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TABLE OF CONTENTS

FDA-PNP Implementing Rules and Operational Guidelines

Pages
Article I – General Policy……………………………………………………………… 4

Section 1 – Purpose ………………………………………………………… 4


Section 2 – Scope and Application…………………..…………………….. 4
Section 3 - Vision and Mission Statement……………….………………… 4
Section 4 - Core Values……………………………………………………... 4
Section 5 – Application of Administrative Code and Rules of Court……. 5

Article II – Definition of Terms……………………………………………….………. 5

Article III – Organizational Structure: FDA-PNP Task Force D-Punch………... 9

Section 1. Composition……………………………………………………… 9
1.1 Command Group
1.2 Secretariat
1.3 Staff
1.4 Task Group Cluster/STG D-PUNCH

Section 2. Duties, Functions and Responsibilities ………….……………. 10


2.1 Powers and Functions
2.2 Functions of Secretariat
2.3 Staff Functions
2.4 Functions of Task Group Clusters
2.5 Functions of Legal Assistance Board

Section 3. Coordinating Requirements…………………………………….. 13

Section 4. Reporting Requirements………………………………………... 13

Section 5. Planning and Preparation………………………………………. 14

Section 6. Conduct of Operation……………………………………………. 15

Article IV – System and Procedures………………………………………… ……... 16

Section 1. Complaint/Information received by the PNP


regarding FDA cases…………………………………............... 16
1.1 Case Build Up
1.2 Operation

Section 2. Complaint/Information received by FDA……………… ……... 18


regarding FDA cases
2.1. Case Build-up
2.2. Operation

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Article V – Handling, Custody and Disposition of Evidence……………………. 19

Section 1. Procedures……………………………………………………….19

Section 2. Health Product Evidence………………………………………. 20

Section 3. Non-Health Product Evidence………………………………… 21

Section 4. Chain of Custody……………………………………………….. 22

Section 5. Destruction……………………………………………………… 22

Article VI – Common Provisions…………………………………………………….. 25


Article VII – Legal Assistance………………………………………………………… 25

Section 1. Composition of Board………………………………………….. 25


Section 2. Scope……………………………………………………………..26
Section 3. Exclusion………………………………………………………… 26
Section 4. Rules and Regulations…………………………………………. 26
4.1 Administration of Legal Fund and Legal Assistance
4.2 Entitlement of Legal Fund
4.3 Duties and Responsibilities of Task Force Member Availing
Legal Fund
4.4 Qualification, Duties and Responsibilities of the Private Lawyer
or Special Counsel
4.5 Legal Fund Coverage
4.6 Suspension of Legal Fund

Article VIII – Final Provisions………………………………………………………… 30

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FOOD AND DRUG ADMINISTRATION-PHILIPPINE NATIONAL POLICE
IMPLEMENTING RULES AND OPERATIONAL GUIDELINES ON THE
MEMORANDUM OF AGREEMENT DATED NOVEMBER 28, 2016

WHEREAS, the Food and Drug Administration (“FDA” for brevity) is mandated by
law to establish standards and regulations and to adopt measures to ensure pure, safe,
efficacious and good quality drugs in the country as well as pure, safe and quality foods,
health products, medical devices and equipment and the regulation of household
hazardous substances;

WHEREAS, the Philippine National Police (“PNP” for brevity) is mandated to


enforce the law, prevent and control crimes, maintain peace and order, and ensure
public safety and internal security with the active support of the community;

WHEREAS, under Section 15, Article II of the 1987 Constitution of the Republic of
the Philippines, it is the policy of the State to “protect and promote the right to health of
the people and instill health consciousness among them”, and Section 12, Article XIII of
the aforesaid Constitution provides that, “The State shall establish and maintain an
effective food and drug regulatory system and undertake appropriate health manpower
development and research, responsive to the country’s health needs and problems”;

WHEREAS, Republic Act No. 9711, otherwise known as the “Food and Drug
Administration Act of 2009”, has declared that it is a policy of the State to adopt, support,
establish, institutionalize, improve and maintain structures, processes, mechanisms and
initiatives that are aimed, directed and designed to: a) protect and promote the right to
health of the Filipino people; and b) help establish and maintain an effective health
products system regulatory

WHEREAS, the presence and proliferation of counterfeit, unregistered,


adulterated, misbranded health products in the market pose danger to life, health and
safety of the public.

WHEREAS, pursuant to Paragraph 5, Section 14 of Republic Act No. 9711, the


Director-General of the FDA is empowered to call on the assistance of any department,
office or agency and deputize members of the PNP or any law enforcement agency for
the effective implementation of Republic Act No. 9711;

WHEREAS, the FDA, in its campaign against the proliferation of illegal drugs and
substances, counterfeits, unregistered, adulterated, misbranded health products in the
country, needs the assistance of the law enforcement authorities particularly the PNP,
for the effective implementation of the provisions of RA No. 3720, as amended by EO
No. 175 and further amended by RA No. 9711, RA No. 8203, RA No. 9502, RA No.
10611 and all the other FDA-implemented laws, rules and regulations;

WHEREAS, pursuant to the afore-cited provision of Republic Act No. 9711, the
FDA and the PNP entered into a Memorandum of Agreement (“FDA-PNP MOA” for
brevity) last November 28, 2016 wherein the PNP members deputized and specifically
authorized by the FDA shall assist the FDA in the enforcement of its regulatory and

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monitoring functions pursuant and subject to the pertinent provisions of RA No. 9711, its
implementing rules and regulations.

NOW THEREFORE, in order to carry out the implementation of the FDA-PNP


MOA, the following Implementing Rules and Regulations are hereby prescribed and
promulgated.

ARTICLE I
GENERAL POLICY

Section 1 – Purpose

These Rules and Regulations provide for the rules to be followed by, including the
duties and responsibilities of all PNP members deputized and specifically authorized by
the FDA to enforce RA No. 3720, as amended by EO No.175 and further amended by
RA No. 9711, RA No.8203, RA No.9502, RA No. 10611 and all the other FDA-
implemented laws, rules and regulations.

Section 2 – Scope and Application

These Rules and Regulations implementing the FDA-PNP MOA, shall apply to all
members of the FDA-PNP Taskforce “D-PUNCH” deputized and specifically authorized
by the FDA to enforce RA No. 3720, as amended by EO No. 175 and further amended
by RA No. 9711, RA No. 8203, RA No. 9502, RA No. 10611 and all the other FDA-
implemented laws, rules and regulations.

Section 3 – Vision and Mission Statement

FDA-PNP Task Force “D-PUNCH” shall be governed by the following Vision and
Mission:

Vision

Ensure protection and advancement of public health.

Mission

Prevent and control the proliferation of sub-standard, counterfeit, unregistered,


adulterated, misbranded and unsafe medicine, medical devices and equipment,
food and health products by enforcing FDA-related laws and regulations

Section 4 – Core Values

Firmness We are firm in implementing proper actions to secure the safety,


efficacy and quality of health products in the Philippines

Discipline Ensure the responsible obedience of the public in maintaining our


established regulatory system on health products

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Awareness Aspire to achieve an overall awareness to the public protecting them
from unqualified and substandard form of health products circulating
in the country

Section 5 – Application of Administrative Code and Rules of Court

In the absence of any applicable provisions in these rules and regulations the
pertinent provisions in Book VII (Administrative Procedure) of Executive Order No. 292
or the Administrative Code of 1987, Executive Order No. 26 series of 1992 or the Rules
of Court shall have suppletory application.

ARTICLE II
DEFINITION OF TERMS

For purposes of these Rules and Regulations the definition of terms in the FDA-
PNP MOA is hereby adopted. In addition: (Annex A: Definition of Terms)

1. Biologic/Biologic Product – means any attenuated or inactivated virus


or bacteria, or sub-components attached to adjuvants, toxoids, hyperimmune
serum, and analogous products applicable to diagnosis, prevention, treatment or
cure of disease or injuries to man, obtained or derived from living matter - animals,
plants or microorganisms, or parts thereof. It includes preparations primarily
designed to develop a type of immunity or preparations that are concerned with
immunity. (as per A. O. No. 47-A s. 2001)

2. Biological Medicinal Products / Biological Products / Biologics /


Biotherapeutic Product - any product of biological origin, prepared with
biological processes, derived from human blood and plasma, or manufactured by
biotechnology, consisting of substances of higher molecular weight whose purity,
potency, and composition cannot readily and reliably be determined by chemical
or physiochemical analysis. Examples of this group include vaccines, blood
products, modified animal tissues, high molecular weight hormones, allergens,
and the products of genetic engineering or other newer biotechnological
techniques. This definition does not include antibiotics and substances that,
although of biological origin, are of low molecular weight and can be isolated as
pure substances, such as purified steroids and alkaloids. (as per A. O. No. 2014-
0016)

3. Case Build-Up - refers to the entire process of investigation and case


preparation, including surveillance, collection and preservation of evidence,
documentation, and identification of suspects to ensure the successful
prosecution of the FDA case.

4. Case Investigation Plan (CIPLAN) – serves as a working plan and strategy in


the conduct of investigation to come up with a detailed planning, preparation,
implementation, and monitoring among concerned offices/units for funding and
other relevant purposes.

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5. Case Operation Plan (COPLAN) – a time phase plan of action under an
intelligence project directed to specific personalities/organization, crime group,
through infiltration and penetration by action agents with the ultimate objective of
neutralizing the target personalities.

6. Conflict of Interests – All covered FDA and PNP members or operatives having
conflict of interest, such as but not limited to:

a. owning, directly or indirectly, an establishment or entity, including health


products, under the jurisdiction of FDA;

b. stockholder of an establishment or entity under the jurisdiction of FDA;

c. having relative(s) up to 4th degree consanguinity and affinity being employed in


an establishment or entity under the jurisdiction of FDA;

Above enumerated are hereby tasked to declare the conflict of interest and to take
appropriate action to suppress the conflict.

7. Cosmetics – means any substance or preparation intended to be placed in


contact with the various external parts of the human body or with the teeth and the
mucous membranes of the oral cavity, with a view exclusively or mainly to
cleaning them, perfuming them, changing their appearance and/or correcting body
odor, and/or protecting the body or keeping them in good condition.

8. Devices – means medical devices, radiation devices and health related devices.

a. “Medical Device” means any instrument, apparatus, implement, machine,


appliance, implant, in-vitro reagent or calibrator, software, material, or other
similar or related article intended by the manufacturer to be used alone, or in
combination, for human beings for one or more of the specific purpose(s) of
diagnosis, prevention, monitoring, treatment or alleviation of disease;
diagnosis, monitoring, treatment, alleviation of, or compensation for an injury;
investigation, replacement, modification, or support of the anatomy or of a
physiological process; supporting or sustaining life; preventing infection;
control of conception; disinfection of medical devices; and providing
information for medical or diagnostic purposes by means of in-vitro
examination of specimens derived from the human body. This device does not
achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means but which may be
assisted in intended function by such means.

b. “Radiation Device” means an electrical or electronic apparatus emitting any


ionizing or non-ionizing electromagnetic or particulate radiation; or any sonic,
infrasonic, or ultrasonic wave. It includes ionizing radiation emitting equipment,
which is not intentionally designed to produce radioactive materials.

c. “Health-related Device” means any device not directly used in health care but
has been determined by the FDA to adversely affect the health of the people.

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9. Drugs - means any of the following:

a. Articles recognized in official pharmacopoeias and formularies, including


official homeopathic pharmacopoeias, or any documentary supplement to any
of them, which are recognized and adopted by the FDA.

b. Articles intended for use in the diagnosis, cure, mitigation, treatment, or


prevention of disease in man or other animals;

c. Articles (other than food) intended to affect the structure of any function of the
body of human beings or animals; or

d. Articles intended for use as a component of any articles specified in clauses


(a),(b), or (c) but do not include devices or their components, parts or
accessories.

10. FDA Cases – refer to cases brought about by violations of the provisions of RA
No. 3720, as amended by EO No. 175 and further amended by RA No. 9711, RA
No. 8203, RA No. 9502, RA No. 10611 and all the other FDA-implemented laws,
rules and regulations.

11. FDA Officials/Employees shall mean officials and employees of the FDA who
are incumbent to a position regardless of whether permanent, casual, or
contractual subject to the rules on exclusion provided in this Order, including
those validly deputized to perform FDA functions, duties and responsibilities.

12. FDA Personnel Order (FPO) – issuance directed to FDA offices, officials,
employees, or group of persons, including those validly deputized concerning
specific matters including assignments, re-assignments, detail, transfer,
secondment; attendance to conferences, training, workshops, meetings, seminars
and other government sponsored activities on official business or time; delegation
of authority to subordinate officials, creation of committees, technical working
group (TWG), Task force even with the participation of external experts or persons
and all movements of personnel for compliance of all concerned. It has identifiable
targets usually for a certain period of time.

13. FDA-PNP Examiner- refers to the PNP chemist/analyst deputized by the FDA to
conduct product analysis or verification or coordination regarding the conduct of
product analysis or verification pertaining to violations of FDA-implemented laws
and regulations.

14. FDA-PNP Task Force “D-PUNCH”– refers to the task force composed of both
the FDA and PNP officers mandated to spearhead the collective effort to ensure
the enforcement of FDA laws and regulations.

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15. FDA-PNP Task Force “D-PUNCH” Secretariat – refers to the Office from both
the FDA and PNP, which shall provide administrative and technical support to the
Task Force;

16. FDA-PNP Task Force “D-PUNCH” Investigator – refers to the PNP investigator
deputized by the FDA and FDA-identified officers specifically authorized to
conduct case build-up on FDA cases.

17. FDA-PNP Task Force “D-PUNCH” Operative – refers to the PNP operative
deputized by the FDA and FDA-identified officers specifically authorized to
conduct operations pertaining to violations of FDA laws and regulations.

18. Food - means any processed substance, which is intended for human
consumption and includes drinks for human beings, beverages, chewing gum and
any substances, which have been used as an ingredient in the manufacture,
preparation or treatment of food.

19. Health Products - means food, drugs, cosmetics, devices, biologicals, vaccines,
in-vitro diagnostic reagents and household/urban hazardous substances and/or a
combination of and/or a derivative thereof. It shall also refer to products that may
have an effect on health which require regulations as determined by the FDA.

20. High Risk – denotes to a case or situation that is subject or exposed to a danger
or difficulty in operating. The danger or difficulty may be by any or all of the
following factors: Personality, Area, Activity, Products.

21. Legal Action shall mean action, suit or proceeding whether criminal, civil or
administrative in nature, filed against FDA Officials/Employees in connection with
the lawful exercise of their official functions, duties or responsibilities as such.

22. Legal Assistance- refers to the provision of legal fund which shall cover the cost
of suit and Attorney’s fee as mentioned in section 4.5 of article VII.

23. Legal Assistance Board – a group of responsible individuals tasked to evaluate


and determine whether the members of the Task Force D-PUNCH charged
criminally or administratively are entitled to legal assistance.

24. Legal Fund refers to the amount out of the total interest earned from the retained
income gained every calendar year by the Food and Drug Administration net of
withholding tax.

25. PNP Operational Procedure (POP) – pertains to the set of rules, policies,
guidelines and procedures to be observed in the conduct of police operations

26. Team Leader – a responsible Police Commission Officer with a rank of at least
Police Inspector who leads and take responsibility in the conduct of operation.

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ARTICLE III
ORGANIZATIONAL STRUCTURE: FDA-PNP Task Force “D-PUNCH”

Section 1 – Composition

1.1 The TF shall be headed by TDIDM who shall be designated as the TF


Commander. He shall be assisted by the Executive Officer, DIDM who
shall be designated as the Deputy Commander.

1.2 FDA-PNP Task Force “D-PUNCH” Secretariat

Head Secretariat C, CRAC


Deputy Head Secretariat Asst. C, CRAC
Two (3) Action PCOs (1) CRAC
(1) CMD
(1) SIDD
Legal Officer (LS) SLO, DIDM
Five (4) Action PNCOs (1) CRAC
(1) CMD
(1) BFO
(1) SIDD
Three (3) NUPs (2) CRAC, (1)BFO
One (1) Legal FDA Officer
One (1) FDA personnel

1.3 The TF shall have the following Staff:

Personnel ADMO, DIDM


Training C, SIDD
Investigation/Intelligence/Operations C, CMD, CIDG-AFCCU
Logistics/Finance C, BFO
Technical Support CL, ACG
Information and Awareness DPCR
Legal Assistance Board LS

1.4 Task Groups Clusters shall be composed by Sub-Task Groups (D-


PUNCH) comprised of the following:

a. Task Group Cluster NCR- MPD, SPD, EPD, QCPD, NPD

Task Group Cluster Commander DRDO


Asst. Task Group Cluster RC, NCRCIDU
Action PCO (1) RIDMD, NCRPO
Action PNCO (2) RIDMD

District Sub-Task Group:

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Sub Task Group Leader BC, DPSB
Asst. STGL TL, CIDT
Tactical Team DPSB
Inves/Intell CIDT/DPSB
Technical Support Team CLO, ACG
Legal LS
FDA Representative

b. Task group clusters NL, SL, VIS, EM, WM

Task Group Cluster Commander Ex-O of all DIPOs


Asst. Task Group Cluster Commander C, OD of all
DIPOs
Action Officer Asst. C, OD of all DIPOs
2 Action PNCOs 1 OPN, 1 Intel of all DIPOs

Regional Sub-Task Group:

Sub-Task Group Commander RC, CIDG


Asst. Sub-Task Group BC, RPSB

Members:

Tactical Team RPSB/ PPSC Inves/


Intel RCIDU
Technical Support Team CLO, ACG
Legal RLS
FDA Representative

Section 2 – Duties, Functions And Responsibilities

2.1. The FDA-PNP Taskforce “D-PUNCH” shall have the following


powers and functions:

a. Prevent and control violations of FDA-implemented health laws,


rules and regulations and investigate persons violating the same.
effect the arrest of criminal offenders, bring offenders to justice and
assist in their prosecution;

b. Effect lawful arrests, search and seizures in covered products and


establishments pursuant to the provisions of the Rules of Court

c. File criminal case in any court or tribunal upon the prior approval
by the FDA Director General. The approval of the institution of a
criminal prosecution against the offender shall be accompanied by
a certification certifying the facts to the Secretary of Justice,
through the Secretary of Health, together with the laboratory
report, the findings of the FDA and PNP, or other documentary
evidence on which the charge is based.
d. Seize health products pursuant to orders; or

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e. Padlock establishments pursuant to orders of the FDA or any court
or tribunal;

f. Inform the FDA in writing of the operations within twenty-four (24)


hours from the time of the actual custody of the suspects or
seizure of said health products, as well as, labeling, other relevant
documents, or machine, other equipment and vehicles used to
perpetrate the offense or illegal activities violating FDA-
implemented health laws; - maintain the reporting established by
PNP;

g. Act as witness and testify in any pending criminal case in Court or


before the FDA in administrative proceeding;

h. Provide regular updates, through the FDA-PNP Taskforce “D-


PUNCH” Secretariat, of the status of pending cases filed in court
until their final disposition.

i. Provide investigative and other relevant enforcement trainings to


FDA personnel.

2.2. Functions of the Secretariat

a. Maintain database of cases and statistics relative to the conduct of


operation and case build-up on cases;

b. Monitor the conduct of operation and case build-up on cases;

c. Prepare the reportorial requirements of FDA-PNP Task Force “D-


PUNCH” (COPLAN/CPLAN, Incident/Spot Report, Report of
Operation)

d. Coordinate the administrative requirements of the FDA-PNP Task


Force “D-PUNCH” including the preparation of agenda for the
quarterly consultative meeting, the circulation of papers, among
others;

e. Recommend the issuance of policy directives in relation to the


conduct of operation and case build-up on cases and the
development of programs that will enhance and strengthen the
capabilities of FDA-PNP Task Force “D-PUNCH” investigators and
operatives;

f. Endorse request for legal assistance to Legal Assistance Board;

g. Perform other tasks as directed by the FDA-PNP Task Force “D-


PUNCH”

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2.3. Staff Functions

a. Personnel – Issue appropriate orders to D-PUNCH members.

b. Training – Conduct of training and other enhancement programs of


D-PUNCH members.
c. Inves/Intel/Opn – Conduct validation and operation, production of
intelligence, consolidate reports, monitor and supervise the filing of
cases relative to the implementation of FDA-related laws.

d. Logistics/Finance – Provide logistics and financial requirements of


TF D-PUNCH.

e. Technical Support – Examine, analyze and interpret evidences


submitted in aid of investigation.

f. Public Information – Disseminate information materials and publish


significant accomplishments of the TF

2.4. Functions of Task Group Clusters (NL, SL, Vis, EM, WM, and
NCRPO)

a. Maintain close coordination with the Secretariat in relation to


matters pertaining to operations;

b. Attend to the quarterly consultative meeting to discuss and tackle,


among others, various issues and concerns, necessary policy-
directives and updates on FDA cases;

c. Provide the Secretariat with reports and updates on operation and


case build-up conducted;

d. Activate a Special Tracker Team to locate and arrest wanted


persons criminally charged in relation to FDA cases;

e. Develop and support programs that will enhance and strengthen


the capabilities of FDA-PNP Task Force “D-PUNCH”

f. Intelligence production

2.5. Functions of the Legal Assistance Board

a. Accept application for legal assistance from members of the TF


who has been administratively or criminally charged by virtue of
implementing FDA laws.

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b. Review and evaluate the application for completeness in form and
in substance.

c. Recommend the application to the Director General for approval,


through the TF Commander.

Section 3 – Coordinating Requirements

3.1. FDA-PNP Taskforce “D-PUNCH” investigator or operatives authorized


for the purpose, prior to any operations, shall, as far as practicable,
coordinate with the office of the FDA through the Task Force Secretariat.

3.2. The word “As far as practicable” means that prior


coordination/information with FDA Director General shall be done,
practiced or accomplished when feasible and possible to be performed.
Nonetheless, it admits exceptions. The following instances, among
others, are deemed not practicable for prior coordination, subject to the
rules on post coordination:

a. In remote places where coordination is not possible;


b. When coordination will compromise the lives of police operatives,
informants and witnesses, involved in FDA-related operations;
c. When coordination will prejudice the apprehension of suspects and
confiscation of violative health products;
d. When prior coordination will compromise the entire operation.

3.3. In any case, FDA-PNP Taskforce “D-PUNCH” investigator or operatives


shall coordinate/inform in writing the FDA Director General of their
operations within twenty four (24) hours from the time of the actual
custody of the suspects or seizure of said health products, as well as,
labelling, other relevant documents, or machine, other equipment and
vehicles used to perpetrate the offense or illegal activities.

Section 4 – Reporting Requirements

4.1. In every successful operations, FDA-PNP Taskforce “D-PUNCH”


investigator or operatives shall submit to the Taskforce Secretariat the
following reports:

a. SMS Report – to be submitted within one hour after the operation is


conducted
b. Spot Report – to submitted within 24 hours after the operation is
conducted
c. Progress Report – to be submitted whenever developments are
obtained

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d. After Operations Report – to submitted after the completion of the
operations
e. Development Report – result of case monitoring containing the
details and development of the case until the verdict or decision is
made.

Section 5 – Planning and Preparation

5.1. As a general rule, all operations must be preceded by adequate planning


and preparation to ensure the successful prosecution of cases,
observance of the rights of suspects, safety of operating elements and
the security and integrity of seized items/evidence.

5.2. All operations shall be covered with a CIPLAN/COPLAN to be submitted


to FDA-PNP Taskforce “D-PUNCH” Secretariat for evaluation and
appropriate action.

5.3. The designated Team Leader must determine the number of agents
he/she will need to successfully implement the FDA-related operations,
provided that an FDA officer and member of the taskforce shall always
be included. In choosing his members, the following shall be considered:

a. Expertise;
b. Experience;
c. Technical Aptitude.

No PNP personnel shall be allowed to conduct any operation unless he


is a member of the FDA-PNP Taskforce “D-PUNCH” and authorized
specifically for the purpose.

5.4. The Team Leader shall secure, through the FDA-PNP Taskforce
Secretariat the required FDA Personnel Order identifying the team
members and the scope of their operation.

5.5. The Team Leader shall, prior to the actual operations, conduct a detailed
briefing for the operating personnel. Charts, photographs, maps, etc.,
should be used as necessary and the specific duties and responsibilities
of each member, clearly discussed.

5.6. The Team Leader, in coordination with the assigned Legal Officer should
see to it that appropriate warrant/s are obtained when necessary.

5.7. Without sacrificing operational security, coordination must be done with


local Police Units in the area of operation to prevent any possible
confrontation in consonance to Rule 5 (Inter Unit Coordination) of the
Revised PNP Operational Procedures.

5.8. The Team Leader must also designate an investigator who shall keep
and preserve notes to record the actual conduct of the operation

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including valuable information that can be used in the prosecution of the
case or in the conduct of future operations.

5.9. All operating Units shall designate a “Seizing Officer” who shall be
responsible for taking into custody all violative health products and non-
drug evidence during the operation to ensure that all these evidences
are safe and handled in accordance with applicable law, rules and
regulations.

5.10. The Team Leader shall secure, through the FDA-PNP Taskforce “D-
PUNCH” Secretariat, the required certification from the FDA prior to filing
of the case.

Section 6 – Conduct of Operation

6.1. All operations to be conducted shall be led by the Regional/District Sub-


Task Group Commander or his authorized representative.

6.2. The FDA-PNP Taskforce “D-PUNCH” investigator or operative shall


secure, through the FDA-PNP Taskforce Secretariat, the required
authorization for operation from the Office of the Director General of
FDA.

6.3. In any operation, the Team Leader must see to it that all actions are in
accordance with the law, the crime-scene is preserved and well-
managed, the suspects are arrested, all possible evidence are taken into
custody and that the safety of operating elements and innocent people in
the area of operations are ensured.

6.4. All FDA-PNP Taskforce “D-PUNCH” operative shall be required to have


at least one (1) female member operative who shall be responsible for
arresting and frisking female suspects and for taking into custody,
children found in the place of operation.

6.5. Task Force Investigator shall maintain a record of the events, which
include among others, jump-off time and date, name of the Team
Leader, area/s of operation and vehicles used. A record book shall be
preserved for the purpose and shall form part of the documents covering
the operation.

6.6. Upon arrival in the area of operation, immediate area observation and
assessment must be conducted by the Team Leader and last minute
instructions to be given, as necessary.

6.7. In case an arrest is to be made, the arresting elements must do it


immediately and with reasonable force, anticipating possible resistance
with the use of deadly weapons which may be concealed in the
suspect/s’ body, in a vehicle or in a place within arm’s reach.

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6.8. Any arrested suspect shall be apprised of his/her CONSTITUTIONAL
RIGHTS (I/We are Police Officers. I/we are arresting you for violation of
RA __________ (FDA Law). You are hereby informed that you have the
right to remain silent. Anything that you say, can and will be used for or
against you in any Court of Law. You have the right to a counsel of your
own choice and if you cannot afford one, you shall be provided with a
counsel to assist you. You can waive all this rights in the presence of a
Lawyer and in writing. Do you understand these rights?)

“Kami ay alagad ng batas, inaaresto ka namin sa paglabag sa


Republic Act _______(FDA- Law). Pinapaalalahanan ka namin
na ikaw ay may karapatang manahimik o magsawalang kibo.
Anuman ang iyong sasabihin ay maaring gamitin pabor o laban
sa iyo sa anumang hukuman. Ikaw ay mayroon ding
karapatang kumuha ng tagapagtanggol na iyong pinili at kung
wala kang kakayahan, ito ay ipagkakaloob sa iyo. Nauunawaan
mo ba ito?”

In instances wherein arrested suspects are foreign nationals or persons


with impaired senses, Police Officers must inform them of their rights in
a manner understood by them or through an interpreter, if practicable.

6.9. All arrested suspects must be handcuffed. Should there be shortage of


handcuffs, suspects’ hands may be bound by any restraining material.
In situations involving Children in Conflict with the Law (CICL), they
shall not be handcuffed unless there is a valid reason to restrain them.

6.10. The Team Leader must see to it that all pieces of evidence from the
suspect/s or those found in the area of operation are handled in
accordance with the standardized pro-forma Forms established in this
these Guidelines. Search warrant, inventory report, cer of peaceful and
orderly search, arrest report, affidavit, SMS, spot report, after operation
report, complaints – search this forms.

6.11. Upon return of the operating personnel to their Station, the Task Force
Investigator must record the time and date of return, name/s of the
arrested person/s, and other significant circumstances that transpired
during the operation.

ARTICLE IV
SYSTEM AND PROCEDURE

Section 1 – Complaint/Information received by the PNP regarding FDA cases

1.1. Case Build-up:

a. Any PNP Units, upon receipt of a complaint or information or


evidence of FDA cases, shall refer the same to the Task Force
Secretariat which shall recommend to the FDA for the conduct of

16
validation and investigation. Upon approval, the Secretariat shall
assign the case to the concerned FDA-PNP Task Group Cluster
which shall effect an investigation and other appropriate intervention.
The Sub-Task Group Commander shall assign a FDA-PNP
Taskforce investigator or operative and shall inform the secretariat
the results thereof.;

b. The appropriate FDA Personnel Order (FPO) shall be issued by the


FDA in favor of the investigators and operatives;

c. During case build-up, FDA shall provide technical assistance to the


FDA-PNP Task Force “D-PUNCH” investigators and operatives;

d. FDA-PNP Task Force “D-PUNCH”, through the Secretariat, shall


closely monitor the progress of the FDA cases as well as the case-
build up conducted by the Task Force “D-PUNCH” members or
operatives

e. FDA shall be furnished immediately of the reports and updates on


the case-build up conducted by the FDA-PNP Task Force “D-
PUNCH”

1.2 Operation:

a. If, as a result of the case build up, there is a reasonable ground to


believe that the elements of the crime are present, the FDA-PNP
Taskforce “D-PUNCH” investigator or operative shall prepare a
report and shall secure, through the FDA-PNP Taskforce
Secretariat, the required authorization for operation from the Office
of the Director General of FDA;

b. The appropriate FDA Personnel Order shall be issued by the FDA in


favor of the investigators and operatives;

c. FDA-PNP Task Force “D-PUNCH”, through the Secretariat, shall


closely monitor the progress of the operation conducted by the Task
Force “D-PUNCH” investigator or operatives as well as the case
filed, if any, as a result of the operation;

d. FDA shall be furnished immediately of the reports and updates on


the operation conducted by the FDA-PNP Task Force “D-PUNCH”.
The Team Leader shall immediately submit incident report through
SMS within one hour after the conduct of the operation to be
followed by spot report within 3 hours and written report to be
submitted within 24 hours.

e. If a search warrant has been secured and implemented, the FDA-


PNP Taskforce “D-PUNCH” investigator or operative shall inform in
writing the FDA Director General of their operations within twenty-
four (24) hours from the time of the actual custody of the suspects or

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seizure of said health products, as well as, labelling, other relevant
documents, or machine, other equipment and vehicles used to
perpetrate the offense or illegal activities.

f. No criminal case shall be filed in any court or tribunal without the


prior approval by the FDA Director General. The approval of the
institution of a criminal prosecution against the offender shall be
accompanied by a certification certifying the facts to the Secretary of
Justice, through the Secretary of Health, together with the laboratory
report, the findings of the FDA and PNP, or other documentary
evidence on which the charge is based.

g. FDA shall be furnished immediately of the reports and updates of


the case until its final disposition.

h. In all operations, the Police Operational Procedure (POP) shall be


observed.

NB: Process Flow Annex B

Section 2 – Complaint/Information received by the FDA regarding FDA cases

When any violation of any provisions of any FDA-implemented laws comes


to the knowledge of the Director, of such character that a criminal prosecution ought to
be instituted against the offender, the same shall be forwarded to the FDA-PNP
Taskforce Secretariat together with the laboratory report, the findings of the FDA, or
other documentary evidence on which the charge is based.

2.1 Case Build-up:

a. The Task Force Secretariat upon receipt of a complaint or


information or evidence from FDA, shall refer the case to the
concerned FDA-PNP Task Group Cluster which shall effect an
investigation and other appropriate intervention. The Sub-Task
Group Commander shall assign a FDA-PNP Taskforce investigator
or operative and shall inform the secretariat the results thereof.;

b. The appropriate FDA Personnel Order shall be issued by the FDA in


favor of the investigators and operatives;

c. During case build-up, FDA shall provide technical assistance to the


FDA-PNP Task Force “D-PUNCH” investigators and operatives;

d. FDA-PNP Task Force “D-PUNCH”, through the Secretariat, shall


closely monitor the progress of the FDA cases as well as the police
operation and case-build up conducted by the Task Force “D-
PUNCH”
e. FDA shall be furnished immediately of the reports and updates on
the case-build up conducted by the FDA-PNP Task Force “D-
PUNCH”

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2.2 Operation:

a. If, as a result of the case build up, there is a reasonable ground to


believe that the elements of the crime are present, FDA-PNP
Taskforce investigator or operative shall prepare a report and shall
secure, through the FDA-PNP Taskforce “D-PUNCH” Secretariat,
the required authorization for operation from the Office of the
Director General of FDA.;

b. The appropriate FDA Personnel Order shall be issued by the FDA in


favor of the investigators and operatives;

c. During operation, FDA shall provide technical assistance to the


FDA-PNP Task Force “D-PUNCH” investigators and operatives;

d. FDA-PNP Task Force “D-PUNCH”, through the Secretariat, shall


closely monitor the progress of the FDA the operation conducted by
the Task Force, as well as the case filed, if any, as a result of the
operation;

e. FDA shall be furnished immediately of the reports and updates on


the operation conducted by the FDA-PNP Task Force “D-PUNCH”.

f. If a search warrant has been secured and implemented, the FDA-


PNP Taskforce “D-PUNCH” investigator or operative shall inform in
writing the FDA Director General of their operations within twenty-
four (24) hours from the time of the actual custody of the suspects or
seizure of said health products, as well as, labelling, other relevant
documents, or machine, other equipment and vehicles used to
perpetrate the offense or illegal activities.

g. No criminal case shall be filed in any court or tribunal without the


prior approval by the FDA Director General. The approval of the
institution of a criminal prosecution against the offender shall be
accompanied by a certification certifying the facts to the Secretary of
Justice, through the Secretary of Health, together with the laboratory
report, the findings of the FDA and PNP, or other documentary
evidence on which the charge is based.

h. FDA shall be furnished immediately of the reports and updates of


the case until its final disposition.

Article V
HANDLING, CUSTODY AND DISPOSITION OF EVIDENCE

Section 1 – Procedures

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1.1 During handling, custody and disposition of evidence, provisions of all
applicable laws and its IRR shall be strictly observed.

1.2 Photographs of pieces of evidence must be taken immediately upon


discovery of such, without moving or altering its original position including
the process of recording the inventory and the weighing of violative health
products in the presence of required witnesses.

1.3 The Seizing Officer must mark the evidence with his initials indicating
therein the date, time and place where the evidence was found/recovered
or seized.

1.4 Containers, packaging, labelling, equipment, etc., suspected as used in


the perpetration of the offense are considered evidence and shall be
seized as part of the evidence.

1.5 In every operation, a “Seizing Officer” shall be designated who would be


responsible for the inventory and initial custody of all violative health
product and non-health product evidence confiscated during the
operations. All these would later be turned over to the Investigation
Officer or any member of the apprehending team, and submitted to the
FDA-PNP Taskforce “D-PUNCH” for proper disposition.

1.6 Digital evidence such as computers, laptops, cellphones, CDs, flash


drives and other forms of storage peripherals found at the crime scene
during the conduct of FDA-related operations, shall be referred to the
Anti-Cybercrime Group (ACG) for purposes of Forensic Digital
Examination.

Section 2 – Health Product Evidence

2.1 Upon seizure or confiscation of violative health products, containers,


packaging, labelling, equipment, etc., the operating Unit’s Seizing
Officer/Inventory Officer must conduct the physical inventory, markings
and photograph the same in the place of operation in the presence of:

a. The suspect/s or the person/s from whom such items were


confiscated and/or seized or his/ her representative or counsel;

b. With an elected Public Official; or

c. Any representatives from the Department of Justice or Media who


shall affix their signatures and who shall be given copies of the
inventory.

2.2 For seized or recovered health products, containers, packaging,


labelling, equipment, etc., covered by Search Warrants, the inventory
must be conducted in the place where the Search Warrant was served.

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2.3 For warrantless seizures like buy-bust operations, inventory and taking
of photographs should be done at the nearest Police Station or Office of
the apprehending Officer or Team.

2.4 All the violative health products, containers, packaging, labelling,


equipment, etc., shall be properly marked for identification, inventoried or
counted, sealed, packed and labeled. The exact inventory or count of the
health products, containers, packaging, labelling, equipment, etc. seized
or recovered should be recorded in the Inventory and Chain of Custody
Forms or Evidence Vouchers

2.5 Within the same period, the Seizing/ Inventory Officer shall prepare a list
of inventory receipt of confiscation/ seizure, to include but not limited to,
the following:

a. Time, date and place of occurrence/seizure.

b. Identity of person/s arrested.

c. Identity of the Seizing Officer and all persons who witnessed the
operations.

d. Circumstances in which the seizure took place.

e. Description of the vehicle, vessel, place or person searched from


where/whom the substance was found.

f. Description of packaging, seals and other identifying marks.

g. Description of quantity, volume and unit/measurement method


employed.

h. Description of the health products, containers, packaging, labelling,


equipment, etc. found.

2.6 Within 24 hours upon confiscation/ seizure when practicable, all health
products, containers, packaging, labelling, equipment, etc. shall be
submitted to the FDA-PNP Taskforce “D-PUNCH” for proper disposition.

2.7 All pieces of health products, containers, packaging, labelling,


equipment, etc. seized as evidence shall be turned over by the Seizing
Officer to the Investigator-On-Case who shall submit the same to the
FDA laboratory or PNP Crime Laboratory or FDA Center as the case
may be for examination or verification. All the phases of turn-over of
evidence must have corresponding receipts to show continuance of
chain of custody.

2.8 The Seizing Officer shall properly accomplish the Chain of Custody Form
and turn it over including the evidence to the Investigator-On-Case for

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submission to the FDA Laboratory or PNP Crime Laboratory or FDA
Center as the case may be.

Section 3 – Non-Health Product Evidence

3.1 All pieces of non-health product evidence shall be photographed,


inventoried and properly marked:

a. Buy-bust money, if applicable.


b. For motor vehicles, a sticker containing pertinent information (names
of suspects, date and time of arrest, arresting Unit, and arresting
Officers to include the place where the motor vehicle was seized)
shall be attached on an area where it is most visible.

c. For firearms, ammunition, explosives or other deadly weapons, tags


containing the same information shall be attached.

d. For smaller pieces of evidence, pertinent information such as quality,


quantity and place where it was seized/recovered shall be placed
inside the evidence bag.

e. For digital evidence such as computers, cell phones, laptops, other


similar gadgets, and storage peripherals, procedures indicated in the
Miscellaneous Provisions of this Guidelines shall be strictly observed.

3.2 After the conduct of operation, the Investigator-On-Case shall


immediately prepare a detailed report including photographs of all
seized/ confiscated non-health product evidence. As far as practicable,
the Legal Officer of the operating unit should be present during the
operation to ensure that all the information gathered can hold ground
during Court proceedings.

3.3 For seized/ confiscated motor vehicles, a Technical Inspection and


Inventory Report (TIIR) shall be prepared by the Seizing
Officer/Investigator-On-Case immediately after the seizure/confiscation
in the presence of the suspect/occupant, whenever possible, with his/her
signature affixed on the report.

Section 4 – Chain of Custody

4.1 The Seizing Officer must preserve the integrity and evidentiary value of
the pieces of evidence.

4.2 Persons handling health product evidence from the time of its
seizure/confiscation should be limited to the Seizing Officer, the
Investigator-On-Case and FDA Laboratory or PNP Crime Laboratory or
FDA Center personnel. All non-health product evidence shall be turned-
over to the evidence custodian.

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4.3 An acknowledgement receipt shall be issued by the person receiving the
evidence. Such receipt shall form part of the case folder of the
transmitting Unit.

4.4 The Seizing Officer shall accomplish the Chain of Custody Form and with
it, submits the evidence to the FDA Laboratory or PNP Crime Laboratory
or FDA Center, as the case may be, for examination or verification.

Section 5 – Destruction

5.1 Early disposal of seized violative health products or hazardous health


products.

a. After filing of the case, the Food and Drug Administration (FDA) shall,
within seventy-two (72) hours, conduct an ocular inspection of the
confiscated, seized and/or surrendered violative health products or
hazardous health products.

b. Within a reasonable period of time after the inspection, the FDA


through the Regulatory Enforcement Unit (REU) shall proceed with
the destruction or burning or disposal of subject items.

c. Prior to its destruction, representative samples shall be taken, and


recorded by the FDA laboratory, or PNP Crime Laboratory or FDA
Center, as the case may be, which conducted the examination or
verification of the seized violative health products or hazardous
health products for presentation as evidence in the case. The
concerned agency shall determine the amount of samples needed to
be retained.

d. Where the amount of seized violative health products or hazardous


health products is equal to or less than the required amount of
retention, all the seized items shall be preserved as evidence in court
or FDA until the court or FDA terminates the case.

e. In all cases involving hazardous health products, the FDA officer-in-


charge of disposal of the hazardous health product should also refer
to the Material Safety Data Sheet (MSDS) of the hazardous health
product for further guidance on safe handling and disposal.

f. Violative health products shall be disposed of by means of the


following methods:

1) Thermal destruction method in accordance with applicable laws.


The FDA may engage the provisional services of third parties
with thermal facilities covered by valid and subsisting permits and
clearances issued by appropriate government agencies; or

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2) Other lawful appropriate methods as may be authorized by the
DOH, in consultation with DENR.

g. Witnesses may be allowed to observe the procedures for the conduct


of destruction or disposal of violative health products. Witnesses shall
wear “dust mask.” In case of destruction of hazardous health
products in a thermal facility, witnesses should stay no less than
fifteen (15) meters away from the facility when the burning starts. In
this regard, the FDA officer supervising the destruction will make the
judgment call.

h. FDA shall maintain a watch detail until the destruction process is


completed.

i. Destruction or disposal or burning of seized violative health products


upon approval of the court or hazardous health products shall be
done in public and witnessed by any of the following:

1) A representative from the Court.

2) A representative from the media.

3) A representative from DOJ

j. The alleged offender or his/her representative or counsel shall be


allowed to personally observe all the above proceedings. In case said
offender refuses or fails to appoint a representative after due notice
in writing to the accused or his/her counsel within seventy-two (72)
hours before the actual burning or destruction of the evidence in
question, the Secretary of Justice shall appoint a member of the
Public Attorney’s Office to represent the former.

k. The FDA officer-in-charge of destruction through the Task Force


Secretariat shall issue a sworn certification as to the fact of
destruction or burning of the subject items, which together with the
representative sample(s) in the custody of FDA, shall be submitted to
the court having jurisdiction over the case.

l. The cost of disposition or destruction of seized violative health


products or hazardous health products shall be borne by the
offender.

m. After the promulgation and judgement in the case wherein the


representative samples were presented as evidence, the prosecutor
shall inform the Secretariat of the final termination of the case and, in
turn, shall request the court for leave to turn over the said
representative samples to the FDA for proper disposition and
destruction within seventy-two (72) hours after receipt of same,
unless justified by circumstances beyond the control of FDA.

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n. In cases of seizure where no person is apprehended and no criminal
case is filed, the FDA may order the immediate destruction or burning
or disposal of seized violative health products or hazardous health
products: Provided that appropriate inventory of health products, in
the presence of witnesses, laboratory examination and prescribed
reports have been carried out. Such destruction shall be made in the
presence of prescribed witnesses. The FDA officer-in-charge of
destruction through the Task Force Secretariat shall issue a sworn
certification as to the fact of destruction or burning.

5.2 Violative Health Product or Hazardous Health Product Evidence


Tracking and Inventory.

a. A database system shall be maintained by FDA to track evidence


from receipt to destruction or disposal.

b. The officer designated by FDA shall conduct routine annual


inventories of the evidence stored in the FDA evidence vault or steel
cabinet or storage area. Similar inventories shall be performed each
time an FDA official or any FDA-designated individual who has
access to the vault or cabinet or storage area retires or leaves the
job.

Article VI
Common Provisions

Section 1 During operation or case build-up FDA-PNP Task Force “D-PUNCH


investigators and operatives shall strictly observe the applicable provisions of the PNP
Operational Procedure;

Section 2 In accordance with R.A. 9711, and its Implementing Rules and Regulations,
and other relevant laws, the seized article or articles of food, device, cosmetics,
household hazardous substances and health products that are adulterated,
counterfeited, misbranded or unregistered; or any drug, in-vitro diagnostic reagents,
biologicals, and vaccine that is adulterated or misbranded, by virtue of operation
conducted pursuant to these Operational Guidelines, shall be under the control,
possession and custody of the FDA. The FDA-PNP Task Force “D-PUNCH” shall
provide for the warehouse for seized health products in every Region;

Section 3 All case build up and operations shall be covered by separate FDA
Personnel Orders duly approved and signed by the Director General, FDA.

Section 4 FDA-PNP Task Force “D-PUNCH investigators and operatives shall act as
witness and testify in Court, or when called upon before the FDA, performing its quasi-
judicial function, for the speedy prosecution of criminal complaints against violators of
FDA-implemented health laws, rules and regulations.

Section 5 FDA-PNP Task Force “D-PUNCH” shall jointly conduct quarterly consultative
meeting, or as often as necessary, to discuss and tackle, among others, various issues
and concerns, necessary policy-directives and updates on FDA cases;

25
Section 6 Other stakeholders may be invited during the consultative meeting to provide
assistance to the FDA-PNP Task Force “D-PUNCH”.

Section 7 Relevant seminars and trainings shall be provided to members of FDA-PNP


Task Force “D-PUNCH

Article VII
Legal Assistance

Section 1 – Composition of the Legal Assistance Board

Chairman – FDA Legal Officer


Vice-Chairman - PNP LS

Members:
(1) Sub-Task Group Concerned
(1) TG Cluster
(1) FDA Representative

Section 2 – Scope

These rules shall govern the use of legal fund established out of the interest
earned from the retained income of the Food and Drug Administration. Additionally, a
portion of the fund transferred to the PNP may be used to cover legal assistance.

The legal assistance shall cover the cost of suit and attorney’s fees reasonably
incurred by the FDA officials and employees in connection with any criminal, civil or
administrative action or proceeding, to which they may be, or have been made, a party
by reason of the performance of their functions and duties. Notwithstanding, it is subject
to prohibitions, restrictions, exceptions, or limitations as stipulated below or as may be
provided by law rules and regulations.

Section 3 – Exclusion

The legal fund for the legal assistance shall not cover:

3.1 Any action or suit initiated by the FDA Officials/Employees in his/her


personal capacity, by the FDA itself or the DOH against FDA;

3.2 FDA official or employee whose services to the FDA has been severed or
otherwise terminated by the FDA for any legal cause except compulsory
retirement;

26
3.3 The FDA Officials/Employees is found, with finality, criminally, civilly or
administratively liable for the crime or offense charged subject to the rule
on paragraph 5.1.5 of Rule V below

3.4 Any action or suit filed against the FDA Officials/Employees who is
already entitled similar entitlement provided under any other laws, rules
and regulations;

3.5 Any action that is to be handled by the Office of the Solicitor General; or

3.6 Such other justifiable cause as determined by the head of the agency.

Section 4 – Rules and Regulations

4.1. The following rules and regulations shall govern the establishment and
administration of the legal fund and legal assistance in the FDA.

a. In case a duly deputized and authorized investigators and operatives


were charged with criminal, civil or administrative case in the
performance of his/her duty, the FDA-PNP Task Force “D-PUNCH”
Secretariat shall immediately coordinate with the Legal Assistance
Board;

b. FDA shall provide the legal assistance fund in favor of any member of
the Task Force “D-PUNCH” who will be charged with criminal, civil or
administrative case in the performance of his/her duty.

c. FDA shall provide court duty representation and travel expenses.

4.2. Entitlement to the Legal Fund

a. Upon receipt of notice that any legal action, suit or proceeding is filed
against him/her in the exercise of their official functions, the taskforce
member shall notify the Secretariat in writing of such action, suit or
proceeding;

b. The task force member shall signify his/her intention to avail of the
fund and assistance and secure the approval of the FDA Director
General on the terms and conditions of the engagement of counsel
for the purpose of entitlement to the legal fund;

c. The Secretariat shall thereafter endorse it to the Legal Assistance


Board which shall examine, review and validate the documents
presented by the taskforce member within five (5) days from receipt;

d. Upon finding that all the requirements have been fully complied with
and that all the necessary documents submitted are in order, the

27
Legal Assistance Board shall then recommend the processing of the
claims, and the subsequent release of funds for consideration of the
FDA Director General. The Director General can exercise prerogative
on whether to grant or deny the request for legal assistance.

e. Any expenses incurred in advance by the task force member for


payment of the Attorney’s Fees, required Docket Fees, etc shall be
subject to reimbursement upon submission of the Official Receipt
issued by the lawyer, court and other documents necessary for the
said claim and approval thereof by the head of the agency.

f. If the taskforce member is finally adjudged guilty, whether criminally,


civilly or administratively, of the crime or offense charged he/she shall
return the cash advanced to him/her or cash reimbursed either
through salary deductions (FDA officers only) or reimbursement (FDA
and PNP officers). Provided that, if during the pendency of the case
the employment of the official or employee is severed and later on
he/she is finally adjudged guilty the official or employee shall return
the cash advanced to him/her or cash reimbursed either through
deduction of benefits (if his/her benefit has not yet been released) or
reimbursement;

g. In case of settlement or compromise which may involve monetary


considerations and/or money judgment in favor of the taskforce
member, the legal fund shall be reimbursed on actual fees and other
expenses incurred by such task force member in connection with any
administrative, civil or criminal action, suit or proceeding to which they
may have been made a party by reason of the lawful performance of
their official functions and duties in such capacity;

h. Any approved legal fund or assistance to the claiming task force that are yet
to be released may continue until any of the applicable conditions in the
Exclusion above becomes present or is otherwise suspended pursuant to
Item 4.5 below.

4.3. Duties and Responsibilities of Task Force Member Availing the Legal
Fund

a. The task force member shall ascertain and disclose in writing to the
Legal Assistance Board that the private lawyer or law firm engaged or
to be engaged is not connected or related to any FDA regulated
establishment, including related foundations, to avoid impropriety and
conflict of interest. In the event that it should come to the knowledge
of the FDA official or employee that the lawyer/firm so engaged is
connected or related to any FDA regulated establishment including

28
related foundations, such fact should be disclosed immediately to the
head of the agency for appropriate decision.

b. For any cash advance claim or payments personally made for


purposes of reimbursement, the task force member shall submit the
true and correct official receipts and other documents necessary for
the said claim or reimbursement.

c. The task force member shall be required to submit a periodic status


report of his/her case to the Secretariat and the Legal Services
Support Center of the FDA

4.4. Qualification, Duties and Responsibilities of the Private Lawyer or Special


Counsel
a. The private counsel or special attorney that will represent the FDA
official or employee should be a bona fide member of the Integrated
Bar of the Philippines, of good standing and shall submit the following
documents:

1. Mandatory Continuing Legal Education (MCLE) Certificate for the


current compliance period;

2. Copy of the Proposed Contract of Service;

3. Integrated Bar of the Philippines (IBP) Certificate of Good


Standing;

4. Professional Tax Receipt (PTR);

5. Such other legal requirements when deemed necessary for the


engagement.

b. The private lawyer, special counsel or law firm to represent the FDA
official or employee shall disclose in writing to the FDA that the former
is not connected or related to any FDA regulated establishment,
including related foundations, to avoid impropriety and conflict of
interest.

c. The private lawyer, special counsel or law firm shall be required to


submit a periodic Status Report of Case/s being handled.

4.5. Legal Fund Coverage

a. The legal assistance shall cover the cost of suit and attorney’s fees
not to exceed the schedule of fees issued by the Supreme Court.

29
b. Provided that all the above expenses arising from the suit or
proceeding shall not exceed the total amount of Php250,000.00.
(maximum).

c. The prescribed rates above may be modified by the Director-General


of the FDA, as the circumstances may warrant, subject to existing
rules and regulations.

4.6. Suspension of the Legal Fund

The release of the legal fund to the task force member may be
suspended anytime by the head of the agency for just cause. Non-compliance
by the official or employee of his/her obligation or nonfulfillment of the private
lawyer or special counsel of his qualification, duties or responsibilities of the
member as mandated in these rules may be construed as just cause.

ARTICLE VIII
FINAL PROVISIONS

Separability. If any section of these Operational Guidelines or part thereof is held


invalid or unconstitutional, the remainder not otherwise affected shall remain valid and
subsisting.

Effectivity. These Operational Guidelines shall take effect immediately upon


signing.

Adopted and signed this _____th day of _____________ 2017 at


_____________

Food and Drug Administration Philippine National Police


By: By:

_____________________________ _____________________________
Nela Charade G. Puno PDG Ronald M. De la Rosa
Director-General Chief, PNP

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