KUALA LUMPUR, July 11 – Harsher enforcement on medicine-related offences under the government’s proposed amendments to the Poisons Act 1952 could discourage generic substitution in pharmacies, said a natural products biotech company.
Rajen M., who is a trained pharmacist and CEO of Holista Biotech that serves community pharmacies, explained that currently, pharmacists usually ask patients if they would like to purchase cheaper generic alternatives to the original medications prescribed by their doctors, as chain pharmacies tend to compete over prices.
However, the raised general penalties for offences under the Poisons amendment Bill 2022 – up to five years’ imprisonment, a maximum RM50,000 fine, or both – could scare off pharmacists from recording or tracking dispensations of multiple generic substitutes.
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.
“The moment this becomes a challenge, pharmacists will say they don’t want the extra risk,” Rajen said at a webinar with pharmacists last Friday to discuss the Poisons amendment Bill that is scheduled for second reading in the upcoming Parliament meeting that is scheduled from July 18.
“If I’m running a business but there is such a huge penalty, I’ll just stick with whatever is given; it’s easier to track.”
Enhanced enforcement powers for pharmacy officers under the bill would also increase the costs of community pharmacies in doing business, Rajen said.
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.
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”.
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.
Rajen pointed out that the Poisons amendment Bill does not clearly define “reasonable” cause for suspicion of offences or what actions or communications are defined as the refusal of compliance with an enforcement officer’s orders.
“This is a massive grey area that can possibly be open to corruption,” he said.
“Pharmacists are bound to make mistakes, as there are always long queues of people with prescriptions.”
He pointed out that harsher enforcement proposed under the Poisons amendment Bill would also make it harder for pharmacies to recruit younger pharmacists into retail, who are already less inclined to take up the job due to long hours and weekend work.
“It’ll affect your chances of employing young pharmacists and it’ll scuttle your growth.”
Rajen further highlighted the possibility of highly competitive chain pharmacies using the legislation to attack their business rivals.
“We’re all business rivals, but this is a law that will affect us all very adversely. I’m concerned by the high-handed powers given to enforcement officers,” he said.
“All of us pharmacists know what happens when you get raided. We don’t want to be at the mercy of the raiding officer,” he added.
Rajen criticised a provision in the Poisons amendment Bill 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.
“There is inordinate and unquestionable power given to enforcement officers. It’ll be pharmacists prosecuting pharmacists.”
He urged pharmacists to express their concerns to Members of Parliament in their constituencies so as to delay passage of the bill and allow revisions for a better law.
“They need to see it from our perspective on how this can affect every one of us voters, those who run a business on how this affects their business and employ people in our pharmacies that become voters in the election.”