01 July 2018

Memorandum Circular No. 2017-0014

02 May 2017


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


No comments: