CHAPTER FOUR: Healthcare Regulations in Malaysia. 4.1 Regulatory Overview of Healthcare in Malaysia

Transcription

1 CHAPTER FOUR Healthcare Regulations in Malaysia 4.1 Regulatory Overview of Healthcare in Malaysia There are generally two key aspects of private healthcare regulation regulating private healthcare facilities and regulating the medical profession. The particular concern is issues of equitability and accessibility and the quality of healthcare services. In healthcare, there is imperfect information since consumers have only limited understanding of what will or will not restore health, while the provider has much better information on what the patient requires and usually has influence over what is supplied and consumed. The challenge for the regulator is to deal with this information asymmetry and protect the patient-consumers. Another issue is the implicit understanding between the professions and the state that the professions will ensure safe and competent services in exchange for the exclusive rights to provide these services. The concern here is that the professions may use their powers to further their own interests, rather than that of the general public basing on the principal-agent theory. The challenge for the state is to identify regulatory mechanisms and structures that are effective in protecting public interest [1]. 4.2 Historical development of the Existing Framework The principal-agent theory also known as the agency theory is important in regulating healthcare professionals. In healthcare services, the patients have scan knowledge or information on the treatments provided by the healthcare providers. They are at the mercy of the healthcare professionals placing their trusts on their advice and treatment. There is always the concern that the providers will place their personal interest above that of the patients to their detriment. With his concern the healthcare professionals are regulated through occupational licensing. Occupational Licensing of Healthcare Professionals Healthcare professionals have been regulated since before the country s independence. The earliest of the healthcare professions acts was the Nurses Act 1950 (Act 14) which was amended in The Registration of Pharmacists Act 1951 (Act 371) was the next to be enacted to be followed by the rest as shown in Table 4.1. There are other healthcare professionals who are not yet subjective to occupational licensing. These are the Allied Health Professionals (AHP). The Ministry of Health have identified 23 types of AHP and are working on the regulations to regulate them. 37

2 With occupational licensing of the healthcare professionals, the regulators assume the role of principal who ensures that the safety and rights of the patient are protected. The requirements ensure that only competent professionals with adequate and recognized qualifications get into the system. The regulatory control legitimizes the professionals by ensuring that incompetent, unqualified and fraudulent individuals do not get into the system. In a sense this provides these licensed professionals exclusive rights to practise. Table 4.1 Regulation of Healthcare Professionals No. Professions Acts & Regulations Regulators Licensing 1 Medical practitioner (Doctors) & specialists Medical Act 1971 (Act 50) Malaysian Medical Council Registration & Annual Practicing Certificate 2 Dentists Dental Act 1971 (Act 51) Malaysian Dental Council Registration & Annual Practicing Certificate 3 Nurses Nurses Act 1950 (Act 14) & Nurses Registration Regulations Malaysia Nursing Board Registration & Annual Practicing Certificate Midwives Midwifery Act 1966 (Act 436) Malaysia Midwife Registration & Annual 5 Pharmacists Registration of Pharmacists Act 1951 (Act 371) & Registration of Pharmacists Regulations Medical Assistants Medical Assistants (Registration) 7 Opticians & Optometrists 8 Allied Health Professionals (32 categories) Source Author Act 1977 (Act 180) Optical Act 1991 (Act 469) Bill has been drafted. Board Malaysia Pharmacy Board Medical Assistants (Registration) Board Malaysian Optical Council Practicing Certificate Certification of Registration & Annual Retention of Registration Annual Certificate of Registration Registration and Annual Practicing Certificate Registration required by These healthcare professionals are required to be registered formally with the regulators and apply for a practicing license to practice. The license needs to be renewed yearly with further provisions that the professionals achieve certain level of continuous professional development (CPD). This ensures that the professionals keep up with current development in knowledge and practice in their respective fields. Private Hospital Licensing The regulation for private hospitals was first established in 1971 with the enactment of the Private Hospitals Act 1971 (Act 43). The requirements then were not as stringent as the Act of the day as the explicit objective then was on the protection of the rights and safety of patients. There were then few private hospitals in the country and those in existence then were generally not-for-profit type of private hospitals established by religious organizations as such as Assunta Hospital, the Penang Adventist Hospital, Hospital and Mount Miriam Hospital to name a few. The others are the Chinese community-based charity hospitals such as the Tung Shin Hospital in Kuala Lumpur and the Lam Wah Ee Hospital in Penang. 38

3 However, after the 1980s, with the privatizing policy and the healthcare policy realignment, the government encourages the setting up of private healthcare facilities and services to complement the public healthcare services. With the new policy focus, the establishment of private for-profit hospitals grew quickly. The number of private healthcare facilities then grew from 50 in 1980 to over 200 by year Unfortunately the then Private Hospitals Act 1971 lacks to teeth to adequately regulate these private healthcare facilities and services from various policy concerns. Before 2006, the main Acts under which private hospitals were regulated are the Local Government Act 1976 (Act 171), the Private Hospitals Act 1971 (Act 43) and the Atomic Energy Licensing Act 1984 (Act 304). For the Federal Territory of Kuala Lumpur, Putrajaya and Labuan, there is the Federal Territory (Planning) Act 1982 (Act 267). The Local Government Act 1976 provides local governments with regulating powers and functions largely relating to the efficient use of land and on the liveability of the environment. The governance is based on the Uniform Building Bylaws However these laws and regulations are about standard local government planning and building procedures and are not specific to healthcare facilities. The Private Hospitals Act 1971 then provided the governance of private healthcare facilities including the private hospitals. The regulatory control was through licensing and inspection of the healthcare facilities private hospitals, nursing homes and maternity homes. An issued or renewed license was valid for a year. Together with this Private hospitals Act, the Atomic Energy Licensing Act 1984 provided regulatory control and licensing of radiation equipment and use of radioactive materials and for the establishment of standards, liability for nuclear damage and related matters. However, this Act did not provide adequate provisions to regulate all private healthcare facilities and services, such as medical and dental clinics, day surgeries, clinical laboratories, haemodialysis centres, ambulance services, and hospice. These limitations and omissions are addressed in the new Act, the Private Healthcare Facilities and Services Act 1988 (Act 586) [1]. The two main institutions involved in regulating private hospitals are the Ministry of Health (MOH) and the local authorities. Regulatory control is achieved through licensing. In establishing a private hospital, there is the need to construct the building and approval planning is necessary from the local authority. The process often referred to as dealing with construction permits involves the application for development order, a type of building license, followed by approvals for building plans and finally the issuance of certificate of completion and compliance. Act 568, however, also empowered MOH in planning approval for the pertinent requirements of a private hospital. This is explicitly stated in Section 9 of the Act. Once the planning approval is obtained, the licensee has to complete the building and then apply for the operating license from MOH within three years as is explicitly state in Section 14 of the Act. To qualify for the operating licensing the hospital has to 39

4 meet all the regulatory requirements prescribed in the Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities) Regulations 2006 [P.U. (A) 138/2006]. Within these regulations, there is also the license for installation and usage of radiation equipment issued by the Radiation Safety Unit of the MOH. 4.3 Current Legislative Arrangements In general, policymakers concerns with private healthcare are accessibility, equity and quality care. Achieving these objectives can be complex and it is difficult to formulate performance measures for them as they are multi-faceted and multidimensional. Depending on the context, there can be different dimensions to them. Malaysia s approach has been to formulate prescriptive regulations as in the PHFS Regulations 138. Accessibility From the World Health Organization s (WHO) definition, accessibility to health services can take four dimensions which encompass availability, accessibility, affordability and acceptability. The Government aspiration on this is to achieve universal accessibility on healthcare for the population. In general, the government has been quite successful in achieving universal accessibility to all Malaysians through public healthcare facilities and services. Public hospitals are generally available in all states, cities and towns across the country to ensure that primary, secondary and even tertiary care is accessible. Unfortunately, high demand for this welfare-oriented service has created overloading in the public hospitals resulting in long waiting times and the perception of poor services. For the services of private hospital where out-of-pocket payment is the norm in Malaysia, accessibility is confined to the higher income group. Although medical fees are somewhat regulated for medical consultation and medical procedure, the total treatment charges for private healthcare services is relatively hefty and unaffordable to more ordinary Malaysians (see Figure 4.1). While the WHO Health for All Strategy seeks to achieve access by all to a minimum standard of health services according to need, not according to the ability to pay, this is difficult to implement in the for-profit private hospital sector unless government directly subsidises costs for patients. For-profit private hospitals have the obligations to provide quality care and at the same time to ensure a reasonable return-oninvestment to the shareholders. 40

5 Figure 4.1 Income Distributions in Malaysia Source World Bank Report [http// ] Quality care Quality can be viewed from different perspectives. It can be defined in the light of the provider s technical standards and patients expectations and even from the clinicians perspectives, which equate quality in patient care to the improved clinical outcome. Improved outcomes mean lower mortality and better neurological function. To the patients, however, quality is more than optimum outcome, as increasingly, the nature of experience is as important. Quality is subjective and multidimensional, and includes patient safety, effectiveness of treatment, patient-centred service, timeliness and efficiency [2]. Asymmetric information and the principal-agent theory Besides the concerns for accessibility and quality care, there is also the dilemma of information asymmetry. This is particularly serious in healthcare in spite of the profusion of information on the Internet. With the commercialisation of healthcare and the increasingly competitive environment in healthcare business, patients as consumers of healthcare services do not have adequate knowledge nor expertise to make informed judgements about the quality of care. They have to place their trust on the well-informed professional provider [3]. They depend and delegate decision making to the attending professional healthcare provider. To protect the consumers the principal-agent theory is applicable here, with the regulator acting as the principal to ensure the safety and protect the rights of the patient. 41

6 The Private Healthcare Facilities and Services Act 1998 (Act 586) The Private Healthcare Facilities and Services Act 1998 (Act 586) Gazette on 27 th August 1998, but only came into operation on 1 st May 2006 with the issuance of the Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities) Regulations 2006 [P.U. (A) 138/2006] (referred here as PHFS Regulations 138). This regulation provides for the licensing of private hospitals and other private healthcare facilities to ensure that the minimum acceptable standards are complied with the provisions of the legislation together with the mandated accountability of private healthcare providers towards patient safety, the upholding of patient rights, and the assurance of quality care. The stringent provisions under Act 586 stipulated the mandatory approval and licensing of all private hospitals and other private healthcare facilities and services for the protection of patients and the accessibility of healthcare consumers in the country [2]. The analysis on the focus of the Act 586 is given in Appendix 4.1. The Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities) Regulations 2006 [P.U. (A) 138/2006] The PHFS Regulations 138 is a highly prescriptive regulatory instrument with the aim of addressing the concerns discussed above. It comprises 434 separate regulations and 13 th schedules. It is organized into 29 parts covering both private hospitals and other healthcare facilities and services as defined in the Act 586. The summary of the relevant parts of the regulations for private hospitals is listed in Box 4.1 below. More details of these regulations are in presented in Appendix 4.2. As many management system practices and clinical protocols have been prescribed in the regulations, any non-compliance on any of these prescribed requirements constitutes an offence. For example, Part III of the Regulations 2006 encompassing Regulation 11 to Regulation 20 mandates the planning of the organisation and management of the private hospitals and other private healthcare facilities or services. Under Regulation 11 stipulates that all private healthcare facilities and services shall have a plan of organisation outlining the staff and practitioners in the facility and the chain of command. Further as provided under Regulation 13 the Person-In-Charge (PIC) is responsible on the employment of qualified healthcare professionals including foreigners registered under the law and recognised by the Director General of Health. Besides, the licensee or PIC of a licensed private healthcare facility or service shall not indulge in any form corrupt practice of feesplitting and shall ensure that all healthcare professionals do not practise fee spitting too. Any person who contravenes these sub-regulations commits an offence and shall be liable on conviction to a fine not exceeding ten thousand ringgit or to imprisonment for a term not exceeding three months or both. 42

7 Box 4.1 Relevant PHFS Regulations for Private Hospitals Parts of Requirements of PHFS Regulations 138 for Private Hospitals II III IV V VI VII VIII IX X XI XII XIII XIV XV XVI XVII XVIII XIX XX XXI XXII XXIII XXIV XXV XXVI XXVII XXVIII XXIX Application for approval to establish or maintain or license to operate or provide private healthcare facilities or services and other applications Organization and management of private healthcare facilities and services Policy Registers, rosters and returns Grievance mechanism Patient medical record Consent Infection control General provisions for standards of private healthcare facilities or services Standards for Obstetrical or Gynaecological care Standards for newborn nursery facilities Standards for paediatric patient care Standards relating to Anesthesia Standards for surgical facilities and services Special requirements for critical care on intensive care unit Special requirements for emergency care services Special requirements for pharmaceutical services Special requirements for central sterilizing and medical-surgical supply facilities and services Standards for dietary services Special requirements for blood bank services, blood transfusion services or blood donation programme Special requirements for haemodialysis facilities and services (Applicable in some hospitals) Standards for rehabilitation facilities and services (Not applicable) Standards for specialist outpatient facilities and services Standards for ambulatory care (Not applicable) Special requirements for radiological or diagnostic imaging services and radiotherapy and radioisotope services Standards for private nursing homes (Not applicable) Special requirements for hospice and palliative care services (Not applicable) Miscellaneous (other facilities, ancillary services, fee schedule and penalty) Source PHFS Regulations 2006 [P.U. (A) 138/2006] The burden of accountability on business is speciality defined in the responsibility of the licensee and particularly in the PIC. The penalty for offences includes hefty fines and/or imprisonment, which makes the PHFS Regulations 138 to be perceived draconian control. Policy Objectives of the Government as in the National Healthcare Plan The Malaysian Government and in particular the Ministry of Health (MOH) recognise the rising expectations and demands for quality healthcare and better accessibility to services. The Ministry believes that it has some control over the supply of health services but not on the demand for healthcare services. The issues to the Ministry continue to be inequity of access to health services, inappropriate interventions and treatments as demanded by patients or induced by providers, varying quality and standards of care and costs that cannot always be effectively controlled. The issues are summarized in Box

8 Box 4.2 Summary of Issues Healthcare delivery Public-Private Dichotomy and other Structural Factors Accessibility to Services Responsiveness Quality and Standards of Care Variation in Quality\Pursuit of Affordable World Class Quality and Standards of Care Inappropriate Utilization Rising cost of care Inefficiency Increasing demand for health services in institutions Wasted resources Cost drivers Wealth Epidemiological transition Facing emerging/re-emerging infectious diseases Demographic transition Technology Financing the system Financial crisis Health awareness and lifestyle Knowledge behaviour gap Community s reluctance to take ownership of health issues Insufficient number of health promotion workforce Lack of supportive environment Empowerment of individuals and communities Constraints in implementing healthy public policy Weakness of legislation and enforcement Policies of other Ministries not in line with MOH Lack of public awareness Weaknesses in programme implementation Constrains in empowering women and specific risk groups Lack of supportive environment Lack of resources Organizational issues Information and communication technology Inadequate integrated planning of health information system Lack of health informatics expertise (subject matter and technical experts) Inadequate infrastructure Lack of standards Research Human Capital Development Mismatch of Supply and Demand Source Country Health Plan, MOH The Ministry continues to be concerned about the quality of care, service standards and high fee charges in the private health sector. It desires further integration of primary, secondary and tertiary services through strong public and private partnerships and strengthening the enforcement of the Private Health Care Facilities and Services Act 1998 (Act 586). The variation of quality of care is believed to be due to inadequate regulations and/or enforcements over health professionals and hospitals. Bearing in mind these issues or challenges, MOH has instituted six strategic directions in the 10 th Malaysia Plan- 1. Competitive Private Sector as Engine of Growth 44

9 2. Productivity and Innovation through K-economy 3. Creative and Innovative Human Capital with 21 st Century Skills 4. Inclusiveness in Bridging Development Gap 5. Quality of Life of an Advanced Nation, and 6. Government as an Effective Facilitator. Through these strategic directions, the Ministry aims to achieve quality healthcare and active healthy lifestyle in the country. The desired outcome is the provision of and increased accessibility to quality health care and public recreational and sports facilities to support active healthy lifestyle. The summary of MOH Key Result Areas and Strategy is in Box 4.3 [4]. Box 4.3 MOH Strategies and KRAs Key Result Areas 1. Health sector transformation towards a more efficient and effective health system in ensuring universal access to healthcare 2. Health awareness and healthy lifestyle 3. Empowerment of individual and community to be responsible for their health Source Country Health Plan, MOH Strategies 1. Establish a comprehensive healthcare system and recreational infrastructure 2. Encourage health awareness & healthy lifestyle activities 3. Empower the community to plan or implement individual wellness programme (responsible for own health) 4. Transform the health sector to increase the efficiency and effectiveness of the delivery system to ensure universal access The understanding of these policy objectives as laid out in the Country Health Plan will hopefully give us some understanding and appreciation of the motivation of MOH in its regulatory role of the private hospital sector though budgetary instruments are also important to achieve some of these results. The reader should refer to the Country Health Plan 10 th Malaysia Plan for further details on MOH policy objectives. 4.4 Regulators and Other Relevant Bodies The regulatory regimes for health in Malaysia are very extensive and complex and range across three levels of government and involve many different ministries, agencies, and departments. The principal regulator is the Ministry of Health (MOH). The comprehensive list of the licensing, permits, approvals and registrations is given in appendix 4.3 (in Bahasa Malaysia). However, the primary focus of this report is on regulatory aspects of Private Hospital operation by the MOH. Operating a private hospital is a complex business and the current regulatory regime makes it even more complicated. To establish a hospital business from planning to building to commissioning and licensing will take no less than four years. The investor has to deal with numerous Acts and Regulations and interacts with many regulators at the federal, state and local government levels. 45

10 Table 4.2 Business Life Cycle Regulations Business Life Cycle Acts and Regulations Regulatory bodies a) Start up Starting a business Companies Act 1965 Registration of Business Act 1956 b) Operation/ Expansion Dealing with construction permits Town and Country Planning Act 1976 Uniform Building By-laws 1984 Fair trade Competition Act 2010 Price Control and Anti Profiteering Act 2011 Utilities Fire Services Act 1988 Water Services Industry Act 2006 Electricity Supply Act 1990 Paying taxes Income Tax Act 1967 Service Tax Act 1975, Sales Tax Act 1972 Assessment Tax (Local councils) Trading across borders Employing workers Ownership of property Getting credit/raising fund Protecting investors Customs Act 1967, Excise Act 1976, Customs Duties order 1996 Exchange Control Act 1953 Employment (Amendment) Act 2011 Industrial Relation Act 1967 Minimum Wages Order 2012 Minimum Retirement Age Bill 2012 Employees Provident Fund Act 1991 Employees Social Security Act 1969 Pembangunan Sumber Manusia Berhad Act 2001 Occupational Safety and Health Act 1994 National Land Code 1965 Strata Titles Act 1985 EPU Guideline on the Acquisition of Properties (foreign investment) Anti-Money Laundering Act 2001 Capital Market & Services Act SC Guidelines on Private Debt Securities SC Guidelines on Sales Practice of Unlisted Capital Market Products Malaysian Code on Corporate Governance 2012 Bursa Malaysia Listing & Trading Requirements Enforcing contracts Contracts Act 1950 Stamp Act 1949 Specific Relief Act 1963 Windingup/Receivership Bankruptcy Act 1967 Source MITI-PwC Report 2013 [1] Note Author s addition in bold italic Companies Commission Malaysia (SSM) Ministry of Domestic Trade, Co-operatives, and Consumerism Local and municipal councils, Ministry of Housing and Local Government Note Kuala Lumpur, Putrajaya and Labuan come under a different Act and Ministry. Malaysia Competition Commission (MyCC), Ministry of Domestic Trade, Co-operatives, and Consumerism Fire and Rescue Department (BOMBA), Ministry of Housing and Local Government National Water Services Commission (SPAN), Ministry of Energy, Green Technology and Water Energy Commission (Suruhanjaya Tenaga ST & Tenaga Nasional Bhd. TNB) Inland Revenue Board (LHDN), Ministry of Finance Royal Malaysian Customs Department, Ministry of Finance Local and municipal councils, Ministry of Housing and Local Government Royal Malaysian Customs Department, Ministry of Finance Central Bank Malaysia (BNM) Ministry of Human Resource Employees Provident Fund (EPF) Social Security Organisation, (SOCSO), Ministry of Human Resource Human Resource Development Fund (HRDF) Ministry of Human Resource National Institute of Occupational Safety & Health (NIOSH), Ministry of Human Resource Ministry of Housing and Local Government Department of Director General of Lands and Mines (JKPTG), Ministry of Natural Resource & Environment Economic Planning Unit (EPU), Prime Minister s Department Bank Negara Malaysia Securities Commission (SC) Bursa Malaysia (Bursa) Attorney General s Chambers (AGC) Malaysia Department of Insolvency (MDI) 46

11 For example, Table 4.2 illustrates the general regulatory requirements that any business incorporations in Malaysia will have to comply with. For a private hospital, there are other regulatory requirements that have to be met. These are covered by the various health and medical Acts and Regulations that have been introduced over the years. Health regulations in Malaysia is extensive and expansive, covering the total health business value chain, including food, beauty products and services, and other health related activities. The health regulatory regime is relatively matured and well developed and is well aligned with World Health Organization standards and requirements. The health regulatory regime continues to be improved with the introduction of new regulations and the continual reviews of existing regulations in line with new challenges in healthcare, economic development, development in medical and pharmaceutical technology and societal and demographic changes. For example, the Ministry of Health has on first July 2013 implemented the Medical Device Act 2012 (Act 737) and the accompanying Regulations Apart from health regulations, the Ministry continues to develop and formulate new policy and operational guidelines for industry to self regulate their activities. The Ministry web-site has a listing of 36 Acts and Regulations on the healthcare sector under its purview and 15 policy papers for health professional reference. It has also published some 50 guidelines and electronic books for reference by both public and private hospitals. Prior to 1998, there is no specific regulation to govern the planning, establishment and operation of the private hospital business. The regulations on private hospitals were the same as that of public hospitals. In 1998, the Private Health Care Facilities and Services Act 1998 (Act 586) was enacted and was implemented on 1 st May 2006 with the gazette of the Private Health Care Facilities and Services (Private Hospitals and Other Private Healthcare Services) Regulations 2006 [P.U. (A) 138/2006] and the Private Health Care Facilities and Services (Private Medical Clinics or Dental Clinics) Regulations 2006 (P.U. (A)) 137/2006]. The MOH is the principal regulator for private hospitals and other private healthcare facilities in the country. There are also other regulators involved in the private hospital business as illustrated in Table

12 Table 4.3 Facilities and Services Regulations and Regulators for Private Hospitals Primary Activity Acts and Regulations Regulatory body Establishment Healthcare professionals Specialists Medical supplies Facilities Medical tourists Operations Services Healthcare professionals Specialists Diagnostics Treatment Rehabilitation Reporting (statistics & incident reporting) Sales & Marketing Promotion Brand development Market development Services Immigration Transportation Accommodation Financial Source MITI-PwC Report 2013 [6] Note Author s addition in bold italic Private Healthcare Facilities and Services Act 1998 Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities) Regulations 138/2006 Medical Act 1971 Dental Act 1971 Nurses Act 1950 & Nurses Registration Regulations 1985 Midwifery Act 1966 (Act 436) Medical Assistants (Registration) Act 1977 (Act 180) Registration of Pharmacists Act 1951 & Registration of Pharmacists Regulation 2004 Private Healthcare Facilities and Services Act 1998 Private Healthcare Facilities and Services (Medical Clinics or Dental Clinics) Regulations 2006 Medical Act 1971 Medical Regulations 1974 Dental Act 1971 Nurses Act 1950 Registration of Pharmacists Act 1951 & Registration of Pharmacists Regulation 2004 Optical Act 1991 (Act 469) & Optical Regulations 1994 Medical Device Act 2012 Medical Device Regulations 2012 Atomic Energy Licensing Act 1984 (Act 304) Environmental Quality Act 1974 (Act 1270 Factory and Machinery Act 1967 Fire Services Act 1988 Control of Drugs and Cosmetics Regulations 1984 (for manufacturing license) Statistics Act 1965 (Act 415) Medicines (Advertisement and Sale) Act 1956 Medicines Advertisements Board Regulations 1976 Malaysia Health Tourism Council Requirements Immigration Act 1959/63 Insurance Act 1996 Exchange Control Act 1953 Tourism Industry Act 1992 Land Public Transport Act 2010 Ministry of Health (various departments) Malaysian Medical Council (MMC) National Specialists Registration (NSR) Malaysian Dental Council (MDC) Malaysia Nursing Board (MNB) Malaysia Midwives Board (MMB) Malaysia Medical Assistants (Registration) Board (MMAB) Malaysian Pharmacy Board (MPB) Ministry of Health Malaysian Medical Council (MMC) Malaysian Dental Council (MDC) Malaysia Nursing Board (MNB) Malaysian Pharmacy Board (MPB) Malaysian Optical Council (MOC) Medical Device Board (MDB) Engineering Department of MOH Department of Environment (DOE) Department of Occupational Health and Safety (DOSH) BOMBA Malaysian Pharmacy Board Department of Statistics (DOS) Medicine Advertisements Board (MAB) Malaysia Health Tourism Council (MHTC) Immigration Department Malaysia Bank Negara Malaysia (BNM) Ministry of Tourism (MOT) Land Public Transport Commission & Road Transport Department (JPJ) The functional responsibilities for regulating the private healthcare providers are shared between different agencies, whether they are councils, boards, registrars or specialized departments and divisions, under the umbrella of MOH. These various agencies within MOH have their established roles defined by the various Acts and 48

13 Regulations a show in Table 4.4. [See also Table 4.1 on healthcare professionals registration and licensing]. Apart from these regulatory agencies, the private healthcare providers are also being represented by non-regulatory bodies which play important roles in the development and growth of the healthcare industry. Many of them have close working relationships with MOH and provide feedbacks and inputs to the Ministry on their regulatory roles. These non-governmental organizations (NGOs) represent the voice of its members and liaise with the Government. They also look into the continuous develop of their members. Table 4.4 MOH Agencies and Their Legislative Provisions Agencies Medical Practice Division Private Medical Practice Control Section (CKAPS) Malaysian Medical Council (MMC) Malaysia Dental Council Malaysia Nursing Board Malaysia Midwife Board Medical Assistant Board Malaysian Optical Council (MOC) Pharmacy Enforcement Division (PED) Legislative provisions Private Healthcare Facilities and Services Act 1998 [Act 586] Section 3 Approval and Licensing of facilities other than clinics; Section 4 Registration of clinics; Part XIV Managed Care Organisation; and Part XVI Enforcement (Section ). Regulations under Act Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities) Regulations 2006; 2. Private Healthcare Facilities and Services (Private Medical Clinics and Private Dental Clinics) Regulations 2006; 3. Private Healthcare Facilities and Services (Official Identification Card) Order 2006; and 4. Private Healthcare Facilities and Services (Compoundable Offences) Regulations Section of the Medical Act 1971; Section 20 of the Medical Act 1971; Section 29 31A of the Medical Act 1971 and Regulation of the Medical Regulation 1974; Second Schedule Medical Act 1971; and Malaysia Qualification Agency Act 2007 [Act 679]. Dental Act 1971 (Act 51) Nurses Act 1950 (Act 14) & Nurses Registration Regulations 1985 Midwifery Act 1966 (Act 436) Medical Assistant (Registration) 1977 Act [Act 180] Section 3(1); Section 6(1), 7(1); and Section 9(1). Optical Act 1991 (Act 469) Optical Regulations Poisons Act 1952 Section 31 Power of investigation, examination and entry into premise. Section 34 Sanction to prosecute and conduct prosecution. 2. Sale of Drugs Act 1952 Section 4(1)(a) Power to enter and inspect any place where he has reason to believe that there is any drug intended for sale. Section 4(1)(b) Power to mark, seal, otherwise secure, weigh, count or measure any drug, the sale, preparation or manufacture of which is or appears to be contrary to this Act Section 4(1)(c) Power to inspect any drug wherever found which is or appears to be unwholesome or deleterious to health. Section 4(2)(a) Power to seize any drug wherever found which is or appears to be unwholesome or deleterious to health. Section 4(2)(b) Power to destroy any drug wherever found which is decayed or putrefied. 49

14 Pharmacy Board Malaysia National Pharmaceutical Control Bureau Medicine Advertisement Board Food Safety and Quality Division Disease Control Division Source Author Section 5 Power to demand, select and take samples. Section 9 Power to call for information. Power to prosecute and conduct prosecution given by DPP under Section 376 of Criminal Procedure Code. 3. Registration of Pharmacists Act 1951 Section 21(2) power to enter premises to inspect, remove and detain 4. Medicines (Advertisement and Sale) Act 1956 Section 6B Power of investigation. Section 6C Power of Examination of witnesses. Section 6D Power to enter premises. Section 6F Sanction to prosecute and conduct prosecutions. Registration of Pharmacist Act 1951; and Registration of Pharmacist Regulations Control of Drugs and Cosmetics Regulations 1984 Where the Authority (known as the Drug Control Authority, DCA) established under these Regulations, is tasked with ensuring the quality, safety and efficacy of medicinal products through the registration, including quality control, inspection and licensing and postregistration activities. The NPCB acts as a secretariat to the Authority. The Medicines (Advertisement and Sale) Act 1956 [Act 290]; and Medicines Advertisements Board Regulations 1976 Food Regulation 1985 Food Hygiene Regulation 2009 Food Analyst Act 2011 Prevention and Control of Infectious Diseases Act 1988 (Act 342); Prevention and Control of Infectious Diseases (Importation and Exportation of Human Remains, Human Tissues and Pathogenic Organisms and Substances) Regulations 2006; and International Health Regulations These key non-regulatory bodies provide additional oversights on the behaviour and performance of the healthcare providers. The MSQH for example, provides voluntary quality accreditation for hospitals which assures quality patient care and protection of the rights of patients. In addition, it follows closely the requirements of the PHFS Regulations The accreditation process complements the licensing role of the MOH. The MHTC is under the umbrella of MOH and overseas the promotion of health tourism in the country. The main agenda of MTHC is to promote the Malaysian healthcare industry internationally and to develop healthcare into a global export. In this facilitating role it also ensures that health visitors into the country are protected and receive quality care. The MMA is another NGO that provides oversight of medical professionals. It has close liaison with the MMC in particular and other MOH regulators in general. Its oversight role is complementary to the licensing role of MMC. Together with this is the NSR which caters for voluntary registration of medical specialists. The MOH recognizes the Specialist Certification by NSR which is a requirement for licensing the specialist medical clinics. The certification legitimises the specialty area of the medical practitioner. These bodies also ensure the continuing professional development of its members as part of the regulatory requirements. The other 50

15 professional bodies with similar roles as MMA, although not as authoritative, are listed in Table 4.5 below. Table 4.5 Key Non-Governmental Bodies in Healthcare Regulation Bodies Malaysian Health Tourism Council [Note MHTC was established under MOH with Cabinet approval in 2009] Malaysian Medical Association http// [A National Association for Medical Doctors] National Specialist Register http// The Academy of Medicine Malaysia http// my/ Association of Private Hospitals Malaysia http// Malaysian Pharmaceutical Society http// Purpose/objective/function Mission To promote global awareness of Malaysian healthcare facilities and services. To promote and facilitate the development of the Malaysian healthcare industry so as to penetrate the global market. Objective To facilitate public-private sector collaboration so that issues affecting this industry can be effectively addressed to ensure that health visitors have a seamless experience with Malaysian healthcare services. Objective To promote and maintain the honour and interest of the profession of medicine To serve as a vehicle of the integrated voice of the whole profession To participate in the conduct of medical education, as may be as appropriate Purpose To ensure that doctors designated as specialists are appropriately trained and fully competent to practise the expected higher level of care in the chosen specialty. With the National Specialist Register in place, doctors will be able to identify fellow specialists in the relevant specialties to whom they can refer either for a second opinion or for further management. Importantly, the National Specialist Register protects the public and will help them to identify the relevant specialist doctors to whom they may wish to be referred or may wish to consult. AMM is a professional organisation to assure the maintenance of a high standard of professional and ethical practice. AMM was formed in 1966 and was registered on 22nd December, 1966 under the Societies Act (1966). The Academy of Medicine of Malaysia embraces all specialities in medicine. The APHM plays an important role in its objective of helping to raise standards of medical care within the country. Some of the activities geared towards this objective include- Ensuring patient safety and quality as a member of the National Patient Safety Council, the Malaysian Society for Quality in Health and the Malaysian Productivity Council. Working dialogues with public sector agencies including Ministry of Health Malaysia Participation in National working groups such as MPC, MITI and MATRADE. Training programs for all Healthcare providers which include the yearly Conference and Exhibition and regular smaller group workshops on clinical and administrative / managerial topics. Promotion of Health Tourism Activities regionally and internationally with the Malaysia Healthcare Travel Council (MHTC) Among the aims of the Society are To promote and maintain the honour and interest of the profession of pharmacy To encourage and further the development of Pharmacy and Pharmaceutical Education and to foster intra-professional relationship among members. To improve the Science of Pharmacy for the general welfare of the public by fostering the publication of scientific and professional information relating to the practice of pharmacy and aid in the development and stimulation of discovery, invention and research. To uphold and enhance the standard and ethics of the profession. To affiliate an co-operate with any organization as may be deemed desirable in furthering the aims of the Society. To represent the views of the members in matters affecting the common interest of the profession. 51

16 Malaysian Society of Anaesthesiologists http// Malaysian Nurses Association http// To assist in improving the health services in the country. To enhance the professionalism of pharmacists, the Society endorsed the Code of Conduct For Pharmacists And Bodies Corporate as established by the Pharmacy Board. The Malaysian Society of Anaesthesiologists was founded in It was initially Registered as Malayan Anaesthetic Society but changed its name to Malaysian Society of Anaesthesiologists in the 1970s. Objectives To promote the art and science of Anaesthesiology. To co-ordinate the activities of Anaesthesiologists. To represent Anaesthesiologists and protect their interests. To encourage and promote co-operation and friendship between Anaesthesiologists and to do such lawful things as may be indicated or conducive to the attainment of such objects. MNA Objectives To achieve liaison with similar bodies and other specialties in other regions. To achieve our mission, the Association aims to- develop and promote high standards of nursing practice and research. uphold the image of nursing. abide by the professional ethics. be the centre of National and International Nursing networking. implement and collaborate with other organizations for health promotion. Malaysian Association of Objectives Of The Association Medical Assistants http// om/ To cater for the professional interests of medical assistants and to all those having connection with and the practice of medical and health sciences towards helping to sustain standard and work ethics. To facilitate the exchange of information and ideas by literary, technical and social activities on matters affecting the role of medical assistants in relation to primary health and medical care, emergency medicine, medical/ surgical specialisation and super specialisation and medical management, administration and supervision. To foster and preserve the unity and aim or purpose of the profession. To support a high standard of professional ethics and conduct. To enlighten and direct public opinion on professional aspects in relation to medical and health problems. To promote the advancement of medical assistants as a profession and to maintain the standard of training, service, education and interests of the profession at all levels. To voice its opinion and to acquaint the government and other bodies with the policy and attitude of the medical assistants profession. To promote and participate in social, medical and charitable activities in building an united Malaysian nation. Malaysian Dental Objectives Association To promote the art and science of dentistry http// To maintain the honour and interest of the dental profession. Affiliations a) Malaysian Endodontic To foster and preserve unity, aim and purpose of the dental profession as a whole. Society To hold periodical meetings of members of the association for the b) Malaysian Private discussion of scientific subjects professional matters and social purposes. To encourage study and research in the field of dentistry. Dental Practitioners To support and promote a high standard of ethics and professional Association conduct. c) Malaysian Association To enlighten and direct public opinion on dentistry and problems of dental of Aesthetic Dentistry health. d) Malaysian Oral Implant Association To publish papers, journals and other materials in furtherance of the above objects Source Websites of associations and bodies. 52

17 Private Hospital Life-cycle Value Chain - Regulatory Regimes Having identified the various Acts and Regulations the linkage to the business lifecycle value chain for the private hospital and the resulting regulatory regimes can be established. This provides an overview of the complex nature of regulatory regimes from the stage of starting the business, its continuing operation and growth to its eventual winding-up. The details of the regulatory regime are in Appendix 4.3. Using the business life-cycle value chain established in Chapter two (see Figure 2.4), the resultant linkage can be formulated as in Table 4.6. There are four stages to the business life-cycle a) Establishment (start-up), b) Operation and maintenance (license renewal), c) Expansion (growth & improvement), and finally d) Winding-up. Table 4.6 provides an overview of the regulatory regimes for the business life-cycle for private hospital. Table 4.6 Private Hospital Life-cycle Value Chain - Regulatory Regimes Acts & Regulations Business life-cycle Regulatory regime (Appendix 4.3) Companies Act 1965 Registration of Business Act 1956 National Land Code 1965 Strata Titles Act 1985 EPU Guideline on the Acquisition of Properties (foreign investment) Town and Country Planning Act 1976 Federal Territory Planning Act 1982 Uniform Building By-laws 1984 Fire Services Act 1988 Water Services Industry Act 2006 Electricity Supply Act 1990 PHFS Act 1998 PHFS Regulations 138/2006 Contracts Act 1950 Stamp Act 1949 Specific Relief Act 1963 Establishment Starting a business Acquiring property (land matters) Establishment of private hospital Construction of building Land conversion Utilities requirements Establishing contracts Business registration (SSM) Land acquisition and registration (State) Strata title (State) Dealing with construction permits Development Order (LA) Planning Approval (LA) Land conversion & registration (State) Approval to Establish (MOH) Fire safety (BOMBA) Water & sewerage (SPAN) Approval for electricity (ST/TNB) Certificate of completion & compliance (LA) Registration of contracts Stamp duties PHFS Act 1998 PHFS Regulations 138/2006 Medical Device Act 2012 Medical Device Regulations 2012 Atomic Energy Licensing Act 1984 Environmental Quality Act 1974 Factory and Machinery Act 1967 Fire Services Act 1988 Control of Drugs and Cosmetics Regulations 1984 Poisons Act 1952 Sale of Drugs Act 1952 Medicines (Advertisement and Sale) Act 1956 Medical Act 1971 Medical Regulations 1974 Dental Act 1971 Nurses Act 1950 Registration of Pharmacists Act 1951 Operation & Maintenance Operation & maintenance of hospital & healthcare facilities Healthcare professionals o Medical doctors o Medical specialists o Dentist & dental specialists o Nurses Operation licensing (MOH - CKAP) Licensing of medical devices (MDB) Licensing of radioactive medical equipment (MOH) Licensing of hazardous waste (DOE) Passenger lifts safety certificate (DOSH) Autoclaves & other pressure vessels (DOSH) Fire safety certificate (BOMBA) Drugs and pharmaceuticals manufacturing license (MPB) Approvals for advertisement and adverting materials (MAB) Registrations for all healthcare professionals (various boards/councils) Annual Practising Certificate for all healthcare professionals, including Allied Health Professionals (various boards/councils) 53

18 Registration of Pharmacists Regulation 2004 Optical Act 1991 (Act 469) & Optical Regulations 1994 Employment (Amendment) Act 2011 Industrial Relation Act 1967 Minimum Wages Order 2012 Minimum Retirement Age Bill 2012 Employees Provident Fund Act 1991 Income Tax Act 1967 Employees Social Security Act 1969 Pembangunan Sumber Manusia Berhad Act 2001 Occupational Safety and Health Act 1994 Immigration Act 1959/63 Local Government Act 1976 Land Public Transport Act 2010 Similar to operation and maintenance o Midwives o Medical Assistants o Opticians & Optometrists o Pharmacists o Other Allied Health Professionals Other employment requirements Other business licensing Continuing operation Private Hospital License is renewable every 2 years. Other types of licensing are usually on an annual basis Specialist Certification (NSR) Registration of workforce (MOHR) Registration of Unions (Industrial Relations Department MOHR) Registration of employees with SOCSO Registration of employees with PSMB Registration of employees with LHDN Work Permits (Immigration) Various types of permits on workforce (see Appendix 4.3) Premise License (LA) Advertising License (LA) Vehicle Parking License (LA) Food Premise License (LA) Vehicle Type Approval (JPJ) Except for those one-off registrations, all other renewable licenses and certifications are the same of Operation and Maintenance. Similar regulations are applicable as for establishing a new hospital PHFS Act 1998 PHFS Regulations 138/2006 Companies Act 1965 Income Tax Act 1967 Bankruptcy Act 1967 Employment (Amendment) Act 2011 Industrial Relation Act 1967 Source Author Expansion/Growth (include improvement) Renovation on building Up-grading of facilities Extension of building Acquiring adjacent land for extension Winding up business Closing down Sales or ownership transfer Bankruptcy Similar planning as in dealing with construction permits (LA) Establishment approval (MOH) Re-licensing on completion by MOH to include the new facility. Surrender of operating license (MOH) Notification on retrenchment (MOHR) Receivership processing (MDI) Registration of company (SSM) 54