Support for Affected Customers in Cord Blood Storage Incident and Review of Obligations of Commercial Cord Blood Banks

2 Ms Nadia Ahmad Samdin asked the Minister for Health as the Ministry carries out its supervision priority for Cordlife to rectify their shortcomings pending the investigations, whether there are strategies in place to ensure that (i) there will be open and clear communication between Cordlife and the parents affected and (ii) affected parents are well informed on potential ramifications of their decision to transfer their cord blood units to another private cord blood bank backed by scientific evidence, should they opt to do so.

3 Mr Chua Kheng Wee Louis asked the Minister for Health (a) whether the Ministry will assist customers whose cord blood units have been damaged while being stored by Cordlife with receiving a baseline level of compensation regardless of the type of service contract; (b) if so, how will this compensation be determined; and (c) if not, why not.

4 Mr Saktiandi Supaat asked the Minister for Health (a) what is the precise scope and extent of the Ministry’s regulatory action in the Cordlife incident involving damaged cord blood units; (b) how will the Ministry further intervene following international experts’ criticism of Cordlife’s announced one-year timeline to complete significant testing of its cord blood samples; and (c) how will the Ministry assist unaffected parents who wish to transfer their cord blood units to another service provider for greater peace of mind.

5 Mr Dennis Tan Lip Fong asked the Minister for Health whether the Ministry will consider strengthening the obligations of commercial cord blood banking service providers to include the requirement of a full refund of the initial contract fees or other earlier payments when these service providers are found to be responsible for any damage to cord blood units under their care, rendering such units unsuitable for stem cell transplant services.

The Senior Minister of State for Health (Dr Janil Puthucheary) (for the Minister for Health): Mr Speaker, may I have your permission to answer Question Nos 2 to 5 on today's Order Paper?

Mr Speaker: Please proceed.

Dr Janil Puthucheary: Sir, we understand the anxiety and concern amongst parents as a result of the lapses at Cordlife Group Limited (Cordlife). Cord blood banking is an elective, commercial service provided by the private sector. Customers entered into a commercial contract with the service providers when they sign up and the Ministry of Health (MOH) is not a party to these contracts. The Government cannot overstep the law. There are limits to which the Government can intervene, especially when it comes to issues of compensation and refunds.

What MOH is actively doing is with respect to regulation and facilitation. The Ministry will be supervising the proper completion of further tests in the affected tanks to achieve a high level of confidence in the findings. Given the sample sizes and the testing capacity available, this will take another year.

MOH will also closely monitor Cordlife's dissemination of information to its customers and the public, as well as progress in addressing the deficiencies identified and in making improvements. These include directing Cordlife to properly validate and implement its new temperature monitoring system, revalidate its processing method for cord blood units and enhance staff training and supervision of its operations more closely.

MOH has also discussed with other providers who are prepared to facilitate transfer of their cord blood units. Parents who wish to do so can contact Cordlife and the receiving cord blood bank to discuss the transfer arrangements. That said, we urge parents to carefully consider the risks of doing so, given the logistical complexity of making a physical transfer at sub-zero temperatures, particularly so when the cord blood is not ascertained to be impacted.

Mr Speaker: Ms Nadia Samdin.

Ms Nadia Ahmad Samdin (Ang Mo Kio): Mr Speaker, I thank the Senior Minister of State. I understand that MOH has more supervisory and regulatory authority in this case. The Senior Minister of State highlighted about the one-year duration which, understandably, is causing parents even further anxiety, given the long wait. What is the Ministry's assessment on the reasonableness of this one-year duration for completing the remaining testing? Is there any other way that MOH can provide direction or support for other industry partners to expedite the testing of the cord blood units?

Dr Janil Puthucheary: Sir, I thank Ms Nadia for the question. There has been some commentary about the length of time that is projected. The comments provided by some international experts are based on the typical turnaround time for routine testing and samples that are already in a laboratory. I think some people have quoted two to three weeks for a single potency test and returning the results.

But that series of comments does not take into account the other related factors and the full context of this case. The estimation of one year for the timeline for completing the testing involves several operational considerations. The resources that Cordlife has, the resources that are available at the third-party laboratory that has been engaged to perform the testing and the rectification measures that Cordlife has been instructed to put in place to mitigate further warming events, the limited resources that the laboratory and Cordlife have, as well as what MOH needs to do in terms of assessing these processes, those parts of the explanation that are under our control, we will try to minimise the time taken, expedite the process, but maintain the quality of our findings.

We need the process to be robust so that when the findings are validated, there is a high level of confidence in that validation. Perhaps, I might just explain why it takes so long.

There are several stages for what is called the post-thaw study. These have to be designed carefully, the samples have to be retrieved very carefully, the testing has to be done very carefully and the third parties, the people who are validating and auditing this, also need to be satisfied that the samples are being dealt with in the proper manner.

A cord blood unit is not stored in an individual tank. The storage units contain many, many cord blood units. They were retrieved and stored under different conditions. So, the sampling needs to take into account the processing methods at the time of freezing. The way in which the retrieval is done has to be very, very careful because you do not want, in the course of establishing the potency of the unit, to then invalidate the potency of that sample. So, you have to make sure that there is no inadvertent compromise to the cord blood unit.

And the testing laboratory needs to then have the capacity to immediately receive the sample. So, you cannot ship the whole unit and then let them take their own time to process all the samples. Each sample has to have a specified time slot for receipt and processing so that they are not then subject to risks at the laboratory side. And there is a limited capacity available for the testing. The laboratories that can do this are quite limited. There is also no way to divide up a sample volume and send it out to different laboratories. There is only so much of the sample that is there. So, that small amount has to be dealt with in a very particular way. So, for all of these reasons and then, subsequently, the assessment and review of the results, it does appear that the one-year timeline is reasonable.

We understand the need, from the parents' concerns, to expedite this to reassure people as fast as possible, but I think it is important that when the process is complete, that all who are involved have confidence in the findings from the process. So, I would ask for Members and parents' understanding that it will take some time for us to go through this process.

Mr Speaker: Mr Dennis Tan.

Mr Dennis Tan Lip Fong (Hougang): Thank you, Mr Speaker. I have two supplementary questions for the Senior Minister of State. A resident of mine wrote to me recently and informed me that she and her husband invested $12,000 from their children's Child Development Account for the cord blood bank services. She said that they have been paying a premium for a service that has not met expectations and, had they been aware of the situation, they would have made very different choices today.

As general mid-working-class citizens, $12,000 is a significant amount of money for them. They shared that the current compensation offered by Cordlife, which includes a refund of the annual fee of $250 per year and the waiver of further fees going forward, is, unfortunately, not sufficient and it does not include the initial contract fee, hence, my initial Parliamentary Question (PQ). She told me that the token gesture does not address the fundamental issue at hand, which is the catastrophic failure of Cordlife's services, which has irreversibly compromised the viability of their twins' cord blood samples.

Sir, I would therefore like to ask the Government, to reconsider whether they can assist the affected person's parents to obtain a higher level of compensation, including a refund of the initial contract fee. This is, given the quantum of claim and the likely legal costs involved, some parents may be deterred from engaging lawyers. I take the point that the Senior Minister of State has shared which is that, even if, indeed, it is the case that the company is not legally obliged to respond to any Government efforts, I wish the Government can engage the company on this front.

My second supplementary question is, moving forward, will the Government consider legislating a better protection regime for parents to recover all monies paid, including a refund to the CDA account for payments made when there are fundamental failures in the provision of blood cord services?

Dr Janil Puthucheary: Sir, I thank Mr Dennis Tan for his questions. If I understand the Member's position with respect to his first supplementary question, he recognises and agrees that these are contractual matters between the parents and Cordlife. So, the role that we might play in the Government is to engage with Cordlife and ask them to facilitate some form of recompense to maintain their relationship with their customers. We continue to engage with Cordlife. But as the Member has agreed and as he has highlighted, this is a contractual matter between two private parties, and MOH and the Government are not a party to these contracts.

As for the Member's second question about legislating further protection, I think we do have to study the regulatory lessons that have come out of this episode and to see whether or not such services need a further type of regulation. I would say that this is one operator amongst several and I think this is one incident in that operator. It does not automatically mean that the regulatory regime or the legislative framework is inherently wrong. It may be issues about operationalising it and auditing it. But, nevertheless, we will study this episode to see how we can make sure that there is confidence in the industry, going forward.

Mr Speaker: Can I remind Members to keep your supplementary questions succinct? Mr Saktiandi Supaat.

Mr Saktiandi Supaat (Bishan-Toa Payoh): Mr Speaker, I have a very succinct supplementary question. May I seek clarification with the Senior Minister of State whether other cord blood banks are willing to accept the cord blood units, as the Senior Minister of State shared earlier, and whether they have the capacity to accept them? May I ask for more details because the Senior Minister of State mentioned that there were some guidelines about how they can go about the process to seek help as well?

Dr Janil Puthucheary: Speaker, I thank Mr Saktiandi for the question. I suspect Speaker's direction was also targeted to me. My apologies.

Sir, Singapore Cord Blood Bank (SCBB), Stemcord Private Limited and Cryoviva Singapore have indicated their ability and willingness to accept cord blood units transferred from Cordlife. However, each of the cord blood banks has indicated that specific conditions must be met prior to accepting the cord blood units from Cordlife.

So, there is some variance and the parents, the customers will have to work directly with the receiving cord blood banks to operationalise the transfer. MOH will try to facilitate the connections and processes, where it is within our power to do so.

However, I would want to take this opportunity to point out a couple of points. All of the three cord blood banks have processes in place to facilitate the transfer of the cord blood units, but they will only accept cord blood units that are demonstrated to be still viable and the receiving cord blood banks are unlikely able to guarantee the viability of cord blood units that are then transferred from Cordlife. So, there is some risk to the customer, the parents associated with making the choice for this transfer and it will also take some time. It is not a small decision to be taken lightly.

Mr Speaker: Mr Louis Chua.

Mr Chua Kheng Wee Louis (Sengkang): Thank you, Speaker. Just one supplementary question for the Senior Minister of State. I note in the press release by Cordlife yesterday that they mentioned the remaining five tanks are deemed to be so-called "low risk" in terms of the viability of the cord blood units there. In the testing that the Senior Minister of State mentioned, this one-year period, does it involve comprehensive testing of all the various tanks and units that are stored within Cordlife, and at the same time, also in the operational processes, to give parents the assurance that there is indeed a low risk of the remaining cord blood units being affected and so that there is greater confidence as to any potential future lapses by having this independent third-party audit of Cordlife's assurances?

Dr Janil Puthucheary: Sir, the short answer is yes. The entire process is designed to provide a high level of confidence in the findings, to make sure that Cordlife themselves can demonstrate that they are doing the right thing and moving in the right direction to improve protections, and for confidence in the industry as a whole to be shored up. So, the short answer is yes.

He had a specific question on the five tanks that were in the report. I do not have the information about exactly where those five tanks are in our overall assessment and the one-year timeline. If he would like to, I can follow up with him separately on this.