TWENTIETH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
First Regular Session
S.B. No.
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SENATE
564
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of Ini'
25 JUL 14 P3 '48
RI-CElVtD BY.
INTRODUCED BY SENATOR RISA HONTIVEROS
AN ACT
STRENGTHENING THE REGULATORY SYSTEM IN THE COUNTRY TO 
PREVENT COUNTERFEIT PHARMACEUTICAL PRODUCTS, DECLARING 
LARGE-SCALE COUNTERFEITING ACTIVITIES AS AN OFFENSE INVOLVING 
ECONOMIC SABOTAGE, PROVIDING FOR THE PROHIBITIONS AND 
PENALTIES FOR VIOLATIONS THEREOF, AND REPEALING FOR THE 
PURPOSE REPUBLIC ACT NO. 8203 OTHERWISE KNOWN AS THE "SPECIAL 
LAW ON COUNTERFEIT DRUGS"
EXPLANATORY NOTE
Republic Act 8203, also known as the Special Law on Counterfeit Drugs, defines 
counterfeit medicines, declares prohibited acts, identifies liabie parties, and imposes 
administrative sanctions and penaities. Enacted in September 1996, this law has been 
in force for over 29 years. Despite this, counterfeit drugs continue to proliferate in the 
country1.
The enforcement of R.A. 8203 has been hampered by several counterfeit drug- 
related cases in which Supreme Court rulings favored the accused.2 In one decision, 
the Court held that "Republic Act No. 9502, or the Universally Accessible Cheaper and 
Quality Medicines Act of 2008, nullifies the purpose of R.A. 8203, effectively rendering 
it meaningless and without function."3 Furthermore, several laws enacted by Congress, 
including R.A. 9502, Republic Act 9711 (the FDA Act of 2009), and Repubiic Act 10918 
(the Phiiippine Pharmacy Law), contain inconsistent definitions of the term "drugs," 
which has complicated enforcement efforts.
Pharmaceutical crimes and the spread of falsified medicines have become 
increasingly complex and multifaceted. As an archipelago, the Philippines is particularly 
vulnerable to the illegal entry of smuggled goods, including medicines. In addition, the 
rise of internet sales of pharmaceutical products has further contributed to the influx
1 Medicines Transparency Alliance Report, Addressing the Barriers to Effective Monitoring, Reporting and 
Containment of Spurious/Substandard/Falsely-Labelled/Falsified/Counterfeit Medical Products through 
Sustainable Multi-stakeholder Collaboration and Community/Consumer-based Interventions, 2015. Available at: 
http;//www.who.int/medicines/areas/coordinationySSFFC_Report.pdf
2 Ibid.
3 G.R. No. 149907, Roma Drug, et al. v. Glaxo SmithKline, et al.
1


of counterfeit medicines circulating domestically and internationally.
This bill seeks to strengthen prohibitions against counterfeit pharmaceutical 
products by declaring the manufacture, importation, distribution, sale, offering for 
sale, donation, trafficking, brokering, exportation, or possession of counterfeit 
pharmaceutical products as acts of economic sabotage. It also proposes stricter 
penalties for violations to effectively address the ongoing threat counterfeit medicines 
pose to public health.
Medicines must conform to national and international standards of quality, 
efficacy, and safety. Failure to meet these standards not only endangers health but 
also introduces additional risks. This bill will complement Republic Act No. 11223, or 
the Universal Health Care Act, which ensures comprehensive outpatient drug benefits 
and improves access to quality healthcare products for all Filipinos.
In view of the foregoing, the passage of this bill is earnestly sought.
RISA HONTIVEROS b
Senator


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TWENTIETH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
First Regular Session
)
)
)
SENATE
W.' I0flicr of t:
25 JUL 14 P3 -.48
S.B. No.
INTRODUCED BY SENATOR RISA HONTIVEROS
AN ACT
STRENGTHENING THE REGULATORY SYSTEM IN THE COUNTRY TO PREVENT 
COUNTERFEIT PHARMACEUTICAL PRODUCTS, DECLARING LARGE-SCALE 
COUNTERFEITING ACTIVITIES AS AN OFFENSE INVOLVING ECONOMIC 
SABOTAGE, PROVIDING FOR THE PROHIBITIONS AND PENALTIES FOR 
VIOLATIONS THEREOF, AND REPEALING FOR THE PURPOSE REPUBLIC ACT 
NO. 8203 OTHERWISE KNOWN AS THE "SPECIAL LAW ON COUNTERFEIT 
DRUGS"
Be it enacted by the Senate and the House of Representatives of the Philippines in 
Congress assembled:
SECTION 1. Title. — This Act shall be known as the "Counterfeit Pharmaceutical 
Products Prevention Act."
SEC. 2. Declaration of Policy. - It is the policy of the State to protect and 
promote the right to health of the people and instill health consciousness among them. 
It is likewise the policy of the State to establish and maintain an effective food and drug 
regulatory system and undertake appropriate health manpower development and 
research responsive to the country's health needs and problems.
To this end, the State shall adopt, support, establish, institutionalize, improve, and 
maintain structures, processes, mechanisms, and initiatives that are aimed at, and 
designed to strengthen its capability to prevent counterfeiting activities or detect, 
investigate, suppress, and more effectively respond to actions that may result in 
counterfeit pharmaceutical products.
In furtherance of the purpose of this Act, the State shall provide stricter prohibitions 
and stiffer penalties to prevent counterfeit pharmaceutical products, declaring large 
scale counterfeiting activities as offenses involving economic sabotage.
SEC. 3. Definition of Terms. - As used in this Act:
a. Blopharmaceuticals refer to pharmaceutical products that are used for 
therapeutic or 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 in vivo diagnostic purposes;


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b. Brokering refers to any act of facilitating the disposal or sale of counterfeit 
pharmaceutical products, through offline and online services, including acts of 
agency;
c. Counterfeit pharmaceuticai products refer to pharmaceutical products that fall 
under any of the following conditions, which result in the reduction of the safety, 
efficacy, quality, strength, or purity of pharmaceutical products:
1) With correct ingredients but do not contain the amounts as claimed;
2) With wrong ingredients;
3) Without active ingredients; or
4) 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.
The term shall also refer to products that are deliberately and fraudulently 
misrepresented with respect to their identity, composition and/or source or with 
fake packaging, which applies to both branded and generic products, including 
the following:
1) The pharmaceutical product itself or the container or labelling thereof or 
any part of such product, container, or labelling, bearing without 
authorization the trademark, trade name, or other identification marks or 
imprints or any likeness to that which is owned or registered in the 
Intellectual Property Office (IPO) in the name of another natural or 
juridical person;
2) A pharmaceutical product refilled in containers bearing legitimate labels or 
marks, without authority; and
3) A pharmaceutical product derived from any of the following instances:
i. 
Those stolen from the legitimate supply chain, including 
manufacturers, wholesalers, pharmacies or prescribers;
ii. 
Those containing dosages of the active ingredient higher than the 
nationally approved or therapeutic dosage;
iii. Those obtained fraudulently through healthcare professionals or by 
using forged prescriptions; or
iv. Those diverted from licit and legitimate use.
For this purpose, the terms:


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1) Identity refexs to the name, labelling, or packaging or to documents that 
support the authenticity of an authorized pharmaceutical product;
2) Composition refers to any ingredient or component of the pharmaceutical 
product in accordance with applicable specifications authorized or 
recognized by the Food and Drug Administration (FDA); and
3) Source refers to the identification, including name and address, of the 
marketing authorization holder, manufacturer, importer, exporter, 
distributor or retailer, as applicable.
d. Counterfeiting activities refer to the illicit manufacture, importation, distribution, 
sale, or offer for sale, donation, trafficking, brokering, exportation, transfer, use, 
testing, promotion, advertising, or sponsorship, or possession of counterfeit 
labels or pharmaceutical products;
e. Drugs 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 animals, including 
but not 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;
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 drugs which are articles of plant or animal origin 
used in folk medicine, which are:
i. 
Recognized in the Philippine National Drug Formulary;
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;
iv. In finished or ready-to-use dosage form; and
V. Intended for use as a component of any of the articles specified in 
clauses (i), (ii), (iii), and (iv).


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f. Economic Sabotage refers to any of the acts that are declared unlawful and 
prohibited under this Act when committed and the amount of the counterfeit 
pharmaceutical ;abels or products involved is One Million Pesos (Php 
1,000,000.00) or more, whether as a single label or product or totality of different 
pharmaceutical labels or products, as determined by the FDA;
g. Establishment refers to a natural or juridical person engaged in the manufacture, 
importation, exportation, sale, offer for sale, distribution, donation, trafficking, 
brokering, transfer, use, testing, promotion, advertising, or sponsorship of 
pharmaceutical products, including the facilities, vehicles, and installations 
needed for its activities;
h. Large scale counterfeiting activities refer to counterfeiting activities defined in 
this Act and the value of the counterfeit labels or pharmaceutical products 
involved is One Million Pesos (Php 1,000,000.00) or more, whether as a single 
label or pharmaceutical product, or totality of different pharmaceutical labels or 
products, as determined by the FDA. Large-scale counterfeiting activities shall 
be deemed as economic sabotage;
i. 
Medicines refers to drugs in their appropriate dosage forms, with assured quality, 
safety and efficacy for humans or animals, or both;
j. Online Service refers to the sale, offering for sale, donation, distribution, 
trafficking, brokering, promotion, advertising, or sponsorship of pharmaceutical 
products, 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 term 
shall also cover online selling or online pharmacy or other similar services;
k. Owner refers to a person or group of persons who is the owner of a business or 
business undertaking in the Philippines or the branch manager or operator, 
licensee, franchisee, or any person acting on behalf of the business entity;
l. Pharmaceutical Products refer to drugs, medicines, biologicals, pharmaceutical 
and biopharmaceutical products/specialties, veterinary biologies and veterinary 
medicinal products;
m. Residence refers to a private dwelling or abode where a person lives, either as 
owner or lessee, or usufructuary including, 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 same shall not fall as a residence but 
be considered as establishment;
n. Trafficking refers to the manufacturing, importing, exporting, storing, 
transporting, donating, dispatching, dispatching in transit, dispatching in free 
trade zones, trans-shipping, distributing, brokering, advertising, promoting, 
sponsorship, offering, keeping for offer, selling, or supplying, dispensing, or


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possession of counterfeit pharmaceutical products, whether on one's own behalf 
or for a third party.
SEC. 4. Prohibited Acts. - The following acts are prohibited:
a) The manufacture, importation, distribution, sale, offering for sale, donation, 
trafficking, brokering, exportation, or possession of counterfeit pharmaceutical 
products.
The presence or availability of counterfeit pharmaceutical products within the 
premises of any entity engaged in the manufacture, importation, distribution, 
sale, offering for sale, donation, trafficking, brokering, or exportation of 
pharmaceutical products or in a private residence, or in a 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, official receipts, delivery receipt, or 
their equivalence showing their purchase or receipt from an establishment 
suspected by them of dealing 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 
turned over to the FDA within a period often (10) days from the date of purchase 
or receipt of such counterfeit pharmaceutical product as indicated in the sales 
invoice, official receipt, delivery receipt, or their equivalence to the time the 
counterfeit pharmaceutical products are reported and turned over to the FDA;
b) Possession of any counterfeit pharmaceutical product for personal use. 
However, any person found in possession of counterfeit pharmaceutical 
products, in violation of this subsection, shall be exempted from liability under 
the provisions of this Act after:
i. Presentation of sales invoices, official receipt, or other legally acceptable 
documents evidencing his purchase or receipt thereof from a drugstore, 
hospital pharmacy or dispensary, or any other person or place duly 
licensed to sell and/or dispense pharmaceutical products at retail, 
indicating therein the batch and lot numbers, as well as the expiry dates 
of such pharmaceutical products, or legally acceptable documents 
evidencing his receipt in case of donation or other acts of gratuity; or
ii. Presentation of certificates and other documents evidencing the 
importation or exportation of the counterfeit pharmaceutical products 
found in his possession as required by existing laws, including those 
documents required in the preceding paragraph covering the transactions 
involving counterfeit drugs.
In both cases, the subject counterfeit pharmaceutical products must neither on 
its face appear to be counterfeit pharmaceutical products, nor bear any marking


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or any patently unusual characteristic sufficient to arouse the suspicion that such 
pharmaceutical products are counterfeit. The amount or volume of counterfeit 
pharmaceutical products should not negate or be inconsistent also with the 
averment that the same is for personal use, notwithstanding the presentation by 
the possessor of medical records and other similar documents accompanying and 
justifying the use of such pharmaceutical product;
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 or counterfeiting activity: 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 purpose for which the labels are intended, the 
former shall also be liable under this 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 pharmaceutical product or device or its container or label 
without authority from the legitimate owners of the trademark or trade name.
SEC. 5.
this Act:
Parties Liable. The following persons shall be liable for violations of
a) The manufacturer, importer exporter, distributor, seller, distributor, trafficker, 
broker, promoter, advertiser, sponsor, or donor of the counterfeit 
pharmaceutical product and their agents, as the case may be;
b) The possessor of counterfeit pharmaceutical product as provided in Section 
4(b) 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;
e) The licensed and registered pharmacist of the establishment where the 
counterfeit pharmaceutical product is sold, dispensed, or found; and
f) The officer or officers of the corporation, partnership, association, or entity, 
should the offense be committed by a juridical person: Provided, That if such 
officer is an alien, he shall, in addition to the penalties herein prescribed, be 
deported without further proceedings.
SEC. 6. Liability under Other Laws. - A prosecution under this Act shall be 
without prejudice to any liability for violation of any provision of other laws.


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SEC. 7. Administrative Proceedings. - Notwithstanding any provision of law, 
the FDA is hereby further authorized to undertake the following administrative actions:
a) Procedure when Counterfeit Pharmaceutical Product is Monitored in the Market 
Pursuant to a Routine Inspection of the Food and Drug Regulation Officer 
(FDRO):
If the FDRO, in the course of his routine or regular inspection of a factory, 
warehouse, establishment, or vehicle in which drugs are manufactured, 
processed, packed, or held for introduction into domestic commerce, or export, 
held for donation, or further trafficking, or brokering, and all pertinent 
equipment, finished or unfinished materials, containers, and labeling therein, 
upon the authority conferred by Section 27 of Republic Act No. 3720, otherwise 
known as the "Food, Drug, and Cosmetics Act," as amended, or any other law, 
shall suspect certain stocks as a 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.
As an integral part of the inspection, the FDRO is further authorized to require 
and take copies of documents related to the covered activities subject of 
inspection, or capture photographs of documents, or obtain voice or video 
recordings of the premises and/or equipment, whenever necessary, and solely 
as an evidence on the inspection conducted, subject to the rules on 
confidentiality;
b) Procedure When Information is Received About the Presence of Counterfeit 
Pharmaceutical Products in the Possession of Any Person or Establishment:
1) Any information, either referred by the government office or officer or from 
anonymous sources or persons requesting confidentiality of their identities, 
on the existence of suspected counterfeit pharmaceutical product in the 
possession of any manufacturer, seller, or distributor, shall undergo the 
verification process by the FDRO, or any officer deputized or authorized by 
the FDA Director General. Verification process shall follow the existing 
system and procedure in the conduct of case build-up, investigation or other 
appropriate interventions adopted by the FDA;
2) If the counterfeit pharmaceutical product is located in an establishment:
i. Seize the counterfeit pharmaceutical product and take them into custody; 
and
ii. Proceed in filing a criminal complaint and/or administrative complaint;
3) If the counterfeit pharmaceutical product is located in a private residence: 
i. Secure a valid search warrant from a competent court;


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ii. After having obtained the search v\/arrant, inventory and seize such 
counterfeit pharmaceutical product and take them into custody; and
iii. Proceed in filing a criminal complaint and/or administrative complaint.
c) Findings of Counterfeit Drug by Owners of Trademarks, Trade Names or Other 
Identifying Marks:
Owners 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.
SEC. 8. Hearing of Administrative Complaints and Institution of 
Criminal Action. - The FDA shall hear and decide administrative complaints filed 
before the agency following its existing rules of administrative procedure.
Upon preliminary findings of the conduct of prohibited acts, the FDA Director General 
shall issue the proper notices or orders to the concerned persons who shall be given an 
opportunity to be heard before the FDA.
If seizure cannot be reasonably effected, a 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, or in case of vehicles, 
the preventive impounding order thereof, within fifteen (15) days upon the filing of the 
administrative complaint.
After the lapse of the 30-day period, the preventive closure or impounding 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 FDA 
Director General, of such character that a criminal prosecution ought to be instituted 
against the offender, the FDA Director General shall certify the facts together with the 
laboratory or verification report, the findings of the FDA, and other documentary 
evidence on which the charge is based.
Both criminal and administrative actions may be instituted separately and independent 
of one another.
The FDA Director General is hereby authorized to enlist the assistance of the national 
or local law enforcement agencies, or any department, office, agency, organization, 
body, and experts.
SEC. 9. Penalties.
A. ADMINISTRATIVE SANCTIONS AND OTHER REMEDIES
1) Upon finding 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:
8


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a)
b)
C)
Minimum Penalty. An administrative fine of not less than One 
hundred thousand pesos (PHPlOO,000.00) but not more than Five 
hundred thousand pesos (PHP500,000.00);
Medium Penalty. An administrative fine of at least Three hundred 
thousand pesos (PHP300,000.00) but not less than Five hundred 
thousand pesos (PFIP500/000.00) and suspension not exceeding one 
(1) year or revocation of its license to do business;
Maximum Penalty. An administrative fine of Five hundred thousand 
pesos (PHP500,000.00) and permanent closure of the establishment 
concerned as well as the revocation of its license to do business;
Provided, That if any or all of the instances below occur, a fine of Five million 
pesos (PHP5,000,000.00), revocation of license to do business, permanent 
closure of the establishment, and permanent disqualification of the person 
concerned, whether natural or juridical, from owning or operating a drug 
establishment or outlet, as the case may be, shall be imposed:
a) If the respondent or any of his officers or agents shall conceal, 
substitute, dispose, or destroy any pharmaceutical product that may 
have been segregated and sealed by the FDA;
b) If the respondent or any of his officers or agents shall break, alter, 
or tamper any mark or seal used by the FDA to identify those 
segregated drugs;
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; or
d) If the act constitutes large-scale counterfeiting activity.
Any of the imposable penalties in the preceding paragraphs shall be accompanied 
by forfeiture, confiscation and destruction of the pharmaceutical products found 
to be counterfeit and the equipment, instrument vehicles, and other articles used 
in violation of this Act or its implementing rules and regulations.
2) Other Remedies.
a) Filing of appropriate proceedings against the licensed and registered 
pharmacist with the Professional Regulations Commission for 
imposition of the appropriate penalties as provided under Republic 
Act No. 10918, otherwise known as the "Philippine Pharmacy Act;" 
or its amendment;
b) Filing of criminal charges against the violator, which can be instituted 
independently from the administrative case: Provided, That the


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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.
B. 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 or a fine 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 imprisonment and fine 
at the discretion of the court, for mere possession of counterfeit 
pharmaceutical product for personal use as provided for in Section 4 
(b) of this Act;
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 
(PHPlOO,000.00) but not more than Five hundred thousand pesos 
(PFIP500,000.00) or both such imprisonment and fine at the discretion 
of the court in any other case mentioned in Section 4 of the Act: 
Provided, That if the offender is a manufacturer, importer, or 
distributor of the counterfeit pharmaceutical product, the penalty of 
imprisonment and a fine shall be imposed;
c) 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 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 9 (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;
d) Imprisonment from twelve (12) years to fifteen (15) years and a fine 
of One million pesos (PHP1,000,000.00) shall be imposed if, as a result 
of the use of the pharmaceutical products found to be counterfeit, the 
illness sought to be cured is aggravated or physical injury or suffering 
results therefrom; or
e) The penalty of life imprisonment and a fine of Three million pesos 
(PHP3,000,000.00) to Five million pesos (PHP5,000,000.00) shall be 
imposed should a counterfeit pharmaceutical product be the proximate 
cause of death of a victim, who unknowingly purchased and took a 
counterfeit pharmaceutical product.
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Provided, That when any of the acts declared unlawful and prohibited under 
Section 4 above is committed and the market value of the counterfeit label or 
pharmaceutical products involved, whether as a single label or product or totality 
of different labels or pharmaceutical products, is One million pesos 
(Phpl,000,000.00) or more, as may be determined by the FDA, it shall be 
deemed as a large-scale counterfeiting activity and 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 (Phpl0,000,000.00).
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 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 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, otherwise known as 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. Inter-agency, Stakeholders, and International Cooperation. -
All relevant inter-agency, stakeholders and international instruments, programs, 
cooperation, and arrangements agreed, whether in regulatory or criminal matters, to 
the widest extent possible for 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.
The FDA shall, in coordination with the Bureau of Customs (BOC) or other concerned 
agencies, undertake and adopt measures relating to border control such as, but not 
limited to, sampling and examination, of every incoming shipment of pharmaceutical 
products, or limiting the ports of entry for imported pharmaceutical products, in 
accordance with existing laws and regulations.
A National Network to address the prevention of activities, or to detect, investigate, 
suppress, and more effectively respond to actions that may result in counterfeit 
pharmaceutical products shall be established.
The FDA shall lead the network, having the technical and administrative functions 
related to pharmaceutical product regulation and control, including the operation and 
maintenance of quality control laboratories.
The National Network shall be composed of the Department of Health (DOH), 
Department of Justice, Department of the Interior and Local Government, Department 
of Trade and Industry, BOC, National Telecommunications Commission, National Bureau
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of Investigation, Philippine National Police, and other government agencies which shall 
be determined by the FDA. The FDA may engage with and tap industry associations, 
relevant consumer groups, and local or international experts, organizations or bodies in 
the field of pharmaceutical product regulation and enforcement for the effective 
implementation of this Act.
The FDA is authorized to design a system of document classification based on secrecy 
and need to know basis, and to acquire the necessary resources to include primarily, 
but not limited to, personnel training, equipment acquisition for mobility, 
communication, and security, and needed critical structures and fortifications to 
effectively carry out its duties and functions pursuant to this Act.
SEC. 11. Responsibility of Establishments and Other Stakeholders. - All
pharmaceutical product establishments, including licensed and registered pharmacists, 
and personnel under their employment, shall ensure at all times that pharmaceutical 
products satisfies the requirements of this Act, other pharmaceutical products' laws, 
rules, 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 pharmaceutical 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 that it produced, processed, imported, distributed, sold, offered 
for sale, donated, brokered, transferred, used, tested, promoted, advertised, or 
sponsored is counterfeit, it shall immediately withdraw the pharmaceutical product in 
question from the market and inform immediately the FDA.
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 products they have manufactured and distributed.
In the case of online services, the obligations and responsibilities of online or similar 
service providers and other parties in transactions through and with the use of 
information and communication technology system under Republic Act No. 11976, 
otherwise known as the "Internet Transactions Act of 2023," its implementing rules and 
regulations including appropriate rules issued by the FDA in line with section 10 of this 
Act are hereby adopted.
Local government units (LGUs) are hereby mandated to enact ordinances that shall 
supplement the implementation of this Act in the exercise of their mandates to promote 
health and safety, foster the general welfare, enhance economic prosperity and social 
justice, and preserve the comfort and convenience of their inhabitants, among others, 
pursuant to Section 16 and other pertinent provisions of Republic Act No. 7160, 
otherwise known as the "Local Government Code of 1991," as amended.
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SEC. 12. Rapid Alert System. - The rapid alert system in place for the 
notification of direct or indirect risk to human health due to counterfeit pharmaceutical 
products shall be strengthened by the FDA. Emphasis shall be made on the 
strengthening and full implementation of science-based risk analysis, emergency 
measures, crisis management, and stakeholders involvement and participation.
The State's poiicy on whistle blowing and whistie biower's protection is hereby reiterated 
and adopted. The FDA shall institutionalize a whistleblower policy in coordination with 
concerned government agencies and stakeholders.
SEC. 13. Strengthening the Pharmacovigilance System. - In addition to 
Sections 10,11, and 12 of this Act, the FDA shaii, in coordination with the DOH or other 
stakeholders, strengthen the existing National Policy and Program on 
Pharmacovigilance, underscoring the adoption, support, estabiishment, 
institutionaiization. Improvement and maintenance of structures, processes, 
mechanisms, and initiatives that are aimed, directed, and designed to strengthen the 
government and other stakeholders' capability to prevent activities that may result, or 
detect, investigate, suppress, and more effectively respond to actions that result in 
counterfeit pharmaceutical products.
Within one hundred twenty (120) days from effectivity of this Act, the FDA shall, 
pursuant to its authority to create organizational units under Republic Act No. 9711, 
otherwise known as the "Food and Drug Administration Act of 2009," strengthen its 
existing pharmacovigiiance unit and estabiish a market surveiiiance and control unit 
within its Center for Drug Reguiation and Research and its Fieid Regulatory Operations 
Office.
Section 35 of Republic Act No. 9711 is hereby reiterated mandating the FDA to improve, 
upgrade, and increase the capabiiity of the agency to test, calibrate, assay, and examine 
samples of pharmaceutical products. The FDA shall establish at least one (1) testing 
laboratory each in Luzon, Visayas and Mindanao, which shall have the necessary and 
appropriate state-of-the-art laboratory equipment and qualified and duly trained 
technical and other personnel complement. The testing iaboratories may be increased 
by the FDA Director General, upon approval of the Secretary of Health.
The FDA Director General may call upon other government and private testing 
laboratories to conduct testing, calibration, assay, and examination of samples of 
pharmaceutical products: Provided, That the private testing iaboratories are accredited 
by the Philippine Accreditation Office of the Department of Trade and Industry (DTI) 
and the FDA.
The FDA Director General shall, in consuitation with the Secretary of the DOH, 
determine the organizational structure and staffing pattern of the Center for Drug 
Reguiation and Research in accordance with the revised compensation and position 
classification system subject to the evaluation and approval of the Department of 
Budget and Management and in compliance with the civil service and other pertinent 
laws, rules and regulations.
SEC. 14. Training and Consumer Advocacy and Education. - Training, 
education, and other advocacy activities shall be regularly provided by the FDA to
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pharmaceutical product establishments, communities, and other sectors. As such, 
Proclamation No. 2082 which proclaims every third week of November of every year as 
the National Consciousness Week Against Counterfeit Medicines, including all directives 
therein are hereby adopted and reiterated for implementation by the FDA: Provided, 
That the word "medicine" shall now be termed as "pharmaceutical products".
A consumer advocacy and education program shall be developed and implemented by 
the FDA in partnership with relevant NGOs, private organizations, coalitions, academic 
institutions, or government agencies.
SEC. 15. 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. 16. Enforcement and Implementation. - The FDA is hereby authorized 
to administer and supervise the implementation of this Act subject to the applicable 
provisions of Republic Act No. 10175, otherwise known the "Cybercrime Prevention Act 
of 2012."
SEC. 17. Implementing Rules and Regulations. - The FDA shall, in 
consultation with concerned government agencies and other stakeholders, promulgate 
the implementing rules and regulations within one hundred twenty (120) days from the 
effectivity of this Act.
SEC. 18. Interpretation and Construction in Favor of Protection of 
Public Health. - All doubts in the implementation and interpretation of the provisions 
of this Act, including its implementing rules and regulations, shall be resolved in favor 
of protecting public health against counterfeit pharmaceutical products.
SEC. 19. Separability Clause. - If any provision of this Act is held invalid or 
unconstitutional, the same shall not affect the validity and effectivity of the other 
provisions hereof.
SEC. 20. Repealing Clause. - Republic Act No. 8203, otherwise known as the 
"Special Law on Counterfeit Drugs" 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. 21. Effectivity. - 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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