NINETEENTH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
First Regular Session
o!t!ic0r:;-tacp
72 SEP 14 P5’09
SENATE
S.B. No. 1314
INTRODUCED BY SENATOR RISA HONTIVEROS
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"
EXPLANATORY NOTE
Republic Act 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 24 years. In spite of this, counterfeit drugs still proliferate in the country1.
The implementation of R.A. 8203 has been affected by several counterfeit drug- 
related cases where the Supreme Court ruling favored the accused2. On one case, the 
court stated that "Republic Act No. 9502 or the Universally Accessible Cheaper and Quality 
Medicines Act of 2008 nullifies the reason or purpose of R.A. 8203 so the latter loses all 
meaning and function3". Several laws enacted by Congress also significantly affected the 
provisions of RA 8203. Alongside R.A. 9502, Republic Act 9711 or the FDA Act of 2009, 
and Republic Act 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
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/coordination/S SFF C_Report.pdf
2 Ibid.
3 G.R. No. 149907, Roma Drug, et al. v. Glaxo SmithKline, et al
1


pharmaceutical products entering and moving through countries worldwide.
This bill seeks to strengthen the prohibitions against counterfeit pharmaceutical 
products, declare the manufacture, importation, distribution, sale, offering for sale, 
donation, trafficking, brokering, exportation, or possession counterfeit pharmaceutical 
products as offenses involving economic sabotage, and provide stricter penalties for 
violations of this Act. This is to address the continuing real threat that counterfeit 
pharmaceutical products presents to Filipinos.
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 forgoing, the passage of this bill Is earnestly sought.
RISA HONTIVEROS 0 
Senator


NINETEENTH CONGRESS OF THE 
}
REPUBLIC OF THE PHILIPPINES 
)
First Regular Session 
)
SENATE
S.B. No. 1314
of II"
^ciuui
•22 SEP 14 P5 ;09
lu-ctivto B-.
INTRODUCED BY SENATOR RISA HONTIVEROS
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 Phiiippines in Congress 
assembied:
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Sec. 1. Short Tide. - This Act shall be known as the "Counterfeit Pharmaceutical
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Products Prevention Act".
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Sec. 2. Deciaration ofPoiicy. - It is the policy of the State, under Article II, Section
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15 of the 1987 Constitution, to protect and promote the right to health of the people and
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Instill health consciousness among them.
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The 1987 Constitution also provides, under Article XIII, Section 12, that: The State
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shall establish and maintain an effective food and drug regulatory system and undertake
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appropriate health manpower development and research, responsive to the country's
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health needs and problems.
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Pursuant to the above policies, the State must adopt, support, establish,
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institutionalize, improve and maintain structures, processes, mechanisms and initiatives
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that are aimed, directed and designed to strengthen its capability to prevent activities
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that may result, or detect. Investigate, suppress, and more effectively respond to actions
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that result in counterfeit pharmaceutical products.
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It shall likewise provide for the strengthening of prohibitions against counterfeit
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pharmaceutical products; declare the manufacture, importation, distribution, sale or offer
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for sale, or possession of counterfeit pharmaceutical products as offenses involving
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economic sabotage; and provide stricter penalties for violations of the Act.
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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 products 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.


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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
Hi. 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 (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, importation, exportation, sale, offer for sale, 
distribution, donation, transfer, use, testing, promotion, advertising, or


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sponsorship of pharmaceutical product, including the facilities and
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installations needed for its activities.
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j) "FDA" shall refer to the Food and Drug Administration.
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k) "FDRO" shall refer to the Food and Drug Regulation Officer of the FDA.
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I) "LSD" shall refer to the laboratories under the FDA including those private
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laboratories accredited by the agency to conduct particular scope of
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analysis.
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m) "LSSC" shall refer to the Legal Services Support Center of the FDA.
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n) "Medicines" shall refer to drugs in their appropriate dosage forms, with
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assured quality, safety and efficacy for humans or animals, or both.
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o) "Online Service" shall refer to the sale, offering for sale, donation,
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distribution, trafficking, brokering of pharmaceutical product, or the sale
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of any punch, dye, plate or any other equipment or instrument designed
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to print, imprint or reproduce the trademark, trade name or other
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identifying mark for use to any pharmaceutical product, through and with
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the use of information and communication technology system. The term
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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
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owner of a license to operate a business or business undertaking in the
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Philippines or the branch manager or operator, license, franchise, or any
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person acting on behalf of the corporate entity.
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q) Pharmaceutical Products" shall refer to drugs, medicines, biologicals,
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pharmaceutical and biopharmaceutical products/specialties, veterinary
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products, veterinary biologies and veterinary medicinal products.
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r) "Residence" shall refer to a private dwelling or abode where a person
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lives, either as owner or lessee, or usufructuary including, for purposes of
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this Act, its yard, garage, storage rooms or premises; provided that where
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the yard, garage, storage rooms or premises are used to manufacture,
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process, pack, or hold pharmaceutical products for introduction Into
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domestic commerce, the same shall not fall as residence but be
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considered as establishment
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Sec. 4. Prohibited Acts. - The following acts are declared unlawful and therefore
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prohibited:
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a) The manufacture, importation, distribution, sale, offering for sale, donation,
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trafficking, brokering, exportation, or possession of counterfeit
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pharmaceutical products as defined in Section 3 hereof.


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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;


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act:
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
a) the manufacturer, importer exporter, distributor, seller, trafficker, broker or 
donor of the counterfeit pharmaceutical product and their agents, as the 
case may be;


;. ■:> -n u.
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b) the possessor of counterfeit pharmaceutical product as provided in Section
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4(b) of this Act;
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c) the manager, operator or lessee of the laboratory or laboratory facilities
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used in the manufacture of counterfeit pharmaceutical product;
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d) the owner, proprietor, administrator or manager of the drugstore, hospital
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pharmacy or dispensary, laboratory or other outlets or premises where the
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counterfeit pharmaceutical product is found who induces, causes or allows
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the commission of any act herein prohibited;
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e) the licensed and registered pharmacist of the establishment, or the licensed
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and registered pharmacist of the outlet where the counterfeit
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pharmaceutical product is sold or found, who sells or dispenses such
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pharmaceutical products to a third party; and
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f) should the offense be committed by a juridical person the penalty shall be
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imposed upon the officer or officers of the corporation, partnership,
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association or entity responsible for the violation; and if such officer is an
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alien, he shall, in addition to the penalties herein prescribed be deported
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without further proceedings.
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Sec. 6. Liability under Other Laws. - A prosecution under this Act shall be without
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prejudice to any liability for violation of any provisions of other laws.
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Sec. 7. Administrative Proceedings. - The FDA is hereby further authorized to
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undertake the following administrative actions.
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a) Procedure when Counterfeit Pharmaceutical Product is Monitored in the
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Market Pursuant to a Routine Inspection of the FDRO.
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If the FDRO, in the course of his/her routine/regular inspection of a factory,
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warehouse, establishment in which pharmaceutical products are
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manufactured, processed, packed, or held for introduction into domestic
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commerce, or vehicle, and all pertinent equipment, finished or unfinished
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materials, containers, and labeling therein, upon the authority conferred by
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Section 27 of Republic Act No. 3720, as amended, shall suspect certain
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stocks as counterfeit pharmaceutical product, the FDRO shall conduct an
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inventory, segregate and seal the suspected stocks, and collect samples for
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examination as to the pharmaceutical product's genuineness and
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authenticity;
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b) Procedure when Information is Received about the Presence of Counterfeit
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Pharmaceutical Product In the Possession of Any Person or Establishment.


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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
Hi. 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 Compiaints 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


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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 (PFIP300,000.00) but not more than 
Five hundred thousand pesos (PHP500,000.00) and


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suspension or revocation of its license to do business shall be 
the medium administrative penalty.
iii. Maximum Penalty. An administrative fine of Five hundred 
thousand pesos (PHP500,000.00) and permanent closure of 
the establishment concerned as well as the 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
10


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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)
11


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involve (whether as a single product or totality of different pharmaceutical
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products) is One Million Pesos (Phpl,000,000.00) or more, as valued by the
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Food and Drug Administration, it shall be deemed as an offense involving
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economic sabotage and punishable by life Imprisonment and a fine of Five
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Million Pesos (Php5,000,000.00) to Ten Million Pesos (Phpl0,000,000.00).
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In case any Act prohibited in Section 4 of this Act is also punishable under
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other laws, the offender shall, if warranted by the evidence, be prosecuted
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under the law prescribing the highest penalty.
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When the sale, offering for sale, donation, distribution, trafficking, or
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brokering of counterfeit pharmaceutical product, or the sale of any punch,
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dye, plate or any other equipment or instrument designed to print, imprint
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or reproduce the trademark, trade name or other identifying mark of
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another registered producer or any likeness thereof, upon any
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pharmaceutical product or device or its container or label without authority
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from the legitimate owners of the trademark or trade name, as prohibited
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in Section 4 of this Act, is committed by, through and with the use of online
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service, the same shall also be covered by the relevant provisions of
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Republic Act No. 10175 or the "Cybercrime Prevention Act of 2012".
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Provided, that the penalty to be imposed shall be one (1) degree higher
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than that provided under this Act.
21 
Sec. 10. Inter-agency, Stakeholders and International Cooperation. - All relevant
22 
inter-agency, other stakeholders and international instruments, programs, cooperation,
23 
and arrangements agreed, whether in regulatory or criminal matters, to the widest extent
24 
possible for the purposes of detection, investigation, suppression, proceedings or
25 
effective response concerning administrative or criminal offenses related to counterfeit
26 
pharmaceutical products, or for the collection of evidence, shall be given full force and
27 
effect.
28 
Sec. 11. Establishments' Responsibilities. - All pharmaceutical product
29 
establishments, including the licensed and registered pharmacist under their employ, shall
30 
ensure at all times that pharmaceutical products satisfy the requirements of
31 
pharmaceutical products' laws and standards relevant to their activities in the
32 
pharmaceutical product supply chain and that control systems are in place to prevent or
33 
eliminate counterfeit pharmaceutical products and counterfeiting activities.
34 
Pharmaceutical product establishments shall be knowledgeable of the specific
35 
requirements and standards of pharmaceutical product laws and regulations relevant to
12


1 
their activities in the pharmaceutical product supply chain and the procedures adopted
2 
by the regulatory authority.
3 
If a pharmaceutical product establishment considers or has reason to believe that
4 
a pharmaceutical product which it produced, processed, imported, distributed, sold,
5 
offered for sale is counterfeit, it shall immediately initiate procedures to withdraw the
6 
pharmaceutical product in question form the market and inform the regulatory authority.
7 
Pharmaceutical product establishments shall allow inspection of their business and
8 
collaborate with the regulatory authority on actions taken to avoid risks posed by the
9 
counterfeit pharmaceutical product they have supplied.
10 
Sec. 12. Rapid Alert System. - The rapid alert system in place for the notification
11 
of direct or indirect risk to human health due to counterfeit pharmaceutical product shall
12 
be strengthened by the FDA.
13 
Emphasis shall be made on the strengthening and full implementation of science-
14 
based risk analysis, emergency measures, crisis management, and stakeholders
15 
involvement and participation.
16 
Sec. 13. Strengthening the Pharmacovigiiance System. - In addition to Sections
17 
10,11, and 12 of this Act, the FDA, in coordination with the DOH or other stakeholders,
18 
shall strengthen the existing National Policy and Program on Pharmacovigiiance,
19 
underscoring the adoption, support, establishment, institutionalization, improvement and
20 
maintenance of structures, processes, mechanisms and initiatives that are aimed,
21 
directed and designed to strengthen the government and other stakeholders' capability
22 
to prevent activities that may result, or detect, investigate, suppress, and more effectively
23 
respond to actions that result in counterfeit pharmaceutical products.
24 
Within one hundred twenty (120) days from effectivity of this Act, the FDA shall establish
25 
a pharmacovigiiance unit within its CDRR with appropriate staffing of officers and
26 
personnel and experts and be regularly allocated with appropriate budget.
27 
Sec. 14. Training and Consumer Advocacy and Education - Training, orientation,
28 
education, and other advocacy activities shall be regularly provided by the FDA to
29 
pharmaceutical product establishments, communities, and other sectors of the
30 
community. As such Proclamation No. 2082 which proclaims that every third week or
13


»'JP 
11
1 
November of every year shall be the National Consciousness Week against counterfeit
2 
medicines, including all directives therein are hereby adopted.
3 
A consumer advocacy and education program shall be developed and implemented
4 
by the FDA in partnership with relevant NGOs, private organizations, coalitions, academic
5 
institutions, or other relevant government agencies. The FDA shall allocate and provide
6 
funds for the development and implementation of training and consumer advocacy and
7 
education programs.
8 
Sec. 15. Appropriations-The amount necessary to carry out the provisions of this
9 
Act shall be included in the General Appropriations Act for the year following its enactment
10 
and every year thereafter.
11 
Sec. 16. Enforcement and Impiementation - The FDA of the Depa rtment of Health
12 
is hereby authorized to administer and supervise the implementation of this Act subject
13 
to the applicable provisions of Republic Act No. 10175 or the "Cybercrime Prevention Act
14 
of 2012".
15 
Sec. 17. Impiementing Ruies andReguiations. - The FDA, in consultation with the
16 
stakeholders, shall promulgate the implementing rules and regulations within One
17 
Hundred Twenty (120) days from the effectivity of this Act.
18 
Sec. 18. Interpretation and Construction in Favor of Protection of Pubiic Heaith. -
19 
All doubts in the implementation and interpretation of the provisions of this Act, including
20 
its implementing rules and regulations, shall be resolved in favor of protecting public
21 
health against counterfeit pharmaceutical products.
22 
Sec. 19. Separabiiity Cause. - If any provision of this Act is held unconstitutional
23 
or invalid, the same shall not affect the validity and effectivity of the other provisions
24 
hereof.
25 
Sec. 20. Repeaiing Cause. - Republic Act No. 8203 is hereby revised. All other
26 
laws, decrees, executive orders and rules and regulations contrary to or inconsistent with
27 
the provisions of this Act are hereby repealed, amended or modified accordingly.
14


1 
Sec. 21. Effectivity. - This Act shall take effect fifteen (15) days after its publication
2 
in the Official Gazette or in a newspaper of general circulation.
Approved,
15