Registered medical practitioners have the right to dispense Ivermectin as a Group B poison under the Poisons Act 1952, irrespective of its unregistered status for human use.

Tengku Maimun Tuan Mat CJ:

Introduction

[1] The core issue in this appeal concerns the interpretation of certain provisions in the Poisons Act 1952 [Act 366] and the Poison Regulations 1952, as well as the Sale of Drugs Act 1952 [Act 368] and its regulations, namely the Control of Drugs and Cosmetics Regulations 1984 . We shall respectively refer to them asAct 366, the 1952 Regulations, Act 368, and the 1984 Regulations.

[2] The six questions upon which leave was granted ('Leave Questions'), are these:

"Leave Question 1

Whether the legal principles enunciated in Datuk Syed Kechik Syed Mohamed v. Government Of Malaysia & Anor; [1979] 2 MLJ 101 and YAB Dato' Dr Zambry Abd Kadir & Ors v. YB Sivakumar Varatharaju Naidu; Attorney-General Malaysia (Intervener); [2009] 4 MLJ 24; [2009] 4 CLJ 253 apply to the situations or circumstances or cases where there are substantial issues or grievances regarding pending criminal investigation, criminality, criminal charges and prosecutorial discretion of the Public Prosecutor?

Leave Question 2

In the circumstances where the disputes canvassed by the applicant is on the registered medical practitioners' right to dispense Ivermectin to patients for the specific purpose of pandemic Covid-19 treatment, is it apt for the Court to only rely on the provisions of the Poisons Act 1952 [Act 366] and Poison Regulations 1952 [1952 Regulations] and disregard the provisions of the Sale of Drugs Act 1952 [Act 368] and Control of Drugs and Cosmetics Regulations 1984 [1984 Regulations] in determining whether a registered medical practitioner is entitled to dispense Ivermectin to patients for the purpose of prophylaxis and / or medical treatment?

Leave Question 3

In the circumstances where at present, no product with Ivermectin as an active ingredient has been registered with the Drug Control Authority for human use and that it is the policy of the Government on the prohibition of Ivermectin for Covid-19 treatment, whether it is apt for the Court to directly or indirectly permit the use of an unregistered poison like Ivermectin including and not restricted to the treatment of Covid-19 which was contrary to the regulatory regime and framework of the Sale of Drugs Act 1952 [Act 368], Control of Drugs and Cosmetics Regulations 1984 [1984 Regulations], Poisons Act 1952 [Act 366] and Poison Regulations 1952 [1952 Regulations]?

Leave Question 4

In the circumstances where to date, it is the Government's policy that the use of unregistered Ivermectin for the treatment of Covid-19 is only permitted for the purpose of clinical trials subject to the approval of the Ministry of Health which is then in line with the guidance of the World Health Organisation (WHO) and that clinical trials to establish the efficacy and effectiveness of Ivermectin in this regard have yet to be concluded, whether it is apt for the Court to directly or indirectly permit the use of an unregistered poison like Ivermectin including and not restricted to the treatment of Covid-19 which was contrary to the regulatory regime and framework of the Sale of Drugs Act 1952 [Act 368], Control of Drugs and Cosmetics Regulations 1984 [1984 Regulations], Poisons Act 1952 [Act 366] and Poison Regulations 1952 [1952 Regulations]?

Leave Question 5

In the circumstances where the pandemic of Covid-19 gave rise to a public health emergency at a national and global level and that policy measures in respect of Covid-19 must necessarily be highly flexible, adapted based on every new development in scientific and medical knowledge, based on the collective experience of the world in dealing with a novel and deadly virus, whether it is apt for the Court to directly or indirectly permit the use of an unregistered poison like Ivermectin including and not restricted to the treatment of Covid-19 which was contrary to the regulatory regime and framework of the Sale of Drugs Act 1952 [Act 368], Control of Drugs and Cosmetic Regulations 1984 [1984 Regulations], Poison