Medicinal Products Regulation

Dáil Éireann Debate, Thursday - 19 April 2018

Thursday, 19 April 2018

Ceisteanna (9)

Bobby Aylward

Ceist:

9. Deputy Bobby Aylward asked the Minister for Health the steps he and the Health Service Executive have taken regarding the issue of children affected by foetal anticonvulsant syndrome, FACS, in circumstances in which children were exposed to sodium valproate medicines in the womb; his plans to conduct a review of the families and children affected by this issue; his further plans to set up a compensation scheme for the families affected in view of the compensation scheme set up in France; and if he will make a statement on the matter. [17017/18]

Freagraí ó Béal (6 píosaí cainte)

Deputy Simon Harris

I thank the Deputy for raising this important question. I had an excellent meeting with FACS Forum Ireland two or three weeks ago in Leinster House. A number of Deputies had requested the meeting. I met FACS Forum Ireland with representatives of my Department and the HSE.

Sodium valproate is a medicine licensed for use in Ireland to treat epilepsy and bipolar disorder, and is marketed in Ireland under the brand name Epilim. It is now well established that children exposed to valproate in the womb have an increased risk of congenital malformations and developmental disorders, often described as foetal anticonvulsant syndrome, FACS. In 2014, the European Medicines Agency, EMA, conducted a review of valproate and issued advice placing additional restrictions on the use of valproate for women and girls.

In March 2017, the EMA's risk assessment committee initiated a new review of the use of valproate in the treatment of women and girls who are pregnant or of childbearing age. This review has now been concluded and the committee’s new recommendations on sodium valproate were published by the EMA in February.

Some of the key measures recommended by the EMA are that valproate must not be used in pregnancy for the treatment of migraine or bipolar disorder; valproate must not be used in pregnancy for the treatment of epilepsy unless there is no other treatment option available - some women may have to continue treatment with appropriate specialist care in pregnancy; valproate must not be used in female patients from the time they become able to have children, unless the conditions of a new pregnancy prevention programme are met; the outer packaging of all valproate medicines must include a visual warning about the risks in pregnancy; and a patient reminder card will also be attached to the outer package for pharmacists to discuss with the patient each time the medicine is dispensed.

The HSE is working with my Department and other stakeholders, such as the Health Products Regulatory Authority, HPRA, and the Pharmaceutical Society of Ireland, to communicate and implement the recommendations of the EMA review. Yesterday, the HPRA issued a drug safety newsletter on sodium valproate to all relevant healthcare professionals, together with updated safety information from the drug's manufacturer. Both of these communications reflect the new EMA recommendations and restrictions.

Additional information not given on the floor of the House

I recently met with members of the FACS Forum Ireland to discuss the new EMA recommendations and other issues relating to the use of sodium valproate and children affected by foetal anticonvulsant syndrome. I have asked Department officials and the HSE to follow up on the issues raised at that meeting and I know that there will be further engagement with FACS Forum Ireland over the coming months.

At present, health-related therapy supports and interventions for children can be accessed through both the HSE's primary care services and its disability services, depending on the level of need. It is estimated that 95% of people’s health and social services needs can be met in a primary care setting. The specialist disability services look after children with more complex needs.

It is important to note that patients currently taking medicines containing valproate are advised not to stop taking these medicines and, if they have any concerns about their specific drug treatment and management of their condition, to discuss these with a healthcare professional.

Deputy Bobby Aylward

In a reply to a parliamentary question from my colleague, Deputy Lisa Chambers, in November last year the Minister acknowledged that children exposed to valproate in the womb had an increased risk of congenital malformations and neural development disorders, including autism. He also stated that a warning label for the outer packaging of the Epilim product was introduced in Ireland in early 2017 and that products carrying the new external warning label were being supplied to retail pharmacies. I have different information. I met two mothers from Kilkenny who got a packet of the product in a local chemist in Kilkenny in November and there were no warning signs on it. It is not being implemented. Are the Department and the HSE enforcing this directive well enough?

Is the Minister monitoring the implementation of this warning label on these products, which he previously acknowledged pose an increased risk to pregnant women? I ask this because I met two women who have been affected by this and both of them were still receiving the drug Epilim in a plastic bag with no warning label. They were understandably and genuinely upset, not only because of their own personal situation but because they were all too familiar with the increased risk and danger being posed to other women by the lack of such warning labels. Are the Department and the HSE doing enough in raising awareness and warning vulnerable women of the risks posed by medicines that contain sodium valproate?

Deputy Simon Harris

I had an excellent meeting with FACS Forum Ireland and I heard directly from parents whose children have been impacted by foetal anticonvulsant syndrome. I believe parents have been let down. As the Deputy said, it is not just an issue in Ireland and this is why the European Medicines Agency, EMA, has looked at the matter.

There are three issues, which I discussed with the FACS Forum Ireland. The first issue is what we do going forward to address the concerns, as raised by Deputy Aylward, such as labelling, safety and awareness of the appropriateness of prescribing this drug or not prescribing it. As recently as yesterday the Health Products Regulatory Authority, HPRA, issued new guidelines to all stakeholders on the use of the drug. I am confident and satisfied that HPRA is implementing the recommendations of the European Medicines Agency. This is the body of work we need to keep a close eye on; that it is progressing well; and how to make sure that from this point on the correct information, correct labelling, correct warning and appropriate prescribing is dealt with.

The second issue is what to do for the children who have been born with malformations and disabilities as a result of this situation. When I met with FACS Forum Ireland I was concerned that these are children who must deal with lots of different doctors and various different conditions. No two affected children have the same set of conditions. I am a little concerned that they have been run around from Billy to Jack. I want them to have one single point of contact within the HSE that can give them all of the information. I wrote to the director general of the HSE on 17 April instructing him that all the clinical leads in the HSE and the Children's Hospital Group need to meet with the FACS Forum Ireland to discuss how we deal with these children's needs, just as we have done in other areas.

The third issue is around how we look at the past and how we check that in the past Ireland did everything it could to make sure that parents were aware and that appropriate guidance was followed. My colleagues in the UK and France have initiated some reviews in this regard and I have promised to consider that and revert to the FACS Forum Ireland within the next month.

Deputy Bobby Aylward

With regard to directives, implementation is the important thing. Who will monitor this? This is the problem. Young children in the State are suffering due to exposure to medicine that contains valproate. Children as young as six years of age have had to endure more hospital appointments and hospital surgeries than most adults do in a lifetime, as the Minister admits also. Will the Minister commit to looking at a specific support and service system for affected children and their parents? When asked about this previously the Minister pointed to the national disability strategy. This is a very complex and difficult issue, which requires a targeted and specific support service system. I do not believe it is fair or proper simply to cite a commitment in the programme for Government and consider this problem solved. These children and their families need recognition and support from the State.

With regard to compensation for these families, the Minister has previously responded to a written parliamentary question that he was aware of a State-funded compensation scheme in France that was considering claims from individuals affected by valproate. Will the State set up a compensation scheme or system, and if so what timescale are we looking at?

Deputy Simon Harris

This is not an issue just of today or yesterday. Unlike how it has been dealt with in the past by the Department of Health I have taken a very personal interest in the matter. I have met with FACS Forum Ireland and I heard what they have had to say. I have made three very clear commitments to them, the first of which is how we make sure this does not happen, going forward; appropriate labelling; and implementing the EMA recommendations. The second commitment is how to deal with the children now who, the Deputy rightly said, are living with very difficult and complex conditions, and their parents who are not being adequately supported. This is the purpose of the Children's Hospital Group and the clinical leads sitting down with FACS Forum Ireland and having an understanding of what these kids need and how supports for them can be streamlined. The third commitment, which is the kernel of Deputy Aylward's question, is around what are we going to do about what happened in the past with regard to investigating what happened and seeing if the State did everything appropriate. The Deputy is correct that my counterparts in the UK and France have recently announced processes to do this. I have informed FACS Forum Ireland that I am considering that, in consultation with officials, and I will come back to FACS Forum Ireland within one month with my proposed course of action.

Acting Chairman (Deputy Eugene Murphy)

I thank the Minister and the Deputy.

We might be able to include three further questions but the timeframe is tight. If all Members co-operate then we might get the three questions in.