Better laws for better health : Western Pacific regional action agenda on strengthening legal frameworks for health in the Sustainable Development Goals

Better Laws for Better Health Western Pacific Regional Action Agenda on Strengthening Legal Frameworks for Health in the Sustainable Development Goals

Better Laws for Better Health Western Pacific Regional Action Agenda on Strengthening Legal Frameworks for Health in the Sustainable Development Goals © World Health Organization 2020 ISBN 978 92 9061 904 1 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules). Suggested citation. Better laws for better health: Western Pacific regional action agenda on strengthening legal frameworks for health in the Sustainable Development Goals. Manila, Philippines, World Health Organization Regional Office for the Western Pacific. 2020. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. 1. Legislation as topic. 2. Public Health–legislation and jurisprudence. 3. Conservation of natural resources. 4. Regional health planning. I. World Health Organization Regional Office for the Western Pacific. (NLM Classification: WA 32.1). Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. For WHO Western Pacific Regional Publications, request for permission to reproduce should be addressed to Publications Office, World Health Organization, Regional Office for the Western Pacific, P.O. Box 2932, 1000, Manila, Philippines, Fax. No. (632) 521 1036, email: wpropuballstaff@who.int. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Photo credits: Cover: ©WHO/Y. Shimizu – pp. 1, 10, 42: WHO/Y. Shimizu CONTENTS Abbreviations ......................................................................................................................................................................................................................................................................................................................................................v Foreword .........................................................................................................................................................................................................................................................................................................................................................................vi Executive summary....................................................................................................................................................................................................................................................................................................................viii Setting the Regional Action Agenda ...........................................................................................................................................................................................................................ix Pillar 1: What can be done? ..................................................................................................................................................................................................................................................................ix Pillar 2: How to do it? ................................................................................................................................................................................................................................................................................................x Pillar 3: Who is involved? ...............................................................................................................................................................................................................................................................................x Recommendations .............................................................................................................................................................................................................................................................................................................xi 1. INTRODUCTION AND BACKGROUND .....................................................................................................................................................................................................................................1 1.1 What is law? .......................................................................................................................................................................................................................................................................................................................2 1.2 Increasing linkages between law and health ................................................................................................................................................................4 1.3 Role of law in UHC and the SDGs ......................................................................................................................................................................................................................6 1.4 Common challenges and issues .............................................................................................................................................................................................................................8 2. ACTING ON THE AGENDA .................................................................................................................................................................................................................................................................................10 2.1 What can be done? .................................................................................................................................................................................................................................................................................10 2.1.1 Potential actions to better enhance health system governance and leadership......................................................................................................................................................................................................................................................................11 2.1.2 Potential actions to respect, protect and fulfil the right to health .........................12 2.1.3 Potential actions to improve access to affordable, safe and quality health services .....................................................................................................................................................................................................................................................................14 2.1.4 Potential actions to prevent and manage public health risk ....................................................17 2.1.5 Potential actions to foster multisectoral collaboration to address the social determinants of health .............................................................................................................................................................................20 2.2 How to do it? .............................................................................................................................................................................................................................................................................................................24 2.2.1 Potential actions to analyse the problem(s) and identify viable options ...........24 2.2.2 Potential actions to overcome obstacles and get to a decision .......................................27 2.2.3 Potential actions to design the law .....................................................................................................................................................................29 2.2.4 Potential actions to implement the law .................................................................................................................................................31 2.2.5 Potential actions to monitor and evaluate legal frameworks ...............................................34 2.3 Who is involved? ............................................................................................................................................................................................................................................................................................36 2.3.1 Potential actions to build the capacity of policy-makers ....................................................................36 2.3.2 Potential actions to build the capacity of regulators .......................................................................................37 2.3.3 Potential actions to engage parliamentarians ....................................................................................................................38 2.3.4 Potential actions to empower and ensure the participation of communities ..................................................................................................................................................................................................................................................................39 2.3.5 Potential actions to coordinate with health providers .....................................................................................41 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS 3. RECOMMENDATIONS .................................................................................................................................................................................................................................................................................................42 3.1 Recommendations for Member States .........................................................................................................................................................................................42 3.2 Recommendations for WHO .........................................................................................................................................................................................................................................43 REFERENCES .....................................................................................................................................................................................................................................................................................................................................................44 GLOSSARY ................................................................................................................................................................................................................................................................................................................................................................49 ANNEXES Annex 1. Summary of common strategies, challenges and issues, and practices in strengthening legal frameworks for health in the SDGs ..........................................................56 Annex 2. Examples of laws relevant to health that may lie outside the health portfolio ..............................................................................................................................................................................................................................................66 Annex 3. Legal systems of WHO Member States and areas in the Western Pacific Region ..........................................................................................................................................................................................................................................................................68 Annex 4. Detailed situational analysis and mapping by action areas .......................................................70 Annex 5. Summary of medicines regulatory authorities in the Western Pacific Region ..........................................................................................................................................................................................................................................................................85 Annex 6. Summary of tobacco control progress in Member States via MPOWER .................87 Annex 7. Using law to implement policies protecting children from the harmful impact of food marketing in the Western Pacific Region.................90 Annex 8. Strengthening an international mandate: evolution of the International Code of Marketing of Breast-milk Substitutes and through subsequent resolutions by the World Health Assembly ....................................................................................................................................92 Annex 9. Details of assessment criteria and legislation coverage for major risk factors of road safety among countries in the Western Pacific Region .................95 Annex 10. Sustainable Development Goals: rule of law mapping .............................................................................99 vABBREVIATIONS ASEAN Association of Southeast Asian Nations CAC Codex Alimentarius Commission CEDAW Convention on the Elimination of All Forms of Discrimination against Women CRC Convention on the Rights of the Child CRPD Convention on the Rights of Persons with Disabilities HiAP Health in All Policies ICESCR International Covenant on Economic, Social and Cultural Rights IHR (2005) International Health Regulations NCD noncommunicable disease ODI Overseas Development Institute PIP Framework Pandemic Influenza Preparedness Framework SDG Sustainable Development Goal UHC universal health coverage WASH water, sanitation and hygiene WHO World Health Organization WHO FCTC WHO Framework Convention on Tobacco Control BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS vi FOREWORD Legal frameworks – instruments of law and the institutions responsible for putting them into effect – are essential to advance universal health coverage (UHC) and achieve health in the Sustainable Development Goals (SDGs). Law can be used to organize and manage health systems, allocate responsibilities, set standards, and authorize and constrain action. Law can promote, protect and fulfil the right to health. Law can regulate health services and products to ensure quality, safety and efficacy. Law can shape markets, from regulating potentially harmful products to mandating procurement practices that promote healthier products. The very act of passing or deliberating a law can convey information, alerting people of health risks and influencing their behaviour. As many social determinants of health lie beyond the health sector, law can be a powerful tool for coordinating and consolidating action across sectors, such as agriculture, environment, education, labour and housing. Strengthening legal frameworks for health presents enormous challenges for Member States in the Western Pacific Region. Countries vary greatly in terms of legal systems and traditions, as well as political, economic, social, cultural and historical circumstances. As reflected in the interlinked nature of the SDG agenda, laws that impact health may fall beyond the health sector, requiring careful multisectoral collaboration to ensure policy coherence and consistent implementation. In the age of global health, legal frameworks should be aligned with international health commitments. Legal frameworks should also be updated regularly based on the latest evidence, to respond appropriately to contem- porary and emerging public health risks. To be effective, legal frameworks should be sufficiently resourced and enforced, with monitoring and regular evaluation to ensure effectiveness and inform further strengthening. A strong foundation of law for health is more important now than ever before. The Western Pacific Regional Action Agenda on Strengthening Legal Frameworks for Health in the Sustainable Development Goals was endorsed by the Regional Committee for the Western Pacific in October 2018. WHO developed the Action Agenda in consul- tation with Member States, in response to the ever-increasing demand from countries for technical assistance in developing, implementing and evaluating legal frameworks to advance health under the 2030 Agenda for Sustainable Development. WHO recently established the first dedicated health law unit in the Regional Office for the Western Pacific. vii FOREWORD The unit engages closely with key stakeholders working on legal frameworks for health, such as legal officers in government, parliamentarians and mayors. As part of these efforts, the Action Agenda takes a contemporary approach to enhance the rule of law and expand the role of law in health by highlighting priority areas that countries may consider, providing guidance on navigating complex processes and emphasizing the importance of capacity-building for stakeholders. With this powerful mandate, we continue to bolster our support for Member States in their efforts to strengthen legal frameworks to advance health in the Sustainable Development Goals. Takeshi Kasai, MD, Ph.D. Regional Director BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS viii EXECUTIVE SUMMARY Legal frameworks – both the instruments of law and the institutions responsible for putting them into effect – are essential to advance universal health coverage (UHC) and achieve health in the Sustainable Development Goals (SDGs). Laws are critical to organizing and regulating health systems and services, protecting rights, and preventing and managing public health risks. However, in many countries and areas, legal frameworks are out of date, have been developed in a reactive fashion, are not coherent or consistent with the existing evidence or the relevant country or area context, and/or are not consistently implemented and enforced. More attention is needed on improving the processes and the capacities of stakeholders to implement and review legal frameworks effectively to promote and protect public health. The importance of legal frameworks was reaffirmed by the WHO Regional Committee for the Western Pacific through the endorsement of Universal Health Coverage: Moving Towards Better Health – Action Framework for the Western Pacific Region (2016) and the Regional Action Agenda on Achieving the Sustainable Development Goals in the Western Pacific (2017). Better Laws for Better Health – Western Pacific Regional Action Agenda on Strengthening Legal Frameworks for Health in the Sustainable Development Goals builds on these agendas. FIG. 1 Three strategic pillars in strengthening legal frameworks for health Getting to a decision Policy-makers Identification & development Parliamentarians Implementation & enforcement Civil society & communities Monitoring & evaluation Service providers Drafting Regulators Public health risk RightsGovernance Social determinants of health Service delivery ACTION AREAS PROCESSES CAPACITIES WHAT CAN BE DONE? HOW TO DO IT? WHO IS INVOLVED? EXECUTIVE SUMMARY ix Setting the Regional Action Agenda The Regional Action Agenda provides guidance on strengthening legal frameworks to achieve UHC and advance health in the SDGs by providing a range of options that countries may consider as part of their broader strategies. The options are presented across three pillars in response to the following questions: 1. What can be done? Areas where law plays an essential role in impacting health, such as health govern- ance, health services and public health, which countries may prioritize for action. 2. How to do it? Processes in the development, implementation and evaluation of laws for health, which countries may choose to prioritize for improvement. 3. Who is involved? Capacities of stakeholders involved, which countries may prioritize for enhancement. While each country is different, there are many shared challenges and opportunities to use legal frameworks more effectively to drive health and development. PILL AR 1: WHAT C AN BE DONE? ACTION AREAS 1.1 Enhance health system governance and leadership 1.2 Respect, protect and fulfil the right to health 1.3 Improve access to affordable, safe and quality health services 1.4 Prevent and manage public health risk 1.5 Foster multisectoral collaboration to address the social determinants of health The priorities for strengthening legal frameworks across a wide range of potential action areas will be different from country to country. Actions should be informed by available evidence and knowledge, consistent with international obligations, integrated with non-legislative strategies, responsive to the needs of the country and feasible within its capacities. Countries should consider actions to enhance health system governance and stewardship; respect, protect and fulfil the right to health, particularly for the most vulnerable; improve access to affordable, safe and quality health services; prevent and manage public health risk; and foster multisectoral collaboration to address the social determinants of health. BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS x PILL AR 2: HOW TO DO IT? PROCESSES 2.1 Analyse the problem(s) and identify viable options 2.2 Overcome obstacles and get to a decision 2.3 Design the law 2.4 Implement the law 2.5 Monitor and evaluate the legal framework Countries will have different priorities for improving various processes to strengthen legal frameworks for health. Processes should address the full cycle of legal development, including problem analysis, evidence evaluation, stakeholder engagement, drafting and enactment, implementation and evaluation. Each of these processes can occur together or serially and is affected by technical, political and other factors. Careful mapping and navigation are essential in successfully strengthening legal frameworks. PILL AR 3: WHO IS INVOLVED? CAPACITIES 3.1 Build the capacity of policy-makers 3.2 Build the capacity of regulators 3.3 Engage parliamentarians 3.4 Empower and ensure the participation of communities 3.5 Coordinate with health providers Countries will have different priorities for enhancing the capacities of various stakeholders involved in strengthening legal frameworks for health. Policy-makers and regulators are essential players in developing and implementing laws for health. Parliamentarians are critical with their powers to enact law, approve budgets and provide oversight. The integral role of health providers and communities demand transdisciplinary approaches to public health law, which can help break down disciplinary, cultural and resource barriers. EXECUTIVE SUMMARY xi Recommendations WHO and its Member States have complementary roles and commitments in strength- ening their legal frameworks for health. As appropriate to national needs and capacities, Member States may consider taking the following actions towards strengthening their legal frameworks for health: — Review legal frameworks for health in aligning their national health strategies with broader efforts to advance UHC and achieve health in the SDGs. — Set priorities for action areas and develop a programme for strengthening legal frameworks for health. — Improve processes in the development, implementation and evaluation of legal frameworks for health. — Enhance the capacities of stakeholders involved in strengthening legal frameworks within and beyond the health sector. — Cooperate with other countries to ensure health is considered in the development of international legal instruments, such as agreements on trade, investment and environment. — Enable action on cross-border health risks and issues through legal frameworks. Upon request, WHO may support Member States in strengthening their legal frame- works for health, as follows: — Raise awareness on the importance of law for health and advocate the strengthening of legal frameworks to advance UHC and achieve health in the SDGs. — Enhance access to evidence and knowledge to support Member States in their efforts to review existing legal frameworks for health and determine priorities for action. — Provide technical support to Member States in their efforts to improve processes and enhance capacities for strengthening legal frameworks for health. — Facilitate dialogue and cooperation between Member States to address cross-border health issues, foster regional collaboration opportunities, and engage in joint advocacy and action to shape international agendas. — Mobilize legal expertise for health. HOW TO DO IT? Problem definition Analysis and development of options Review of existing law Stakeholder engagement Opportunities for change Formal processes and approvals Political, social and commercial interests, and obstacles Clear policy intent Precise and well- organized text Implementation and enforceable Consistency and coherence across laws Immediate roll-out (budget, reporting, HR) Ongoing resourcing and administration Evidence-based enforcement Monitoring and data collection of law and implementation Analysis, evaluation and research Communications and accessibility of findings STRENGTHENING LEGAL FR AMEWORK TO ADVANCE HEALTH IN THE SDGs WHAT CAN BE DONE? Health system governance, including allocation of mandate, functions and responsibilities Public administration, including public financing and public service laws Commercial regulation, including corporations and competition law, labour and consumer protection Legal entrenchment of rights, including the right to health Antidiscrimination Patients’ rights, including privacy, informed consent and complaints, and appeal mechanisms Compliance with international obligations Health research and clinical trials Health services, practitioners and medicines, including traditional medicines Specialized areas of care, including mental health, end-of-life and palliative care, blood products and human tissue, and embryos Health financing, including social health insurance Management of public health risk, including surveillance, public health and emergency response powers Manufacture, marketing and food safety NCD risk factors, including tobacco, harmful use of alcohol, unhealthy diets and sources of radiation Prevention and multisectoral action, including requirements for health planning and health impact assessments Areas that influence health, including in relation to social protection, education, housing, migration, trade, intellectual property, environment, agriculture, traffic, and criminal offences and procedures WHO IS INVOLVED? Political leadership and support Decision-making Exercising oversight Resource mobilization Analysis and option development Process management Inform, advise and collaborate Input in development and review Monitoring, supervision and enforcement Building consensus and support Input in development and review Exercise rights Input in analysis and options development Communication and implementation Input in reviews OVERVIEW OF THE REGIONAL ACTION AGENDA GOV ERN A NCE RIG HT S SERVICE DELIV ERY PUBLIC HE A LTH RISK SOCIA L DE TERMIN A NT S OF HE A LTH PARLIAMENTARIANS POLIC Y-M A KER S REGUL ATOR S CIVIL SOCIETY & COMMUNITIES SERVICE PROVIDER S IDENTIFICATION & DEVELOPMENT G E T TING TO A DECISION DR A F TING IMPLEMENTATION & ENFORCEMENT MONITORING & E VA LUATION BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS xii 1REHABILITATION INTRODUCTION AND BACKGROUND 1. Legal frameworks – both the instruments of law and the institutions responsible for putting them into effect – are essential to advance universal health coverage (UHC) and achieve health in the Sustainable Development Goals (SDGs). Law has played a key role in many great public health achievements, including vaccination programmes, motor vehicle safety, reducing smoking, the control of infectious diseases, and food and pharmaceutical safety. However, countries often struggle to develop, implement and evaluate effective legal frameworks to improve public health. While each country differs, there are many shared challenges and opportunities to harness the law effectively to drive health and development. Better Laws for Better Health – Western Pacific Regional Action Agenda on Strengthening Legal Frameworks for Health in the Sustainable Development Goals provides guidance to more effectively use law to advance UHC and achieve health in the SDGs. This includes: setting priorities for action areas; improving processes in the development, implementation and evaluation of laws; and enhancing the capacity of stakeholders. This document provides an overview of the diversity and commonalities of approaches to legal frameworks in the Western Pacific Region in relation to health and the challenges involved. The document is designed not to be prescriptive, but rather to provide specific options countries may consider as part of their broader strategies. 2BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS The Regional Action Agenda is presented across three pillars in response to the following questions: 1. WHAT CAN BE DONE? Areas where law plays an essential role in impacting health, such as health govern- ance, health services and public health, which countries may prioritize for action. 2. HOW TO DO IT? Processes in the development, implementation and evaluation of laws for health, which countries may choose to prioritize for improvement. 3. WHO IS INVOLVED? Capacities of stakeholders involved, which countries may prioritize for stronger engagement. WHAT IS L AW? Throughout this document, the broad term “legal frameworks” includes both the various instruments of law and the institutions responsible for putting them into effect. Instruments of law may include national constitutions, legislation enacted by Parliament, ministerial by-laws or regulations, presidential decrees, agency guidelines, administrative rules and other forms of official order. Depending on the jurisdiction, laws may also include court rulings by judges, as well as interpretations and actions of regulatory bodies or other bureaucratic institutions. In limited cases, so-called coregulatory schemes involving combined authority between state and non-state actors for making and enforcing rules, such as the accreditation of medical specialists by practitioner associations or restrictions on television advertisement to children by the food industry, may take the place of formal 1.1 FIG. 1 Three strategic pillars in strengthening legal frameworks for health Guidance and suggested actions are provided for each pillar, as well as a set of guiding questions for countries to consider in taking action (Table 1). Getting to a decision Policy-makers Identification & development Parliamentarians Implementation & enforcement Civil society & communities Monitoring & evaluation Service providers Drafting Regulators Public health risk RightsGovernance Social determinants of health Service delivery ACTION AREAS PROCESSES CAPACITIES WHAT CAN BE DONE? HOW TO DO IT? WHO IS INVOLVED? 31. INTRODUCTION AND BACKGROUND legal frameworks. Such self-regulation often has weaker remedies or less stringent oversight to ensure compliance compared to traditional command-and-control systems maintained exclusively by the government. Laws exist at local, national and international levels. These instruments, often working in some combination with each other, prescribe duties and rights, powers and limitations for specific actors in specific contexts, and provide for coordination, implementation and enforcement mechanisms. At a more fundamental level, the rule of law refers to a principle of governance in which all persons, institutions and entities, public and private, including the state itself, are accountable to laws that are publicly promulgated, equally enforced and independently adjudicated, and which are consistent with international human rights norms and standards. It also requires measures to ensure adherence to the principles of supremacy of law, equality before the law, accountability to the law, fairness in the application of the law, separation of powers, participation in decision-making, legal certainty, avoidance of arbitrariness, and procedural and legal transparency. These aspects of rule of law are embedded in SDG 16, which like SDG 3, is a cross-cutting goal (see Annex 10). Member States across the Western Pacific Region have different legal systems and traditions, including civil law, common law, customary law and Islamic law; further, many incorporate a mix of legal systems (see Annex 3). These systems and traditions have been shaped by diverse political, economic, social, cultural and historical circumstances. There is also variation in systems of government, including federalist systems of government. These different legal systems and legacies have an impact on the relationship between the law and health. While in all countries the law plays some role in relation to establishing health system governance and leadership, protecting rights, and managing public health risks, the understanding of what law is and approaches to its use vary. This translates into the types of provisions that appear in health laws, how they are understood and imple- mented. For example, some countries have orders and decrees, which provide guidance through statements of principle and direction, which differ from other legal traditions that specifically emphasize the articulation of rights, responsibilities and powers in law. Other countries have a federal system that relates to the allocation of functions and authority to different levels of government. There can be specific challenges to navigate in federal health systems due to the relationship between government delegations and levels, the complexity of health-care provision across these levels, the importance of maintaining public health functions and its impact as a significant proportion of public spending. Legal frameworks, however, are not an end in themselves. The relationship between law and health is shaped by the knowledge, attitudes and practices of individuals and institutions, as well as the social context and political environment. Laws need to be understood as behaviour change interventions, and they need to be developed, imple- mented and evaluated as part of broader public health strategies. In public health practice, law is relevant not only to lawyers; it is an integral part of the work of any public health professional whether they are studying health threats, developing solutions, working with governments, or monitoring and evaluating initiatives, policies and programmes. 4BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS INCREA SING LINK AGES BET WEEN L AW AND HEALTH Legal frameworks are an important tool for organizing and managing health systems. They codify and allocate responsibilities, foster cooperation and coordination, set standards, and authorize or constrain action. The law can be used to shape markets, for instance, by banning dangerous products or mandating government procurement practices that give incentives to producers to make healthier products. Passing a law can also be a good way to convey information, to alert people to particular health risks, and to influence social norms and behaviours. Overarching health system legislation is receiving increasing attention in the Western Pacific Region, in particular in transitional economies as part of broad economic and legal reforms (see example in Box 1). It is a feature of Pacific island country legislation that the responsible minister is generally granted strong powers for implementation, administration and enforcement. Health boards provide a different governance structure and aim to promote better linkages within the health sector, as demonstrated in Fiji, Papua New Guinea and the Republic of Korea, but how far these can be leveraged depends on the extent to which such boards are supported by and engage with senior officers and other participants. In the Lao People’s Democratic Republic, broad powers are granted to the Ministry of Health for research, planning, regulation, administration and issuing of authorization to practice. BOX 1 Development of the Basic Healthcare and Health Promotion Law in China China has drafted a Basic Healthcare and Health Promotion Law that seeks to provide a comprehensive and coordinating legal framework to guide future health reform and health system development. The draft Law, which was first released for public consultation on 29 December 2017, contains 10 chapters with provisions in relation to general principles, citizen health rights and obligations, major measures of health promotion, organization and supply of public health medical services, health-care professionals, drug supply, financing and payment, comprehensive supervision and management, legal responsibilities, and other supplementary provisions. There is a clear intention under the draft Law that the Government at all levels and across all sectors consider health in formulating and implementing policy. Further, it supports effective stewardship by the Government across both public and private health-care providers. Many countries are choosing to adopt a Health in All Policies (HiAP) approach to policy development, implementation and agenda-setting. However, this approach has not often been integrated into legislative mechanisms. For example, only a few countries in the Western Pacific Region have specific requirements for health impact assessments. Some countries have also used mechanisms such as declarations on noncommunicable 1.2 51. INTRODUCTION AND BACKGROUND diseases (NCDs) with powers to formulate and implement orders and guidelines to formalize their approach to managing NCDs (see Annex 4, Table A4.8). In the Republic of Korea, the Korean Framework Act on Health and Medical Services requires state and local governments to implement projects of lifelong health care for citizens, which take into account health characteristics of the life cycle and major factors harmful to health. Historically, legal frameworks have been well established in most countries for the management of communicable diseases. Nearly every country in the Western Pacific Region has a system for identifying and notifying the diagnosis of specified communi- cable diseases to a health authority with accompanying powers to address a possible outbreak. Even though the systems, notifiable diseases, responsible authorities and their powers may differ, use of this approach is almost universal, with a strong reliance on regulation by the state through the use of legal rules backed by (sometimes criminal) sanctions, but often without adequate provisions limiting the breadth of such powers and protecting the rights of those affected. In many cases, lists of notifiable diseases are outdated and systems are not in place to effectively operationalize them. Few countries have taken the opportunity to align powers to manage communicable diseases with those for other health risks, particularly in a multi-hazard incident. Without an alignment of powers, a country may, especially at a time when coordinated and rapid action is needed, be trying to utilize different powers based on different laws with different triggers and empowering different officers across different authorities, be they health, agriculture, food safety, quarantine or others. Innovations from other countries may serve as useful examples. Furthermore, at a time when health systems are becoming more complex with the addition of new providers, a broader scope of the legislative mandate and oversight may be necessary to cover communicable disease management, as well as NCD management, emergency management, and multisectoral approaches to priorities such as antimicrobial resistance, compliance with the International Health Regulations (2005) and UHC. Countries are increasingly relying on legal frameworks to help address NCDs, including measures such as excise taxes, restrictions on marketing, commercial availability and public consumption, and labelling requirements. These target products associated with NCD risk factors include tobacco, alcohol and unhealthy foods. All Member States in the Western Pacific Region are party to the WHO Framework Convention on Tobacco Control (WHO FCTC), which took effect in 2005. The WHO FCTC, as the world’s first global health treaty negotiated under the auspices of WHO, commits Parties to implement a wide range of supply and demand reduction measures, many through law (see Annex 6). Australia, Hong Kong SAR (China), New Zealand and Singapore continue to stand as leaders in reducing tobacco use. China is taking innovative approaches with legal reform at the city level, particularly with respect to smoke-free zones. The Philippines has successfully implemented increased taxes on tobacco, alcohol and sugar-sweetened beverages, with revenues allocated to supporting national programmes for UHC. The Republic of Korea has successfully banned the marketing of specific types of food to children and is a leader 6BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS in cancer surveillance, screening and referral systems. Countries are also strengthening legal frameworks to address other health issues through the life course, including child and maternal health, reproductive health, disabilities and rehabilitation, mental health, road traffic safety, injuries and violence prevention, workers’ health, environmental health and healthy ageing (see also Annexes 5–9). ROLE OF L AW IN UHC AND THE SDGs Since the adoption of the 2030 Agenda for Sustainable Development in 2015, develop- ment has been guided by the 17 bold and transformative SDGs. They contain 169 targets “to ensure that all human beings can fulfil their potential in dignity and equality and in a healthy environment”. Member States are not confined by a single path in pursuing the SDGs. Rather, they plan, design and stage interventions based on national and local contexts and the most pressing health challenges. Similarly, as health systems reflect the social, economic and political contexts of the country, as well as decisions about national priorities, there is no one-size-fits-all formula to achieve UHC. In pursuing the vision of UHC and the aspirations of the SDGs, Member States are encouraged to take evidence-based actions on multiple fronts that are mutually reinforcing and to embed them in their national health policies and reforms. SDG 3 aims to “ensure healthy lives and promote well-being for all at all ages”. But health in the SDGs goes well beyond SDG 3. All the SDGs – such as those addressing clean water and energy, education, gender equality, hunger and poverty – influence and are influenced by health. In October 2016, the Regional Action Agenda on Achieving the Sustainable Development Goals in the Western Pacific was endorsed by the WHO Regional Committee for the Western Pacific. The Regional Action Agenda presents a menu of options for countries to progress towards achieving health in the SDGs. It articulates a vision that requires a comprehensive approach, bringing together relevant government sectors, stakeholders and communities. Table 1 provides an overview of the guiding questions and action domains. UHC is a target in the SDGs, but it also serves as a platform to bring together diverse programmes and actions for health and development. The vision for UHC is all people having access to high-quality health services without suffering financial hardship. The structure and implementation of UHC will differ according to the local context; however, Member States are encouraged to take a comprehensive whole-of-system approach. Advancing UHC and the SDGs requires collaborative partnerships across government, engagement of stakeholders beyond government and participation of communities to address many interconnected health and development challenges. 1.3 71. INTRODUCTION AND BACKGROUND TABLE 1. Guiding questions and action domains to advance the SDGs GUIDING QUESTIONS ACTION DOMAINS 1. What are countries aiming to achieve, and how will they know? 1.1 Country-led selection of health goals, targets and indicators 1.2 Robust monitoring and review process 1.3 Adequate information capacity 2. What are the policy and programme priorities for leaving no one behind? 2.1 Equity in health services 2.2 Realizing win–wins through collaboration across sectors 2.3 Financing strategies for promoting equity of access 3. How will countries put their priorities into effect? 3.1 Collaboration across government 3.2 Engagement of stakeholders beyond government 3.3 Participation of affected communities 4. How can the health sector drive the agenda? 4.1 Capabilities for knowledge exchange 4.2 Leadership skills to navigate the policy system 4.3 Institutional capacity for present and future challenges Source: Regional action agenda for achieving the Sustainable Development Goals in the Western Pacific. Manila: WHO Regional Office for the Western Pacific; 2017. TABLE 2. Health system attributes and action domains for achieving UHC HEALTH SYSTEM ATTRIBUTES ACTION DOMAINS Quality 1.1 Regulations and regulatory environment 1.2 Effective, responsive individual and population-based services 1.3 Individual, family and community engagement Efficiency 2.1 Health system architecture to meet population needs 2.2 Incentives for appropriate provision and use of services 2.3 Managerial efficiency and effectiveness Equity 3.1 Financial protection 3.2 Service coverage and access 3.3 Non-discrimination Accountability 4.1 Government leadership and rule of law for health 4.2 Partnerships for public policy 4.3 Transparency, monitoring and evaluation (M&E) Sustainability and resilience 5.1 Public health preparedness 5.2 Community capacity 5.3 Health system adaptability and sustainability Source: Universal health coverage: moving towards better health – Action framework for the Western Pacific Region. Manila: WHO Regional Office for the Western Pacific; 2016. 8BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Universal Health Coverage: Moving Towards Better Health – Action Framework for the Western Pacific Region was endorsed by the WHO Regional Committee for the Western Pacific in October 2015. Table 2 summarizes the 15 action domains across five essential health system attributes that are set out in the Action Framework. Legal frameworks play an important role in creating a mandate for UHC, strengthening the rule of law for health, establishing the principles upholding the health system, and defining roles and core service packages. Laws are central to creating and enforcing standards for health infrastructure and the health workforce, developing and implementing regulatory interventions for health protection, and strengthening the regulation of medicines and technologies (see Annex 5). They are also essential tools for protecting patient rights, preventing discrimination and promoting equity. More broadly across the SDGs, legal frameworks support multisectoral collaboration for achieving potential win–win situations. COMMON CHALLENGES AND ISSUES In many countries, laws are out of date and not consistent with evidence in relation to public health. As a result, inconsistencies exist between domestic and international laws and commitments. This is compounded by the fact that the countries with the oldest laws tend to be those with few resources to modernize laws. Some countries pass statutes, regulations and other instruments reactively over a long period of time, usually in response to specific issues or threats. These separate pieces of legislation often contain conflicting or redundant provisions. The use of models from other countries, cut and pasted into existing laws, also sometimes leads to unworkable or ineffective public health laws in the statute book. Many countries have passed primary legislation in particular areas of health law but have not developed the necessary subsidiary legislation that enables implementation and enforcement. In efforts to strengthen existing legal frameworks, legislative review processes may not be robust and may not involve necessary stakeholders. Policy documents may be drafted as legislation without a clear understanding of the purpose, the context, the relevant evidence or stakeholder feedback. This is particularly an issue in countries that lack in-country expertise and thus need to draw on external consultants who may not be well grounded in local knowledge or important contextual information. Furthermore, the evidence base for effective legal interventions, as well as aspects of the policy development process, and its implementation and enforcement, may be limited. Weak implementation and enforcement may result from lack of sustainable resourcing and technical capacity of the public sector, conflicts with cultural appropriateness and norms, resistance to perceived 1.4 91. INTRODUCTION AND BACKGROUND abuse of power (corruption) or infringement of rights, lax regulatory systems and admin- istration, and/or lack of coherence with other policies, legal frameworks and incentives. While creating opportunities for health, globalization also presents serious risks. Existing domestic legal frameworks are often inadequate to cope with the vast potential health impacts of international trade and investment. For example, they may increase access, availability, affordability and, through online and other globalized marketing platforms, attractiveness of products associated with NCDs such as tobacco and ultra-processed foods high in sugar, salt and fat. Even when taking steps to develop and implement new legal frameworks, countries are often ill-equipped and under-resourced to overcome challenges from the private sector. Another risk posed by globalization is the potential spread of infectious diseases as humans and disease vectors congregate, migrate and travel. Within the health system, trade in goods and services is increasingly globalized. Along with climate change, this places greater emphasis on the need for preventive environmental health interventions as well as surveillance and response systems that are responsive to these changes. Finally, globalization presents the risk of spread of infectious diseases as humans and disease vectors congregate, migrate and travel. The formulation and breadth of the SDGs reflect the growing recognition that current health and development challenges are complex and interlinked, and that they demand coherent and inclusive strategies. WHO and its Member States are being challenged to develop new ways of working that address the underlying determinants of health and well-being through the strengthening of legal frameworks. 10 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS ACTING ON THE AGENDA 2. This Regional Action Agenda is not intended to be prescriptive. It is a starting point for Member States as they consider their responses to the expectations for achieving health in the SDGs. Strengthening legal frameworks should be based on evidence and knowledge, feasible and responsive to the country’s context, and consistent with international commitments. Strengthening legal frameworks for health is not just a matter for lawyers, but rather an integral part of the work of all in public health. WHAT C AN BE DONE? The priorities for strengthening legal frameworks across a wide range of potential action areas will be different from country to country. Actions should be informed by available evidence and knowledge, consistent with international obligations, integrated with non- legislative strategies, and responsive to the needs and feasible within the capacities of the country. Countries should consider actions to enhance health system governance and stewardship; respect, protect and fulfil the right to health, particularly for the most vulnerable; improve access to affordable, safe and high-quality health services; prevent and manage public health risks; and foster multisectoral collaboration to address the social determinants of health (see Annex 2 for examples of laws relevant to health that may lie outside the health portfolio). 2.1 11 2. ACTING ON THE AGENDA 2.1.1 Potential actions to better enhance health system governance and leadership Legal frameworks can help drive a country’s endeavours to improve the health and well- being of its people (see Annex 3 for the distribution of legal systems in the Western Pacific Region). It is through law that government institutions are assigned their powers and functions, as well as where the limits to their powers are defined. Clarity, certainty, coor- dination and leadership are needed to manage the matrix of factors that shape health, provide for the basic needs and rights of the population, coordinate policy responses across sectors, promote the rule of law for health, and ensure sustainable development. Member States may consider the following options, as appropriate to their context (select country examples are provided in the boxes): a. Setting a clear mandate to assure population health and well-being: — Grant a mandate to the responsible minister (or relevant authority), ministry of health and head of department. — Ensure the mandate addresses current and future health and demographic changes. — Grant a power to provide guidance across other sectors in relation to health matters. — Extend the scope of the mandate to cover subnational (local and region in-country) governments and agencies, as appropriate. b. Allocating health system functions and powers across government agencies and officers (see example in Box 2), and promoting roles for non-state actors: — Allocate health system functions at both national and subnational levels consistent with other relevant laws. — Clearly define the roles and powers of institutions and individuals to prevent any misunderstanding. — Give authority to delegate powers. — Establish the legal parameters for relationships with non-state actors such as private providers, civil society and international agencies. BOX 2 Provincial Health Authorities Act in Papua New Guinea The Provincial Health Authorities Act was passed in Papua New Guinea in 2007 to provide the foun- dation for integrated health service delivery in each province. With the One System Tasol, provincial governors may bring together provincial health service delivery and hospital service delivery under one authority together with health financing and human resources. Provincial health authorities are designed to enable integrated service delivery and overcome fragmentation caused by successive decentralization reforms. 12 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS c. Establishing coordination and accountability mechanisms (see example in Box 3), with service users and communities at the core: — Define criteria for the use of powers. — Define planning and reporting requirements, including public reporting. — Establish appropriate systems for the investigation, suspension and dismissal of officers. — Establish systems for the review of decisions and appeals in keeping with wider legal and judicial systems and oversight bodies. — Ensure non-state actors, such as private providers, and service users are actively encouraged and engaged in the processes of review and accountability, while protecting against vested interests that may conflict with public health objectives and duties. BOX 3 Role Delineation Policy in Solomon Islands The health system in Solomon Islands is in transition, and the Ministry of Health and Medical Services has embarked on an ambitious reform process based on its recently drafted Role Delineation Policy. The Policy, reflecting the principle of UHC as the backbone of the National Health Strategic Plan 2016–2020, was developed through a series of consultations and meetings beginning in 2011. It is a tool for better defining the range and level of services – or packages of care – to be delivered to given populations across the country. The Government is structuring its legislative reform programme in health to support the roll-out of the Role Delineation Policy. In particular, it is reviewing the overarching health administration and service delivery legislation, while taking into consideration the timing of the roll-out, the capacity and readiness to implement reform, and the importance of establishing policy coherence across government and balancing other concurrent priorities under the national legislative reform programme. 2.1.2 Potential actions to respect, protect and fulfil the right to health Legal frameworks can help advance the right to health, particularly for the most vulner- able (see Annex 4). Law can be a tool, for example, to prohibit and criminalize violence, especially against women and children. It can prescribe the right to privacy, which is core to good public health. A rights-based approach can strengthen the effectiveness of health programmes and services by mandating the effective participation of affected communities (see example in Box 4). 13 2. ACTING ON THE AGENDA BOX 4 Recognizing the rights of indigenous and vulnerable populations in New Zealand As expressly stipulated in the New Zealand Public Health and Disability Act 2000, one of the objectives of the public health system is “to reduce health disparities by improving the health outcomes of Maori and other population groups … to be pursued to the extent that they are reasonably achievable within the funding provided”. One way to achieve this objective is by involving key populations in health sector planning. To this end, the Act provides for “mechanisms to enable Maori to contribute to decision-making on, and to participate in the delivery of, health and disability services”. As outlined in the Act, District Health Boards are expected “to establish and maintain processes to enable Maori to participate in, and contribute to, strategies for Maori health improvement” and “to continue to foster the development of Maori capacity for participating in the health and disability sector and for providing for the needs of Maori”. Source: Ministry of Health, New Zealand; 2018. WHO Member States may consider the following options, as appropriate to their context: a. Enshrining the rights of health-care users, families and communities: — Entrench the right to health and other health-related rights. — Set standards to respect the dignity of patients and protect them from discrimina- tion, abuse or degrading treatment. — Protect the privacy, confidentiality and security of personal health information and promote a person’s right and ability to access their own health information. — Require informed consent for medical procedures and promote informed choices by patients, families and communities, particularly for people with an impaired capacity for decision-making. — Establish new or strengthen existing mechanisms to collect and process complaints and provide redress. — Strengthen coherence between international, regional and national commitments to health-related rights and health justice. — Consider ratification of existing international instruments related to health and strengthen engagement with international mechanisms that promote health rights. b. Protecting all persons equally and effectively from discrimination: — Prohibit discrimination on any ground (including for example that based on race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth, disability, health status including HIV/AIDS, sexual orientation, and civil, political, social or other status). — Take immediate action to eliminate discrimination, including by reducing barriers in access to needed services, with particular attention to disadvantaged population groups. 14 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS c. Allowing for human rights derogations in line with the Siracusa Principles1: — Scale the availability of legislative actions in proportion to the assessed risk of the situation. — Require officials to choose the alternative that least restricts the liberty/freedoms of the affected populations that will accomplish the public health goal. — Provide strong protections for privacy and security of information. — Incorporate protections for procedural due process, including the right to appeal. 2.1.3 Potential actions to improve access to affordable, safe and quality health services Legal frameworks can help provide accessible and acceptable health services that are safe and of good quality. Laws may include regulations specifying standards of health service delivery, including the qualifications and capability of staff, the adequacy of infra- structure, the safety of medicines and health technologies, as well as the way people are treated when seeking health services. Regulations for the public and private provision of health services will depend on the way the country’s health system is organized (see example in Box 5). It may include the assignment of particular responsibilities, standard- setting, licensing and registration, the location of health services, consistency with state planning requirements, and conditions on partnerships and contracting arrangements. Governments are increasingly reliant on regulatory strategies to promote health and provide health care, as the role of non-state actors, such as private providers of health services, expands and changes. The environment is also becoming more complex and regulators need to take into account such complicating factors as the mobility of people and medicines across national borders. BOX 5 Development of a subdecree on traditional medicine practitioners in Cambodia Traditional medicine is used extensively in Cambodia. While the production and sale of traditional medicines have been regulated for some time, ensuring quality and safety has been challenging. To ensure the quality of traditional health services and to protect patient safety, the National Assembly in Cambodia adopted a new Royal Kram promulgating the Law on Management of Private Medical, Paramedical, and Medical Aide Practice on 7 October 2016. The scope of the Law includes traditional medicine practitioners. The Government is now developing a subdecree on traditional medicine practitioners. The regulation of traditional medicine practitioners (Kru-khmer) is a key strategy in the Traditional Medicine Policy of the Kingdom of Cambodia and the Traditional Medicine Strategic Plan 1. The Siracusa Principles were produced following an international conference of the International Commission of Jurists, the International Association of Penal Law, the American Association for the International Commission of Jurists, the Urban Morgan Institute of Human Rights, and International Institute of Higher Studies in Criminal Sciences in Siracusa, Italy in 1984, which sought to examine limitation and derogation clauses in the International Convention for Civil and Political Rights. 15 2. ACTING ON THE AGENDA 2012–2020. The draft subdecree is composed of eight chapters that cover matters such as definitions, governance, registration requirements and disciplinary processes. The subdecree is expected to play a critical role in improving the safety and quality of traditional medicine services as a significant part of primary health care in the country. In developing and implementing the subdecree, the Govern- ment is seeking not only to ensure access to traditional medicine services, but also to improve their quality and safety. WHO Member States may consider the following options, as appropriate to their context: a. Regulating the public and private provision of health services to ensure public safety: — Regulate public and private facilities (see example in Box 6) to ensure compliance with minimum standards. — Regulate the health workforce to ensure access to competent and safe health workers. — Regulate medicines to ensure equitable access to medicines that are of a required quality, safety and efficacy. — Regulate traditional medicine products and practitioners to ensure access to quality, safe and effective traditional medicine products and services, while integrating them into national health systems. — Regulate the use of blood products and human tissue to protect donors, recipients and the national supply of these products. b. Establishing quality assurance mechanisms in health facilities: — Establish independent mechanisms vested with the power to investigate adverse events. — Allocate functions, including the power to assess health services, make recom- mendations concerning quality, and monitor the implementation of the recommendations. c. Enabling and supporting partnerships and the engagement of service providers: — Define basic criteria and requirements for the establishment of partnerships between public entities, and between public and private entities. — Set requirements regarding data collection needs, financial accountability and compliance with relevant standards under such partnerships. d. Promoting active engagement that is transparent and accountable with non-state actors for the provisions of health care; mandating requirements for the provision of data and information from public and private facilities. 16 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS BOX 6 Laws in relation to hospitals A wide range of laws relating to the operation of hospitals need to be considered in efforts to improve the quality, safety, efficiency and equity of access to hospitals services. Some countries have dedicated hospital legislation. In most countries, legal frameworks for hospitals cover: • health practitioners, medicines, human organs and tissue, quality and safety, patient protection and antidiscrimination; • health insurance, including private health insurance; • public health events and emergencies; • ethics review and approval, and clinical trials and use of data; • administration of public hospitals, including those relating to public finance and public workforce; • fair competition, consumer protection, corporation regulation, directors’ duties, labour, foreign ownership and investment restrictions, taxation and insurance requirements, occupational health and safety, and environmental impact; and • torts, including negligence, nuisance and misrepresentation, and contracts. e. Enabling pooled and integrated funding and transparency and accountability for public finances (see example in Box 7): — Set budgetary and expenditure controls, including delegations and procurement regulations. — Undertake pricing regulation, including transparency on services and goods pricing. — Undertake earmarking and taxation for public health. — Define governance arrangements, membership and benefits under social health insurance systems. — Ensure appropriate regulation of private health insurance. — Set reporting and audit requirements to be followed by external providers. BOX 7 Financing for UHC in the Philippines In 2012, through collaboration among the Department of Health, Department of Finance, Congress and the Office of the President, the Philippines enacted Republic Act 10351, commonly referred to as the Sin Tax Reform Law, which amended the tax structure applicable to the sale of alcohol and tobacco products, and increased taxation rates and allocated tax revenues to support a wide range of public health initiatives, including UHC, while aiming to decrease consumption of alcohol and tobacco as risk factors for NCDs. 17 2. ACTING ON THE AGENDA During the first five years of implementation, the reform generated an additional US$ 5.05 billion2 and tripled both the Department of Health’s annual budget and national health insurance coverage from 5.2 million to 15.7 million users from 2013 to 2018, and also contributed to a reduction in tobacco use prevalence from 29.7% in 2009 to 23.8% in 2015. In 2018, the Philippines implemented one of Asia’s first taxes on sugar-sweetened beverages, which seeks to address diet-related NCDs, with a focus on childhood obesity. Sources: Sin tax law incremental revenue for health: annual report 2018. Manila: Health Policy Development and Planning Bureau, Department of Health; 2018; Stats & charts 2018. Manila: PhilHealth; 2018. 2.1.4 Potential actions to prevent and manage public health risk Legal frameworks can help to address public health risks. For communicable diseases, these may include information collection and dissemination, surveillance, testing, screening, contact tracing, quarantine, isolation, vaccination and treatment. Law can also be a powerful tool for NCD prevention by shaping the information environment and commercial marketing activities, creating financial incentives and disincentives through taxation and expenditure, shaping the physical environment, and directly regulating the activities of individuals and institutions. Actions should be aligned to meet the country’s international health commitments, such as those under the International Health Regulations (2005) (see Box 8), the WHO Framework Convention on Tobacco Control (see Annex 6) and Codex Alimentarius. BOX 8 The adoption of the International Health Regulations (2005) The International Health Regulations, or IHR (2005), are an international legal instrument designed “to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade”. Revised and adopted by Member States at the World Health Assembly in 2005, they came into force in 2007 and are legally binding upon 196 States Parties around the world (including all Member States) as of October 2018. They require States Parties to collaborate with each other in developing national legal, regulatory and administrative provisions for their implementation. Many Member States in the Western Pacific Region have undertaken assessments of their existing legis- lation in relation to IHR (2005) compliance. For example, in Australia, amendments were made to the National Health Security Act 2007, and the Biosecurity Act 2015 was developed to further implement the IHR (2005) requirements. Cambodia initiated the development of laws governing communicable disease control in 2008. Though the laws are not yet enacted, the country has demonstrated an ability to 2. Equivalent to 257.3 billion Philippine pesos based on the exchange rate in October 2017. 18 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS act during public health emergencies, such as the quarantine of persons exposed to pandemic influenza in 2009, through administrative mechanisms. Viet Nam has an extended legal framework to support IHR (2005) implementation, comprising various laws, regulations, decrees, circulars and decisions. The country conducted an evaluation of the Law on Prevention and Control of Infectious Diseases in 2015 after 10 years of implementation, which is informing an ongoing process of legislative review. Sources: Joint external evaluation of IHR core capacities of Australia. Geneva: WHO; 2018; Joint external evaluation of IHR core capacities of the Kingdom of Cambodia. Geneva: WHO; 2017; Joint external evaluation of IHR core capacities of Viet Nam. Geneva: WHO; 2017. WHO Member States may consider the following options, as appropriate to their context: a. Granting powers to appropriate authorities to effectively manage communicable diseases, including sufficient flexibility to investigate and address non-specific public health risks: — Specify who has the power to act or lawfully direct individuals suspected of having a communicable condition that presents a major public health threat. — Define the range of powers necessary to manage public health risk, when these powers should be activated and criteria for their use. — Specify the responsibilities of individuals with communicable conditions and stipulate related enforcement measures. — Define consequences for failure to comply with lawful direction and relevant enforcement measures. — Define limits on powers, including rights and avenues of appeal. b. Assigning power to the health minister or other responsible person for declaring a public health emergency and authorizing the necessary responses: — Define who has the power to declare a public health emergency and in what circumstances they can use it. — Once the public health emergency is declared, define who has which powers to manage the risk to public health, and what the respective role and responsibilities are. — Define enforcement measures, as well as relevant offences. — Consider relevant national emergency provisions. — Consider requirements for international support, including expedited importation of approved medicines and supplies, urgent registration of health personnel, and delegation of particular powers, with appropriate safeguards and limitations. 19 2. ACTING ON THE AGENDA c. Assigning responsibility and powers to a relevant authority for the supply of clean water and public sanitation. d. Protecting the public from products that pose public health risks, for example, unsafe foods and radiation sources. BOX 9 Incremental whole-of-government approach to strengthening legal frameworks for tobacco control in the Republic of Korea In 2014, the National Health Insurance Service of the Republic of Korea, which manages the country’s single national health insurance system, filed a lawsuit against the three largest tobacco companies in the country to recover the equivalent of US$ 51.9 million3 in health-care costs resulting from tobacco use, claiming wrongful manipulation of tobacco products to addict consumers. While the National Health Insurance Service continues to pursue the litigation in court, the Ministry of Health and Welfare has leveraged the strong public support in the wake of the lawsuit to secure a tax reform leading to an 80% retail tobacco price increase in 2015 – the first in over a decade – and then the implementation of the country’s first graphic health warnings in 2016. Source: Reducing tobacco use through taxation: the experience of the Republic of Korea (English). WBG Global Tobacco Control Program. Washington, DC: World Bank Group; 2018. e. Strengthening health promotion and health education, and protecting the public from exposure to products associated with NCD risk factors, such as tobacco (see example in Boxes 9 and 10), alcohol, breast-milk substitutes, and foods high in sugar, salt and fat: — Ban or restrict product marketing, including advertising, promotion and sponsor- ship, particularly to children (see Annex 7). — Increase taxation on products associated with NCD risk factors. — Restrict sales to minors. — Implement labelling requirements, including content disclosures and warning labels. f. Facilitating the sharing of information between countries and collaboration in addressing regional health threats for more effective and coordinated prevention and management of public health risks. 3. Equivalent to 53.7 billion won based on the exchange rate in 2014. 20 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS BOX 10 WHO Framework Convention on Tobacco Control – the global health treaty The WHO Framework Convention on Tobacco Control (FCTC) is the first international treaty negotiated under the auspices of WHO. Having come into force in 2005, the WHO FCTC currently has 181 States Parties, including all WHO countries within the Western Pacific Region. From global commitment to national implementation, the WHO FCTC is a legally binding instrument of international law that obligates Parties to implement domestic policy on a wide range of supply and demand measures, including through legal frameworks, while protecting against the vested interests of the tobacco industry. The importance of the WHO FCTC was recognized within the framework of the SDGs, which calls on countries to “strengthen the implementation of the WHO Framework Convention on Tobacco Control in all countries, as appropriate” (SDG 3.a). The Protocol to Eliminate the Illicit Trade in Tobacco Products (the Protocol) is a “treaty within the treaty” to secure cooperation between countries in addressing illicit tobacco trade practices through the supply chain, often across borders. This requires collaboration across sectors, including health, trade, finance, customs, police and foreign affairs. The Protocol was adopted by the Conference of the Parties to the WHO FCTC in 2012. The Protocol required ratification by 40 countries to take effect. In June 2018, with 41 Parties, the conditions for the Protocol’s entry into force were met. Subsequently, the new treaty was entered into force on 25 September 2018. As of October 2019, the Protocol counts 56 Parties. Source: WHO Framework Convention on Tobacco Control. Geneva: WHO; 2003; Protocol to eliminate illicit trade in tobacco products. Geneva: WHO; 2013. 2.1.5 Potential actions to foster multisectoral collaboration to address the social determinants of health Legal frameworks can help foster collaboration between the health sector and other sectors on the spectrum of issues that influence and are influenced by health (see Table 3). For example, the criminalization or stigmatization of particular behaviour can be a barrier to accessing treatment and care, trade law can impact on access to medicines, and finance and tax laws affect consumer choices for food, tobacco, alcohol and other products that influence health. These effects can be intended or unintended, more or less direct, and positive or negative. WHO Member States may consider the following options, as appropriate to their context: a. Incorporating specific legislative requirements to facilitate cross-sectoral policy and action (see Box 11): — Define circumstances in which health impact assessments must be carried out and how they are to be undertaken. — Specify how and when the results of a health impact assessment are to be published. 21 2. ACTING ON THE AGENDA — Provide a statutory basis for cross-sectoral health plans, agreements and perfor- mance frameworks. — Establish intersectoral and intergovernmental bodies to work together on shared priorities (see Box 13). BOX 11 Health in All Policies and health impact assessments Health in All Policies (HiAP) is an approach to public policies across sectors that systematically takes into account the health and health system implications of decisions, seeks synergies, and avoids harmful health impacts in order to improve population health and health equity. A HiAP approach is founded on health-related rights and obligations. It emphasizes the consequences of public policies for health determinants and aims to improve the accountability of policy-makers for health impacts at all levels of policy-making. Health impact assessments are an important tool available to governments to advance HiAP. Broadly speaking, it is a process that evaluates the potential health effects of a particular policy or project before it is implemented. Legal frameworks can enable this through specific legislative requirements such as defining circumstances in which health impact assessments must be carried out and how. Legal frameworks may further specify in what form and in what circumstances the results of a health impact assessment are to be published. Source: Leppo K, Ollila E, Pena S, Wismar M, Cook S, editors. Health in All Policies: seizing opportunities, implementing policies. Helsinki: Ministry of Social Affairs and Health, Finland; 2013. b. Promoting healthier behaviours through laws (see examples in Box 12): — Promote planning measures to establish safe and health-promoting environments. — Encourage healthy behaviours with subsidies or tax deductions. — Work with relevant sectors to protect public health in the negotiation of trade and other international and bilateral agreements. — Participate in the development of international conventions and standards and adopt these into domestic frameworks, including in relation to climate change, migration and labour protection. 22 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS BOX 12 Promoting healthy diets in and around schools in the Republic of Korea The Republic of Korea takes a multisectoral approach to promoting a healthy diet for children in and around schools. The Ministry of Health and Welfare leads implementation of the Child Welfare Act as well as the national obesity programme, which mandate government responsibility to discourage children consuming unhealthy foods. Under the School Meals Act and Early Childhood Education Act, implemented by the Ministry of Education, school curricula are required to incorporate nutrition literacy, sales of sugary drinks are banned in schools, and nutrition labelling is required for all school meals. The Ministry of Food and Drug Safety implements the Special Act on Safety Management of Children’s Dietary Lifestyle, which establishes “Green Food Zones” where stores are subsidized to limit the sale of energy-dense, nutrition-poor foods within 200 metres of schools. In recent years, students in the Republic of Korea have reported a decline in their consumption of fast food, instant noodles, confectionaries and carbonated beverages. Source: Be smart, drink water: A guide for school principals in restricting the sale and marketing of sugary drinks in and around schools. Manila: WHO Regional Office for the Western Pacific; 2016. BOX 13 Multisectoral collaboration in tackling antimicrobial resistance Antimicrobial resistance occurs naturally over time, usually through genetic changes. However, the misuse of antimicrobials is accelerating this process. In many places, antibiotics are overused and misused by people and animals, and often given without professional oversight. Antimicrobial-resistant microbes are found in people, animals, food and the environment (in water, soil and air). They can spread between people and animals, including from food of animal origin, and from person to person. Poor infection control, inadequate sanitary conditions and inappropriate food handling encourage the spread of antimicrobial resistance. Law is one possible tool that may assist a country to manage and address antimicrobial resistance. One of the challenges facing countries is that the approach must be multisectoral given that the risk factors arise in areas administered by different sectors within a national or subnational government. There are several laws that have the potential to assist in a coordinated multisectoral approach. These include the following: • laws that establish the health system, including allocation of national and subnational health functions and that establish a legal mandate for intersectoral action; • public health laws that grant power to take or require action to mitigate public health risk; • laws that establish regulatory systems for access to quality medicines, including licensing of pharmacies and pharmacists; • laws that establish regulatory systems for health practitioner registration and licensing; • food safety laws and laws that regulate the use of antibiotics in agriculture and animal husbandry; and • customs laws that regulate imports, including in relation to medicines and animal feed. Source: Fidler DP. Legal issues associated with antimicrobial drug resistance. Emerg Infect Dis. 1998;4(2):169–77. doi:10.3201/eid0402.980204. 23 2. ACTING ON THE AGENDA TABLE 3. Role of law in multisectoral win–win solutions for health in the SDGs Stimulating social development Legal frameworks can: – promote healthy school environments with access to adequate and safe food, water and sanitation; – ensure improved working conditions for men and women in the formal and informal sectors based on internationally agreed standards to reduce their exposure to physical and psychosocial hazards; – mandate working and employment arrangements that include family leave, social protection, breastfeeding at work, and support for family and child care; and – strengthen actions to tackle forced labour, including child labour and human trafficking, and to improve access to basic services for refugees and migrants. Protecting the health of the environment Legal frameworks can: – provide access to safe spaces and community settings free from violence, with particular attention to women and girls and other disadvantaged groups, and incorporate these into urban design; – invest in and regulate for safe and accessible transport, road infrastructure and education to reduce injuries and road traffic accidents, and improve road and rail access to health and other facilities and services; and – support cities and rural areas to prepare for, respond to and recover from disasters. Promoting healthy urbanization Legal frameworks can: – improve systems for food safety and food security, especially for low-income communities and other disadvantaged groups; – assess the health and health equity impacts of proposed infrastructure, mining and other industrial projects; and – strengthen mechanisms and processes to protect the environment from water, air, land and soil pollution and protect biodiversity and ecosystems. Source: Regional action agenda on achieving the Sustainable Development Goals in the Western Pacific. Manila: WHO Regional Office for the Western Pacific; 2017. 24 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS HOW TO DO IT? Countries will have different priorities in improving various processes to strengthen legal frameworks for health. Processes should address the full cycle of legal development, including problem analysis, stakeholder engagement, drafting and enactment, imple- mentation and evaluation. Each of these processes can occur together or serially, and are affected by technical, political and other factors. As illustrated in Fig. 2, the players, processes and sequence of activities often overlap, circle back on one another, and have multiple iterations. Necessarily complex and inherently messy, careful mapping and navigation are essential in successfully strengthening legal frameworks. 2.2 FIG. 2 Navigating the messiness of the legislative process Implementation & Enforcement Monitoring & Evaluation Identification & Development Getting to a decision Drafting SPECIAL CHOICE SOCIAL MOVEMENTS REGULATORS CIVIL SOCIETY POLICY-MAKERS PARLIAMENTARIANS SERVICE PROVIDERS Source: Adapted from Overseas Development Institute (ODI), undated. 2.2.1 Potential actions to analyse the problem(s) and identify viable options Legal frameworks for health can be improved to analyse the problem and identify viable options. The process in the development of law should be based on a clear definition of the problem that the law is aiming to address, and should address the root causes of 25 2. ACTING ON THE AGENDA the problem, objectives of the law, people likely to be affected and the intended (and possible unintended) consequences. This is critical to ensure that the legal framework is fit for purpose. The process should draw on available evidence and include consideration of different legislative and non-legislative options, as appropriate to country needs and capacities, as well as development strategy. WHO Member States may consider the following options, as appropriate to their context: a. Gathering evidence and analysing the problem to be addressed: — Consider and focus on the underlying issues. — Consult with affected communities in identifying the problem and ways forward, for example, through participation in assessments and enquiries. — Analyse whether the problem is one of legislative design or implementation, or both. — Find out and assess how the problem was previously addressed. b. Deciding whether government action is the appropriate course of action: — Consider whether there is an unacceptable hazard or risk that requires action. — Consider whether the government has the capacity to intervene and address the risk successfully. — Consider costs to the government and parties affected by the intervention, and any potential unintended impacts. — Consider whether the government is meeting its obligations under international law. c. Identifying a range of viable options to address the problem: — Consider both legislative and non-legislative options and explore a mix of different options (see example in Box 14). — Decide whether maintaining the status quo or strengthening enforcement of the existing legislation will suffice, and use this as a reference point for future decision-making. — Consider adopting a mix of options. — Ensure that legislation is aligned with the intended regulatory strategy. BOX 14 Elements of a legal framework for standard-setting One of the most flexible and simple regulatory mechanisms available to governments is standard- setting. Standards are norms or measures designed to ensure quality, safety and reliability. In public health, standards are ordinarily set in relation to a system, a service, the safety and composition of therapeutic goods or a health provider’s characteristics or competency. Standards may be set as a component of another mechanism, for example, as a requirement for registration or as a prerequisite to obtaining an import permit or licence. 26 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS In legislation, standards can be applied to a class of entities, goods or activities with sanctions for failing to comply. Governments can also impose standards by way of policy without legislative authority. For example, a public health authority could determine that it is going to purchase health services only from providers that meet certain standards. The basic elements of a legal framework for standard-setting include the following: Standards: The legislation will either prescribe standards or empower an authority to set standards by notice or subordinate legislation, or approve standards developed by a technical body. Standards are often technical and complex and may require specialist expertise. Administering authority: The authority will need to be given a mandate to administer the standards. Offences and penalties: The legislation may contain offences and penalties for failing to comply with the standards. Compliance plan or certification: Regulated entities may be required to demonstrate their compli- ance. Two common mechanisms are: (1) compliance plans that set out how they will implement systems to ensure standards are met; and (2) certification from a third party that ensures systems, practices or products meet the required standards. Sampling and testing: If the standards relate to the composition of a product, such as food or medicines, the scheme will need to give the authority power to sample and test the products, on a random or selective basis. Monitoring and investigation powers: The authority may require monitoring and investigation powers to carry out inspections and ensure compliance with the standards. Enforcement powers: The authority will need to be given enforcement powers. This may include the power to issue infringement notices, particularly where there are lower-level breaches of standards. Public disclosure: The authority should be able or required to disclose incidences of noncompliance with the standards. Public disclosure can be a powerful deterrent to breaches of standards. d. Considering whether the problem is better addressed at the regional or international level (see example in Box 15): — Identify existing regional and/or international legal instruments and consider whether relying on or modifying them is sufficient. — Decide whether these regional and/or international mechanisms need to be incorporated into domestic legislation. — Consider whether new instruments or mechanisms are viable options. e. Developing a stakeholder consultation strategy: — Undertake a range of consultations based on the size and nature of the initiative and the stakeholder groups it is most likely to affect. 27 2. ACTING ON THE AGENDA — Include consultation across other relevant government agencies and affected stakeholder groups. — Use consultation methods that are inclusive and match the needs of the stake- holder groups. — Ensure there are opportunities for active, free and meaningful participation, with an emphasis on stakeholder groups that are socially marginalized and risk being excluded from mainstream efforts. — Ensure relevant documents are available in formats that are clear and accessible, particularly for target populations (for example, migrants and others who do not speak the national language, indigenous people, people with disability) who may need translations or other modified formats. BOX 15 Regulatory cooperation and convergence for medicines and the health workforce in the Western Pacific Region The Western Pacific Regional Action Agenda on Regulatory Strengthening, Convergence and Cooperation for Medicines and the Health Workforce was endorsed by the WHO Regional Committee for the Western Pacific in 2017. It guides Member States to strengthen regulatory systems for medicines and the health workforce through a stepwise approach and to consider participating and utilizing global and regional convergence and cooperation platforms to support this process. It emphasizes cooperation among Member States as a way for them to extend regulatory reach, to implement the full range of regulatory functions, to enhance compatibility, and to improve compliance and enforcement of regulatory processes. Source: Regulatory strengthening, convergence and cooperation for medicines and heath workforce (Resolution WPR/RC68.R7). Brisbane: WHO Regional Committee for the Western Pacific; 2017. 2.2.2 Potential actions to overcome obstacles and get to a decision Legal frameworks for health can be improved to overcome obstacles and get to a decision. Technical challenges should be addressed using the formal processes required, gathering evidence and using these to illuminate and resolve the issue. Political challenges involve a range of interests and stakeholders, whose authentic involvement may be a powerful factor in shaping people’s knowledge and attitudes towards the law, and therefore its legitimacy and efficacy. The process should be fair – and seen to be fair – by those affected. Strengthening legal frameworks for health will often be incremental and require ways of identifying windows for change and building political will and support to achieve particular goals (see Annex 8 for an illustrative example of a legal framework supporting health goals). 28 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS WHO Member States may consider the following options, as appropriate to their context: a. Seeking political opportunities to influence and persuade those in positions of leader- ship and power: — Draw attention to the need for public health law reform based on international instruments and commitments (see example in Box 16). — Advocate public health considerations in trade negotiations and agreements. BOX 16 Trade law and public health in the Pacific Globally, bilateral and regional trade agreements have risen in number and reach. Pacific island countries are no exception, becoming involved in a number of trade agreements with other countries. Trade agreements can lead to higher living standards and better health, but they can also pose risks if the health implications are not taken into account during their design and negotiation. Samoa agreed to fully apply most World Trade Organization provisions immediately following accession as a member in May 2012 (with a few exceptions). As a condition of accession, the country agreed to remove its ban on the importation and domestic distribution of turkey tails (a high-fat meat product) within 12 months and replace the ban with less trade-restrictive measures, including a domestic ban on the sale of these products and a 300% import duty. During the 2-year period following accession, a nationwide programme to promote healthier diets and lifestyle choices was to be implemented, after which the ban on sales would be lifted and the import duty reduced to 100% or replaced by other taxes or regulatory measures compliant with the World Trade Organization. Source: Legge D, Gleeson D, Snowdon W, Thow AM. Trade agreements and non-communicable diseases in the Pacific islands. Fiji: Pacific NCD Forum; 2011 (revised 2013). b. Navigating the formal processes and approvals for legislative review: — Clearly understand the stakeholders, approvals and processes required for the introduction of legislation. — Specify the required approvals, timelines, steps in a plan and timetable for legislative review. — Be familiar with the information needs of the cabinet or other high-level bodies responsible for approvals, and ensure they are accurately and well informed. — Follow established rules in relation to drafting of legislation and liaise with relevant agencies of government. c. Navigating the informal systems that affect the passage of legislative review: — Undertake stakeholder analysis with potentially interested and affected individuals and groups. 29 2. ACTING ON THE AGENDA — Be aware of and engage with, as appropriate, groups and interests that may oppose particular reforms based on factors such as ideological, economic, religious, political or financial interests, while protecting against vested interests that may conflict with public health objectives. — Understand the concerns of particular audiences and use relevant arguments and evidence, including public health, rights-based or economic arguments when addressing these concerns. — Inform and mobilize the media and the public on relevant issues, including identifying appropriate champions and building networks and coalitions. — Draw on regional and international evidence, strategies, mechanisms and instru- ments to support advocacy efforts. d. Considering incremental steps to the development and passage of law based on capacity to introduce and implement change, and a judgement of social acceptance and political feasibility. e. Considering related health agendas and take advantage of the access to stakeholders to build support for these other changes as well (see example in Box 17). BOX 17 Constitutional provisions for participation in the legislative review process in Vanuatu The Vanuatu Constitution provides for the organization of a National Council of Chiefs composed of custom chiefs elected by their peers who sit on District Councils of Chiefs (section 29), and for its participation in the legislative review process. The Constitution notes that the National Council of Chiefs “has a general competence to discuss all matters relating to custom and tradition and may make recommendations for the preservation and promotion of ni-Vanuatu culture and languages”, and that it “may be consulted on any question, particularly any question relating to tradition and custom, in connection with any bill before Parliament” (section 30). Source: Constitution of the Republic of Vanuatu. Republic of Vanuatu; 1980. 2.2.3 Potential actions to design the law Legal frameworks for health can be improved to better design the law. The proposed law should translate the underlying policy and expectations, with drafting instructions providing sufficient detail for the drafter to have a clear sense of what the legislation is intended to achieve, what interventions are required, how the law aligns with existing legal frameworks, and anticipated impacts. Moreover, the legal instrument should be developed from the outset with implementation in mind, including responsibilities for coordination, monitoring and enforcement, and clarity of offences and penalties for noncompliance, including use of revenues from fines. Planning should start early, including 30 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS resource requirements and the development of new skills (and potentially new agencies or divisions), and they should address educational needs, attitudes and behaviours of the staff to be involved. WHO Member States may consider the following options, as appropriate to their context: a. Developing drafting instructions prior to drafting the law: — Include sufficient detail for the drafter to have a clear sense of what the law is intended to achieve, but do not write instructions in the form of an actual bill. — Use clear, ordinary language. — Explain why the law is needed, what it intends to achieve, and how it will achieve this. b. Drafting law that translates the policy intention into an enforceable and effective legal instrument: — Research the existing law and the likely effect of the new law on it. — Prepare required amendments to other legal instruments during the drafting process. — Ensure the law is legally effective, complies with constitutional issues and is consistent with the rest of the jurisdiction’s legal frameworks. — Provide for other subsidiary legal instruments, including regulations, rules and delegations to be developed as appropriate. — Ensure that the proposed legislative scheme is implementable and enforceable (see Box 18). — Provide for appropriate enforcement mechanisms, including penalties, to ensure compliance. BOX 18 Opportunities and risks from legal transplantation Legal transplantation – importing the law from one country or one tradition to another – is a way of learning and incorporating best practice from other legal regimes. In doing so, it is essential that the transplanted law be adapted to local social, political and cultural realities and broader legal frameworks. In capacity-poor jurisdictions, a new legal instrument may be drafted with the technical assistance of donors without the consultation process that would usually be the norm because of time and resource constraints, and can result in cut-and-paste laws that are not fit for purpose. Due consideration should be given to what is appropriate and can be accommodated in each context, including its fit with administrative capability and available staffing, expertise and funding for implementation. Sources: Palacio A, Sage CM, Woolcock MJV, editors. The World Bank legal review: law, equity, and develop- ment. Volume 2. Washington, DC: World Bank; 2006; Footer M. Technical assistance and trade law reform post-Doha: a brave new world. In: Hatchard J, Perry-Kessaris A, Slinn P, editors. Law and development: facing complexity in the 21st century. London: Cavendish; 2003. 31 2. ACTING ON THE AGENDA c. Drafting legislation in an organized way with simple and clear language: — Draft legislation in a coherent and logical manner to accommodate a range of readers, not all of whom will have relevant expertise. — Be direct and use short sentences that convey the intended meaning without using unnecessary or complicated words or qualifications. — Exclude language and material that have no legal effect. — Be consistent in the use of language – that is, not using the same word(s) to convey different meanings or different word(s) to convey the same meaning. 2.2.4 Potential actions to implement the law Legal frameworks for health can be improved to better implement laws. There are two relatively distinct phases of implementation: the initial phase when a new legislative regime is introduced; and the second phase, which is the ongoing administration of the law (see example in Box 19). As emphasized in Section 2.2.3, legal frameworks should be designed in a manner that is implementable and enforceable (see Box 18). The ongoing administration of the law is a matter for authorities charged with this responsibility. These authorities, such as regulatory bodies, often work within an envelope of resources, which falls short of their needs. This means important decisions and choices have to be made to meet the demands and expectations of their role. WHO Member States may consider the following options, as appropriate to their context: a. Planning and managing the implementation phase in a proactive manner, including where necessary: — Amend relevant policy and planning documents to reflect changes in legal frame- works. — Revise organizational structures and staffing and undertake necessary profes- sional education; recruit and, where necessary, manage retrenchments in a fair and transparent manner. — Develop change management strategies for relevant staff, including necessary training, mentoring and development. — Consider possible implications for current contractual obligations and assets and liabilities, including infrastructure and intellectual property. — Amend relevant information, reporting systems and delegations to reflect the changes. — Budget for one-off and recurrent costs associated with the new legislative regime, its introduction and staffing consequences. — Develop and implement communication strategies to ensure all necessary stake- holders are aware of relevant changes. 32 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS BOX 19 Regulating food safety in Viet Nam In Viet Nam, the Law on Food Safety provides the legal basis for the national food safety system and defines the institutional arrangements for food control. The roles and responsibilities for food safety are divided among three ministries, Ministry of Health, Ministry of Agriculture and Rural Development and Ministry of Industry and Trade, and shared with their subordinate departments and agencies. With multiple regulatory agencies involved, the risk of overlaps and gaps in the enforcement of legal requirements is significant. In 2017, the National Assembly reviewed the implementation of the Law on Food Safety and related policies from 2011 to 2016. The review considered technical guidance from WHO and other partners and outlined a series of recommendations for improvements in the legal framework for food safety. As a result of the review, the Viet Nam Food Administration under the Ministry of Health in early 2018 was tasked with revising the Law. With the involvement of food safety regulators from all three ministries, the Law is now being revised with the purpose of overcoming overlaps and gaps in the management of food safety risks. This initiative is part of the Government’s effort to strengthen the overall national food safety system. Source: Nguyen-Viet H, Tuyet-Hanh T, Unger F, Dang-Xuan S and Grace D. Food safety in Vietnam: where we are at and what we can learn from international experiences. Infect Dis Poverty. 2017;6(1):39. b. Administering regulation in a manner that supports achievement of policy objectives while minimizing burdens and costs to all parties: — Define desired regulatory outcomes. — Identify and document historical, current and emerging risks in relation to regulatory outcomes. — Assess risks to inform the design of regulatory activities, allocation of resources and selection of enforcement strategies (see example in Box 20). BOX 20 Resourcing and recognition of regulatory functions for medicines International experience suggests that regulation is only as strong as the political support and allocated resources. Government budgetary support is the financing method employed in most countries; others have a combination of fees and government allocations. Where drug regulatory authorities are financed through a government budget, the fees they charge are almost always much lower than the real costs of the regulatory function. The fees charged vary widely across countries, being much lower in developing countries. This can constrain the ability of the regulatory authority to meet its mandate. Australia is the only country in the Western Pacific Region that is almost entirely self-financed through cost recovery fees and levies. For 2017–2018, the sum of application and evaluation fees for each new generic medicine was US$ 67 000.4 Source: Ratanawijitrasin S, Wondemagegnehu E. Effective drug regulation: a multicountry study. Geneva: World Health Organization; 2002. 4. Equivalent to 89 000 Australian dollars based on the exchange rate as of 20 June 2018 (indexation increase will be applied to fees for 2018–2019). 33 2. ACTING ON THE AGENDA c. Undertaking regulatory activities in a manner that is responsive to the context and conduct of those being regulated: — Restrict entry into markets and industries where regulatory requirements are not met. — Take a systematic approach to monitoring compliance and enable targeted and proactive response. — Employ a range of strategies to manage noncompliance that are proportionate to the risks presented by the noncompliance (see Fig. 3). — Develop systems to respond to adverse events to protect the community from harm, including event notification, assessment, response and evaluation. FIG. 3 Regulatory pyramid of sanctions PERSUASION WARNING LETTER CRIMINAL PENALTY LICENCE REVOCATION LICENCE SUSPENSION Source: Adapted from Ayres I, Braithwaite J. Responsive regulation: transcending the deregulation debate. New York: Oxford University Press; 1992. d. Considering social norms and forces as they relate to the achievement of regulatory outcomes: — Take account of existing norms and practices and leverage them, where appro- priate, to achieve regulatory goals (see example in Box 21). — Develop strategic communications campaigns to influence norms and attitudes. — Identify and use social and cultural institutions, including traditional leaders and community groups, where appropriate, to facilitate better regulatory outcomes. BOX 21 WHO Nutrient Profile Model for the Western Pacific Region Nutrient profiling is a method of classifying foods based on nutritional composition, such as amounts of energy (calories), saturated fat, sugar and/or sodium. The WHO Nutrient Profile Model for the Western Pacific Region (2016) was developed by WHO, through extensive consultation with Member States, as a tool to identify whether any given food item (for example, fruit juice) should be prohibited from 34 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS being marketed to children because it exceeds an established threshold of a nutritive element (for example, more than 5 grams of sugar per 100 grams of product). The Model also calls for marketing restrictions on items in certain categories (for example, confectionaries, energy drinks), while allowing for the marketing of traditional items associated with celebratory events (for example, moon cakes during lunar new year), even if the item would otherwise fail the test. Where countries develop legal frameworks to restrict food marketing to children, a tool of this kind facilitates consistent enforcement. Source: WHO nutrient profile model for the Western Pacific Region: a tool to protect children from food marketing. Manila: WHO Regional Office for the Western Pacific; 2016. e. Using big data and technology, with appropriate safeguards, to support regulatory activities, including design, targeting and enforcement. f. Ensuring transparency and accountability in the administration of regulation (see example in Box 22): — Maintain and secure all documentation in relation to regulatory decisions. — Develop and implement conflict-of-interest policies and procedures. — Establish processes to handle disputes or disagreements. — Monitor complaints and maintain internal review and improvement systems. BOX 22 Regulatory Powers (Standard Provisions) Act 2014 in Australia The Australian Regulatory Powers (Standard Provisions) Act 2014 provides for a standard suite of provisions in relation to monitoring and investigation powers, as well as enforcement provisions through the use of civil penalties, infringement notices, enforceable undertakings and injunctions. It is anticipated that implementing the Act will support the Government’s regulatory reform agenda as it intends to simplify and streamline regulatory powers across the statute book. This will provide regulatory agencies with an opportunity to use more uniform powers and increase legal certainty for businesses and individuals that are subject to those powers. Source: Regulatory Powers (Standard Provisions) Act 2014. Australia; 2014. 2.2.5 Potential actions to monitor and evaluate legal frameworks Legal frameworks for health can be improved to better monitor and evaluate their effectiveness. Reliable evidence is needed to inform strategy development. Policy and legal interventions will never be perfect, and policy-makers need to be able to adapt and respond. Policy-makers need to know what effects law and policy are having and, as far as possible, why and how. Monitoring and evaluation activities should not be limited to the legal intervention itself but extended to other aspects of the policy development process, and its implementation and enforcement. 35 2. ACTING ON THE AGENDA WHO Member States may consider the following options, as appropriate to their context: a. Identifying priorities for monitoring and evaluation and developing sound evaluation plans (see Box 23). b. Including evaluation as part of the identification and development phase: — Identify implementation barriers. — Determine whether a proposed strategy will work or not. — Specify the outcomes to be monitored and evaluated. c. Collecting and managing data necessary for monitoring and evaluation work: — Share information among sectors and countries to the mutual benefit of all. — Promote the public availability of information and data at all stages of the process to ensure informed community participation. d. Developing expertise to undertake monitoring and evaluation work: — Engage academic and research institutions. — Identify pressing policy issues for evaluation and research. — Ensure that external experts have proven subject matter/content knowledge and experience. — Ensure that all relevant ethical and privacy clearances are obtained before under- taking research. e. Making evaluation and research findings accessible through virtual and other chan- nels that are readily accessible to health professionals, policy-makers and the public. f. Including persons most directly affected by legislation, as much as possible in the monitoring and evaluation of its effects, to ensure the subjects’ perspective is prominent in assessing the impact of the legislation. BOX 23 Policy surveillance for health law Policy surveillance is the ongoing, systematic collection, analysis and dissemination of information about laws and other policies of health importance. The rationale for policy surveillance is that if law matters to health, then public health officers, policy-makers, researchers and the general population need basic information about what the law requires and where it applies. Policy surveillance can serve a number of basic country needs. It answers the consistent demand of countries for information about what other countries are doing in a particular area, and provides access to policy models that can help countries devise their own versions. Policy surveillance allows the identification of trends that can influence lawmakers to take action. It creates data for evaluation and research, and it supports diffusion of knowledge and legal competency. Source: Burris S, Ashe M, Levin D, Penn M, Larkin M. A transdisciplinary approach to public health law: the emerging practice of legal epidemiology. Annu Rev Publ Health. 2016;37:135–48. 36 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS WHO IS INVOLVED? Countries have different priorities for enhancing the capacities of various stakeholders involved in strengthening legal frameworks for health. Policy-makers and regulators are essential players in developing and implementing laws for health. Parliamentarians are critical with their powers to enact law, approve budgets and provide oversight. Health providers and communities that demand transdisciplinary approaches to public health law can help break down disciplinary, cultural and resource barriers. 2.3.1 Potential actions to build the capacity of policy-makers Legal frameworks for health can be strengthened through enhanced capacities of policy- makers. Policy-makers are central to the development, implementation and evaluation of health policy, including through law, from defining the problem and setting the scope and objectives of legal review, to monitoring implementation, evaluating the effective- ness of the legal framework and drawing on related research. WHO Member States may consider the following options, as appropriate to their context: a. Building the capacity to define problems and develop viable options to address them: — Develop an appreciation of legal and non-legal strategies to advance UHC and health in the SDGs. — Develop and ensure access to relevant evidence and understand the impact of legal intervention (see example in Box 24). — Draw, as needed, upon legal expertise in relevant areas of practice, including specializations such as legislative drafting. b. Planning and coordinating formal legal review processes, including approvals and stakeholder management and implementation strategies. c. Building the skills and knowledge for communicating with different categories of stakeholders: — Provide advice and use effective communications strategies to engage parliamen- tarians and other decision-makers. — Strengthen relationships across ministries and build the capacity to articulate the centrality of health to social and economic development and to other sectoral priorities. — Build expertise in health diplomacy and the political process to influence and shape global and regional initiatives that have on impact on health. — Consult, research and seek informed advice on the potential impacts of the law and the steps needed to ensure it benefits its intended communities. 2.3 37 2. ACTING ON THE AGENDA — Develop expertise and an understanding of economic development through trade, including international, regional and bilateral trade agreements and their potential impact on health. — Raise awareness of entry points that provide opportunities to influence legal development and be able to navigate the political and economic forces that can be obstacles to or support legal changes. BOX 24 International Legal Training Program at the McCabe Centre for Law & Cancer WHO supports Member States in strengthening national capacities in the effective use of law for the prevention and control of NCDs. The McCabe Centre for Law & Cancer (Melbourne, Australia) has been a WHO Collaborating Centre for Law and Noncommunicable Diseases since 2018, also designated as a WHO Framework Convention on Tobacco Control (FCTC) Knowledge Hub on legal challenges to the implementation of the WHO FCTC. The Centre conducts an International Legal Training Program. Covering a wide range of topics (including global governance; post-2015 sustainable development agenda; global NCD agenda; legal issues in tobacco control, alcohol control and promotion of healthy diets; WHO FCTC; international trade and investment law; intellectual property law; and law enforcement in low-resource settings), the curriculum includes classroom training and development of individual priority projects for each participant. In collaboration with WHO, the Program invites government lawyers, NCD focal points, and others well placed to drive action on NCDs in low- and middle-income countries. 2.3.2 Potential actions to build the capacity of regulators Legal frameworks can be strengthened through enhanced capacities of regulators. Effec- tive regulatory administration supports the achievement of key policy objectives while minimizing the burden and compliance cost for regulated entities. Well-functioning regulators should clearly understand the regulatory outcomes being sought, apply a risk-based approach to regulatory administration, effectively engage with stakeholders to share and collect information, use information as a source of intelligence to guide regulatory activity, be transparent in their approach, be accountable for their actions and decisions, and monitor and report on their performance and the effectiveness of the regulatory regime. WHO Member States may consider the following options, as appropriate to their context: a. Developing guidance for regulators to improve their understanding of relevant legal frameworks, powers and constraints within which they operate. b. Using information and evidence to inform regulatory approaches: — Develop systems and capacity to manage and analyse data. — Develop an understanding of regulatory theory and different approaches and strategies. 38 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS c. Fostering productive relationships with relevant stakeholders, including the regulated entities, as well as other regulators within the country, regionally and internationally. d. Securing adequate financial support for the regulatory system, along with the recognition that it is an essential component of the health system. 2.3.3 Potential actions to engage parliamentarians Legal frameworks can be strengthened through enhanced capacities of parliamentar- ians. In addition to passing legislation, approving budgets and providing oversight, parliamentarians foster multisectoral collaboration, encourage participation among their constituencies and ensure alignment of national implementation with international commitments. Engagement with parliamentarians represents a whole-of-government approach to strengthening legal frameworks for health. WHO Member States may consider the following options, as appropriate to their context: a. Raising awareness for parliamentarians on their central role in advancing UHC and achieving health in the SDGs (see example in Box 25): — Develop policy briefs and other advocacy materials targeting parliamentarians. — Organize policy dialogues to inform parliamentarians about priority health issues. — Identify champions for health among parliamentarians. b. Establishing strategic platforms for engagement between government and parliament: — Map budget cycles, parliamentary schedules and the electoral calendar to assist in identifying entry points and timing. — Engage with standing health committees and other committees relating to health, such as population and development, gender and equality, environment, labour, agriculture, education, finance, and trade. — Maintain lines of communications with parliamentarian secretariat staff to ensure immediate access and follow-up to address health issues. — Support participation of parliamentarians in domestic and regional health forums. c. Providing technical assistance to parliamentarians in advancing action on health: — Offer public support and visibility to parliamentarians who champion public health priorities. — Provide access to evidence and knowledge to support policy development, including the development of law. 39 2. ACTING ON THE AGENDA BOX 25 Asia-Pacific Parliamentarian Forum on Global Health The Asia-Pacific Parliamentarian Forum on Global Health is a platform for parliamentarians to exchange ideas, build political will, strengthen capacities and foster collaboration in driving sustainable action for health. Launched in 2015 by the Republic of Korea, with support from WHO, the Forum is open to 30 countries across the Asia-Pacific region. The Forum has addressed a wide range of issues, including global health security, health in the Sustainable Development Goals, noncommunicable diseases and ageing, universal health coverage, and climate change. Championing health beyond the health sector, engagement with parliamentarians through the Forum represents an important part of WHO’s support to Member States in strengthening legal frameworks through a whole-of-government approach. 2.3.4 Potential actions to empower and ensure the participation of communities Legal frameworks can be strengthened through enhanced capacities of communities. The active involvement of communities, as represented by civil society, is essential to shaping the substance, legitimacy and acceptability of law. As users of the law, communities can themselves be agents and advocates of change. It is important to ensure that steps are taken to improve “legal literacy”, particularly among disadvantaged groups. WHO Member States may consider the following options, as appropriate to their context: a. Ensuring the participation of communities in developing or amending health-related law (see Box 26): — Identify and reduce barriers to the free, active and meaningful participation of communities in legislative review processes. — Use the law to set requirements for the participation of civil society and communities in legislative review. — Engage communities and civil society in the implementation of the law and regulatory strategies. — Build communities’ knowledge of their rights, legal entitlements and obligations, and the avenues for asserting them. — Facilitate the organization of community groups to strengthen the community voice and ensure that law and policy respond to community needs. — Identify the most vulnerable of the populations affected by the law and ensure their voices are heard. b. Identifying potential champions, such as community leaders, media and celebrities, who are well positioned and willing to support the changes proposed and their purposes. 40 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS c. Engaging academic institutions in the monitoring, evaluation and research of the law and public health: — Identify pressing policy issues that need to be subjects of evaluation and research. — Support and commission work on, for instance, the monitoring of laws, comparative analysis and empirical research. — Draw on findings of evaluation and research and incorporate these into the strengthening of legal frameworks. — Support the development of courses and professional development programmes on policy, law, health ethics and public health. — Engage academic institutions in the continuing professional development of the public health workforce. BOX 26 Engaging health users and civil society in transforming legislation in Fiji Established in the 1970s by people with disabilities themselves, the Fiji Disabled Persons Federation actively advocates for Fijians who have a disability, so that they can participate on an equal basis as other Fijians (https://fdpf.org/overview). At the national level, the Federation works with the Government and key actors to give a voice to people with disability from communities across Fiji. By engaging community members with disability and their families directly, the Federation can legitimately gather information on the priorities and needs of people with disability to ensure the Government develops relevant laws and policies. The United Nations Convention on the Rights of Persons with Disabilities (CRPD) was signed by Fiji in 2010 and ratified in 2017. The engagement of the Fiji Disabled Persons Federation has been instrumental in encouraging and supporting the Government of Fiji to understand and implement its obligations under the Convention. The tireless activism from civil society such as the Federation not only contributed to the ratification of this ground-breaking treaty on human rights, and particularly those rights associated with persons with disabilities and their families, but also contributed to Fiji’s Rights of Persons with Disabilities Act 2018. The Act will help the Government to ensure people with disabilities have access to services like health care, and to promote, protect and fulfil their rights on an equal basis. The engagement of representative organizations of people with disability is essential to support governments to develop effective legislation and policy and support their implementation. In many countries in the Western Pacific Region, civil society organizations work from the community level to the national level as government counterparts to help inform legislation and provide feedback to facilitate implementation. Source: https://fijisun.com.fj/2018/03/14/disability-bill-applauded-by-federation. 41 2. ACTING ON THE AGENDA 2.3.5 Potential actions to coordinate with health providers Legal frameworks can be strengthened through enhanced capacities of health providers. Service providers and professional associations have multifaceted roles in relation to strengthening legal frameworks. They are the subject of regulation, but they are also an important source of information on problems and issues as well as being able to assist in generating solutions and navigating legislative change. Professional associations are well positioned to explain proposed changes to their members and other stakeholders, to provide constructive criticism and suggestions, and to help build consensus. WHO Member States may consider the following options, as appropriate to their context: a. Engaging with service providers and professional associations throughout the process of developing, implementing and evaluating legal frameworks: — Gather views and information and develop options during the identification and development phase of legal review. — Ensure those represented by providers and associations are aware of how legal reforms will affect them and can contribute meaningfully to the process. — Take into consideration the feedback and its significance for the content and framing of legal design. — Involve service providers in ongoing monitoring and evaluation with the aim of improving and strengthening legal frameworks. 42 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS RECOMMENDATIONS3. WHO and its Member States have complementary roles and commitments in the strengthening of legal frameworks for health. RECOMMENDATIONS FOR MEMBER STATES As appropriate to national needs and capacities, Member States may consider taking the following actions towards strengthening their legal frameworks for health: a. Review legal frameworks for health in aligning their national health strategies with broader efforts to advance UHC and achieve health in the SDGs. b. Set priorities for action areas and develop a programme for the strengthening of legal frameworks for health. c. Improve processes in the development, implementation and evaluation of legal frameworks for health. d. Enhance the capacities of stakeholders involved in strengthening legal frameworks within and beyond the health sector. e. Cooperate with other countries to ensure health is considered in developing inter- national legal instruments, such as agreements on trade and environment. f. Enable action on cross-border health risks and issues through legal frameworks. 3.1 43 3. RECOMMENDATIONS RECOMMENDATIONS FOR WHO Upon request, WHO may support Member States in strengthening their legal frame- works for health, as follows: a. Raise awareness on the importance of law for health and advocate the strengthening of legal frameworks to advance UHC and achieve health in the SDGs. b. Enhance access to evidence and knowledge to support Member States in their efforts to review existing legal frameworks for health and determine priorities for action. c. Provide technical support to Member States in their efforts to improve processes and enhance capacities for strengthening legal frameworks for health. d. Facilitate dialogue and cooperation between Member States to address cross- border health issues, foster regional collaboration opportunities, and engage in joint advocacy and action to shape international agendas. e. Mobilize legal expertise for health. 3.2 44 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS REFERENCES Australian National Audit Office. Administering regulation: achieving the right balance. Barton, ACT: Australian National Audit Office; 2014. Burris S, Ashe M, Blanke D, Ibrahim J, Levin DE, Matthews G, Penn M, Katz M. Better health faster: the 5 essential public health law services. Public Health Rep. 2016;131(6):747–53. doi: 10.1177/0033354916667496 Burris S, Ashe M, Levin D, Penn M, Larkin M. A transdisciplinary approach to public health law: the emerging practice of legal epidemiology. Annu Rev Publ Health. 2016;37:135–48. Chantry CJ, Dewey KG, Peerson JM, Wagner EA, Nommsen-Rivers LA. In-hospital formula use increases early breastfeeding cessation among first-time mothers intending to exclusively breastfeed. J Pediatr. 2014;164(6):1339–45. doi: 10.1016/j.jpeds.2013.12.035 Commission on Human Rights. The Siracusa Principles on the limitation and derogation provisions in the International Covenant on Civil and Political Rights, 28 September 1984 (E/CN.4/1985/4, http://www.unhcr.org/refworld/docid/4672bc122.html, accessed October 2016). Dittrich R, Cubillos L, Gostin L, Chalkidou K, Li R. The international right to health: what does it mean in legal practice and how can it affect priority setting for universal health coverage? Health Systems & Reform. 2016;2(1):23–31. doi:10.1080/23288604.2016.1124167 Drahos P, editor. Regulatory theory: foundations and applications. Acton, ACT: ANU Press; 2017. Drop J, Schluger N, Cahn Z, Drope J, Hamill S, Islami F, Liber A, Nargis N, Stoklosa M. The tobacco atlas (Sixth Edition). Atlanta: American Cancer Society and Vital Strategies; 2018. Eriksen M, Mackay J, Ross H, editors. The tobacco atlas (fourth edition). Atlanta: American Cancer Society and New York: World Lung Foundation; 2012. Fidler DP. Legal issues associated with antimicrobial drug resistance. Emerg Infect Dis. 1998;4(2):169–77. doi:10.3201/eid0402.980204. Footer M. Technical assistance and trade law reform post-Doha: a brave new world. In: Hatchard J, Perry-Kessaris A, Slinn P, editors. Law and development: facing complexity in the 21st century. London: Cavendish; 2003. Gostin L. Global health law. Cambridge: Harvard University Press; 2014. Gostin L. Public health law: power, duty, restraint. Berkeley: University of California Press; 2000. Gostin L, DeBartolo MC, Katz R. The global health law trilogy: towards a safer, healthier, and fairer world. Lancet. 2017;390(10105):1918–26 (http://dx.doi.org/10.1016/ S0140-6736(17)31261-8). Gostin L, Sapsin JW, Teret SP, Burris S, Mair JS, Hodge JG Jr, Vernick JS. The Model State Emergency Health Powers Act: planning and response to bioterrorism and naturally occurring infectious diseases. JAMA. 2002;288(5):622–8. Health Policy Development and Planning Bureau, Department of Health. Sin tax law incremental review for health: annual report 2018. Manila: Department of Health; 2018. Legge D, Gleeson D, Snowdon W, Thow AM. Trade agreements and non-communicable diseases in the Pacific islands. Fiji: Pacific NCD Forum; 2011 (revised 2013). 45 REFERENCES Leppo K, Ollila E, Pena S, Wismar M, Cook S, editors. Health in All Policies: seizing opportunities, implementing policies. Helsinki: Ministry of Social Affairs and Health, Finland; 2013. Liberman J. Building a law and NCDs workforce: a necessity for global cancer and NCD prevention and control. J Cancer Policy. 2017;12:72–4. Lindsey T, editor. Law reform in developing and transitional states. London and New York Routledge; 2007. Mann J, Gostin L, Gruskin S, Brennan T, Lazzarini Z, Fineberg H. Health and human rights. Health Hum Rights. 1994;1(1):6–23. Moodie R, Stuckler D, Monteiro C, Sheron N, Neal B, Thamarangsi T, Lincoln P, Casswell S. Profits and pandemics: prevention of harmful effects of tobacco, alcohol, and ultra-processed food and drink industries. Lancet. 2013;381(9867):670–9. Nguyen-Viet H, Tuyet-Hanh T, Unger F, Dang-Xuan S, Grace D. Food safety in Vietnam: where we are at and what we can learn from international experiences. Infect Dis Poverty. 2017;6(1):39. Organisation for Economic Co-operation and Development. OECD Journal on Budgeting. Special Issue: The legal framework for budget systems – an international comparison. 2004;4(3). Palacio A, Sage CM, Woolcock MJV, editors. The World Bank legal review: law, equity, and development. Volume 2. Washington, DC: World Bank; 2006. PhilHealth. Stats & charts 2018. Manila: PhilHealth; 2018. Rasanathan K, Bennett S, Atkins V, Beschel R, Carrasquilla G, Charles J, et al. Governing multisectoral action for health in low- and middle-income countries. PLoS Med. 2017;14(4):e1002285. Ratanawijitrasin S, Wondemagegnehu E. Effective drug regulation: a multicountry study. Geneva: World Health Organization; 2002. Rosenberg KD, Eastham CA, Kasehagen LJ, Sandoval AP. Marketing infant formula through hospitals: the impact of commercial hospital discharge packs on breastfeeding. Am J Public Health. 2008;98(2):290–5. Schmets G, Rajan D, Kadandale S, editors. Strategizing national health in the 21st century: a handbook. Geneva: World Health Organization; 2016. Sridhar D, McKee M, Ooms G, Beiersmann C, Friedman E, Gouda H, et al. Universal health coverage and the right to health: from legal principle to post-2015 indicators. Int J Health Serv. 2015;45(3):495–506. doi: 10.1177/0020731415584554 United Nations. The rule of law and transitional justice in conflict and post-conflict societies: report of the Secretary-General. New York: United Nations; 2004. United Nations Development Programme. Using competition law to promote access to health technologies. New York: UNDP; 2014. United Nations System Standing Committee on Nutrition. Enhancing coherence between trade policy and nutrition action: implementing the Framework for Action of the Second international Conference on nutrition. New York: United Nations; 2016. University of Ottawa. JuriGlobe – world legal systems [website]. Ottawa: University of Ottawa (http://www.juriglobe.ca). Wagenaar A, Burris S, editors. Public health law research: theory and methods. San Francisco: Jossey-Bass; 2013. World Bank Group. Governance and the law. Washington: World Bank; 2017. 46 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS World Bank Group. Reducing tobacco use through taxation: the experience of the Republic of Korea (English). WBG Global Tobacco Control Program. Washington, DC: World Bank; 2018. World Bank Group. Tobacco tax reform at the crossroads of health and development: technical report. Washington, DC: World Bank; 2017. World Economic Forum. From burden to “best buys”: reducing the economic impact of non-communicable diseases in low- and middle-income countries. Geneva: WEF; 2011. World Health Organization. International code of marketing of breast-milk substitutes. Geneva: WHO; 1982. World Health Organization. 25 questions & answers on health and human rights. Health and human rights publication series. Issue No. 1; July 2002. World Health Organization. Towards health with justice: litigation and public inquiries as tools of tobacco control. Geneva: WHO; 2002. World Health Organization. Mental health legislation & human rights. Geneva: WHO; 2003. World Health Organization. Enhancing health policy development: a practical guide to understanding the legislative process. Geneva: WHO; 2004. World Health Organization. Global strategy on diet, physical activity and health. Geneva: WHO; 2004. World Health Organization. International Health Regulations (2005). Geneva: WHO; 2005. World Health Organization. Enforcement of public health legislation. Geneva: WHO; 2006. World Health Organization. MPOWER – a policy package to reverse the tobacco epidemic. Geneva: WHO; 2008. World Health Organization. Asia Pacific strategy for emerging diseases. Geneva: WHO; 2010. World Health Organization. Set of recommendations on the marketing of foods and non-alcoholic beverages to children. Geneva: WHO; 2010. World Health Organization. Technical manual on tobacco tax administration. Geneva: WHO; 2010. World Health Organization. Addressing the harmful use of alcohol: a guide to developing effective alcohol legislation. Geneva: WHO; 2011. World Health Organization. A framework for implementing the set of recommendations on the marketing of foods and non-alcoholic beverages to children. Geneva: WHO; 2012. World Health Organization. Safe abortion: technical and policy guidance for health systems. Geneva: WHO; 2012. World Health Organization. Technical resource for country implementation of WHO Framework Convention on Tobacco Control Article 5.3. Geneva: WHO; 2012. World Health Organization. Apia outcome: Tenth Pacific Health Ministers Meeting. Geneva: WHO; 2013 World Health Organization. Basic documents. Geneva: WHO; 2014. World Health Organization. Making fair choices on the path to universal health coverage: final report of the WHO Consultative Group on Equity and Universal Health Coverage. Geneva: WHO; 2014. World Health Organization. Western Pacific regional action plan for the prevention and control of noncommunicable diseases (2014–2020). Manila: WHO Regional Office for the Western Pacific; 2014. 47 REFERENCES World Health Organization. Action plan to reduce the double burden of malnutrition in the Western Pacific Region (2015–2020). Manila: WHO Regional Office for the Western Pacific; 2015. World Health Organization. Healthy cities: good health is good politics – toolkit for local governments to support healthy urban development. Manila: WHO Regional Office for the Western Pacific; 2015. World Health Organization. Regional action plan for the Tobacco Free Initiative in the Western Pacific Region (2015–2019). Manila: WHO Regional Office for the Western Pacific; 2015. World Health Organization. REGULA technical reference document: noncommunicable disease risk factors in the Americas: considerations on the strengthening of regulatory capacity. Washington, DC: WHO/Pan American Health Organization; 2015. World Health Organization. Strategy on health-related law. Washington, DC: WHO/Pan American Health Organization; 2015. World Health Organization. WHO report on the global tobacco epidemic, 2015: raising taxes on tobacco. Geneva: WHO; 2015. World Health Organization. Be smart, drink water: A guide for school principals in restricting the sale and marketing of sugary drinks in and around schools. Manila: WHO Regional Office for the Western Pacific; 2016. World Health Organization. Joint External Evaluation tool – International Health Regulations (2005) monitoring and evaluation framework. Geneva: WHO; 2016. World Health Organization. Regional framework for urban health in the Western Pacific (2016– 2020): health and resilient cities. Manila: WHO Regional Office for the Western Pacific; 2016. World Health Organization. Report of the Commission on Ending Childhood Obesity. Geneva: WHO; 2016. World Health Organization. Road safety in the Western Pacific Region 2015. Manila: WHO Regional Office for the Western Pacific; 2016. World Health Organization. Universal health coverage: moving towards better health – action framework for the Western Pacific. Manila: WHO Regional Office for the Western Pacific; 2016. World Health Organization. WHO nutrient profile model for the Western Pacific Region: a tool to protect children from food marketing. Manila: WHO Regional Office for the Western Pacific; 2016. World Health Organization. Childhood overweight – situational analysis of policy and legal measures, and recommended actions for the Western Pacific. Manila: WHO Regional Office for the Western Pacific; 2017. World Health Organization. Joint external evaluation of IHR core capacities of the Kingdom of Cambodia. Geneva: WHO; 2017. World Health Organization. Joint external evaluation of IHR core capacities of Viet Nam. Geneva: WHO; 2017. World Health Organization. Overweight and obesity in the Western Pacific Region – an equity perspective. Manila: WHO Regional Office for the Western Pacific; 2017. World Health Organization. Protecting children from the harmful impact of food marketing. Manila: WHO Regional Office for the Western Pacific; 2017. World Health Organization. Regional action agenda for achieving the Sustainable Development Goals in the Western Pacific. Manila: WHO Regional Office for the Western Pacific; 2017. BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS 48 World Health Organization. Regional framework for action on food safety in the Western Pacific. Manila: WHO Regional Office for the Western Pacific; 2017. World Health Organization. Regulatory strengthening and convergence for medicines and health workforce. Manila: WHO Regional Office for the Western Pacific; 2017. World Health Organization. Global status report on road safety 2018. Geneva: WHO; 2018. World Health Organization. WHO report on the global tobacco epidemic 2017: monitoring tobacco use and prevention policies. Geneva: WHO; 2017. World Health Organization. Good country practices in the implementation of WHO FCTC Article 5.3 and its guidelines. Geneva: WHO; 2018. World Health Organization. Joint external evaluation of IHR core capacities of Australia. Geneva: WHO; 2018. World Health Organization. WHO report on the global tobacco epidemic, 2019: offer to help to quit tobacco use. Geneva: WHO; 2019. World Health Organization, International Development Law Organization, O’Neill Institute, Georgetown University, University of Sydney. Advancing the right to health: the vital role of law. Geneva: WHO; 2017. World Health Organization Framework Convention on Tobacco Control Secretariat: guidelines for implementation Article 5.3; Article 8; Article 9 and 10; Article 11; Article 12; Article 13; Article 14. Geneva: WHO FCTC Convention Secretariat; 2013. World Health Organization Framework Convention on Tobacco Control Secretariat, Conference of the Parties to the WHO Framework Convention on Tobacco Control, sixth session. Decision: Guidelines for implementation of Article 6 of the WHO FCTC (Price and tax measures to reduce the demand for tobacco). Geneva: WHO FCTC Convention Secretariat; 2014. 49 GLOSSARY Civil society organization Civil society organizations are non-state, non-profit-making, voluntary organizations formed by people from the community, but excluding political parties and commercial firms. This includes a wide range of organizations, networks, associations, groups and movements independent from government. They sometimes unite to advance common interests through collective action. Some definitions also include certain businesses (for example, media, private schools, for-profit associations); however, by definition, all civil society organizations are not affiliated with government and would be expected to have mandates to benefit society and those in need. Source: Glossary of globalization, trade and health terms. Geneva: WHO (http://www.who.int/ trade/glossary/en). Community A community is a specific group of people, often living in a defined geographical area, who share a common culture and are arranged in a social structure according to relationships. Members of a community gain their personal and social identity by sharing common beliefs, values and norms. Source: The WHO health promotion glossary. Geneva: WHO (http://www.who.int/health promotion/ about/HPG/en). Disability Disability is a complex phenomenon, reflecting the interaction between features of a person’s body and features of the society in which they live. It is an umbrella term, which includes impairments, activity limitations and barriers to their full and effec- tive participation in society on an equal basis with others. Overcoming the limitations faced by people with disabilities requires interventions to remove these barriers. Source: World report on disability. Geneva: WHO; 2011 (http://www.who.int/disabilities/world_ report/2011/report/en). Disadvantaged, vulnerable or marginalized groups Disadvantaged, marginalized or vulnerable groups are groups of people who, due to factors outside their control, do not have the same opportunities as the more fortunate groups in society and are at a higher risk of poverty and social exclusion. Depending on the context, these may include unemployed people, refugees, indigenous peoples or those from ethnic minorities, internally displaced people and migrants, the homeless, those struggling with substance abuse, people with mental illness and disabilities, isolated older people and children. Source: Health impact assessment (HIA): glossary of terms used. Geneva: WHO (http://www.who. int/hia/about/glos/en). 50 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Discrimination Discrimination in health is any negative judgement about a person or group made on the basis of race, colour, ethnicity, sex, language, religion, national or social origin, property, birth, physical or mental disability, health status (including HIV/AIDS), sexual orientation, civil, political, social or other status or opinion that has the intention or effect of impairing the equal enjoyment or exercise of the right to health. Discrimination can mean poorly targeted health programmes or restricted access to services. Discrimination means that those with equal need are not treated equally. Overcoming discrimination demands objective, reasonable criteria intended to rectify inequities in health. Source: Health and human rights. Geneva: WHO; 2015 (http://www.who.int/mediacentre/factsheets/ fs323/en). Governance Governance is the exercise of economic, political and administrative authority to manage a country’s affairs at all levels. It comprises the mechanisms, processes and institutions through which citizens and groups articulate their interests, exercise their legal rights, meet their obligations and mediate their differences. Good governance characteristics and principles include: consensus-orientation, participation, rule of law, effectiveness and efficiency, accountability, transparency, responsiveness, equity and inclusiveness. Source: What is good governance? Bangkok: UNESCAP; 2008 (http://www.unescap.org/sites/default/ files/good-governance.pdf). Health diplomacy Health diplomacy brings together the disciplines of public health, international affairs, management, law and economics, and focuses on negotiations that shape and manage the policy environment for health. The relationship between health, foreign policy and trade is at the cutting edge of global health diplomacy. Source: Global health diplomacy. Geneva: WHO (http://www.who.int/trade/diplomacy/en). Health equity Health equity is the absence of avoidable or remediable differences among groups of people to enjoy or exercise the right to health, whether those groups are defined socially, economically, demographically or geographically. Source: Health topics: Equity. Manila: WHO Regional Office for the Western Pacific (http://www. wpro.who.int/topics/equity_health/en). Health impact assessment Health impact assessment is a means of assessing the health impacts of policies, plans and projects in diverse economic sectors using quantitative, qualitative and participatory techniques. Health impact assessments help decision-makers make choices about alternatives and improvements to prevent disease/injury and to actively promote health. Source: Health impact assessment. Geneva: WHO (http://www.who.int/hia/en). 51 GLOSSARY Health sector A wide variety of actors and organizations that are held politically and administratively accountable for the health of the population at various levels. Source: Health in All Policies training manual. Geneva: WHO; 2015 (http://who.int/social_determi- nants/publications/health-policies-manual/en). Health services Health services are any services (not limited to medical or clinical services) that contribute to improved health or to the diagnosis, treatment and rehabilitation of sick people. Source: Health systems: health systems strengthening glossary. Geneva: WHO (http://www.who. int/healthsystems/hss_glossary/en). Health system Health systems encompass: (1) all the activities whose primary purpose is to promote, restore and/or maintain health; and (2) the people, institutions and resources and policies intended to improve the health of the population and protect people from the cost and burden of ill health through activities planned and provided to improve health. Source: Health systems: health systems strengthening glossary. Geneva: WHO (http://www.who. int/healthsystems/hss_glossary/en). Health workforce Health workers are all people engaged in actions whose primary intent is to enhance health. Source: The world health report: working together for health. Geneva: WHO; 2006 (http://www. who.int/whr/2006/en). Instruments of law Instruments of law may include national constitutions, legislation enacted by Parliament, ministerial by-laws or regulations, presidential decrees, agency guidelines, administrative rules and other forms of official order. Depending on the jurisdiction, laws may also include court rulings by judges, as well as interpretations and actions of regulatory bodies or other bureaucratic institutions. Intersectoral action Intersectoral action refers to the coordinated efforts of two or more sectors within government, including across different levels of government (national and subnational) to improve health outcomes. Whole-of-government, Health in All Policies (HiAP) and healthy public policies are similar terms used in the literature. Source: Health in All Policies training manual. Geneva: WHO; 2015 (http://who.int/social_determi- nants/publications/health-policies-manual/en). Legal framework A legal framework incorporates the various instruments of law being used and the institutions responsible for putting the instruments of law into effect. Legal frame- works incorporate the capacity, knowledge and processes needed for their effective design, implementation and enforcement, monitoring and evaluation. 52 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Multisectoral or whole-of-government approach A whole-of-government or multisectoral approach refers to the coordinated efforts of two or more sectors within government to improve health outcomes. This can include such partnerships as information-sharing arrangements or joint programmes. Such coordination and integration is often centred on overarching societal goals rather than the specific objectives of one sector. Source: Health in All Policies training manual. Geneva: WHO; 2015 (http://who.int/social_determinants/ publications/health-policies-manual/en). Multi-stakeholder or whole-of-society approach A whole-of-society or multi-stakeholder approach refers to coordinated efforts by multiple stakeholders within and outside of government (including the private sector, civil society or communities). However, WHO does not engage with persons that may be described as “stakeholders” with respect to the tobacco and arms industries and/or those who work to further the interests of the tobacco or arms industries, even if they are themselves non-profit-making. Source: Health in All Policies training manual. Geneva: WHO; 2015 (http://who.int/social_determinants/ publications/health-policies-manual/en). Nongovernmental organization Nongovernmental organizations are organizations not affiliated with government. The term is used to describe non-profit-making, nonviolent organizations that seek to influence the policy of governments and international organizations and/or to comple- ment government services (such as health and education). They usually have a formal structure, offer services to people other than their members, and are, in most cases, registered with national authorities. Nongovernmental organizations vary greatly in their size, scope of activity and goals. They may operate nationally or internationally, or they may be small community-based organizations that aim to mobilize, organize or empower their members and others, usually in a local area. WHO does not engage with nongovernmental organizations that work to further the interests of the tobacco or arms industries, even if they are themselves non-profit-making. Source: A glossary of terms for community health care and services for older persons. Geneva: WHO; 2014 (http://www.who.int/kobe_centre/ageing/ahp_vol5_glossary.pdf). Non-state actor Non-state actors are nongovernmental organizations, private sector entities, philanthropic foundations and academic institutions. WHO does not engage with the tobacco and arms industries or with non-state actors that work to further the interests of the tobacco or arms industries. Any reference to engagement with non-state actors 53 GLOSSARY Non-state actor (continued) within this document therefore does not advocate for engagement with the tobacco or arms industries. Source: Handbook for non-State actors on engagement with WHO. Geneva: WHO; 2018 (https://www. who.int/about/collaborations/non-state-actors/Handbook-for-non-State-actors-on-engagement- with-WHO.pdf). Participation All people and groups are entitled to active, free and meaningful participation in, contribution to, and enjoyment of civil, economic, social, cultural and political devel- opment in which human rights and fundamental freedoms can be realized. Human rights law recognizes the participation of the population in all health-related decision- making at the community, national and international levels. Participation is one of the human rights principles that should be considered when applying a human rights-based approach to health. Adequate and sustainable financial and technical support, including investment in empowerment of rights-holders, is essential to enable meaningful participation. Source: CESCR General Comment No. 14: The right to the highest attainable standard of health. Geneva: UNCESCR; 2000 (www.refworld.org/pdfid/4538838d0.pdf); UN Statement of Common Understanding on Human Rights-Based Approaches to Development Cooperation and Program- ming. New York, NY: UNDG; 2002 (http://hrbaportal.org/the-human-rights-based-approach-to- development-cooperation-towards-a-common-understanding-among-un-agencies). Social determinants of health Social determinants of health refer to the conditions in which people are born, grow, live, work and age, including the health system. These circumstances are shaped by the distribution of money, power and resources at global, national and local levels. Source: Commission on Social Determinants of Health. Closing the gap in a generation: health equity through action on the social determinants of health. Geneva, WHO; 2008 (http://www.who.int/ social_determinants/thecommission/finalreport/en). Stakeholders beyond government As used in this Regional Action Agenda, the term encompasses a broad scope of different actors, organizations and partners, such as non-state, nongovernmental and civil society actors, professional and faith-based organizations, some politicians and parliamentarians, academic and research organizations, foundations and businesses. A stakeholder is a person or group who has an interest or concern in a process or issue. WHO does not engage with the tobacco industry or non-state actors that work to further the interests of the tobacco industry. WHO also does not engage with the arms industry. Any reference to engagement with stakeholders within this document therefore does not advocate for engagement with the tobacco or arms industries. Source: Health in All Policies training manual. Geneva: WHO; 2015 (http://who.int/social_determi- nants/publications/health-policies-manual/en). 54 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Sustainable development Development that meets the needs and aspirations of the present without compro- mising the ability of future generations to meet their own needs. Source: Report of the World Commission on Environment and Development: our common future. Appendix to document A/42/427 on Development and International Co-operation: Environment. Geneva: WCED; 1987 (http://www.un-documents.net/wced-ocf.htm). Universal health coverage Universal health coverage means that all people and communities receive the health services they need. This includes health promotion, treatment, rehabilitation and palliation of sufficient quality to be effective while at the same time ensuring such care does not cause financial hardship. Source: Universal health coverage: moving towards better health. Action framework for the Western Pacific Region. Manila: WHO Regional Office for the Western Pacific; 2016 (http://iris.wpro.who.int/ handle/10665.1/13371). Whole-of-government approach See multi-stakeholder approach. Whole-of-society approach See multisectoral approach. 55 56 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS OBJECTIVE SDG Health system governance and leadership HEALTH SECTOR GOVERNANCE Common strategies Legal mechanisms, proces ses and institutions that determine the allocation of power and accountability for its exercise in the administration of health. Legislation that establishes clear mechanisms for coordinating the health activities of government. Framing public health laws in a manner consistent with human rights obligations. 3 Challenges and emerging issues Corruption in the health sector. Ensuring transparency during law reform processes. Coordination and cooperation across the health system. Promising practices Legislation that facilitates a Health in All Policies (HiAP) approach. Legislative and/or constitutional recognition of the right to health of individuals. Legislative recognition of the entitlement of everyone to a basic system of health protection. Anticorruption and bribery legislation and enforcement, including protection for whistle-blowers. HEALTH INFORMATION Common strategies Mandated civil registration system (e.g. registration of live births). Mandatory requirement to report key health information (e.g. notifiable diseases). Privacy and confidentiality regimes governing treatment of health data and information, and facilitating patient access and control of health records. Licensing of health-related research information actors. Legislation that addresses the sharing and processing of health-related data, including for research purposes. 3 Challenges and emerging issues Coordinating data-sharing and information dissemination. Integrating non-state health providers into the health information system. Legal frameworks defining ethical parameters for data collection, information dissemination and use. Compliance with privacy legislation. Laws that balance individual needs against the need to collect data for public health purposes. Promising practices Legislation that governs the control of health information (e.g. health records, data collection, retention and access). Mandatory collection and reporting of data for public health. Human rights–based protections of privacy. Regulatory system for research authorization and access to research information, including provisions for informed consent. Guidelines in health-care settings on treatment of patient information and codes of conduct for professionals. ANNEX 1. Summary of common strategies, challenges and issues, and practices in strengthening legal frameworks for health in the SDGs Legal and regulatory barriers and solutions are present across WHO programmatic areas. The table below is intended to be a summary and not a comprehensive review of some of the legal and regulatory strategies, challenges and emerging issues and promising legal and regulatory practices highlighted within programme and issue areas. The table illustrates the cross-cutting nature of law as a tool for addressing health-related challenges and as a determinant of health. 57 ANNEX 1 OBJECTIVE SDG Ensuring access to affordable, safe and quality health services ACCESS TO QUALITY MEDICINES Common strategies Legislation that establishes a regulatory authority to oversee the provision of safe, effective, quality medicines. Regulation of the marketing, production, storage, dispensation and distribution of pharmaceuticals and medical devices. Licensing scheme for the importers of pharmaceuticals and medical equipment. Legislation that governs the public procurement of essential medicines. 3 Challenges and emerging issues Addressing public spending on procurement and medicines lost due to corruption. Eliminating tariffs on imported drugs. Controlling mark-ups on drugs at wholesale and retail levels. Creating incentives for the supply of generic versions of drugs. Promising practices Regulatory harmonization to enable accelerated product approval and access. Flexibilities within licensing regimes to ensure prioritization of essential medicines and emergency medicines. Strategic use of flexibilities under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to ensure access to essential medicines that are under patent. Regional collaboration on medicines procurement (e.g. Pacific medicines pool). ACCESS TO QUALITY SERVICES Common strategies Health worker regulation schemes. Accreditation of health providers and training institutions. Complaints and investigation system to support registration and accreditation of health providers. Public health insurance systems that formally recognize the right of members to access a defined set of health benefits or services. Legal regulation of the financing of health services, which includes regulation of revenue collection, legal control of funding pools, and regulation of purchasing of health services. Establishment of a duty of care for the provision of quality services within a system of tort law or civil liability. 3 Challenges and emerging issues Ensuring that persons are not excluded from health coverage as a result of social, economic or health status. Ensuring coordination between branches of the health system and between private and public health providers. Weak enforcement of health provider regulatory regimes. Fragmentation of regulation of financing of health systems. Promising practices Legislation that governs the registration, licensing and regulation of health insurance schemes (public or private). Subsidies to ensure health insurance for vulnerable populations (e.g. extension of insurance to children under 12). Legislation that prohibitis discrimination in service delivery. Accreditation of health-care providers that is linked to monitored performance. Regional collaboration on the accreditation of health service providers and health workers (e.g. cross-accreditation of health workers in Fiji and Vanuatu). Instruments that empower patients’ rights (e.g. developing a patient’s charter). 58 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS OBJECTIVE SDG Ensuring access to affordable, safe and quality health services (continued) ADEQUATE AND SUSTAINABLE FINANCING Common strategies Funding universal health coverage (UHC) through taxation, compulsory insurance contributions, or a combination of these or other mechanisms. Regulation of revenue collection, i.e. health-related taxation on products such as alcohol. Legal control of funding pools that are used to pay for health services. Regulation of private health insurance. Regulation of the financial relationship between health service providers and the provision of health services and government agencies, health insurance schemes or other entities purchasing health services. Regulation of the purchasing of health services provided to the covered population. 3 Challenges and emerging issues Transitioning and evolving financing arrangements that do not always fully understand existing health-care organization. Inappropriate billing practices and corrupt practices that inflate the cost of health services. Promising practices Performance-based contracting of health service providers through a performance criterion set out in a contract or agreement with the funder, rather than being based on inputs, such as salaries and pharmaceuticals. Governance-related legislation that may include requirements relating to: the appointment, tenure and removal of senior executives; the establishment of principal committees, units and directorates; and provisions relating to meetings and conflicts of interest for health institutions. Governing legislation may also specify a level of direct government control over the organization (e.g. through ministerial directives), and include provisions relating to accounts, auditing requirements and annual reports. MENTAL HEALTH Common strategies Legislation that ensures appropriate access to care and treatment related to mental health. Reform of current legislation on mental health to ensure it is consistent with human rights standards. Legislation that prevents inappropriate institutionalization and provides appropriate services that are integrated with the community. 3 Challenges and emerging issues Ensuring consistency with the United Nations Principles for the Protection of Persons with Mental Illness and the Improvement of Mental Health Care 1991 through the development of evidence-based legislation. Historical or outdated legislation that takes away the rights of persons with mental health conditions and is inconsistent with a rights-based approach. Misuse of current mental health legislation (e.g. misuse of regimes of involuntary incarceration). Legislation that places an improper or unnecessary barrier or burden on persons with mental health conditions. Elimination of legislation that facilitates negative health outcomes (e.g. use of isolation rooms, including in prisons). Promising practices Legislation that controls dangerous substances (e.g. agricultural poisons used in suicide attempts). Legislation that prevents discrimination against persons with mental health conditions. Mental health legislation that protects a person’s autonomy and liberty (e.g. automatic periodic review for any detention associated with a mental health condition). Regulation of specialized mental health professionals. PREVENTING DISCRIMINATION AND STIGMA Common strategies Legislation that protects against discrimination in health systems. Defining entitlement to maternal and child health services. Legislation that affirmatively improves access to needed services for vulnerable, marginalized and impoverished persons. Human rights legislation that protects people from stigma and discrimination. Embedding principles of non-discrimination across policy areas and law reform. 3 5 10 59 ANNEX 1 OBJECTIVE SDG Ensuring access to affordable, safe and quality health services (continued) Preventing discrimination and stigma (continued) Challenges and emerging issues Enforcement of antidiscrimination provisions within existing legislation. Social context that contributes to discrimination and stigma and can result in the routine denial of equal access to opportunities and services within the health system or forming a barrier to access by resulting in self-exclusion. Ensuring public health legislation is not merely reactive and thereby resulting in inconsistent, redundant, ambiguous, confusing or discriminatory legislation. Removal or amendment of laws that contribute to systematic discrimination (e.g. laws that explicitly criminalize the transmission of HIV, key populations – e.g. commercial sex workers – or impose compulsory testing and disclosure). Restricted access to reproductive health services. 3 5 10 Promising practices Dismantling laws that are harmful and stigmatize vulnerable, marginalized and impoverished people. Notifiable diseases legislation that requires the protection of personal information, requires anonymous or de-identified-based reporting and/or clearly defines any exceptions. Strengthening legal regimes for the protection of privacy and confidentiality. Legislation that establishes a complaints-handling body that addresses issues of discrimination with the power to investigate and conciliate complaints or pursue other remedies. Incorporating principles of non-discrimination in legal regimes for financial protection and the delivery and health services (e.g. insurers cannot deem childbirth to be a pre-existing condition). Preventing and managing public health risk CLEAN WATER, SANITATION AND HYGIENE Common strategies Public health legislation that addresses water management, sanitation facilities and water contaminants. Legislation that sets out duties, powers and responsibilities to relevant ministries or local governments, including a duty to provide a sufficient supply of clean water. Legislation that empowers the inspection, control or regulation of activities likely to contaminate public water supplies (e.g. accreditation) of water sanitation facilities. Regulation and coordination of non-state actors delivering water, sanitation and hygiene (WASH) support Inclusion of a common duty not to pollute or contaminate sources of drinking-water. 3 6 Challenges and emerging issues Lack of integration with vertical programme management of actors delivering WASH support, including as a result of the privatization of water supplies without close monitoring and safeguarding of access, resulting in inequities. Disruption in the supply of clean water during emergencies. Ensuring that sanitation infrastructure meets the needs of women and girls, including their health, safety and privacy. Resource constraints that prevent the construction of infrastructure for the provision of safe water. Promising practices Legislation empowering the inspection, control and/or regulation of activities likely to contaminate public water supplies (e.g. mandatory public reporting of water quality). Legislation that obligates landowners and/or occupiers of premises to ensure adequate drainage of waste and flood water and encourage water self-sufficiency (e.g. mandatory rainwater collection and conservation). Agreements between relevant government entities and partners to coordinate the delivery of WASH services (e.g. memorandum of understanding between water, health, education and finance ministries in Ethiopia). Public health legislation that requires the installation of public toilets and washing facilities in public places and minimum standards for new buildings and facilities that include requirements for the provision of equitable sanitation facilities. 60 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS OBJECTIVE SDG Preventing and managing public health risk (continued) FOOD SAFETY AND SECURITY Common strategies Food safety regulations and standards in line with international recommendations such as Codex Alimentarius. Food safety guidelines and codes of practice that improve the nutritional requirements on foods sold, including mandating the fortification of foods with essential nutrients. Legislation restricting or banning the sale of foods containing harmful ingredients (e.g. trans fats) Regulation and codes of conduct for handling of food. Legislation that controls the food environment, such as zoning and licensing controls affecting retail food businesses. Legislation regulating the use of subsidies for the production and use of some food products (e.g. agricultural subsidies on sugar and high-fructose corn syrup). Legislation proscribing food and nutrition labelling requirements, including front-of-packaging requirements and warning labels. 2 3 Challenges and emerging issues Evolving food environment leading to new food safety and security challenges (e.g. climate change, antimicrobial resistance and new technologies). Internationalization of the food chain and therefore an enhanced need for an alignment of food safety systems. Standard use and harmonization of units and requirements on food labels. Differing approaches to the regulation of risk: precautionary principle and familiarity principle. International trade agreements setting new norms for standard-setting and regulatory coherence can cause tensions with existing legislative frameworks. Promising practices Legislation that makes clear the roles and obligations of bodies that are responsible for food and nutrition security, including between government ministries. Legislation restricting the advertising and promotion of foods that are high in saturated fat, salt or added sugar, particularly to children. Legislation that only permits manufacturers and advertisers to make health claims where they satisfy a minimum criteria for good nutrition. Legislation directed at preventing the use of misleading and deceptive health claims, particularly in breast-milk substitutes as set out in the International Code of Marketing of Breast-milk Substitutes. MANAGEMENT OF COMMUNICABLE DISEASES Common strategies Legislation that allocates appropriate powers to government and health-care providers to respond to infectious diseases and interagency coordination. Legislation that clearly sets out the institutional structures and processes through which government responds to communicable diseases. Establish principle of universal access to prevention, diagnostics and treatment for communicable diseases. Legislation that protects people living with infectious diseases to live free from discrimination. Regulation of blood products under a regulatory body with authority and responsibility to ensure safe blood supply and delivery. 3 Challenges and emerging issues Public health legislation that was developed in the late 19th and early 20th centuries and does not reflect current evidence-based best practice or fails to adequately allocate needed public health powers. Supportive legal framework for harm reduction for people who inject drugs. Heavy use of criminal law to prevent the transmission of infectious diseases that instead acts as a deterrent to engagement with public health. Ensuring that a person’s liberty is only restricted to the extent necessary to most effectively reduce risks to public health. 61 ANNEX 1 OBJECTIVE SDG Preventing and managing public health risk (continued) Management of communicable diseases (continued) Promising practices Public health legislation that may interfere with individual freedoms should be balanced by private rights, including the right to control one’s health, body, privacy and property, and include procedural safeguards. Earmarking of budget line or other sources of funds for immunization, surveillance and monitoring of infectious diseases. Legislation that clearly sets out the institutional structures and processes through which government responds to communicable diseases, including a legal framework for vaccine introduction, and supports access to treatment. Limitations on the use of coercive powers within public health legislation so that they are used only where necessary, effective and proportional to the risk, and in a transparent manner. 3 PUBLIC HEALTH EMERGENCIES Common strategies Public health legislation that not only authorizes public health officials to take action to investigate potential public health emergencies, but also limits that power so that actions are not arbitrary, discriminatory or disproportionate. Alignment of national legislation with internationally agreed standards and instruments, particularly the International Health Regulations (IHR) and Pandemic Influenza Preparedness (PIP) Framework. Legislation that establishes or empowers an authority with powers for prevention, planning, coordination, communication, financing and expenditure allocation to respond to an emergency, including the power to take control of premises and supplies, provided reasonable compensation is paid. 3 Challenges and emerging issues Coordination, coherence and collaboration between preparedness for zoonotic diseases, natural disasters, chemical disasters and other man-made emergencies within national legislative frameworks. Establishing clear triggers within legislation for when emergency powers are appropriate and to what level they can and should be scaled. Adequately addressing liability risks and protections for health-care practitioners during an emergency. Promising practices Legislation that clearly sets out the institutional structures and formal processes through which governments respond to disease outbreaks and emergencies, including regional and global collaboration and information sharing. Establishment of infection control protocols and guidelines. Legal framework that supports investment in preparedness, including earmarking of budget line for preparedness. Legislation that designates emergency powers for public health officials to prepare for and respond to an emergency (e.g. ability to enter into contracts to purchase essential medicines). Laws that set limits for the exercise of coercive powers over legal persons. Legislation that ensures the “full respect for the dignity, human rights and fundamental freedoms of persons” in the exercise of public health powers, including compliance with the Siracusa Principles. VECTOR ABATEMENT Common strategies Legislation that empowers health authorities to take actions to develop and implement national control strategies (e.g. establishment of multisectoral committees or task forces to oversee vector control). Public health legislation that permits local authorities to enter and inspect premises with suspected nuisances. Compulsory notification of suspected or confirmed cases of vector-borne diseases. Bans on over-the-counter antimalarial medicines to prevent inappropriate use and antimicrobial resistance. Regulation on the use, storage and labelling of insecticides and pesticides used in vector control to prevent misuse or leakages. 3 62 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS OBJECTIVE SDG Preventing and managing public health risk (continued) Vector abatement (continued) Challenges and emerging issues Capacities for vector surveillance and control may be limited in some country contexts. Strategies and requirements under legal frameworks that do not optimally leverage synergies and/or compete for resources on vector abatement in places with more than one major vector-borne disease. 3 Promising practices Environmental regulation that tackles public health concerns (e.g. building codes to reduce vector breeding sites). Obligation on public health officers to report periodically on vector-related health data. Regulation and coordination of private and non-state actors working on vector abatement. Regulations that create an offence for causing or permitting a nuisance, which would include creating environments that encourage pests, that applies to owners or occupiers of premises that permits authorities to issue an abatement notice or intervene. MONITORING AND SURVEILLANCE OF PUBLIC HEALTH THREATS Common strategies Mandatory monitoring and reporting health data and vital statistics (e.g. births, deaths and causes of death). Notifiable diseases legislation based on clinical observation and laboratory confirmation. Assign duties and powers to a body for collection of data (e.g. an office of national statistics and strategic planning). Accreditation of laboratories that have sufficient experience and reliability to conduct tests on samples to confirm the presence of notifiable diseases. 3 Challenges and emerging issues Ensuring notifiable diseases legislation supports identification reporting and treatment of suspected cases with respect, protection from discrimination and adequate disease management. Ensuring that reporting requirements are flexible enough so that they can be rapidly applied to emerging diseases and conditions, where appropriate, and that they extend to regulations over the private health sector. Ability of a relevant authority to amend the list of notifiable diseases to ensure that it is kept up to date. Improving surveillance in low-resource settings. Promising practices Confidentiality and privacy laws that protect personal information in the reporting of notifiable diseases (with reporting done on an anonymous or de-identified basis). Legislation that clearly designates who is responsible for mandatory reporting of health data and notifiable diseases. Interagency agreements on information sharing to improve quality of data and reduce duplication of effort Systems to ensure the quality of data (e.g. mandatory data audits). Reporting obligations that go beyond the health sector, particularly in low-resource settings where a patient may not come into contact with health systems but may present in other public places (e.g. schools). REDUCTION IN HARMFUL USE OF ALCOHOL Common strategies Offences and penalties for driving under the influence (DUI) and other drink–driving countermeasures (e.g. random breathalyser test). Legislation and regulation on the sale and consumption of alcohol, including restrictions on age of purchaser, time and locations for the sale of alcohol. Licensing of alcohol vendors and legal liability for sale of alcohol to underage or intoxicated person. Taxation of alcohol to ensure it does not become more affordable. Regulation of alcohol marketing, advertising, promotion and sponsorship, particularly to young people. Mandatory health warnings on alcohol products at point of sale and labelling controls to inform consumers on content (e.g. alcohol by volume). Removal of subsidies for alcohol manufacturers, distributors or agricultural products. 3 63 ANNEX 1 OBJECTIVE SDG Preventing and managing public health risk (continued) Reduction in harmful use of alcohol (continued) Challenges and emerging issues Illegal, semi- or quasi-legal production and sale of alcoholic beverages. Ensuring that local authorities are not reliant on a sale-of-alcohol licensing system as a source of funding as this can incentivize the distribution of licences. Under-regulated platforms for the sale of alcohol (e.g. online marketing). Cultural norms associated with alcohol use and breaking the law (e.g. “fake IDs”). A lack of evidence-based understanding of what is enticing to young people in marketing and therefore the development of legislation that is relevant and effective. Improving access to alcohol-disorder treatment programmes. Commercial interests influencing laws and policies affecting the regulation of alcohol. 3 Promising practices Entitlement to measure blood alcohol levels by law enforcement (e.g. random compulsory breath testing in New Zealand). Licensing of drivers linked with DUI offences and penalties. Legislation that regulates the consumption of alcohol in public spaces (e.g. prohibition of consumption of alcoholic beverages in public spaces in the Philippines or in the vicinity of schools). Planning and built environment regulations that limit the density of alcohol outlets within a geographic area. Importation standards and controls on illegal importation, illegally produced alcohol, and regulation of alcohol not made for consumption (e.g. industrial alcohol). In some circumstances, court-mandated compulsory and/or voluntary treatment for recidivist drink– drivers may be appropriate. Exclusion of the alcohol industry from discussions regarding alcohol control. TOBACCO CONTROL Common strategies Implement WHO FCTC. Implement WHO FCTC MPOWER principles: ◊ Protect people from tobacco smoke (e.g. smoke-free spaces legislation) ◊ Offer help to quit tobacco use ◊ Warn about the dangers of tobacco (e.g. packaging and labelling regulation) ◊ Enforce bans on advertising, promotion and sponsorship (e.g. specific offences and penalties for actors violating tobacco-related restrictions) ◊ Raise taxes on tobacco products 3 Challenges and emerging issues Legal capacity and support. Defending tobacco control policies and legislation from industry challenges and influence. Tobacco industry interference. Emergence of novel products. Creation of tobacco industry “front organizations” such as the Foundation for a Smoke-Free World, set up by Philip Morris International. Enforcement of tobacco regulation and control. Promising practices Budget line earmarking tobacco revenue for tobacco control measures. Increased and sustained tobacco taxation. Packaging and labelling regulation, including tobacco plain packaging. Adoption of the Protocol to Eliminate Illicit Trade in Tobacco Products, which provides a framework for national legislation to eliminate smuggled, counterfeit and illicit tobacco products. Strategic litigation against tobacco companies. 64 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS OBJECTIVE SDG Preventing health through action on social determinants of health REDUCTION IN OBESITY Common strategies Legislation that covers the main areas associated with food policy: food environment, food production and consumer behaviour. Regulation of food marketing, advertising, sponsorship and promotion, particularly of energy-dense but nutrient-poor foods. Regulation of nutritional information and labelling that may include warning systems (e.g. traffic light system used to signal foods high in salt, sugar and fats). Legislation that improves food environments, particularly for children (e.g. restrictions on advertising within the vicinity of schools). 3 Challenges and emerging issues Rapidly changing food environments due to changing trade and investment landscapes and new technologies that can make the development of evidence-based legislation challenging. Food industry’s role in undermining and weakening public health policy and regulation. Coordination between authorities to improve food and physical environments. Promising practices Abolishing subsidies on sugar and sweeteners. Taxation on the sale of sugar-sweetened beverages and foods that are high in salt, saturated fat and/or sugar. Zoning and planning controls to encourage healthy environments, including the delegation of appropriate authority to local districts to improve food environments. Bans (e.g. on trans fats) or mandatory food standards on harmful substances (e.g. thresholds for sugars, fats and sodium in processed food). Mandatory standards on nutritional quality and food fortification. Social protection schemes that support access to good-quality nutritional quality foods (e.g. food stamp programmes). Consumer protection legislation. Parental leave protections to facilitate breastfeeding. REDUCTION OF ROAD TRAFFIC INJURIES Common strategies Legislation and regulation of road use (e.g. speed limits). Licensing and registration system for users of road vehicles, including minimum age for obtaining a licence. Prohibitions on dangerous driving behaviours (e.g. driving under the influence of alcohol or drugs, texting while driving) and associated offences and penalties for violating such rules. Worker safety legislation (e.g. limits on the number of hours that commercial drivers can work). Product regulation for vehicles to ensure they are road worthy and safe. Regulation requiring mandatory use of safety equipment (e.g. use of seat belts by passengers). Regulation of the built environment (e.g. barriers between pavements and roads). Mandating the use of seat belts and child restraints in cars, helmets by motorcyclists and cyclists. 3 Challenges and emerging issues Road infrastructure, including design, that does not serve the needs of the community, resulting in unsafe road environments. Ensuring that legal rules are translated into social norms associated with regular driving behaviour. Where enforcement of legislation relies on a system of tort law or civil wrongs, ensuring there is adequate access to civil courts to make enforcement meaningful. Support and training for the development of policy to monitor and consistently enforce road safety rules. Balancing personal liberties against the public good (e.g. mandatory breath-testing). 65 ANNEX 1 OBJECTIVE SDG Preventing health through action on social determinants of health (continued) Reduction of road traffic injuries (continued) Promising practices Implementation of drink–driving countermeasures, e.g. routine drink–driver testing in New Zealand. Guaranteed access to emergency care post accident. Prohibitions and associated offences for DUI and other traffic violations. Graduated licensing schemes for drivers. Voluntary harmonization of highway code and signs at the international level. Regulation of infrastructure (i.e. road system design and construction) that conforms with best safety practices and vehicle standards, which may include mandatory road safety audits for planning and design of new infrastructure. Mandatory insurance requirement or pooled risk scheme. Appropriate regulation to address post-crash care (e.g. protection of individuals who assist the injured). 3 66 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS ANNEX 2. Examples of laws relevant to health that may lie outside the health portfolio AREA OF REGULATION Occupational health and safety These laws usually oblige employers to create a safe working environment for employees. There may be an insurance scheme that compensates workers injured at work. Poor working conditions may give rise to hazards. A lack of breaks or excessively long shifts may lead to negative health consequences and greater risk of injury. Agriculture, livestock production and slaughtering and fisheries Agriculture laws govern legal issues affecting farming and the production of primary products, for example, timber and fish. Laws on livestock production cover the conditions under which food-producing animals are raised, while slaughtering laws regulate the conditions under which food-producing animals are slaughtered. Recent outbreaks of zoonotic diseases show the importance of managing human contact with livestock animals. Consumer protection and product safety Laws that regulate consumer protection and product safety have obvious health implications. Most importantly, they provide regulators and consumers with a right of recourse against manufacturers that make false claims about the efficacy and safety of their products. Rapidly emerging microtechnologies are examples of areas with potential health consequences that are still unknown. Consumer protection agencies are attempting to predict and address these potential risks to public health. Injury and accident, motor vehicle and traffic laws Laws in this area have had a demonstrable impact on public health and safety. For example, mandatory seat belt laws as well as the imposition of speed limits and blood alcohol limits on drivers have led to lower numbers of death and catastrophic injury resulting from motor vehicle use. Construction laws, particularly about space requirements, waste management and other matters affecting health Construction laws that regulate the use of space in domestic dwellings, distance between dwellings and waste management arrangements, for example, have important health implications. Sometimes such laws are jointly administered by the ministry responsible for the construction industry and the ministry of health. Planning laws Planning laws can have an impact on decisions about funding programmes, planning of buildings and community settings with significant impacts on health. Migration laws and laws about refugees The treatment of refugees has health consequences for refugee populations and for those who work with them, and ultimately for the communities in which they are housed. 67 ANNEX 2 AREA OF REGULATION Antidiscrimination laws Laws that protect persons from discrimination, including prohibition of discrimination on any ground (including based on race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth, disability, health status [including HIV/AIDS], sexual orientation, and civil, political, social or other status), can improve health outcomes for populations. Coronial services Many countries have granted powers to coroners to make recommendations to protect public health arising from coronial investigations. Laws establishing subnational levels of government These laws often specify areas of function and law-making. When subnational governments are given authority and responsibility over health functions, it becomes important to understand the configuration of the health system and where to place resources and efforts aimed at the use of law for health system strengthening. Certain criminal laws relevant to health Some countries choose to criminalize activities that lead to adverse health consequences for affected populations. Taxation laws Taxation laws have enormous potential to affect health outcomes. This is particularly true in the case of NCDs. Tax laws can encourage or discourage exercise or the consumption of unhealthy products, and they can affect activities such as the purchase and use of cars and the availability of sports grounds in community settings. Tax laws can also provide a significant income stream to fund health promotion activities and sponsorships. Laws creating system accountability Laws establishing and empowering tribunals, courts, offices such as ombudspersons, health commissioners, human rights commissioners and other independent agencies can often have ramifications for health. International trade and investment laws Laws in this area govern a country’s approach to its management of bilateral and multilateral trade and investment relationships. The trade regime, as confirmed by the Doha Declaration, affirms states’ abilities to tackle both present and emerging global health challenges and confirms that the Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS) should be interpreted and implemented consistently with public health objectives. Public international law Public international law governs the conduct of nation states and international organizations, including key international health organizations such as the World Health Organization, as well as international organizations with natural and juridical persons. Public international law, therefore, governs formal sources of international health law, including international instruments such as the WHO Constitution, and international health instruments such as the International Health Regulations (2005). 68 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS ANNEX 3. Legal systems of WHO Member States and areas in the Western Pacific Region Distribution of legal systems in the Western Pacific Region Common law: Political entities whose law, for the most part, is technically based on English common law concepts and methods that assign a preeminent position to case law. Civil law: Political entities that for the most part give precedence to written law and opt for a systematic codification of their general law. Customary law: Customary law systems vary and are usually rooted in wisdom born of concrete daily experience or more intellectually based on great spiritual or philosophical traditions. Islamic law: An autonomous legal system that is of a religious nature and predominantly based on the Koran. Mixed: Common/Customary Mixed: Common/Islamic Mixed: Civil/Customary Mixed: Civil/Common/Islamic Mixed: Civil/Common/Customary Mixed: Civil/Common Common Civil 0 2 4 6 8 10 12 14 16 18 Source: JuriGlobe – world legal systems [website]. Ottawa: University of Ottawa (www.juriglobe.ca). AREA (WHO Member State with responsibility) LEGAL SYSTEM Hong Kong SAR (China) Mixed: Common/Customary law Macao SAR (China) Civil law French Polynesia, New Caledonia, Wallis & Futuna (France) Civil law Pitcairn Islands (United Kingdom of Great Britain and Northern Ireland) Common law American Samoa, Guam, Commonwealth of the Northern Mariana Islands (United States of America) Common law 69 ANNEX 3 MEMBER STATE LEGAL SYSTEM Australia Common law Brunei Darussalam Mixed: Islamic/Common/Customary laws Cambodia Civil law China Mixed: Civil/Customary laws Cook Islands Common law Fiji Common law Japan Mixed: Civil/Customary laws Kiribati Common law Lao People’s Democratic Republic Civil law Malaysia Mixed: Islamic/Common/Customary laws Marshall Islands Common law Micronesia (Federated States of) Mixed: Common/Customary laws Mongolia Mixed: Customary/Civil laws Nauru Common law New Zealand Common law Niue Common law Palau Common law Papua New Guinea Mixed: Customary/Common laws Philippines Mixed: Common/Civil laws Republic of Korea Mixed: Customary/Civil laws Samoa Mixed: Customary/Common laws Singapore Mixed: Common/ Islamic laws Solomon Islands Mixed: Customary/Common laws Tokelau Common law Tonga Common law Tuvalu Common law Vanuatu Mixed: Civil/Customary/Common laws Viet Nam Civil law 70 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS ANNEX 4. Detailed situational analysis and mapping by action areas Health system governance and leadership Legal frameworks play an important role in defining a health mandate and establishing the health system in all countries (see also Annex 1). Overarching health system legislation is receiving increasing attention in transitional economies in the Western Pacific Region as part of broad economic and legal reforms, with a number of countries pursuing overarching law reforms with a view to clearly articulate roles and responsibilities in the health system (see Table A4.4). In Fiji, Papua New Guinea and the Republic of Korea, the powers of the minister are narrowed because of the existence of health boards and other mechanisms. Health boards can be a way of taking an intersectoral approach and engaging sectors beyond health in health matters. However, the extent to which these boards can be leveraged to improve health governance depends on whether such boards are supported and engage senior officers and other key participants. The Republic of Korea’s Health and Medical Services Policy Deliberation Committee has achieved a high level of engagement because its chairperson is the Prime Minister and its vice-chairperson is the Minister for Health Welfare and Family Affairs. In the Lao People’s Democratic Republic, the Ministry of Health is granted broad powers that include research, planning, regulating administration and issuance of authorization to practise. Most countries in the Western Pacific Region have a mandate for disease control, which often extends to health protection and promotion; a broader system-wide mandate is less common. Protection of rights As States Parties to the Constitution of the World Health Organization, WHO Member States are committed to respecting, protecting and fulfilling the right to health: The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition. – Preamble to the Constitution of the World Health Organization Further, all WHO Member States have committed to at least one international convention that enshrines the right to health; the majority have committed to several (see Annex 3). In the Western Pacific Region, recent years have seen major strides in countries’ efforts to advance rights. Table A4.1 gives an overview of the ratification by country of four major human rights treaties, all of which recognize the right to health. These treaties encompass economic, social and cultural rights (1966), the elimination of discrimination against women (1979), the rights of the child (1989) and the rights of persons with disabilities (2006). Explicit recognition of health rights in national constitutions or related laws provides a strong basis for protecting, promoting and fulfilling the right to the highest attainable standard of health for all. Some countries have included health as a constitutional right and others as a directive principle. 71 ANNEX 4 Country or area International Covenant on Economic, Social and Cultural Rights (ICESCR), 1966 Convention on the Elimination of All Forms of Discrimination against Women (CEDAW), 1979 Convention on the Rights of the Child (CRC), 1989 Convention on the Rights of Persons with Disabilities (CRPD), 2006 Australia ü ü ü ü Brunei Darussalam ü ü ü Cambodia ü ü ü ü China ü ü ü ü Cook Islands ü ü ü ü Fiji ü ü ü Japan ü ü ü ü Kiribati ü ü ü Lao PDR ü ü ü ü Malaysia ü ü ü Marshall Islands ü ü ü ü Micronesia ü ü ü Mongolia ü ü ü ü Nauru ü ü ü New Zealand ü ü ü ü Niue ü ü ü ü Palau ü* ü* ü ü Papua New Guinea ü ü ü ü Philippines ü ü ü ü Republic of Korea ü ü ü ü Samoa ü ü ü Singapore ü* ü* ü Solomon Islands ü ü ü ü* Tokelau* ü ü Tonga ü ü* Tuvalu ü ü ü Vanuatu ü ü ü Viet Nam ü ü ü ü * Signature only. Lao PDR: Lao People’s Democratic Republic; Micronesia: Federated States of Micronesia TABLE A4.1 WHO Member State ratification or accession of selected international treaties 72 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS There are some interesting examples of specific references to health in national constitutions and laws in the Western Pacific Region: • The Constitution of the Lao People’s Democratic Republic provides that the “State and society attend to building and improving disease prevention systems and providing health care to all people, creating conditions to ensure that all people have access to health care, especially women and children, poor people and people in remote areas, to ensure people’s good health”. It also provides that the “State promotes private sector investment in public health services in accordance with the laws and regulations”. • The Constitution of the Marshall Islands “recognizes the right of the people to health care … and the obligation to take every step reasonable and necessary to provide these services”. The protection of rights within public health legislation is an area in which opportunities for reform have generally not been taken up. For many countries, there is no provision for the application of the Siracusa Principles or few obligations restricting the use of broad coercive powers to manage communicable disease. This is another area in which to expand the protection of rights to advance the right to health (see Table A4.5). Access to affordable, safe and quality health services and products This includes assignment of particular responsibilities, standard-setting, licensing and registration, the location of health services, consistency with planning requirements, conditions on partnerships, contracting arrangements and private sector conditions. The movement of people and products, particularly medicines, across national borders, adds another layer of complexity to regulation. Generally speaking, advanced economies have more mature regulatory systems overseeing the provision of health services. The good performance of regulatory systems relies on the presence of adequately trained and experienced regulators, supporting legal and regulatory infrastructure, and specialized technicians to perform regulatory functions. Table A4.3 gives an overview of the number of regulated health professionals within the Western Pacific Region. As with the regulation of medicines, for many countries, particularly smaller countries, national regulators may not be best placed to perform all the regulatory functions across the product life cycle; other options should be considered that pool resources and expertise such as through regional or multilateral regulatory processes. Table A4.2 gives a sample overview of some of the legal provisions associated with market exit activities associated with medical products. 73 ANNEX 4 Country or area Legal provisions for recalls and withdrawals List of recalled and withdrawn products publicly available Australia ü ü Brunei Darussalam ü Cambodia ü China ü ü – Hong Kong SAR (China) ü ü – Macao SAR (China) Cook Islands Fiji ü Japan ü ü Kiribati Lao PDR ü ü Malaysia ü ü Marshall Islands Micronesia Mongolia ü Nauru New Zealand ü ü Niue Palau Papua New Guinea ü Philippines ü ü Republic of Korea ü ü Samoa Singapore ü ü Solomon Islands Tonga Tuvalu Vanuatu Viet Nam ü ü Lao PDR: Lao People’s Democratic Republic; Micronesia: Federated States of Micronesia TABLE A4.2 Legal provisions and market exit activities within WHO Member States or areas of the Western Pacific Region 74 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Country or area Number of regulated health professions Country or area Number of regulated health professions American Samoa1 12 Mongolia1 5 Australia1 142 Nauru 3 Brunei Darussalam 22 New Zealand1 162 Cambodia 5 Northern Mariana Islands1 23 China1 7 Palau1 13 – Hong Kong SAR1 (China) 13 Papua New Guinea 19 Cook Islands1 20 Philippines1 12 Fiji1 8 Republic of Korea1 24 Guam1 9 Samoa1 27 Japan1 16 Singapore1 11 Kiribati 15 Solomon Islands 4 Lao PDR 4 Tonga 6 Malaysia1 23 Tuvalu 5 Marshall Islands1 13 Vanuatu 9 Micronesia 4 Viet Nam1 5 Lao PDR: Lao People’s Democratic Republic; Micronesia: Federated States of Micronesia; Northern Mariana Islands: Commonwealth of the Northern Mariana Islands * Based on a review of the WHO Member State legislation. 1: Indicates WHO Member States that have regulation on traditional and complementary medicine practitioners. 2: Includes 22 occupation groups. TABLE A4.3 Number of regulated health professions within WHO Member States or areas of the Western Pacific Region* 75 ANNEX 4 Management of public health risk Generally, legal frameworks are in place for the management of communicable diseases, and they rely on the local system to report the presence of notifiable diseases (see also Annex 1). Nearly every country in the Western Pacific Region has a system for identifying and notifying diagnosis of specified communicable diseases to a health authority with accompanying powers to address a possible outbreak. The systems, the notifiable diseases and the authorities to whom they are reported, and the available powers differ, but use of this approach is almost universal. A surprising number of these frameworks require not just doctors and nurses to notify, but also other public institutions, such as schools and even employers in some cases. Kiribati, Malaysia, Nauru, Niue, Papua New Guinea, the Republic of Korea, Singapore, Solomon Islands, Tokelau, Tuvalu and Vanuatu all have duties on lay people to report when a person contracts or may have contracted a notifiable disease set out in law (see Table A4.7). Public health theory and evidence has advanced since many legislative instruments governing public health were put in place. Across the Western Pacific Region, command-and-control mechanisms are heavily used without provisions limiting the breadth of such powers and protecting the rights of individuals. In many cases, lists of notifiable diseases are outdated and systems are not in place to effectively operationalize them. Many countries also use nuisance as the legislative mechanism to manage low-level public health risk. However, there has been some innovation among regional statutory responses to public health risk. Japan requires a review of definitions and categories of diseases every five years. Tonga enables the issuance of a public health order that requires a person to do something that is reasonably necessary to remove, reduce or contain a public health risk or the adverse effects of a public health risk. Few countries have taken the opportunity to align powers to manage communicable disease to powers to manage other health risks, particularly in a multi-hazard incident. The lack of alignment of powers may lead to confusion and uncoordinated responses to public health risks when they arise. In this important area, some countries have innovated and their ideas may serve as models for the consideration of others. The Republic of Korea’s Infectious Disease Control Committee is empowered to formulate a master plan and crisis control measures, including a response system and roles of each agency at emergency scenes, a determination and decision-making system of emergencies, and schemes for stockpiling and supplying medical supplies. In respect of managing public health risks associated with NCDs, in 2013, Pacific health ministers adopted the Tobacco-Free Pacific Goal by 2025, which aims to see an adult tobacco use prevalence of less than 5% in each country in the Pacific. Australia was the world’s first country to implement plain packaging of tobacco products and successfully defended challenges to the measure from the tobacco industry at national and international levels. Tobacco industry interference has been cited by WHO Member States as one of the biggest impediments to effective tobacco control, and countries also report on resistance from other industries against product regulation. Policy-makers must, however, take strong, proactive steps to protect the development, implementation and evaluation of legal frameworks from undue influence based on vested corporate interests. Other NCD risk management control initiatives include Samoa’s establishment of the Samoan Parliamentary Advocacy Group on Healthy Living (SPAGHL), a platform for stakeholders to engage with parliamentarians in strengthening their role in NCD prevention and control. 76 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Australia started one of the first health promotion foundations, followed by Mongolia, Tonga and Malaysia, which has since pioneered effective cross-sectoral governance arrangements and funds various community initiatives on health promotion. Lao People’s Democratic Republic, Samoa, Solomon Islands, Vanuatu and Viet Nam are all working towards autonomous infrastructure and financing for the promotion of health and prevention of disease. The Republic of Korea has successfully banned the marketing of specific types of food to children and is a leader in cancer surveillance, screening and referral systems. Action on social determinants of health In 2013, the Association for Southeast Asian Nations (ASEAN) leadership called on all sectors to accelerate the adoption of Health in All Policies (HiAP) in tackling unhealthy lifestyles, including risk behaviours for NCDs. This has often meant the adoption of planning requirements for health, but some countries also used mechanisms such as a declaration on NCDs with a power to formulate and implement orders and guidelines. Laws can also create mandates for the active and meaningful participation of affected communities and other stakeholders, for example, by enshrining their participation in law. For example, some countries have laws that set out who is to be consulted and how this should be done. In the Republic of Korea, state and local governments must collect the opinions of nationals, including interested persons, in formulating and implementing policies on health and medical services that exert significant influence on the life of nationals, including the rights and duties of nationals. The Papua New Guinea Organic Law on Provincial Governments and Local-level Governments requires consultation with provincial governments in formulation of new national laws affecting provinces, such as the exploitation of natural resources. 77 ANNEX 4 TABLE A4.4 Administration and allocation of health mandate of WHO Member States of the Western Pacific Region Co un try o r a re a Do es th e M in ist er ha ve al lo ca te d po we rs an d re sp on sib ili tie s re le va nt to a he al th m an da te o r ov er ar ch in g he al th sy st em re sp on sib ili ty ? Do es th e de pa rtm en t he ad h av e al lo ca te d po we rs an d re sp on sib ili tie s re le va nt to a he al th m an da te o r ov er ar ch in g he al th sy st em re sp on sib ili ty ? Do es th e go ve rn m en t or d ep ar tm en t h av e al lo ca te d po we rs an d re sp on sib ili tie s re le va nt to a he al th m an da te o r ov er ar ch in g he al th sy st em re sp on sib ili ty un de r i ts p ub lic he al th la w? Is th er e a h ea lth bo ar d, or e qu iv al en t ? (Y es , N o, Pa rti al ly) Do es th e he al th bo ar d, or e qu iv al en t ha ve ad vis or y a nd / or p ol icy -m ak in g po we rs? Do es th e M in ist er , de pa rtm en ta l h ea d or h ea lth b oa rd (o r eq ui va le nt ) h av e an y i nt er se ct or al po we rs a nd /o r re sp on sib ili tie s? (Y es , S om e, No , Un kn ow n) Au st ra lia No No No No N/ A Ye s Br un ei D ar us sa la m Pa rti al ly Pa rti al ly Pa rti al ly No N/ A No Ca m bo di a No No Ye s No N/ A No Ch in a No No Ye s No N/ A Ye s Co ok Is la nd s No No No No N/ A No Fij i Ye s Ye s No Ye s Po lic y- m ak in g No Ja pa n Ye s Un kn ow n Ye s Ye s Ad vis or y So m e Ki rib at i No No No No N/ A No La o PD R Ye s No Ye s No N/ A Un kn ow n M al ay sia No No No No N/ A No M ar sh al l I sla nd s No Ye s No No N/ A No M icr on es ia No Ye s Ye s No N/ A Un kn ow n M on go lia N/ A1 N/ A1 N/ A1 N/ A1 N/ A1 Un kn ow n Na ur u No No No No N/ A No Ne w Ze al an d Ye s No No Ye s Ye s No Ni ue No Ye s No No N/ A Ye s 78 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Co un try o r a re a Do es th e M in ist er ha ve al lo ca te d po we rs an d re sp on sib ili tie s re le va nt to a he al th m an da te o r ov er ar ch in g he al th sy st em re sp on sib ili ty ? Do es th e de pa rtm en t he ad h av e al lo ca te d po we rs an d re sp on sib ili tie s re le va nt to a he al th m an da te o r ov er ar ch in g he al th sy st em re sp on sib ili ty ? Do es th e go ve rn m en t or d ep ar tm en t h av e al lo ca te d po we rs an d re sp on sib ili tie s re le va nt to a he al th m an da te o r ov er ar ch in g he al th sy st em re sp on sib ili ty un de r i ts p ub lic he al th la w? Is th er e a h ea lth bo ar d, or e qu iv al en t ? (Y es , N o, Pa rti al ly) Do es th e he al th bo ar d, or e qu iv al en t ha ve ad vis or y a nd / or p ol icy -m ak in g po we rs? Do es th e M in ist er , de pa rtm en ta l h ea d or h ea lth b oa rd (o r eq ui va le nt ) h av e an y i nt er se ct or al po we rs a nd /o r re sp on sib ili tie s? (Y es , S om e, No , Un kn ow n) Pa la u No Ye s Ye s No N/ A No Pa pu a N ew G ui ne a Ye s Ye s Ye s Ye s No Ye s Ph ili pp in es Ye s No No No N/ A No Re pu bl ic of K or ea No No Ye s Ye s No Ye s Sa m oa Ye s Ye s Ye s No N/ A Ye s Si ng ap or e Pa rti al ly Pa rti al ly Pa rti al ly Ye s Ye s No So lo m on Is la nd s Pa rti al ly No No Pa rti al ly2 Ad vis or y No To ke la u No No No No N/ A No To ng a No Ye s No Tu va lu No No No No N/ A No Va nu at u Ye s No Ye s No N/ A No Vi et N am No No Ye s Ye s N/ A Ye s La o PD R: L ao P eo pl e’s D em oc ra tic R ep ub lic ; M icr on es ia: F ed er at ed S ta te s o f M icr on es ia N/ A re fe rs to “n ot a pp lic ab le ”. 1: U nk no wn (r eg ul at io ns n ot d isc ov er ab le o r n ot a va ila bl e in E ng lis h wi th in th e pa ra m et er s o f t he se ar ch co nd uc te d) . 2: P ow er e xi st s t o cr ea te a h ea lth b oa rd a nd co m m itt ee s. TABLE A4.4 Administration and allocation of health mandate of WHO Member States of the Western Pacific Region (continued) 79 ANNEX 4 TABLE A4.5 Protection of rights within the health legislation of WHO Member States of the Western Pacific Region Co un try o r a re a Pr ot ec tio n of ri gh ts 1 Ar e S ira cu sa p rin cip le s ap pl ie d di re ct ly in to le gi sla tio n? (a) Pr op or tio na l r es po ns e (b ) Le as t r es tri ct ive op tio n (c) Ti m e- lim ite d or de rs (d ) Ri gh ts o f a pp ea l Au st ra lia No N/ A N/ A N/ A N/ A Ye s Br un ei D ar us sa la m No No No No No No 2 Ca m bo di a Ye s No No No No No 2 Ch in a Ye s No No No No No 2 Co ok Is la nd s No No No No No Ye s Fij i Ye s No No No No So m e Ja pa n Pa rti al ly3 So m e No No Ye s Ye s Ki rib at i Pa rti al ly3 No No No No No 2 La o PD R Ye s No No No No No 2 M al ay sia Pa rti al ly3 No No No No No 2 M ar sh al l I sla nd s Ye s No No No No No 2 M icr on es ia Ye s So m e No Ye s Ye s Ye s M on go lia N/ A4 N/ A4 N/ A4 N/ A4 N/ A4 N/ A4 Na ur u Pa rti al ly3 No No No No No 2 Ne w Ze al an d Ye s Ye s Ye s Ye s Ye s Ye s Ni ue Ye s No No No No No 2 Pa la u Ye s No No No No No 3 Pa pu a N ew G ui ne a Ye s No No No No No 2 Ph ili pp in es Ye s No No No No No 2 80 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Co un try o r a re a Pr ot ec tio n of ri gh ts 1 Ar e Si ra cu sa pr in cip le s a pp lie d di re ct ly in to le gi sla tio n? (a) Pr op or tio na l re sp on se (b ) Le as t r es tri ct ive op tio n (c) Ti m e- lim ite d or de rs (d ) Ri gh ts o f a pp ea l Re pu bl ic of K or ea Ye s No No No No Ye s Sa m oa Pa rti al ly3 No No No No No 2 Si ng ap or e Ye s No No No No No 2 So lo m on Is la nd s Pa rti al ly3 No No No No No 2 To ke la u Ye s No No No No No 2 To ng a No So m e Ye s No Ye s No 2 Tu va lu Pa rti al ly3 No No No No No 2 Va nu at u Pa rti al ly3 No No No No No 2 Vi et N am Ye s No No No No No 2 La o PD R: L ao P eo pl e’s D em oc ra tic R ep ub lic ; M icr on es ia: F ed er at ed S ta te s o f M icr on es ia 1: A re h um an ri gh ts o r a sp ec ifi c r ig ht to h ea lth o r h ea lth ca re p ro te ct ed (C on st itu tio n or P ub lic H ea lth A ct )? 2: N o ex pl ici t r ig ht o f a pp ea l o r s pe cia liz ed sy st em o f a pp ea ls bu t a ss um e a fo rm o f j ud ici al re vi ew is a va ila bl e as p ar t o f t he w id er le ga l s ys te m . 3: R ef er en ce to h um an ri gh ts m or e br oa dl y o r r el at ed h um an ri gh ts ; f or e xa m pl e, rig ht to li fe . 4: Un kn ow n (re gu la tio ns n ot d isc ov er ab le o r n ot av ail ab le in E ng lis h wi th in th e pa ra m et er s o f t he se ar ch co nd uc te d) . TABLE A4.5 Protection of rights within the health legislation of WHO Member States of the Western Pacific Region (continued) 81 ANNEX 4 Country or area Are there provisions for data collection? Are there provisions to protect confidentiality of data? Are there specific provisions for data warehousing? Are there provisions for regional information sharing? Australia Yes Yes No Yes Brunei Darussalam Yes Yes No No Cambodia N/A2 N/A2 N/A2 N/A2 China Yes Yes No No Cook Islands Yes Yes No No Fiji Yes1 Yes1 No No Japan Yes Yes No No Kiribati Yes Yes No No Lao PDR Yes Yes No No3 Malaysia Yes Yes N/A2 N/A2 Marshall Islands No No No No Micronesia Yes Yes N/A2 N/A2 Mongolia N/A2 N/A2 N/A2 N/A2 Nauru Yes Yes No No New Zealand Yes Yes No No Niue Yes4 Yes4 No No Palau No No No No Papua New Guinea Yes Yes No No Philippines Yes Yes No No Republic of Korea Yes Yes Yes No Samoa Yes4 Yes4 No No Singapore Yes Yes Partial Yes Solomon Islands Yes Yes No No Tokelau No No No No Tonga Yes Yes No No Tuvalu Yes4 Yes4 No No Vanuatu Yes4 Yes4 No No Viet Nam Yes Yes Yes No Lao PDR: Lao People’s Democratic Republic; Micronesia: Federated States of Micronesia 1: Some confidentiality provisions; for example, doctor–patient confidentiality obligation. 2: Unknown (regulations not discoverable or not available in English). 3: May be permitted. 4: Obligation to report rather than a duty to collect. TABLE A4.6 Data and information health surveillance within WHO Member States of the Western Pacific Region 82 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS TABLE A4.7 Management of communicable diseases in WHO Member States of the Western Pacific Region Co un try o r a re a Is th er e a no tifi ab le di se as es li st ? Ca n th e no tifi ab le d ise as es lis t b e qu ick ly am en de d in th e fa ce o f a n em er ge nc y in vo lv in g a n ew co m m un ica bl e di se as e th re at ? Do es th e no tifi ab le di se as es li st in clu de se ve re ac ut e re sp ira to ry sy nd ro m e (S AR S) a nd /o r in flu en za v iru s ( H1 N1 )? Ar e th er e po we rs to re sp on d to an o ut br ea k o f co m m un ica bl e di se as e? Do es th e he al th ac t re co gn ize th e ne ed fo r po we rs to al ig n wi th na tio na l e m er ge nc y po we rs? Au st ra lia N/ A1 N/ A1 N/ A1 Ye s Ye s Br un ei D ar us sa la m Ye s Ye s Bo th Ye s Un kn ow n Ca m bo di a N/ A2 N/ A2 N/ A2 N/ A2 N/ A2 Ch in a Ye s No Bo th Ye s Ye s Co ok Is la nd s Ye s No In flu en za Ye s No Fij i Ye s Ye s3 In flu en za Ye s No Ja pa n Ye s Ye s3 Bo th Ye s Ye s Ki rib at i Ye s Ye s No Ye s No La o PD R No No No Ye s No M al ay sia Ye s No Bo th Ye s No M ar sh al l I sla nd s No N/ A N/ A Ye s Un kn ow n M icr on es ia N/ A2 N/ A2 N/ A2 Ye s Ye s M on go lia N/ A2 N/ A2 N/ A2 N/ A2 N/ A2 Na ur u Ye s No Bo th Ye s4 No Ne w Ze al an d Ye s No Bo th Ye s No Ni ue Ye s Ye s3 No Ye s No Pa la u No No No No No Pa pu a N ew G ui ne a Ye s No No Ye s No 83 ANNEX 4 TABLE A4.7 Management of communicable diseases in WHO Member States of the Western Pacific Region (continued) Co un try o r a re a Is th er e a no tifi ab le di se as es li st ? Ca n th e no tifi ab le d ise as es lis t b e qu ick ly am en de d in th e fa ce o f a n em er ge nc y in vo lv in g a n ew co m m un ica bl e di se as e th re at ? Do es th e no tifi ab le di se as es li st in clu de se ve re ac ut e re sp ira to ry sy nd ro m e (S AR S) a nd /o r in flu en za v iru s ( H1 N1 )? Ar e th er e po we rs to re sp on d to an o ut br ea k o f co m m un ica bl e di se as e? Do es th e he al th ac t re co gn ize th e ne ed fo r po we rs to al ig n wi th na tio na l e m er ge nc y po we rs? Ph ili pp in es No No No Pa rti al No Re pu bl ic of K or ea Ye s Ye s Bo th Ye s Ye s Sa m oa Ye s No In flu en za Ye s No Si ng ap or e Ye s Ye s Bo th Ye s Ye s So lo m on Is la nd s Ye s Ye s No Ye s No To ke la u No N/ A N/ A Ye s4 No To ng a Ye s N/ A2 N/ A2 Ye s Ye s Tu va lu No N/ A N/ A Ye s4 No Va nu at u Ye s Ye s No Ye s4 No Vi et N am Ye s Ye s Bo th Ye s Ye s La o PD R: L ao P eo pl e’s D em oc ra tic R ep ub lic ; M icr on es ia: F ed er at ed S ta te s o f M icr on es ia 1: P ow er d ev ol ve d to th e st at e le ve l. 2: U nk no wn (r eg ul at io ns n ot d isc ov er ab le o r n ot a va ila bl e in E ng lis h) . 3: A dd iti on al st ep re qu ire d. 4: Li m ite d. 84 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Country or area Is there a requirement for health planning for NCDs under public health legislation? Is there a requirement to produce health impact statements within public health legislation? Are there any other provisions in public health legislation relevant to NCD management? Australia Yes Partially Partially Brunei Darussalam No No No Cambodia No1 No2 No China No No2 Yes3 Cook Islands Yes No2 No Fiji No No2 No Japan Yes No Yes Kiribati No1 No2 No Lao PDR Yes No2 Yes Malaysia Yes No2 No Marshall Islands Partially No2 Yes Micronesia Partially No2 Yes Mongolia Partially No2 No Nauru Partially No No New Zealand Yes Partially Yes Niue Partially No2 No Palau No No No3 Papua New Guinea Partially No2 Yes Philippines Yes No2 Yes Republic of Korea Yes Partially No3 Samoa Yes No2 No3 Singapore Yes No Yes Solomon Islands No No2 Yes Tokelau No No No Tonga No No2 Yes Tuvalu No No2 No Vanuatu Partially No2 Yes Viet Nam Yes No2 No3 Lao PDR: Lao People’s Democratic Republic; Micronesia: Federated States of Micronesia 1: Not in primary legislation. 2: Environmental impact assessment with a health-related component or other community impact assessment required. 3: But some specific legislation around risk factors or specific NCDs; for example, mental health. TABLE A4.8 Management of noncommunicable diseases in WHO Member States of the Western Pacific Region 85 ANNEX 5 ANNEX 5. Summary of medicines regulatory authorities in the Western Pacific Region Co un try o r a re a Na tio na l r eg ul at or y a ut ho rit y Ph ar m ac eu tic al leg isl at ion Re gis te re d p ro du cts M ed ici ne s Va cc ine s an d bio lo gic als Tr ad iti on al an d co m pl em en ta ry m ed ici ne s M ed ica l de vic es Au st ra lia Th er ap eu tic G oo ds A dm in ist ra tio n Na tio na l H ea lth A ct 1 95 3 ü ü ü ü Br un ei D ar us sa la m M ed ici ne s C on tro l A ut ho rit y, M in ist ry o f H ea lth M ed ici ne s O rd er 2 00 7, M ed ici ne s R eg ul at io n 20 10 ü ü ü Ca m bo di a De pa rtm en t o f F oo d an d Dr ug s, M in ist ry o f H ea lth La w on th e M an ag em en t o f P ha rm ac eu tic al s 20 07 ü ü ü ü Ch in a Ch in a F oo d an d Dr ug A dm in ist ra tio n Ph ar m ac eu tic al A dm in ist ra tio n La w ü ü ü ü – H on g K on g S AR (C hin a) De pa rtm en t o f H ea lth Ph ar m ac y a nd P oi so ns O rd in an ce , Ch in es e M ed ici ne O rd in an ce ü ü ü ü – M ac ao S AR (C hi na ) Dr ug O ffi ce ü ü ü ü Fij i Fi ji Ph ar m ac eu tic al an d Bi om ed ica l Se rv ice s, M in ist ry o f H ea lth M ed ica l P ro du ct s A ct 2 01 1 Ja pa n Ph ar m ac eu tic al s a nd M ed ica l De vic es A ge nc y Ph ar m ac eu tic al A ffa irs L aw 1 96 0 (re vis ed in 2 01 3) ü ü ü ü La o PD R Fo od an d Dr ug D ep ar tm en t, M in ist ry o f H ea lth La w on D ru g an d M ed ica l P ro du ct s 2 01 1, Re gu la tio n go ve rn in g dr ug re gi st ra tio n 20 03 ü ü ü ü M al ay sia Na tio na l P ha rm ac eu tic al R eg ul at or y Ag en cy Po iso ns A ct 1 95 2, S al e of D ru gs A ct , C on tro l of D ru gs an d Co sm et ics R eg ul at io ns ü ü ü ü M on go lia Dr ug R eg ul at or y U ni t – C en te r f or He al th D ev el op m en t, M in ist ry o f He al th co or di na tin g re gu la to ry fu nc tio ns ac ro ss d iff er en t a ge nc ie s Dr ug L aw 1 99 8 (re vi se d in 2 01 0) ü ü ü Ne w Ze al an d M ed ici ne s a nd M ed ica l D ev ice s Sa fe ty A ut ho rit y M ed ici ne s A ct 1 98 1, M ed ici ne s R eg ul at io n 19 84 ü ü ü Pa pu a N ew G ui ne a Ph ar m ac eu tic al S er vic es S ta nd ar d, Na tio na l D ep ar tm en t o f H ea lth M ed ici ne s a nd C os m et ic Ac t 1 99 9, Re gu la tio n 20 01 86 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Co un try o r a re a Na tio na l r eg ul at or y a ut ho rit y Ph ar m ac eu tic al leg isl at ion Re gis te re d p ro du cts M ed ici ne s Va cc ine s an d bio lo gic als Tr ad iti on al an d co m pl em en ta ry m ed ici ne s M ed ica l de vic es Ph ili pp in es Fo od an d Dr ug A dm in ist ra tio n Ge ne ric s A ct 1 98 8, U ni ve rs al ly A cc es sib le Ch ea pe r a nd Q ua lit y M ed ici ne s A ct 2 00 8, Fo od a nd D ru g Ad m in ist ra tio n Ac t 2 00 9, Ph ili pp in es P ha rm ac y A ct 2 01 6 ü ü ü ü Re pu bl ic of K or ea M in ist ry o f F oo d an d Dr ug S af et y Ph ar m ac eu tic al A ffa irs A ct ü ü ü ü Si ng ap or e He al th S cie nc es A ut ho rit y He al th P ro du ct s A ct , M ed ici ne s A ct ü ü ü (re qu ire d fo r C hi ne se pr op rie ta ry m ed ic in es o nl y) ü Vi et N am Dr ug A dm in ist ra tio n of V ie t N am Ph ar m ac y L aw N o. 34 /2 00 5/ QH 11 , D ec isi on 10 /2 00 7/ QD -B TM ü ü ü ü La o PD R: L ao P eo pl e’s D em oc ra tic R ep ub lic ANNEX 5. Summary of medicines regulatory authorities in the Western Pacific Region (continued) 87 In 2008, to accelerate implementation by Member States of interventions called for under the WHO Framework Convention on Tobacco Control (WHO FCTC), WHO devised the MPOWER package: M (monitor tobacco use and prevention policies), P (protect people from tobacco smoke), O (offer help to quit tobacco use), W (warn about the dangers of tobacco), E (enforce bans on tobacco advertising, promotion and sponsorship), and R (raise taxes on tobacco). MPOWER illustrates the need for a comprehensive approach to tobacco control. Law is an important tool to ensure implementation of many MPOWER measures, particularly smoke-free zones, warning labels, marketing bans, and tobacco taxation. While all WHO countries in the Western Pacific are Parties to the WHO FCTC and thus legally bound to implement their obligations, the table shows the progressive nature of how countries develop their legal frameworks over time and according to national priorities and capacities. ANNEX 6. Summary of tobacco control progress in Member States via MPOWER Change since 2016 Country P 0 W E R Smoke-free policy Cessation programme Health warnings Advertising bans Taxation Australia Brunei Darussalam Cambodia China Cook Islands Fiji Japan Kiribati Lao PDR Malaysia Marshall Islands Micronesia Mongolia Nauru New Zealand Niue Palau Papua New Guinea Philippines Republic of Korea Samoa Singapore Solomon Islands Tonga Tuvalu Vanuatu Viet Nam Lao PDR: Lao People’s Democratic Republic; Micronesia: Federated States of Micronesia Change in POWER indicator group, up or down, between 2016 and 2018. Some 2016 data were revised in 2018. The 2018 grouping rules were applied to both years. 88 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Country Adult daily smoking prevalence, 2017 (in percentage) M P 0 W E R Monitoring Smoke-free policy Cessation Warnings Advertising bans Lines represent level of compliance Health warning Mass media Lines represent level of compliance Taxation (in percentage) Cigarettes less affordable since 2008 IIIIIIIIII IIIIIII IIIIIIIIII III IIIIIIIII IIIII IIIIIII IIIIIIIIII IIIIIIIIII IIIIIIII IIIIIIIII — 8 — IIIII IIIIIIIII IIIII IIIIIIII — IIIII IIIIIII IIIIIIIIII IIIIIIII — IIIII IIIIIIII IIIIIIIIII IIIIIIIIII — 88 — 8 IIIIIII IIIIIIIII IIIII IIIII IIIIIIII . . . III IIIIIIIII IIIIIIII IIIIIIIIII IIIIIIIIII IIIIIII IIIIIIIIII IIIIIII IIIIIIII — IIIIIIIII III IIIIIIII Australia Brunei Darussalam Cambodia China Cook Islands Fiji Japan Kiribati Lao PDR Malaysia Marshall Islands Micronesia Mongolia Nauru New Zealand Niue Palau Papua New Guinea Philippines Republic of Korea Samoa Singapore Solomon Islands Tonga Tuvalu Vanuatu Viet Nam Lao PDR: Lao People’s Democratic Republic; Micronesia: Federated States of Micronesia Summary of MPOWER measures: 2018 indicator and compliance 13 YES77.5 12 16 NO25.1 22 NO55.7 19 YES70.3 19 YES63.1 45 NO41.7 24 NO18.8 18 YES58.6 22 47.4 38 YES48.3 14 YES82.2 15 73.0 19 YES71.3 21 73.8 23 YES49.5 13 NO67.1 30 34.1 26 YES62.4 30 29.5 13 NO58.6 … YES48.6 … … …… … … … 87.7 … 54.2 … NO36.7 … NO54.1 17 YES42.1 89 ANNEX 6 Source: WHO report on the global tobacco epidemic, 2019: offer to help quit tobacco use. Geneva: World Health Organization; 2017. ADULT DAILY SMOKING PREVALENCE: AGE-STANDARDIZED* PREVALENCE RATES FOR ADULT DAILY SMOKERS OF TOBACCO (BOTH SEXES COMBINED), 2017 COMPLIANCE: COMPLIANCE WITH BANS ON ADVERTISING, PROMOTION AND SPONSORSHIP, AND ADHERENCE TO SMOKE-FREE LAWS MONITORING: PREVALENCE DATA SYMBOLS LEGEND MASS MEDIA: ANTI-TOBACCO CAMPAIGNS SMOKE-FREE ENVIRONMENTS: SMOKING BANS ADVERTISING BANS: BANS ON ADVERTISING, PROMOTION AND SPONSORSHIP TAXATION: SHARE OF TOTAL TAXES IN THE RETAIL PRICE OF THE MOST WIDELY SOLD BRAND OF CIGARETTES AFFORDABILITY OF CIGARETTES CESSATION PROGRAMMES: TREATMENT OF TOBACCO DEPENDENCE HEALTH WARNINGS: HEALTH WARNINGS ON CIGARETTE PACKAGES . . . Estimates not available 30% or more From 20% to 29.9% From 15% to 19.9% Less than 15% * The figures should be used strictly for the purpose of drawing comparisons across countries and must not be used to estimate absolute number of daily tobacco smokers in a country. No known data or no recent data or data that are not both recent and representative Recent and representative data for either adults or youth Recent and representative data for both adults and youth Recent, representative and periodic data for both adults and youth Data not reported/not categorized Complete absence of ban, or up to two public places completely smoke-free Three to five public places completely smoke-free Six to seven public places completely smoke-free All public places completely smoke-free (or at least 90% of the population covered by complete subnational smoke-free legislation) Data not reported None NRT and/or some cessation services (neither cost-covered) NRT and/or some cessation services (at least one of which is cost-covered) National quit line, and both NRT and some cessation services cost-covered Data not reported No warnings or small warnings Medium-size warnings missing some or many appropriate characteristics OR large warnings missing many appropriate characteristics Medium-size warnings with all appropriate characteristics OR large warnings missing some appropriate characteristics Large warnings with all appropriate characteristics Data not reported No national campaign conducted between July 2016 and June 2018 with duration of at least three weeks National campaign conducted with one to four appropriate characteristics National campaign conducted with five to six appropriate characteristics, or with seven characteristics excluding airing on television and/or radio National campaign conducted with at least seven appropriate characteristics including airing on television and/or radio Data not reported Complete absence of ban, or ban that does not cover national television, radio and print media Ban on national television, radio and print media only Ban on national television, radio and print media as well as on some but not all other forms of direct and/or indirect advertising Ban on all forms of direct and indirect advertising (or at least 90% of the population covered by subnational legislation completely banning tobacco advertising, promotion and sponsorship) Data not reported < 25% of retail price is tax ≥25% and <50% of retail price is tax ≥50% and <75% of retail price is tax ≥75% of retail price is tax YES Cigarettes less affordable – per capita GDP needed to buy 2000 cigarettes of the most sold brand increased on average between 2008 and 2018 NO Cigarettes more affordable – per capita GDP needed to buy 2000 cigarettes of the most sold brand declined on average between 2008 and 2018 No trend change in affordability of cigarettes since 2008 . . . Insufficient data to conduct a trend analysis |||||||||| ||||||||| |||||||| High compliance (8/10 to 10/10) ||||||| |||||| ||||| |||| ||| Moderate compliance (3/10 to 7/10) || | Minimal compliance (0/10 to 2/10) ✩ Country has one or more public places where designated smoking rooms (DSRs) are allowed. Separate, completely enclosed smoking rooms are allowed if they are separately ventilated to the outside and/or kept under negative air pressure in relation to the surrounding areas. Given the difficulty of meeting the very strict requirements delineated for such rooms, they appear to be a practical impossibility but no reliable empirical evidence is presently available to ascertain whether they have been constructed. 8 Policy adopted but not implemented by 31 December 2018. ▲▼ Change in POWER indicator group, up or down, between 2016 and 2018. Some 2016 data were revised in 2018. 2018 grouping rules were applied to both years. PLEASE REFER TO TECHNICAL NOTE I FOR DEFINITIONS OF CATEGORIES 90 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS ANNEX 7. Using law to implement policies protecting children from the harmful impact of food marketing in the Western Pacific Region The table below summarizes the implementation of policies to protect children from the harmful impact of food marketing in the Western Pacific Region. LEGAL ACTION A green cell implies that some type of legislation (legally enforceable measure) is in place. Refer to A, B and C below the table for further classification or explanation. VOLUNTARY ACTION A yellow cell implies that some type of voluntary action is in place. This might include voluntary pledges, voluntary initiatives by the government, self-regulations or voluntary industry codes. NO ACTION A red cell implies that no action is taken. NO INFORMATION A blank cell implies that no information is available. Country or area COLUMN 1 COLUMN 2 COLUMN 3 COLUMN 4 COLUMN 5 International Code of Marketing of Breast-milk Substitutes Marketing of foods for infants and young children covered up to 36 months Marketing of foods and non-alcoholic beverages to children Nutrition labelling (especially nutrient declaration) Front-of-pack labelling Milk products Comple- mentary foods American Samoa Australia Brunei Darussalam Cambodia B (24) China C (4) – Hong Kong SAR (China) – Macao SAR (China) Cook Islands Fiji A (6) (24) French Polynesia Guam Japan Kiribati Lao PDR C (24) (24) Malaysia Marshall Islands Micronesia Mongolia B (24) (24) 91 ANNEX 7 Country or area COLUMN 1 COLUMN 2 COLUMN 3 COLUMN 4 COLUMN 5 Nauru New Caledonia New Zealand (12) Niue Northern Mariana Islands Palau A (36) (12) Papua New Guinea C Philippines A (36) (24) Pitcairn Islands Republic of Korea C Samoa Singapore Solomon Islands C Tokelau Tonga Tuvalu Vanuatu Viet Nam A (24) (24) Wallis and Futuna Lao PDR: Lao People’s Democratic Republic; Micronesia: Federated States of Micronesia; Northern Mariana Islands: Commonwealth of the Northern Mariana Islands Source: Protecting children from the harmful impact of food marketing. Manila: WHO Regional Office for the Western Pacific; 2017. Notes: • Column 1 pertains to the national adaptation of the International Code of Marketing of Breast-milk Substitutes and subsequent relevant World Health Assembly resolutions. Data were obtained from the WHO/UNICEF/IBFAN status report on regulatory measures and IBFAN status report 2016 on voluntary measures. Legislation is marked in green under three categories: (A) full provisions in law; (B) many provisions in law; and (C) few provisions in law. • Column 2 pertains to national implementation of World Health Assembly resolution WHA69.9 welcoming the Guidance on Ending the Inappropriate Promotion of Foods for Infants and Young Children, aged 6–36 months. Data were obtained from the 2016 status report on Code implementation, or through consultations with WHO Member States. References to an age group in any policy are noted (in months of age). • Column 3 pertains to national implementation of the WHO Set of Recommendations on the Marketing of Foods and Non- alcoholic Beverages to Children. Legislation is marked in green. • Column 4 pertains to national implementation of the nutrient declaration aligned with Codex Alimentarius guidelines (CAC-CL2-1985, last update 2016); accurate nutrition labelling is essential to enforce marketing restrictions based on amounts of nutrient content (for example, salt, sugar, and/or fats). • Column 5 pertains to national implementation of policies on front-of-pack labelling; in addition to the nutrient declaration, front-of-pack labelling informs consumers of potential concerns arising from a food product’s nutrient content (for example, high amounts of salt, sugar and/or fats). 92 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS ANNEX 8. Strengthening an international mandate: evolution of the International Code of Marketing of Breast-milk Substitutes and through subsequent resolutions by the World Health Assembly The World Health Assembly has the power under Article 23 of the WHO Constitution to make recommendations to WHO Member States. The International Code of Marketing of Breast-milk Substitutes (the Code) was an important example of WHO using its powers under international law to set norms and standards for the furtherance of health. The table below demonstrates the evolution of the Code and the impact the Code has had in empowering the WHO Secretariat to support Member States in addressing global issues associated with maternal and child health. Year Resolution Selected highlights and features 1981 WHA34.22 Code adopted by the World Health Assembly (118 in favour, 1 no, 3 abstentions). Stressed that the adoption of and adherence to the Code is a minimum requirement. Urged Member States to translate the Code into national legislation, regulations and other suitable measures. 1982 WHA35.26 Recognized that commercial promotion of breast-milk substitutes contributes to an increase in artificial feeding. Called for renewed attention to implement and monitor the Code at national and international levels. 1984 WHA37.30 Requested the WHO Director-General to work with Member States to implement and monitor the Code and to examine the promotion and use of foods unsuitable for infant and young child feeding. 1986 WHA39.28 Urged WHO Member States to ensure that small amounts of breast-milk substitutes needed for a minority of infants are made available through normal procurement channels and not through free or subsidized supplies. Directed the attention of Member States to the following: – Any food or drink given before complementary feeding is nutritionally required may interfere with breastfeeding and therefore should neither be promoted nor encouraged for use by infants during this period. – The practice of providing infants with so-called follow-up milks is not necessary. 1988 WHA41.11 Requested the WHO Director-General to provide legal and technical assistance to Member States in drafting or implementing the Code into national measures. 1990 WHA43.3 Urged Member States to ensure that the principles and aim of the Code are given full expression in national health and nutrition policy and action. 1992 WHA45.34 Urged Member States to: – Encourage and support all public and private health facilities providing maternity services so that they become “baby-friendly”. – Take measures appropriate to national circumstances aimed at ending the donation or low-priced sale of supplies of breast-milk substitutes to health-care facilities providing maternity services. – Draw upon experiences of other Member States in giving effect to the Code. 93 ANNEX 8 Year Resolution Selected highlights and features 1993 WHA46.7 Urged Member States by year 2000 to: – Reduce substantially the prevalence of starvation and widespread chronic hunger; undernutrition, especially among children, women and older people; iron deficiency anaemia; foodborne diseases; and social and other impediments to optimal breastfeeding; and to remedy inadequate sanitation and poor hygiene. – Contain and reduce the rate at which the prevalence of diet-related diseases and of conditions related to them is rising. 1994 WHA47.5 Urged Member States to foster appropriate complementary feeding practices from the age of about 6 months. Reiterated earlier calls in 1986, 1990 and 1992 to end free or low-cost supplies of breast- milk substitutes and extended the ban to all parts of the health-care system (effectively superseding provisions of Article 6.6 of the Code). 1996 WHA49.15 Called on Member States to ensure that: – Complementary foods are not marketed or used in ways that undermine exclusive and sustained breastfeeding. – Financial support to health professionals does not create conflicts of interest. – Code monitoring is carried out in an independent, transparent manner, free from commercial interest. 2001 WHA54.2 Extended global recommendation of exclusive breastfeeding from 4 months to 6 months. Emphasized that, to meet evolving nutritional requirements, infants should receive nutritionally adequate and safe complementary foods, while breastfeeding continues for up to 2 years of age or beyond. 2002 WHA55.25 Endorsed the Global Strategy on Infant and Young Child Feeding (GSforIYCF). Recognized that infant and young child mortality can be reduced with nutritionally adequate and safe complementary feeding through the introduction of safe and adequate amounts of indigenous foodstuffs and local foods. Recognized the role of optimal infant feeding in reducing the risk of obesity. Alerted that micronutrient interventions should not undermine exclusive breastfeeding. Urged Member States to ensure that the introduction of micronutrient interventions and marketing of nutrient supplements do not replace or undermine support for the sustainable practice of exclusive breastfeeding and complementary feeding. 2005 WHA58.32 Urged Member States to: – Ensure that nutrition and health claims for breast-milk substitutes are not permitted unless national or regional legislation specifically allows for them. – Be aware of the risks of intrinsic contamination of powdered infant formula and ensure this information is conveyed through label warnings. – Ensure that financial support and other incentives for programmes and health professionals working in infant and young child health do not create conflicts of interest. 2006 WHA59.11 Asked Member States to ensure the response to the HIV pandemic does not include non- Code-compliant donations of breast-milk substitutes or promotion thereof. 2006 WHA59.21 Welcomed the 2005 Innocenti Declaration on Infant and Young Child Feeding. Requested the WHO Director-General to mobilize technical support for Code implementation and monitoring. 2007 WHA60.23 Requested the WHO Director-General to promote responsible marketing, including the development of a set of recommendations on the marketing of foods and non-alcoholic beverages to children, in order to reduce the impact of foods high in saturated fat, trans- fatty acids, free sugars, or salt, in dialogue with all relevant stakeholders, including private- sector parties, while ensuring avoidance of potential conflicts of interest. 94 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Year Resolution Selected highlights and features 2008 WHA61.20 Urged Member States to scale up efforts to monitor and enforce national measures and to avoid conflicts of interest. Investigated the safe use of donor milk through human milk banks for vulnerable infants, mindful of national laws, and cultural and religious beliefs. 2010 WHA63.23 Recognized that promotion of breast-milk substitutes and some commercial foods for infants and young children undermines progress in optimal infant and young child feeding. Expressed deep concern over persistent reports of violations of the Code by some infant food manufacturers and distributors. Urged Member States to: – Develop and strengthen legislative and regulatory measures to control marketing of breast-milk substitutes to give effect to the Code and resolutions. – End all forms of inappropriate promotion of foods for infants and young children, and to ensure that health and nutrition claims shall not be permitted on these foods. – Ensure that required breast-milk substitutes in emergency responses are purchased and distributed according to strict criteria. 2012 WHA65.6 Requested the WHO Director-General to provide clarification and guidance on the inappropriate promotion of foods for infants and young children cited in resolution WHA63.23, taking into consideration the ongoing work of the Codex Alimentarius Commission (CAC). 2014 WHA67(9) Requested the WHO Director-General to provide clarification and guidance by the end of 2015 on the meaning of “inappropriate promotion of food for infants and young children” as cited in resolution WHA63.23 on infant and young child nutrition. 2016 WHA69.9 Welcomed technical guidance on ending inappropriate promotion of foods for infants and young children (up to 36 months). Urged Member States to continue to implement the International Code of Marketing of Breast-milk Substitutes and WHO recommendations on marketing of foods and non- alcoholic beverages to children. 95 ANNEX 9. Details of assessment criteria and legislation coverage for major risk factors of road safety among countries in the Western Pacific Region Legislation is part of a process of encouraging a culture of safe road behaviour that in turn achieves sustained reductions in road traffic injuries. Road safety legislation has been strengthened across the Western Pacific Region but more work is still needed to address all five key risk factors. The table below is a summary of the road safety legislation, policies and interventions in place. 96 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Co un try o r a re a SP EE D DR IN K– DR IV IN G CH IL D RE ST RA IN TS HE LM ET S SE AT B EL TS Ur ba n s pe ed lim it (k m /h ) Lo ca l au th or iti es ca n r ed uc e sp ee d l im its as re qu ire d Bl oo d a lco ho l co nt en t (B AC ) l im it of ≤ 0.0 5 g/ dl fo r t he ge ne ra l po pu la tio n BA C lim it of ≤ 0.0 2 g/ dl fo r y ou ng or no vic e d riv er s Re qu ire m en t fo r t he us e o f ch ild re str ain ts is ba se d o n a ge , we igh t, h eig ht or co m bin at ion of th es e f ac to rs Re str ict ion of ch ild re n u nd er a c er ta in ag e or h eig ht fr om sit tin g i n t he fro nt se at Pr ot ec tiv e he lm et s m us t be w or n b y a ll dr ive rs an d pa ss en ge rs, on al l r oa ds , on bi ke s o f a ll en gin e t yp es La w sp ec ifi es he lm et m us t be pr op er ly fa ste ne d La w sp ec ifi es a n at ion al or in te rn at ion al qu ali ty sta nd ar d Ap pl ies to dr ive rs an d fro nt -se at pa ss en ge rs Ap pl ies to re ar -se at pa ss en ge rs Au st ra lia 50 YE S < 0. 05 0. 00 AG E (u p t o 7 ye ar s) AG E (u p t o 7 ye ar s) YE S YE S YE S YE S YE S Ca m bo di a 40 N O < 0. 05 <0 .0 5 AG E (u p t o 4 ye ar s) AG E (u p to 1 0 ye ar s) YE S N O YE S YE S N O1 Ch in a 50 YE S < 0. 02 < 0. 02 N O N O YE S N O YE S YE S YE S Co ok Is la nd s 50 2 N O ≤ 0. 08 ≤ 0. 08 N O N O YE S N O YE S N O N O Fij i 50 N O ≤ 0. 08 0. 00 AG E (u p t o 8 ye ar s) AL LO W ED in a ch ild re st ra in t YE S YE S N O YE S YE S Ja pa n 60 YE S ≤ 0. 03 ≤ 0. 03 AG E (u p t o 6 ye ar s) AL LO W ED in a ch ild re st ra in t YE S N O YE S YE S YE S Ki rib at i 40 N O ≤ 0. 05 3 0. 00 3 N O N O YE S N O YE S YE S YE S La o PD R 40 N O ≤ 0. 05 ≤ 0. 05 YE S4 N O YE S N O N O YE S N O M al ay sia 90 5 YE S ≤ 0. 08 ≤ 0. 08 N O N O YE S YE S YE S YE S N O M icr on es ia 40 6 YE S O TH ER 7 O TH ER 7 N O N O YE S N O N O N O N O M on go lia 60 N O < 0. 04 8 < 0. 04 8 N O N O YE S N O N O YE S YE S 97 ANNEX 9 Co un try o r a re a SP EE D DR IN K– DR IV IN G CH IL D RE ST RA IN TS HE LM ET S SE AT B EL TS Ur ba n s pe ed lim it (k m /h ) Lo ca l au th or iti es ca n r ed uc e sp ee d l im its as re qu ire d Bl oo d a lco ho l co nt en t (B AC ) l im it of ≤ 0.0 5 g/ dl fo r t he ge ne ra l po pu la tio n BA C lim it of ≤ 0.0 2 g/ dl fo r y ou ng or no vic e d riv er s Re qu ire m en t fo r t he us e o f ch ild re str ain ts is ba se d o n a ge , we igh t, h eig ht or co m bin at ion of th es e f ac to rs Re str ict ion of ch ild re n u nd er a c er ta in ag e or h eig ht fr om sit tin g i n t he fro nt se at Pr ot ec tiv e he lm et s m us t be w or n b y a ll dr ive rs an d pa ss en ge rs, on al l r oa ds , on bi ke s o f a ll en gin e t yp es La w sp ec ifi es he lm et m us t be pr op er ly fa ste ne d La w sp ec ifi es a n at ion al or in te rn at ion al qu ali ty sta nd ar d Ap pl ies to dr ive rs an d fro nt -se at pa ss en ge rs Ap pl ies to re ar -se at pa ss en ge rs Ne w Ze al an d 50 YE S < 0. 05 0. 00 AG E (u p t o 7 ye ar s) AL LO W ED in a ch ild re st ra in t YE S YE S YE S YE S YE S Pa pu a N ew G ui ne a 60 N O N O9 N O9 N O N O1 0 YE S YE S YE S YE S YE S Ph ili pp in es 40 YE S < 0. 05 < 0. 05 N O AG E (u p t o 6 ye ar s) YE S N O YE S YE S YE S Re pu bl ic of K or ea 80 YE S < 0. 05 < 0. 05 N O1 1 N O1 1 YE S N O YE S YE S YE S Sa m oa ~ 56 N O ≤ 0. 08 ≤ 0. 08 N O1 2 N O1 2 YE S YE S N O YE S N O Si ng ap or e 70 13 N O ≤ 0. 08 ≤ 0. 08 H EI GH T (u p t o 1 35 cm ) AL LO W ED in a ch ild re st ra in t YE S YE S YE S YE S YE S So lo m on Is la nd s N O1 4 YE S < 0. 05 < 0. 05 N O N O YE S YE S YE S N O N O To ng a 50 N O < 0. 03 15 < 0. 03 15 N O N O YE S YE S YE S N O N O Va nu at u N O N O N O9 N O9 N O1 6 AL LO W ED in a ch ild re st ra in t17 YE S YE S YE S YE S N O Vi et N am 60 N O 0. 00 – 0 .05 18 0. 00 – 0 .05 18 N O N O YE S YE S YE S YE S N O La o PD R: L ao P eo pl e’s D em oc ra tic R ep ub lic ; M icr on es ia: F ed er at ed S ta te s o f M icr on es ia So ur ce : D er iv ed fr om th e Gl ob al st at us re po rt on ro ad sa fe ty 2 01 8. G en ev a: W or ld H ea lth O rg an iza tio n; 2 01 8. 98 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Notes: 1: Obligation to use seat belts for all passengers only applies outside cities and densely populated areas. Inside cities and densely populated areas, only the driver and front-seat passengers are required to wear a seat belt. 2: Speed limit applicable on any road, decreased to 30 km/h in reduced speed zones. 3: BAC limit introduced by the Traffic Act 2017; in December 2017, the notice of commencement had not yet been signed. 4: The law states that children unable to wear normal seat belts must be placed in a child restraint seat but no specific age/weight/height is specified. 5: Speed limit set per vehicle and road type with a maximum speed limit for passenger cars of 110 km/h on highways and 90 km/h on other roads. 6: Speed limit may be increased by the governor (Kosrae, Yap) or by the director of the department of public safety (Pohnpei). 7: In Yap a BAC limit is provided in the law (≤ 0.08). In Kosrae and Phonpei the law does not specify a BAC limit. No data are available for Chuuk. 8: Law based on breath alcohol concentration; values converted to BAC. 9: Driving under the influence is prohibited but no BAC or BrAC (breath alcohol concentration) limits are defined in legislation. 10: Children can sit in the front as long as they are using a seat belt. 11: Only required for children (under 6 years) sitting in the front seat; required use of a safety seat for such children. 12: Legislation refers to either child restraint or seat belt to restrain children under 12. 13: Different speed limits are set in urban areas ranging from 30 km/h to 70 km/h. 14: Speed limits are established locally per vehicle type and/or per road names or areas. 15: Law based on breath alcohol concentration; values converted to BAC. 16: Legislation allows infants to be held by a responsible person as an alternative to using special seats. 17: Infant (children under 3 years) shall be placed in a restraining seat while travelling in the front. 18: Different BAC limits are set depending on the type of vehicle used: for drivers of cars the BAC limit is set at 0.00 g/dl while for drivers of motorcycles and mopeds the legal BAC limit is set at 0.05 g/dl. 99 ANNEX 10. Sustainable Development Goals: rule of law mapping The rule of law runs through the Sustainable Development Goals (SDGs). Goal 16 specifically focuses on the legal dimensions of the development and principles of the rule of law, such as equality before the law, independent adjudication, procedural and legal transparency, and the supremacy of laws. Many of the SDGs also set out how the law can or should be used as a tool to deliver the SDGs. The law encompasses a formal set of rules and the legal processes for implementing and enforcing them. The principles of the rule of law, such as accountability, fairness and certainty, are embedded throughout the SDGs. Goal 16, along with Goal 3 has been referred to as a “cross-cutting goal”, and the need to address both, as well as the intersection between law and health, is clear if the ambitions of the SDGs are to be realized. The table below links the rule of law principles, as defined in the 2004 report of the United Nations Secretary-General, The Rule of Law and Transitional Justice in Conflict and Post-conflict Societies (United Nations, 2004), against the goals and targets within the SDGs. It aims to demonstrate the rule of law’s cross- cutting nature under the SDGs and its interrelatedness with health goals under the SDGs. Sustainable Development Goal Selected highlights and features Goal 3 – Ensure healthy lives and promote well-being for all at all ages Target 3.A Strengthen implementation of the World Health Organization Framework Convention on Tobacco Control in all countries, as appropriate The WHO Framework Convention on Tobacco Control (FCTC) and its implementation reflect the power of international consensus to advance health objectives. Article 19, in particular, allows for legislative action to deal with liability. Implementing the Convention is a realization of international health law. Target 3.B Support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all. Access to medicines for all remains essential to achieving the health goals, and the realization of international trade law, particularly as it relates to adherence to provisions that protect public health and provides a mechanism for accountability. Goal 5 – Achieve gender equality and empower all women and girls Target 5.A Undertake reforms to give women equal rights to economic resources, as well as access to ownership and control over land and other forms of property, financial services, inheritance and natural resources, in accordance with national laws. Women’s rights are fundamental human rights enshrined in international legal instruments, including the Declaration on the Elimination of Discrimination against Women (1967). The adoption of legal reforms, as needed, is intended to encourage a fair application of the law. 100 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Sustainable Development Goal Selected highlights and features Goal 5 – Achieve gender equality and empower all women and girls (continued) Target 5.C Adopt and strengthen sound policies and enforceable legislation for the promotion of gender equality and the empowerment of all women and girls at all levels. Strengthening enforceable legislation for the promotion of gender equality and empowerment embeds human rights norms and standards at the national level. It also ensures that laws are fairly applied to persons of all genders. Through law-making, public entities are made more accountable on issues of gender equality and empowerment. Goal 8 – Promote sustained, inclusive and sustainable economic growth, full and productive employment and decent work for all Target 8.7 Take immediate and effective measures to eradicate forced labour, end modern slavery and human trafficking and secure the prohibition and elimination of the worst forms of child labour, including recruitment and use of child soldiers, and by 2025 end child labour in all its forms. The taking of measures to eradicate forced labour, end modern slavery and human trafficking represents a realization of international human rights law, and also ensures adherence to enforcement of existing legislation and obligations. Target 8.8 Protect labour rights and promote safe and secure working environments for all workers, including migrant workers, in particular women migrants, and those in precarious employment. The equal protection under and enforcement of labour rights, consistent with human rights norms and standards, observes principles of adherence to laws and a realization of international labour law to address social determinants of health and address issues of occupational health. Goal 10 – Reduce inequality within and among countries Target 10.3 Ensure equal opportunity and reduce inequalities of outcome, including by eliminating discriminatory laws, policies and practices and promoting appropriate legislation, policies and actions in this regard. Improving equality before the law by reducing discrimination and increasing fairness in the application of laws. Supporting the development of rule by law through the utilization of appropriate legislation. Target 10.5 Improve the regulation and monitoring of global financial markets and institutions and strengthen the implementation of such regulations. Improve accountability of financial markets and institutions through the making of laws and regulations to ensure that financial markets and institutions adhere to publicly set standards. Target 10.6 Ensure enhanced representation and voice for developing countries in decision-making in global international economic and financial institutions in order to deliver more effective, credible, accountable and legitimate institutions. Participation in decision-making impacts the structure and constraints on the exercise of authority as set out through laws and regulation that hold people and institutions accountable to society. Target 10.A Implement the principle of special and differential treatment for developing countries, in particular least developed countries, in accordance with World Trade Organization agreements. International trade law is an important body of law that recognizes that differential treatment for developing countries is needed. Countries are ensuring that they adhere to these principles through the use of national legal frameworks. 101 ANNEX 10 Sustainable Development Goal Selected highlights and features Goal 11 – Make cities and human settlements inclusive, safe, resilient and sustainable Target 11.B By 2020, substantially increase the number of cities and human settlements adopting and implementing integrated policies and plans towards inclusion, resource efficiency, mitigation and adaptation to climate change, resilience to disasters, and develop and implement, in line with the Sendai Framework for Disaster Risk Reduction 2015–2030, holistic disaster risk management at all levels. International commitments are being used to build resilience to disasters and adapt to climate change, as demonstrated through instruments such as the Sendai Framework for Disaster Reduction 2015–2030. This reflects the highest international commitment to healthier and safer environments and the need to incorporate such standards into the local context. Goal 12 – Ensure sustainable consumption and production patterns Target 12.4 By 2020, achieve the environmentally sound manage- ment of chemicals and all wastes throughout their life cycle, in accordance with agreed international frame- works, and significantly reduce their release to air, water and soil in order to minimize their adverse impacts on human health and the environment. The realization of international legal commitments in the area of the environment highlights the need to ensure adherence to those global commitments to create healthier environments. Target 12.C Rationalize inefficient fossil fuel subsidies that encourage wasteful consumption by removing market distortions, in accordance with national circumstances, including by restructuring taxation and phasing out those harmful subsidies, where they exist, to reflect their environmental impacts, taking fully into account the specific needs and conditions of developing countries and minimizing the possible adverse impacts on their development in a manner that protects the poor and the affected communities. The need to ensure that communities are protected from environmental degradation is tied to the realization of economic and social rights. This includes the amendment of legal frameworks in the collection of taxation and distribution of subsidies to ensure rights are protected, and the promotion of community participation in these decisions. Goal 13 – Take urgent action to combat climate change and its impacts Target 13.A Implement the commitment undertaken by developed- country parties to the United Nations Framework Convention on Climate Change to a goal of mobilizing jointly US$ 100 billion annually by 2020 from all sources to address the needs of developing countries in the context of meaningful mitigation actions and transparency on implementation and fully operationalize the Green Climate Fund through its capitalization as soon as possible. The commitment to the realization of international environmental law instruments like the Framework Convention on Climate Change echoes the need to tackle climate change through transparent institutions committed to realizing environmental justice. Goal 14 – Conserve and sustainably use the oceans, seas and marine resources for sustainable development Target 14.4 By 2020, effectively regulate harvesting and end overfishing, illegal, unreported and unregulated fishing and destructive fishing practices and implement science- based management plans, in order to restore fish stocks in the shortest time feasible, at least to levels that can produce maximum sustainable yield as determined by their biological characteristics. The need to engage communities in the effective creation and implementation of regulation to improve fish stocks and practices, to improve sustainability and consistency of the food supply. 102 BETTER LAWS FOR BETTER HEALTH – WESTERN PACIFIC REGIONAL ACTION AGENDA ON STRENGTHENING LEGAL FRAMEWORKS FOR HEALTH IN THE SUSTAINABLE DEVELOPMENT GOALS Sustainable Development Goal Selected highlights and features Goal 14 – Conserve and sustainably use the oceans, seas and marine resources for sustainable development (continued) Target 14.5 By 2020, conserve at least 10 per cent of coastal and marine areas, consistent with national and international law and based on the best available scientific information. The need to realize the commitment to international environmental law as the highest commitment made to preserving marine environments. This commitment needs to be reflected in policy and legislation at the national level to ensure their effective enforcement. Target 14.6 By 2020, prohibit certain forms of fisheries subsidies which contribute to overcapacity and overfishing, eliminate subsidies that contribute to illegal, unreported and unregulated fishing and refrain from introducing new such subsidies, recognizing that appropriate and effective special and differential treatment for developing and least developed countries should be an integral part of the World Trade Organization fisheries subsidies negotiation. Improve legal certainty through the creation of systems to regulate and enforce the regulation of responsible fishing, within the context of international trade law. Goal 15 – Protect, restore and promote sustainable use of terrestrial ecosystem, sustainably manage forests, combat desertification, and halt and reverse land degradation and halt biodiversity loss Target 15.6 Promote fair and equitable sharing of the benefits arising from the utilization of genetic resources and promote appropriate access to such resources, as internationally agreed. The equitable sharing of benefits of genetic resources already reflects some of the agreed aspects of international health law, for example, Pandemic Influenza Preparedness (PIP) Framework, and is consistent with international human rights principles such as the right to benefit from scientific progress under the Universal Declaration of Human Rights. Goal 16 – Promote peaceful and inclusive societies for sustainable development, provide access to justice for all and build effective, accountable and inclusive institutions at all levels Target 16.1 Significantly reduce all forms of violence and related death rates everywhere. The need for a realization of human rights and international law through reform and enforcement of existing legal frameworks prohibiting violence. Target 16.3 Promote the rule of law at the national and inter national levels and ensure equal access to justice for all. The rule of law and access to justice is a thread that runs through the SDGs starting from Goal 16 and an understanding of its implications. Target 16.9 Broaden and strengthen the participation of developing countries in the institutions of global governance. The need for participation in the creation and development of legal and governing institutions supports sustained compliance, and legitimate and effective institutions. Target 16.10 Ensure public access to information and protect fundamental freedoms, in accordance with national legislation and international agreements. Access to information supports values of accountability and transparency in the affairs of government and the administration of justice. 103 ANNEX 10 Sustainable Development Goal Selected highlights and features Goal 16 – Promote peaceful and inclusive societies for sustainable development, provide access to justice for all and build effective, accountable and inclusive institutions at all levels (continued) Target 16.B Promote and enforce non-discriminatory laws and policies for sustainable development. Equal treatment before the law and non-discrimination are cornerstones to effective administration of the law and key to preserving the law as a tool for development. Goal 17 – Strengthen the means of implementation and revitalize the global partnership for sustainable development Target 17.1 Strengthen domestic resource mobilization, including through international support to developing countries, to improve domestic capacity for tax and other revenue collection. Basic legal frameworks are needed for the operation of taxation. Taxes should be levied through lawful enactments, applied impartially, followed by an application of taxes for lawful public purposes.