Dáil Éireann Debate, Thursday - 26 May 2022
3. Deputy David Cullinane asked the Minister for Health the status of the sodium valproate inquiry and the provision of community-based care to patients and families affected by foetal valproate syndrome; and if he will make a statement on the matter. [26376/22]
View answerThe Minister will know that 1,500 children have experienced a major congenital malformation or some form of neurodevelopmental delay because of exposure to sodium valproate. He committed to an inquiry into this but that has not happened. I believe terms of reference have still not been agreed. Support packages were supposed to be put in place for victims and survivors but that has not happened. I want to get a sense of the status and how this can be advanced as quickly as possible.
I thank the Deputy for raising the matter. I am very sympathetic to the patients and their families over what has happened. I met the patient groups involved in late 2020 and supported their call for a review into sodium valproate. I committed to making it happen. Since then, senior officials in my Department have been engaging closely with the patient groups and other stakeholders over the past year to finalise the terms of reference to get this review under way.
Critically, the review will be designed around giving a voice to patients and their families and looking at the use of sodium valproate in Ireland since it was first licensed. It was important that enough time and resources were invested in scoping out the work to be done and engaging with patient groups as opposed to simply designing something and telling them what it would be. Many factors needed to be considered and I wanted to ensure the terms of reference incorporated what people wanted to see.
Many different groups are involved here, including the manufacturer, prescribers of the drug, our medicines and pharmacy regulators, and most important the patients and their families.
As a result, there has been a lot of preparatory work to get this together and to make sure all of the groups involved would come together for the review.
With regard to community-based care, as part of the valproate response project, the HSE has developed a diagnostic and community pathway to ensure patients are properly assessed and are referred to community services if they receive a diagnosis of foetal valproate syndrome, FVS. The first step in developing the pathway was establishing a dedicated diagnostic clinic in 2019. That was established in Children's Health Ireland in Crumlin and is headed by a specialist consultant geneticist. As of today, 36 patients have received a diagnosis. There is, critically, no waiting list at the moment for that diagnosis. I will, in my next response, continue on the rest of the community pathways.
People want to hear when the terms of reference will be complete and when the inquiry will be established. Does the Minister have any timeframe at all? That commitment was given a long time ago. There was also a commitment given in 2019, when the HSE recommended medical cards for all individuals who have FVS. That has not happened.
I understand it was also recommended that community healthcare organisations, CHOs, submit business cases for additional supports to provide these services. According to a report in The Medical Independent, none have been submitted. A national FVS co-ordinator was to be appointed. Has such a person been appointed? My understanding is that to date, only 35 people have been diagnosed with FVS and we know the number is going to be much higher than that.
There is a diagnostic pathway but it is clearly not working fast enough. When will the inquiry be established? When will the supports that were promised be put in place?
The inquiry will be established as soon as we get the terms of reference finalised. It is important that the terms of reference, first and foremost, make sense for the patients, families and groups. We must also ensure all the stakeholders can work with those terms of reference. We are reviewing the terms of reference at the moment. I cannot give an exact date but I will revert to the Deputy with an update when I have it.
After a diagnosis, the geneticist makes a recommendation on the health services that are needed for the patient. This is important. The geneticist is designing or recommending a package of care. The relevant CHO is then informed and a liaison officer is appointed. We will all agree that is important. The liaison officer establishes the link to the services and, critically, is an advocate for the patient. At that point, the appropriate healthcare services and the appropriate equipment are provided through the care pathway and with the CHO.
I have met with the campaign group and many of the affected families. They are very sore about this. They said that nurses were sent to families to assess their support needs but no supports ever came. That is the problem. There has been a commitment to an inquiry which has still not been established. I heard the Minister say he wants to get it right. Those affected also want to get it right but they need some sort of timeframe for when it will happen. Solid commitments were given in respect of community care, as the Minister has outlined. Nurses sat down with patients and assessed their needs but those patients simply have not received supports. Commitments and promises were made in respect of medical cards and a whole range of medical supports. It is a sore point for them that while they are still waiting for word on when the inquiry will be established, their healthcare needs have not yet been met. It is great that nurses are engaging with these individuals but it does not suit anybody if there is nothing coming out the other end, the HSE is stating it does not have the resources and there is a blame game going on. The situation needs to be resolved.
I thank the Deputy. It is very serious if that is the case. It is not the advice I have from the Department or the HSE. The advice I have is that the services and equipment are being provided. There is a mechanism whereby if a CHO does not have a budget specifically for this group of patients, it can put a business case together centrally. The HSE has not received any business cases and the advice I have is that the CHOs are providing support. What the Deputy is saying is serious. I will look into it today.
Somebody is at fault and it is not the patients.
Let us take a look. I will revert to the Deputy with a note.
