Commencement Matters

Medicinal Products Regulation

For the first Commencement matter we have the Minister of State, Deputy Finian McGrath. Cuirim fáilte roimhe. I ask Senator Rose Conway-Walsh to outline her case.

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.

I am sure if the matter is not resolved, the Senator will be back here again soon.

Cross-Border Co-operation

Gabhaim buíochas leis an Aire as a bheith linn ar maidin don cheist seo. I welcome the Minister of State at the Department of Housing, Planning and Local Government and I thank him for taking the time to address this matter. It is one I have been kicking around since entering the Seanad. Given the weather over the past number of weeks, it is particularly timely. We know that weather does not recognise borders, so it makes perfect scientific, social, economic and agricultural sense that neither would those who provide us with our weather information. There are people who move, go to school, work or farm on both sides of the Border, and in periods of adverse and emergency weather alerts we should operate in a more cooperative and cohesive way to ensure people are kept safe and have access to the fullest information available to them, given the nature of the Border and how open it is at the moment. The Minister will have noticed on many instances over recent weeks, whether on "The Late Late Show" or Met Éireann, the Six Counties in the north east have been amputated from many maps. The HSE issued us, as Oireachtas Members, maps with those Six Counties amputated from them.

It does not need to be a contentious political issue; it is relatively easily resolved. I understand there are jurisdictional issues and all of that. Perhaps I am naïve in this sense, but it seems relatively straightforward to merely obtain the relevant information that pertains to the Six Counties and highlight it as well. Weather agencies and emergency bodies in the North have a responsibility to show what is happening across the rest of the country as well.

The Commencement matter speaks for itself. We have a particular need to engage the local government authorities on the issue because in my experience, having previously been a member of Belfast City Council, our local government structures are often the front line in dealing with these emergencies.

I welcome the Minister of State, Deputy English.

I thank Senator Ó Donnghaile for raising this issue as it gives me the chance to outline the situation with him directly. On the issue of the Six Counties and the map, certainly with the planning end of our Department under Project 2040, we made sure to try to engage properly and to plan for the island as a whole, including the linkages with the towns and cities in the Border region, and to make sure we got that right.

I hope the Senator recognises that we do try to do that when we can while respecting all the different jurisdictions, who is in control in different areas and so on. We have had debates here on the marine spatial strategy. Latterly we have also tried to do that on a whole-island basis and engage with our colleagues across the Border as well.

The response to all emergencies is appropriately locally led in the first instance. Local authorities, An Garda Síochána and the Health Service Executive are designated as the principal response agencies. Local authorities are further designated by the framework for major emergency management as lead agency for co-ordinating the local response to severe weather events. The generic response arrangements enabling the three principal response agencies to collaborate are set out in “A Framework for Major Emergency Management” which was published in 2006, together with a range of other guidance documents and protocols. That is something we keep under constant review. Local authorities liaise with the other principal response agencies - the HSE, An Garda Síochána - and, where necessary, activate interagency structures to manage the response and incorporate a range of other agencies as well as communities themselves.

Protocols in place in both this State and Northern Ireland provide guidance on the co-ordination of response and recovery during emergencies. These protocols reflect the required responses to major emergencies in the Republic of Ireland and major incidents in Northern Ireland. While emergencies can have different terminology in both jurisdictions, they effectively recognise the same types of events and incidents. A range of bilateral arrangements are in place between local authorities and relevant agencies on both sides of the Border to cover the response to major emergencies that may occur in Border areas. As the Senator said, the line on the map is not recognised by weather events.

A number of service level agreements and memoranda of understanding are in place with agencies in Northern Ireland by virtue of the work carried out between individual emergency services on both sides of the Border, along an area classed as the Border corridor. These agreements are for task-specific resources, which in the event of an emergency could be activated first.

Fire services in counties along the Border corridor currently have both formal and informal arrangements regarding mutual aid support in emergency response situations. Both jurisdictions provide assistance when requested from their colleagues across the Border. For example, Donegal fire service has a formal memorandum of understanding in place with the Northern Ireland Fire and Rescue Service covering the response to fires.

The Department of Housing, Planning and Local Government is designated as the lead Department for co-ordinating the response to severe weather. When the local-level response is stretched or when national-level assistance is required, the Department convenes a national emergency co-ordination group, NECG. People have seen that in action during the previous two status-red weather warnings we had in the past 12 months. The NECG co-ordinates the response measures in place and deals with emerging issues. The NECG will arrange for relevant Departments and agencies to liaise with their equivalents in Northern Ireland as required.

The national steering group on major emergency management has approved "Host Nation Support Guidance for the Principal Response Agencies". This document details arrangements that would be required and activated in the event of Ireland requesting international assistance, including in respect of assistance received from Northern Ireland. I hope that brings some clarity to the situation.

It is very detailed and I appreciate the clarity. While I did not have all of that information at hand, it does not necessarily surprise me to hear that work is ongoing. I am a great advocate in this Chamber for saying that Ireland works best when it works together. We have certainly seen that in instances of fortress Ireland relating to different agricultural emergencies and things like that. The Minister of State has outlined a number of practical measures where that co-operation is ongoing. I welcome it and I would encourage more of it.

However, the big gap comes with the issue of communication and how we show everything that is going on. I do not doubt that all of that is going on at an emergency co-ordination and response level. I do not know if it is in the gift of Government to direct and encourage Met Éireann and other agencies to ensure that all that collated information is then communicated and shown. It needs to be shown via the maps, RTÉ and Met Éireann in order that people in Strabane or Lifford, Newry or Dundalk know the state of the emergency and what kind of care and precaution they should take. The Minister of State might reflect on that.

That is a worthy request. I will look at it and discuss it with the other agencies around the table in an effort to do that. There is no point in having all these good structures in place if no one knows anything about it. The communities on both sides of the Border who are all our neighbours, friends and colleagues need to understand we work together and we are ready and happy to do to that. Everyone needs to know to whom to respond at the right time. I am happy to look at the communication.

School Patronage

I raise concerns over the Carlow County Childcare Committee surveys on school reconfiguration for diversity being carried out on behalf of Kilkenny and Carlow Education and Training Board. This is being done through the Department of Education and Skills. I am sure the Minister of State is standing in for the Minister for Education and Skills and I know he will relay my concerns.

The Government’s plan to increase provision of multidenominational and non-denominational schools is dependent on choice. With this in mind, surveys of parents of preschool children were completed in recent months. These surveys of parents in 16 areas across the country commenced the schools reconfiguration for diversity process to fulfil a key action in the Action Plan for Education, which aims to make Ireland’s education and training service the best in Europe by 2026.

These childcare surveys should use approved methodology to identify the exact needs of the whole community by gathering information in a systematic way. However, I have been contacted by a number of my people in my area who felt they were not consulted during this survey. In fact, they felt actively excluded. Tullow with 4,673 citizens is the third largest town in the Carlow-Kilkenny constituency only surpassed by Kilkenny city with 26,512 citizens and Carlow town with 24,272 citizens. Tullow is now the 94th largest population centre in Ireland. The town and surrounding areas have nine primary schools, eight of Catholic patronage and one of Church of Ireland patronage, and one post-primary school, which provided educational facilities for the town and the surrounding hinterland.

Tullow is an important service centre in north-east Carlow and has a significant role in accommodating future population growth and economic development of the area. This role in County Carlow and its growing population urged an examination of the need for multidenominational and non-denominational school for the town to see if there was an appetite within the area for an Educate Together school.

The anonymous survey asked parents to indicate if they were happy with the current primary school provision and what type of primary school they would choose for their children. However, if a child was not attending an ECCE-approved preschool in the area, his or her parents were not asked their opinion. Parents who work outside of Tullow and place their small children in a crèche or Montessori closer to their workplace for convenience were not consulted. Public health nurses who have access to the information of all children in the target group were not consulted to balance up the numbers to ensure all parents were consulted.

In the survey, some parents, whose intention is to send their child to an Educate Together school already in another area closer their work, were asked their opinion. The numbers then do not give a true reflection of satisfaction with the currently available choice. Given that only a fraction of the population of potential primary school children had access to the survey, it indicates that the survey results cannot possibly give a true reflection of the need or desire for a multidenominational or non-denominational school for primary aged children.

No parent of a child currently in the school system who did not have a younger sibling in ECCE-approved preschool was asked for his or her opinion.

We have a problem getting DEIS status in Tullow. This matter needs to be conveyed to the Minister for Education and Skills. I have fought for DEIS status to be granted to schools in Tullow for years. The people in the area have been ignored. However, that is a matter for another day. We need to ensure that we get a multidenominational or non-denominational school in the area. The Government has said that it aspires to make Ireland's education system a world leader but there is a problem in the context of how the data upon which plans are made is gathered. I would like to be informed as to the exact instructions that were given to the Carlow County Childcare Committee, which comes under the remit of the Department of Children and Youth Affairs and which carried out this survey on behalf of the Department of Education and Skills. The measure was applied to 16 areas. There is great confusion in my area and I ask the Minister of State present to clarify the matter. I want people to have equal opportunities. In that context, we must ensure that everyone concerned is surveyed.

I thank the Senator Murnane O'Connor for raising this issue. The Minister for Education and Skills sends his apologies for not being present. I am taking this matter on his behalf and I will set out for the Seanad the position in terms of the schools reconfiguration for diversity process.

In January 2017, the Minister announced new plans aimed at accelerating the provision of multidenominational and non-denominational schools across the country in line with the choices of parents, families and school communities and the programme for Government commitment to reach 400 such schools by 2030. He would like to point out that the previous model of patronage divestment yielded only a limited number of schools for transfer to multidenominational patrons, and only ten since 2013. He believes that this new schools reconfiguration for diversity process, which will involve the transfer of live schools, has the potential to significantly increase patron diversity in our school system. He also believes that lessons have been learned from the previous process.

The main provision of the schools reconfiguration for diversity process involves a survey of preschool parents across specific geographical areas and the potential for a subsequent transfer of patronage of a school by the existing patron to a multidenominational or non-denominational patron on the basis of a report on the survey outcomes. This process consists of two separate and distinct phases. The identification phase includes the current roll-out of surveys across 16 pilot areas, including Tullow, and is being conducted by the educational training boards, ETBs. This phase is under way. The ETBs have identified, on the basis of census date, towns or areas where there is likely to be demand from families for a greater diversity of school patronage. The ETBs have worked with Childcare Committees Ireland, CCI, to establish evidence of this demand among a cohort of preschool parents, via surveys being facilitated by the relevant local city and county childcare committees in conjunction with the CCI. There will then be discussions between individual ETBs and existing patrons or landowners concerning the possible transfer of existing schools to accommodate a demonstrated demand for diversity of patronage. Each ETB will then prepare a report for the Department outlining the levels of indicated demand arising from the surveys and the responses of the existing patrons as to how this might be accommodated through the reconfiguration of existing school provision. These reports will be published on the website for the Department of Education and Skills, with quarterly reports on implementation.

The second phase relates to implementation. In the event that the identification phase reveals a level of demand for multidenominational schools sufficient to justify transfer of at least one school from denominational to multidenominational patronage, a process will commence to give effect to this. There will be a role for the existing patron or landowner in consulting with local community and school interests. The development of protocols for the implementation phase is proceeding. It is clear from the discussions that have taken place that all parties, including church authorities, want the process of the selection of a new patron to reflect the wishes of the parents and school community. In agreeing the protocols for the implementation phase, the Department of Education and Skills will be clear that, in arranging for transfers of schools to multidenominational patrons, the choice of alternative patronage should be based on principles of transparency and co-operation, and reflect the wishes of parents. The Minister for Education and Skills has already stated his belief that the best way to achieve this will be to hold a public meeting where each prospective patron can make his or her case to the school community, followed by a vote of all parents within that school community whether they attended the meeting or not. It is envisaged that in most cases transfer will be by way of voluntary live school transfer rather than the amalgamation and closure model that formed the basis of the previous patronage divesting process. It is expected that in many cases the school property will simply be leased at a modest or nominal rent from the existing landowner.

I hope that I have clarified the position and reaffirmed that Tullow, and other areas, are being considered in a proper and clear way.

I thank the Minister of State for his reply. I tabled a Commencement matter on this topic due to the confusion generated by the survey. There are parents who feel that they should have been surveyed but, unfortunately, it was only the parents of children who participate in ECCE schemes that were surveyed. As the Minister of State stated, surveys have been circulated in 16 pilot areas. I ask him to convey and highlight all of my concerns to the Minister for Education and Skills. We need to work together and we need to ensure that all parents have an opportunity to express their views about education for their children. No matter what, we must respect everybody's wishes and that is what I am here to do. I know the Minister of State will convey my concerns to the Minister for Education and Skills.

I do not think the Minister of State has much more to add. I call on him for a brief comment.

Yes, I will convey the Senator's concerns to the Minister for Education and Skills. The Minister has clearly stated that he wants parents to be consulted and for the system to be right. That is what he is trying to do and it is the reason he changed the process.

I thank the Minister of State.