.',
Republic of the Phhippines
HOUSE 0F REPRESENTATIVES
Quezon City, Metro Manila
NINETEENTH CONGRESS
First Regular Session
HOusE BIL-i ino. 6 3 4 2
Introduced by Representative CIRIACO 8. GATO, JR., MD, FPSO-HNS
ERTLANATORY NOTE
In the proliferation of counterfeit drugs, the most vulnerable members of the community suffer
the  most,  especially  during  public  health  emergencies.    At  the  height  of the  COVID-19
pandemic, with misinformation-driven panic and the problem of access  and supply of high
quality essential drugs, counterfeit drugs easily found their way into the Filipino market, often
preying on the poorest households.
In  1996,  RA  8203  or the  Special  Law  on  Counterfeit  Drugs  was  enacted  to  prohibit  the
manufacture,    sale,   distribution,   possession,   and   similar   acts   that   spread   counterfeit
phamaceutical products. Its implementation, however, has been tested by several counterfeit
drug-related cases.
Several laws enacted by Congress also significantly affected the provisions of RA 8203 such as
RA 9711 or the FDA Act of 2009 and RA 10918 or the Philippine Pharmacy Law. Under these
laws, the definition of "drugs" is inconsistent with the definition under RA 8203.
With a lower production cost and a wider customer base, the problem on counterfeit drugs has
been compounded with the rapid adoption of internet selling through the years.  Thus, there is
an urgent need to ensure that our laws remain applicable to the increasing complexity of the
counterfeit  drug  trade.  As  the  UN  Office  on  Drugs  and  Crime  (UNODC)  2019  report  on
"Transnational   Organized   Crime   in   Southeast   Asia:   Evolution,   Growth   and   Impact"
recommended, outdated laws should be revised to respond to the increasingly complex natue
of pharmaceutical markets and pharmaceutical crimes.
Twenty- two years after the enactment of RA 8203, the counterfeit dnig market in the country
continuous to wreak havoc at the expense of the local pharmaceutical industry and the health
security of Filipinos. As stronger regulations on phannaceutical products are sought, this bill
also seeks to declare the manufacture, importation, distribution,  sale, offering, for donation,
trafficking,  brokering,  exportation,  or possession  of counterfeit  phamaceutical  products  as
offenses involving economic sabotage.
In the view of the foregoing, the urgent passage of the bill is earnestly sought.
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Republic of the Philippines
HOUSH 0F REPRESENTATIVES
Quezon City
NINETEENTH CONGRESS
First Regular Session
HOUSE BIL~L-N-o.   63 4 2
Introduced by Representative CIRIACO 8. GATO, JR„ MD, FPSO-IINS
AN ACT
STRENGTIRENING TIIE REGULATORY SYSTEM IN TIIE COUNTRY T0
cormAT cOuNTERFHIT pllARMACEUTlcAL pRODucTs, DECLARING
TIRE MANUFACTURE, IMPORTATION, DISTRIBUTION, SALE OR OFFHR FOR
sALn, oR poSsESsloN oF COUNTERFEIT PIIARMACEUTICAL
PRODUCTS AS AN OFFENSE INVOLVING ECONOMIC SABOTAGE, PROVIDING
FOR TIIE pROHIBITIONs AI`m pENALTIEs FOR VIOLATloNs AND REVISING
FOR TIIE PURPOSH REPUBLIC ACT NO. 8203 0R TIIE
``SPECIAL LAW ON COUNTERFEIT DRUGS''.
Be it e_n_ac!ed by the Senate and the House Of Representatives Of the Philippines in Congress
assembled:
SECITt}IV I.  rljlJe.  - This Act shall be known as the "Counterfeit Phamaceutical
Products Prevention Act".
SEC. 2. Dec/¢ro!fo# a/Po/I.ey. - It is the policy of the State, under Article 11, Section
15 of the 1987 Coustitution, to protect and promote the right to health of the people and instill
health consciousness among them.
The  1987  Constitution  also  provides,  under  Article  XIII,  Section  12,  that:  The  State  shall
establish and malntaln an effective food and drug regulatory system and undertake appropriate
health  manpower  development  and  research,  responsive  to  the  country's  health  needs  and
problems.
Pursuant  to  the  above  policies,  the  State  must  adopt,  support,  establish,  institutionalize,
improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed
and  designed  to  strengthen  its  capability  to  prevent  activities  that  may  result,  or  detect,
investigate,  suppress,  and  more  effectively  respond  to  actions  that  result  in  counterfeit
pharmaceutical products.
It   shall   likewise   provide   for   the   strengthening   of   prohibitions   against   counterfeit
pharmaceutical products; declare the manufacture, importation, distribution, sale or offer for
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I
sale,  or  possession  of counterfeit pharmaceutical  products  as  offenses  involving  economic
sabotage; and provide stricter penalties for violations of the Act.
a.
C.
SEC. 3. Def inition Of Terms. - A;s used ." tJds Aict.
"Brokering"  shall  refer to  any  act of facilitating  the  disposal  or  sale  of counterfeit
pharmaceutical products, including acts of agency.
"Biopharmaceuticals"   shall   refer   to   pharmaceutical   products   that   are   used   for
therapeutic or for in vivo diagnostic purposes, such as vaccines, sera, and drugs derived
from life forms 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 puaposes.
"CDRR" shall refer to the Center for Drug Regulation and Research of the
FDA.
"Counterfeit pharmaceutical products" shall refer to phanaceutical products which fall
under  any   of  the   following   conditions,   which  results   in  the   reduction  of  the
pharmaceutical products' safety, efficaey, quality, strength or purity:
i.           do not contain the amounts as claimed;
ii.         with wrong ingredients;
iii.        without active ingredients; or
iv. with 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.
It shall also refer to products that are deliberately and fraudulently misrepresented with respect
to their identify, composition and/or source.  For this purpose, the terms:
i.          "Identity" shall refer to the name, labelling or packaging or to documents that
support the authenticity of an authorized phamiaceutical product.
ii.         "Composition" shall refer to any ingredient or component of the phannaceutical
product  in  accordance  with  applicable  specifications  authorized/recognized  by  the
FDA.
iii.        "Source" shall refer to the identification,  including name and address,  of the
marketing authorization holder, manufacturer, importer, exporter, distributor or retailer,
as applicable.
Any consideration related to intellectual property rights does not fall witlin this definition.
"Director General" shall refer to the Director General of the FDA.
"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, prevention or diagnosis of disease in humans or aninals, including but not
limited to:
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1)         any  article recognized in the   Philippine pharmacopoeia,  Philippine National
Drug Fomulary, or in any foreign official pharmacopoeias and fomularies which are
adopted by the FDA or any documentary supplement to any of them;
2)         any article, other than food, intended to affect the structure or any function of
the human body or animals;
3)         any  article  intended  for  use  as  a  component  of any  chemical  compound  or
biological   substance   or   articles   specified   above,   not   including   devices   or  their
components, parts, or accessories; or
4) herbal and/or traditional drug which are articles of plant or animal origin used in folk
medicine, which are:
i. recognized in the Philippine National Drug Formulary; or
ii. intended  for use in the treatment, cure, mitigation, prevention or diagnosis of disease
symptoms, injury or body defects in humans;
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. intended for use as a component of any of the articles specified in clauses (i), (ii),
(iii), and (iv);
9.  Department shall refer to the Department of Health.
h.  "Economic  Sabotage"  shall  refer  to  any  of the  acts  which  are  declared  unlawful  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 pharinaceutical products)
is   One   Million   Pesos   (Phpl,000,000.00)   or  more,   as   valued   by   the   Food   and   Drug
Administration, any provision of law to the contrary notwithstanding.
i.  "Establishment"  shall  refer  to  a  sole  proprietorship,  a  partnership,  a  corporation,  an
institution,  an  association,  or  an  organization  engaged  in  the  manufacture,  inportation,
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"  shall refer to the  laboratories under the FDA including those private  laboratories
accredited by the agency to conduct particular scope of analysis.
in. "LSSC" shall refer to the Legal Services Support Center of the FDA.
n.  "Medicines"  shall refer to drugs in their appropriate dosage foms, with assured quality,
safety and efficacy for humans or aninals, 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  any  other
equipment or instrument designed to print, imprint or reproduce the trademark, trade name or
other identifying mark for use to  any pharmaceutical product, through and with the use of
information and communication technology system. The tern shall also cover Online Selling
or Online Pharmacy Services.
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p. "Owner" shall refer to a person or group of persons who is the registered owner 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 and
biopharmaceutical products/specialties, veterinary products, veterinary biologics and 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, storage rooms or
premises;  provided  that  where  the  yard,  garage,  storage  rooms  or  premises  are  used  to
manufacture, process, pack,  or hold pharmaceutical products  for introduction into  domestic
commerce, the sanie shall not fall as residence but be considered as establishment.
SEC.  4.  Proftz.b!.fed Acts.  -  The following acts are declared unlawful  and   therefore
prohibited:
a)  The  manufacture,  inportation,  distribution,  sale,  offering  for  sale,  donation,  trafficking,
brokering,  exportation,  or  possession  of counterfeit  pharmaceutical  products  as  defined  in
Section 3 hereof.
Any provision of law to the contrary notwithstanding, when any of the acts in the preceding
paragraph is committed and the amount of the counterfeit phamaceutical 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 the Food and Drug Administration, they shall
be deemed as an offense involving economic sabotage.
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.
The above presumption shall not apply to the legitimate owners of trademarks, trade names or
other  identifying  marks,  or  the  legitimate  or  authorized  representatives  or  agents  of such
owners,  who  have  in  their possession  counterfeit  pharmaceutical  products  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, that such counterfeit pharmaceutical 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 pharmaceutical product as indicated in the sales invoice,
official  receipt,  or  other  similar  documents  abovementioned  to  the  time  the  counterfeit
pharmaceutical product 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,  shall  be
exempted from liability under the provisions of this Act after:
1) Presentation of sales invoices, official receipt or other legally acceptable documents
evidencing his purchase thereof from a drugstore,  distributor, manufacturer, hospital
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pharmacy  or  dispensary;  or  any  other  person  or place  duly  licensed  to  sell  and/or
dispense pharmaceutical product, and indicating therein the batch and lot numbers, as
well as the expiry dates of such phamaceutical product; 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
paragraph covering the commercial transactions involving counterfeit drugs;
In both cases, the subject counterfeit pharmaceutical product must not on its face appear to be
as such, or do not bear any marking or any patently unusual characteristic sufficient to arouse
the  suspicion  of  a  reasonable  and  prudent  person  that  such  phamaceutical  product  is
counterfeit.  Furthermore, the amount or volume of counterfeit pharmaceutical product 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 pharlnaceutical product.
When the amount of the counterfeit pharmaceutical product(s)  in possession of any person
(whether as a single product or totality of different pharmaceutical products) is One Million
Pesos ¢1,000,000.00) or more, as valued by the Food and Drug Adnrinistration, the act of
possession shall be deemed as an offense involving economic sabotage.
c)         Photocopying, duplicating, altering, 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 pharmaceutical product: Provided, that if
the person who committed any of the acts 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 pulpose for which the labels are intended, the former shall also be liable
under the act notwithstanding the fallure 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
pharmaceutical product or device or its container or label without authority from the legitimate
owners of the trademark or trade name.
SEC. 5. P¢#I.es fi.¢b/c.  The following persons shall be liable for violation(s) of the act:
a)         the manufacturer, importer exporter,  distributor, seller, distributor, trafficker, broker or
donor of the counterfeit pharmaceutical product and their agents, as the case may be;
b)         the possessor of counterfeit phamaceutical product as provided in section 4@) of this
Act;
c)         the manager,  operator or lessee of the laboratory  or laboratory facilities used in the
manufacture of counterfeit pharmaceutical product;
d)         the owner, proprietor, administrator or manager of the drugstore, hospital pharmacy or
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;
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counterfeited shall file an administrative case before the FDA following the procedure
in the preceding section.
SEC. 8. Hearing Of Administrative Coiil'|plalrits and Institution Of Crindnal Action. -
The FDA shall hear and decide administrative complaints filed before the agency following the
rules of procedure provided under Republic Act No. 3720, as aniended, and its Implementing
Rules and Regulations.
Upon prelindnary findings of the conduct of prohibited acts, the Director General shall issue
the proper notices or orders to the person or persons concerned and such person or persons
shall he given an opportunity to he heard before the FDA.
Preventive Closure Order.   A summons with preventive closure order shall be issued against
the warehouse, building, factory, store, shop or any other structure where the said counterfeit
pharmaceutical product  are  contained  or  stored  within  fifteen  (15)  days  upon the  filing  of
administrative complaint.  This is for the purpose of preventing the disposition or tanpering of
evidence, the continuance of acts being complained of, and/or the flight of the Respondent.
After the lapse of the  30-day period, the preventive closure order is deemed lifted without
prejudice to the resolution of the case.
When any violation of any provisions of this Act comes to the knowledge  of the Director
General,  of  such  character  that  a  criminal  prosecution  ought  to  be  instituted  against  the
offender, he shall certify the facts together with the laboratory report, the findings of the FDA,
or other documentary evidence on which the charge is based.
Both criminal and administrative actions may be instituted separately and independent of one
another.
The Director General is hereby authorized to call on the assistance of any Department, Office
or Agency for the effective implementation of the provisions of this Act.
SEC. 9. Penalties.
A. ADMn`usTRATIVE SANCTloNS AND OTIHR REMEDIEs
Upon fmding that the pharmaceutical product examined is counterfeit and the determination of
the parties  liable thereof,  the  FDA  shall  impose  any  or all  of the  following  administrative
penalties and/or pursue other remedies:
1.  (i) Mininum Penalty.  An administrative fine of not less than One hundred thousand
pesos (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 fine of at least Three hundred thousand
pesos  (PIFT300,000.00)  but less than Five hundred thousand pesos  a'IIf500,000.00)
and  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
¢HP500,000.00) and pemianent closure of the establishment concerned as well as the
revocation of its license to do business shall be the maxinum administrative penalty.
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Provided, that if any or all of the instances below occur, the maximum imposable fine of Five
hundred  thousand  pesos  (PHP500,000.00),    revocation  of its  license  to  do  business  and
permanent closure of establishment, and permanent 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:
a.          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 by
the; or
b.         If the Respondent or any of his officer or agent shall break, alter or tanper any
mark or seal used by the FDA  to identify those segregated drugs; or
c.          As a result of the use of the pharmaceutical product found to be counterfeit, the
illness sought to be cured is aggravated or physical injury or suffering results therefrom,
or be the proximate cause of death or permanent disability of the victim or patient.
Any of the imposable penalties in Paragraphs (i), (ii) and (iii) above shall be accompanied by
forfeiture, confiscation and destruction of the pharmaceutical product(s) found to be counterfeit
and  the  equipment,  instrument  and  other  articles  used  in  violation  of  this  Act  or  this
implementing rules and regulations.
2. Other Remedies.
i.          filing of an appropriate proceedings against the registered pharmacist with the
Professional  Regulations  Commission  for imposition of the  appropriate  penalties  as
provided  under  Republic  Act  No.   10918  or  the  Philippine  Pharmacy  Act  or  its
amendment;
ii.         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 shall 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
8. CRIMINAL SANCTIONS
The commission of any of the acts prohibited under Section 4 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 pharmaceutical product as provided for
in Section 4 ®) of this Act; 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 ¢HP100,000.00) 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
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 pharmaceutical product is intended
for aninals; or
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d)         imprisorment 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 pharmaceutical product as may have been segregated and sealed
by the FDA, or who shall break, alter or tamper any mark or seal used by the FDA to
identify those segregated drugs as provided for under Section 6(A) of this Act.   Any
other person  who  breaks,  alters  or  tampers  any  mark  or  seal  used  by  the  FDA  to
identify the segregated pharmaceutical product 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 pharmaceutical product 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 ¢100,000.00) to Five hundred
thousand pesos (PHP500,000.00) shall be meted out; or
D          should a counterfeit pharmaceutical product be the proximate cause of death of
a victim, who unknowingly purchased and took a counterfeit phanaceutical product,
the   penalty   of  life   imprisonment  and   a  fine   of  Five   hundred  thousand  pesos
¢HP500,000.00) to Five million pesos ¢HP5,000,000.00) shall be imposed.
Provided that,  any provision of law to the  contrary notwithstanding,  when any  of the  acts
declared unlawful and prohibited under Section 4 above   is conhitted 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 the Food and Drug Administration, it shall be deemed as an offense involving economic
sabotage   and   punishable   by   life   imprisonment   and   a   fine   of   Five   Million   Pesos
(Php5,000,000.00) to Ten Million Pesos ¢hpl 0,000,000.00).
In case any Act prohibited in Section 4 of this Act is also punishable under other laws, the
offender  shall,  if warranted  by  the  evidence,  be  prosecuted  under  the  law prescribing  the
highest penalty.
When the sale, offering for sale, donation, distribution, trafficking, or brokering of counterfeit
phamaceutical  product,  or  the  sale  of 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
pharmaceutical product or device or its container or label without authority from the legitimate
owners of the trademark or trade name, as prohibited in Section 4 of this Act 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 of 2012".  Provided,
that the penalty to be imposed shall be one (1) degree higher than that provided under this Act.
SEC.  10.  IuterLagenay, Stakeholders  and International Cooperoitton. - AJ:A reA!evarlit
inter-agency,  other  stakeholders  and  international  instruments,  programs,  cooperation,  and
arrangements agreed, whether in regulatory or criminal matters, to the widest extent possible
for the purposes  of detection,  investigation,  suppression,  proceedings  or effective  response
concerning administrative or criminal offenses related to counterfeit pharmaceutical products,
or for the collection of evidence, shall be given full force and effect.
SEC.     11.     Establishments'    Responsibilities.     -     AIL    pharm;aceutieal    prodrct
establishments,  including  the  licensed  and  registered  pharmacist  under  their  employ,  shall
ensure at all times that phamaceutical products satisfies the requirements of pharmaceutical
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products' laws and standards relevant to their activities in the pharmaceutical product supply
chain and that control systems are in place to prevent or eliminate counterfeit pharmaceutical
products.
Pharmaceutical product establishments  shall be knowledgeable  of the  specific  requirements
and standards of pharmaceutical product laws and regulations relevant to their activities in the
phamaceutical product supply chain and the procedures adopted by the regulatory authority.
If  a  pharmaceutical   product   establishment   considers   or  has   reason  to   believe  that   a
pharmaceutical product which it produced, processed, imported, distributed, sold, offered for
sale  is  counterfeit,  it  shall  immediately  initiate  procedures  to  withdraw the pharmaceutical
product in question form the market and inform the regulatory authority.
Pharmaceutical product establishments shall allow inspection of their business and collaborate
with  the  regulatory  authority  on  actions  taken  to  avoid  risks  posed  by  the  counterfeit
pharmaceutical product they have supplied.
SEC. J2. Rapid ,4/eJt fys/em. - The rapid alert system in place for the notification of
direct  or  indirect  risk to  human  health  due  to  counterfeit pharmaceutical  product  shall  be
strengthened by the FDA.
SEC. 13. Strengthening the Pharmacoviguance System - Tlrve FDA., in coordiun:rfuon
with the DOH or other stakeholders shall strengthen the existing Pharmacovigilance System.
Within one hundred twenty (120) days from effectivity of this Act, the FDA shall establish a
phamacovigilance unit within its CDRR with appropriate staffing of officers and persomel
and experts and be regularly allocated with appropriate budget.
SEC. 14. Training and Consumer Advocaay and Education. - Trainiing, oirenidfuon,
education,   and   other   advocacy   activities   shall   be   regularly   provided   by   the   FDA   to
pharmaceutical product establishments, communities, and other sectors of the community.
A consumer advocacy and education program shall be developed and implemented by the FDA
in partnership with relevant NGOs, private organizations, coalitious, academic institutions, or
other  relevant  government  agencies.    The  FDA  shall  allocate  and  provide  frods  for  the
development and implementation of training and consumer advocacy and education programs.
SEC. J5. 4zpropr!.¢frous. - The amount necessary to carry out the provisions of this
Act shall be included in the General Appropriatious Act for the year following its enactment
and every year thereafter.
SEC. 16. Erforcement and Implementation. -The FDA of the Depart.nem o£ Health
is hereby authorized to administer and supervise the implementation of this Act subject to the
applicable provisions of Republic Act No. 10175 or the "Cybercrime Prevention Act of 2012".
SEC. 17. Implementing Rules and Regulations. -The FDA, in oouswh+at3\or\ with the
stakeholders,  shall promulgate the  implementing rules  and regulations within One Hundred
Twenty (120) days from the effectivity of this Act.
SEC. 18. Iuterprctodion and Construction im Favor Of Protection Of Publie Health. -
All doubts in the implementation and interpretation of the provisions of this Act, including its
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implementing  rules  and  regulations,  shall  be  resolved  in  favor  of protecting  public  health
against counterfeit pharmaceutical products.
SEC.  Jg.  Separ¢bl.Jrty  CJ¢use.  -  If any  provision  of this  Act  is  held  invalid  or
uncoustitutional, the sane shall not affect the validity and effectivity of the other provisions
hereof.
SEC. 20.   jRepcaJI.ng CJ¢use. - Republic Act No.  8203 is hereby repealed.   All other
laws, decrees, executive orders and rules and regulations contrary to or inconsistent with the
provisions of this Act are hereby repealed, amended or modified accordingly.
SEC. 2J. Ejj7electr.tirty7. -This Act shall take effect fifteen (15) days after its publication
in the Official Gazette or in a newspaper of general circulation.
Approved,
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