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A collection of Philippine laws, statutes and codes
not included or cited in the main indices
of the Chan Robles Virtual Law Library.
 
This page features the full text of
Republic Act No. 8203
Special Law on Counterfeit Drugs.

 
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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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