KUALA LUMPUR, July 29 — Seven medical and dental groups, as well as an individual general practitioner (GP), have taken the government to court to quash a medicine price display mandate.
A judicial review application was filed in the High Court here last Thursday by the Association of Private Practitioners, Sabah (APPS), the Malaysian Medical Association (MMA), the Malaysian Association for the Advancement of Functional and Interdisciplinary Medicine (Maafim), the Organisation of Malaysian Muslim Doctors (Perdim), the Federation of Private Medical Practitioners Associations Malaysia (FPMPAM), the Malaysian Private Dental Practitioners’ Association (MPDPA), the Society of Private Medical Practitioners Sarawak (SPMPS), and Dr Saifulbahri Ahmad, a medical practitioner who operates a GP clinic in Lahad Datu, Sabah.
The eight applicants named the domestic trade and cost of living minister (first respondent), the health minister (second respondent), and the government (third respondent) in their lawsuit over the Price Control and Anti-Profiteering (Price Marking for Drug) Order 2025 that was gazetted under Section 10 of the Price Control and Anti-Profiteering Act [PCAPA] 2011 and came into effect last May 1.
“The Impugned Order was made in excess of the 1st Respondent’s power as Section 10 of the PCAPA 2011 cannot apply to poisons administered by registered medical practitioners in the course of treatment authorised under Section 19 of the Poisons Act 1952,” said applicants in their 78-page statement of claim, as sighted by CodeBlue.
Section 10 of the PCAPA empowers the minister to gazette price marking orders for “any goods or services which are to be supplied”, whereas Section 19 of the Poisons Act empowers registered medical doctors and dentists to “sell, supply or administer” poisons to their patients for the purpose of medical or dental treatment.
Applicants maintained that medical and dental clinics operated by registered medical and dental practitioners cannot be said to be supplying “goods or services”, as per Section 10 of the PCAPA.
“The enabling parent act of the Impugned Order, i.e. the PCAPA 2011, cannot have any application to the sale, supply and administration of poisons by professional men for purposes of medical/ dental treatment under Section 19 of the Poisons Act 1952,” said applicants.
“The enabling parent act of the Impugned Order, i.e. the PCAPA 2011, when the purpose and object is examined and interpreted in the proper context, only empowers the 1st Respondent to control prices of goods and charges for services. The administration of medical/ dental treatment by professional men is neither sale of goods nor supply of services within the context of the PCAPA 2011.
“As such, charges for medical treatment, including the dispensing of drugs, are not ‘prices of drugs’ but are part of the fees of professional services.”
Applicants explained that the administration of medical or dental treatment, including professional fees, is regulated by specific laws applicable to medical or dental professionals, including the Medical Act 1971, the Dental Act 1971, the Poisons Act 1952 and the Poisons Regulations 1952, the Private Healthcare Facilities and Services Act (PHFSA) 1998 and the Private Healthcare Facilities and Services (Private Medical Clinics or Private Dental Clinics) Regulations 2006, as well as the Medicines (Advertisement & Sale) Act 1956 and the Medical Advertisements Board Regulations 1976.
Applicants contended that the doctor-patient or dentist-patient relationship, unlike a trader-customer/ consumer relationship, is not “an agreement to sell and offer to sell” as envisaged under the PCAPA.
“Medical/ dental practitioners do not sell nor supply goods within the meaning of ‘sale’ and ‘supply’ under the PCAPA 2011. Rather, dispensation, sale, supply and administration of drugs by professional men comes within the composite process of treatment provided for under Section 19 of the Poisons Act 1952.
“The sale of drugs within the context of Section 19 of the Poisons Act 1952 is ancillary to the process of treatment and comes as an end product to consultation, examination, diagnosis, prescription.”
Labelling Of Drugs Already Regulated Under PHFSA
Applicants pointed out that the pharmaceutical aspects of a private health care facility, such as labelling of drugs, are already regulated under Part XI of the Private Healthcare Facilities and Services (Private Medical Clinics or Private Dental Clinics) Regulations 2006 and Part XVIII of the Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities) Regulations 2006.
Part XI of the clinic regulation includes a provision on “labelling of medications” that requires the “proper filling and labelling of all drug containers”, “adequate and proper labelling and storage of all medicines, poisons and dangerous drugs”, and “use of properly labelled medication counters”.
The “labelling of medications” provision in Part XVIII of the hospital regulation requires medications to be labeled with the “name and strength of the medications, expiration date, lot or control number and any precautionary labels as appropriate.”
“As such, should the 3rd Respondent find that measures ought to be imposed to control medical costs and to prevent any alleged acts of profiteering for the purpose of patient protection, it is the 2nd Respondent who should exercise his power under Sections 106 and 107 of the Private Healthcare Services and Facilities Act 1998 to impose such measures,” said the applicants.
Section 106 provides for fee schedules for private health care facilities or services, whereas Section 107 empowers the minister to make regulations.
“The Impugned Order has the effect of displacing the established legislative regulatory scheme in relation to the governance of the medical fees and patient rights, within the framework of the Poisons Act 1952 and the Private Healthcare Services and Facilities Act 1998.”
MMC, MDC Prohibit Sale Of Drugs Over The Counter Without Going Through Process Of Treatment
Applicants described the indiscriminate requirement for all private health care facilities to display retail medicine prices as “irrational and unreasonable” because Codes of Professional Conduct by both the Malaysian Medical Council (MMC) and the Malaysian Dental Council (MDC) prohibit medical and dental practitioners from selling drugs “in a mercantile sense.”
“In other words, unlike the setting that takes place in community pharmacies and/ or drug retail stores – medical and dental clinics are prohibited by the MMC and MDC to sell drugs over the counter without going through a thorough and composite process of treatment,” said the applicants.
“This entails prior consultation between a doctor/ dentist and his patient, examination of the patient’s condition, diagnosis of the underlying ailment, prescription of the applicable Group B poison and dispensing of drugs for the purposes of treatment.
“To require medical and dental clinics to display drug prices at the outset even before any consultation is done essentially conflates the process of medical or dental treatment into a single, isolated transaction of buying and selling drugs – such a measure is incongruent with the reality, structure and context in which medical/ dental treatment is carried out and the relevant laws and guidelines enacted specifically to regulate the medical and dental professions.”
Applicants pointed out that PHFSA regulations already mandate private clinics and health care facilities to provide patients, upon request, itemised billing that sets out the estimated charges of the entire treatment process (beyond drug prices), “bespoke to the patient’s condition after diagnosis.”
“Through this existing structure, patients will then be in a position to consciously decide on a comprehensive basis – whether to proceed with treatment as a whole, or any part thereof (including the purchase of drugs).”
Disproportionate Impact On Small GP And Specialist Clinics
Applicants highlighted the disproportionate impact of mandatory medicine price display on small-scale GP and specialist clinics that will now have to compete with large-scale drug retailers, such as international chain pharmacies, that are able to sell drugs at a much lower price.
Small-scale community clinics, they said, would suffer a disadvantage compared to large chain pharmacies in price competition, as drug prices in clinics are determined by various factors, including manufacturers, freight charges, export/ import duties, importers, distributors, smaller volume purchased, location of clinics, different formulations of the same product, provisions for wastages of expired unused drugs, and staff and administrative expenses.
“Whilst the purported objective in introducing the Requirement to Mark Drug Sale Prices is ultimately to reduce drug prices by encouraging transparency, the measure imposed results in creating an unwarranted competition amongst providers of drugs, with the singular denominator [being] purely the price of drugs,” said the applicants.
“The objective and purpose of anti-profiteering is not met when the persons that will be adversely affected are the general practitioners who do not actually profiteer.
“The adverse consequences against non-profiteering parties result in an overkill, rendering the Impugned Order disproportionate against the objective that it seeks to achieve.”
KPDN Minister Failed To ‘Meaningfully Consult’ Stakeholders
Applicants accused Domestic Trade and Cost of Living Minister Armizan Mohd Ali of failing to “meaningfully consult” or to respond to objections made by various associations representing medical practitioners against the drug price display order.
They also accused Armizan of failing to confer with Health Minister Dzulkefly Ahmad to understand the predicament faced by medical practitioners and the profession, despite Dzulkefly taking note on March 10 of issues raised by private GP groups.
Armizan allegedly failed to conduct any survey or investigation on the actual reason behind an increase in drug prices and whether this could be attributed to the medical and dental professions.
“The Impugned Order therefore suffers from procedural impropriety,” said the applicants.
Although the drug price display order is legally under the purview of the Domestic Trade and Cost of Living Ministry (KPDN), the price transparency policy came from the Ministry of Health (MOH).
Health deputy director-general (pharmaceutical services) Azuana Ramli told a media briefing last May 2 that the MOH held a poll via the government’s unified public consultation (UPC) platform on its price display policy, among four stakeholder engagement sessions organised by the ministry.
Quash Drug Price Display Order, Stay Enforcement
Besides seeking for the drug price display order to be nullified, applicants also sought to stay enforcement of the mandate against private health care facilities, pending the full disposal of their judicial review application.
The order – which requires private health care facilities and community pharmacies to display retail medicine prices – is currently in a grace period of enforcement that is scheduled to end this Thursday.
Neither KPDN nor MOH have, to date, announced any extension to the three-month grace period beyond July 31.
“If criminal prosecutions are commenced against registered medical practitioners and dental practitioners and the Impugned Order is ultimately quashed and/ or qualified by this Honourable Court, the costs incurred, damage suffered, judicial time and public funds used for the commencement of these criminal prosecutions, as well as the fines paid are irreversible and irreparable despite the decision of the court,” explained the applicants in requesting a stay of enforcement.
“No prejudice would occasion to the Respondents as there is no urgency in the implementation of the Impugned Order. This is especially so when the decision to implement the said order has been postponed several times.”
Case management has been set in the High Court for August 22. The applicants’ lead lawyers for the case are Gurdial Singh Nijar and Abraham Au from G.S. Nijar.
The representatives of the seven doctors’ and dentists’ associations that filed suit were Dr Deva Das Pathiyil Ramankutty (APPS), Dr Vasu Pillai Letchumanan (MMA), Dr Narjit Singh Harbans Singh (Maafim), Dr Boi Saidi Abdul Razak (Perdim), Dr Shanmuganathan TV Ganeson (FPMPAM), Dr Mahendran Ponnudurai (MPDPA), and Dr Tan Cheow Hwa (SPMPS).
This is the second lawsuit by medical groups against Prime Minister Anwar Ibrahim’s administration over a public policy, after a judicial review against the removal of liquid and gel nicotine from the list of scheduled poisons under the Poisons Act in 2023 under then-Health Minister Dr Zaliha Mustafa.
On May 6, over 700 doctors held an historic demonstration in Putrajaya against KPDN’s jurisdiction over drug price display.
Citing “unresolved jurisdictional ambiguity” between the MOH and KPDN, the MMA, FPMPAM, and Perdim boycotted a July 21 stakeholder engagement session by MOH on medicine price display, three days before they and the other applicants filed suit.
Source link
-
-
-
-
-
