RULES AND REGULATIONS IMPLEMENTING REPUBLIC ACT 8203,

OTHERWISE KNOWN AS THE SPECIAL LAW ON COUNTERFEIT DRUGS

 

AUTHORITY

 

Pursuant to Section 11 of RA 8203, otherwise known as the Special Law on Counterfeit Drugs, the following rules and regulations are hereby promulgated and consultation of the Secretary of Health.

 

RULE I. INTERPRETATION AND DEFINITION OF TERMS

 

Section 1. Short Title. These rules and regulations shall be cited as ”IRR of RA 8203”.

 

Section 2. Construction. The words and phrases used in these rules shall be interpreted to give meaning to the provisions of RA 8203 in order to safeguard the health of the people and to protect them from counterfeit drugs.

 

a.   “Bureau or BFAD” – shall refer Bureau of Food and Drugs

b.   “Constructive Knowledge” as herein applied shall mean, that by exercise of reasonable care, one would have known the fact or suspect that the drug product he or she has sold, is selling or in possession of is counterfeit, such as, but not limited to the knowledge, that the drug was not covered by any sales invoice or evidence of delivery or purchase from a BFAD licensed drug establishment.

c.    “FDRO” shall mean the Food and DRUG regulation Officer.

d.    “LICD” shall mean Legal, Information and Compliance Division of the BFAD

e.    “Life-saving drugs” shall refer to drug products indicated for life-threatening condition(s).

f.     “LSD” shall mean Laboratory Services Division of the BFAD.

g.    “PSD” shall mean Product Services Division of the BFAD

h.    “Unregistered hospital drug product” – as distinguished from counterfeit drug defined under Section 3 of RA 8203 shall refer to unregistered imported drug product without a registered counterfeit brand in the Philippines. If the unregistered imported drug product has a registered counterpart brand in the Philippines, their product shall be considered counterfeit.

 

RULE II. PROHIBITED ACTS

 

Section 1. Prohibited Acts. The acts prohibited or declared unlawful under Section 4 of RA 8203 are adopted as same acts that are prohibited by these rules and therefore punishable by the administrative sanctions herein prescribed.

 

The following acts are declared unlawful and therefore prohibited:

 

a.   The manufacture, sale or offering for sale, donation, distribution, trafficking, brokering, exportation, or importation of counterfeit drugs.

 

b.   Possession of counterfeit drugs.

 

c.   Forging, counterfeiting, simulating or falsely representing or without proper authority, using any mark, stamp, tag, label or other identification mark or device authorized by RA 3720 as amended, and /or regulations promulgated under RA 8203.

 

d.   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 hereof.

 

e.  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 product or any likeness thereof, upon any drug product or device or its container or label without authority from the legitimate owners of the trademark or trade name.

 

Section 2. Parties Liable. The parties who are liable under Section 5 of RA 8203 are likewise made liable under these rules. These include the following:

 

a.  The manufacturer, exporter or importer of the counterfeit drugs and their agents: Provided, that the agents shall be liable only upon proof of actual or constructive knowledge that the drugs are counterfeit.

 

b.   The seller, distributor, trafficker, broker or donor and their agents, upon proof of actual or constructive knowledge that the drugs sold, distributed, offered or donated are counterfeit.

 

c.   The possessor of counterfeit drugs.

 

d.   The manager, operator or laboratory facilities used in the manufacture of counterfeit drugs.

 

e.   The owner, proprietor, administrator, or manager of the drugstore, hospital, pharmacy or dispensary, laboratory or other outlets or premises where the counterfeit drug is found who induces, causes or allows the commission of any prohibited act;

 

f.  The registered pharmacist of the outlet where the counterfeit drug is sold or found, who sells or dispenses such drug to a third party and who shall have actual or constructive knowledge that said drug is counterfeit.

 

g.  Should the offense be committed by a juridical person, the president, general manager, the managing partner, chief operating officer or the person who directly induces, causes or knowingly allows the commission of the offense shall be penalized.

 

RULE III. MONITORING OF COUNTERFEIT DRUGS

 

Section 1. Procedure for Monitoring Counterfeit Drugs in the Market.

 

a.      The Food and Drug Regulation Officers (FDRO’S) in the course of their inspection of a factory, warehouse, establishment or vehicle, finished or raw materials, containers and labeling therein upon the authority conferred by Section 27 of RA 8203 as amended, shall further determine during such inspection, whether the drug products therein found are counterfeit or not. For the effective implementation of RA 8203, the said inspection shall be without prior notice in any place within the Philippines to prevent the parties liable from concealing them and avoiding inspection.       

 

b.        If upon such inspection, the FDRO shall suspect certain stocks as counterfeit drugs, the FDRO shall conduct an inventory, segregate and seal the suspected stocks, and collect samples for examination as to the products’ genuineness and authenticity.

 

c.       The FDRO shall require the owner or the representative of the inspected establishment or outlet to produce the sales invoice, delivery receipts or documents covering the suspected counterfeit drugs. The FDRO shall only acknowledge and recognize invoices or documents that have been issued by a BFAD  licensed manufacturer, trader, distributor, wholesaler or importer with the lot number and expiry date of the drug product(s) indicated herein.

 

d.        Immediately upon return to his/her office, the FDRO concerned shall submit the samples to either the LSD or PSD for their examination or evaluation. The examination or evaluation shall be for the purpose of determining the authenticity and/or genuineness of the said samples.

 

Section 2. Duration in the Conduct of Examination. The BFAD shall have twenty (20) working days to determine the genuineness and authenticity of the product.

 

Section 3. When There is No Need for Laboratory Testing. When the genuineness of the product can be determined by the mere physical examination of the product or the labeling thereof, the PSD shall conduct the examination or evaluation of the same. The result of the physical examination shall be reduced into a certificate of findings.

 

         The Regulation Division I may also require the registered-brand owner of the suspected counterfeit drug to certify whether or not the suspected drug product has been manufactured, imported and/or distributed by them; or whether they own the Lot Number and Expiry Date of the same suspected drug product. The certification issued by the registered brand-owner shall be supported by the batch, production and distribution records. However, the brand-owner’s certification shall be validated by the PSD for evidentiary purposes.

 

Section 4. When to Refer to LICD for Investigation. When the result of examination shall confirm the suspicion of the FDRO that in fact the drug product is counterfeit, the LSD or PSD shall forward the result of examination to the LICD for a motu proprio investigation. Otherwise, the result of the examination shall be released to the Regulation Division concerned.

 

Section 5. When the Product is Found Not Counterfeit. When the result of the examination reveals that the sample collected is genuine, the PSD or LSD shall forward the report of examination or evaluation to the FDRO through his/her division chief.

 

         If the sealed and segregated products are within the Metro Manila area, the Regulation Division concerned, shall within sixteen (16) working hours from receipt of such report, notify the outlet or the communication available. However, only a FDRO can unseal the suspected product before it can be released for sale or distribution to legitimate commerce.

 

            When the segregated and sealed product are located outside the Metro Manila area, the Regulation Division concerned shall send a notice to release the product to the Food and Drug Section having territorial jurisdiction over the same through the Regional Director within sixteen (16) working hours from receipt of the notice. The FDRO assigned in the said province shall, within sixteen (16) hours from receipt of the notice, unseal the suspected drugs for distribution to legitimate commerce.

 

Section 6. Possession of Counterfeit Drugs by Owners of Trademark, Trade Names or Other Identifying Marks: When to Report. Owners of trademarks, trade names or other identifying marks, shall report in writing and turn over the said counterfeit drugs to the BFAD within ten (10) days from the time of purchase or acquisition of such drugs as indicated in the sales invoices or official receipts or other similar documents. The sales invoice, official receipts or other similar documents shall be attached to the said report on counterfeit drugs. Failure to comply with this section will give rise to the presumption of violation as provided under Section 4 (a) of RA 8203.

 

RULE IV.  PROCEDURE IN THE FILING OF ADMINISTRATIVE COMPLAINT

 

Section 1. Where to File the Complaint. Any person may file a complaint whether in an affidavit or letter with the BFAD LICD or in any BFAD Accredited Complaint Desk as provided for in Section 8, Rule II of this order.

 

Section 2. Complaint Filed by a Registered Brand Name. A drug establishment or a registered brand owner may file an administrative action against any person or establishment for any acts in violations of RA 8203 in the form of an affidavit of complaint.

 

Section 3. Contents of the Complaint Affidavit. The affidavit of complaint of the registered brand owner shall state:

 

a.   name of the product, the lot number and expiry date of the product he shall allege as counterfeit;

 

b. name and address of the person and/or drug establishment or company he shall name as party-respondent;

 

c.   specific  acts that shall allege as having been committed by the party-respondent;

 

d.   remedy or relief or action he shall intend BFAD to take.

 

The affidavit of complaint shall be accompanied by samples of counterfeit drug products duly marked for identification purposes.

 

Section 4. Complaint Filed By A Consumer, A Physician Prescriber and Other Interested Party. A consumer, physician-prescriber or other interested party other than the registered brand owner may file a letter of complaint or information about a suspected counterfeit drug product. His letter shall state:

 

a.   name of suspected product;

 

b.  the source or the name and address of the person from whom he/she acquired the said suspected drug product;

 

c.   the mode of his acquisition;

 

d.   the reason or fact giving rise to the suspicion that the drug product is counterfeit.

 

Section 5. When The Consumer, Physician Prescriber or Interested Party May File An Affidavit Of Complaint And Not A Letter Of Complaint. When the consumer, physician-prescriber or other interested party is in possession of evidence to prove that the product is counterfeit and an act in violation of RA 8203 has been committed, he/she shall file an affidavit of complaint stating:

 

a.       the name and address of the person who has committed the act in violation of RA 8203

 

b.       the specific acts committed.

 

He/She shall submit and submit and offer the evidence in his/her possession specifically including the sample of the counterfeit drug product or the container of such product he shall allege as counterfeit. Such an affidavit of complaint shall be processed in accordance with Section 3 of Rule IV hereof.

 

RULE V. ADMINISTRATIVE PROCEEDINGS

 

Section 1. When initiated by the BFAD FDRO’s. When the administrative action is initiated by FDRO, the FDRO shall submit a report of violation to the LICD.

 

a.        Upon receipt of the report of violation and when such report is found in form and substance, the LICD shall immediately prepare the formal charge in the form of a memorandum of evidence. The memorandum of evidence shall contain a statement giving the party-respondent fifteen (15) working days within which to file his position paper and submit evidence contrary to that which was found, or justifying the acts in violation of RA 8203, failing in which, the case will be considered submitted for resolution based upon the evidence.

 

b.        If the party-respondent is a drug establishment, outlet or business establishment, the memorandum of evidence shall be accompanied by a preventive closure order for thirty (30) days from the receipt of the order.

 

c.        If the position paper filed by the respondent shall raise no factual issues that necessitates a trial, the case will be considered submitted for resolution.

 

 

d.        If the position paper will raise factual issues necessitating a trial, or the respondent moves for a hearing to confront the witnesses upon which the memorandum of evidence was instituted, a hearing will be conducted.

 

e.        In the hearing, upon motion of the respondent, the witnesses upon which the memorandum of evidence was instituted, shall file their reports. If any, the party-respondent shall be given the opportunity to confront or cross-examine the said witnesses.

 

f.        After such affirmation and cross-examination, the party-respondent shall be given another ten (10) working days to supplement his position paper to manifest his intention to present evidence in support of his position paper, if he shall so intend.

 

In case the party-respondent manifests his intention to present evidence in support of his position paper, the continuation of the hearing shall be conducted. Otherwise, the case shall be considered submitted for resolution based on evidence on record.

 

The administrative proceedings shall be completed and terminated within the thirty (30) day period, otherwise, if such proceedings can not be completed within the thirty (30) days period from notice, an order lifting the preventive closure shall be issued without prejudice to the resolution of the administrative case.

 

Section 2. Procedure When A Complaint Is Based On A Letter Of Complaint Or Information.

 

a. Upon receipt of the letter of complaint or information about a suspected counterfeit drug, and upon a preliminary finding that there is sufficient basis to conduct an investigation, the letter of complaint or information will be assigned to an FDRO for verification.

 

b. If the information is verified, in fact the drug product is counterfeit and that a person, a drug outlet, or business establishment or drug establishment has committed acts in violation of RA 8203, a memorandum of evidence shall be issued and the administrative proceedings provided for in Section 1 hereof shall be instituted.    

 

Section 3. Procedure When A Complaint Is Initiated By A Drug Establishment Or Registered Brand Owner.

 

a.  Upon receipt of the complaint and a finding that the complaint is proper in form and substance, the party-respondent shall be summoned to answer within fifteen (15) days from receipt thereof.

 

b.  The party-respondent shall file an answer and not a motion to dismiss except when the subject matter of the complaint is not within the administrative jurisdiction of the BFAD.

 

c.  The hearing of the case shall be summary in nature and that direct testimonies of the witnesses shall be reduced to an affidavit which shall be submitted within three (3) days before the date of the hearing.

 

Section 4. Decision. Administrative cases under RA 8203 and these implementing rules and regulations shall be decided by the Director of BFAD within thirty (30) days from the date it shall be deemed submitted for decision.

 

Section 5. Finality of Decision/Resolution. Decisions and resolutions shall be final and executory after the lapse of fifteen (15) days from receipt of parties or from notice.

 

RULE VI. APPEAL

 

Section 1. Motion for Reconsideration; When and When Not Allowed. No motion for reconsideration from an interlocutory order shall be allowed. Only one motion for reconsideration from the final resolution or decision shall be allowed and only upon the grounds that:

 

a.   the resolution is not supported by substantial evidence, and;

 

b.   the conduct of the administrative investigation is attended with irregularity.

 

Section 2. Appeal: When. The aggrieved party may appeal the decision of the BFAD Director within fifteen (15) days from receipt thereof to the Secretary of Health.

 

Section 3. Grounds For Appeal. No appeal shall be given due course on the following grounds:

 

a.   Abuse of discretion;

 

b.   Decision is not supported by substantial evidence; or

 

c.   Irregularity in the conduct of investigation.

 

Section 4. How Appeals Are Made. A party who intends to appeal the decision of the BFAD Director shall file a notice of appeal with the BFAD. The BFAD shall forward the records of the case to the Office of the Secretary within fifteen (15) days from receipt of the notice of appeal.

 

Section 5. Execution Pending Appeal. The appeal when filed by a respondent shall not stay the execution of the decision, unless a bond in the amount of one hundred thousand pesos (PhP 100,000.00) which is the minimum administrative fine imposable, is posted.

 

RULE VII. ADMINISTRATIVE SANCTIONS

 

Section 1. Minimum Penalty. An administrative fine of not less than one hundred thousand pesos (PhP 100,000.00) but not more than five hundred thousand pesos (PhP 500,000.00) shall be the minimum administrative penalty.

 

Section 2. Medium Penalty. An administrative fine of not less than one hundred thousand pesos (PhP 100,000.00) but not more than three hundred thousand pesos (PhP 300,000.00) and permanent closure of the establishment shall be the medium administrative penalty.

 

Section 3. Maximum Penalty. An administrative fine of not less than three hundred thousand pesos (PhP 300,000.00) but not more than five hundred thousand pesos (PhP 500,000.00) and the permanent closure of the establishment as well as the revocation of the licenses to do business shall be the maximum administrative penalty.

 

Section 4. Accessory Penalties.

a.  Upon order of the court, all administrative shall be accompanied by forfeiture, confiscation and destruction of products found to be counterfeit and the equipment, instrument and other articles used in violation of RA 8203.

 

b.  Permanent disqualification of the person concerned, whether natural or juridical, from owning or operating an establishment engaged in any business activity under the supervision of the BFAD shall be imposed together with the maximum administrative penalty.

 

Section 5. Proceedings Against The Registration Of A Pharmacist. If the offense shall be committed with the actual or constructive knowledge of the registered pharmacist, the administrative sanction that shall be imposed shall be accompanied by the filing of certificate of violation for the appropriate proceedings against said pharmacist with the Professional Regulations Commission to cancel his/her professional license.

 

Section 6. When To File Criminal Charges. Criminal charges shall be filed against the party liable when the evidence found by BFAD is considered sufficient to establish a probable cause and the drug products involved are life saving or if the drug products are not life saving, the volume or number of the drug products subject of the case will manifest the criminal intent of the party liable to introduce into commerce counterfeit drug products. This, however, shall not preclude any interested party from initiating a criminal action against the party liable independent of BFAD.

 

Section 7. When the Minimum Penalty Shall Be Applied. The minimum administrative penalty shall be imposed when the counterfeit drug products subject of the case are not life saving and the volume of the said products is not worth more than one hundred thousand pesos (PhP 100,000.00); or the number of drug product subject of the case is not more than three brands or generic products.

 

Section 8. When the Medium Penalty Shall Be Applied. The medium administrative penalty shall be imposed when the counterfeit drug products subject of the case are not life saving and the volume of the said products is worth more than one hundred thousand pesos (PhP 100,000.00) but not more than one million pesos (PhP 1,000,000.00); or the number of drug product subject of the case is more than three brands or generic products.

 

Section 9. When the Maximum Penalty Shall Be Applied. The maximum administrative penalty shall be imposed when the counterfeit drug products subject of the case are life saving regardless of the volume; or the volume of the counterfeit drug products is worth more than one million pesos (PhP 1,000,000.00.

 

RULE VIII. FINAL PROVISIONS

 

Section 1. Separability. If, for any reason, any part or provision of these rules and regulations shall be held to be unconstitutional or invalid, other parts or provisions hereof which are not affected thereby shall continue to be in full force and effect.

 

Section 2. Prospectivity. The administrative sanctions herein imposed shall not apply to acts committed prior to October 26, 1996 or the effectivity of the law RA 8203.

 

Section 3. Amendments. These rules and regulations maybe amended, modified or supplemented when effective implementation and enforcement of RA 8203 would require.

 

Section 4. Effectivity. This order shall take effect thirty (30) days after its publication in two (2) newspapers of general circulation.

 

 

PRIMER ON REPUBLIC ACT 8203, AN ACT PROHIBITING COUNTERFEIT DRUGS, PROVIDING PENALTIES FOR VIOLATIONS AND APPROPRIATING FUNDS THEREFOR

 

     1.  What is the short title of RA 8203?

 

      The “Special Law on Counterfeit Drugs”.

 

     2.  When did RA 8203 become effective?

 

After October 26, 1996, which is the fifteenth day following its publication in the newspapers “Manila Standard on October 10, 1996 and “Today” on October 11, 1996.

 

     3.  What agency of the government shall administer and supervise the implementation of RA 8203”?

 

The Bureau of Food and Drugs of the Department of Health (DOH).

 

     4. What are the declared state policies under RA 8203?

 

The State shall protect and promote the right to health of the people and still health consciousness among them as provided in Section 15, Article 11 of the Constitution, and to safeguard the health of the people, the State shall provide for their protection against counterfeit drugs.

 

     5.  In line with the declared State policies, how shall the words and phrases of the Implementing Rules

     and Regulations (IRR of RA 8203) be interpreted?

 

The words and phrases of the IRR of RA 8203 shall be interpreted to give meaning to the provisions of the Act in order to safeguard the health of the people and to protect them from counterfeit drugs.

 

     6.  For purposes of RA 8203, how are counterfeit drugs or medicines defined?

 

Counterfeit drugs/medicines refer to medicinal products with the correct ingredients but not in amounts as provided hereunder, wrong ingredients, with the insufficient quantity of active ingredients, which results to the reduction of the drug’s safety, quality, strength or purity. It is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products. It shall also refer to”

 

a.  The drug itself or the container or labeling thereof or any part of such drug, container or labeling bearing without the authorization or trademark, trade name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person.

 

b.   A drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used.

 

c.  An unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records.

 

d.  And a drug which contain no amount of or a different active ingredient or 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.

 

     7.  When may an unregistered imported drug be considered counterfeit?

 

When such unregistered imported drug has a registered counterpart branded or generic drug in the Philippines Bureau of Food and Drugs.

 

     8.  What are prohibited acts under RA 8203?

 

The following acts are declared unlawful and therefore prohibited:

 

a. The manufacture, sale or offering for sale, donation, distribution, trafficking, brokering, exportation, or importation of counterfeit drugs.

 

b.  Possession of counterfeit drugs.

 

c. Forging, counterfeiting, simulating or falsely representing or without proper authority, using any mark, stamp, tag, label or other identification mark or device authorized by RA 3720 as amended, and /or regulations promulgated under RA 8203.

 

d.  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 hereof.

 

e.  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 product or any likeness thereof, upon any drug product or device or its container or label without authority from the legitimate owners of the trademark or trade name.

 

     9.   What is meant by the prohibited act of brokering counterfeit drugs?

 

Brokering counterfeit drug means any act of facilitating the disposal or sale of counterfeit drugs including acts of agency.

 

    10.  When the act is punishable by RA 8203 and also by other existing laws, under what law should the

           accused or respondent be prosecuted?

 

If warranted by the evidence, the offender shall be prosecuted under the law prescribing the highest penalty.

 

    11.  What constitute a prima facie evidence of manufacture, sale or offering for sale, donation,

           trafficking, brokering, importation or possession of counterfeit drugs?

 

The presence or availability of counterfeit drugs in the premises of any entity engaged in the sale, manufacture, distribution of drugs-and/or-pharmaceutical products or in a private residence or in public or private vehicle or in the premises not covered by a valid license to operate from the BFAD.

 

This presumption shall not apply however to 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 drugs which bear the trademarks, trade names or marks if they can show the sales invoices or official receipts evidencing their purchase from a drugstore, manufacturer or distributor suspected by them of dealing in counterfeit drugs involving the trademarks, trade names and other similar identifying marks registered in their names provided that they shall report the acquisition of those drugs and turn over the same to the BFAD within ten (10) days from the time of purchase or acquisition of such drugs as indicated in the sales invoices or official receipts or other similar documents.

 

    12.  Who shall be the parties liable for violation of RA 8203?

 

a.  The manufacturer, exporter or importer of the counterfeit drugs and their agents: Provided, that the agents shall be liable only upon proof of actual or constructive knowledge that the drugs are counterfeit.

 

b. The seller, distributor, trafficker, broker or donor and their agents, upon proof of actual or constructive knowledge that the drugs sold, distributed, offered or donated are counterfeit.

 

c.   The possessor of counterfeit drugs.

 

d.   The manager, operator or laboratory facilities used in the manufacture of counterfeit drugs.

 

e. The owner, proprietor, administrator, or manager of the drugstore, hospital, pharmacy or dispensary, laboratory or other outlets or premises where the counterfeit drug is found who induces, causes or allows the commission of any prohibited act;

 

f.   The registered pharmacist of the outlet where the counterfeit drug is sold or found, who sells or dispenses such drug to a third party and who shall have actual or constructive knowledge that said drug is counterfeit.

 

g. Should the offense be committed by a juridical person, the president, general manager, the managing partner, chief operating officer or the person who directly induces, causes or knowingly allows the commission of the offense shall be penalized.

 

    13.   What is constructive knowledge?

 

For purposes of RA 8203, constructive knowledge shall mean, that by exercise of reasonable care, one would have known the fact or suspect that the drug product he or she has sold, is selling or in possession of is counterfeit, such as, but not limited to the knowledge, that the drug was not covered by any sales invoice or evidence of delivery or purchase from a BFAD licensed drug establishment.

 

    14.   Who monitors the presence of counterfeit drugs?

 

The designated officers of the BFAD under the Department of Health or the Food and Drug Regulation Officers (FDRO’s).

 

    15.   How are counterfeit drugs monitored by FDRO’s of the BFAD?

 

By inspection upon the authority conferred upon them under Section 27 of RA 3720 as amended.

 

    16.   What acts are performed in the conduct of monitoring counterfeit drugs?

 

In the course of the FDRO’s inspection of a factory, warehouse, establishment or vehicle, the FDRO shall further determine during such inspection, whether the drugs that they shall find are counterfeit or not. If they shall suspect that certain drugs are counterfeit, they shall conduct an inventory, segregate and seal the suspected stocks, collect samples and submit them for examination to determine their genuineness and authenticity. They shall require the owner or the representative of the establishment or outlet they are inspecting to produce the invoice or delivery receipts or documents covering the suspected counterfeit drugs.

 

    17. Can the suspecting FDRO recognize or acknowledge any document covering the suspected

           counterfeit or counterfeit drugs?

 

No. They can only honor invoices or documents that they have been issued by a BFAD licensed manufacturer, trader, distributor, wholesaler or importer with the lot number and expiry date of the drug products indicated therein.

 

    18.  May the FDRO take into his/her custody counterfeit products he/she shall find during inspection?

 

Yes. When he/she is certain that the drug is counterfeit and the counterfeit drugs are found during his/her routine or regular inspection of any factory, warehouse, or establishment in which drugs are manufactured, processed, packed or held, for introduction into domestic commerce.

 

    19. What action will be taken by the BFAD if the suspected counterfeit drugs are found in the private

          residence or in the premises not covered by a valid license to operate by BFAD?

 

The BFAD authorized officer or deputized officer shall secure a search warrant for the purpose of seizing and taking into custody such suspected counterfeit drugs.

 

    20.  What legal action will BFAD undertake upon finding that the suspected drug product is counterfeit?

 

The BFAD shall issue an order directing the preventive closure of the business establishment for a period not exceeding thirty (30) days and initiate administrative proceedings where the respondent shall be given the opportunity to be heard and present evidence in his behalf.

 

    21. How does BFAD initiate the administrative proceeding?

 

By issuing a notice in the form of a memorandum of evidence (ME) informing the respondent of the charges against him and providing him with a copy of the evidence therefore.

 

    22. What is the procedure adopted for administrative investigations under the IRR of RA 8203 upon

          BFAD’s own motion or motu propio?

 

The BFAD by its Legal, Information and Compliance Division (LICD) issues an ME that they will include an Order of Preventive Closure for thirty (30) days to inform the respondent of the nature of the charges and the evidence upon which such charges are being made.

 

The respondent is given the opportunity to submit evidence contrary to what may have been found and/or a position paper within fifteen (15) days from his receipt of the ME. A trial, summary in nature, will be held in cases where the respondent shall move for a hearing, or when factual issues raised in the position paper.

 

After hearing the evidence upon which the ME has been issued, where such is applicable, the party respondent shall be given another ten (10) days to supplement his position paper or to manifest his intention to present evidence in support of his position paper. If he shall not so manifest, the case will be considered submitted for resolution based on the evidence on record.

 

    23. When may preventive closure of an establishment be lifted?

 

If after the lapse of thirty (30) days from its effectivity, the administrative proceedings could not be completed. The preventive closure shall be lifted without prejudice to the resolution of the administrative case.

 

    24. Who may file an administrative complaint under RA 8203?

 

      Any interested party including the legitimate manufacturer or registered owner of the genuine drug product, consumer and physician-prescriber.

 

    25. How may a complaint be filed?

 

A. By executing an affidavit of complaint, if the complaint is in possession of evidence to prove that the respondent has committed any of the unlawful act defined under RA 8203; and submitting therewith samples of the counterfeit drug.

 

The Affidavit of complaint shall state the following:

i.   the name of the product including the lot number and expiry date;

 

ii.  the name and address of the person and/or the drug establishment or company who has committed the unlawful act;

 

iii.  a description of the unlawful act committed, and

 

iv.  the remedy or relief of action he shall intend BFAD to take.

 

B.  By a letter of complaint or information about the presence of a counterfeit drug: The letter shall state

 

i.    the name of the suspected product;

 

ii.   the source or the name and address of the person from whom he/she acquired the said suspected drug product;

 

iii.  the mode of his acquisition, and

 

iv.  the reason or fact giving rise to the suspicion that the product is counterfeit.

 

    26. What administrative procedure will be conducted in cases where affidavit of complaint for violation

          of RA 8203 is filed with BFAD?

 

A.      When the complaint is found proper in form and substance, the party-respondent will be summoned to answer within fifteen (15) days from receipt.

 

B.       The respondent shall file and answer and not a motion to dismiss except when the subject matter of the complaint is not within the administrative jurisdiction of the BFAD.

 

C.    After the answer, a hearing shall be conducted which will be summary in nature. The direct testimony/testimonies of the witness shall be reduced to an affidavit which shall be submitted within three (3) days before the date of the hearing.

 

    27. What administrative procedures will be undertaken in cases where a letter of complaint or

          information will be filed?

 

      The BFAD will follow the procedure adopted for motu proprio administrative investigation, when the information submitted shall have been verified by its FDRO.

 

    28. What are the administrative sanctions or penalties imposable under RA 8203?

 

A. Minimum Penalty. The minimum administrative penalty is a fine of not less than one hundred thousand pesos (PhP 100,000.00) but not more than five hundred thousand pesos (PhP 500,000.00).

 

B. Medium Penalty. The medium administrative penalty is a fine of not less than one hundred thousand pesos (PhP 100,000.00) but not more than three hundred thousand pesos (PhP 300,000.00) and permanent closure of the establishment as well as the revocation of the license to do business.

 

C. Maximum Penalty. The maximum administrative penalty is a fine of not less than three hundred thousand pesos (PhP 300,000.00) but not more than five hundred thousand pesos (PhP 500,000.00) and the permanent closure of the establishment as well as the revocation of the licenses to do business.

 

    29. What are the accessory penalties?

 

A. All administrative penalties shall be accompanied by forfeiture, confiscation and destruction of products found to be counterfeit and the equipment, instrument and other articles used in violation of RA 8203.

           

B.  Permanent disqualification of the person concerned, whether natural or juridical, from owning or operating an establishment engaged in any business activity under the supervision of the BFAD shall be imposed together with the maximum administrative penalty.

 

    30. When may BFAD recommend the cancellation of the registration of the pharmacist-respondent with

           the Professional Regulations Commission?

 

               When the pharmacist-respondent has actual or constructive knowledge of the offense committed.

 

    31. When Will The Minimum Penalty Be Imposed?

 

          The minimum administrative penalty shall be imposed when the counterfeit drug products subject of the case

          are not life saving and the volume of the said products is not worth more than one hundred thousand pesos

          (PhP 100,000.00); or the number of drug product subject of the case is not more than three brands or generic 

          products.

 

    32. When Will The Medium Penalty Be Imposed?

         

          The medium administrative penalty shall be imposed when the counterfeit drug products subject of the case

          are not life saving and the volume of the said products is worth more than one hundred thousand pesos (PhP

         100,000.00) but not more than one million pesos (PhP 1,000,000.00); or the number of drug product subject of

          the case is more than three brands or generic products.

 

    33. When Will The Maximum Penalty Be Imposed?

 

        The maximum administrative penalty shall be imposed when the counterfeit drug products subject of the case

        are life saving regardless of the volume; or the volume of the counterfeit drug products is worth more than one

        million pesos (PhP 1,000,000.00).

 

    34. What is meant by life-saving drug?

 

            Life-saving drug refers to the drug products indicated for life-threatening conditions.

 

    35. What are the criminal penalties imposable for violation of RA 8203?

 

       A. Imprisonment of not less than six (6) months and one (1) day, but not more than six (6) years for mere possession of counterfeit drugs.

 

       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 (PhP 100,000.00) but not more than five hundred thousand (PhP 500,000.00) or both such imprisonment and fine at the discretion of the court for all prohibited acts other than mere possession.

 

      C. Imprisonment not less than six (6) months and one (1) day but not more than two (2) years and four (4) months if the counterfeit drug is intended for animals.

 

      D. Imprisonment of not less than six (6) months 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 drug as may have been segregated and sealed by the bureau or who shall break, alter or tamper any mark or seal used by the BFAD-FDRO who identify a segregated counterfeit drugs.

 

      E. Imprisonment from twelve (12) years to fifteen (15) years and a fine ranging from one hundred thousand pesos (PhP 100,000.00) to five hundred thousand pesos (PhP 500,000.00) for any person who shall violate RA 8203, if, as result of the use of the drug found to be counterfeit, the illness sought to be cured is aggravated or physical injury or suffering results there from.

 

      F. Life imprisonment and a fine of five hundred thousand pesos (PhP 500,000.00) to five million pesos (PhP 5,000,000.00) shall be imposed to any person who shall violate RA 8203 when the counterfeit drugs subject of the case will be the proximate cause of the death of the victim.

 

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