REQUIRING GRAPHIC HEALTH INFORMATION ON TOBACCO PRODUCT PACKAGES, ADOPTING MEASURES TO ENSURE THAT TOBACCO PRODUCT PACKAGING AND LABELLING DO NOT PROMOTE TOBACCO BY ANY MEANS TH…

I. RATIONALE/BACKGROUND

The right to health is one of the fundamental rights enshrined in
Article II of the Constitution. Section 15 states that “the State shall
protect and promote the right to health of the people and instill health
consciousness among them.” Likewise, under Republic Act No. 7394 or the
Consumer Protection Act, Filipinos have the right to obtain accurate
information as to the nature, quality and quantity of the contents of
consumer products, as well as the right to be protected from deceptive,
unfair and unconscionable sales acts or practices.

As a State-Party to the International Covenant on Economic, Social
and Cultural Rights, the Philippines recognized the right of everyone to
the enjoyment of the highest attainable standard of physical and mental
health. The right to health includes the right to health-related
education and information. Access to information, including the right to
seek, receive and impart information and ideas concerning health issues
is considered an integral component of the right to health.

There is unequivocal scientific evidence establishing that death,
disease and disability result from tobacco consumption and exposure to
tobacco smoke. At present, there are about 5 million deaths a year
worldwide directly 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 developing countries. In the Philippines, 240
Filipinos die everyday or over 87,000 a year from what is clearly a
preventable disease. Tobacco products contain toxic compounds and over
forty carcinogens, including carbon monoxide, arsenic, benzene, butane,
formaldehyde, lead, toluene, and nicotine, among others. Nicotine, a
by-product unique only to tobacco, is the substance that eventually
leads the smoker to addiction.

Recognizing the magnitude of the tobacco epidemic, the Philippines,
along with other States, signed the Framework Convention on Tobacco
Control (FCTC) – the only public health treaty initiated by the World
Health Organization (WHO). The FCTC requires State parties to adopt a
comprehensive range of measures designed to reduce the devastating
health and economic impacts of tobacco.

On 4 September 2005, following its ratification through the
concurrence of two-thirds of the Philippine Senate in accordance with
the Constitution, the FCTC was transformed into municipal law. As such,
the FCTC became legally binding upon state organs.

As a State Party to the FCTC, the Philippines is duty-bound to comply
with FCTC provisions in good faith, in observance of the principle of
pacta sunt servanda, such that, the failure of the Philippines to
perform its treaty obligations under the FCTC constitutes an
internationally wrongful act under the doctrine of state responsibility,
a norm of general international law that every internationally wrongful
act of a State entails international responsibility of that State.

Article 11 of the FCTC provides that Parties shall, within three
years after entry into force of the treaty, adopt, and implement
effective measures to ensure that each unit packet and package of
tobacco products and any outside packaging and labelling of such
products (i) carry rotating health warnings that shall, among others,
cover 50% or more but no less than 30% of the principal display area,
placed in the principal language or languages and may be in the form of
pictures or pictograms, and approved by the competent national
authority; and (ii) do not promote tobacco products by means that are
false, misleading, deceptive or likely to create an erroneous impression
about its characteristics, health effects, hazards, or emissions. The
inclusion of a specific timeframe of three years in Article 11
underscores the mandatory and prescriptive nature, as well as the
exigency, of the Philippines’ obligation to adopt and implement
effective measures in compliance with said provision.

Article 5.2 of the FCTC mandates Parties to adopt and implement not
just effective legislative, but also executive, administrative and/or
other measures in developing appropriate policies for preventing and
reducing tobacco consumption, nicotine addiction and exposure to tobacco
smoke.

Under the Constitution and the Administrative Code of 1987, the
Department of Health (Department) is the competent national authority
mandated to ensure the propagation of health information. In its
discussion of the Department’s power to regulate private industries in
the area of health information, the Supreme Court held that “[h]ealth is
a legitimate subject matter for regulation by the DOH (and certain
other administrative agencies) in exercise of police powers delegated to
it. The sheer span of jurisprudence on that matter precludes the need
to further discuss it.” The Supreme Court, in its examination of the
nature, purpose, and depth of the regulatory powers of the Department,
cited the Administrative Code, which tasked the Department to carry out
the state policy pronounced under Section 15, Article II of the 1987
Constitution, which is “to protect and promote the right to health of
the people and instill health consciousness among them.” To this end,
the Department was “granted under Section 3 of the Administrative Code
the power to propagate health information and educate the population on
important health, medical and environmental matters which have health
implications.”

The Department is likewise mandated, under the Consumer Protection
Act, to protect the interests of the consumer, promote his general
welfare, and establish standards of conduct for business and industry.
To this end, the Department has the duty to implement measures that
ensure the provision of information necessary for the protection of
public health and the protection of consumers against deceptive
practices.

Evidence shows that health information with pictures communicates
health risks better especially to children and young people as well as
the illiterate, and increase the motivation of tobacco users to quit and
to decrease their tobacco consumption.

Pursuant to Department Order 2009-0116, the Department may promulgate an
Administrative Order (Order) that prescribes policies, rules and
regulations, and procedures in accordance with or pursuant to law to
supplement provisions of the law or provides means for carrying them
out, and is primarily applicable to individuals and organizations
outside the Department.

Through this Order, the Philippines, through the Department, is
taking a definitive step towards complying with its binding
international obligations under the FCTC.

Through this Order, the Department underscores the primacy of public
health and affirms its primary function to promote, protect, preserve,
and restore the health of the people.

II. OBJECTIVES

It is the policy of the State to promote the right to health of all
the people and instill health consciousness among them. The State
affirms this as one of the fundamental rights of a human being. Towards
this end, the State shall implement effective measures to achieve the
following objectives:

a. Provide necessary information about the health consequences,
addictive nature, and mortal threat posed by tobacco consumption and
exposure to tobacco smoke through measures that are scientifically
proven to be effective in increasing public awareness of the health
effects of tobacco use and in reducing tobacco consumption;

b. Protect consumers from deceptive labels, packaging, descriptions
and practices related to tobacco use;

c. Implement measures to prohibit means that are false, misleading,
deceptive or likely to create an erroneous impression about the
characteristics of tobacco, its health effects, hazards or emissions, so
as to promote tobacco products in tobacco product packages.

To achieve these objectives, the Department shall ensure that
effective, distinct, and highly visible graphic health information is
placed on tobacco product packages.

Moreover, the Department shall ensure that tobacco product packaging
and labelling do not promote a tobacco product by any means that are
false, misleading, deceptive, or likely to create an erroneous
impression about the product and its characteristics, health effects,
hazards or emissions.

III. SCOPE AND COVERAGE

These policies and guidelines shall apply to all tobacco products and
to all tobacco manufacturers, importers, exporters, wholesalers,
distributors, retailers, concessionaires, and other sellers of tobacco
products, as well as their agents and representatives, which are
operating, existing, and/or found within the Republic of the
Philippines.

IV. DEFINITION OF TERMS

a. “Graphic Health Information” means statements, and/or
other information, accompanied by related full-color pictures or
pictograms, which inform about the contents and substances, in
descriptive form, of tobacco products as well as inform against health
dangers and other problems related to tobacco products, tobacco
consumption, exposure to tobacco smoke, or other effects of tobacco use.

b. “Tobacco Product Package” means the packet and package of
tobacco products and any outside packaging and labelling of tobacco
products for sale, distribution, exportation, importation, trade,
exchange, or exhibition, such as, but not limited to, packs, tins,
boxes, pouches, flip-tops, slide and shell packages, cartons,
transparent wrappers, clear packaging, packages containing one product
unit, master cases, or other containers of tobacco products.

c. “Tobacco Products” means products entirely or partly made
of leaf tobacco as raw material, which are manufactured to be used for
smoking, sucking, chewing or snuffing, or by any other means of
consumption.

d. “Insert” means any communication inside an individual
package and/or carton purchased at either wholesale or retail by
consumers, such as a leaflet or brochure.

e. “Onsert” means any communication affixed to the outside
of an individual package and/or carton purchased at either wholesale or
retail by consumers, such as a brochure beneath the outer cellophane
wrapping or glued to the outside of the cigarette package.

V. SPECIFIC PROVISIONS

The Department hereby promulgates the following rules and regulations
governing packaging and labelling of tobacco products:

A. Graphic Health Information

1. Scope of Graphic Health Information. – Each unit packet
and package of tobacco products, including package inserts and onserts,
and any outside packaging and labelling of such products for sale,
distribution or importation within the country, shall bear large, clear,
visible, and legible full-color graphic health information, as attached
in Annex 1^*.

2. Size and Position of Graphic Health Information. – The
graphic health information shall occupy the upper portions of each
tobacco product packet or package and no less than thirty percent (30%)
of the front panel and sixty percent (60%) of the back panel (or all
corresponding panels of the unit packet or package if in non-standard
packaging) in a manner that ensures maximum visibility.

3. Rotation. – There 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 retail tobacco product packages for
each brand and for each package size and type.

4. Transitions. – During transition periods, when an old set
of graphic health information is being replaced by a new set, there
shall be a phase-in period of sixty (60) days between sets of graphic
health information, during which time both sets may be used
concurrently.

5. Templates. – The templates of graphic health information,
which contain specific printing and other requirements, shall be issued
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 Department as such. The template(s)
shall be approved by the Secretary within thirty (30) days from its
submission and shall be deemed automatically approved if not acted upon
thereafter.

These templates shall be issued by the Department every two (2) years
or as the need for it arises.

6. Strict Adherence. – The tobacco manufacturers, importers,
exporters, wholesalers, distributors, retailers, concessionaires, and
other sellers, shall strictly follow the templates and shall submit
their packagings and labellings for approval to the Department no later
than three (3) months before they are to be used. The Department shall
act on the packaging and labeling of the unit packet and package of
tobacco products within thirty (30) days from its submission and shall
be deemed automatically approved if not acted upon thereafter.

B. Misleading Descriptors

1. General Prohibition. – Each unit of packet and package of
tobacco products, including package inserts and onserts, and any
outside packaging and labelling of such products for sale, distribution
or importation within the country shall not promote a tobacco product
by any means that are false, misleading, deceptive or likely to create
an erroneous impression about the product’s characteristics, health
effects, hazards or emissions, including any term, descriptor,
trademark, figurative or any other sign (including colors, images, or
numbers) or any package or product design feature that directly or
indirectly create or are likely to create the false impression that a
particular tobacco product or brand is less harmful than any other
tobacco product or brand.

Use of misleading descriptors on tobacco product packages such as,
but not limited to, “low tar”, “light”, “ultra-light”, “mild”, “extra”,
“ultra”, and similar terms in any language that might mislead consumers,
is prohibited. Use of corresponding symbols or colors signifying the
same is also prohibited. No misleading descriptor shall be used as part
of a brand name or trademark for tobacco products introduced after the
effectivity of this Order.

2. Prohibition on Misleading Information. – Information that
may imply that one variant or brand is safer that the other is
prohibited, such as statements indicating that the tobacco product
contains “reduced levels” of contents, substances, and emissions.
Figures for emission yields, such as for tar, nicotine and carbon
monoxide, shall be prohibited, including when used as part of a brand
name or trademark.

VI. COMMON PROVISIONS

1. Compliance. – Tobacco product packages that do not comply
with this Order shall be prohibited after ninety (90) days from the
effectivity of this Order. Non-compliant products must be withdrawn no
later than such date. Absolutely no extensions of time to comply with
the provisions of this Order shall be granted to tobacco manufacturers
or any other affected party.

Imported tobacco products meant to be sold in the Philippines, even
if they are in product packages that carry graphic health information
compliant with the country of origin shall comply with this Order within
thirty (30) days from this Order’s effectivity.

2. Duty Not to Sell/Display Non-Compliant Products. –
Manufacturers, importers, exporters, wholesalers, distributors,
retailers, concessionaires and other sellers shall not sell and/or
display tobacco products that do not comply with this Order.

3. Burden of Costs on Tobacco Companies. – All costs
relative to the packaging and labelling of tobacco products shall be
borne by the respective tobacco manufacturers, importers, and/or
exporters responsible for packaging and labelling of the products.

4. Monitoring Teams. – There shall be Monitoring Teams at
the national, regional, provincial, city, municipal, and barangay
levels (in coordination with respective Local Government Units), as
well as in civil society, to ensure compliance with, and implementation
of, this Order.

Monitoring Teams shall be composed of:

a. National Level:

i. National Center for Health Promotion (NCHP)
ii. Non-Government Organizations (NGOs) as deputized by the
Department
iii. Any other office/agency designated by the Department

b. Regional/Provincial/City/Municipal/Barangay Level:

i. Centers for Health Development (CHDs)
ii. Provincial Health Offices iii. City Health Offices
iv. Municipal Health Offices/Rural Health Units v. Barangay Health
Offices
vi. NGOs as deputized by the Department
vii. Any other office/agency designated by the Department

5. Monitoring Teams; Functions and Responsibilities. –
Monitoring teams shall have the following responsibilities:

a. Monitor compliance with, as well as problems encountered in, the
implementation of this Order and submit timely reports thereon;
b. Monitor labels and packages of tobacco products within the scope
of the Order and marketing practices in various distribution centers and
points of sale establishments;
c. Verify reports of violations of this Order;
d. Submit timely reports on their monitoring and verification and
follow-up on the actions and/or resolutions with the concerned
office/agency; and
e. Such other functions and responsibilities as may be assigned by
the Department.

6. Contents of Violation Reports. – Reports of alleged
violations shall include: (i) the specific location where the violation
was found and the corresponding date; (ii) a picture or sample of the
violative label or packaging; (iii) as much as possible, a picture of
the violative product as displayed in the point of sale/distribution
outlet; and (iv) such other information as the Department may later
require. Monitoring Teams shall keep proper documentation of all
reported violations, which documentation may be made available to the
public.

7. Cooperation/Coordination with Organizations. – The
Department and Official Monitoring Teams may engage other civil society
organizations, individuals, and other agencies, to closely monitor
implementation of and compliance with this Order in their respective
areas of jurisdiction, and submit timely reports to the Department or
the monitoring teams of any alleged violation.

8. Public Vigilance. – The Department, monitoring teams,
other agencies, and stakeholders, shall encourage the public to report
what they deem to be violations under this order.

9. Where to Report. – Reports of violations shall be
submitted to the Office of the Secretary, or any other office/agency
designated by the Secretary, at the national level, and to the CHDs at
the local level. The concerned office/agency shall provide immediate
feedback within five (5) working days on actions taken based on the
received reports of alleged violations.

VII. VIOLATIONS

The Department, or any office designated by the Secretary of Health,
shall investigate any reported violations of this Order, and after due
notice and hearing, if found responsible thereof, apply such
administrative sanctions and penalties, including seizure, recall and
condemnation, where appropriate, on the concerned manufacturers,
importers, exporters, wholesalers, distributors, retailers,
concessionaires, sellers, or other concerned individuals/entities.

VIII. SEPARABILITY CLAUSE

If, for any reason, any section or provision of this Order is
declared invalid, illegal or unconstitutional, such invalidity or
unconstitutionality shall not affect the other provisions of this Order,
which shall remain in full force and effect.

IX. REPEALING CLAUSE

The provisions of other existing provisions or issuances found
inconsistent or contrary with this Order are hereby repealed or modified
accordingly.

X. EFFECTIVITY

This Order shall take effect fifteen (15) days following the date of
its publication in a newspaper of general circulation.

Adopted: 12 May 2010

(SGD.) ESPERANZA I. CABRAL, MD
Secretary of Health