Counterfeit Pharmaceutical Products Prevention Act

TWENTIETH CONGRESS OF THE Offer of tut REPUBLIC OF THE PHILIPPINES First Regular Session P3:48 25 JUL 14 SENATE S.B. No. _ RECEIVED 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 liable parties, and imposes administrative sanctions and penalties. Enacted in September 1996, this law has been in force for over 29 years. Despite this, counterfeit drugs continue to proliferate in the country!. The enforcement of R.A. 8203 has been hampered by several counterfeit drug- related cases in which Supreme Court rulings favored the accused.? 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 Republic Act 10918 (the Philippine 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 ' 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: 2 Ibid. http://www.who.int/medicines/areas/coordination/SSFFC_Report.pdf 3 G.R. No. 149907, Roma Drug, et al. v. Glaxo SmithKline, et al.

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. animeros taraque RISA HONTIVEROS Senator

TWENTIETH CONGRESS OF THE REPUBLIC OF THE PHILIPPINES First Regular Session SENATE 25 JUL 14 P3:48 S.B. No.. RECEIVE 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. Biopharmaceuticals 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;

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 pharmaceutical 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; ili. 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:

1) Identity refers 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; ili. 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).

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; I. Pharmaceutical Products refer to drugs, medicines, biologicals, pharmaceutical and biopharmaceutical products/specialties, veterinary biologics 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

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 of ten (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 portionest 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

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. Parties Liable. The following persons shall be liable for violations of

this Act: a) The manufacturer, importer exporter, distributor, seller, distributor, trafficker, donor of the counterfeit broker, promoter, advertiser, sponsor, or 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.

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;

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 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:

a) 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); b) Medium Penalty. An administrative fine of at least Three hundred thousand pesos (PHP300,000.00) but not less than Five hundred thousand pesos (PHP500,000.00) and suspension not exceeding one (1) year or revocation of its license to do business; c) 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 Republi 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

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 (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: 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 (PHP 1,000,000.00) shall be imposed it, 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

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 (Php1,000,000.00) 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 (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, 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

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 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.

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 policy on whistle blowing and whistle blower'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 shall, in coordination with the DOH or other strengthen the existing National Policy and Program on stakeholders, 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, 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 pharmacovigilance unit and establish a market surveillance and control unit within its Center for Drug Regulation and Research and its Field Regulatory Operations Office.

Section 35 of Republic Act No. 9711 is hereby reiterated mandating the FDA to improve,

upgrade, and increase the capability 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 laboratories 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 laboratories are accredited by the Philippine Accreditation Office of the Department of Trade and Industry (DTI) and the FDA. The FDA Director General shall, in consultation with the Secretary of the DOH, determine the organizational structure and staffing pattern of the Center for Drug Regulation 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

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,