Ao 2021-0011 Coi
Ao 2021-0011 Coi
Ao 2021-0011 Coi
Department of Health
OFFICE OF THE SECRETARY
ADMINISTRATIVE ORDER
No. 2021001)
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Section 35 of the UHC Act mandates that the implementation of the law shall be
strengthened by commitment of all
stakeholders to abide by ethical principles in public health
practice. This shall be achieved through (1) a Conflict of Interest (COI) declaration and
management policy; (2) tracking of financial relationships between health and health-related
commodity manufacturers, healthcare providers and health professionals; and (3) the constitution
of a Public Health Ethics Committee.
Under the law’s IRR, all stakeholders involved in policy-determining activities at all levels
of policy-making are required to act in a manner that shall serve the public’s best interest and thus
are required to disclose and manage any real or perceived conflicts of interest. As such, Section
35.3 of the same directs the DOH
and management
to
issue guidelines that specify standards for receipt, assessment,
of declared COI.
Together with this Order, the following Orders are to be issued: (1) Creation of the Public
Health Ethics Committee (PHEC), and Guidelines on the Public Health Ethics Review, and (2)
Guidelines for the tracking of financial relationships between health and health-related commodity
manufacturers, healthcare providers, and health professionals.
In order to strengthen the implementation of the existing issuances and standardize the
procedures across the
all implementing agencies of the UHC Act, this Order is hereby promulgated
to provide the guidelines on the standards of disclosure, receipt, assessment and management of
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Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 Local 1113, 1108, 1135
Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh.gov.ph; e-mail: [email protected]
COls, which shali be applicable to all persons involved in the policy-determining activities of the
said law.
Il. OBJECTIVE
To provide a clear, specific, and standard process in the declaration and management
COI of all persons involved in the policy-determining activities of the implementing agencies and
of
advisory bodies/committees of the UHC Law in order to ensure integrity and impartiality in
decisions, as well as to address potential graft and corruption practices.
B. COI Management Plan - refers to a document describing the methods for mitigating or
eliminating identified actual or potential COI.
C. Covered Individuals — refers to the individuals as enumerated under Section III Scope
and Coverage of this Order.
D. Declaration of Conflict of Interest Form - the standard form that will be used for persons
covered under this Order to disclose any and all conflicts of interest. (Annex A)
4)
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. Financial Interest - any monetary interests gained for the past 5 years; i.e. salary or other
payments for services or equity interests such as stocks, stock options, intellectual property
rights, among others.
. Head of the Advisory Body — refers to the head/chair of the independent advisory body
created pursuant to the UHC Acct, such as, but not limited to the HTAC and PNB.
. Originating Office — refers to all agencies, bodies, or committees tasked to implement any
of the provisions in the UHC Act.
. Relatives - those related within the fourth civil degree of consanguinity (relationship by
blood) or affinity (relationship by marriage) as defined in RA No. 6173, otherwise known
as the “Code of Conduct and Ethical Standards for Public Officials and Employees.”
. Total Exclusion - refers to a situation where the member will not be allowed to take part
in the deliberation and decision-making processes.
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Q. 201 File — refers to a set of documents containing a person’s comprehensive profile, which
is in the custody of the Personnel and Administrative Division (PAD) or the Human
Resource Office of the concerned Office.
V. GENERAL GUIDELINES
A. The covered agencies, offices, and advisory bodies/committees shall ensure the disclosure
and management of COIs in
all
its policy-determining activities to safeguard professional
integrity and preserve public trust while sustaining the collaboration with private
stakeholders.
B. Each covered agency, office, and advisory body/committee shall develop their guidelines
in receiving, evaluating and managing declared COIs according to the standards set forth
in this Order. They shal! each create their own COI Management Plan for all
identified
actual or potential COI according to the format prescribed by the PHEC.
C. All heads of covered offices shall ensure the disclosure and management ofactual or
potential COIs of persons under their supervision that are involved in any level of
policy-
making. They shall ensure that all covered persons under their offices shall fill-out a
Declaration of Conflict of Interest Form (Declaration Form) under Annex A.
D. The Heads of Agencies covered under this Order shall identify which offices in their
respective agency is tasked to implement any of the provisions of the UHC Act.
E. All persons covered under this Order shall accomplish a Declaration Form, and update such
form as may be necessary. They shal! report any financial, non-financial, or any other
interests relevant to their function in which they have been asked to participate, as well as
any interest that could be affected by the outcome of their function. A list of the reportable
financial and non-financial is provided herein under Annex B. The list provided is not an
exclusive list.
F. The Head of Office/Agency/Advisory Body shall be responsible in (1) preparing the COI
Management Plan of such office, (2) receiving the Declaration Form of all covered
individuals in such office, (3) ensuring completeness of the Declaration Form prior to
submission to the PHEC Secretariat, and (4) submission of COI documents to the PHEC
Secretariat. ~
G. Notwithstanding any declaration made, all individuals covered under this Order shall
promptly disclose any circumstance that could result in potential COI related to their
functions in which they will be engaged, and cooperate in the management such.of
H. Any doubt as to whether there exists a conflict or not shall be brought to the PHEC for
assessment.
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I. The PHEC shall recommend the appropriate course of action based on their review of the
Declaration Forms, the corresponding COI Management Plan, and other supporting
documents.
J. This Order shall be reviewed every after two (2) years following its effectivity to determine
any need for revision.
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A. Declaration and Management of Conflict of Interest in the DOH
exci
CONCERNED HEADS
OFFICES
OF
|» PHEC
SECRETARIAT » PHEC
1. All covered individuals shall complete the Declaration Form where they must disclose any
financial, non-financial, or any other interests relevant to their function in which they have
been asked to participate, as well as any interest that could be affected by the outcome of
their function. Non-completion and non-disclosure of all relevant information from the
Declaration Form may be subject to administrative sanctions or a valid cause for pre-
termination of contract, as the case may be.
2. They shall also declare, to best of their knowledge, substantial interests (financial, non-
financial or any other interests) of their relatives up to the fourth (4") civil degree of
consanguinity or affinity as defined under this Order that may be perceived as unduly
influencing their judgment.
3. The Declaration Form shall be accomplished in three (3) copies. It shall! then be submitted
to their respective Heads of Office within ten (10) days from effectivity of this Order, or
from the date of the person’s employment or engagement of his/her services.
4. The Head of Office shall collect all the Declaration Forms and Summary Reports of all the
covered individuals in the respective office. He/She shall be responsible in transmitting the
same to the PHEC Secretariat.
5. The Head of Office shall ensure completeness of the Declaration Forms prior to submission
to the PHEC Secretariat.
6. The Head of Office shall also prepare a Summary Report in three (3) copies indicating any
personnel/employee with declared conflict and an initial assessment as to whether such
conflict is significant, generally permissible or not significant.
7. The Head of Office shall retain one (1) copy of the Declaration Forms and Summary Report
in their records. He/She shall transmit one (1) copy of the same to the Personnel
(
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Administrative Division (PAD, for inclusion in the 201 File of covered individuals, and
one (1) copy to the PHEC Secretariat.
8. Should the Head of Office himself/herself have COI, he/she must immediately report the
COIto the PHEC, through the PHEC Secretariat, for assessment and management such of
conflict.
9. Covered individuals with declared COIs shall promptly inform the PHEC Secretariat,
through the Head of Office, of any change of information prior to the course of carrying
out their functions.
CONCERNED
INDIVIDUAL |»| HEADS OF
OFFICES |»| HEADS OF
AGENCY
BD
PHEC
secretariat
| PHEC
4. The Declaration Form shall be accomplished in three (3) copies. It shall then be submitted
to their respective Heads of Office within ten (10) days from effectivity of this Order, or
from the date of the person’s employment or engagement of his/her services.
5. The Head of Office shall collect all the Declaration Forms and Summary Reports of all the
covered individuals in the respective office. He/She shall be responsible in transmitting the
sameto the respective Head of Agency.
6. The Head of Office shall ensure completeness of the Declaration Forms prior to submission
to the Head of Agency.
7. The Head of Office shall also prepare a Summary Report in three (3) copies indicating any
personnel/employee with declared conflict and an initial assessment as to whether such
conflict is significant, generally permissible or not significant.
8. The Headof Office shall retain one (1) copy of the Declaration Forms and Summary Report
in their records. He/She shall transmit one (1) copy of the same to the personnel division
of the concerned office for inclusion in the 201 File of covered individuals, and one (1)
copy to the Head of Agency, which shall then be submitted to the PHEC Secretariat.
9. The Head of Agency shall collect all the Declaration Forms and Summary Reports from
the concerned Heads of Offices. He/she shall be responsible for the submission of the
Agency’s COI Summary Report and the attached Declaration Forms to the PHEC
Secretariat.
10. The Head of Agency shail report to the PHEC Secretariat all identified COIs under the
agency.
11. Should the Head of Office/A gency himself/herself have conflict of interest, he/she must be
immediately report the COI to the PHEC, through the PHEC Secretariat, for assessment
and management of such conflict.
1. All covered individuals shall complete the Declaration Form where they must disclose any
financial, non-financial, or any other interests relevant to their function in which they have
been askedto participate, as well as any interest that could be affected by the outcome of
their function. Non-completion and non-disclosure of all relevant information from the
Declaration Form may be subject to administrative sanctions or a valid cause for pre-
termination of contract, as the case may be.
2. They shall also declare, to best of their knowledge, substantial interests (financial, non-
financial or any other interests) of their relatives up to the fourth (4) civil degree of
consanguinity or affinity as defined under this Order may be perceived as unduly
influencing their judgment.
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The Head of Advisory Body shall collect all the Declaration Forms and Summary Reports
of all the covered individuals in the respective office. He/She shall be responsible in
transmitting the same to the PHEC Secretariat.
The Head of Advisory Body shall ensure completeness of the Declaration Forms prior to
submission to the PHEC Secretariat.
The Head of Advisory Body shall also prepare a Summary Report in three (3) copies
indicating any personnel/employee with declared conflict and an initial assessment to as
whether such conflict issignificant, generally permissible or not significant.
The Head of Advisory Body shall retain one (1) copy of the Declaration Forms and
It
Summary Report in their records. shall transmit one (1) copy of the same to the Personnel
Division of such office for inclusion in the 201 File of covered individuals, and one (1)
copy to the PHEC Secretariat.
Should the Head of Advisory Body have conflict of interest, he/she must immediately
report the COI to the PHEC, through the PHEC Secretariat, for assessment and
management ofsuch conflict.
Covered individuals with declared COIs shall promptly inform the PHEC Secretariat,
through the Head of Advisory Body, of any change of information prior to the course of
carrying out their functions.
The deliberation or decision-making process shall follow the Public Health Ethics Review
Process set forth in the PHEC Guidelines.
. The covered individual with partial participation shall be allowed to be present during the
deliberation proceedings. However, only members with full participation shall vote to
make the final recommendations with respect to the issue/topic under deliberation.
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VII. Roles and Responsibilities
B. Head of Agency
The PAD or
the Personnel Division/Unit of the Office concerned shall retain a copy
of the Declaration Forms for inclusion in the 201 File of covered individuals.
1. Any falsification made in the Declaration Form and/or Summary Report punishable under
the Revised Penal Code of the Philippines; and
Any
of theacts/omissions punishable under Revised Rules on Administrative Cases in the
Civil Service.
,/
VIII. REPEALING CLAUSE
Department Order No. 2017-0332 titled: “Guidelines on the Disclosure and Management
of Conflict of interest in Relation to the use of Pharmaceutical Products and Medical Devices” is
hereby repealed by this Order. Meanwhile, all other issuances whose provisions are inconsistent
with this Order are hereby repealed.
IX. EFFECTIVITY
This Administrative Order shall take effect after fifteen (15) days following the completion
of its publication in a newspaper of general circulation, and its submission in the Office of the
National Administrative Register (QNAR) of the UP Law Center.
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ANNEX A
a. INVESTMENTS (e.g. stocks, bonds, retirement plans, trust, partnerships, sector O NONE
(/f “none”, skip to Item b.)
funds, etc.)
CHECK PERCENTAGE NET WORTH
OWNER
ESTABLISHMENT INVESTMENT OF SHARES CURRENT VALUE LESS MORE
if spouse, etc.)
(self, t THAN 5-15% THAN
5% 15%
ONo
O YES
ONo
Oyves ONO
Oyes ONO
Oves ONO
RELATED TO LISTED
Oyves ONO
Oyves ONO
Oyves ONO
Qyes ONO
Oyes ONO
Oyves ONO
2. PAST FINANCIAL INTERESTS
a. To the best of your knowledge, do 1) you or any of your relative within the fourth (4) civil degree, by affinity or consanguinity, 2) organization in which you serve as an
officer, director, trustee, general partner, or employee have any past involvement with any policy determining activity of the office/agency/advisory body/committee:
Oyves ONO
Oyves Ono
Oyes ONO
Oyes Ono
4. CERTIFICATION STATEMENT
L designated as of the ,
of Agency, Office, Bureau,
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(First Nome, Mi, Family Name) (Position/Designation, when applicable) (Name Service, Hospital, or Unit}
do hereby declare on my honor that the above information is true and complete, to the best of my knowledge. !f
there are any changes, will promptly notify you. This
includes any change that occurs before or during the meeting or work itself and through the period up to the publication of the final results or completion of the activity
concerned.
CONFIDENTIALITY STATEMENT
The primary use
of this information is for review of the Public Health Ethics Committee (PHEC) to determine compliance with applicable conflict of interest with laws and
regulations.
This confidential report will not be disclosed to any requesting person, unless authorized by law.
Falsification of information or failure to file or report of information required to be reported is subject to disciplinary action by the OOH.
FOR PHEC USE ONLY
NAME AND SIGNATURE OF REVIEWING OFFICIAL DATE
a
Financial agreements linked to the outcome of clinical trial;
Any proprietary interest in the investigational product; and
So
Any other financial interests relevant to the declarant’s function in which
he/she has been asked to participate, as well as any interest that could be
affected by the outcome of his/her function/s.
a. Personal and professional relationship that includes but not limited to:
i. Family relationships
ii. Friends or adversaries
iii. Volunteer commitments;
Conflict of commitment with other institutions and/or activities and
programs;
Involvement in institutional decisions or consulting positions concerning
the purchase or approval of medications or equipment, or the negotiation of
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