KUALA LUMPUR, Dec 17 — The Ministry of Health (MOH) has proposed repealing the Pathology Laboratory Act 2007 (Act 674) that was never enforced since its gazettement into law 17 years ago.
MOH opened the proposed abolition of Act 674 for two-week public consultation from last December 13 until December 31 on the government’s Unified Public Consultation (UPC) portal.
“The Pathology Laboratory Act 2007 (Act 674) gazetted in 2007 was never enforced because of the absence of regulations needed for the purposes of enforcement,” the MOH told CodeBlue in a statement, when asked for comments.
“Previously, the draft Private Pathology Laboratory Regulations had been fully developed based on the latest policy needs, but it did not get approval from the Attorney-General’s Chambers because Act 674 in its current form does not provide for the needed source of authority (punca kuasa).
“Most of the provisions in Act 674 are also no longer relevant in current times; some in fact conflict with other Acts that are already in force. This was a result of rapid medical development and changes in the landscape of pathology services in Malaysia.”
The MOH added that its medical practice division presented a legal review of Act 674 to Health director-general Dr Muhammad Radzi Abu Hassan last October and proposed to continue regulating private pathology labs under other existing legislation in force, such as the Private Healthcare Facilities and Services Act 1998 (Act 586).
Hence, the MOH is suggesting a repeal of Act 674 and to either enact a standalone Act to replace it or to amend Act 586 to expand its scope to private pathology labs.
“Any change will be done carefully so as to preserve continuity, effectiveness, and sustainability in the legal and regulatory framework.”
In its statement to CodeBlue, the MOH said Act 586 is currently under review to make it more holistic and future-proof.
The Pathology Laboratory Act is a 74-page long piece of legislation. It contains multiple provisions, covering regulation of pathology laboratories, the necessary approvals or licenses to set up or maintain a pathology lab, the responsibility of the licensee, suspension or cancellation of approvals or licenses, closure, quality, a pathology laboratory advisory committee, managed care organisations, and enforcement powers, among others.
A few people commenting on the UPC portal disagreed with abolishing Act 674.
“If this Act is repealed, there is concern that private pathology laboratory services may be unethical, substandard, or even endanger the lives of patients or customers,” one person wrote.
“Therefore, this Act should not be repealed; instead, its implementation should be expedited to safeguard the quality, standard, and safety of pathology laboratory services for patients or customers.”
Anyone who wants to participate in the public survey or submit comments on the proposed repeal of the Pathology Laboratory Act can visit the government’s UPC portal here. Public feedback is open until December 31 this year.
