountered in, the implementation

ofthis Order and submit timely reports thereon;

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b. Monitor labels and packages of tobacco products within thc scope of the Order

and marketing practices in various disiribution centeN and points of sale

estoblishments;

c. V€rify repons ofviolations of this ordcr;

d. Submit tinely repofts on their monitoring ard verification and follow-up on the

actions and/or resolutions rvith the concerned olllce/agency; and

e. Such other hlnctions and responsibilities .!s may be assigned by the Depafment.

6. Conlents of Wolation -Repolrs. - Rcports of alleged violafions shall include: (i) the

specific location where the violation was fbltnd and lhc corresponding daie; (ii) a pictlLre

or sarnple of the violative label or pacleging; (iii) as mllch as possible, a picture of ihe

violativo product as displaycd in the point ol sale/distribution outlet; and (iv) such other

information as the Departmcnt may later require. Monitoring Teams shall keep proper

documentation ofall repoft€d violations, which documentation may be made availahie lothe publ;c.

Coopelation/Cootdhtotion vith Otganizntions. - 'fhe Department and officialMonitorins Teans may engage olher civiL society organizations, individuals, and otlrer

agenqies, to closely monitor impLementatioD of and oompliance with this ordet ilr their

respective areas of jurisdiction, and submit timely reports to the l)epartment or the

monitoring teams ofany alleged violation.

Pubtic Vigilance. -The l)epaflment, lnoniloring teams, other ageDcies, and stakeholders,

shall encourage the public to report what they deem to be violations under this order.

lyherc to Repofi, -lileports olviolations shall be submitled to rhe Olfice oltLre Secretaly,

or any othel offioe/agency designated by tlle Secretary, at the nalional level, and io ihc

CHDS at the local level. The concemcd olfice/agency shall provide immediate feedback

within five (5) working days on actions talien based on the receivcd reports of alleged

violations.

7.

8

9.

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\1I. VIOLATIONF

The Department, or any office desiguated by the Seqetart' of Health, shall investigale any

rcported violations of this Order, and affer due notice and hearing, if found responsible thereof,

apply such adminisualive sanctiorls and penaltiss, including scizure, recall and condemnation,

wh€re approp ate, on the concerned nranufacturers, importeN, expo ers, wholesalers,

distributors, retajlers, co$cessioDaires, selle!s, or other concemed iudivjduals/cntities,

VXI. , SEPARABILITY CLAUSE

If, for any rcason: any section or provision of this Order is declared iuvalid, illegal orrmconstitutional, such invalidity or uncoDstitutionality shall not aff€ct the other provisioDs ofthisOrder, which shall remain in full force and effect.

IX. REPDALING CLAUStr

The provisions of other existing provisions or issuances found inconsisteut or contrary with thisOrder are hereby repealed or modifieil accordingly.

X. EFFECTIVITY

This Order shalLtake elfect fifteen (15) days follo1!-irg the date ofits pLrblication in a newspcper

of general oiroulalion,

BldB. I, San Lddo Co,npound, Rial Avctru., Sla CnE, Ma ila 1003'Trunklin€ (632) 7438301 lomls 1125, I ll2Tclefax (612) ?43 I ?86 ' URL: wv,Ejoh49!.d . E-n,ail inlo(ldoh ei'v.pl,

RANZA I. CABRAL, MD