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This page features the full text of
Republic
Act No. 8203
Special
Law on Counterfeit Drugs.
REPUBLIC
ACT No. 8203
AN
ACT PROHIBITING DRUGS, PROVIDING PENALTIES FOR VIOLATIONS AND
APPROPRIATING
FUNDS THEREFOR.
Section 1. Title. - This
act shall be known as the “Special
Law
on Counterfeit Drugs.”
Sec. 2. Declaration of Policy. - It is hereby
the policy of
the
State of protect and promote the right of the people and instill
health consciousness among them as provided in Sec. 15, Article II
of
the Constitution.
It
is also further declared the policy of the State that in order to
safeguard
the health of the people, the state shall provide for their protection
against counterfeit drugs.
Sec. 3. Definition of
Terms. - For the purpose of this
act, the terms:
(a)
Drugs shall refer to any chemical compound or biological
substance,
other than food, intended for use in the treatment, prevention of
diagnosis
of disease in man of animal, including but not limited to:
(1)
any article recognized in the official United States Pharmacopoeia -
National
Formulary (USP-NF), official Homeopathic Pharmacopoeia of the United
States,
Philippine National Drug Formulary, British Pharmacopoeia, any National
Compendium or any supplement to any of them;
(2)
any article intended for use in the diagnosis, cure, mitigation,
treatment,
(b) intended for use in the treatment of cure or mitigation of disease
symptoms, injury or bodily defect in man; (c) other than food,
intended
to affect the structure or any function of the body of man; (d) in
finished
or ready-to-use dosage form; and (e) intended for use as a
component
of any of the articles specified in clauses (a), (b), c), and (d).
(b) Counterfeit drug/medicine
refers to medicinal products
with
the correct ingredients but not in the amounts as provided
hereunder,
wrong ingredients, without active ingredients, with insufficient
quantity of active ingredient, which results in the reduction of the
drug’s
safety, efficacy, quality, strength or purity. It is a drug which
is deliberately and fraudulently mislabeled with respect to
identity
and/or source or with fake packaging, and can apply to both branded and
generic products. It shall also refer to:
(1)
the drug itself, or the container or labeling thereof or any part
of such drug, container or labeling bearing without authorization the
trademark,
trade name or other identification mark or imprint or any likeness to
that
which is owned or registered in the Bureau of Patent, Trademark
and
Technology Transfer (BPTTT) in the name of another natural or
juridical
person;
(2)
a drug product refilled in containers by unauthorized persons if
the legitimate labels or marks are used;
(3)
an unregistered imported drug product, except drugs brought in the
country
for personal use as confirmed and justified by accompanying
medical records; and
(4)
a drug which contains no amount of, or a different active
ingredient,
or less than eighty percent (80%) of the active ingredient it purports
to possess, as distinguished from an adulterated drug including
reduction
or loss of efficacy due to expiration.
(c)
Brokering shall refer to any act of facilitating the
disposal
or sale of counterfeit drugs, including acts of agency.
(d)
Bureau shall refer to the Bureau of Food and Drugs (BFAD) of the
Department of Health (DOH).
(e)
Department shall refer to the Department of Health.
(f)
Business Establishment shall refer to any entity, whether a single
proprietorship,
partnership or corporation engaged in, or doing business in the
Philippines.
(g)
Owner shall refer to a person or group of persons who is the registered
owner of a license of operate a business or business
undertaking
in the Philippines or the branch manager or operator, licensee,
franchisee,
or any person acting on behalf of the corporate entity.
(h)
Residence shall refer to a private dwelling or abode where a
person
lives, either as owner of lessee, or usufructuary including, for
purposes of this Act, its yard, garage, storage rooms or premises.
Sec. 4. Prohibited
Drugs. - The following acts are
declared
unlawful and therefore prohibited:
(a)
The manufacturer, sale, offering for sale, donation, distribution,
trafficking,
brokering, or importation or possession of counterfeit drugs as
defined
in Sec. 3 hereof not otherwise by Republic Act No. 3720, as
amended.
The presence or availability of such counterfeit drugs within the
premises of any entity engaged in the sale, manufacture of distribution
of drugs and/or pharmaceutical products or in a
private
residence, or in public vehicles, or in the premises not covered by a
valid
license to operate from the Bureau, shall constitute a prima facie
evidence of violation to this Act: Provided, however, That this
presumption shall not apply to the legitimate owners to trademarks,
trade
names or other identifying marks, or the legitimate or authorized
representatives or agents of such owners, who have in their
possession
counterfeit drugs which bear the trademarks, trade names or marks if
they
can show the sales invoices or official receipts evidencing their
purchase from a drugstore, manufacturer or distributor suspected
by them of dealing in counterfeit drugs involving the
trademarks, trade names and other similar identifying marks
registered
in their names: Provided, further, That such
counterfeit
products shall be reported and immediately turned over to the Bureau: Provided,
finally, That compliance with the preceding proviso
shall
be made within a reasonable period from the date of purchase of
such
counterfeit drugs as indicate in the sales invoice, official
receipt,
or other similar documents abovementioned to the time the counterfeit
drugs
are reported and turned over to the Bureau;
(b)
Possession of any such counterfeit drugs. However, any person
found
in possession of counterfeit drugs in violation of this subSec.
shall
be expected from liability under the provisions of this Act after:
(1)
presentation of sales invoices, official receipts, or other
legally
acceptable documents evidencing his purchase thereof from a
drugstore,
distributor, manufacturer, hospital pharmacy or dispensary; or
any
other person or place duly licensed to sell and/or dispense drugs or
medicines,
and indicating therein the batch and lot numbers, as well as the expiry
dates of such drugs; or
(2)
presentation of certificates and other documents evidencing the
importation
or exportation of the counterfeit drugs found in his possession
as
required by existing laws, including those documents
required
in the preceding paragraph covering the commercial transactions
involving
counterfeit drugs.
In
both cases, the subject counterfeit drugs must not on their face,
appear
to be as such, or do not bear any marking or any patently unusual
characteristics sufficient to arouse the suspicion of a reasonable and
prudent that such drugs are counterfeit. Furthermore, the amount
or volume of counterfeit drugs held is such that it does
not
negate or is inconsistent with the averment that the same are for
personal
use, notwithstanding the presentation by the possessor of medical
records and other similar documents accompanying and justifying
the
use of such drugs;
(c)
Forging, counterfeit, simulating or falsely representing, or without
proper
authority , using any mark, stamp, tag, label or other
identification
mark or device authorized or required by Republic Act No. 3720,
as
amended, and/or the regulations promulgated under this Act;
(d)
Photocopying, duplicating, alerting, printing, transferring,
obliterating
or removing the approved label or any part thereof, lawfully belonging
to another person, for the purpose of using such label or a part
thereof
on any counterfeit drug: Provided, That if the person who
committed any of the enumerated in this paragraph and the person
who used the labels produced thereby are not one and the same person
and
the former had knowledge of the purpose for which labels are intended,
the former shall also be liable under this Act notwithstanding the
failure
of the latter to achieve the intended purpose; and
(e)
Making, selling, or concealing any punch, plate or any other equipment
or instrument designed to print, imprint or reproduce the
trademark,
trade name or other identifying mark of another registered producer or
any likeness thereof, upon any drug product or device or its container
or label without authority from the legitimate owners of the trademark
or trade name.
Sec. 5. Parties Liable. -
The following persons shall be
liable
for violation(s) of this Act:
(a)
the manufacturer, exporter or importer of the counterfeit drugs and
their
agents: Provided, That the agents shall be liable only
upon
proof of actual or constructive knowledge that the drugs are
counterfeit;
(b)
the seller, distributor, trafficker, broker and their agents,
upon
proof of actual or constructive knowledge that the drugs sold,
distributed,
offered or donated are counterfeit drugs;
(c)
the possessor of counterfeit drugs as provided in Sec. 4
(b) hereof;
(d)
the manager, operator or lessee of the laboratory or laboratory
facilities
used in the manufacture of counterfeit drugs;
(e)
the owner, proprietor, administrator of the drugstore, hospital
pharmacy
or dispensary, laboratory or other outlets or premises where the
counterfeit drug is found who induces, causes or allows the
commission
of any act herein prohibited;
(f)
the registered pharmacist of the outlet where the counterfeit
drug
is sold or found who, sells or dispenses such drug to a third
party
and who has actual or constructive knowledge that said is counterfeit;
and
(g)
should the offense be committed by a juridical person, the president,
general
manager, the managing partner, chief operating officer or the person
who
directly induces, caused or knowingly allows the commission of the
offense
shall be penalized.
Sec. 6. Administrative
Proceedings. - The Bureau is hereby
further
authorized to undertake the following actions:
(a)
upon verified information on the existence of suspected counterfeit
drugs
in the possession of any manufacturer, seller or distributor, the
duly authorized officers of the Bureau or any officer deputized by the
Bureau for the purpose shall segregate, seal and, after
having
obtained a valid search warrant from a competent court, seize such
counterfeit
drugs and take them into custody: Provided, That in case
the
suspected counterfeit drugs are found in a private
residence,
as defined in Sec. 3 of this Act or in other premises not
covered
by a valid license to operate issued by the Bureau, the duly authorized
officer of the Bureau or deputized officer thereof shall secure a
search
warrant for the purpose or seizing an taking into custody such
suspected
counterfeit drugs;
(b)
if, after the appropriate examination of the samples by the Bureau, the
seized drugs are determined or found to be found to be
counterfeit,
the Bureau shall, within fifteen (15) days from their
seizure,
issue an order directing the preventive closure of the business
establishment
for a period not exceeding thirty (30) days. Thereafter,
administrative
proceedings shall be limited by the Bureau against the parties
concerned
where they shall have the opportunity to be heard present evidence on
the
behalf, and
(c)
to ensure the effective enforcement of the forgoing, the Bureau may
enlist
the assistance of the national or local law enforcement agencies.
Sec. 7. Administrative
Sanctions. - Upon finding
that
the drugs examined are counterfeit and the determination of the parties
liable thereof, the Bureau shall impose any or all of the following
sanctions:
(a)
permanent closure of the establishment concerned and the
revocation
of its license to do business;
(b)
a fine of not less than One hundred thousand pesos (P100,000) but
not more than Five hundred thousand pesos (P500,000);
(c)
upon order of the Court, forfeiture, confiscation, and
destruction
of products found to be counterfeit and the equipment, instruments, and
other articles used in violation of this Act;
(d)
filing of an appropriate proceedings against the registered
pharmacist
with the Professional Regulations Commission for cancellation of
professional
license;
(e)
filing of criminal charges against the violator(s), which can be
instituted
independently from the administrative case: Provided,
That
the dismissal of the criminal case not lift the closure order, except
when
it is a dismissal on the merits or for lack of basis: Provided
further, That the withdrawal of the private criminal
complaint shall not
be
a ground for the dismissal of the administrative proceedings; and
(f)
permanent disqualification of the person concerned, whether natural or
juridical, from owning or operating an established engaged in any
business
activity under the supervision of the Bureau.
Sec. 8. Penalties.
- The commission of any of the acts
prohibited
under Sec.s 4 and 6 of this Act shall be punished by:
(a)
imprisonment of not less than six (6) months and one (1) day, but not
more
than six (6) years for mere possession of counterfeit drugs as
provided
for in Sec. 4 (b) hereof; or
(b)
imprisonment of six (6) years and one (1) day, but not more than ten
(10)
years or a fine of not less than One hundred thousand pesos
(P100,000) but not more than Five hundred thousand pesos
(P500,000)
or both such imprisonment and fine at the discretion of the court in
any
other case mentioned in Sec. 4 hereof; or
(c)
imprisonment of not less than six (6) months and one (1) day, but not
more
than two (2) years and four (4) months if the counterfeit drug is
intended
for animals; or
(d)
imprisonment of not less than six (6) years and one (1) day, but not
more
than ten (10) years for any manufacturer, seller or distributor
who
shall conceal, substitute, dispose or destroy any drug as may
have
been segregated and sealed by the Bureau, or who shall break, alter or
tamper any mark or seal by the Bureau to identify those
segregated
drugs as provided for under Sec. 6 (a) of this Act. Any other
person who breaks, alters or tampers any mark or seal by the Bureau to
identify the segregated drugs shall suffer the penalty of not less than
six (6) months and one (1) day, but not more than six (6) years
imprisonment;
or
(e)
if, as a result of the use of the drugs found to be counterfeit, the
illness
sought to be cured is aggravated or physical injury or suffering
results therefrom, a punishment of imprisonment from twelve
(12) years to fifteen (15) years and a fine ranging from One hundred
thousand
pesos (P100,000) to Five hundred thousand pesos (P500,000) shall be
meted
out; or
(f)
should a counterfeit drug be the proximate cause of death of a
victim,
who unknowingly purchased and took a counterfeit drug, the
penalty
of life imprisonment and a fine of Five hundred thousand pesos
(P500,000)
to Five million pesos (P5,000,000) shall be imposed.
In
case any act prohibited in Sec. 4 thereof is also punishable under
other
laws, the offender shall, if warranted by the evidence, be prosecuted
under
the law prescribing the highest penalty.
Sec. 9. Appropriations. -
The amount necessary to carry out the
provisions
of this Act shall be included in the General Appropriations Act for the
year following its enactment and every year thereafter.
Sec. 10. Implementation. -
The Bureau of Food and Drugs
of
the Department of Health is hereby authorized to administer and
supervise
the implementation of this Act.
Sec. 11. Implementing
Rules and Regulations. - Within
ninety
(90) days from the approval of this Act, the Bureau of Food and Drugs,
in consultation of the Department of Health, shall promulgate the
rules and regulations implementing the provisions of this Act.
The
implementing rules and regulations issued pursuant to this Sec.
shall
take effect thirty (30) days after its publication in two (2)
national
newspapers of general circulation.
Sec.
12. Separability Clause. - If for any reason, any
portion
of provision of this Act is subsequently declared
unconstitutional
or invalid such declaration shall not nullify the other portions or
provisions
hereof.
Sec.
13. Repealing Clause. - All laws, executive or
administrative
orders, rules or regulations inconsistent with the provisions of
this Act are hereby repealed or modified accordingly.
Sec. 14. Effectivity.
- This Act shall take effect fifteen
(15)
days after its publication in at least two (2) national newspapers of
general
circulation.
Approved: September
09, 1996
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