SINGAPORE - All cord blood banks in Singapore are subjected to biennial inspections to assess their compliance with regulatory requirements, and unannounced visits may be conducted if there are suspected lapses.
Health Minister Ong Ye Kung gave this update in written replies to parliamentary questions by MPs Alex Yam (Marsiling-Yew Tee GRC) and Louis Chua (Sengkang GRC) on Jan 9 on how the cord blood banking industry is regulated.
Questions have been raised on the inspection frequency for cord blood banks after private cord blood bank, Cordlife, was found to have improperly stored cord blood units.
Following feedback from a member of the public, unannounced audits at Cordlife in August and November uncovered temperature lapses at seven of the 22 storage tanks.
This exposed cord blood units to suboptimal temperatures at different periods from November 2020. Cord blood units have to be stored at temperatures below minus 150 deg C.
Cord blood units in one of its tanks, Tank A, which had an estimated 2,200 cord blood units belonging to approximately 2,150 clients, were damaged and are unlikely to be suitable for stem cell transplant purposes. Investigations into the viability of cord blood units in the other six tanks are still ongoing.
Cord blood banking is regulated under the Healthcare Services Act, which covers the activities on the handling, processing and storage of cord blood obtained from an individual and intended for clinical use.
Said Mr Ong: “If a cord blood bank is found to be non-compliant, the Ministry of Health (MOH) can take regulatory action. This includes modifying any licence condition, shortening the licensing term, or enforcement actions such as imposing financial penalties or prosecution.
“The penalties include fines up to $20,000, or imprisonment for a term not exceeding 12 months, or both.”
On the issue of compensation or restitution for service lapses, Mr Ong said consumers can seek recourse from their cord blood banking provider, depending on the service contracts that they have entered into.
Deputy Prime Minister and Finance Minister Lawrence Wong said in a separate written reply that the Singapore Exchange Regulation is reviewing information it has received from Cordlife before making an assessment of whether the company had breached regulations under the Securities and Futures Act 2001 (SFA).
It will then follow up with the Monetary Authority of Singapore (MAS) as appropriate.
DPM Wong was replying to a query by Ms Hany Soh (Marsiling-Yew Tee GRC) on whether the MAS is investigating possible breaches of disclosure requirements by Cordlife for not making announcements on issues related to storage temperatures of its cord blood storage tanks or audits by MOH prior to Nov 30, when the ministry revealed the irregularities.
Cordlife Group said on Dec 10 that its board was informed of irregular temperatures in one of its tanks in February.
But it was not reported to the stock exchange, as it assessed that there would be no material impact on the financial performance of the group for the 2022 and 2023 financial years.
Under the SFA and the Singapore Exchange’s listing rules, a listed company and its directors must ensure timely disclosure of information that may materially affect the price or value of its listed securities. Failure to do so is a breach under the SFA if it is committed intentionally, recklessly or negligently.
