Special Law on Counterfeit Drugs (Republic Act No. 8203)

S. No. 1284 H. No. 5666 SEC. 3. Definilion ofTenr,s. - For purposes ofthis Acl. the terms: �epuhfu of t�e lJJrilippine1 a) Drugs shall refer to any chemical compound or biological <1Iongms of t4e Jlplippines substance, other than food, intended for use in the treatment, pre.,ention or diagnosis of dise...se in man or animais, including but not limited to: �rtro�nila 1) any article recognized in the official United Statcs Pharmacopoeia-National Formulary (USP-NF), official �econb l\cgular &euion Homeopathic Pharmacopoeia ofthe United States, Philippine National Drug Formula�·. British Pharmacopoeia. any National Compendium or any supplement to any of thcm: - egun and h�ld in l\1e1ro Manila. on Mon ay, lhe lwent . (. ii · _ � y-second day of July, runelcen hundrcd and mnet y-SL\. 2) any article intended for use in the diagnosis. cure. mitigation, trcatment. or prcvention of disease in man or animais: 3) any article olher than food intended to alTcct lhe [ REPUeuc AcT No. 8203 ] structure or any function of the body of man or animais: 4) any articlc intcndcd for use as a component of any AN ACT PROHIBITING COUNTERFEIT DRUGS. PROVIDING articles specified in clauscs ( 1 ), (2). (3) not including deviccs PENAL TIES FOR VIOLATIONS ANO APPROPRJATING or their components, parts, or acccssories; and FUNDS THEREFOR 5) herbal and/or traditional drugs which are articles of /Je il enactecl hy lhe .\'c!nate and 1/ou.,·e ofRepre.renta/ive:.· of the plant ·or animal origin uscd in folk medicine which are: . /'hi/ippines in Co11gre.\'x asxemhled: (a) rccognized in thc Philippine National Drug Formula�·; SECTION 1. Til/e. - This Acl shall bc known as lhe ··spcc (b) intended for use in the treatment or cure or miligation of ial Law diseasc symptoms. inju�· or bodily defcct in man; (c) olher QD Counlerfeil Drugs. - . than food, intendcd to afTect the structure or any function ofthc SEC. 2. Dedaratio11 of Policr. - li is hcrcby lhe policy bodv of man; (d) in finished or ready-to-usc dosage form; and of lhe Stalc (e) ·intcnded for use as a componcnl of any of the articles lo prolecl and promote the righl lo hcalth of the pcople and inslill health spccified in clauses (a). (b). (c) and (d). conscioMsness among lhcm as pro\'ided in Section 15. Article li of the Constilution. b) Counterfeil drug ·medicine refcrs to medicinal products with the corTCCt ingrcdients but not in the amoUnts as proúdcd hereundcr, wrong lt is also furlher declared thc policy of the State that in order to ingredienls. without aclive ingredients. with insufficient quanti�· of sa�guard lhe health of the pcople. lhe S1a1e shall proúde for their acth·e ingrcdient. which rcsults in lhe reduction of lhe d rug's safety. protection againsl coun1erfcit drugs. efficacy. qualit y. strength or purity. lt is a dmg which is delibcrat�ly and fraudulently mislabclcd with respect to identity and/or source or wllh fakc

any part of such drug, container or .labeling bearing without SEC. 4. J 1rohibitedActs. -The lollowmgactsarcdcclared unlawlul authorization the trademark, trade name or other identification and thcrefore prohibited: mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Tradernark and Technology a) The manufacturc. sale. offering for sale. donation. distribution Transfer (BPTIT) in the name of another natural or juridical trafficking, brokering. exportation, or importation or possession of person; counterfeit drugs as defined in Section 3 hereof not otherwise covered b\' Republic Act No. 3720. as amcnded. The presence or availability of such 2) a drug product refilled in containers by unauthorized counterfeit drugs ,,ithin lhe premises of any entityengaged in the salc, pcrsons if the legitimate labels or marks are used; manufacture or distribution of drugs and/or pharmaceutical products or in a private residence, or in public or private vehicle, or in the premises 3) an unregistered imported-drug product, except drugs not covered by a valid license to opcrate from the Bureau. shall constitute brought in the country for pcrsonal use as confirmcd and a primafacie evidence ofviolation ofthis Act: Provided, however. That justified by accompanying medical records: and this presumption shall not apply to the lcgitimate owners of tradcmarks. tradc names or other idcntifying marks. or the lcgitimate or authorizcd 4) a drug which contains no amount of. or a different represcntatives or agcni� of such owners. who have in their possession acti,·e ingredient, or lcss than eighty pcrcent (80%) of thc countcrfeit drugs which bcar thc trademarks, trade namcsor marks if thc\' active ingrcdient it purports to possess, as distinguished from can show the sales invoiccs or official receipts evidcncing their purcha� an adulterated drug including reduction or loss ofefficacy duc from a drugstorc. manulàcturcr ordistributor suspectcd by them ofdcaling to cxpiration. in countcrfcit drugs in\'olving the tradernarks. tradc namcs and othcr similar idcntifying marks rcgistcrcd in their namcs: Provided, further, e) Brokering shall refer to any act or íacilitating thc disposal or sal e That such counterfcit products shall bc reported and immediatcl\' turned of counterfeit dmgs, including acts of agenC)'. over to thc Bureau: Provided, flnal�v. That compliancc ,�·ith thc prcccding proviso shall bc made within a reasonable pcriod from thc date d) Bureau shall rcfcr to thc Bureau of Food and Drugs (BFAD) of of purchasc of such counterfeit drugs as indicated in the sales in\'oice. thc Dcpartment of Health (DOH). official rcccipt, or other similar documents abovcmcntioncd to thc time the counterfeit drugs an-_rcported and turncd over to thc Bureau; e) Depart111ent shall refer to the Department of Health. b) Possession ofany such counterfeit drugs. Howe\'er, any pcrson f) Business estab/ishmenr shall referto anycntity, whethcra singlc lound in posscssion of counterfeit drugs, in violation of this subsection. proprietorship, partncrship or corporation engaged in, or doing busincss shall bc exccptcd from liability under thc provisions of this Act after: in the Philippines. 1) prescntation of salcs invoiccs, official rcceipts, or g) Owner shall rcfer to a pcrson or group of pcrsons who is the other legally acceptable documents evidencing bis purchasc rcgistcred owncr ofa license to opera te a business or business undcrtaking thereof from a drugstore. distributor, manufacturer, hospital in the Philippincs or the branch managcr or opcrator. liccnscc. franchi:,ec. pharmacy or dispensa[}·. or any other pcrson or placc duly or any pcrson acting on bchalí oí thc corporatc cntit:y.

• 5 6 licensed to sell and/or dispense drugs or medicines, and lhe 1rademark. trade name or other identifying r::.• rk of ano1her indicating therein the batch and lot numbers, as well as the registered producer or any likeness thereof, upon any drug producl or expiry dates of such drugs; or device or ils container or label wilhout aulhority from lhe legi1ima1e owners of lhe lrademark or lrade name. 2) presentalion of certificales and other documents e\'idencing the importation or exportation of the counterfeit SEC. 5. Parties Liab/e. - The following persons shall bc liable for drugs found in his possession as required by existing laws, violation(s) of this Acl: including thoscdocwnents required in the preceding paragraph co\'ering lhe commercial transaclions involving counterfeil a) lhe manufacturer, exporter or importer of the counlerfeil drugs drugs. and their agents: Provided, Thal the agenls shall be liablc only upon proof of aclual or conslructive knowledge thal 1he drugs are counterfeil: ln both cases. lhe subjecl coun1erfei1 drugs must not on their face. appcar 10 bc as such, or do nol bear any marking or any patently unusual b) lhe seller, dislríbulor. 1rafficker, broker or donor and their characteristic sufficient to arousc the suspicioit of a reasonablc and agenls, upon proofofac1ual or construc1ive knowledge 1ha1 lhe drugs sold. prudenl person thal such drngs are coun1erfeit. Furthermore, lhe amounl distríbu1ed, offered or donaled are counlerfeil drugs: or , olume of counterfeit drugs held is such thal il does nol negale or is inconsislent with the averment that lhe sarne are for perSÔnal use. c) lhe possessor of coun1erfei1 drugs as provided in Seclion -l (b) nolwithsranding the presentation by the possessor ofmedical r1.:cords and hereof; 01her similar doc11men1s accompanying and jus1ifying lhe use of such drugs: d) the manager, operat6r or lessee ofthe laboratory or laboratory facilities used in lhe manufacture of counterfeit drugs: e) Forging. coun1erfei1ing. simula1ing or falsely represenling. or \\'ilhou! propcr au1hori1y. using any mark. stamp. tag. label or other e) lhe owner, proprielor, administrator or manager of the id1:n1ifica1ion mark or de\"ice authorized or required by Republic Acr drugstore, hospital pharmacy or dispcnsary, laboratory or other outlcts or No. 1720. as amended. and/or lhe regulalions promulgaled under 1his premises where the counterfeit drug is found who induccs, causes or Acl: allows lhe commission of any act herein prohibited; d) Photocopying. duplica1ing. allering, prinling, lransferring. f) the registered pharmacist ofthe outlet where the counterfeit drug obliteraling or remoúng lhe approved labcl or any part 1hereof. la\\full�· is sold or found who, sells or dispenses such drug to a third party and oclonging 10 anolher pcrson. for lhe purpose ofusing such label or a part who has actual or constructive knowledge that said drug is counterfeit; thercof on any coun1erfei1 drng: Prol'ided. That if lhe pcrson who and commilled any of lhe acls en11mera1ed in 1his paragraph and lhe pcrson ,,·ho used lhe labcls produced lhereby are nol one and lhe sarne person and g) should the offense be commilled by a jurídica) person, the rhe former had knowledge or 1he purpose for which lhe labcls are president. general manager. the managing partner, chiefopcrating officer i111e11ded. lhe former shall also be liable under lhis Act notwithstanding or the pcrson who directly induccs. causes or knowingly allows the lhe failurc or lhe lauer 10 acl,ie,·e lhe i111ended purpose: and commission oíthe offense shall be penalized.

e) Making. sclling. or com:ealing an�- punch. dye. pla1e or any SEC. 6. A dministrative Proceedings. - The Bureau is hereby further oltter eq11ipmen1 or ins1rume111 designed lo pri111. imprinl or reproduce authorized 10 undertake the following administrative ac1ions: 7 8 d) filing of an appropriate proceedings againsl lhe regislered a) upon verified informalion on lhe exislence of suspecled pharmacisl wilh lhe Professional Rzgulalions Commission for counlerfeil drugs in lhe possession of any rnanufaclurer, seller or cancellation of professional license: dislribulor, lhe duly aulhorized officers of lhe Bureau or any officer depulized by lhe Bureau for lhe purpose shall segregale, seal and, after e) filing of criminal charges against lhe violator(s). which can bc having oblained a valid search warranl from a compelenl court, seize instituled independently from lhe adminislrative case: Provided, Thal lhe such counlerfeit drugs and take lhem into custody: Provided, That in case dismissal ofthe criminal case shall nol lift lhe closure order. excepl when the suspected counterfeit drugs are found in a private residence, as defined it is a dismissal on the merits or for lack ofbasis: Provided.further, That in Scclion 3 ofthis Act or in other premises not covered by a valid license the withdrawal ofthe private criminal complaint shall not be a ground for to operate issued by �.e Bureau, the duJy authorized officer ofthe Bureau the disrnissal oflhe administrative proceedings: and or deputized officer lhereofshall secure a search warrant for the purpo!>.: ()r seizing and taking into custody such suspected counterfeil drugs; f) permarient disqualification of thc pcrson conccrned. whether .. .· natural or juridical, from owning or opcrating an eslablishmenl cngaged b) if. after lhe appropriale examinalion of the samples by lhe. in any busincss activity under lhe super\ision of the Burcau. · Burcau, the seized drugs are determined or found to be counterfeit, the Bureau shall, within fifteen ( 15) days from their seizurc.:, issue an order SEC. 8. Penalties. - The commission ofany ofthe acts prohibited dirccling lhe preventive closure ofthe business establishmenl for a period under Sections 4 and 6 of this Acl shall bc punished by: nol excccding lhirty (30) days. Thereafter, administralive proceedings shall be initiated by the Bureau against the parties concemcd where they a) imprisontnent ofnot less than six (ó) months and one ( 1) day. bul shall ha\'C lhe opportunil)• to bc heard and presenl evidence on their behalf: not more than six (6) years for mere posscssion of coun1erfei1 drugs as and pro\"idcd for in Seclion 4 (b) hercof: or c) 10 ensure the cffective enforcemenl ofthe foregoing, lhe Bureau b) impriso1101en1 ofsix (6) years and one ( 1) day. but nol more than may enlist lhe assislance of lhe nalional or local law enforcement 1cn ( IO) years or a fine of 1101 less than One hundred lhousand pesos agcncies. (PI00.000) bul nol more than Fi\·e hundred thousand pesos(P500.000) or bolh su_ch imprisonment and fine at the discretion ofthc court in any other SEC. 7. Administrative Sanctions. - Upon finding thal the drugs case mentioned in Section 4 hereof: or examined are counterfeil and the determinalion of lhe parties liablc lhercfor. lhe Bureau shall imposc any or ali ofthe following sanctions: e) imprisonment ofnot less than six (6) months and onc ( l) day, but not morc than two (2) ycars and four (4) months ifthe counterfeit drug a) pcrrnanent closure of lhe eslablishment concemcd and the is intended for animais: or re\'ocalion of its license lo do business: d) imprisonmenl ofnot less than six (6) years and one ( 1) day, but b) a fine ofno1 less than One hundrcd thousand pesos (PI00.000) nol more than lcn (IO) -ycars for any manufacturer. sei ler or distributor but n<c>t more lhan Fi,·e hundred thousand pesos (P500.000): who shall conccal, substitute. dispose or deslroy any drug as may ha,·c been segregated and sealed by the Burcau. or who shall brcak. alter or e) upon order ofthe Court. forfciture. confiscation, and destruction tampcr an�· mark or seal used by the Bureau to iden1i(nhose segrcga1ed of producls found to be counterfeil and the equipment. instrumcnts. and drugs as pro\"ided for undcr Sec1io11 6 (a) of this Act. An� other pcrson other articles used in ,·iolation of this Act:

I) /O SEC. 12. Sepm·abili�v Clause. - Iffor any rcason, any portion or who breaks. alters or tampers any mark or seal used by the Bureau to prO\'ÍSÍon ofthis Act is subsequently declarcd unconstitutional or invalid. identi�· the segregated drugs shall suffer the penalty of not less than six such dcclaration shall not nullify the other portions or provisions hereof (6) months and one ( 1) day, but not more than six (6) years imprisonment; or SEC. 13. Repealing Clause. - Ali laws. decrccs, executive or administrati,·e orders, rules or regulations inconsistent with the e) if, as a resull of the use of lhe drug found to be counterfeil, the pro\'isions ofthis Act are hereby repcaled or modified accordingly. illness sought to be cured is aggravated or physical injul)' or suffering results therefrom, a punishment ofimprisonment from twelve (12) years SEC. 1-l. Effectivity. - This Act shall take elTect fifteen ( 15) days to fifteen ( 15) years and a fine ranging from One hundred thousand pesos after its publication in at least two (2) national newspapers of general (P 100,000) to Five hundred thousand pesos (P500,000) shall be meted circulation. out; or Appro,·ed. f) should a counterfeit drug be the proximate cause of death of a victirn, who uilknowingly purchascd and took a counterfeit drug, lhe pc�ally of life imprisonment and a fine of Five hundred thousand pesos (P500.000) to Fi\'C rnillion pesos (P5,000,000) shall be imposcd.- ln case any act prohibited in Section 4 hcreof is also punishable under other laws, the offender shall. if warranted by the evidencc, be prosccuted under the law prescribing thc highest penal()·. This Act. which is a consolidation of Scnate Bill No. 1284 and SEC. 9. .4.ppropriations. - The arnount necessary to cany out lhe Housc Bill No. 5666 was finally passcd by the Senate and thc House pro,·isions ofthis Act shall be included in lhe General Appropriations Act of Rcprescntativcs on August 27. 1996 and August 22, 1996. for the year following its enactment and cvel)' year thcrcafter. respccti\'ely. SEC. 1O. lmplementalion. - The Bureau of Food and Drngs of lhe Departrnent of Hcalth is hereby authorizcd to administer and supcrvise the irnplemcntation ofthis Act. . NAZARENO �� Secretnry ofthe Sena/e SEC. 11. lmplemenling Ru/e!; and Regulalions. - Within ninet y (90) days from the approval of this Act. the Bureau of Food and Drugs. in consúllatiõn \\ith the Dcpartment of Hcalth. shall prornulgate the rules and regulations implerncnting the provisions of this Act. The Approved: implcmenting rulcs and rcgulations issued pursuant to this section shall takc effccl thirty (30) days aftcr its publication in two (2) national ne"·spapers of general circulation. FIDEL V RAMOS Preside11I o/lhe l'hi/ippines

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