Thursday, 5 July 2018
Medicinal Products Regulation
I thank the Minister of State for coming into the House to hear this Commencement matter on the impact of prescribing sodium valproate, or Epilim, which is a drug licensed in Ireland for the treatment of epilepsy and bipolar disorder. The teratogenic effects of valproate, as the Minister of State will be aware, were first reported in the 1980s and have been widely accepted since the mid-1990s. Last year, the French regulator said women taking valproate were four times more likely to give birth to babies with malformations. The types of birth defects attributed to the drug include spina bifida, autism and developmental problems as well as neural tube defects, malformation of limbs, digits and organs and cleft palate. Bipolar women taking the drug were twice as likely to give birth to children with major birth defects. The FACS Forum Ireland is the umbrella group of organisations that have come together to advocate for better services and supports for families and children affected by foetal anticonvulsant syndrome.
The crux of the matter is that parents were not informed of the risks or risk reduction measures that needed to be put in place. Therefore, they continued to be prescribed valproate during pregnancy. The European Medicines Agency introduced measures to strengthen the warnings and restrictions on the use of valproate in women and girls. In February of this year, following a further review, the agency issued additional instructions aimed at further reducing the risks of this drug. While there are no definitive Irish data on how many children may have been affected by exposure to valproate, the FACS Forum Ireland estimates that more than 400 children have been affected since 1983, and I know some of these children. Our Lady's Children's Hospital in Crumlin has indicated that 43 children have received a diagnosis of foetal anticonvulsant syndrome.
We urgently need an independent investigation into the historical prescribing of valproate to pregnant women. If the Minister of State or the Minister has decided that an independent investigation is not warranted, I want to know in detail why. We need an investigation to address whether and how existing cases of FACS could have been prevented; whether appropriate and timely information was provided to healthcare professionals and patients in line with knowledge at the time; whether appropriate decision-making processes were in place concerning the treatment of women taking valproate in line with knowledge at the time; whether appropriate regulatory steps have been taken over time to ensure patient safety; and how a system of redress should be established to meet the lifelong care needs of children and the impact of diagnosis on their families to avoid the need for legal solutions for already burdened families.
I believe the valproate project group has met many times, but we are still waiting for the Department of Health to sign off on funding for the group. Has this funding been signed off on? This is one of the main things I want to leave here knowing today. If the money has not been signed off on, why not?In November last year the French Government approved a €10 million fund to meet compensation, and it said that was just a starting point for what it needed to do. In February of this year the British Health Secretary, Jeremy Hunt, announced a review of how valproate concerns were handled in the past. A do-nothing approach is not acceptable in this State. Appropriate services must be put in place for these children and their families. Valproate-related disabilities are complex, wide-ranging and individual. Obtaining diagnosis in Ireland is difficult and lengthy. Treatment often involves attending a multitude of unconnected and uncoordinated speciality services. Families often have more than one child affected, and in many cases are caring full time for a number of children. It is critical that appropriate supports are put in place. I know families who are desperately in need of therapies and treatment which they cannot afford. Parents have to give up work to care for these children with disabilities that were avoidable at the time. They have no income, and they have no means of getting the support and services they need. That must be done.
I thank the Senator for raising this important issue. I accept it is a hugely important issue which criss-crosses my own portfolio relating to children with disabilities. As she noted, the Oireachtas Joint Committee on Health recently published a report on sodium valproate and the foetal anticonvulsant syndrome, FACS, following a meeting with FACS Forum Ireland, the Health Products Regulatory Authority, HPRA, and the HSE. The joint committee's report includes a number of recommendations, all of which are being considered and are being implemented by the HSE, the HPRA and my own Department. The first three recommendations made by the joint committee relate to measures recommended by the European Medicines Agency, EMA, on foot of a review of valproate medicines which took place in 2017 and early 2018. Following the European Commission's decision to endorse EMA recommendations, valproate medicines are now contraindicated in women who are able to have children, unless the terms of special pregnancy prevention programme are met. This programme includes measures to ensure patients taking Valproate are fully aware of the risk and the need to avoid becoming pregnant while taking it.
I am happy to report the HPRA has made significant progress in implementing the EMA's recommendations that fall under its remit. In March, for example, the HPRA approved an application to include a warning on the outer carton of the drug packaging in the form of a visual symbol and box warning. The HPRA also approved an application to include a visual warning symbol on the drug's blister pack. In early June, the marketing authorisation holder distributed the new Valproate educational materials approved by the HPRA to all relevant healthcare professionals and patient groups. These educational materials include a patient guide, a healthcare professional guide, a patient card and an annual risk acknowledgement form, as recommended by the EMA. Several of the recommendations made by the joint committee relate to providing a clear diagnostic pathway for children suspected of having FACS, and establishing support services for children and families affected. This ties into the work of the HSE Valproate response team which developed a draft plan to address these particular issues. Officials in my Department and the HSE are working together to identify the requirements for infrastructure and resources. The joint committee also made recommendations concerning an investigation into the historical use of Valproate, as well as a consideration of the issue of compensation.
There are several projects planned or early in progress that will give us a much clearer picture of the numbers affected by FACS., and of the information provided to patients and doctors at different points since the drug was fully licensed. It is appropriate to allow these projects to conclude in the first instance.
Finally, I will need to give the issue of compensation further consideration, as recommended by the committee. This issue is particularly complex given the number of different parties involved to one degree or other, where a woman is prescribed and dispensed sodium valproate.
I welcome Ms Karen Keely, chairperson of the Organisation for Anticonvulsant Syndrome, Ms Valerie Brenann, Ms Danielle Delaney, Ms Beverley Dunne and others to the Gallery. I thank them for all the work they have done on that.
The money is not there. The letter has not been sent out to the GPs. The Minister of State has not answered why that letter was not sent out. Medication is still being given in plastic bags. We need an independent investigation. What he said is skirting around the problem. Will the Minister of State ask the Minister for Health for an independent investigation? Without it, the letters to the GPs or the funding for the services, it will not happen. It is not happening on the ground in the manner the Minister of State outlined. I will speak to him further outside the House because we have limited time. What is purported to be happening is not happening. It needs to be done immediately. In the meantime, there are parents watching their children, and they do not get the services or supports. Every day that goes by without the letter going to the GPs, more women and children are at further risk. This is a serious problem that will not go away, and we cannot keep kicking the can down the road.
I thank the Senator for her additional comments. I will convey the points she has raised to the Minister for Health because I understand the seriousness and complexity of the issues facing the children and families affected by FACS. I am glad to see there has been some positive engagement between FACS Forum Ireland and other stakeholders, including the HSE, the HPRA, and the Department of Health. There will not be any skirting around the issues raised today.
It seems it is also a European issue, rather than one that affects only Irish women and children. It is good that EMA issued such clear guidelines on the safe use of this medicine. It is also good that our medicines regulator, the HPRA, has been working so diligently to implement the EMA recommendations. I hope the measures taken by the HPRA, the HSE, and healthcare professionals more generally mean every woman prescribed the drug is fully aware of the implications of taking the drug so they can make a properly informed decision about their own healthcare.
I will convey the points raised to the Minister for Health to seeks further details on the issues of children, the independent investigation, the signing off of the funding, and also the Senator's strong point about the French Government, which I was not conscious of. It is an example of a European country responding to it. These are all important points. We are committed to doing our best to support people in the best way possible.