KUALA LUMPUR, March 15 – The Ministry of Health’s (MOH) proposed amendment to the Poisons Act significantly raises penalties for medicine-related offences committed by health care providers and allows for clinic or pharmacy raids akin to raids for banned narcotics.
Under Clause 20 of the Poisons amendment Bill 2022, which was tabled in the Dewan Rakyat yesterday, general penalties for offences under the Poisons Act – which regulates medicines – will see a multi-fold increase in jail time of up to five years, a maximum RM50,000 fine, or both, from the current jail term of not more than a year, a fine of up to RM3,000, or both.
The Poisons amendment Bill also seeks to raise the penalty for any act or omission relating to wilful default or culpable negligence – which had endangered or was likely to endanger human life – to prison time of up to 10 years, a maximum RM200,000 fine, or both, from the existing maximum jail sentence of not more than two years, a fine of up to RM5,000, or both.
In comparison, a similar but worse offence of causing death by negligence under Section 304A of the Penal Code carries a lighter imprisonment sentence of up to two years, a fine, or both, compared to the proposed punishment in the Poisons amendment Bill.
The Poisons amendment Bill also seeks to raise 10-fold the fine for offences related to psychotropic substances from the current maximum RM10,000 to a maximum RM100,000 fine, besides raising the jail sentence limit from four to five years.
The Health director-general or any appointed drug enforcement officer can also compound any offence prescribed by the Health Minister via regulations to be an offence under the Poisons Act, with approval of the public prosecutor, in a new proposed Section 32A. The compound quantum is not specified in the Bill.
Typical offences under the Poisons Act include the non-tallying of records of medicines provided to patients, particularly Group B prescription drugs, such as diabetic and hypertension medication; dispensing unregistered or expired medicines; as well as dispensing prescription medicines without a prescription. Doctors can also dispense medicines, besides pharmacists, as there is no dispensing separation yet in Malaysia.
“You have to record in the poisons book the name of the patient, the patient’s IC number, the date, the address of the patient, the name of the medicine, the amount to be supplied, and the dose,” medical specialist Dr Milton Lum told CodeBlue. “Sometimes mistakes can arise, whether it’s the date or amount.”
According to Medical Practitioners Coalition Association of Malaysia (MPCAM) president Dr Raj Kumar Maharajah, private general practitioner (GP) clinics sometimes provide medicines that are not registered in Malaysia by getting them from abroad as they are cheaper overseas, such as hydroxyzine for flu or itchiness or creams like tacrolimus for chronic skin infection, besides providing abortion pills that are still not registered in Malaysia.
The new Poisons Amendment Bill tabled this time under Health Minister Khairy Jamaluddin does not include mandatory prescriptions upon request, after widespread outrage from doctors forced the withdrawal of proposed amendments to the Poisons Act tabled three years ago under the-then Pakatan Harapan (PH) administration in 2019.
A new proposed Section 26A under the Poisons Amendment Bill criminalises non-compliance with directives issued by the Health director-general that are not inconsistent with provisions of the Act that he or she thinks “necessary or expedient for the proper implementation” of Section 26 that relates to licences.
Enforcement powers of drug enforcement officers, whose powers can be exercised by any registered pharmacist in the public service, are significantly enhanced in the Poisons Amendment Bill to powers of a police officer under a new proposed Section 31A.
Appointed drug enforcement officers can search any premises and seize any drug, machinery, equipment, register, document, or computerised data by force if there is “reasonable” cause to suspect that an offence is being committed.
These include breaking open any door, gate or fence that obstructs entry into the premises and detaining any person found in the premises until the search is completed.
Any person who impedes the authorised officer from conducting his or her duties, refuses to comply with any orders, or supplies any false or misleading information, can be liable upon conviction to a maximum RM10,000 fine, jail of up to two years, or both.
A new proposed Section 31F prohibits anyone from recovering the costs from entry, search or seizure by enforcement officers or from claiming any damages unless such actions were made “without reasonable cause”.
Interestingly, the amendment Bill also offers a clause that protects authorised officers from civil lawsuits or criminal prosecution for any act if it was done “in good faith and in the reasonable belief” that it was necessary to enforce the Poisons Act or its regulations.
The Poisons Amendment Bill also permits evidence from an agent provocateur to be admissible in court.
Many of the changes proposed in the Poisons (Amendment) Bill 2022 are similar to existing provisions in the Dangerous Drugs Act 1952 that bans narcotics ranging from heroin to cocaine and marijuana – such as the clauses on indemnity from damages, admissibility of evidence from an agent provocateur, and seizure and forfeiture of drugs.
Ironically, the Dangerous Drugs Act does not state that an individual cannot sue the government, unlike the Poisons amendment Bill, only that nothing done by government officers in the course of their duties shall be deemed an offence under the Dangerous Drugs Act.
The Poisons amendment Bill also introduces a provision for electronic prescriptions by medical practitioners, dentists, or veterinary surgeons that must be signed with a digital signature made in accordance with the Digital Signature Act 1997.
The amendment Bill was tabled in the Dewan Rakyat yesterday by Deputy Health Minister Dr Noor Azmi Ghazali for first reading; the government is expected to attempt to pass the law during the current meeting that concludes next week.