Health workforce regulation in the Western Pacific Region

Health workforce regulation in the Western Pacific Region

Health workforce regulation in the Western Pacific Region ii WHO Library Cataloguing-in-Publication Data Health workforce regulation in the Western Pacific Region 1. Health manpower – organization and administration. 2. Health personnel. I. World Health Organization Regional Office for the Western Pacific ISBN 978 92 9061 723 5 (NLM Classification: W 76) © World Health Organization 2016 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; email: bookorders@ who.int). Requests for permission to reproduce or translate WHO publications –whether for sale or for distribution –should be addressed to WHO Press through the WHO (www.who.int/about/licensing/copyright_form/en/index.html). For WHO Western Pacific Regional Publications, requests for permission to re- produce should be addressed to Publications Office, World Health Organization, Regional Office for the Western Pacific, P.O. Box 2932, 1000, Manila, Philippines (fax: +632 521 1036, email: publications@wpro.who.int). 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 the World Health Organization 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 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 the World Health Organization 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 the World Health Organization 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 the World Health Organization be liable for damages arising from its use. Cover photo: WHO iii CONTENTS Acknowledgements iv 1. Introduction 1 2. Terminology 3 3. Maturity 4 4. Components of health workforce regulatory systems 6 4.1. Institutional arrangements 6 4.2. Regulated professions 8 4.3. Education and accreditation 11 4.4. Licensing or registration requirements 14 4.5. Notifications, complaints and disciplinary processes 18 4.6. Reciprocal agreements 19 5. Financing 23 6. Emerging issues 26 6.1. Global mobility 26 6.2. Telemedicine 26 6.3. Private providers 26 6.4. Interprofessional practice 27 7. Conclusion 29 References 32 Annex 1: Legislation, acts and decrees consulted for this review, by country and area 34 Annex 2: Countries and areas of the Western Pacific Region and number of regulated professions 36 Annex 3: Questions to guide the desk review and list of professions reviewed 37 Annex 4: The best practice regulation model: principles and assessments 38 Annex 5: Council of Australian Governments principles of best practice regulation 39 Annex 6: Right-touch regulation, Council for Healthcare Regulatory Excellence 40 iv ACKNOWLEDGEMENTS This was prepared by Brenda Wraight, Director, BKWraight Consulting, Wellington, New Zealand, for the Human Resources for Health Unit, Regional Office for the Western Pacific, World Health Organization, in collaboration with Gülin Gedik, Team Leader, Human Resources for Health. Gratitude is extended to Vivian Lin and Martin Fletcher, who reviewed the drafts and provided insightful comments. The views expressed in this report are those of the author and do not necessarily reflect the policies of the Organization. 1 1. INTRODUCTION Along with fiscal and monetary policy, regulation has a key role in shaping the welfare of economies and society, and is one of the key levers for government influence (1). Governments regulate health services and systems to improve the quality of health services and health outcomes, ensure equity and access, protect the public, promote social cohesion and increase economic efficiency (2). The core, common elements of many regulatory systems include the standards required to become registered or licensed (i.e. prescribed educational pathways and qualifications); standards set for entry into a profession; standards required to maintain registration (including continuing professional education); and mechanisms for dealing with people who breach the standards (e.g. how fitness to practise is assessed, and complaints and notifications are managed). The arrangements, approaches and processes that are established to implement these systems may vary considerably, according to the legislation (Annex 1), the purpose of the regulation itself, and whether regulation is profession- or government-led. The 37 countries and areas that make up the World Health Organization (WHO) Western Pacific Region (Annex 2) are diverse, with respect to culture, socio-political histories, population size and demography, geography, economic prosperity, resources and health status. This diversity is mirrored in the significant variation in equitable access to health care; in the number, type and distribution of workforces that provide health services; and in the development and implementation of legislation that regulates the education and practice of health-care workers (3). Despite these differences, there are also opportunities to draw on the experiences of many of the countries and areas in the Region to better understand how to extend the knowledge of regulation and regulatory processes, and further, what support can be put in place at the country level. This report provides an overview of the status of the regulation of the health workforce across the Region. It relates only to regulatory regimes, not the overall functionality of each area or whether intended outcomes are being achieved. These are wider issues, beyond the scope of this initial review. Published information relating to legislation, governance arrangements, registration and renewal processes, accreditation of education providers and programmes, and approaches for setting and monitoring adherence to practice standards was identified through a desk review. This material was augmented with information from a small number of interviews. 2For the desk review, an assessment was conducted for each country and area, by profession, using a set of key questions (Annex 3).1 Searches included websites and publications from national and international organizations and agencies; government departments and ministries; country-specific legislation, acts, decrees and regulations; professional associations; research-based organizations and universities; and WHO collaborating centres. A comprehensive list of reference material has been compiled and is available separately. Where significant information gaps and/or contradictory information emerged, interviews with a few key informants were undertaken to augment and validate material from the desk review. The review findings identified that regulation of health professionals is well established in some countries and areas, and an evolving feature of health system development in others. This diversity is evident in the various systems for accrediting education programmes and monitoring provider performance, in the range of approaches for regulating health professional practice, and in information gaps on how regulation is being implemented. A number of emerging issues, such as telemedicine, and increased population and practitioner mobility, complicate an already complex landscape. 1 The questions that were used to guide this review sought “yes” or “no” answers, whereas the more correct answers might have been “partially”, “in progress”, “under consultation” or “unclear about extent of implementation”. 32. TERMINOLOGY Terminology or nomenclature comprises terms that are used to describe processes and systems. Across countries, professions, organizations and agencies, there is a subtle but significant difference in terminology applied to aspects of regulation of health professional education and practice. For example, the terms “licensure” and “registration”, which are used interchangeably, may have (often subtly) different meanings within the regulatory system of a particular country or between professions. Similarly, the terms “accreditation” and “credentialing” may have similar or significantly different meanings, depending on the context in which they are used. Other terms, such as “discipline”, may indicate different sanctions and penalties for different professional groups and in different jurisdictions. It is beyond the scope of this review to conduct an extensive analysis of the extent of variation in regulatory nomenclature across the Region. Nonetheless, this variability is assumed to have an impact on how different regulatory systems and processes are described within countries and areas, and also on the apparent extent of gaps in published information.2 The review thus highlighted the importance of a shared understanding of the range of terminology applied to regulation across the Region. 2 The review acknowledges the potential for interpretative or confirmation bias. 43. MATURITY The notion of “maturity” of regulatory systems is subjective; however, for the purpose of this review, it was taken to mean systems that are embedded, i.e. ingrained in the context and culture of a country, and where the principles of good regulation (and best practices) are evident in the processes and structures in place (4). The review acknowledged that the term “good practice” is also subjective, and perceptions of best practice will vary depending on the cultural paradigm and socio-political history in each country. However, the principles of good and effective regulation (i.e. proportionate to the risks and costs involved; applied consistently; targeting the problem; and minimizing side-effects, transparency, accountability and relative agility) should still apply (5). Within this theme of maturity, countries and areas appear to fall into three broad categories or “clusters” with regard to documented regulatory systems for education and practice.3 The intention is not to signal uniformity in regulatory practice, as within each of these clusters, there is also variation across most regulatory activities. The clusters are simply one way to show general patterns and to indicate a possible approach for knowledge-sharing. Cluster one The first cluster features countries and areas with strong, embedded regulatory systems. This includes recent enactment or amendment of legislation and boards or councils responsible for: registration; setting and ensuring adherence to standards, notifications and complaints; and discipline. These systems appear to be clearly linked to education, signalling roles and responsibilities that link accreditation of programmes and/or providers to practice. The regulatory mechanism covers the largest range of health professional groupings. Countries and areas in this cluster include Australia, Hong Kong SAR (China), New Zealand and Singapore. Cluster two The second cluster groups countries and areas that have legislation, acts, decrees or codes in place that describe a regulatory system, primarily for medicine, dentistry, nursing and midwifery and sometimes pharmacy, but often patchy information about implementation or how agreed professional standards or competencies are determined, monitored and sanctioned. These countries and areas also appear to have weaker links between education standards and accreditation, as well as the mechanisms that ensure ongoing adherence to standards of practice. This cluster 3 The delineation between clusters is permeable, as many countries and areas could be placed in another cluster for some of their regulatory activities. 5of countries and areas also has the largest variation in the amount of information available on different health profession groups. Countries and areas in this cluster include China, Fiji, Japan and the Philippines. Cluster three The third cluster includes countries and areas that appear to have limited or no systems in place. An act or decree may exist, but there is often little information about implementation; there is almost total reliance on foreign-trained health workforces; they are under another country’s jurisdiction; and/or there are large information gaps. Countries and areas in this cluster include French Polynesia, the Lao People’s Democratic Republic, Mongolia and Viet Nam. Countries and areas could also be clustered according to other dimensions, such as those with a similar socio-political history and therefore a similar legislative base (e.g. former British colonies or former Socialist countries). Given that differences in socio-political history also determine the design and purpose of legislation, grouping countries and areas with similar histories does provide an opportunity for cross-learning and knowledge-sharing.4 As with the “maturity” clusters above, there are variations within countries and areas grouped by history. Some crossovers between history and maturity dimensions are worth exploring further. 4 To illustrate, countries and areas that were formerly British colonies include Australia, Fiji, New Zea-land and Singapore. Countries with Socialist histories include Cambodia, China, Lao People’s Demo-cratic Republic, Mongolia and Viet Nam. 64. COMPONENTS OF HEALTH WORKFORCE REGULATORY SYSTEMS In organizing the material collected, several common components and general themes emerged. These six themes, which are discussed in the following sections, are inherently complex. Each piece of information identified potentially links to many other issues that could be considered but are outside the scope of this review. Nonetheless, the themes do correspond to the criteria (i.e. principles) that are known to improve effective regulation, and provide guidance for further analysis that could support the development of health practitioner regulation across the Region. 4.1. Institutional arrangements This section refers to the way health practitioner regulation is organized structurally, not to the overarching governance of countries and areas, jurisdictional relationships5 or the legislation that underpins these. The different constitutional arrangements, internal legislation and regulations, and international conventions and treaties will inevitably intersect with health professional education and practice to some degree.6 This review did not seek to examine these jurisdictional differences; The six themes are: 1. the institutional arrangements in place; 2. number of health professions whose practice is regulated (and extent of that regulation); 3. degree to which education and accreditation of programmes links to the setting and ensuring adherence to standards of practice; 4. requirements for licensure (e.g. passing a national exam) and evidence of qualifications from an approved course; 5. the processes for credentialing or approving registration of foreign-trained health practitioners; and 6. the extent to which countries rely on support and supply of health practitioners from other countries, and evidence of intergovernmental agreements for this purpose. 5 The United States of America has special relations with six jurisdictions in the Region: American Samoa, Guam, Marshall Islands, Federated States of Micronesia, Commonwealth of the Northern Mariana Islands and Palau. Some are independent nations; others are territories or commonwealths, with each category denoting different citizenship or status for residents. French Polynesia, New Caledonia and Wallis and Futuna are under French jurisdiction and law. 6 For example, laws relating to the protection of patients as health consumers (e.g. patient bill of rights, including access to services and medical technologies), monitoring the performance of the health system, poisons, and access to vaccines and medical technologies. 7however, they did have an impact on the amount of published country-specific information and on the ability to cross-reference some of that information. In relation to health practitioner education and practice, there is variation in the extent and coverage of legislation, how legislation is interpreted, how regulatory mechanisms and processes give effect to legislation, and accountability arrangements and governance. In this review, governance was taken to mean the arrangements in place that dictate or denote accountability among the legislator (i.e. governments), the regulator and the public, and how these are structured and organized. The relative maturity of regulatory systems, and whether regulation is government- or profession-led, appears to influence the type of institutional arrangements in place, and whether other professions (e.g. the legal profession) and the general public or community are involved. In some countries and areas, regulation of health professionals is the direct responsibility of the ministry or department of health, such as Cambodia, China and Japan. Other countries have structures that are within the government or ministry of health, but also have a separate board or council for licensing or registering each profession. In Malaysia, the Professional Regulation Commission confers licensing responsibilities on profession-specific regulatory boards. Other countries have systems that are more independent of government, such as New Zealand or Australia, but where board or council members are ministerial appointments. Responsibility for licensure, setting standards and discipline may be assumed by different agencies or bodies. In some countries, the board established under legislation is responsible for all functions; in others, the responsibility for registration or licensure and discipline may be under the board, but setting and assuring standards may be the responsibility of a professional body (e.g. Fiji). In the Federated States of Micronesia, governance and licensure responsibilities sit firmly with the “parent” jurisdiction, but disciplinary matters may (at least initially) be with local employers. A few require that the director-general or secretary of health presides over the regulatory body, including for disciplinary matters, while some delegate this function to profession-specific roles (e.g. a chief nurse). Information about registration requirements for foreign-trained health professionals varies considerably, although reliance on health professionals who are foreign-trained is common to all countries and areas in the Region, regardless of the maturity of their regulatory systems. Australia and New Zealand import relatively high numbers of foreign medical graduates to fill vacancies in some medical specialties. It is beyond the scope of this review to investigate the patterns, issues and pressures in relation to workforce migration, other than noting their significance for most countries and areas in the Region, and that in general, countries and areas with more “mature” regulatory systems are also likely to have more sophisticated processes for assessing applications for registration from foreign-trained health professionals. They may also have other legislation in place that protects the public (e.g. the Code of Rights in New Zealand). 8In summary, governance and structural arrangements do appear to broadly influence the degree to which initial education, qualifications and licensure to practice are linked, and the effectiveness of processes that relate to ongoing adherence to standards, managing complaints and implementing disciplinary decisions. 4.2. Regulated professions There is wide variation in the number of health professions that are regulated in the Region. Legislation in the Commonwealth of the Northern Mariana Islands, for example, covers 28 health professions; in Australia, 14; in Hong Kong SAR (China), 13; in New Zealand, 16; and in Singapore, 8. Other countries and areas that have regulatory systems regulate 3–5 health professions. Countries that have no documented health practitioner regulatory systems include the Lao People’s Democratic Republic (although legislation exists), Viet Nam and some smaller Pacific island countries such as Tuvalu, although they may have a register of health professionals. From the desk review, it was often difficult to clarify the extent to which regulation for particular professions covered education as well as practice. A summary of the number of regulated professions by country is included in Annex 2. 4.2.1. Medicine, dentistry, nursing and midwifery, and pharmacy Almost all countries that have a documented regulatory system for health professional practice include medicine, dentistry, nursing (and midwifery), and often pharmacy in their regulatory systems. Most countries and areas, except Australia and New Zealand, view midwifery as advanced nursing practice, and most regulate it within nursing legislation. 4.2.2. Other professions For some countries that regulate only medicine, dentistry, nursing and midwifery, and pharmacy, there is also information on the presence of professional associations for other or allied health professions (e.g. Fiji) that may carry out a type of self-regulatory role in terms of developing education and standards of practice. A number of publications accessed highlighted the importance of self- regulation through professional bodies in underpinning successful regulation (2). Information available on the regulation of education and practice of allied health professionals varies, as does the number of allied health professions that are regulated in any one country. Australia, Hong Kong SAR (China) and New Zealand have legislation that regulates up to 10 allied health professions. Singapore has a specific Allied Health Professions Act (2011) that regulates 9three allied health professions. Japan also regulates some allied health professions, such as physical and occupational therapy. Apart from the four countries and areas in the first cluster, a few in the second cluster (e.g. the Republic of Korea) have also passed legislation to regulate allied health professions. Yet there was often little information to demonstrate whether that legislation has been implemented, or if processes are in place to set and sanction standards. Further, there were no obvious links to education, or processes for complaints and disciplinary mechanisms. Absence of these links was particularly evident where education and initial registration occur outside the country. In some countries and areas, legislation did not appear to have been rolled out formally. In Guam, a government code contains articles specific to some allied health professions, but a separate act (for nursing and pharmacy) has not been passed. Other countries recognize and regulate allied health professions under medical or more general legislation. In Papua New Guinea, the Medical Registration Act (1980) regulates prescribed categories of allied health work, but does not specify particular professions. Legislation in Samoa regulates 11 allied and traditional medicine professions under the Healthcare Professions Standards and Registrations Act (2007), but there is no information available about implementation. Kiribati has the Medical Services Act (1996), but the review found no information that demonstrated implementation of the act. Health professionals in areas under the jurisdiction of the United States of America or France are assumed to be covered by the laws of those countries. There was little information on allied health practitioner regulation or monitoring of practice, standards or requirements for professional development for these areas. Some countries are in the process of recognizing a broader range of health professions in their legislation, such as Fiji, which passed the Allied Health Practitioners Decree (2011), and China, which has regulation in place that covers rehabilitation therapists and is in the process of considering the recognition of the profession of physiotherapy. 4.2.3. Traditional medicine Information accessed suggests actions are under way by many countries to better integrate traditional and complementary medicine. Regulation is considered to be a useful vehicle for improving the training and standards of traditional medicine practitioners; however, not all countries and areas regulate traditional medicine, and one country, Vanuatu, specifically excludes traditional medicine from its health practitioners act. 10 Countries and areas that do regulate traditional medicine practice include: Australia, which regulates Chinese medicine (since 2000 in Victoria and nationally since 2012); China, which separately regulates Chinese medicine and acupuncture; Hong Kong SAR (China), which also regulates Chinese medicine; Japan, which regulates acupuncture; the Republic of Korea; and Singapore, through the Traditional and Chinese Medicine Act (2011). Malaysia’s Traditional and Complementary Medicines Act (2013) is expected to be implemented in 2015, and will regulate Malay, Chinese and Indian traditional medicine. The existence of legislation may not mean that a separate regulatory system is in place, however. In the Philippines, although there is the Traditional and Alternative Medicines Act (1997), medical professionals who wish to incorporate Chinese medicine or acupuncture into their practice do so, and there is no separate regulatory oversight for traditional medicine. Australian health practitioner regulation allows for professional registration boards to endorse registered practitioners for the practice of acupuncture. The national health insurance scheme also pays for acupuncture services delivered by doctors, and private health insurance covers a range of complementary therapies whether provided through registered practitioners or not. A slightly different approach has been taken with regard to the regulation of Aboriginal and Torres Strait Islander health workers in Australia. The approach regulates practitioners providing primary care services in Aboriginal and Torres Strait Islander communities, rather than regulating the practice of traditional Aboriginal and Torres Strait Islander medicine. There was little information available that demonstrated a direct link between education, standards and practice, even where institutes for traditional medicine education or research have been established. Cambodia has the National Centre of Traditional Medicine within the Ministry of Health, but published information on how the centre links with traditional medicine education or practice could not be identified. In Mongolia, where most hospitals have traditional medicine departments, and six universities offer bachelor’s and master’s courses in traditional medicine, there was no information on the existence of a regulatory framework, although traditional medicine appears to fall under the National Law on Drugs (1998) and State Policy on Drugs (2002–2011). 4.2.4. Non-regulated health professions Not being regulated under legislation does not necessarily imply a lack of professional standards, or an increased risk of harm to the public. Employers can and do impose education standards and training qualification requirements on employees, and in some cases, such as for paramedics in Australia, employment can act as the regulatory mechanism. Professional associations may take on a self-regulatory role by setting standards, codes of ethics and requirements for continuing professional development. Moreover, a health professional’s practice may also be regulated under employment, consumer protection or public health laws. 11 The term “self-regulation” is used differently across jurisdictions; however, in the context of this review, it is taken to mean oversight of professional practice by a non-legislated body, such as a professional association. Self-regulatory systems rely on established professional associations, which can only “regulate” association members or those that agree to voluntary accreditation, and they cannot license an individual (6). There is interest from some countries and areas in the introduction of enforceable minimum standards of practice for health professionals who provide a health service that is not regulated under national law. Australia is proposing to introduce a national code of conduct for health-care workers, and in New Zealand, the counselling profession has advocated introduction of a similar mechanism, often referred to as “negative licensing”. Further, there are examples across the Region of professional associations taking on a self-regulatory role for their professions. Australia and New Zealand have formalized alliances of self-regulated professions.7 Information about the extent of self-regulatory approaches across the Region was patchy, and in some instances, it was difficult to separate them from the advocacy functions also carried out by a professional association. The role of professional associations in promoting or monitoring standards in education, ethics and practice, and in strengthening regulation, warrants further analysis, and is being explored at the country level. In the Philippines, a proposal by the medical board for mandatory membership of a professional association before registration can be granted is currently being considered. 4.3. Education and accreditation Across the Region, there is wide variation in how standards of education are measured, how accreditation of education programmes and providers occurs, and documented evidence linking accreditation of education programmes and registration or licensure requirements. 4.3.1. Education The number of training schools and professional programmes varies significantly across the Region. In general, developing countries invest fewer resources from smaller education budgets, and their public universities depend almost entirely on this budget. However, the number of schools and programmes is not always directly related to total population size or demographic pressures (7). This review did not examine levels of financial investment, nor curricula and programme content, 7 For example, in Australia, the National Alliance of Self-Regulated Health Professions and the Australian Register of Counsellors and Psychotherapists are the national self- regulatory bodies for those professions. 12 but it is important to note these are likely to be integrally linked to accreditation processes, education standards, registration requirements and ongoing monitoring of practice as well as labour markets. The review also did not seek to examine in detail the structure, length and configuration of programmes, yet these aspects do vary considerably across professions and countries. In pharmacy education, Australia, Malaysia, New Zealand and Singapore require a period of internship prior to full licensure, whereas Japan, the Republic of Korea and Viet Nam do not, although they have longer programmes. China has the shortest pharmacy programme duration and no internship requirements. In general, the duration and configuration of medical programmes appears to be more consistent across the Region, and in nursing, a trend towards degree programmes was observed. Comparability of qualifications is, however, an issue that is increasingly impacting many countries and areas, particularly those that either rely heavily on a foreign-trained health workforce or train extensively for foreign markets. Moreover, although programme accreditation by itself does not guarantee consistent or quality standards of education, it is used by health-care providers and regulators to indicate the relative transferability or applicability of qualifications. 4.3.2. Programme and provider accreditation and quality assurance The purpose of accreditation is to attest to the quality of an educational programme, and for the public, prospective students, graduates, employers and professions to have confidence that a programme will enable graduates to enter a profession with the requisite skills and expected competencies. For providers, such as universities and faculty, accreditation can serve as a lever for both funding and reputation. Almost all countries and areas with internal training programmes have established systems for oversight and quality assurance of education in general, but many do not have systems specific to individual health professions, while others have systems that are only just emerging. Japan has introduced a trial programme of accreditation for basic medical education, using the global standards of the World Federation for Medical Education, to ascertain the quality of undergraduate medical education. Further, many Pacific island countries have few regulatory procedures, criteria or benchmarks for reviewing nursing education, and few regulatory bodies that have the skills or training to review or audit nursing programmes (8). The extent to which training providers in the Region utilize international benchmarks and criteria was difficult to ascertain in the time-frame of this review. Responsibility for accreditation of education programmes and providers differs between countries and areas. In many, programmes and providers are accredited by a ministry or department of education or similar; in others, such as Malaysia, this is done by a qualifications agency, 13 with input from the relevant professional regulatory board. In Hong Kong SAR (China) and the Philippines, education programmes are accredited by agencies other than the body responsible for registration or licensure.8 In Australia and New Zealand, a council or board established under a health professions regulatory act is also responsible for registration or licensure and education programme accreditation. For those countries with well-established training programmes for a wide range of health professionals, there appears to be a link between programme approval and initial registration and licensing. In some, such as the Philippines, informal links between education and registration bodies have recently emerged. However, in many, at the post-registration level, systems for registration and regulation are less consistent than those of initial licensing, particularly for nursing and midwifery, allied health professions and specialists (8–10). Indications are that external accreditation of programmes (i.e. those carried out by a body external to the education institute) is increasing. In the Philippines this increase is motivated by the prerequisite that only foreign-trained health professionals who have graduated from externally accredited schools can apply to practise in the United States of America. Accordingly, there appears to be increased interest in external accreditation bodies providing services to other countries. Organizations, such as the South Pacific Board for Educational Assessment, are increasing their role across the Pacific; Canada offers accreditation services to a few countries across the Region; and Australia and New Zealand have a number of councils that accredit courses and providers across both countries in medicine and pharmacy. Material gathered from interviews suggests that there are different perspectives on whether accreditation and regulation of education courses and providers and that of registration for practice are part of one continuum or are approached as separate endeavours. In part, this appears to be influenced by socio-political histories and broader jurisdictional paradigms. 4.3.3. Credentialing In addition to accreditation of programmes and providers, and regulation of practice, some countries and professions have mechanisms or frameworks to credential practitioners. The term “credentialing” is used differently across professions, countries and regulatory authorities. It is applied to validation and revalidation of qualifications or credentials as well as to authorizing a particular individual to work in a specific (usually advanced) scope of practice, often in a prescribed service setting. Credentialing may also refer to demonstration of skills and recognition of additional training that enables individual health practitioners to provide advanced or specialized care for 8 In the Philippines, the Commission on Higher Education sets minimum education standards and accredits programmes and providers, and the Professional Regulation Commission is responsible for the licensure exam, registration, licensing and “oathtaking”. 14 certain health conditions, in certain specified environments. The processes are usually defined in an organizational policy, and therefore pertain only to that organization. The wide variance in terminology and convention around credentialing means that only a superficial look was possible in the time-frame of this review. That said, it may be an important lever outside of regulation to ensure that practice is benchmarked against a set of agreed standards and assist in the development of processes for performance improvement. Some examples are outlined here to illustrate the use of credentialing. In Australia, credentialing refers to the initial authentication of qualifications and verification of documentation against set criteria that allows a professional to be employed in practice. Re- credentialing formally reconfirms qualifications and currency of practice with respect to professional registration or professional association membership, disciplinary actions, criminal history reports and performance review processes. These processes are undertaken by the national regulatory agency at the time of the annual renewal of practice certificates (if in a regulated health profession), or by the state government if it is a self-regulated or non-regulated profession. In other countries, implementation of formalized systems for revalidation of qualifications is limited or emerging. Japan introduced an e-learning system for pharmacists in 2012 that supports lifelong learning and requirements for revalidation of qualifications (7). However, the review was not able to identify information that describes how this is being implemented, especially given that licensure is granted for life. Credentialing in both definitions appears to be more generalized in developed countries with embedded regulatory systems, and usually exists in addition to the scopes of practice and competencies that must be demonstrated for registration and licensure. 4.4. Licensing or registration requirements 4.4.1. Pre-licensing For those countries with established regulatory systems, there is variation in pre-licensing or pre- registration requirements. This is particularly so in relation to nursing and midwifery, whereby most countries stipulate either a diploma or degree qualification to register as a nurse or a midwife; however, some accept several levels of training to be eligible for registration. In China, 90% of nurses have associate degree-level qualifications, equivalent to secondary education (that of ages 15–16 years), and there is wide variation in information relating to both the standards and quality of training and in the requirements for licensure. 15 Pre-licensing requirements for medicine are generally more consistent across the Region. Most legislation and associated regulatory documents stipulate that qualifications must be from approved courses and from an approved university, and identify the period of internship required before full licensure is granted. Periods of internship may, however, vary between 1 and 2 years. Where training occurs outside a country, most countries outline an approach whereby qualifications must be from a programme of study approved by the relevant council or board (where these bodies exist), the register, or a ministry or department. 4.4.2. National exams There is variation in whether a national exam is used to qualify graduates for registration or licensure, whether this exam is linked to a curriculum, and what involvement professional associations have in setting the content or standards for the exam. In Japan, all regulated health professionals are required to pass the national exam set by the Ministry of Health, Labour and Welfare. There does not appear to be a direct link to education nor to participation from various academic institutions; education providers; professional associations; or the Ministry of Education, Culture, Sports, Science and Technology. Cambodia introduced a national exam for dentists, nurses and pharmacists in 2012, and one in 2014, for medicine. Documents accessed suggest that there is an intention to strengthen the links between the requirements for the exam and the curriculum there. Hong Kong SAR (China) requires passing a national exam for most professions that are regulated, with the exception of medical graduates of the University of Hong Kong and the Chinese University of Hong Kong. Physiotherapy graduates of universities other than the two above may be required to take the physiotherapy board exam (M. Skinner, World Federation of Physical Therapy, personal communication, June 2014). In New Zealand, there is variation among professions as to whether passing a national exit exam9 is required, and if individuals are required to demonstrate that they possess a number of competencies prescribed by the regulatory board or council. Nurses and midwives are required to pass the state finals and national exam, respectively. Doctors and dentists trained in New Zealand or in countries that the respective boards or councils recognize as “equivalent” are not required to take the national exam. Those trained in countries not included in this list are required to take the exam. Australia does not have a national exit exam for graduating nurses and midwives, but the Nursing and Midwifery Board has a number of registration standards that must be met to gain and maintain registration. Other countries stipulate an exam requirement for most professions that are regulated, such as in Malaysia, Mongolia and the Philippines, but the standards may not be consistent across providers. 9 An exit exam is a test or exam that students must pass to graduate or receive their qualification. 16 4.4.3. Registration The terms “registration” and “licensure” are often used interchangeably in relation to health practitioner regulation, but they can imply different status and permissions. Registration in the context of this review is the process of enrolling on a register of health professionals and entering details such as name, occupation and qualifications. It may not indicate full licensure, as many professions require a two-step process to gain full registration and licence to practise independently. This is an important point, as the purpose of good regulation is to manage how practitioners get on the register, how ongoing competent practice is assured to stay on the register, and how to censure or remove practitioners from the register when serious professional or conduct issues arise. The principles of “right-touch” regulation can apply i.e. using the minimum regulatory force to achieve the desired result (Annex 6). Ultimately, the public should have confidence that registered health professionals are safe and their practice relevant. Registration requirements vary considerably between professions and across countries in the Region, and include various categories from student to specialist, the duration may also vary. Most countries require doctors to undergo a period of internship and provisional registration prior to full registration being granted, and some require secondary registration for specialists. Information on the latter was patchy however, and where it did exist, indicates a range of different approaches. Countries and areas in the first cluster have prescriptive requirements to register as a doctor and to obtain specialist registration. They also have strong links between the regulatory body and professional associations in relation to registration processes, as well as mandatory continuing professional development. Processes for countries and areas in the second cluster were less easy to identify, particularly with regard to specialists. In Japan, where registration is for life, professional specialist associations have historically authorized and credentialed specialist practice, yet anecdotally this role is increasingly being undertaken by the Ministry of Health, Labour and Welfare. Discussions about the remodelling of the specialty certification system have commenced, with the intention of introducing a new certification and quality assurance system in 2017. Official recognition of general practitioners and family physicians will also commence in 2017. Papua New Guinea and Solomon Islands require nurses to undergo a provisionally registered or probationary period before being fully registered, whereas other countries have no specified registration requirements other than obtaining a relevant qualification. A few countries require nurses to have a period of practical experience prior to obtaining registration, and many stipulate (often in legislation) that nurses must also be a “fit and proper person” or “of good character”. In some smaller countries such as Tokelau, with no internal nursing training, the chief nurse may assess readiness for (lifetime) registration in that country, but the nurse must also comply with any requirements for renewal of annual practice certificates in the country of first registration. Viet Nam and the Lao People’s Democratic Republic have no registration requirements for any health professionals, but relying only on published information means the status of proposed 17 or recently amended regulations or legislation may be difficult to identify.10 Legislation may also stipulate criteria for granting provisional and temporary registration, including time-frames and supervisory requirements. Provisional registration is most commonly applied to professions that have a period of internship, but may also apply to nursing in some countries. Temporary registration appears to be available for most professions in most countries and areas in the Region, and legislation usually specifies the exemptions, situations and time-frames for which it may be granted. These most often relate to emergencies and relief missions. Because of the significant variability in prerequisites and criteria across professions and countries in relation to temporary or provisional registration, this report simply notes it rather than attempting to compare and contrast. 4.4.4. Renewal There is variability among countries and areas and across professions regarding requirements for renewal of registration or licensure to maintain practice certificates. Where information is available, most countries require renewal of registration on an annual basis, such as Australia and New Zealand, whereas some require biannual renewal, such as the Commonwealth of the Northern Mariana Islands. Hong Kong SAR (China) requires an annual renewal for doctors and dentists and most other regulated health professions, but three-yearly renewal for nurses and midwives. Still others have a longer period of renewal, as in Mongolia, which is every five years for all regulated health professions. Other countries issue lifelong licences for some professions, such as for nurses in Solomon Islands, and all regulated health professionals in Japan. A couple of countries currently have no licensing requirements, such as the Lao People’s Democratic Republic and Viet Nam, and therefore no renewal requirement. Many countries and areas that require periodic renewal of a practice certificate or licence have regulations that also describe the continuing competency that must be demonstrated, and/ or the continuing professional development that must be undertaken to maintain registration. A number of countries have renewal requirements that relate more to declarations of fraud or criminal convictions than to demonstrating professional clinical competence and adhering to practice standards prescribed by the profession. Information about the requirement for continuing professional development was patchy across professions and countries in terms of whether it is mandatory or voluntary. In some countries, even where a continuing professional development requirement is stipulated in legislation, such as Singapore, it was difficult to ascertain how it is monitored by the regulatory body, and if there are penalties for not completing the requirements. In many countries, the relevant professional 10 The Physician Act of 2012 was drafted to replace the Medical Care Act of 1959 but has not yet passed despite a number of attempts to progress it through the legislative timetable. 18 association determines and supports ongoing continuing professional development requirements, but, in general, there did not appear to be a clear link between mandatory continuing professional development and renewal of registration, and whether recent legislation, either primary or amended, made a difference to re-registration processes overall. Beyond this review, the impact of variations in the requirements for continuing professional development on other components of regulation warrants further investigation. Information from interviews suggests that continuing professional development obligations are expected to be complied with rather than enforced, and in most countries, they are not followed up routinely. Introducing a consistent system from undergraduate education through continuing professional development, with oversight from a national body such as the General Medical Council in the United Kingdom, is viewed by some as an important step from a quality assurance perspective (M. Skinner, World Federation of Physical Therapy, personal communication, June 2014). 4.5. Notifications, complaints and disciplinary processes While many countries specify notification and/or complaint procedures in their legislation, aside from countries in the first cluster, published information on how these procedures are implemented is sporadic, including about the type of penalty applied.11 In some countries, such as Malaysia, disciplinary matters appear to pertain more to fraud than professional misconduct. Many countries have legislation that establishes a disciplinary council or professional conduct committee, although, in some cases, it was difficult to identify the disciplinary processes in place. This information gap was common for countries with significant reliance on foreign-trained and foreign-registered health professionals. Where information did exist, it indicated that matters of discipline were managed in the first instance by an employer, and escalated to the external professional or registration body if serious. A few countries in the second cluster have local, regional, provincial and national processes described in legislation, although the level at which disciplinary matters are dealt with may differ across professions. For example, Cambodia’s Medical Council Royal Decree (2000) states that disciplinary matters relating to doctors are dealt with by a national disciplinary council. The Cambodia Dental Council Royal Decree (2005) states that discipline is the responsibility of a regional disciplinary council. The Cambodia Council of Nurses Royal Decree (2007) requires disciplinary matters to be dealt with by a national disciplinary committee, but midwifery is the responsibility of a regional disciplinary committee. In legislation for pharmacists, the Pharmacist Council of Cambodia Royal Decree (2010) established the Board of the Regional Pharmacists’ 11 The Physician Act of 2012 was drafted to replace the Medical Care Act of 1959 but has not yet passed despite a number of attempts to progress it through the legislative timetable. 19 Council to deal with disciplinary issues. Regional complaints processes are also present in Japan, where under the revision of the Medical Service Law (2006), local governments established the Centre for Supporting Safety in Medical Treatment, offering complaint resolution for patients and relatives. However, the Ministry of Health, Labour and Welfare also has the authority to suspend or revoke licences, and a re-education programme for doctors who receive an “administrative penalty” to resume their practice, was introduced in 2005 (N. Ban, O. Fukushima, Japan Society for Medical Education, personal communication, September 2014). In some countries, disciplinary matters are the responsibility of government agencies that also have other, broader responsibilities. In Mongolia, disciplinary matters relating to medical practice may be dealt with by the Department of Health Ethics Committee, State Professional Inspection Agency or National Police Agency (11). Amendments to the Health Law of Mongolia (1998) are currently being considered, and these may assist with clarifying disciplinary processes. Countries and areas in the first cluster appear to have the most transparent processes in relation to notifications, complaints and discipline. Others have clear processes described in legislation, but information from interviews suggests that implementation is not always aligned with legislative intent, and that the way in which complaints and disciplinary matters are dealt with is strongly influenced by socio-political histories. Revision of current legislation relating to complaint processes is occurring in some countries, such as Japan, where responsibility for investigation of medical accidents and complications is moving from the police to new, purpose-specific agencies or centres (N. Ban, O. Fukushima, Japan Society for Medical Education, personal communication, September 2014). Further analysis of systems and processes for managing complaints and discipline across the Region, and their links to governance, education, accreditation, continuing professional development and licensure is needed. 4.6. Reciprocal agreements 4.6.1. Recognition of qualifications and prior learning The increasing mobility of health practitioners throughout their education, training and practice blurs the regulatory picture in an already diverse Region. A health professional may receive training in one country, complete an internship in another and be employed in several others. Further, recognition of prior learning and determining equivalence in regard to qualifications is increasingly complex, given the variability in educational quality and standards, and in the requirements for 20 and institutional oversight of continuing professional development. Some countries list equivalent or recognized qualifications and providers within their legislation, such as Malaysia, while legislation in others simply notes that boards or councils are able to determine equivalence on a case-by-case basis. Japan accepts applicants for licensure from foreign medical graduates that have completed six years of medical education in a school listed in the World Directory of Medical Schools. While this means that licensure is relatively open in Japan to foreign-trained medical professionals, applicants still must take the national exam, which is in Japanese, thus reducing the potential pool of candidates. The processes used to assess the qualifications and registration status of practitioners also vary. One study on nursing in Pacific island countries noted a tendency to rely on material presented, which may include a curriculum vitae, references, copy of qualifications, and sometimes a medical certificate. Few countries use competencies to assess suitability for foreign-trained nurses to gain registration (8). Other countries in the first cluster have prescriptive requirements, including levels and periods of supervision, for recognizing and registering foreign-trained professionals. Several agencies provide services and support to countries across the Region, in terms of educating and training health professionals, accrediting education providers, and supplying health professionals, through aid or other in-country support. This review sought only to identify information as it relates to regulation of health practitioner education and practice, yet it was often difficult to separate arrangements and processes given the number of potential agencies involved and the range and inherent complexity of issues being supported across the Region. Across all of the countries and areas, including those with well-established regulatory systems, the review could not identify a substantial amount of published information on the number, nature, tenure and impact of reciprocal agreements for the provision of training, credentialing, supervision and supply of workforce personnel. While some websites referred to reciprocal agreements for medical training and supply of personnel with countries such as Cuba, it was difficult to ascertain what the arrangements for internships, quality assurance, impact on supervision capacity or assurance of ongoing competence may be. Similarly, in Cook Islands, which has legislation to regulate health professionals but relies on another country to provide medical training and internships, there is little information on how the connection to education quality and the performance of education providers is made. It is also unclear how ongoing competence is assessed or who is responsible for sanctions where standards are not met or for enforcing any disciplinary measures. Anecdotal evidence suggests that local arrangements via an employer would manage some disciplinary matters, referring on to the body that initially registered a practitioner for more serious matters, but the review was unable to obtain published information substantiating this assumption. 21 4.6.2. Mutual recognition agreements The number, purpose and success of memoranda of understanding, mutual recognition agreements or bilateral agreements between countries that exist for the purpose of training and supply into practice varies considerably. Many countries have no health professional training, relying entirely on foreign-trained personnel, such as Macao SAR (China), which relies on China or Hong Kong SAR (China); Palau, which relies on Fiji, New Zealand and the United States of America; and many smaller Pacific island countries that rely on Australia, Fiji, New Zealand and Papua New Guinea. Reciprocal and mutual recognition agreements to facilitate training and workforce supply across the Region are consequently diverse, and may include numerous interconnected arrangements among governments, states, training providers, international agencies and individual countries. A health professional licence may enable him or her to practise across, for example, American state and territory boundaries, such as for nurses in American Samoa,12 or conversely, registration enables practice only in the province in which a practitioner is initially registered, such as in Cambodia. Even where bilateral agreements are in place, such as between Australia and New Zealand, there is variability between professions on whether courses and qualifications will be recognized from each country. Aside from agreements in place for American states and territories and Association of Southeast Asian Nations (ASEAN) member states, material on other agreements is scattered across agency, department and institutional publications and difficult to identify. A brief outline of ASEAN mutual recognition agreements for the seven countries in the Region which are ASEAN members illustrates the intent and potential breadth of mutual recognition agreements in the Region.13 Under ASEAN agreements,14 the governments of Brunei Darussalam, Cambodia, the Lao People’s Democratic Republic, Malaysia, the Philippines, Singapore and Viet Nam permit the mobility of medical, nursing and dental practitioners within ASEAN. Specifically, these mutual recognition agreements exist to exchange information and enhance cooperation in respect of mutual recognition of health practitioners; promote adoption of best practices on standards and qualifications; and provide opportunities for capacity-building and training of medical, nursing and dental practitioners. According to the mutual recognition agreements, each host country, subject to its own domestic regulations, is responsible for evaluating the qualifications, training and experiences of foreign medical, nursing and dental practitioners, and can impose any other requirement or assessment 12 The mutual recognition model of nurse licensure allows a nurse to have one licence (in his or her home state of residency) and to practise (both physically and electronically) in other states or territories that participate in this model of nursing regulation. Under mutual recognition, a nurse may practise across state lines unless otherwise restricted. Practice is subject to each state’s laws and rules. 13 The review did not assess the implementation status or success of this agreement on strengthening practitioner regulation for any of the ASEAN member countries. 14 The ASEAN Framework Agreement on Services and the ASEAN Vision 2020 aim for a stable, prosperous and highly competitive ASEAN economic region that results in the free flow of goods, services and investment; equitable economic development and reduced poverty and socioeconomic disparities; and enhanced political, economic and social stability. 22 for registration where applicable. Once registered, practice is assessed, monitored and disciplined according to the professional and ethical codes of conduct and standards of practice of the host country. ASEAN has established joint coordinating committees on medical, nursing and dental practitioners to facilitate the implementation of mutual recognition agreements, and to encourage standardization and adoption of mechanisms and procedures in the implementation of the mutual recognition agreements. The joint committees also encourage the exchange of information regarding laws and developments in the practice of medicine, nursing and dentistry within the Region with a view to harmonization in accordance with regional and/or international standards. ASEAN integration in 2015 is likely to put pressure on governments to streamline and accelerate these mutual recognition arrangements as well. 23 5. FINANCING Regulatory systems, schemes and processes require a significant amount of financial investment in time and resources, at various levels and by a range of contributors. Although legislation in most countries and areas in the Region describes the mechanism for funding registration processes, regulatory systems span a far broader array of functions. Costs can occur across several areas of the regulatory process, including accreditation of education and training programmes and providers; pre-licensing application and examination processes; registration and licensing; renewal of registration and issuing of practice certificates; assuring competence through imposing and monitoring requirements for continuing professional development; and notifications, complaints and disciplinary processes. Who bears those costs and how much funding is required at each level are generally determined by the number of applicants and candidates, the type of institutional arrangements that are in place, as well as the purpose of regulation itself. The exact amounts and sources of funding across an entire regulatory system are difficult to ascertain for most countries and areas because of the multidimensional nature of regulation, and because responsibility for various functions can sit across a range of agencies. All countries and areas in the Region that have a system for regulating health professional education and practice impose registration and licensing fees to finance regulatory processes, some also receive a level of state funding, and a degree of private investment or nongovernmental assistance exists in many systems.15 Along with regulation and legal requirements, many countries offer incentives to guide and change the behaviour of private entities, including health-care consumers, providers and insurance companies, and these activities could broadly be considered part of the regulatory system (2). Cognizant of the complexity and differences in regulatory approaches across the Region, only a brief overview of the financing of regulatory systems, using the six thematic areas discussed above, is provided here. At the education and training level, the accreditation of programmes and providers, which aims to improve quality by combining predefined standards and financial incentives, may be funded through a mix of institution, state and private funding, and involve agencies within or outside countries and areas. Implementing the WHO guidelines on transforming and scaling-up health professionals education and training implies a concomitant investment in time and resources relating to accreditation processes to ensure the quantity, quality and relevance of health 15 For example, assistance provided by the World Bank, WHO and other international organizations. 24 professionals (12). This is particularly relevant with the rapid growth of private, for-profit institutions operating in the health education arena. The second area of cost is registration processes, including pre-registration applications and examinations, re-licensing and renewal of practice certificates. Registration typically incurs a fee, payable by the applicant to a regulatory agency or board, for each step in the career and registration process. In the Philippines, examination fees are paid to the Commission for Higher Education, whereas registration fees are paid to the Professional Regulation Commission. In Hong Kong SAR (China), different fees are required for the licensing exam, general registration, specialist registration and practice certificates, and are paid to the relevant health professional regulatory board. Cambodia has five levels of registration, annual registration fees, and for some registrants, a monthly fee. Countries and areas that require foreign-trained health professionals to pass the relevant language proficiency tests to be eligible for registration charge individual applicants an examination fee. Some countries and areas support applicants to prepare for this exam, such as in New Zealand where a partially government-funded scheme has operated for the last several years, aimed at reducing the number of re-examinations. In some systems, although registration and practice certificate fees are paid by individual health professionals, employees may be reimbursed for those fees by their employers. This is the case in New Zealand, meaning that some of the costs of running the regulatory system are indirectly met by the Government for public sector employees, or by the private sector if privately employed. Australian legislation, on the other hand, does not permit payment of registration fees by employers, on the premise that achieving the standards required to be eligible for registration, and maintaining ongoing competence and fitness to practise, are individual responsibilities. Across the Region, notifications, complaints and disciplinary processes may be administered at national or local levels, and receive funding from a range of sources. In New Zealand, although the Health Practitioners Competence Assurance Act (2003) requires each registration authority to appoint an executive officer to the national Health Practitioners Disciplinary Tribunal, the tribunal is administered by the Ministry of Health. Fees for tribunal members, including for the chair and deputy chair, are also met by the Ministry of Health. In Australia, disciplinary matters may be referred to state-based disciplinary tribunals, and administrative costs met at a state level. Both countries have a range of other entities whose roles may intersect with the discipline of health professionals at some point. In Cambodia, disciplinary matters may be dealt with at either national or provincial level depending on the profession and seriousness of complaints. In Japan, where responsibility for managing complaints sits with local government at the prefecture level, administrative costs are incurred 16 The tribunal hears and determines disciplinary proceedings brought against registered health practitioners. 17 Other legislation establishes entities such as the Health and Disability Commissioner in New Zealand, and Health Ombudsmen in New Zealand and Australia who also hear complaints and disciplinary matters, and incur costs related to regulation. 25 at this level. Countries and areas that have recently reviewed or audited their regulatory systems appear to be moving towards more connected processes, even if professions are each regulated by separate boards. Interest is emerging from some countries, such as Australia, in the concept of multi-profession approaches, and in New Zealand, in a shared secretariat across several professions. It would be useful to explore the costs and financing of the specific tasks and responsibilities that fall within each of the core elements of regulation described above (e.g. the time and financial resources required to set and assure practice standards, to whom this responsibility falls, and if other agencies contribute). Similarly, for notifications, exploring the complaints and disciplinary processes, what other agencies or commissions may be involved, and where the costs fall (administrative and participatory) across the system would be useful. Whatever institutional arrangements are in place, regulatory systems need clear operational rules to ensure efficient use of funds, transparent financial reporting mechanisms, a greater degree of public accountability embedded in their legislation or regulations, and implementation of financial audit and public expenditure reviews (13). The principles of good regulation and a responsive regulatory framework18 that reduces the administrative and financial burden on health professionals and governing entities are important considerations in strengthening regulation in the Region. 18 The responsive regulatory framework developed by Ayres and Braithwaite in 1995 views regulation as a series of regulatory actions or tools of varying degrees of intervention and cost, arranged in the shape of a pyramid. At the base of the pyramid are the least interventional and costly activities, such as self-regulation and persuasion, while progressively more intensive and costly interventions occupy successive levels of the pyramid. At the apex are the sanctions and ruinous powers available to government. This approach proposes that regulation should focus on low-cost and low-intervention activities at the base of the pyramid, and only progressively escalate if these activities fail to have the desired effect. See Ayres, I. and Braithwaite, J. Responsive regulation: transcending the regulation debate. Oxford, Oxford University Press, 1992. 26 6. EMERGING ISSUES 6.1. Global mobility The health workforce is increasingly mobile across the Region and around the globe. Rapid economic growth, declining fertility, changing demography and demand driven by distribution and shortage issues are just some of the factors influencing this trend. This review did not seek to examine mobility in detail; however, it is evident from the literature that mobility is impacting regulatory systems, across all core elements of statutory regulation. Ensuring that quality and standards in education, standards for registration and ongoing competency and fitness to practise meet the requirements of destination countries is complex and challenging, particularly with multiple entry points and destinations for an increasing number of health professionals. 6.2. Telemedicine As telemedicine becomes more widely used, the issue of assuring competence and adherence to standards becomes complex. Regulatory authorities in Australia and New Zealand are exploring the implications for individual health professionals of telehealth services provided from another country (C. Reid, Nursing Council of New Zealand, personal communication, July 2014). Fiji National University has a memorandum of understanding with a private health-care provider in India for cooperation in training, capacity-building and organizing telemedicine, along with a mobile health programme. Although the obligations for assuring competence may be captured in service-level agreements between countries, this remains a grey area and particularly difficult with the increase in the number of private health-care providers, external accreditation bodies and countries providing training. 6.3. Private providers There is an increasing number of private education providers, as well as demand from the private sector for health practitioners. In Malaysia, there is increasing demand for pharmacists to practise in both the public and private sectors, and this, in turn, is driving positive change in pharmacy education and in the status of pharmacists in both the public and private sectors. However, there 27 is also increasing difficulty in: finding clinical placements for students from both private and public institutions; shortages of teaching academics and increased foreign recruitment to meet this shortage; and ensuring quality (7). Information suggests that the rapid increase in the number of private education providers is creating challenges in monitoring poorly performing education providers, and in restricting the number of new schools opening. For example, in the Philippines, despite a significant increase in the number of nursing schools (from 40 in 1980 to 470 in 2010), less than half of the students pass the licensure exam.19 While similar issues are reported in regard to the number and quality of private medical schools,20 initiatives such as the introduction of an outcome-based education framework from 2015 are expected to improve standards (14). Some countries require private health-care service providers to be registered. In Kiribati, the Medical Council also licenses private hospitals, but it is unclear how this is linked to a requirement for practitioners to also be registered. There was insufficient information to enable clarification, and further analysis in these areas of regulation may be required. 6.4. Interprofessional practice The trend in many countries towards strengthened primary health-care services, and for primary and secondary care settings and services to become more integrated, means that a regulatory model that takes into account interprofessional collaborative practice is likely to be most effective. Australia and New Zealand are investigating whether current regulation is sufficiently flexible to accommodate changes in the way practitioners will work, including across multiple settings, particularly in response to changing population health demands and ongoing resource challenges. In the Philippines, where regulation of education and practice has been undertaken by separate commissions, health panels from both the Commission on Higher Education and the Professional Regulation Commission now meet regularly, albeit informally. Panel members are strongly supportive of this development and its potential to foster more interprofessional practice. The emergence of interprofessional practice and integrated clinics is less evident in other countries such as Japan, where patients do not need a referral to see a specialist, and can choose either a clinic or a hospital as their first point of contact with the health-care system. The Japanese health system overall is physician dominated, with nursing playing a much smaller role in patient care. 19 A Lancet commission highlighted a call from 20 professional and academic leaders for major reform in the training of doctors and other health-care professionals for the 21st century. Changes are needed because of fragmented, outdated and static curricula that produce ill-equipped graduates. The commission argued for major reform across the entire medical education system to produce competency-led curricula for the future. 20 Of the 38 medical schools, only 6 are government-owned and funded, and the remaining 32 are privately run. 28 Exacerbated by increased health-care demands from a rapidly ageing population, the resultant shortages in the number of doctors is particularly evident in some areas of medical specialty and in rural locations. Information from interviews suggests that regulation could play a stronger role in influencing the number, type and deployment of health professionals to meet some of the aforementioned challenges. For many countries in the Region, however, severe workforce shortages and ensuring access, coverage and quality are more pressing issues. Many health professionals in these countries are already working across a diverse range of responsibilities by necessity, a range that would cross professional boundaries in other countries. 29 7. CONCLUSION This review sought to identify published information on the systems and processes for the regulation of health professional education and practice in the Western Pacific Region. It did not seek to ascertain the relative efficiency or effectiveness of regulatory systems on how well they achieve outcomes or improve health-care coverage. However, apart from the countries that fall into the first cluster, and a few in the second, there was a paucity of information on, or evidence of, implementation of regulatory processes. The report provides an overview, summarizing findings to date, but information gaps remain. Each piece of information identified potentially yields a further cascade of questions. Further consideration is needed to determine whether exploring answers to many of these questions sits within this project, or comprises separate work streams.21 Regulation exists in global, economic and socio-political contexts. Regulatory systems and processes are impacted by numerous factors, including mobility, government policies, international programmes, incentives, private investment and broader political agendas. Reviewed material indicates that the systems and processes that regulate health professionals in the Region are reflective of socio-political and cultural histories in each country. Across paradigms of individualism and professional self-determination to collectivism and tight government control are philosophical and practical differences that determine where regulation is focused, and how it is implemented. This review did not seek to explore the relative merits of the different approaches; rather, it sought to describe systems and processes and to articulate the similarities and differences, noting links and identifying emerging themes. Socio-political and cultural histories also influence nomenclature, i.e. the terms used and applied to describe systems and sets of activities. This review highlights the importance of clarifying and generating a shared understanding of the range of terminology applied to regulation across the Region. The findings reinforce the premise that regulatory processes and systems must be considered in context, cognizant of country characteristics, and that countries are supported to design, implement and enforce regulation according to their political, economic and cultural milieu (2). 21 Limitations of the desk review method are acknowledged. Written documents do not necessarily provide comprehensive or correct answers and are simply one form of evidence, and should be used carefully and with other types of data. 30 Health professional education, training and practice are not necessarily linear in nature, and there may be multiple parties, agencies and countries involved in the training, registration and deployment of any one practitioner. Further analysis is suggested to help identify the impacts of out-of-country training and accreditation on intern places, teaching and supervisory capacity, and the issuing and renewal of registration or licensure certificates. Emerging issues, such as the increased use of external education accreditation agencies and advances in telemedicine, create further challenges for regulators. An understanding of this multidimensional picture and its influence on regulatory approaches, including in relation to memoranda of understanding, mutual recognition agreements and bilateral agreements, becomes important. This review highlights that there is unlikely to be a single strategy for moving closer to best practice regulation. In some countries, it may be a case of maintaining the momentum of reforms or improving regulatory agency performance or processes within existing legal frameworks. In others, a new impetus may be required that focuses on knowledge-sharing, and moving towards better regulatory processes and a legal framework. Regardless of the processes that are in place, and their level of development, regulation is more likely to be successful if it is based on a set of principles that ensure it is the right vehicle to give effect to policy, and the risk that is being managed (Annex 5). Good regulation also needs political commitment, reasonable institutional capacity, systematic interaction with representatives of the private sector, professional representative bodies performing self-regulation and clarity of long-term purpose (1). Despite gaps and limitations, the information gathered in this review does provide a regional overview of the current status of health practitioner regulation. This report also establishes a baseline against which progress in strengthening capacities and processes for health practitioner regulation can be measured. The themes that emerged could form the building blocks for knowledge-sharing and a framework that will support best practice, effective and “right-touch” approaches to regulation at a country level (Annex 6). 31 In building this framework, the following questions may be useful in guiding discussion on the options and next steps for strengthening regulation in the Region. 1. What should be the basic objective for workforce regulation (e.g. protecting public health and safety, ensuring professional accountability or recognizing professional standing)? 2. Is there a minimum set of regulatory requirements needed to make a difference? 3. Are there examples of good practices across regulatory components? 4. What are the optimal institutional arrangements? 5. Should people other than those in the profession, including consumers, be involved in governance? 6. How should regulators be made accountable, and to whom? 7. How should the legislative framework be set out (e.g. profession-specific or overall)? 8. What options can be implemented for non-regulated professions? 9. What are the options for strengthening the relationship between education and regulation? 10. What are the impacts of increased mobility on regulation? 11. What mutual recognition agreements exist; at what level; and what are their implications for education, practice and regulation? 12. What resources are needed, both time and financial, to support effective and efficient regulation? 32 1. Regulatory policy and the road to sustainable growth. Paris: Organisation for Economic Co-operation and Development; 2010. 2. Harding A, Preker A, editors. Private participation in health services. Washington (DC): World Bank; 2003. 3. Western Pacific country health information profiles: 2011 revision. Manila, Regional Office for the Western Pacific: World Health Organization; 2011. 4. The best practice regulation model: principles and assessments. Wellington: New Zealand Treasury; 2012. 5. Council for Healthcare Regulatory Excellence. Right-touch regulation. London: Professional Standards Authority; 2010 (http://www.professionalstandards.org.uk, accessed 5 August 2015). 6. Randall G. Understanding professional self-regulation. Toronto: Ontario Association of Veterinary Technicians; 2000 (http://www.oavt.org/self_regulation/docs/about_selfreg_randall.pdf, accessed 5 August 2015). 7. 2013 FIPEd global education report. The Hague: International Pharmaceutical Federation (FIP); 2013. 8. McManus M, Usher K. Overview of regulation of nurses in the Pacific region. Melbourne: South Pacific Nurses Forum; 2012 (www.spnf.org.au/reports, accessed 6 August 2015). 9. Health Practitioner Regulation National Law (2010) Australia. 10. Health Practitioners Competency Assurance Act (2003) New Zealand. 11. Kwon S, Richardson E, editors. Mongolia health system review – World Health Organization. Health Syst Transit. 2013;3(2). 12. Transforming and scaling up health professionals’ education and training: World Health Organization guidelines 2013. Geneva: World Health Organization; 2013. REFERENCES 33 13. Leadership and governance: Monitoring the building blocks of health systems: A handbook of indicators and their measurement strategies. Geneva: World health Organization; 2010. 14. Roxas, A. Rationalizing medical education in the Philippines. Manila: Health Human Resource Development Bureau, Department of Health, http://hhrdb.doh.gov.ph/hrhnetworkphils/hrhn-dl file/5th%20Forum/1%20Panel%20A%20-%20Rationalizing%20of%20Medical%20Education%20 in%20the%20Philippines.pdf. 34 Country Legislation Kiribati Act on Public Health Nurses, Midwives and Nurses 1948, amended 2009 Pharmacists Act 1950 Medical and Dental Practitioners Act 1981 Medical Services Act 1996 Medical Services Act 1996. Enrolled Nurses, Nurses and Midwives Ordinance 1968 rev 1977 Medical Services Act 1996; Para Medical Lao People’s Democratic Republic Law on Health Care No.139/PM. 2005 Medical Act 1971, amended 2012 Dental Act 1971 and amendments Nursing Act 1950; amended 1985 Midwifery Act 1966 Registrations of Pharmacists Act 1951 Optical Act 1991 and amendments Traditional and Complementary Medicine Act 2013 Marshall Islands Marshall Islands Revised Code, Title 19, Regulation of Professions and Occupations 2004 Nursing Practice Act 2005 Mongolia Health Law 1998 Law on Drugs 1998 State Policy on Drugs 2002–2011 Nauru Health Practitioners’ Act 1999 (Commenced 2003) Nauru Practitioners Board Act 1999 New Zealand Health Practitioners Competence Assurance Act 2003 Health and Disability Commissioner Act 1994 Commonwealth of the Northern Mariana Islands Health Care Professions Licensing Act 2005 Niue Niue Act 1966 (NZ); Article 21 – Niue Constitution Palau Palau Health Professionals Licensing Act 2000 (Palau National Code, Title 34) Papua New Guinea Medical Registration Act 1980 Medical Act 1980, Part 3 Nurses By-Law, Health Practitioners Bill 1984 ANNEX 1: Legislation, acts and decrees consulted for this review, by country and area 35 Country Legislation Philippines Medical Act 1959 Republic Act No. 6111, Medical Care Plan, and Medical Care Commission 1969 Philippine Nursing Act 2001 Higher Education Act 1994 Republic Act No. 8981 – The Professional Regulation Commission Modernization Act 2000 Republic Act No. 7722, Presidential Decree no. 223. 1973 Republic Act No. 4419, The Philippine Dental Act 1965 Republic Act No. 5680, Physical and Occupational Therapy Law Traditional and Alternative Medicines Act 1997 Samoa Healthcare Professions, Registration and Standards Act 2007 Medical Practitioners Act 2007 Dental Practitioners Act 2007 Nursing and Midwifery Act 2007 Pharmacy Act 2007 Singapore Medical Registration Act 1997 Dental Registration Act 1999, revised 2009 Nurses and Midwives Act 2006 Pharmacists Registration Act 2007 Optometrists and Opticians Act 2007 Allied Health Professions Act 2011 Traditional Chinese Medicine Practitioners Act 2000 Solomon Islands Medical and Dental Practitioners Act 1996 Nursing Council Amendment Act 1997 Pharmacy Practitioners Act 1997 Pharmacy and Poisons Act 1988 Tonga Health Practitioners Registration Act 2001 Health Services Act 1991 Health Practitioners Review Act 2001 Medical and Dental Practice Act 2001 Nurses Act 2001 and Amendment Act 2004 Pharmacy Act 2001 Tuvalu Nurses Act 1975 Vanuatu Health Practitioners Act 2006 Nurses Act 2000 Control of Pharmacists Act 1953; scheduled amendment bill 2014 36 Country Number of regulated professions Australia 14 Brunei Darussalam 4 Cambodia 4 China 5 Cook Islands 4 Fiji 6 Japan 13 Kiribati 13 Lao People’s Democratic Republic 0 Malaysia 8 Marshall Islands Micronesia, Federated States of 2 Mongolia 3 Nauru 3 New Zealand 16 Niue Palau 3 Papua New Guinea 3 Philippines 13 Republic of Korea 21 Samoa 3 Singapore 8 Solomon Islands 3 Tonga 4 Tuvalu Vanuatu 8 Viet Nam 0 ANNEX 2: Countries and areas of the Western Pacific Region and number of regulated professions Areas Number of regulated professions American Samoa (USA) 3 French Polynesia (France) 4 Guam (USA) 4 Hong Kong SAR (China) 13 Macao SAR (China) 6 New Caledonia (France) Northern Mariana Islands, Commonwealth of the (USA) 20 Pitcairn Islands (United Kingdom) Tokelau (New Zealand) Wallis and Fortuna (France) USA = United States of America. Notes: 1. A blank space indicates no information or very small number of or no resident health professionals. 2. The exact number of regulated professions per country may differ from the numbers presented in this table due to differences in terminology and titles across countries and areas. Source: Western Pacific country health information profiles: 2011 revision. Manila, Regional Office for the Western Pacific, World Health Organization, 2011. 37 ANNEX 3: Questions to guide the desk review and list of professions reviewed • Is there a regulatory mechanism in place? • Is it underpinned by legislation, and what is the name of the act, decree, code, etc.? • Are there categories of registration? How many registrants are in each? • What are the registration requirements (e.g. licence, registration, secondary licence/registration)? • What are the pre-licensing requirements (i.e. primary qualification and duration, assessment, supervision, and duration of pre-licence period)? • Is there a body responsible for licensure? • Is a register maintained? Is it public? Does it cover complaints or disciplinary history? • What are the APC and other requirements (i.e. re-entry, grandparenting, exclusions, private practice)? • Are there links to education? • Is there an education accreditation mechanism? What is the body responsible for programme or provider performance and sanctions? • How are practice standards set and sanctioned? What is the body responsible? Describe the process. • How is adherence to practice standards ensured? What is the body responsible? Describe the process. • Is there a complaints or disciplinary mechanism(s)? What is the body responsible? Describe the process. • Notes, issues and gaps Medicine Optometry Osteopathy Dentistry Psychology Chiropractic Nursing Physio/physical therapy Chinese medicine Midwifery Occupational therapy Aboriginal/traditional medicine Pharmacy Podiatry/orthotists Acupuncture Medical radiation practice Psychotherapy Technicians Other Other Other 38 ANNEX 4: The best practice regulation model: principles and assessments (Source: The best practice regulation model: principles and assessments. Wellington: New Zealand Treasury; 2012) • Proportionality. The burden of rules and their enforcement should be proportionate to the benefits that are expected to result. Another way to describe this principle is to place the emphasis on a risk-based, cost–benefit regulatory framework and risk-based decision-making by regulators. This includes that a regime is effective and that any change has benefits that outweigh the costs of disruption. • Certainty. The regulatory system should be predictable to provide certainty to regulated entities and be consistent with other policies. There can be a tension between certainty and flexibility. A principles- or performance-based regime that provides for safe harbours, such as deemed-to-comply standards, tries to resolve this tension, but ensuring both attributes are optimally reflected is a challenge. • Flexibility. Regulated entities should have the scope to adopt least-cost and innovative approaches to meeting legal obligations. A regulatory regime is flexible if the underlying regulatory approach is principles- or performance-based; policies and procedures are in place to ensure that it is administered flexibly; and nonregulatory measures, including self-regulation, are used wherever possible. • Flexibility and durability can be two sides of the same coin. A regime that is flexible is more likely to be durable, as long as the conditions are in place for the regime to learn. Indicators of durability are that feedback systems are in place to assess how the law is working in practice, decisions are reassessed at regular intervals and when new information comes up, and the regulatory regime is up-to-date with technological change. These two principles have been grouped for carrying out assessments. • Durability. Closely associated with flexibility, the regulatory system has the capacity to evolve to respond to new information and changing circumstances. • Transparency and accountability. This is reflected in the principle that rules development and enforcement should be transparent. In essence, regulators must be able to justify decisions and be subject to public scrutiny. This principle also includes nondiscrimination, provision for appeals and a sound legal basis for decisions. • Capable regulators. The regulator has the people and systems necessary to operate an efficient, effective regulatory regime. A key indicator is that capability assessments occur at regular intervals and are subject to independent input or review. • Growth-supporting. Economic objectives are given an appropriate weight relative to other specified objectives. These other objectives could be related to health, safety or environmental protection, or consumer and investor protection. Economic objectives include impacts on competition, innovation, exports, compliance costs and trade and investment openness. A regime embodies this attribute if the identification and justification of trade-offs between economic and other objectives are explicit parts of decision-making. The growth-supporting principle is associated with a particular outcome, and hence, to some extent, differs from the previous six, as they can be seen as intermediate objectives. It does not assume that growth should be given prominence over other outcomes, but reflects that growth as an objective is not always identified or given due weight. It seeks to ensure that trade-offs between economic and other objectives are explicitly considered along with any other objectives emphasized in a regime. 39 ANNEX 5: Council of Australian Governments principles of best practice regulation (Source: Best practice regulation: a guide for ministerial councils and national standard setting bodies. Canberra, Council of Australian Governments, 2007) The Council of Australian Governments has agreed that all governments will ensure that regulatory processes in their jurisdiction are consistent with the following principles: 1. Establishing a case for action before addressing a problem. 2. A range of feasible policy options must be considered, including self-regulatory, co-regulatory and non-regulatory approaches, and their benefits and costs assessed. 3. Adopting the option that generates the greatest net benefit for the community. 4. In accordance with the Competition Principles Agreement, legislation should not restrict competition unless it can be demonstrated that: a. the objectives of the regulation can only be achieved by restricting competition, and b. the benefits of the restrictions to the community as a whole outweigh the costs. 5. Providing effective guidance to relevant regulators and regulated parties in order to ensure that the policy intent and expected compliance requirements of the regulation are clear. 6. Ensuring that regulation remains relevant and effective over time. 7. Consulting effectively with affected key stakeholders at all stages of the regulatory cycle. 8. Government action should be effective and proportional to the issue being addressed. 40 ANNEX 6: Right-touch regulation, Council for Healthcare Regulatory Excellence (Source: Right-touch regulation. London: Professional Standards Authority; 2010, http://www.professionalstandards.org.uk) Right-touch regulation describes the approach we adopt in the work we do. It is the approach that we encourage the health professional regulators to work towards. It frames the contributions we make to wider debates about the quality and safety of healthcare. Right-touch regulation means always asking what risk we are trying to regulate, being proportionate and targeted in regulating that risk or finding ways other than regulation to promote good practice and high-quality healthcare. It is the minimum regulatory force required to achieve the desired result. The concept has developed through our oversight role of the health professional regulators. It builds upon the principles of good regulation, identified by the Better Regulation Executive: proportionate, consistent, targeted, transparent, accountable. To these we added a sixth principle of agility. Agility in regulation means looking forward to anticipate change rather than looking back to prevent the last crisis from happening again. In practice, we have identified the following eight elements that sit at the heart of right-touch regulation: • Identify the problem before the solution • Quantify the risks • Get as close to the problem as possible • Focus on the outcome • Use regulation only when necessary • Keep it simple • Check for unintended consequences • Review and respond to change In our view, the benefit of this approach is ensuring that regulation has its most efficient impact on the problem being tackled. It also enables all parts of the system to play their full part in providing a more appropriate response to a problem. In healthcare, this includes the contribution of employers, educators, professionals and patients. The consequences of this approach may be less regulation or may be more regulation, but will certainly mean better regulation. 1.

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