Republic of the Philippines DEPARTMENT OF HEALTH Office of the Secretary BAGONG PILIPINAS JUN 13 202 DEPARTMENT ORDER No. 2024 - 9.225 L SUBJECT: Regulatory Reform Framework for Health Facilities and Services RATIONALE ‘The Department of Health (DOH) is mandated to regulate hospitals under Republic Act (RA) No. 4226, titled “An Act Requiring the Licensure of All Hospitals in the Philippines and Authorizing the Bureau of Medical Services to Serve as the Licensing Agency,” enacted on January 25, 1965. Initially focusing on hospital licensure, the regulatory scope expanded to cover other health facilities, such as clinics, dispensaries, laboratories, and blood banks in 1987, through Executive Order 119, titled “Reorganization of the Ministry of Health, Its Attached Agencies and For Other Purposes.” ‘The operating regulatory framework of DOH has always been through the “command and contro!” approach that requires health facilities to secure an appropriate authorization from DOH based on a uniform administrative process in complying with a set of standards, securing permits, and undergoing inspections and monitoring. At present, the DOH regulates twenty (20) types of health facilities and services offering tiered levels of care. As of December 31, 2023, there are 12,007 regulated health facilities in the country, which greatly outnumbers around 500 regulatory officers from the Health Facilities and Services Regulatory Bureau (HFSRB), Centers for Health Development-Regulation, Licensing and Enforcement Division (CHD-RLEDs), and Bangsamoro Autonomous Region in Muslim Mindanao Ministry of Health-Health Regulation Division (BARMM MOH-HRD). With the directive of the RA No. 11223 or the Universal Health Care (UHC) Act, to expand the regulatory scope to primary care facilities and other modes of health service provision, an estimated additional 2,600 health facilities shall further stretch the already limited capacity and resources of the DOH regulatory offices. The current regulatory framework poses challenges. It comes with high administration and enforcement costs for the DOH, as well as high administrative burden and substantive compliance costs for health facilities. The COVID-19 pandemic has challenged to a greater extent the capacity of the current regulatory scheme of DOH to urgently regulate new types of health facilities and innovations. It has manifested the importance of adopting agile and risk-based regulation to overcome the pandemic. The HFSRB, CHD-RLEDs, and MOH-HRD, in various capacities and quarantine-imposed operational limitations, were able to quickly respond to the emerging health facilities and 4 ‘services during the pandemic through adoption of facilitated regulatory pathways, + reduction of non risk-based regulatory administrative barriers, and virtual inspections and monitoring. ‘ As the regulatory landscape evolves, the HFSRB needs to design “future proof” ‘regulations by shifting from command and control to risk-based regulation, that is aligned if Tlding T, San Lazavo Compound, Rizal Avenue, Sia Cru, 1005 Manin Truk Line €31-7800 foal 1108, THT, T1T2, TH Direct Line: 711-9512, 711-9503 Fax: 743-1829 » URL: hp. doh gov. ph; e-mail dohesec@toh go%-phwith the Philippine Development Plan (PDP) 2023-2028. The PDP emphasizes risk-based regulation, regulatory efficiency, reduction of administrative burden through automation, and elimination of redundant and duplicative regulations. The Regulatory Reform Framework 2023-2028 exemplifies the vision, mission, reform goals and strategies necessary for the progressive transformation of regulation of health facilities and services in the country. This regulatory reform aims to strengthen and expand the capacity of HFSRB, CHD-RLEDs and MOH-HRD to ensure every Filipino experiences health and well-being through safe, high-quality, and people-centered services from health facilities, in line with the National Objectives for Health (NOH) and the strategic thrusts of the 8-Point Action Agenda Medium-Term Health Sector Strategy for 2023-2028 as provided in Administrative Order No, 2023-0015. The reform seeks to establish a resilient, agile, and effective regulatory governance of HFSRB over the CHD-RLEDs and MOH-HRD, as directed by the Implementing Rules and Regulations (IRR) of the UHC Act, through coherence of evidence-based policies, collaborative regulatory decision-making, harmonized implementation, better use of resources, and promotion of regulatory quality mindset and culture. Furthermore, the reform shall be implemented in accordance with the directive and provisions of RA No. 11032, known as the “Ease of Doing Business Act of 2018”. The regulatory processes and activities shall be aligned with the Memorandum Circular No. 2022-06 of Anti-Red Tape Authority (ARTA), titled “Establishing the National Policy on Regulatory Management System (NPRMS)” and the Philippine Good Regulatory Principles (PGRP). Moreover, the reform pursues to provide sustainable actions to address the persistent gaps in the organizational capacity of the Bureau, its regulatory counterparts. in the CHDs, and BARMM MOH. I. OBJECTIVES This Order has the following objectives: 1. Articulate the vision, mission, quality policy, values, and principles necessary to strengthen regulatory governance of health facilities and services; 2. Provide the regulatory reform framework towards agile and risk-based regulation of health facilities and services, in accordance with the NPRMS and PGRP; and, 3. Identify the key strategies to attain the regulatory sectoral goals, in alignment with the NOH 2023-2028 and the 8-Point Action Agenda Medium-Term Health Sector Strategy for 2023-2028, III. SCOPE OF APPLICATION | This Order shall apply to the HFSRB, CHD-RLEDs, and all others concerned 2 3 relevant to the implementation of the Regulatory Reform Framework of Health Facilities = Sand Services. &o2 G! oN In the case of BARMM, the adoption of this Order shall be in accordance with the 35 2 ‘applicable provisions of RA 11054, or the “Bangsamoro Organic Act” and subsequent >S3 mi rules and policies issued by the Bangsamoro government. 3 >Iv. Si 4202 FT NAT Ad09 NUL C Vv. a = i DEFINITION OF TERMS A Good Regulatory Practice (GRP) - This comprises policies and practices that aim to ensure that government regulation achieves the goals of effectiveness and efficiency and continues to do so over time, It involves disciplines for developing new regulations and amending existing regulations. These disciplines include strict adherence to Regulatory Impact Assessment and a commitment to objectively review regulation periodically to assess whether it has remained effective and efficient — and reforming it when necessary Impacts — refers to both positive (benefits) and negative (costs) effects of regulation. These include all economic, social, and environmental impacts, direct and indirect (flow-on), and one-off and recurring/ongoing impacts. Regulation — refers to any legal instrument that gives effect to a government policy intervention and includes licensing, imposing information obligation, compliance to standards or payment of any form of fee, levy, charge or any other statutory and regulatory requirements necessary to carry out activity or modify behavior. Regulatory Impact Assessment (RIA) — refers to a tool used to design and evaluate policies, laws and regulations, that are targeted, proportionate, accountable, transparent, and consistent. It involves a systematic process that examines the expected consequences or range of alternative policy options that could be used to address a particular policy problem or issue. The policy options shall include evidence-based information to decision-makers, regulators and stakeholders. The output of the conduct of RIA is the Regulatory Impact Statement (RIS) to be submitted by the HFSRB, Regulatory Life Cycle ~ refers to the process of designing, introducing, reviewing and possibly amending/temoving regulation to ensure it remains relevant over time and that no alternative policy option would be more effective and efficient in achieving the objectives the regulation was designed to achieve. Regulatory Management System (RMS) — refers to the set of special measures that apply to the development of new, or the review of existing regulations, and has four 4) main components: regulatory quality tools, regulatory practices and processes, regulatory institutions, and overarching policy. Risk-Based Regulation — refers to one of the regulatory approaches which uses appropriate regulatory tools for the identification and analysis of risks to be used as, basis for resource allocation on areas that need it most. This also involves the development of decision-making frameworks and procedure to prioritize regulatory activities and deploy resources, principally relating to inspection and enforcement, based on the risk assessment that regulated forms pose to the regulator’s objectives. | GUIDING PRINCIPLES “The Regulatory Reform Framework for Health Facilities and Services shall be {implemented in accordance with the following PGRP issued by the ARTA:zi | | 2 a! I = zo roo BZ = 2 Sr 2 Principle 1: Clarity HFSRB shall provide clear and coherent regulatory policies that are aligned with the national development objectives and the DOH’s strategic thrusts and objectives. The regulatory policies shall be carefully analyzed using regulatory management tools, such as regulatory impact assessment. Principle 2: Legal and Empirical Basis HPSRB shall ensure sound legal basis for all regulatory policies in accordance with its mandate and function. It shall apply interventions only when empirical evidence provides a need for regulation. The regulation shall be risk-targeted and risk- proportional, supported by data-driven assessments and studies, Principle 3: Benefits vs. Costs HFSRB shall take into account the potential impact and significant costs of the regulatory policies on the economy, society and environment, during its development and implementation. It shall ensure that the benefits of the regulatory policies outweigh the costs of implementation and compliance, prioritizing the well- being, dignity, and rights of patients and healthcare workers. Principle 4: Assessment HFSRB shall consider a spectrum of various regulatory policy tools in the assessment of regulatory policy options, ranging from direct regulation (command and control regulation) to operation of free market (non-regulatory option), based on the ARTA RIA Manual. Principle 5: Engagement HFSRB shall ensure effective and inclusive stakeholder engagement by integrating consultation activities in the different stages of regulatory life cycle. Principle 6: Coherence HFSRB shall ensure that the regulatory policies are aligned and consistent with other regulations, and that the implementation and enforcement of the regulatory policies are harmonized with the CHD-RLEDs and MOH-HRD in order to deliver the desired policy outcomes. Principle 7; Whole-of-Government Approach HFSRB shall coordinate and streamline regulatory efforts with the CHD-RLEDs, MOHL-HRD, and other regulatory agencies, both at the local and national levels, through an adoption of the Whole-of- Government approach, in accordance with the Implementing Rules and Regulations of RA 11032, also known as the “Ease of Doing Business and Efficient Government Service Delivery of 2018”, HFSRB and the CHD-RLEDS shall ensure an adequate number of competent, trained, and skilled technical and support staff to implement regulations and develop evidence-based regulatory policies. fH. Principle 8: Continuous Evaluation HESRB shall ensure that existing regulatory policies are applicable and relevant at the present time, effective and efficient in attaining its objectives, through regular review and evaluation. It must also keep pace with the emerging technologies and innovations in health care services by taking into consideration the resulting enforcement challenges in the design of the regulatory framework. 1. Principle 9: Competition HESRB shall promote and adhere to competition principles and policies in order to support the growth and attain the overall development objectives of the country. J. Principle 10: Risk Management HFSRB shall adopt regulatory risk management to identify and manage risks at every stage of the decision-making process. It shall develop risk assessment guidelines that will identify the potential risks related to noncompliance with the safety standards of service delivery in health facilities, VL POLICY FRAMEWORK A. HESRB Vision ‘An innovative and strong regulatory bureau responsive and compassionate to the needs of the citizens in ensuring access to safe, high-quality, and people-centered health services by 2040, in the attainment of UHC. B. HESRB Mission To ensure accessible, safe, and quality healthcare for all Filipinos through implementation of evidence-based standards for licensing and accreditation of health facilities and services. C. HESRB Core Values Integrity ‘Commitment Excellence Accountability eeNe Ss Regulatory Reform Goals _ 1. The well-being, rights, and dignity of patients and health workers are protected and promoted through humanistic leadership that ensures that the health facilities and services are safe, of good quality, and patient-centered. w * Sop oo | 4200 7 hn | ! AdOO 3. 2. Regulation of health facilities and services is strengthened through collaborative governance and responsive regulation that is data-driven and risk-based to prevent unnecessary burden and cost to both government and stakeholders. aii |Regulatory Reform Strategies 1. Strengthen regulatory governance of health fa agile regulatory reform and humanistic leadership. and services through Objectives: 1.1 Develop regulatory reform framework and operational policies. 1.2. Harmonize and streamline processes for coherent implementation of regulation 2. Enhance organizational capacity to enforce regulatory mandates. Objectives: 2.1. Strengthen the legal mandate and promote the modemization of HFSRB. 2.2 Establish a safe and conducive workplace for HFSRB staff and clients, 2.3 Secure resources for logistics and personnel through adequate budget, allocation. 2.4 Enhance the effectiveness and efficiency of regulation by establishing new functional units within HFSRB. 2.5 Institutionalize knowledge transfer and on-boarding programs for regulatory officers of HFSRB, CHD-RLEDs and MOH-HRD. 3. Improve regulatory efficiency, ease of doing business, and data- generation for policy making through modernizing processes. Objective: 3.1 Upgrade information systems and infrastructure. Vil. IMPLEMENTING GUIDELINES A. The Regulatory Reform Framework 2023-2028 shall be aligned with the strategies and objectives indicated in the PDP 2023-2028, NOH 2023-2028, and 8-Point Action Agenda Medium-Term Health Sector Strategy for 2023-2028. B. HESRB, CHD-RLEDs and MOH-HRD shall adhere to the ARTA NPRMS and comply with all its requirements. C. HFSRB shall ensure that the following RMS elements are integrated in the design and implementation of Regulatory Reform Framework 2023-2028, as well as its strategic and operational policies: 1. The Philippine Good Regulatory Principles 2. Assessing Legal Implications 3. Consultation and Stakeholder Engagement 4, Adoption of Plain Language 5. Digitalization of Regulation and Regulatory Documents 6. Regulatory Coherence and Cooperation kh 7. Capacity-BuildingVii. Ix. G. HESRB shall adopt the Regulatory Life Cycle approach in the development of policies, in accordance with NPRMS. All HFSRB divisions and units shall align their policies, activities, and funds with the Regulatory Reform Framework 2023-2028 (Annex A). HESRB shall develop the necessary operational policies and ensure its effective and efficient cascading to the CHD-RLEDs, MOH-HRD, health facilities, other DOH offices, National Government Agencies, and other relevant stakeholders. ‘The CHD-RLEDs and MOH-HRD shall adopt the Regulatory Reform Framework and are encouraged to use the corresponding strategic plan to be issued by the HFSRB as reference for the development of their respective annual operational plans. SEPARABILITY CLAUSE If any part or provision of this Order is rendered invalid by any court of law or competent authority, the remaining parts or provisions not affected shall remain valid and effective. EFFECTIVITY This Department Order shall take effect immediately. A HERBOSA, MD Spffetary of Health | ERIIFIED TRUE COL y JUN 14 2004 | A oats a4 Poe etree tie ca tte’ See en RC Cen Sot ee et Bett eevee ent itt Rta Cet erte yn Tey oAsiqias Bupbuljoy6pdouw 3p ‘popijpyap ‘sp3617 Excrarans Exon) 8707Z-€707 SAOIAUAS GNV SAILITIOVA HLTVIH dO MUOMINVUT WAOMTA AMOLVIND A AVAANE AVOLVINDTA SADIAUAS UNV SALLITIOVA HLTVAH : WtvaH Jo yuounsedag, saunyddyyg 943 Jo 9y)qudoy ¢ yxeuay 07 °N OG usojay AuozeinBoy guSsH epundy voney aodDO No. 2024- Annex B List of References National Laws Republic Act No. 11223, An Act Instituting Universal Health Care for All Filipinos, Prescribing Reforms in the Health Care System, and Appropriating Funds Therefor,” or the “Universal Health Care Act” Republic Act No. 11032, “An Act Promoting Ease of Doing Business and Efficient Delivery of Government Services, Amending for the Purpose Republic Act No. 9485, Otherwise Known as the Anti-Red Tape Act of 2007, and for Other Purposes” or the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018” Republic Act No. 4226, An Act Requiring the Licensure of All Hospitals in the Philippines and Authorizing the Bureau of Medical Services to Serve as the Licensing Agency” ot the “Hospital Licensure Act” Executive Order No. 119, s. 1987, “Reorganizing the Ministry of Health, its Attached Agencies and for Other Purposes” Department of Health Issuance Department of Health. (2023). Administrative Order No. 2023-0015 on the Adoption of the 8-Point Action Agenda as the Medium-Term Strategy of the Health Sector for 2023-2028 Other National Government Agencies’ Issuances and Publications National Economic Development Authority. (2023). Philippine Development Plan 2023- 2028. https://pdp.neda.gov.ph/philippine-development-plan-2023-2028/ Anti-Red Tape Authority. (2022). Philippine Good Regulatory Principles. https://arta.gov.ph/philippine-good-regulatory-principles/ Anti-Red Tape Authority. (2022). ARTA Memorandum Circular No. 2022-06 on Establishment of the National Policy on Regulatory Management System (NPRMS). https://arta.gov.ph/nprms/ Anti-Red Tape Authority. (2021), Regulatory Impact Assessment Manual: 2021 Philippine RIA Manual. https:/arta gov.ph/regulatory-impact-assessment-tia! Other References National Health Facility Registry. (2023). Statistics of Primary Care Facilities. htips://nhft.doh.gov ph/VActivefacilitiesL ist Health Facilities and Services Regulatory Bureau. (2023) Licensed Number of Health Facilities in the Philippines. hittps://hfsrb.doh.cov.ph/ Organisation for Economic Cooperation and Development (OECD). (2021). OECD Regulatory Policy Outlook 2021, OECD Publishing, Paris, https://doi.org/10.1787/38b0fdb1- en.