Introduced by Representative CHRISTIAN TELL A. YAP
EXPLANATORY NOTE
It  is  the  policy  of the  State  to  protect  and  promote  the  right  to  health,  instill  health
consciousness, establish and maintain an effective food and drug regulatory system and undertake
appropriate health research and development responsive to the country's needs. Towards this end,
the State is duty-bound to craft and enact measures in response and to prevent the proliferation of
counterfeit pharmaceutical products which threatens the life and health of our people.
Counterfeit pharmaceutical  products  refers to  those products  which do  not contain the
anount it claims,  having reduced  safety,  efficacy,  quality,  strength or purity.  It refers also to
products  that  are  deliberately  and  fraudulently  misrepresented  with  respect  to  their  identity,
composition and source. Counterfeit pharmaceutical products pose serious threat to public health
and safety because their effectivity is unverified and questionable. The distribution of these bogus
products may worsen illnesses and diseases that may cause serious adverse health consequences,
drug resistance, or worst, death.
Republic Act No. 8203 or the Special Law on Counterfeit Drugs prohibits the manufacture,
sale,  distribution,  possession,  and  similar acts that spread  counterfeit pharmaceutical products.
However, the law does not contemplate and penalize massive-scale counterfeiting practices which
not only multiplies health-related risks to our people but also undermine and weaken the local
pharmaceutical industry.
TheCounterfeitPharmaceuticalProductsPreventionActseekstostrengthentheregulatory
system  on  pharmaceutical  products  by  deflning  counterfeit  pharmaceutical  products  and  the
prohibited acts associated with it, delineating further the administrative proceedings on the search,
seizureandprosecutionoffoundcounterfeitproductsandthepersonsliable,andprovidingstricter
penalties for violations of this act.
This proposal was originally filed by Senator Risa Hontiveros in the present 19th Congress
of the Philippine Senate. This bill is likewise filed for consideration as its counterpart in the House
of Representatives.


NINETEENTH CONGRESS
0F THE REPUBLIC OF THE PHILIPPINES
First Regular Section
HOUSE OF REPRESENTATIVES
Hou;eBillNo.5252
Introduced by Representative CHRISTIAN TELL A. YAP
AN ACT
STRENGTHHNING THE REGULATORY SYSTEM IN THE COUNTRY TO COMBAT
COUNTERFEIT        PHARMACEUTICAL        PRODUCTS,        DECLARING        THE
MANUFACTURE,IMPORTATION,DISTRIBUTION,SALEOROFFERFORSALE,OR
POSSESSION OF COUNTERFEIT PHARMACEUTICAL PRODUCTS AS AN OFFENSE
INVOLVING ECONOMIC SABOTAGE, PROVIDING FOR THE PROHIBITIONS AND
PENALTIES  FOR VIOLATIONS  AND  REVISING  FOR  THE  PURPOSE  REPUBLIC
ACT NO. 8203 0R THE "SPECIAL LAW ON COUNTERFEIT DRUGS"
Be it enacted by the Senate and House Of Representatives in Congress assembled:
1                     SECTION 1.  Srfeor/ ri.f/c. -This Act shall be known as the "Counterfeit Pharmaceutical
2       Products prevention Act".
3
4                    SEC.2. Dec/¢r¢/I.o# a/Po/J.c}?. -It is the policy of the state, under Article Il, Section l5 of
5       the  1987 Constitution, to protect and promote the right to health of the people and instill health
6       consciousness among them.
7                    The 1987 Constitution also provides, under Article XIII, Section 12, that: The state shall
8       establish and maintain an effective food and drug regulatory system and undertake appropriate
9      health  manpower  development  and  research,  responsive  to  the  country's  health  needs  and
10       problems.
11                     Pursuant to the above policies, the  State must adopt,  support,  establish,  institutionalize,
12       improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed
13       and designed to strengthen its capability to prevent activities that may result, or detect. Investigate,
14      suppress,  and  more  effectively  respond  to  actions  that  result  in  counterfeit  pharmaceutical
15       products.
16                    It   shall   likewise   provide   for  the   strengthening   of  prohibitions   against   counterfeit
17      pharmaceutical products; declare the manufacture, importation, distribution, sale or offer for sale,
18       or possession of counterfeit pharmaceutical products as offenses involving economic sabotage;
19       and provide stricter penalties for violations of the Act.
20


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SEC.3. Dc'#j./I.o# a/ rer#is. - As used in this Act:
a)   "Brokering"  shall  refer to  any  act of facilitating the  disposal  or  sale  of counterfeit
pharmaceutical products, Including acts of agency.
b)   "Biopharmaceuticals"   shall   refer  to   pharmaceutical   products   that   are   used   for
therapeuticorforlnvivodiagnosticpulposes,suchasvaccines,sera,anddrugsderived
from life foms using biotechnology. These Include proteins, nucleic acids, or living
microorganisms where the virulence is reduced and are used for therapeutic or for in
vivo diagnostic puiposes.
c)    "CDRR" shall refer to the Center for Drug Regulation and Research of the FDA.
d)    "Counterfeit pharmaceutical products"  shall refer to pharmaceutical products which
fall  under  any  of the  following  conditions,  which  results  in  the  reduction  of the
pharmaceutical products' safety, efficacy, quality, strength or purity:
1. do not contain the amounts as claimed;
2. with wrong ingredients;
3. without active ingredients; or
4.withlessthaneightypercent(80%)oftheactiveingredientitpuaportstopossessas
distinguishedfromanadulteratedphamaceuticalproductsincludingreductionorloss
of efficacy due to expiration.
It shall also refer to products that are deliberately and fi.audulently misrepresented with
respect to their identify, composition and/or source. For this purpose, the terns:
5.  "Identity"  shall  refer to  the  name,  labelling  or packaging  or to  documents that
support the authenticity of an authorized pharmaceutical product.
6.  "Composition"  shall refer to any ingredient or component of the phamaceutical
product  in  accordance  with  applicable  speciflcations  authorized/recognized  by  the
FDA.
7.  "Source"  shall  refer  to  the  identification,  including  name  and  address,  of the
marketing  authorization  holder,  manufacturer,   importer,   exporter,   distributor  or
retailer, as applicable.
Anyconsiderationrelatedtointellectualpropertyrightsdoesnotfallwithinthisdefinition.
e)   "Director General" shall refer to the Director General of the FDA.
0     "Drugs" shall refer to pharmaceutical products that pertain to any chemical compound
or  biological  substance,  other  than  food,  intended  for  use  in  the  treatment,  cure,
mitigation,preventionordiagnosisofdiseaseinhunansoranimals,includingbutnot
limited to:
1.   any article recognized in the Philippine Pharmacopoeia, Philippine National Drug
Formulary, or in any foreign official pharmacopoeias and formularies which are
adopted by the FDA or any documentary supplement to any of them;


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2.anyarticle,otherthanfood,intendedtoaffectthestructureoranyfunctionofthe
human body or animals;
3.  any  article  intended  for use  as  a component  of any  chemical  compound  or
biological  substance  or  articles  specifled  above,  not  including  devices  or  their
components, parts, or accessories; or
4.herbaland/ortraditionaldrugwhicharearticlesofplantoranimaloriginusedin
folk medicine, which are:
i.recognizedinthePhilippineNationalDrugFormulary;or
ii.  intended for use in the treatment, cure, mitigation, prevention or diagnosis of
disease symptoms, injury or body defects in hunans; or
iii. other than food, intended to affect the structure or any function of the human
body; and
iv. in finished or ready-to-use dosage form; or
v.intendedforuseasacomponentofanyofthearticlesspecifiedinclauses(i),(ii),
(iii), and (iv);
g) "Department" shall refer to the Department of Health.
h)  "Economic  Sabotage"  shall refer to any of the acts which are declared unlawhl and
prohibited   under   this   Act   when   committed   and   the   amount   of  the   counterfeit
pharmaceutical  product(s)  involve  (whether as  a  single  product  or totality  of different
pharmaceutical products) Is One Million Pesos (Phpl,000,000.00) or more, as valued by
theFoodandDrugAdministration,anyprovisionoflawtothecontrarynotwithstanding.
i)  "Establishment"  shall  refer to  a sole proprietorship,  a partnership,  a  colporation,  an
institution,  an association,  or an organization engaged in the manufacture,  importation,
exportation,  sale,  offer for sale,  distribution, donation, transfer, use, testing, promotion,
advertising,   or  sponsorship   of  pharmaceutical   product,   including  the   facilities  and
installations needed for its activities.
j) "FDA" shall refer to the Food and Drug Administration.
k) "FDRO" shall refer to the Food and Drug Regulation Officer of the FDA.
I)"LSD"shallrefertothelaboratoriesundertheFDAincludingthoseprivatelaboratories
accreditedbytheagencytoconductparticularscopeofanalysis.
in) "LSSC" shall refer to the Legal Services Support Center of the FDA.
n)"Medicines"shallrefertodrugsintheirappropriatedosageforms,withassuredquality,
safety and efficacy for humans or animals, or both.
o)  "Online  Service"  shall  refer  to  the  sale,  offering  for  sale,  donation,  distribution,
trafficking, brokering of pharmaceutical product, or the sale of any punch, dye, plate or
anyotherequipmentorinstrumentdesignedtoprint,imprintorreproducethetrademark,
trade name or other identifying mark for use to any pharmaceutical product, through and
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with the use of information and communication technology system.  The tern shall also
cover Online Selling or Online Pharmacy Services.
p) "Ouner"  shall refer to a person or group of persons who is the registered ouner of a
license  to  operate  a business  or business  undertaking  in the  Philippines  or the  branch
manager or operator, license, franchise, or any person acting on behalf of the corporate
entity.
q) Pharmaceutical Products" shall refer to drugs, medicines, biologicals, pharmaceutical
andbiopharmaceuticalproducts/specialties,veterinaryproducts,veterinarybiologicsand
veterinary medicinal products.
r) "Residence"  shall refer to a private dwelling or abode where a person lives, either as
owner or lessee,  or usufructuary  including,  for purposes  of   this Act,  its yard,  garage,
storageroomsorpremises;providedthatwheretheyard,garage,storageroomsorpremises
are used to manufacture,  process, pack, or hold pharmaceutical products for introduction
into  domestic  commerce,  the  same  shall  not  fall  as  residence  but  be  considered  as
establishment
SEC.4.  ProfoI.4J.fed 4c/s.  -  The  following  acts  are  declared  unlawhl  and  therefore
prohibited:
a)   The   manufacture,   importation,   distribution,   sale,   offering   for   sale,   donation,
trafficking,   brokering,   exportation,   or  possession  of  counterfeit  pharmaceutical
products as defined in Section 3 hereof.
The presence  or availability  of such counterfeit pharmaceutical product within the
premises  of any  entity  engaged in the manufacture,  importation,  distribution,  sale,
offering  for  sale,  donation,  trafficking,  brokering,  exportation,  of pharmaceutical
products or in a private residence, or in public or private vehicle, shall constitute a
prima facie evidence of violation of this Act.
Theabovepresunptionshallnotapplytothelegitimateownersoftrademarks,trade
names or other identifying marks, or the legitimate or authorized representatives or
agents  of such  ouners,  who  have  in  their  possession  counterfeit  pharmaceutical
products which bear the trademarks, trade names or marks if they can show the sales
invoicesorofficialreceiptsevidencingtheirpurchasefromadrugstore,manufacturer
or distributor suspected  by them of dealing  in counterfeit phamaceutical products
involvingthetrademarks,tradenamesandothersimilaridentifyingmarksregistered
in   their   names:    Provided,    that    such   material    information   and    counterfeit
phamaceutical products shall be reported and immediately tuned over to the FDA
within  a  period  of ten  (10)  days  from  the  date  of purchase  of such  counterfeit
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phanaceutical  product  as  indicated  in  the  sales  invoice,  official  receipt,  or  other
similardocunentsabovementionedtothetimethecounterfeitpharmaceuticalproduct
are reported and turned over to the FDA.
b)   Possession  of any  such  counterfeit  pharmaceutical  product.  However,  any  person
found  in  possession  of  counterfeit  pharmaceutical  product,  in  violation  of  this
subsection,shallbeexemptedfromliabilityundertheprovisionsofthisActafter:
1.Presentationofsalesinvoices,officialreceiptorotherlegallyacceptabledocunents
evidencinghispurchasethereoffromadrugstore,hospitalpharmacyordispensary,or
anyotherpersonorplacedulylicensedtoselland/ordispensepharmaceuticalproduct,
Or
2.  Presentation  of certificates  and  other  documents  evidencing  the  importation  or
exportation  of the  counterfeit  pharmaceutical  product  found  in  his  possession  as
required  by  existing  laws,  including  those  documents  required  in  the  preceding
paragraphcoveringthecommercialtransactionsinvolvingcounterfeitpharmaceutical
products;
In both  cases,  the  subject  counterfeit pharmaceutical  product must not on its  face
appeartobeassuch,ordonotbearanymarkingoranypatentlyunusualcharacteristic
sufficient  to  arouse  the  suspicion  of a  reasonable  and  prudent  person  that  such
pharmaceutical  product  is  counterfeit.   Furthermore,   the   amount  or  volume  of
counterfeitpharmaceuticalproductheldissuchthatitdoesnotnegateorisinconsistent
withtheavermentthatthesameareforpersonaluse,notwithstandingthepresentation
bythepossessorofmedicalrecordsandothersimilardocunentsaccompanyingand
justifying the use of such pharmaceutical product.
c)Photocopying,duplicating,altering,printing,transferring,obliteratingorremovingthe
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  phamaceutical
product:Provided,thatlfthepersonwhocommittedanyoftheactsenuneratedinthis
paragraph and the person who used the latels produced thereby are not one and the
sane person and the former had knowledge of the puapose for which the labels are
intended, the former shall also be liable under the act notwithstanding the failure of
the latter to achieve the intended purpose; and
d)    Making,  selling,  or  concealing  any  punch,  dye,  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
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pharmaceuticalproductordeviceoritscontainerorlabelwithoutauthorityfromthe
legitimate owners of the trademark or trade name.
Any provision of law to the contrary notwithstanding, when any of the acts in the
preceding  paragraphs  (a)  or  (b)  is  committed  and  the  amount  of the  counterfeit
pharmaceuticalproduct(s)involved(whetherasasingleproductortotalityofdifferent
pharmaceuticalproducts)isonemillionpesos(Php1,000,000.00)ormore,asvalued
bytheFoodandDrugAdministration,theyshallbedeemedasanoffensiveinvolving
economic sabotage.
SEC.5.P".es£!.¢b/c.-Thefollowingpersonsshallbeliableforviolation(s)oftheact:
a)themanufacturer,importerexporter,distributor,seller,trafficker,brokerordonorofthe
counterfeitpharmaceuticalproductandtheiragents,asthecasemaybe;
b)thepossessorofcounterfeitpharmaceuticalproductasprovidedinSection4(b)of this
Act;
c) the manager, operator or lessee of the laboratory or laboratory facilities used in the
manufactureofcounterfeitpharmaceuticalproduct;
d)theowner,proprietor,administratorormanagerofthedrugstore,hospitalpharmacyor
dispensary, laboratory or other outlets or premises where the counterfeit pharmaceutical
product  is  found  who  induces,  causes  or  allows  the  commission  of any  act  herein
prohibited;
e)  the  licensed  and  registered  pharmacist  of the  establishment,  or  the  licensed  and
registeredpharmacistoftheoutletwherethecounterfeitpharmaceuticalproductissoldor
found,whosellsordispensessuchpharmaceuticalproductstoathirdparty;and
Dshouldtheoffensebecommittedbyajuridicalpersonthepenaltyshallbeimposedupon
theofficerorofficersofthecorporation,partnership,associationorentityresponsiblefor
the violation; and if such officer is an alien, he shall, in addition to the penalties herein
prescribed be deported without further proceedings.
SEC.6.  £i.¢Gi.Jrty  %mder  Olfe" £¢ws.  -  A  prosecution  under this  Act  shall  be  without
31       prejudice to any liability for violation of any provisions of other laws.
32
33                    SEC.7. ,4d"i.mi.SJr¢/I.ve proceedi.ngs. -The FDA is hereby further authorized to undertake
34      the following administrative actions.
35
a)   Procedure  when  Counterfeit  Pharmaceutical  Product  is  Monitored  in  the  Market
Pursuant to a Routine Inspection of the FDRO.
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If  the  FDRO,  in  the  course  of  histher  routine/regular  inspection  of  a  factory,
warehouse,   establishment  in  which  pharmaceutical   products   are  manufactured,
processed, packed, or held for introduction into domestic commerce, or vehicle, and
all  pertinent  equipment,  finished  or  unfinished  materials,  containers,  and  labeling
therein,  upon the authority conferred by  Section 27 of Republic Act No.  3720,  as
amended,  shall  suspect  certain  stocks  as  counterfeit  pharmaceutical  product,  the
FDRO shall conduct an  inventory, segregate and seal the suspected stocks, and collect
samples   for   examination   as   to   the   pharmaceutical   product's   genuineness   and
authenticity;
b)   Procedure   when   Infomation   is   Received   about   the   Presence   of  Counterfeit
Phamiaceutical Product in the Possession of Any Person or Establishment.
1.   Any  information,  either  referred  by  the  government  office  or  officer  or  from
anonymous sources or person requesting confldentiality of their identities, on the
existenceofsuspectedcounterfeitpharmaceuticalproductinthepossessionofany
manufacturer,seller,distributor,oranyotherpersonshallundergotheverification
process  by  the  FDRO,  or any  officer  deputized  or  authorized  by  the  Director
General.Verificationprocessshallfollowtheexistingsystemandprocedureinthe
conductofcasebuild-up.Investigationorotherappropriateinterventionsadopted
by the FDA.
2.   If the counterfeit pharmaceutical product is located in an establishment:
i.Seizethecounterfeitpharmaceuticalproductandtakethemintocustody;and
ii.Proceedinfilingacriminalcomplaintand/oradministrativecomplaint.
3.Ifthecounterfeitphamaceuticalproductislocatedinaprivateresidenceasdefined:
i. Secure a valid search warrant from a competent court;
ii. After having obtained the search warrant, inventory and seize such counterfeit
pharmaceutical product and take them into custody; and
iii.Proceedinfilingacriminalcomplaintand/oradministrativecomplaint.
c)   Findings  of Counterfeit  Pharmaceutical  Product  by  Owners  of Trademarks,  Trade
Names  or  Other  Identifying  Marks.  Ouners  of trademarks,  trade  names  or  other
identifying marks,  or their authorized agents  who have  found their pharmaceutical
product being counterfeited shall file an administrative case before the FDA, without
prejudice  to  the  institutions  of a  separate  action  for  criminal  case,  following  the
procedure in Section 8.


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SEC.S. Hearing Of Adndnistrative Complaints and Other Remedies. -
a)  The  FDA  shall  hear  and  decide  administrative  complaints  filed  before  the  agency
followingtherulesofprocedureprovidedunderRepublicActNo.3720,asamended,and
its  Implementing  Rules  and Regulations.  Upon preliminary  findings  of the  conduct  of
prohibitedacts,theDirectorGeneralshallissuethepropernoticesororderstotheperson
orpersonsconcemedandsuchpersonorpersonsshallbegivenanopportunitytobeheard
before the FDA.
Preventive  Closure  Order.  If seizure  camot  be  reasonably  effected,  a  summons  with
preventive closure order shall be issued against the warehouse,  building, factory,  store,
shoporanyotherstructurewherethesaidcounterfeitpharmaceuticalproductiscontained
or stored within flfteen (15) days upon the filing of administrative complaint. This is for
thepuxposeofpreventingthedispositionortamperingofevidence,thecontinuanceofacts
being complained of, and/or the flight of the Respondent. After the lapse of the 30-day
period,thepreventiveclosureorderisdeemedliftedwithoutprejudicetotheresolutionof
the case.
b)  Filing  of  an  appropriate  proceedings  against  the  registered  pharmacist  with  the
Professional  Regulations  Commission  for  imposition  of the  appropriate  penalties  as
providedunderRepublicActNo.10918orthePhilippinePharmacyActoritsamendment;
c)Filingofcriminalchargesagainsttheviolator(s),whichcanbeinstitutedseparatelyand
independently from the administrative case: Provided, That the dismissal of the criminal
case shall not lift the closure order or dismiss the administrative case: Provided, further.
That  the  withdrawal  of the  private  criminal  complaint  shall  not  be  a  ground  for  the
dismissal of the administrative proceedings.
d)TheDirectorGeneralisherebyauthorizedtocallontheassistanceofanyDepartment,
Office,Agency,Organization,orBodyfortheeffectiveimplementationoftheprovisions
of this Act.
SEIC.9. Penalties. -
a) Administrative Penalties
1.   Upon  finding  that  the  pharmaceutical  product  examined  is  counterfeit  and  the
determinationofthepartiesliablethereof,theFDAshallimposeanyorallofthefollowing
administrative penalties :
i.MinimunPenalty.AnadministrativefineofnotlessthanOnehundredthousandpesos
(PHP100,000.00) but not more than Five hundred thousand pesos (PHP500,000.00) shall
be the minimum administrative penalty.
ii.  Medium  Penalty.  An  administrative  flne  of at  least  Three  hundred  thousand  pesos
(PFIP300,000.00) but not more than Five hundred thousand pesos (PHP500,000.00) and
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suspension or revocation of its license to do business shall be the medium administrative
penalty.
iii.   Maximum   Penalty.   An   administrative   fine   of  Five   hundred   thousand   pesos
(PHP500,000.00)  and permanent closure of the establishment concerned as well as the
revocationofltslicensetodobusinessshallbethemaximunadministrativepenalty.
Provided, that if any or all of the instances below occur, the maximum imposable fine of
Fivehundredthousandpesos(PHP500,000.00)revocationofitslicensetodobusinessand
permanent   closure   of  establishment,   and  pemanent  disqualification  of  the  person
concerned whether natural or juridical, from owning or operating a drug establishment or
outlet, as the case maybe, shall be imposed:
iv. If the Respondent or any of his officer or agent shall conceal,  substitute, dispose or
destroy  any  pharmaceutical  product that may  have  been  segregated  and  sealed  Oy  the
FDROoranyofficerdeputizedorauthorizedbytheDirectorGeneral;or
v.IftheRespondentoranyofhisofficeroragentshallbreak,alterortamperanymarkor
sealusedbytheFDAtoidentifythosesegregatedpharmaceuticalproducts;or
vi.Asaresultoftheuseofthepharmaceuticalproductfoundtobecounterfeit,theillness
soughttobecuredisaggravatedorphysicalinjnyorsufferingresultsthere from,orbethe
proximatecauseofdeathorpermanentdisabilityofthevictimorpatient.
Any  of the  imposable  penalties  in  sub-paragraphs  (i),  (ii)  and  (iii)  above  shall  be
accompaniedbyforfeiture,confiscationanddestructionofthephamaceuticalproduct(s)
found to be counterfeit and the equipment, instrument, vehicles, and other articles used in
violation of this Act or its implementing rules and regulations,
b)CriminalPenalties.ThecommissionofanyoftheactsprohibitedunderSection4ofthis
Act shall be punished by:
1.imprisormentofnotlessthansix(6)monthsandone(1)daybutnotmorethansix(6)
yearsformerepossessionofcounterfeitphamaceuticalproductasprovidedforinSection
4 (b) of this Act; or
2.imprisormentofsix(6)yearsandone(I)day,butnotmorethanten(10)yearsorafine
of not less than One hundred thousand pesos (PHP100,000.00) but not more than Five
hundred  thousand  pesos  (PHP500,000.00)  or  both  such  imprisorment  and  fine  at  the
discretion of the court in any other case mentioned in Section 4 of the Act; or
3.imprisonmentofnotlessthansix(6)monthsandone(1)day,butnotmorethantwo(2)
yearsandfour(4)monthsifthecounterfeitpharinaceuticalproductisintendedforanimals;
Or
4. 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


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destroyanypharmaceuticalproductasmayhavebeensegregatedandsealedbytheFDA,
or who shall break, alter or tanper any mark or seal used by the FDA to identify those
segregated pharmaceutical products as provided for under Section 6(A) of this Act. Any
otherpersonwhobreaks,altersortampersanymarkorsealusedbytheFDAtoidentify
the  segregated pharmaceutical product  shall  suffer the penalty  of not less  than  six  (6)
monthsandone(1)day,butnotmorethansix(6)yearsimprisorment;or
5.if,asaresultoftheuseofthephamaceuticalproductfoundtobecounterfeit,theillness
sought  to  be  cured  Is  aggravated  or physical  injny  or  suffering  results  there from,  a
punishmentofimprisormentfromtwelve(12)yearstofifteen(15)yearsandafineranging
from   One  hundred  thousand  pesos   (P100,000.00)  to  Five  hundred  thousand  pesos
(PHP500,000.00) shall be meted out; or
6.shouldacounterfeitpharmaceuticalproductbetheproximatecauseofdeathofavictim,
whounknowinglypurchasedandtookacounterfeitpharmaceuticalproduct,thepenaltyof
life imprisorment and a fine of Five hundred thousand pesos (PHP500,000.00) to Five
million pesos (PHP5,000,000.00) shall be imposed.
Providedthat,anyprovisionoflawtothecontrarynotwithstanding,whenanyoftheacts
declared unlawful and prohibited under Section 4 above is committed and the amount of
thecounterfeitpharmaceuticalproduct(s)involve(whetherasasingleproductortotality
ofdifferentpharmaceuticalproducts)isOneMillionPesos(Phpl,000,000.00)ormore,as
valued by the  Food and Drug Administration, it shall be deemed as an offense involving
economic sabotage and punishable by life Imprisorment and a fine of Five Million Pesos
(Php5,000,000.00)toTenMillionPesos(Phplo,000,000.00).
IncaseanyActprohibitedinSection4ofthisActisalsopunishableunderotherlaws,the
offendershall,ifwarrantedbytheevidence,beprosecutedunderthelawprescribingthe
highest penalty.   When the  sale,  offering for sale, donation,  distribution, trafficking,  or
brokeringofcounterfeitphamaceuticalproduct,orthesaleofanypunch,dye,plateorany
otherequipmentorinstrumentdesignedtoprint,imprintorreproducethetrademark,trade
naneorotheridentifyingmarkofanotherregisteredproduceroranylikenessthereof,upon
any pharmaceutical product or device or its container or label without authority from the
legitimateounersofthetrademarkortradename,asprohibitedinSection4ofthisAct,is
committed by, through and with the use of online service, the same shall also be covered
by the relevant provisions of Republic Act No.10175 or the "Cybercrime Prevention Act
of2012".Provided,thatthepenaltytobeimposedshallbeone(1)degreehigherthanthat
provided under this Act.
SEC.10. Inter-agency, Stakeholders and International Cooperation. -A:Il rctevarr+  .irlter
37      agency,    other    stakeholders    and    international    instruments,    programs,    cooperation,    and
38       arrangements agreed, whether in regulatory or criminal matters, to the widest extent possible for
9


I       the purposes of detection, investigation, suppression, proceedings or effective response concerning
2      administrative  or criminal  offenses related to  counterfeit   pharmaceutical  products,  or for the
3       collection of evidence, shall be given full force and effect.
4
5                   SEC.11. Es/«b/isAme»rs ' Rapous#jmz.es.  -All pharmaceutical product establishments,
6      including the licensed and registered pharmacist under their employ, shall ensure at all times that
7      pharmaceutical products satisfy the requirements of pharmaceutical products' laws and standards
8      relevant to their activities in the pharmaceutical product supply chain and that control systems are
9      in place to prevent or eliminate counterfeit pharmaceutical products and counterfeiting activities.
10                    Pharmaceutical    product    establishments    shall    be    knowledgeable    of   the    specific
11       requirements  and  standards  of pharmaceutical  product  laws  and  regulations  relevant  to  their
12       activities in the pharmaceutical product supply chain and the procedures adopted by the regulatory
13       authority.
14                    If a  pharmaceutical  product  establishment  considers  or  has  reason  to  believe  that  a
15      pharmaceutical product which it produced, processed, imported, distributed, sold, offered for sale
16      is counterfeit, it shall irmediately initiate procedures to withdraw the phamaceutical product in
17      question   form   the   market   and   inform   the   regulatory   authority.   Pharmaceutical   product
18       establishments  shall  allow  inspection  of their  business  and  collaborate  with  the  regulatory
19      authority on actions taken to avoid risks posed by the counterfeit pharmaceutical product they have
20       supplied.
21
22                   SEC.12. iBapjd4/c" fys/em -The rapid alert system in place for the notification of direct
23       or indirect risk to human health due to counterfeit pharmaceutical product shall be strengthened
24      bytheFDA.
25                     Emphasis shall be made on the strengthening and full implementation of science-based
26      risk  analysis,   emergency  measures,   crisis  management,   and  stakeholders  involvement  and
27       participation.
28
29                    SEC.13. S/re«grfec«7.»g ffec pfe¢rm¢covz.g#¢»ce fys/cm. -In addition to sections  lo,11,
30       and l2 of this Act, the FDA, in coordination with the DOH or other stakeholders,  shall strengthen
31       the  existing  National  Policy  and  Program  on  Pharmacovigilance,  underscoring  the  adoption,
32       support,   establishment,   institutionalization,   improvement   and   malntenance   of   structures,
33       processes,  mechanisms  and initiatives that are  aimed,  directed and designed to  strengthen the
34      government  and  other  stakeholders'  capability  to  prevent  activities  that may  result,  or detect,
35       investigate,   suppress,   and   more   effectively   respond   to   actions   that   result   in   counterfeit
36       pharmaceutical products.
10


Withinonehundredtwenty(120)daysfromeffectivityofthisAct,theFDAshallestablish
apharmacovigilanceunitwithinitsCDRRwithappropriatestaffingofofficersandpersonneland
expertsandberegularlyallocatedwithappropriatebudget.
4
Sc       _.____..SEC.1:.  .Trai=ing  and  Consumer  Advocaey  and  Education  -TraLiring,  orieutaton,
6       education, and other advocacy activities shall be regularly provided by the FDA to pharmaceutical
7      product establishments, communities, and other sectors of the community. As such proclamation
8      No. 2082 which proclaims that every third week or Novemoer of every year shall be the National
9       Consciousness  Week  against  counterfeit medicines,  including  all  directives therein are  hereby
10       adopted.
11
12
13
14
15
Aconsuneradvocacyandeducationprogramshallbedevelopedandimplementedbythe
FDAinpartnershipwithrelevantNGOs,privateorganizations,coalitions,academicinstitutions,
or  other  relevant  goverrment  agencies.  The  FDA  shall  allocate  and  provide  funds  for  the
developmentandimplementationoftrainingandconsuneradvocacyandeducationprograms.
16                    SEC.15. 4aprap".¢fi.ores -The amount necessary to cany out the provisions of this Act
17      shall be included in the General Appropriations Act for the year following its enactment and every
18       yearthereafter.
19
20
21
22
23
SEC.16. EH/orceme#J ¢#d Jmp/c"enJ¢JI.on.  - The FDA of the Department of Health is
hereby  authorized  to  administer  and  supervise  the  implementation  of this  Act  subject  to  the
applicableprovisionsofRepublicActNo.10175orthe"CybercrimePreventionActof2012".
2_4.           .      SEC.17.  Implementing Rules  and Regulations.  -The FDA,  in coasultat±on with the
25       stakeholders,  shall  promulgate  the  implementing  rules  and  regulations  within  One  Hundred
26       Twenty (120) days from the effectivity of this Act.
27
I_8_       .    .    SEC.IS. Interpretation and construction in Favor of protection of public Health. -AIL
29      doubts  in  the  implementation  and  interpretation  of the  provisions  of this  Act,  including  its
30       implementing rules and regulations, shall be resolved in favor of protecting public health against
31       counterfeit pharmaceutical products.
32
SEC.19. Scp¢r¢bz./z.fy  C¢«Je.  -  If any provision  of this  Act  is  held  unconstitutional  or
invalid,thesameshallnotaffectthevalidityandeffectivityoftheotherprovisionshereof.
35
36                    SEC.20. Repco/!.ng C¢usa  -Republic Act No.  8203  is hereby revised.  All other laws,
37       decrees, executive orders and rules and regulations contrary to or inconsistent with the provisions
38       of this Act are hereby repealed, amended or modified accordingly.
11


12
1
2                    SEC.21. ELTecfl.vJ.fy. -This Act shall take effect flfteen (15) days after its publication in the
3       Official Gazette or in a newspaper of general circulation
4
S                     Appr ov e d,