On July 21, 2022, Malaysia’s Parliament passed the Poisons (Amendment) Bill 2022 unanimously, three years after the amendment was tabled in 2019. The Poisons Act 1952 regulates the import, possession, manufacture, compounding, storage, transportation, sale, and use of poisons in Malaysia.
The legislation serves to increase penalties for offenses and enhance enforcement power on the use of poisons under the Poison Amendments Bill, to protect the people, the environment, and the market from the harmful effects of drug misuse or mishandling of supplies.
The amendments have received a lot of attention, especially from the healthcare industry. Healthcare professionals have claimed that the reforms had been a "long time coming" since the Poisons Act needed to be updated to reflect substantial developments in the healthcare sector in recent years and to factor in how medicine is practiced in this digital era. The prior law lacked provisions for dealing with issues such as control and limitations on illegal chemical substance usage.
Here are the three key changes to the Poisons Acts:
The general penalties offered by this section range from a fine of no more than RM 3,000 to a period of imprisonment of no more than one year, or both, to a fine of no more than RM 50,000 to a term of imprisonment of no more than five years, or both.
For any intentional misconduct, or negligent acts that endanger or puts in jeopardy human life, the penalty ranges from a fine of no more than RM 5,000 to a term of imprisonment of no more than two years, or both, to a fine of no more than RM 200,000 to a term of imprisonment of no more than ten years, or both.
Authorized officers can enforce, inspect, and investigate any suspected contravention of the Act at any time without any obstruction.
All prescriptions issued via electronic means by healthcare professionals will now be regulated and require digital signatures. These electronic documents should be kept and maintained.
However, there are concerns raised among healthcare practitioners that the excessive enforcement powers under the amended Bill will raise the costs of doing business for community pharmacists, as well as discourage generic substitution and dispensation of cheaper drugs alternative by doctors and pharmacists.
This might pose a challenge and affect the private healthcare professionals, pharmacists, drug owners, and wholesalers in their business modus operandi, pressuring them to always be walking on eggshells.
Getting the Right Support
The new Poisons Law is not a threat, but rather it prompts careful and diliget preparedness for all parties handling poisons. One option is to work with an established regulatory specialist like DKSH who can support your business and comply with the regulations of the newly amended laws.