CHAPTER ONE: INTRODUCTION
by NURUL HAYATI BOHARI
1. RESEARCH QUESTION
1.1. What is the Regulatory Enforcement of Medicine through Responsive Regulation Theory? (Chapter 2)
1.2. What are the current policy, law and practice of Regulatory Enforcement of Medicine in Malaysia through Responsive Regulation Theory? (Chapter 3)
1.3. What are the elements of responsive regulation theory can be adapted by the Regulatory Enforcement of Medicine in Malaysia in the context of policy, law and practice for improvement? (Chapter 4)
1.4. What are the contributing factors to the effective regulatory enforcement of Medicine? (Chapter 5)
2. RESEARCH METHODOLOGY
2.1. RESERACH DESIGN
2.2. SAMPLE SIZE AND SELECTION
2.3. DATA COLLECTION AND EXPLANATION
3. DELIMITATION
3.1. MEDICINE REGULATION
4. LIMITATION
4.1. ACCESSABILITY TO DATA
4.2. CURRENT ISSUES
4.3. AGENCY DEVELOPMENT
5. SIGNIFICANCE OF STUDY
5.1. understanding the regulatory enforcement of medicine
5.2. developing an effective enforcement tools between regulators, enforcement officer and regulatees
6. DIVISION OF CHAPTERS
6.1. INTRODUCTORY
6.2. THEORETICAL FRAMEWORK
6.3. MALAYSIAN POLICY, LAW AND PRACTICE
6.4. EMPIRICAL DATA - METHODOLOGY AND FINDINGS
6.5. MAIN ANALYSIS
6.6. CONCLUSION
7. BACKGROUND OF THE STUDY
7.1. INTRODUCTION
7.1.1. NUMBERS OF REGULATORY ENFORCEMENT AGENCY
7.1.1.1. SAME OBJECTIVE
7.1.1.1.1. PUBLIC INTEREST
7.1.1.1.2. SOCIO-ECONOMIC EFFECT
7.2. INEFFECTIVE AND WEAK REGULATORY ENFORCEMENT APPROACH
7.2.1. PUNITIVE APPROACH AND POLICING METHOD
7.2.1.1. CONTESTATION OR CONFRONTATION
7.2.1.1.1. EXAMPLE: VAPE ISSUE
7.2.2. REGULATORY ENFORCEMENT IMPLEMENTING RESPONSIVE REGULATION THEORY
7.2.2.1. ENFORCEMENT TOOLS
7.3. INSUFFICIENT REGULATION AND REGULATORY STYLE
7.3.1. LEGAL DESIGN
7.3.2. WEAKNESSES AND LACUNA IN THE EXISTING REGULATION
7.3.3. NO DETERRENT EFFECT
7.4. INCREASING REGULATORY ENFORCEMENT ACTIVITIES
7.4.1. NEED OF VARY APPROACHES OR ENFORCEMENT TOOLS
7.4.2. CORE-POLICING
7.5. HIGH RECIDIVISM
8. PROBLEM STATEMENT
8.1. Significant increasing of enforcement activities through policing method yet the numbers of non-compliances and unwillingness regulated actors to follow the laws. The merely effect of policing method reflected the endless effort of regulatory enforcement action and drives contestation. Recent high profile cases (such as the contestation of nicotinated e-cigarettes or “vape” traders) show that there is still a lot to do to make sure that the enforcement approach is efficient and effective. The regulatory enforcement approach is essential to ensure compliance and protect the society. Consequently, the current enforcement approach has deficiencies caused by inadequate of current regulatory enforcement strategy, lack of enforcement resources and insufficient enforcement framework throughout the process of implementation in tackling crime. Therefore, a workable and effective approach to improve enforcement work has been identified as a primary theory and effective called responsive regulation theory which developed by US Law Professor, Professor Ian Ayres and Australian National University, Professor John Braithwaite. In this study, the element of responsive regulation will be investigated and analysed empirically in regulatory enforcement of medicine in Malaysia. The respondents of the research will be the officers in regulatory enforcement and regulated actors of medicine regulations. What are the opinions of the officers and regulated actors about the element of responsive regulation towards Malaysian medicine regulatory enforcement? And does the responsive regulation can be adopted in Malaysia?
9. RESERACH PURPOSES
9.1. To investigate the Regulatory Enforcement of Medicine through Responsive Regulation Theory. (Chapter 2)
9.2. To explore the current policy, law and practice of Regulatory Enforcement of Medicine through Responsive Regulation Theory in Malaysia. (Chapter 3)
9.3. To analyse the element of Responsive Regulation Approach in the context of policy, law and practice of medicine regulation enforcement in Malaysia. (Chapter 5)
9.4. To evaluate the factors that contributes to the effective regulatory enforcement of Medicine. (Chapter 5 and 6)
