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 form 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 Owner. – A drug establishment or a registered brand owner may file an administrative action against any person or establishment for any acts in violation of RA 8203 in the form of an affidavit of complaint.
a. name of the product, the lot numbers and expiry date of the products 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 he 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. The name of the 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, and
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 the 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 instead file an affidavit of complaint station –
a. The name and address of the person who has committed the act in violation of R.A. 8203; and
b. The specific acts committed.
He/she shall 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 BFAD FDROs. – 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 proper 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) days within which to file his position paper and submit evidence contrary to that which was found, or justifying the acts in violation of R.A. 8203, failing in which, the case will be considered submitted for resolution based upon the evidence found and presented to him in the same memorandum of evidence.
b. If the party-respondent is a drug establishment, outlet or a business establishment, the memorandum of evidence shall be accompanied by a preventive closure order for thirty (30) days from receipt of the order.
c. If the position paper filed by the respondent shall raise no factual issue 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 had been issued will be called to affirm the documentary evidence and 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) days to supplement his position paper or to manifest his intention to present evidence in support of his position paper, if he shall so intend. In case the party-respondent manifest 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) days period; otherwise, if such proceedings cannot 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 that 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 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 hearing.
SECTION 4. Decision. – Administrative cases under R.A. 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 Decisions/Resolutions. – Decisions and resolutions shall be final and executory after the lapse of fifteen (15) days from the 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. Ground for Appeal. – No appeal shall be given due course except 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 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 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 that one hundred thousand pesos (PHP 100,000.00) but not more than three hundred thousand pesos (PHP 300,000.00) and permanent closure of establishment as well as the revocation of its license to do business 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 concerned as well as the revocation of its license to do business shall be the maximum administrative penalty.
SECTION 4. Accessory Penalties. –
(a) Upon order of the court, all administrative sanctions 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 R.A. 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 Bureau 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 proceeding against said pharmacist with the Professional Regulation Commission to cancel her/his 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 drug 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 Imposed. – The medium administrative penalty shall be imposed when the counterfeit drug products are not life saving drug products and the volume of the counterfeit drugs is worth more than one hundred thousand pesos (PHP 100,000.00) but not exceeding one million (PHP 1,000,000.00) pesos or the number of counterfeit drug products is more than three brands or generic products.
SECTION 9. When the Maximum Penalty Shall be Imposed. – The maximum administrative penalty shall be imposed when the counterfeit drug products are life saving regardless of the volume; or the volume of the counterfeit drug products is worth more than one million (PHP 1,000,000.00) pesos.
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 R.A. 8203.
SECTION 3. Amendments. – These rules and regulations may be amended, modified or supplemented when effective implementation and enforcement of RA 8203 would require.
SECTION 4. Effectivity. – This Order shall take effect thirty days after its publication in two (2) newspapers of general circulation.
Adopted: November 19, 1996
(SGD.) QUINTIN L. KINTANAR, M.D., PH.D., CESO I
Director
In Consultation with the Department of Health:
(SGD.) CARMENCITA NORIEGA-REODICA, M.D., MPH., CESO II
Secretary of Health
