Memorandum
Circular
No.
2017 – 0014
Subject: Implementing Rules and
Regulations of Republic Act No. 10767 otherwise known as “Comprehensive
Tuberculosis Elimination Plan Act of 2016”
WHEREAS, Republic Act No. 10767, otherwise
known as “Comprehensive Tuberculosis
Elimination Plan Act” was signed into law by the President of the Republic
of the Philippines on April 26, 2016;
WHEREAS, the State, through the Department
of Health (DOH), is mandated to adopt an integrated and comprehensive approach
to health development through the establishment of a comprehensive plan to
eliminate the tuberculosis (TB) in the country. The plan, known as the
Comprehensive Philippine Plan of Action to Eliminate Tuberculosis shall support
efforts of the state to eliminate tuberculosis as a public health problem by
increasing investments for its prevention, treatment, and control and adopting
a multi–sectoral approach in responding to the disease;
WHEREAS, the Philippines as one of the 193
member country’s state of the United Nations committed to adapt the 2030 agenda
of the Sustainable Development Goals (SDG) including goal number 3 of ensuring
healthy lives and promoting well–being for all at all ages and to end the
epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and
combat hepatitis, water–borne diseases and other communicable diseases by 2010;
WHEREAS, Executive Order No. 187 series of
2003, otherwise known as the Comprehensive Unified Policy for TB Control in the
Philippine, supports the collaboration with other government agencies, and
private sector organizations to unify efforts for TB control through the
adoption of a multi–sectoral approach;
WHEREAS, the Department of Health through
the Secretary of Health is mandated to establish a comprehensive plan to
eliminate tuberculosis in the country in consultation with the Department of
Education (DepEd), the Commission on Higher Education (CHEd), the Philippine
Information Agency (PIA), the Local Government Units (LGUs), non–government
organizations, and other concerned entities, including relevant private sector
organizations;
WHEREAS, Section 16 of Republic Act No.
10767 stats that within ninety (90) days from its effectivity, the DOH, in
consultation with the DepEd, the CHED, the PIA, the LGUs, non– government
organizations and other concerned entities, shall issue the rules and
regulations implementing the provisions of this Act;
WHEREAS, Pursuant to Section 16 of the
Comprehensive Tuberculosis Elimination Plan Act, the Task Force was convened on
June 7, 2016, and completed its work on August 11, 2016;
NOW, THEREFORE, the following rules and
regulations are hereby promulgated as the Implementing Rules and Regulations of
Republic Act No. 10767.
RULE 1
General Provisions
Section
1.1
Title
These Implementing Rules and Regulations
(IRR), hereinafter called IRR, shall be known as the “Implementing Rules and
Regulations of the Comprehensive Tuberculosis Elimination Plan Act of 2016
(R.A. 10767).”
Section
1.2
Purpose
These Rules are hereby promulgated to
prescribe the procedure and guidelines for the implementation of the
Comprehensive Tuberculosis Elimination Plan Act in order to facilitate
compliance therewith and to achieve the objectives thereof.
Section
1.3
Declaration
of Policy
The state is mandated to adopt an
integrated and comprehensive approach to health development. Towards this end,
the state shall support and expand efforts to eliminate tuberculosis as a
public health problem by increasing investments for its prevention, treatment
and control, and adopting a multi–sectoral approach in responding to the
disease.
Consistent with the above mentioned
policies, the State further recognizes that:
a. Multi–sectoral
involvement is essential for national and local responses to the TB epidemic;
b. Communities
should be empowered to fight the TB epidemic, which will come through access to
appropriate information and resources for TB prevention, treatment, and care;
c. The
formulation of socio–economic development policies and programs should include
the consideration of their impact on the TB epidemic;
d. Resources
should be allocate taking into consideration the unique vulnerabilities of
various population groups, including the poor, people living with HIV,
children, elderly, contacts of TB cases, diabetics, and smokers; and
e. Continued
efforts should be made to constantly improve the performance and quality of the
TB program.
Section
1.4
Definition
of Terms
For purposes of these rules, the terms
shall be defined as follows:
a. Comprehensive
Philippine Plan of Action to Eliminate Tuberculosis
or herein referred to as the Comprehensive Plan refers to the Program of the
national government for the elimination of tuberculosis in the country. The
“Program” refers to the set of activities, initiatives, and strategies as
states in section 2.2 of this IRR. This is a long term plan that aims to
eliminate TB in the Philippines. It shall form the basis for a series of
national strategic plans.
b. Delivery
of TB Services (DOTS) network refers to a
province or city wide coordinated network of public and private health care
facilities and providers who are capable of giving a part or the entire
spectrum of TB services from prevention, screening, diagnosis to completion of
treatment that follows the policies and guidelines of the National Tuberculosis
Control Program (NTP) of the Department of Health (DOH).
c. Elimination
of TB is defined as less than one (1) case of TB
per million population. This is consistent with the post–2015 TB strategy of
the World Health Organization (WHO) to eliminate TB as a public Health problem
by 2050. To achieve this overall goal, the End TB strategy also aims to reduce
global TB incidence to less than 100 cases per million populations by 2035.
d. Key
affected population refers to a group of
people that experience a high epidemiological impact from TB combined with
reduced access to services and/or being criminalized or otherwise marginalized.
e. Model
center is an institution designated by the DOH as
center for excellence that have shown and generated evidences on the
feasibility, effectiveness and efficiency of TB elimination strategies
concerning prevention, diagnosis, treatment, care and elimination.
f. Multi–sectoral
approach refers to the involvement in TB
elimination efforts of different stakeholders, both public and private,
communities, patient groups, and others.
g. National
Strategic Plan (NSP) is the six–year
strategic rendition of the Comprehensive Philippine Plan of Action to Eliminate
TB which specifies goals and targets, tactical strategies within a specified
time frame, and the investments required for its implementation, consistent with
the overall goal of eliminating TB.
h. National
TB Control Program (NTP) refers to the Program
of the DOH, under the Infectious Disease Prevention and Control Division
(IDPCD) of the Disease Prevention and Control Bureau (DPCB) of the DOH. The NTP
has the mandate to develop TB control policies, standards and guidelines,
formulate the national strategic plan, manage program logistics, provide
leadership and technical assistance to the lower health offices or units,
manage data, and monitor and evaluate the program.
I. Tuberculosis
(TB) refers to an infectious and a curable
disease caused by bacteria called Mycobacterium tuberculosis. It is
transmitted from a person with TB to another person through coughing, sneezing
and spitting. Thus, close contacts, especially household members, could be
infected with TB. Lungs are commonly affected but it could also affect the
kidneys, bones, liver and other organs. TB can be drug susceptible or drug
resistant.
j. TB
Annual Operational Plan (TB AOP) is the annual
operational translation of the NSP to eliminate Tb with a one (1) year time
frame consistent with the overall goal of eliminating TB. It specifies targets
for the current year and activities within a specified time frame, the
investments required for its implementation, including operational units
responsible for carrying out the planned activities.
RULE 2
Comprehensive Philippine
Plan of Action to Eliminate Tuberculosis
Section
2.1
Comprehensive
Philippine Plan of Action to Eliminate Tuberculosis
The DOH shall lead in the development of a
Comprehensive Philippine Plan of Action to Eliminate TB or the Comprehensive
Plan in consultation with relevant agencies, the LGUs, development
organizations and other relevant stakeholders for TB elimination. The
Comprehensive Plan shall serve as the overall strategic roadmap of all entities
and organizations, whether public or private, in implementing relevant
programs, projects, and activities, and in setting targets to eliminate TB as a
public health problem in the country.
The Comprehensive Plan shall consider the
overall national health strategic direction of the DOH. It shall likewise
support the strategic framework of the World Health Organization (WHO) towards
TB elimination by 2050.
To further facilitate adaptation by the
different stakeholders, the Comprehensive Plan shall be further developed into
a series of national strategic plans and annual operational plans. The
Comprehensive Plan, and its first NSP shall be completed within one (1) year
from the effectivity of these Rules.
The Secretary of Health shall deputize the
existing TB TWG to act as the Task Force for the purpose of these rules. The
Task Force shall draft the following plans, which shall be presented to the
National Coordinating Committee (NCC) for approval and adoption:
a. Comprehensive
Plan
b. National
Strategic Plan (NSP)
The DOH – NTP shall develop TB Annual
Operational Plan (TB AOP) prior to the implementation year. Furthermore, the
DOH – NTP shall assist the LGUs at all levels develop and implement a localized
TB elimination plan that is consistent with NSP.
Section
2.2
Contents
of the Comprehensive Plan
The Task Force shall include the following,
among others, in developing the Comprehensive Plan:
a. The
targets and strategies in addressing the TB problem in the country;
b. The
prevention, diagnosis, treatment, rehabilitation, care, client support, and
other components of the country’s response;
c. The
development and application of appropriate technologies to diagnose and treat the
disease;
d. The
strengthening of linkages with local and international organizations for possible
partnerships in education, advocacy, research, and funding assistance for its
operationalization;
e. The
establishment of a review and monitoring system to gather data and monitor the progress
made towards elimination of TB. This also includes enhancement and expansion of
the existing monitoring and evaluation system.
f. The
identification of resource requirements and sources; and
g. The
immediate mobilization of relevant services during and after natural and man–made disasters through collaborative efforts of national and local governments
and other entities.
RULE 3
Strengthening of the
National and Regional Coordinating Committees
Section
3.1
National
Coordinating Committee (NCC)
The NCC of the DOH shall serve as the
steering committee, coordinating, advisory and recommendatory body of the NTP
for strengthening and supporting nationwide capacity for program operations and
bridging collaborative efforts between the public and private sectors.
Specifically, the NCC shall have the
following functions:
a. Oversee
formulation of relevant plans, policies and guidelines to support the
implementation of the Comprehensive Plan;
b. Ensure
the implementation of the Comprehensive Plan, including the NSP and the TB AOP
at the national level;
c. Support
the dissemination of the NSP consistent with the provisions of the
Comprehensive Plan;
d. Assist
in mobilizing the investments and resources for the Comprehensive Plan and its
NSP at the national level;
e. Coordinate
the efforts of various stakeholders from different agencies or institutions,
both from the public and private sectors at the national level, including
agencies specified in Executive Order No. 187 series 2003, otherwise known as
Comprehensive and Unified Policy for TB Control of the Philippines ((CUP);
f. Advise
the DOH on organization of relevant groups or sub–committee based on the
requirements of operationalization of the Comprehensive Plan; and
g. Monitor
and evaluate the progress of implementation of the Comprehensive Plan and its
NSP and TB AOP, and ensure that all concerned agencies and entities will submit
an annual report on the progress of implementation to the Secretary of Health
as stated in Section 10.2 of this rule.
To carry out these functions, the NCC shall
be composed of the following:
a. Chairperson:
The NCC shall be chaired by the Secretary of Health or his/her authorized
representative whose rank shall not be lower than an Undersecretary.
b. Co–Chairperson:
From among the member agencies, the Chairperson shall initiate the selection of
the Co–Chairperson, who will assist in the execution of his/her functions as
NCC Chair.
c. Members:
Member shall come from relevant partner agencies and institutions to include
the following:
(1) Core members:
(a) Director,
Disease Prevention and Control Bureau (DPCB), DOH
(b) Representative
from DepEd
(c) CHED
Commissioner or his/her authorized representative
(d) Head
of Agency of PIA or his or her duly authorized representative
(e) Representative
from Department of Social Welfare and Development
(f) National
Chair, Philippine Coalition Against Tuberculosis (PhilCAT)
(g) Representative
from TB key affected population
(h) Representative
from the League of Provinces of the Philippines (LPP)
(i) Representative
from Food and Drug Administration (FDA)
(j) Representative
from Philippine Health Insurance Corporation (PhilHealth)
(2) Expanded
NCC shall include the following members:
(a) President
of the Philippine Medical Association (PMA) or his or her duly authorized
representative
(b) Representative
from the National Economic and Development Authority (NEDA)
(c) Representative
from Department of Interior and Local Government (DILG)
(d) Representative
from Department of Labor and Employment (DOLE)
(e) Representative
from academic or professional organization of medical and allied professionals
(f) Representative
from development partners
(g) Representative
from Association of Municipal Health Officers of the Philippines
(h) Representative
from other agencies as deemed necessary by the Secretary of Health. The DOH may
reconstitute the membership of the NCC as needed.
Technical
Secretariat: The Technical Secretariat shall be
composed of the NTP Manager as Chair and selected NTP staff as its core
members. The Chair may mobilize other sectors to be a member of the Technical
Secretariat on as needed bases. Specific guideline for the conduct of NCC
meeting and its other functions shall be prepared by the Technical Secretariat
subject to the approval of the Chair.
Section
3.2
Regional
Coordinating Committee (RCC)
The RCC shall support the DOH Regional
Offices and other relevant implementing units at the regional and local levels,
including the local health units to implement DOH NTP policies and guidelines
in eliminating TB. It shall serve as the regional arm of the NTP for strengthening
and supporting region–wide capacity for program operations and bridging
collaborative efforts between the public and private sector. The RCC shall
facilitate technical assistance at the local level with the aim of improving outcomes
for NTP.
The responsibilities and functions of the
RCC shall reflect the same nature of NCC functions but within the scope and
boundaries at the Regional level. These functions shall include the following:
a. Oversee
formulation of regional plans, policies, and guidelines in accordance with the
NSP;
b. Support
the implementation of the Comprehensive Plan of Action to Eliminate TB as
specified in the NSP and TB AOP;
c. Assist
the NCC in the dissemination and localization of the NSP and TB AOP;
d. Assist
the NCC in mobilizing the investments and resources for the implementation of
the Comprehensive Plan and its NSP at the regional and local levels while
leveraging for local counterpart support;
e. Coordinate
the efforts of various stakeholders from different agencies or institutions,
both from the public and private sectors at the regional and local levels,
including agencies at the regional level specified in Executive Order No. 187
series 2003, otherwise known as Comprehensive and Unified Policy for TB Control
in the Philippines or CUP;
f. Advise
the DOH Regional Office on organization of relevant groups or sub–committee
based on the requirements of operationalization of the Comprehensive Plan; and
g. Monitor
and evaluate the progress of implementation of the Comprehensive Plan and its
NSP within the Region by consolidating reports submitted by concerned agencies
and entities to the Secretary of Health.
To carry out these functions, the RCC shall
be composed of the following:
a. Chairperson:
The RCC shall be chaired by the DOH Regional Director (RD).
b. Co–Chairperson:
From among the member agencies, the RD shall initiate the selection of the Co–Chairperson,
who will assist in the execution of his/her function as RCC Chair.
c. Members:
The RD shall reactivate and reconstitute membership of the RCC to reflect the
multi–sectoral nature of the committee and with the inclusion of Key Affected
Population.
d. Technical
Secretariat: The technical secretariat shall be
composed of the Regional TB Team with the NTP Manager as Chair and selected
staff of the Regional TB Program as is core members. The Chair may mobilize
other sectors to be a member of the Technical Secretariat on as needed basis.
Specific guidelines for the conduct of RCC meeting and its other functions
shall be prepared by the Technical Secretariat subject to the approval of the
Chair.
The DOH – NTP through the Regional Office
shall ensure the establishment of similar or equivalent multi–sectoral collaborating
committees in the Provinces/Highly Urbanized Cities (HUCs) and municipalities.
Furthermore, provinces and HUCs shall be supported to ensure that all health
care providers and health facilities providing a part or entire TB diagnosis
treatment and prevention shall be organized as delivery of TB services (DOTS)
network in support of the implementation of multi–sectoral collaboration.
Section
3.3
Strengthening
the NCC and RCC
The Secretary of Health shall continue to
improve the capability of the existing NCC and RCC for ensuring the
implementation of the Comprehensive Plan. For this purpose, the DOH, shall do
the following:
a. Conduct
a capability needs assessment in order to identify additional capacities needed
to ensure efficiency in the implementation, monitoring and evaluation of the
Comprehensive Plan; and
b. Design
and implement a capability building plan that is responsive to the findings of
the capability needs assessment which will include but not necessarily limited
to orienting members of the NCC and RCC on the Comprehensive Plan and NSP and
help mobilize support to its activities
RULE 4
Research, Demonstration
Projects, Education and Training
Section
4.1
Research
and demonstration projects
The Secretary of Health, directly or
through grants to public and non–profit private entities, shall:
a. Update
the National TB Research Agenda every six (6) years, or earlier if necessary,
based on the NSP, and consistent with the overall health research agenda of the
DOH, in coordination with the academe, health professional groups and other
local health partners.
b. Conduct
research which may include, but not limited to, basic, clinical, epidemiologic,
behavioral, and operational researches in accordance with the National TB
Research Agenda with opposite support from local and foreign organizations;
c. Develop
and implement demonstration projects to generate evidence for responsive
policies and to develop regional capabilities for prevention, diagnosis,
treatment, care, and elimination of tuberculosis provided that the said
demonstration projects shall meet the minimum criteria which include but not
limited to the following:
(1) Specific
design addressing an implementation issue;
(2) Defined
baseline process, output and outcome indicators; and
(3) Plant
for monitoring and evaluation
d. Promote
the conduct, dissemination and operational translation of research and
demonstration project findings into policies or program designs and protocol
development. Research promotion activities shall include but not limited to
National Health Research Forum, and other similar activities, scientific
meetings, health policy notes, and publication in peer–reviewed journals.
Section
4.2
Nationwide
Public Information Campaign and Education Program
The Secretary of Health, directly or through
grants to public and non–profit private entities, shall:
a. Conduct
formative research and other studies to gather baseline data for the
development and updating of a communication plan for the TB Program;
b. Develop,
implement and update annually a communication plan for TB prevention,
diagnosis, treatment, care and elimination based on the results of research and
anchored on the Comprehensive Plan and NSPs;
c. Develop
communication materials based on the communication plan. These shall comprise
of materials that will help prevent transmission of TB and will advocate
against unhealthy behavior including the following: (1) spitting in public
places and (2) exhibiting unhygienic behavior;
d. Develop
and disseminate locally appropriate, culturally sensitive and gender responsive
versions of nationally produced materials; and
e. Support
the development and expansion of indigenous media and information and
communication approaches.
Section
4.3
Education
and Training
The Secretary of Health, directly or through
grants to public and non–profit private entities, shall:
a. Conduct
baseline training needs assessment (TNA) of health care providers, program
staff, representatives from key affected population, community volunteers, and
the like based on the requirements of the NSP and consistent with the
guidelines issued by the DOH. The said TNA shall be updated of the process in
the development of the NSP.
b. Modify
existing and develop new training programs based on the results of the TNA and
availability of new technologies, interventions and strategies such as but not
limited to online learning platforms; and
c. Implement,
monitor and evaluate the education programs, trainings and clinical skill
improvement activities for health care providers. A national database of
trainings conducted at the national, regional and local levels, including its
participants shall be maintained by the DOH for this purpose.
Section
4.4
Model
centers
The Secretary of Health, directly or through
grants to public and non–profit private entities, shall:
a. Formulate
guidelines in the search, assessment, selection and renewal or withdrawal of
designation as model centers on TB prevention, diagnosis, treatment, care and
elimination; and
b. Provide
support to model centers to continuously generate evidence, lessons, and
experience on TB prevention, diagnosis, treatment, care and elimination.
Section
4.5
Partnership
with other organizations
The Secretary of Health shall collaborate
with local and foreign organizations in various activities and in providing
technical and funding support for research, demonstration projects, model
centers, and education and training.
Within one (1) year from effectivity of
these rules, the DOH shall develop guidelines relevant to implementation of the
specific Section/s as stated in Rule 4.
RULE 5
Rule Strengthening the
Regional Offices to implement the Comprehensive Plan
Section
5.1
Provision
of free and quality–assured TB laboratory services
The Secretary of Health shall strengthen
the DOH Regional Offices, previously known as Centers for Health Development,
in coordination with the National TB Reference Laboratory of the Research
Institute of Tropical Medicine in the provision of free and quality–assured TB
laboratory services to eliminate TB by undertaking the following:
a. Define
the scope and mechanics of the provision of free TB laboratory services in all
DOH–retained hospitals;
b. Provide
TB laboratory supplies to all DOH–retained hospitals to enable them to provide
free and quality assured laboratory services;
c. Provide
TB laboratory supplies to other health facilities providing TB laboratory
services, whether public or private, that are complying with the DOH NTP
policies and guideline for them to provide free or subsidized quality assured
TB laboratory services; and
d. Establish
and implement Quality Assurance system for TB diagnostic services that
must be participated by all health
facilities complying with DOH NTP policies and guidelines.
Within one (1) year from effectivity of
these rules, the DOH shall develop guidelines for the implementation of this
Section.
Section
5.2
Uninterrupted
supply of free and quality–assured drugs
The Secretary of Health through the Disease
Prevention and Control Bureau in coordination with Procurement Services shall:
a. Define
the scope and mechanics of the provision of free drug supply of local
government health center and other health facilities within the delivery of TB
services (DOTS) network or those complying with NTP policies and guidelines
such as but not limited to hospitals and clinics whether public or private;
b. Provide
reliable supply of quality–assure anti–TB and ancillary drugs to patients for
free by ensuring that:
(1) The
forecast of TB drug requirements per type of regimen, preparation and dose
shall take into consideration but not limited to target number of cases,
consumption levels, current stock levels, and wastage.
(2) All
anti–TB drugs used by the Program are registered with FDA, and listed in the
National Drug Formulary, as well as adapt other criteria as determined
necessary by the DOH such as but not limited to WHO prequalification of
manufacturers, bioequivalence and bioavailability studies, among others.
(3) Distribution
of TB drugs shall cover public and private service delivery points within the
DOTS network, which includes but not limited to health centers, clinics and
hospitals.
(4) Service
delivery points shall submit on a quarterly basis its consumption data, stock
levels, wastage and expected requirements for the succeeding period which shall
serve as basis for subsequent deliveries.
(5) The
health facilities comply with the standard procedures in the disposal of
expired and damaged medicines and other pharmaceutical products.
Within one (1) year from effectivity of
these rules, the DOH shall develop guidelines for the implementation of this
Section.
Section
5.3
Public
Information and Educational Programs
The Secretary of Health, through the Health
Promotion and Communication Service shall strengthen the capacity of the DOH
Regional Offices specifically the unit or section of health education and
promotion to:
a. Collaborate
with relevant sectors to undertake public information and educational programs
to inform the public about prevention and care of tuberculosis;
b. Develop
health promotion plan to include approaches to generate broader community level
actions on TB prevention; and
c. Empower
and engage TB Key Affected Populations (KAP) in program planning,
implementation and service delivery, monitoring and advocacy.
Section
5.4
Capability
building of providers in both public and private hospitals, and other health
facilities
The Secretary of Health shall build and
strengthen the capability of DOH Regional Offices to improve competencies of
health providers in above–mentioned settings for patient–centered TB
prevention, diagnosis, treatment, care and elimination through training and
other approaches. The approaches specified in Section 4.4 shall likewise be
applied in the implementation of this capacity building initiative.
Section
5.5
Monitoring
of cases
The Secretary of Health through the DOH
Regional Offices shall:
a. Through
the local government units, monitor the management of TB cases in both public
and private facilities in accordance with the National TB Control Program
Manual of Procedures (MOP)
b. Monitor,
evaluate and ensure the quality of TB services provided in both public and
private facilities within the delivery of TB services network;
c. Ensure
that all healthcare facilities utilize the existing electronic integrated TB
Information system including the use of other electronic tools, mobile devices
and other wireless technology in monitoring of cases.
RULE 6
Medical and Allied
Medical Education Programs, Basic Education and Media Campaigns
Section
6.1
Medical
and Nursing Education Programs
The Secretary of Health in coordination
with the CHED through the Office of Programs and Standards Development (OPSD)
shall:
a. Integrate
TB prevention, diagnosis, treatment, care and elimination in the curricular of
health professional education and institutions (HEIs);
b. Review
and update TB prevention, diagnosis, treatment, care and elimination in the
curricular, as necessary, in accordance with the existing CHED policies;
c. Issue
guidelines on how to increase the capability of the National Service Training
Program (NSTP) instructors to enable them to learn the principles and practices
of preventing, detecting, controlling, treating and eliminating tuberculosis
through the NTSP, and shall include facility visit and immersion in rural
health units/centers, hospitals and community; and
d. Monitor
and evaluate compliance of schools to the above provisions.
Within one year from effectivity of these
rules, the CHED shall develop guidelines for the implementation of this
Section.
Section
6.2
Basic
Education Programs
The Secretary of Health in coordination
with the Secretary of Department of Education (DepED) through the Bureau of
Learners Support Services (BLSS) and Bureau for Curriculum Development (BCD)
shall:
a. Develop
modules on key core messages for TB prevention, diagnosis, treatment, care and
elimination; and integrate them into relevant subjects of the K–12 curriculum
and for use in the co–curricular and extra–curricular activities in the school
to increase awareness and promote health promoting behavior among learners;
b. Conduct
capacity building activities among teachers and non–teaching personnel to
implement curriculum integration and promote awareness on TB prevention,
diagnosis, treatment, care and elimination in schools; and
c. Monitor
and evaluate the use of modules in all public and private elementary and high
schools.
Within one (1) year from effectivity of
these rules, the DepEd shall develop guidelines for the implementation of this
Section.
Section
6.3
Media
Campaigns
The Secretary of Health, through the HPCS
in coordination with the Philippine Information Agency (PIA) shall:
a. Conduct
formative research on local media outlets to gather baseline data;
b. Develop
a media outreach plan for Tuberculosis prevention, diagnosis, treatment, care
and elimination based on the research findings;
c. Conduct
the below and above the line campaign particularly during the Lung Month, World
TB Day celebration and other similar events through the advocacy and the use of
the multi–media platform in phases as identified in the media outreach plan;
d. Assist
in the mobilization and orientation of Information Officers and organized media
groups or associations;
e. Conduct
monitoring, mid–term assessment and evaluation of the media outreach plan.
Within one year from effectivity of these
rules, the DOH shall develop guidelines for the implementation of this Section.
RULE 7
Regulation on the Sale
and Use of TB drugs
Section
7.1
Implementation
of the “no prescription, no anti–TB drugs” policy
The FDA shall:
a. Assess
the implementation of “no prescription, no anti–TB drug” policy;
b. Develop
and implement a plant to strengthen the implementation of the “no prescription,
no anti–TB drugs” policy to regulate the sale and use of anti–TB drugs in the
market; and
c. Adopt
a multi–disciplinary approach in promoting rational use of drugs among the
general public and providers by raising awareness on the development and spread
of drug–resistant TB cases, promotion of evidence–based clinical medicine
guidelines and prescribing policies, supporting the establishment of
therapeutics committee in hospitals, ensuring adequate labeling and
instructions of medicines, conducting targeted public education campaigns,
among others.
Within one year form effectivity of these
rules, the FDA shall develop guidelines for the implementation of this Section.
Section
7.2
Ensuring
quality of anti–TB drugs available in the Market
The FDA shall ensure the quality of TB
drugs distributed in the market through the following:
a. Enforce
compliance of all drug outlets to distribute, dispense or sell only FDA–
registered anti–TB drugs;
b. Strengthen
post–marketing surveillance including pharmacovigilance, such as reporting of
suspected adverse reactions and quality defects of anti–TB drugs;
c. Strengthen
laboratory capacity of FDA with additional equipment and continuous supply of reference
standards for all anti–TB drugs.
Within one year from effectivity of these
rules, the FDA shall develop guidelines for the implementation of this Section.
RULE 8
Mandatory Notification
of TB Cases
Section
8.1
Notification
of TB Cases
The Secretary of Health through
Epidemiology Bureau in coordination with the Disease Prevention and Control
Bureau and Knowledge Management Information Technology Service shall ensure
that:
a. All
stakeholders, to include the following but not limited to: public and private health
centers and hospitals, NGOs, local and international entities and other
relevant organizations are consulted regarding the current implementation of TB
notification system in terms of coverage, acceptability to providers, and other
operational barriers.
b. The
current TB notification system shall be revised to cover all service providers,
not only those that are considered part of an established delivery of TB
services network, to ensure that all cases diagnosed and treated are reported,
including its outcome, and according to the requirements of the NTP. TB
notification system shall be disseminated to all stakeholders based on the
guidelines formulated.
c. All
public and private health care providers shall report all detected TB cases in accordance
with the guidelines issued by the NTP; and
d. The
conduct of monitoring and evaluation of the implementation of the revised TB
notification system.
Within one year from effectivity of these
rules, the DOH shall develop guidelines for the implementation of this Section.
RULE 9
PhilHealth TB Package
Section
9.1
Expansion
of the TB DOTS Benefit Package
The Philippine Health Insurance Corporation
(PhilHealth) shall enhance its TB DOTS benefit package to make it responsive to
the needs of its members. To enhance the current TB DOTS benefit package,
PhilHealth shall do the following, among others:
a. Conduct
a regular monitoring and evaluation of the implementation of the benefit package
to ensure it is responsive to patients needs and as basis for its future
enhancement;
b. Expand
the benefit package for TB patients to include new, relapse and treatment after
failure, return–after–default cases, and extension of treatment;
c. Institutionalize
the mechanisms to enroll patients without PhilHealth coverage yet needing
health services such as treatment for TB;
d. Review
the current rates and benefit coverage taking into account the real costs and
effects of inflation as well as new diagnostic and treatment modalities for
expansion of benefits for TB based on sound actuarial analysis; and
e. Study
and evaluate various models of care and provider payment schemes for possible
adoption for the purpose of leveraging the package towards improvement in the
outcomes of care and elimination of TB.
Within one year from effectivity of these
rules, the PhilHealth shall develop guidelines for the implementation of this
Section.
Section
9.2
Improving
the system of accreditation of TB DOTS health care institutions
In order to improve access of PhilHealth
beneficiaries that need TB DOTS services, PhilHealth shall likewise improve the
current system of accreditation of facilities that can provide the needed TB
DOTS services under the benefit package. Enhancement of the current system of
accreditation of TB DOTS facilities shall consider the following: streamlining
the certification and accreditation system for the TB DOTS facilities, and ensuring
that healthcare providers are properly oriented and informed among others;
Within one year from effectivity of these
rules, PhilHealth shall develop guidelines for the implementation of this
Section.
RULE 10
Reporting Requirements
Section
10.1
Reporting
Requirements
Before the end of June each year, the DOH
shall submit to the President of the Philippines and Congress an annual
consolidated report of the previous year, which shall provide a definitive and
comprehensive assessment of the Implementation of the Comprehensive Plan based
on its Annual Action Plan and recommend priorities for executive and
legislative actions. The annual report shall contain the progress of
implementation based on the monitoring and evaluation plan.
Section
10.2
Programs
to be Reported
The NCC shall ensure that all implementing
agencies as mentioned in these rules shall submit an annual report.
The NCC shall consolidate all annual
reports submitted.
The annual consolidate report shall include
the documentation of TB elimination related activities of government agencies.
Information in the annual consolidated report shall include, among others;
a. Components
of the programs related to TB AOP, which includes offices involved in the
conduct of the planned activities and areas of implementation;
b. Status
of the implementation of the planned activities, challenges encountered and
best practices;
c. Budgetary
allotments and expenditures relevant to the implementation of the TB AOP which
shall include the following, among others:
(1) Include
budget utilization as per DOH General Appropriations Act (GAA), line item for
the NTP
(2) Relevant
PhilHealth benefit utilization and reimbursements
(3) Foreign
Assisted Projects (FAP) contribution to TB control
d. Results
of the relevant studies and researches that may contribute to the improvement
of the programs; and
e. Recommendations
and plans in addressing challenges and improving performance status.
Section
10.3
Contributions
of other Agencies in Reporting
The following agencies shall submit the
following reports to the DOH for inclusion in the annual consolidated report:
a. The
CHED shall submit a report on the status of implementation of activities as
stipulated in Section 6.1 of this IRR;
b. The
DepED shall submit a report on the status of implementation of activities as
stipulated in Section 6.2 of this IRR;
c. The
PIA shall submit a report on the status of implementation of activities as stipulated
in Sections 7.1 and 7.2 of this IRR; and
d. The
PhilHealth shall submit a report on the status of implementation of activities
as stipulated in Sections 9.1 and 9.2 of this IRR; and
e. Other
government agencies involved to carry out activities to comply with this Act.
RULE 11
Budget Appropriations
Section
11.1
DOH,
DepED, CHED and PIA budget from General Appropriations Act (GAA)
Each agency shall ensure that the amount
necessary for the implementation of these Rules are appropriated in their
annual General Appropriations Act (GAA)
Section
11.2
Budgetary
allocation for the TB program of the DOH
The DOH shall increase its budget for the
NTP both at the national and regional levels in order to adequately support
full implementation of the TB AOP. Specifically, the DOH shall endeavor to
facilitate the following:
a. Increase
the funding for national and regional implementation of the NTP based on the
estimated number of TB cases, overall policy direction of the DOH, level of
intervention, scope, among others;
b. Shift
the funding of its critical investment requirements when necessary from
external to public sources to include but not limited to LGUs, Government Owned
and Controlled Corporations like PhilHealth, PAGCOR, through the relevant line
items of the DOH GAA;
c. Incorporate
in the DOH GAA the cost of introducing new technologies, IEC materials, drugs,
approaches and patient support relevant to TB care, engagement of private
sector partners critical in the implementation of the TB AOP, capacity building
and monitoring and evaluation activities, and other activities as stated in the
TB AOP; and
d. Provide
resources for NCC and RCC in the performance of their functions.
RULE 12
Miscellaneous Provisions
Section
12.1
Rule
of Interpretation
These Implementing Rules and Regulations
shall be interpreted in the light of the provisions of the Constitutions of the
Republic of the Philippines and the Declaration of Policies under Section 2 of
the Republic Act 10767.
Section
12.2
Separability
Clause
If any provision or part hereof is held
invalid or declared unconstitutional, the other provisions which are not
affected thereby shall continue to be in full force and effect.
Section
12.3
Repealing
Clause
All administrative orders, rules, regulations,
memoranda, circulars, local ordinances, resolutions and other issuances or
orders contrary to the provisions of the Comprehensive Tuberculosis Elimination
Plan Act or inconsistent herewith are hereby repealed or modified accordingly.
Section
12.4
Effectivity
These Implementing Rules and Regulation
shall take effect fifteen (15) days after its submission to the office of the
National Administrative Register (NAR) of the UP Law Center and published in at
least two (2) newspapers of general circulation.
PAULYN
JEAN B. ROSELL – UBIAL, MD, MPH, CESO II
Secretary
of Health
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