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of Philippine laws, statutes and codes
REPUBLIC ACT No. 8203
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:
(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).
(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
a drug which contains no amount of, or a different active
or less than eighty percent (80%) of the active ingredient it purports
to possess, as distinguished from an adulterated drug including
or loss of efficacy due to expiration.
(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:
(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:
(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.
(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:
(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:
(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:
(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:
(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
(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.
implementing rules and regulations issued pursuant to this Sec.
take effect thirty (30) days after its publication in two (2)
newspapers of general circulation.
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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