Sanctioning System in Regulatory Enforcement of Medicine in Malaysia Bohari Nurul Hayati1,*, Ghani Abdul Samad Abdul2 1Doctoral Student, Faculty of Law, University of Malaya, Kuala Lumpur, Malaysia 2Senior Lecturer, Faculty of Law, University of Malaya, Kuala Lumpur, Malaysia *Corresponding Author Nurul Hayati Bohari Faculty of Law, University of Malaya, Kuala Lumpur, Malaysia e-mail: nurulhayati@siswa.um.edu.my
Online published on 13 November, 2019. Abstract A regulator uses sanction as a regulatory tool to enforce regulations and punish the non-compliant regulatees. Typically, the given sanction by the regulator will be a backfire when the regulatees are not satisfied with the sanction given. This contestation will definitely result in the regulatee's action against the law and the sanctions will therefore not have any impact on them. However, Responsive Regulation Theory (RRT) has proven that the enforcement pyramid is particularly useful in leading to more compliances, adequate regulatory enforcement and cost-efficiency. The elements of responsiveness in the RRT can lead to the right sanctioning system. Therefore, the aim of this paper is to map the sanctions taken by the Pharmaceutical Enforcement Division (PED) concerning medicine offenses as outlined in the RRT. The method of analysis for this study involved library search of statutory laws or regulation, statistical data, books and annual reports produced by the agencies, and personal communication. This study found that the PED sanctioning system is not in order of the pyramid escalation and a criminal penalty is not reserved as a ‘big gun’ as recommended by RRT. This study also recommends reformation of health policy in Malaysia in regulatory enforcement, enhancement of medicine regulations, expansion of collaboration between the government and businesses and improvement on current awareness programmes to ensure that knowledge given to the regulatees is well comprehended and easily applicable to them. It is suggested that future research should also explore the regulatees response towards enforcement approach. Top Keywords Sanction, enforcement action, regulatory enforcement. Top |