Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City 
NINETEENTH CONGRESS 
First Regular Session 
HOUSE BILL NO. ____ 
Introduced by HON. LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR.,  
HON. MIGUEL LUIS R. VILLAFUERTE, HON. TSUYOSHI ANTHONY G. HORIBATA 
AND HON. NICOLAS “NICK” C. ENCISO VIII 
EXPLANATORY NOTE 
Republic Act No. 8203 or the Special Law on Counterfeit Drugs defines counterfeit 
medicines, declares prohibited acts, identifies liable parties, and imposes administrative 
sanctions and penalties involved. The law was enacted in September 1996 and is in 
force for more than two decades. In spite of this, counterfeit drugs still proliferate in the 
country.  
The implementation of RA 8203 has been affected by several counterfeit drug-related 
cases where the Supreme Court ruling favored the accused. In one case, the court 
stated that Republic Act No. 9502 or the Universally Accessible Cheaper and Quality 
Medicines Act of 2008 nullifies the purpose of RA 8203 so the latter loses all its meaning 
and function. Several laws enacted by Congress also significantly affected the provisions 
of RA 8203. Alongside RA 9502, Republic Act No. 9711 or the FDA Act of 2009 and 
Republic Act No. 10918 or the Philippine Pharmacy Law, all have inconsistent definition 
of "drugs". 
Pharmaceutical crimes and the proliferation of falsified medicines are becoming more 
complex and compounded. The Philippines, being an archipelago, is vulnerable to illegal 
entry of smuggled goods including medicines. Additionally, internet sales of 
pharmaceutical products grow coming from the increasing cases of counterfeit 
pharmaceutical products entering and moving through countries worldwide. 
This bill seeks to (1) strengthen the prohibitions against counterfeit pharmaceutical 
products, (2) declare the manufacture, importation, distribution, sale, offering for sale, 
donation, trafficking, brokering, exportation, or possession of counterfeit pharmaceutical 
products as offenses involving economic sabotage, and (3) provide stricter penalties for 
violations of this Act. This is to address the continuing real threat that counterfeit 
pharmaceutical products present to Filipinos. 
August 23, 2022
2:00 pm
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Our medicines must conform to national and international standards of quality, efficacy, 
and safety. Otherwise, it may potentially harm and even create additional health risks. 
This bill will also complement Republic Act No. 11223 or the Universal Health Care Act 
which implements a comprehensive outpatient drug benefit and ensures that quality 
health care goods are accessible to all Filipinos.  
In view of the foregoing, the passage of this bill is earnestly sought. 
LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR. 
MIGUEL LUIS R. VILLAFUERTE  
TSUYOSHI ANTHONY G. HORIBATA 
NICOLAS “NICK” C. ENCISO VIII 


Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City 
NINETEENTH CONGRESS 
First Regular Session 
HOUSE BILL NO. ____ 
Introduced by HON. LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR.,  
HON. MIGUEL LUIS R. VILLAFUERTE, HON. TSUYOSHI ANTHONY G. HORIBATA 
AND HON. NICOLAS “NICK” C. ENCISO VIII 
AN ACT 
STRENGTHENING THE REGULATORY SYSTEM IN THE COUNTRY TO COMBAT 
COUNTERFEIT PHARMACEUTICAL PRODUCTS, DECLARING THE 
MANUFACTURE, IMPORTATION, DISTRIBUTION, SALE OR OFFER FOR SALE, 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 OR THE "SPECIAL LAW ON COUNTERFEIT 
DRUGS" 
Be it enacted by the Senate and House of Representatives of the Philippines in 
Congress assembled: 
ARTICLE I 
GENERAL PROVISIONS 
Section 1. Short 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, under Article II, Section 15 of 
the 1987 Constitution, 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 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. 
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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 sale, or possession of counterfeit pharmaceutical products as offenses involving 
economic sabotage; and provide stricter penalties for violations of the Act. 
 
Sec. 3. Definition of Terms. – 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 
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 purposes. 
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. with less than eighty percent (80%) of the active ingredient it purports to 
possess as distinguished from an adulterated pharmaceutical product 
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: 


 
 
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 
pharmaceutical product in accordance with applicable specifications 
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. 
Any consideration related to intellectual property rights does not fall within this 
definition. 
e) 
"Director General" shall refer to the Director General of the FDA. 
f) 
"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 
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 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; 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.   intended for use as a component of any of the articles specified in 
clauses (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 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 pharmaceutical products) is One Million Pesos (Php1,000,000.00) 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, 
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. 
l)   "LSD" shall refer to the laboratories under the FDA including those private 
laboratories accredited by the agency to conduct particular scope of analysis. 
m) 
"LSSC" shall refer to the Legal Services Support Center of the FDA. 
n) 
"Medicines" shall refer to drugs in their appropriate dosage forms, with assured 
quality, 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 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 Services. 
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 same 
shall not fall as residence but be considered as establishment. 
 
Sec. 4. Prohibited Acts. – The following acts are declared unlawful 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. 
 
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 pharmaceutical products involving the trademarks, trade 
names and other similar identifying marks registered in their names: Provided, 


 
 
that such material information and counterfeit pharmaceutical products shall be 
reported and immediately turned 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, hospital pharmacy 
or dispensary, or any other person or place duly licensed to sell and/or dispense 
pharmaceutical 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 
pharmaceutical products; 
 
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 pharmaceutical 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 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: 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 
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 pharmaceutical product or device or its container or label without 
authority from the 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 
pharmaceutical product(s) involved (whether as a single product or totality of 
different pharmaceutical products) is one million pesos (PhP 1,000,000.00) or 
more, as valued by the Food and Drug Administration, they shall be deemed as 
an offensive involving economic sabotage. 
 
Sec. 5. Parties Liable. – The following persons shall be liable for violation(s) of the act: 
a) 
the manufacturer, importer exporter, distributor, seller, trafficker, broker 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 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 
registered pharmacist of the outlet where the counterfeit pharmaceutical product 
is sold or found, who sells or dispenses such pharmaceutical products to a third 
party; and 
f) 
should the offense be committed by a juridical person the penalty shall be 
imposed upon the officer or officers of the corporation, partnership, association 
or entity responsible for 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. Liability under Other Laws. – A prosecution under this Act shall be without 
prejudice to any liability for violation of any provisions of other laws. 
 
Sec. 7. Administrative Proceedings. – 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 FDRO. 
If the FDRO, in the course of his/her 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 Information is Received about the Presence of Counterfeit 
Pharmaceutical 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 confidentiality of their identities, on the 
existence of suspected counterfeit pharmaceutical product in the possession of 
any manufacturer, seller, distributor, or any other person shall undergo the 
verification process by the FDRO, or any officer deputized or authorized by the 
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 as 
defined: 
   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.  Proceed in filing a criminal complaint and/or administrative complaint. 
 
c) 
Findings of Counterfeit Pharmaceutical Product 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, without prejudice to the institutions of a separate action for 
criminal case, following the procedure in Section 8. 
 
Sec. 8. Hearing of Administrative Complaints and Other Remedies. – 
a) 
The FDA shall hear and decide administrative complaints filed before the agency 
following the rules of procedure provided under Republic Act No. 3720, as 
amended, and its Implementing Rules and Regulations. 
Upon preliminary 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 be given an opportunity to be heard before the FDA. 
Preventive Closure Order. If seizure cannot be reasonably effected, 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 is contained or stored within fifteen (15) days upon the 
filing of administrative complaint. This is for the purpose of preventing the 
disposition or tampering 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. 
 
b) 
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; 
 
c) 
Filing of criminal charges against the violator(s), which can be instituted 
separately and 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) 
The Director General is hereby authorized to call on the assistance of any 
Department, Office, Agency, Organization, or Body for the effective 
implementation of the provisions of this Act 
 
Sec. 9. Penalties. –  
a) 
Administrative Penalties 
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: 
   i.   Minimum 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 (PHP300,000.00) but not more than Five hundred thousand 
pesos (PHP500,000.00) 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 (PHP500,000.00) and permanent closure of the establishment concerned 
as well as the revocation of its license to do business shall be the maximum 
administrative penalty. 
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: 
   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 by the FDRO or any officer deputized or authorized by the Director 
General; or 
   v.  If the Respondent or any of his officer or agent shall break, alter or 
tamper any mark or seal used by the FDA to identify those segregated 
pharmaceutical products; or 
   vi. 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 sub-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, vehicles, and 
other articles used in violation of this Act or its implementing rules and 
regulations, 
 
b) 
Criminal Penalties. The commission of any of the acts prohibited under Section 4 
of this Act shall be punished by: 
1. 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 (b) of this Act; or 
2. 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 (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 in any other case mentioned 
in Section 4 of the Act; or 
3. 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 animals; 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 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 pharmaceutical products 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 
5. 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 (P100,000.00) to 
Five hundred thousand pesos (PHP500,000.00) shall be meted out; or 


 
 
6. should a counterfeit pharmaceutical product be the proximate cause of death 
of a victim, who unknowingly purchased and took a counterfeit pharmaceutical 
product, the penalty of life imprisonment and a fine of Five hundred thousand 
pesos (PHP500,000.00) to Five million pesos (PHP5,000,000.00) 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 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 (Php1,000,000.00) 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 (Php10,000,000.00). 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 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. Inter-agency, Stakeholders and International Cooperation. – All relevant 
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. 
– 
All 
pharmaceutical 
product 
establishments, including the licensed and registered pharmacist under their employ, 
shall ensure at all times that pharmaceutical products satisfy the requirements of 
pharmaceutical 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 and counterfeiting activities. 
 
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 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. 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 product 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. 
 
Sec. 13. Strengthening the Pharmacovigilance System. – In addition to Sections 
10,11, and 12 of this Act, the FDA, in coordination with the DOH or other stakeholders, 
shall strengthen the existing National Policy and Program on Pharmacovigilance, 
underscoring the adoption, support, establishment, institutionalization. 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 establish 
a pharmacovigilance unit within its CDRR with appropriate staffing of officers and 
personnel and experts and be regularly allocated with appropriate budget. 
 
Sec. 14. Training and Consumer Advocacy and Education. – Training, orientation, 
education, and other advocacy activities shall be regularly provided by the FDA to 
pharmaceutical product establishments, communities, and other sectors of the 
community. As such Proclamation No. 2082 which proclaims that every third week or 
November of every year shall be the National Consciousness Week against counterfeit 
medicines, including all directives therein are hereby adopted. 
 
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 other relevant government agencies. The FDA shall allocate and provide 
funds for the development and implementation of training and consumer advocacy and 
education programs. 
 
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 of the Department of 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 consultation with the 
stakeholders, shall 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 unconstitutional or 
invalid, the same shall not affect the validity and effectivity of the other provisions hereof. 
 
Sec. 20. Repealing Clause. – Republic Act No. 8203 is hereby revised. 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,