By Dr Milton Lum |
Dr Milton Lum says the Bill may force GPs to stop dispensing medicines, which will increase the cost of health care and inconvenience the public, with long-term consequences for health care delivery.
Malaysia is a signatory to the United Nations Sustainable Development Goals (“SDGs”). The goal of SDG 3 is “Good health and well-being.”
Malaysia is also a member of the World Health Organization Western Pacific region, which published “Better laws for better health” in 2020, the introduction of which states: “Legal frameworks – instruments of law and the institutions responsible for putting them into effect – are essential to advance universal health coverage (UHC) and achieve health in the Sustainable Development Goals (SDGs).
“Law can be used to organise and manage health systems, allocate responsibilities, set standards, and authorise and constrain action. Law can promote, protect and fulfil the right to health. Law can regulate health services and products to ensure quality, safety and efficacy. Law can shape markets, from regulating potentially harmful products to mandating procurement practices that promote healthier products.
“The very act of passing or deliberating a law can convey information, alerting people of health risks and influencing their behaviour. As many social determinants of health lie beyond the health sector, law can be a powerful tool for coordinating and consolidating action across sectors, such as agriculture, environment, education, labour and housing.” (Better laws for better health: Western Pacific regional action agenda on strengthening legal frameworks for health in the Sustainable Development Goals. Manila, Philippines, World Health Organization Regional Office for the Western Pacific. 2020) The Poisons Act (Amendment) Bill 2022 was tabled for first reading at the House of Representatives on March 14, 2022. Are the proposed amendments progressive (i.e. better law) or regressive? Poisons Poisons i.e. medicines used in human and animal health care, as well as industry are regulated by the Poisons Act, of which its title states: “An Act to regulate the importation, possession, manufacture, compounding, storage, transport, sale and use of poisons.” Poisons are classified as Groups A, B, C and D under the Poisons Act. Section 21 (1) of the Poison Act states that Group B poisons can only be supplied to a person by a registered doctor, registered dentist or registered veterinary officer; or by a registered pharmacist in accordance with a prescription by a registered doctor, registered dentist or registered veterinary officer. Consonance with Medical, Dental, Private Healthcare Facilities & Services Acts Within the sphere of human health care, the Poisons Act (Amendment) Bill 2022 must be consonant with the Medical and Dental Acts that regulate the practice of medicine and dentistry respectively. It has also to be consonant with the Private Health Care Facilities and Services Act (“PHCFSA”) that regulates private health care facilities and services. Sections 35 and 36 of the PHCFSA and its regulations 18 and 26-27 contain provisions for patients’ rights in its entirety.
Part XI and Part XVIII of the PHCFSA regulations for clinics and hospitals etc respectively titled “Special requirements for pharmaceutical services” contain standards for the possession, compounding, storage, sale and use of poisons by the private health care facilities. There are similar standards in the Health Ministry’s health care facilities. Flawed Poisons Act (Amendment) Bill 2022 There are several flaws in the Poisons Act (Amendment) Bill 2022.
Proposed Section 15(2)(k) – Sales of Poisons by Wholesale This proposed section 15(2)(k) in the Poisons Act (Amendment) Bill 2022 “seeks to amend section 15 of Act 366 to enable a licensed wholesaler to sell poison to a person who requires the poison for the purpose of compliance with any written law for the medical treatment of his employees in any business or trade” does not provide justification. This proposed section usurps the Medical and Dental Acts. What are the legal implications if and when complications arise following an employer’s purchase of poisons to treat his employees? Who will be accountable then?
Proposed Section 21 (2A and 2B) – Electronic Prescription The proposed section 21 (2A and 2B) in the Poisons Act (Amendment) Bill 2022 “deal with the requirements imposed on electronic prescription which include the requirement of digital signature to be made in accordance with the Digital Signature Act 1997 [Act 562]”. The advantages of electronic prescription include reduction of prescription errors; instant notification of allergies, drug interactions, duplicate therapies, and other clinical alerts; reduction of number of lost prescriptions; facilitates workflow; and speeds up reconciliation of poisons.
However, the introduction of electronic prescribing requires an organisational and regulatory framework which are currently not in place. This proposed section may usurp the Medical and Dental Acts that control and regulate the practice of medicine and dentistry respectively, as well as the Private Healthcare Facilities and Services Act.
The proposed section also does not address misuse and abuse by unregulated commercialised online health services that have been reported to be prescribing and dispensing group B poisons without the physical examination of patients. Proposed Section 26A – Directives The proposed section 26A in the Poisons Act (Amendment) Bill 2022 “empowers the Director General of Health to issue directives, as he may consider necessary or expedient for the implementation of Act 366.”
Guidelines are different from directives. The former is usually formulated after consultation and agreement with all stakeholders, whereas the latter is formulated without such consultation and agreement. There is understandable concern that the provision of such unfettered power to an individual may lead to misuse or abuse, and even corruption.
Proposed Deletion of Section 28 of the Poisons Act That States: “(1) The Director General of Health shall, in or about the month of February in each year, cause to be printed and published, in the Gazette, lists of all persons, named in alphabetical order, licensed under this Act together with particulars of the nature of the licence or licences issued to each such person, and specifying the profession or business and the premises in respect of which such licences have been issued.
“(2) Every list so published shall be prima facie evidence that, at the date to which such list relates, the persons therein named are or were licensed under this Act in the manner stated in such list, and that any person not named therein is or was not licensed under this Act.” The explanatory statement to the Poisons Act (Amendment) Bill 2022, which states: “Clause 16 seeks to delete section 28, which requires an annual list of all persons licensed under Act 366 to be published as under section 27 a Licensing Officer for each State is required to keep a register of licenses issued under Act 366” is pathetic.
The Malaysian Medical and Dental Councils provide details of registered medical and dental practitioners on their websites for public verification. Instead of strengthening section 28 of the current Act, the proposed deletion of section 28 of the current Act takes a step back in time by placing obstacles in the way of anyone who wants to verify whether a retail pharmacy is bona fide or not.
Proposed Sections 31A-F These proposed sections in the Poisons Act (Amendment) Bill 2022 include powers of enforcement, inspection and investigation; search and seizure; power to access premises and land; power to require information and documents; access to recorded information and computerised data; and no costs or damages arising from entry, search or seizure to be recoverable.
The proposed sections are very contentious as the enforcement officers are given powers which may, among others, supersede the provisions of confidentiality in the Private Healthcare Facilities and Services Act, the Personal Data Protection Act, and the Codes of Professional Conduct of the Malaysian Medical and Dental Councils. No justification has been given why the current section 31 is not considered adequate for enforcement.
Proposed Section 34A – Protection from Suits and Legal Proceedings The proposal that enforcement officers are immune from legal action or prosecution from any action would mean that there is no check and balance on the power of enforcement officers. This unfettered authority may give rise to misuse, abuse and corruption. Proposed section 34B – Agent provocateur The proposed section 34B in the the Poisons Act (Amendment) Bill 2022 “seeks to provide for the evidence of agent provocateur”.
There is already section 40A in the Dangerous Drugs Act, which states: “(1) Notwithstanding any rule of law or the provisions of this Act or any other written law to the contrary, no agent provocateur shall be presumed to be unworthy of credit by reason only of his having attempted to abet or abetted the commission of an offence by any person under this Act if the attempt to abet or abetment was for the sole purpose of securing evidence against such person.
(2) Notwithstanding any rule of law or this Act or any other written law to the contrary, and that the agent provocateur is a police officer whatever his rank or any officer of customs, any statement, whether oral or in writing made to an agent provocateur by any person who subsequently is charged with an offence under this Act shall be admissible as evidence at his trial.”
It is pathetic that no reasons are provided for the inclusion of this proposed section 34B in the Poisons Act (Amendment) Bill 2022. Why are offences under the Poisons Act treated the same as those in the Dangerous Drugs Act? Proposed Section 32 – Penalties There are no specific penalties in the current Act and the Poisons Act (Amendment) Bill 2022. The general penalty in the current Act and the Poisons Act (Amendment) Bill 2022 apply to all offences.
The proposed section 32 the Poisons Act (Amendment) Bill 2022 “seeks to amend section 32 to enhance the general penalties provided under this section from a fine not exceeding three thousand ringgit or imprisonment for a term not exceeding one year or both to a fine not exceeding fifty thousand ringgit or imprisonment for a term not exceeding five years or both (emphasis added).
“The amendment also seeks to enhance the penalty for any act or omission relating to wilful default or culpable negligence, which had endangered or was likely to endanger human life, from a fine not exceeding five thousand ringgit or imprisonment for a term not exceeding two years or both to a fine not exceeding two hundred thousand ringgit or imprisonment for a term not exceeding ten years or both (emphasis added).
“This clause also seeks to provide that any article in respect of which an offence against this Act has been committed shall be forfeited and shall be disposed of in such manner as the Licensing Officer may direct.”
The explanatory statement is pathetic. It provides no justification for the 1,666 per cent and 4,000 per cent increases in the fines, and 500 per cent increases in the maximum imprisonment terms compared to that in the current Act. Apart from the death penalty, the proposed penalties in the Poisons Act (Amendment) Bill 2022 are not substantially different from that in the Dangerous Drugs Act. There is a spectrum of offences under the Poisons Act. It ranges from lapses in documenting all details in the Registers and insufficient labelling due to administrative mistakes or human error; storage and/or transport non-compliance which may affect the efficacy of poisons; usage of unlicensed poisons; to trafficking of narcotics, psychotropic and other dangerous drugs. It is apparent that the proposed increase in the penalties is an attempt to treat minor offences in the bona fide use of poisons the same as the criminal trafficking of dangerous drugs. As the proposed increases in the penalties are draconian, it may lead to general practitioners stopping dispensing, which would increase the cost of health care and inconvenience the public, with long-term consequences for health care delivery. It would not be cynical to ask whether this is another attempt at dispensing separation. Failure to Follow Due Process There is a process prior to any amendments to the law. A regulatory impact assessment includes, among others, establishing the scope of the problem; consultation with stakeholders; addressing whether the problem has to be addressed by a legal approach; and whether any proposed amendment is consonant with any other law(s). It is apparent that the Health Ministry did not consult stakeholders prior to its tabling the Poisons Act (Amendment) Bill 2022.
Had the Health Ministry done so, the medical profession would have raised issues regarding, among others, counterfeit medicines; precursor diversion; computerised record transmission; and specific user licence for control and curbing irregularities in the use of chemical substances for psychotropics and precursors as required under Malaysia’s obligations to the International Convention on psychotropics and precursors. All these issues have not been addressed in the Poisons Act (Amendment) Bill 2022. Review, Revise and Amend the Flawed Bill It is patently evident that several sections in the Poisons Act (Amendment) Bill 2022 are regressive. There is also a complete lack of proportionality in addressing offences. The flaws in the proposed sections discussed above reflects a clumsy approach to undefined perceived problem(s). Any argument that it will protect patients is not only fundamentally flawed at best, and warped, at worst. In fact, it will deprive patients the opportunity to verify whether a retail pharmacy is bona fide or not.
With the flaws in the Poisons Act (Amendment) Bill 2022, the Health Ministry continues to embarrass itself as it had done so with the previous Poisons Act (Amendment) Bill in 2019. Such an approach by the Health Ministry, which is ill-considered at best or warped at worst, has no place in any developing country, let alone one that aspires to be a developed country. A review and revision of the Poisons Act (Amendment) Bill 2022 and genuine engagement with all stakeholders can lead to a Bill which is in keeping with the times. Dr Milton Lum is a past President of the Federation of Private Medical Practitioners Associations, Malaysia and the Malaysian Medical Association.