The Poisons Act (Amendment) 2019 Bill was tabled for first reading at the House of Representatives on 25 November 2019.
The Bill has drawn the ire of various national medical and dental organisations.
The World Health Organization’s definition of a prescription “is an instruction from a prescriber to a dispenser. The prescriber is not always a doctor but can also be a paramedical worker, such as a medical assistant, a midwife or a nurse. The dispenser is not always a pharmacist, but can be a pharmacy technician, an assistant or a nurse. Every country has its own standards for the minimum information required for a prescription, and its own laws and regulations to define which drugs require a prescription and who is entitled to write it. Many countries have separate regulations for opiate prescriptions.”
Prescriptions Upon Request
The proposed Section 19(2A) in the Bill states “Notwithstanding subsections (1) and (2), a registered medical practitioner, registered dentist or registered veterinary surgeon shall, upon request from his patient or client, issue a prescription for the sale or supply of such poison for the purpose of medical or dental treatment of such patient or animal treatment of animal tended by him, respectively. (2B) Prescription issued under subsection (2A) shall be in accordance with subsection 21(2) or subsection 21(2A) of this Act.”
The proposed amendment to Section 19(4)(b) in the Bill states “Any registered medical practitioner, registered dentist or registered veterinary surgeon who decline to issue a prescription upon request by his patient or client under subsection (2A), shall be guilty of an offence against this Act.”
The proposed amendment to Section 32(2) states “Any person guilty of an offence against this Act, for which no other penalty is specifically provided by this Act or by any regulations made thereunder, shall be punishable by a fine not exceeding fifty thousand ringgit or by imprisonment for a term not exceeding five years or both.”
In short, a doctor, dentist or veterinarian who does not issue a prescription upon request by a patient will be criminalised upon conviction.
The proposed Section 21(2A) in the Bill states “When a prescription is prescribed through electronic means, every prescription for any Group B Poison prescribed by a registered medical practitioner, registered dentist or registered veterinary surgeon shall— (a) be created and dated in electronic form; (b) be signed with a digital signature; (c) be sent to a registered pharmacist as an electronic message; and (d) contain information as in paragraphs (2)(b), (c), (d) and (e).”
The proposed Section 34B in the Bill states “Notwithstanding any written law or rule of law to the contrary, in any proceedings against any person for an offence under this Act or its regulations— (a) no agent provocateur, whether he is an authorised officer or not, shall be presumed to be an accomplice or be unworthy of credit as a witness by reason only of his having attempted to commit or to abet, or having abetted or having been engaged in a criminal conspiracy to commit, such offence if the main purpose of such attempt, abetment or engagement was to secure evidence against such person; (b) any statement whether oral or in writing made to an agent provocateur by any person shall be admissible in evidence at his trial; and (c) a conviction for any offence under this Act or its regulations solely on the uncorroborated evidence of any agent provocateur shall not be illegal and no such conviction shall be set aside merely because the court which tried the case has failed to refer in the grounds of its judgment to the need to warn itself against the danger of convicting on such evidence.”
Medical, Dental, Private Healthcare Facilities & Services and Poison Acts
The title of the Medical Act states “An Act to consolidate and amend the law relating to the registration of medical practitioners, the control and regulation of the practice of medicine, to provide for certain provisions with regard to a period of service in the public services after full registration as a medical practitioner; and to make provisions for matters connected thereto.”
The title of the Dental Act states “An Act to consolidate and amend the law relating to the registration and practice of dental practitioners and for national purposes to provide for certain provisions with regard to a period of service in the public services after registration as a dental practitioner; and to make provision for purposes connected with the aforesaid matters.
The Private Healthcare Facilities and Services Act i.e. Sections 35 and 36, and its regulations 18 and 26-27 contain provisions for patients’ rights in its entirety and not just prescriptions.
The title of the Poisons Act 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 Poisons 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.
Flawed Sections in Poisons Act (Amendment) Bill
(a) Proposed Section 19(2A) and Section 19(4)(b) – Prescriptions upon request
This proposed Section 19(2A), which legally mandates a doctor to provide a prescription upon request, usurps the Medical Act which controls and regulates the practice of medicine and the Dental Act which regulates the practice of dentists.
All registered doctors and dentists are required to comply with the Medical Council (“MMC”) and Dental Council’s (“MDC”) Code of Professional Conduct. Acts such as refusal to provide prescriptions to patients upon request may border on professional misconduct which exposes the doctor to disciplinary action by the MMC or MDC.
There is no provision in the Poisons Act for anyone to encroach on the professional autonomy of the medical and dental professions provided in the Medical and Dental Acts.
Furthermore, there is no other country in the world known to criminalise a refusal to provide a prescription upon request as provided in proposed Section 19(4)(b).
There is a wide spectrum of infractions in medical or dental practice. The refusal to provide a prescription upon request is very different from a refusal to attend to the doctor’s or dentist’s patient who collapses. The former would lead to a custodial sentence under the proposed Bill, whilst the latter would lead to a disciplinary hearing by the MMC or MDC, or a lawsuit.
In short, the argument that the proposed Section 19(2A) protects patients’ rights is fundamentally flawed, at best, and warped, at worst.
The phraseology of the proposed Section 19(2A) does not protect the patient who requests for a prescription when there is no clinical indication e.g. requests for psychotropic drugs, sleeping pills, antibiotics re self-administered abortion pills. This opens up the Pandora’s box of interpretation abuse, threats to doctors and dentists, blackmail and even corruption.
Another implication of the proposed section are adverse consequences to patients from abuse of repeat prescription medicines and self-medication, particularly in non-communicable diseases.
In any case, a patient in Malaysia has the right to consult any registered doctor or dentist. If there is refusal to provide a prescription upon request, the patient can always consult another doctor or dentist who does; complain to the MMC or MDC; or complain to the Health Ministry under the Private Healthcare Facilities and Service Acts.
(b) Proposed Section 21(2A) – Electronic prescription
This proposed section also usurps the Medical Act which controls and regulates the practice of medicine and the Dental Act which regulates the practice of dentists.
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.
The introduction of electronic prescribing requires an organisational and regulatory framework which are currently not in place.
The proposed section can be abused by unregulated commercialised online health services who have been reported to be prescribing and dispensing Group B poisons without physical examination of patients.
(c) Proposed Section 34B – Agent Provocateur
This proposed section provides for the admissibility of the improperly obtained evidence of an agent provocateur.
There is already such a provision i.e. Section 40A in the Dangerous Drugs Act, whose title states “An Act to make further and better provision for the regulating of the importation, exportation, manufacture, sale, and use of opium and of certain other dangerous drugs and substances, to make special provision relating to the jurisdiction of courts in respect of offences thereunder and their trial, and for purposes connected therewith”.
The reason for the inclusion of this proposed Section 34B in the Bill is unclear. Why are offences under the Poisons Act treated the same as that of the Dangerous Drugs Act?
(d) The proposed Sections 31A-F are contentious as the enforcement officers are given powers that may supersede the provisions of confidentiality in the Private Healthcare Facilities and Services Act and the Personal Data Protection Act.
Furthermore, when no costs or damages are recoverable from entry, search or seizure, there is no check and balance on the power of enforcement officers, giving rise to the possibility of abuse.
Follow Due Process
There is a process prior to any amendments to the law. The 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).
Withdraw The Bill
It is patently clear that there is a complete lack of proportionality in addressing prescription practice.
The proposed sections discussed above is a ham-fisted approach to an ill-defined perceived problem. What is the scope of the problem of refusal to provide prescriptions?
Are there no mechanisms currently in place to address the perceived problem? Should a possible unethical practice be treated with criminalisation?
The argument that it will protect patients is not only fundamentally flawed, at best, it is warped, at worst.
With this fiasco, the Health Ministry has embarrassed itself nationally and internationally.
The explanation by the Health Minister to the issue raises more questions than answers.
Are amendments to health laws done lackadaisically? Is there a Deep State in health care?
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.
The withdrawal of the Bill 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. This article is not intended to replace, dictate or define evaluation by a qualified doctor. The views expressed do not represent that of any organization the writer is associated with.
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