KUALA LUMPUR, March 3 — The Federal Court has upheld the right of medical doctors to prescribe and dispense ivermectin, a landmark ruling that curbs the government’s role in public health measures.
The apex court dismissed an appeal by the Ministry of Health (MOH) against the Court of Appeal 2023 judgment that favoured two medical practitioners who filed suit.
In a written summary judgment released today, Chief Justice Tengku Maimun Tuan Mat said ivermectin is classified as a Group B poison under Section 19(1)(a) of the Poisons Act 1952 (Act 366) and that any registered medical practitioner could sell, supply, or administer it for treatment of a patient.
“We are further fortified in this view by reason of the fact that Section 21(2) (which section deals with Group B poisons) contains an entire procedure on prescriptions and how such poison (considered medication) is sold or supplied to the patient for the treatment of that patient,” Tengku Maimun said.
“We therefore agree with the respondents’ submission that under Section 19 of Act 366, and having regard to the scheme of that Act, the second respondent (as are all other registered medical practitioners) is allowed by law to dispense Ivermectin to his patients provided that such dispensation is for the purposes of that patient’s treatment only.”
The government and the MOH argued that ivermectin was not registered for human use and that even if the drug has been used for the treatment of Covid-19, it has only seen such limited use in clinical trials. The appellants further argued that the Poisons Act could not be read alone, but must be read subject to other laws, namely the Sale of Drugs Act 1952 (Act 368) and its 1984 regulations.
However, the Federal Court accepted the respondents’ argument that the Sale of Drugs Act did not apply to all registered medical practitioners who are only subject to the Poisons Act.
“Act 366 was passed with the overt intention of regulating and overseeing all manner of dealings with poisons including their sale and supply. By virtue of Sections 19 and 21 of Act 366, there is an express exemption in favour of registered medical professionals to dispense, in their professional judgment, Group B poisons for the treatment of their patients only. A prescription regime is also put in place to ensure that such dispensations or supplies are done in accordance with the law,” wrote Tengku Maimun.
“We notice that Act 368 pertains more to the establishment of offences against the sale of drugs and the powers of officers in relation to such offences. There is absolutely nothing in Act 368 that speaks to all manner of handlings and dealings of poisons.
“We also notice that in Act 368, there is no mention or reference whatsoever to ‘registered medical professionals’ in the manner clearly and lucidly alluded to in Act 366. Thus, if we were to accept that the two Acts 366 and 368 together constitute a regulatory mechanism for drugs and poisons – which suggestion is also made by the appellants – the silence by lack of such reference in Act 368 paints the impression that Parliament had, in passing both laws in the same year, intended that insofar as registered medical practitioners are concerned, it is Act 366 that should apply.”
The chief justice ruled that the Poisons Act expressly confers “specific rights” onto registered medical professionals to sell, supply, and administer Group B poisons to their patients for treatment only—”a specific regime” that the Sale of Drugs Act does not cater for.
Tengku Maimun stressed that the case was not concerned about the efficacy of ivermectin on Covid-19, but only with the “substantive right of the respondents and other registered medical practitioners to dispense the same to their patients for their treatment only as per Act 366.”
The apex court acknowledged that the government was perhaps rightly wary about the unproven use of ivermectin for Covid-19.
“There is no doubt that the government had its hands full managing: a major international public health crisis; hospitals with not enough beds and support equipment for dying or critical patients; doctors and nurses who were beyond exhausted; and a public that was against many of the measures introduced including vaccinations, and the restrictions on movement and gatherings. We can by no means trivialise any of these matters,” wrote Tengku Maimun.
“However, in relation to ivermectin, to curb its use, the government took it upon itself to decide that Act 368 and its 1984 Regulations can be used as a means to restrict the right accorded to registered medical practitioners to dispense Group B poisons (including ivermectin) as per Act 366, and to prevent any reliance on ivermectin for the treatment and/or prevention of Covid-19.
“Unfortunately, their application and/or constrained reading of Act 368 and the 1984 Regulations is erroneous and misplaced on all accounts of statutory construction.
“The Court of Appeal was correct to observe in this case that the present case only concerns the interpretation of the provisions of Act 366 and its 1952 Regulations as against the application of Act 368 and its subsidiary legislation in the 1984 Regulations. That is all this case is about.”
Tengku Maimun agreed with the respondents’ suggestion that if the government was wary about the use of ivermectin for Covid-19, the health minister should have, in consultation with the Poisons Board, amended the Poisons List.
“All things considered; it is not the Courts but Act 366 (properly interpreted) that grants the right to registered medical practitioners to dispense ivermectin as a Group B poison and if they continue to do so in accordance with Act 366, even if for the treatment/prevention of Covid-19, then this continues to happen because of the appellants’ failure to enforce more suitable legal mechanisms to curb the practice pending any proper determination of ivermectin’s ability to treat or prevent Covid-19 as the respondents and others like them claim it can.”
On September 21, 2021, Malaysian Association for the Advancement of Functional and Interdisciplinary Medicine chairman Dr Vijaendreh Subramaniam and Dr Che Amir Farid Che Isahak filed an originating summons against the government and the MOH.
Their lawsuit was filed after officers from the Selangor state health department’s pharmaceutical services division confiscated ivermectin from Dr Che Amir Farid’s clinic on June 14, 2021, during the Covid-19 pandemic.
Both doctors sought a declaration on the interpretation of the Poisons Act 1952 and the Poison Regulations 1952 to determine whether a registered medical practitioner was entitled to dispense ivermectin to patients.
In 2022, the High Court ruled in favour of the government, saying it was not the court’s role to decide policy issues in the field of scientific and technical expertise. Justice Ahmad Kamal Md Shahid said it was within the jurisdiction of the legislative and executive branches of government to make declarations on whether it was legitimate to use ivermectin on humans.
During the pandemic, anti-vaxxers frequently touted ivermectin, which is an antiparasitic drug intended for animals, to cure Covid-19, even though health regulators in Malaysia and around the world, including the United States’ Food and Drug Administration (FDA), did not approve the medicine for the prevention or treatment of Covid-19.
A study by the Institute for Clinical Research (ICR) under the MOH showed that ivermectin does not reduce the risk of severe disease, intensive care unit (ICU) admission, mechanical ventilation, or death from Covid-19.
“Based on the outcomes of the I-TECH study, ivermectin cannot be recommended for inclusion in current Covid-19 treatment guidelines as ivermectin does not reduce risk of severe illness from Covid-19,” then-Health director-general Dr Noor Hisham Abdullah said in a statement in November 2021.
“Until further supportive evidence becomes available, practitioners are cautioned not to recommend ivermectin, including sharing illegal advertising or sale of ivermectin for treatment of Covid-19.”
In August 2021, the MOH said ivermectin has been approved for off-label use only for clinical trials on Covid-19 treatment, but stressed that there was insufficient clinical evidence for the use of ivermectin to treat or prevent Covid-19. The MOH said only vaccines were proven to prevent the coronavirus.
“Self-medicating with ivermectin is a criminal offence because that product is not registered with the National Pharmaceutical Regulatory Agency (NPRA) for human use, besides the risk of side effects.”
