Healthcare is heavily regulated. There are 33 laws listed on the Health Ministry’s website (www.moh.gov.my).
The only Act that specifies standards for healthcare facilities and services is the Private Healthcare Facilities and Services Act (PHFSA), which has been in force since 2006.
Private Healthcare Facilities and Services Act
The PHFSA was enacted for the purposes of ensuring the integrity of healthcare professions, professionalism, quality of care and patient safety, and social and national interests.
The person in charge of a healthcare facility or service, who is a registered medical or dental practitioner, is liable, upon conviction, to a fine, imprisonment or both for several offences.
They include establishment, maintenance and operation of an unregistered clinic; failure to fulfil the prescribed responsibilities of a holder of a certificate of registration and person in charge; using the healthcare facility for any purpose other than that for which the certificate of registration is issued; non-compliance with an order of the Health director-general to close the healthcare facility; failure to comply with directives on quality and standards issued by the Health director-general; entering into contracts or arrangements with managed care organisations that changes the powers of the doctor in the medical management of patients, changes the role and responsibility of the Medical Advisory Committee, contravenes the Code of Professional Conduct of the Medical/Dental Council and/or contravenes the PHFSA, its regulations or any other written law; failure to provide information to the Health director-general about contracts or arrangements with managed care organisations; failure to provide information required by the Health director-general; employment of unregistered or unqualified staff; treatment provided by a person other than a registered doctor/dentist; non-availability of a registered doctor/dentist during the opening hours of the clinic; failure to comply with the regulatory requirements for orders for diagnostic procedure, medication or treatment; billing procedures; ensuring a patient’s rights; patient medical record system; infection control; basic emergency care services; and storage of vaccines.
A doctor was imprisoned under the PHFSA in 2008. A dentist and a dental facility was charged under the PHFSA in 2016.
Whilst the PHFSA applies to the private sector, the Federal Court has applied the same standards of care to both public and private sectors.
The Federal Court statement on the standard of care is: “The test propounded by the Australian case in Rogers v Whitaker and followed by this Court in Foo Fio Na in regard to standard of care in medical negligence is restricted only to the duty to advise of risks associated with any proposed treatment and does not extend to diagnosis or treatment.
“With regard to the standard of care for diagnosis or treatment, the Bolam test still applies, subject to qualifications as decided by the House of Lords in Bolitho.” (Zulhasnimar Hasan Basri & Khairina Puteri Sariman v Dr Kuppu Velumani Anor 2017)
The duty to warn stated in Rogers v Whitaker (1992) is: “The law should recognise that a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstance of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it or if the practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would likely to attach significance to it. This duty is subject to the therapeutic privilege.”
The duty regarding diagnosis or treatment stated in the English case Bolam v Friern Hospital Manage-ment Committee (1957) is: “In the case of a medical man, negligence means failure to act in accordance with the standards of reasonably competent men at the time...
“Putting it the other way around, a man is not negligent, if he is acting in accordance with such practice, merely because there is a body of opinion that would take a contrary view.”
The qualifications to Bolam stated in Bolitho v City and Hackney Health Authority (1997) is: “The use of these adjectives – responsible, reasonable and respectable – all show that the court has to be satisfied that the exponents of the body of opinion relied on can demonstrate that such opinion has a logical basis.”
Health, Education and Defence Ministry facilities and services
The Health, Education and Defence Ministries’ facilities and services comply with the relevant ministry’s directives on standards.
However, no such document(s) are available in the public domain.
In addition, non-compliance does not incur a fine, imprisonment or both, as there is no statutory provision for it.
One healthcare standard
The Federal Constitution states that all persons are equal before the law.
The PHFSA imposes a statutory duty on facilities, services and registered medical/dental practitioners in the private sector.
There is no similar imposition on the public sector. Is this fair? Are there two healthcare standards – one for the public sector and one for the private sector?
If the answer is in the affirmative, it raises the question as to why patients in the private sector are protected by statute, but the patients in the public sector are not.
Are patients in the private sector privileged? Are patients in the public sector not entitled to the same statutory protection?
After all, the Common Law does not distinguish patients in the public sector from those in the private sector.
A single death in a private healthcare facility led to a criminal prosecution. What happens if the death(s) occur in a public-sector facility?
The PHFSA also raises the question as to whether it is in line with the Constitutional provision of equality before the law.
It is time for the PHFSA to be amended for it to apply to all healthcare facilities and services irrespective of whether they are in the public or private sector.
If the public-sector facilities currently do not comply with these standards, then they should be upgraded until they do.