Dáil Éireann díospóireacht -
Thursday, 20 Jun 2019

Vol. 984 No. 1

Saincheisteanna Tráthúla - Topical Issue Debate

Company Takeovers

Deputy Sean Sherlock

This issue arises from the proposed takeover of GlaxoSmithKline, GSK, in Cork by Thermo Fischer Scientific. It has given rise to concerns on the part of the workers and their representatives, specifically SIPTU which represents the majority of the affected workers. They relate to the interpretation or perceived lack of adherence to the regulations in respect of the transfer of undertakings regulations of 2003. The trade union SIPTU has written to the Minister for Business, Enterprise and Innovation, Deputy Humphreys, but I understand the matter is now in the bailiwick of the Minister for Employment Affairs and Social Protection, Deputy Regina Doherty.

I will quote from a letter I received in respect of concerns that were raised with the Minister, Deputy Humphreys. It refers to:

...GSK management's announcement that they have failed to consult fully with the union and merely put in place a communications strategy to inform our members of both employers' unilateral decisions to change existing terms and conditions of employment. The type of unilateral changes communicated by both employers to workers have far reaching economic impact on our members for example the ceasing of the Defined Benefit Pension Scheme, fundamental changes to the Bonus scheme, non-transfer of annual leave entitlements, ceasing of the revenue approved share purchase scheme.

They are just some of the issues that have arisen. The workers in GSK were informed by their employers on 16 May last that the plant, which employs over 400 people, was to be sold to Thermo Fischer Scientific "under transfer of undertaking for the purposes of the European Communities (Protection of Employees on Transfer of Undertakings) Regulations 2003...". In plain English, one entity has been taken over by another. There were pre-existing and longstanding agreements collectively arrived at and it is feared that they will now be pushed aside. These relate to holidays, sick pay and other changes the employees will have to incur, particularly with regard to their pension entitlements or a previously negotiated pension arrangement.

Any entity, regardless of what it is, must be compliant with the law. I am raising this with the Government to ensure that the workers in GSK and Thermo Fischer Scientific are protected in law and that a process is put in place forthwith through the machinery of the State, be it the Labour Court or through a conciliation process, whereby the Government is watchful of what is happening and ensure it is aware of the situation so there will be a proper dialogue between the two sides to ensure no worker's rights are undermined in any way.

Minister of State at the Department of Employment Affairs and Social Protection (Deputy Finian McGrath)

I thank Deputy Sherlock for raising this important issue. I am replying on behalf of the Minister for Employment Affairs and Social Protection, Deputy Regina Doherty.

As I understand it, Thermo Fisher Scientific has agreed to buy a manufacturing plant in Cork from GlaxoSmithKline, GSK. The sale sees the transfer of ownership of the site, including all facilities as well as business operations and approximately 400 employees, to Thermo Fischer Scientific. GSK employs approximately 1,700 people in Cork, Dungarvan, Dublin and Sligo. Last year it announced plans to close its Sligo plant by 2021, with the loss of 165 jobs. I am told that due to strategic changes in the GSK portfolio, the Cork site had been significantly under utilised and it became clear that it was no longer a competitive fit within GSK manufacturing network. As well as providing certainty for the workers, it is said that the sale will leave the site well positioned for future growth and development.

In terms of my responsibility as Minister for Employment Affairs and Social Protection, what is relevant here is the European Communities (Protection of Employees on Transfer of Undertakings) Regulations 2003. The regulations implement a 2001 EU Directive aimed at safeguarding the rights of employees in the event of a transfer of an undertaking, business or part of a business, to another employer as a result of a legal transfer or merger.

The regulations set out a number of obligations on both the transferor and the transferee in relation to consultation and the provision of information to employees. This must take place at least 30 days in advance of the actual transfer.

The main provisions of the regulations are as follows: all the rights and obligations of an employer under a contract of employment, including terms inserted by collective agreements other than pension rights, are transferred to the new employer on the transfer of the business or part thereof; the new employer must also continue to observe the terms and conditions of any collective agreement until they expire or are replaced; and an employee may not be dismissed by reason of the transfer alone. However, dismissals may take place for economic, technical or organisational reasons involving changes in the workforce. The regulations do not apply where the outgoing employer is subject to proceedings whereby he may be adjudicated bankrupt or wound up for reasons of insolvency, by order of the High Court. The position of the employees’ representatives is protected across a transfer. Both the outgoing and incoming employers are obliged to inform their respective employees’ representatives of the reasons for the transfer and the legal, social and economic implications of the transfer. Where there are no representatives, the employers must arrange for the employees to choose representatives for this purpose. I currently have no reason to believe that the companies involved will not comply with the legislation.

Deputy Sean Sherlock

I welcome the fact that the Minister clearly and unambiguously stated the law. A Minister who sits at Cabinet has stated, on the record of this House, the law of the land in respect of this issue. I hope that any parties bearing witness to this exchange are mindful of this. However, he also stated, "I currently have no reason to believe that the companies involved will not comply with the legislation." I have no way of knowing that and I am sure the Minister of State has no way of knowing it because he is taking this matter on behalf of the Minister, Deputy Regina Doherty. I am hopeful that, by virtue of the fact that we have raised this issue, some process can be entered into whereby the Minister of State's colleagues in Cabinet will take heed of the main provisions of the regulations, as he has clearly set them out. As a Minister of State who sits at Cabinet has set out the regulations on the record of the House, I am pretty sure the parties involved will take heed of them.

Deputy Finian McGrath

Under the regulations, a transfer is defined as the transfer of an economic entity which retains its identity. The question of whether a transfer is a transfer within the meaning of the regulations is a matter to be determined by the adjudicating officer in the Workplace Relations Commission, WRC, or, on appeal, at the Labour Court based on the circumstances of that particular case. Complaints relating to an alleged contravention of the 2003 regulations can be brought in the first instance to an adjudicating officer of the WRC and, on appeal, to the Labour Court. These bodies are guided by national and European Court of Justice case law. Any such case should be taken within six months of the date on which an employee considers there has been a contravention of the regulations. An application to the WRC can be made by the employee or a representative, including a trade union representative. A decision of the adjudicating officer may declare that the complaint is or is not well founded, as the case may be. It may require the employer to comply with the regulations and to take a specific course of action for that purpose or it may require the employer to pay to the employee compensation of such an amount as is just and equitable in the circumstances, up to a maximum of two years' remuneration or four weeks' remuneration in the case of a contravention of the information and consultation provisions of the regulations.

As I said, I currently have no reason to believe that the companies involved will not comply with the regulations but a statutory adjudications framework is in place to provide remedies if necessary. I will bring the issues the Deputy has raised back to the Minister, Deputy Regina Doherty.

Post Office Network

Deputy Sean Fleming

I wish to raise the future of the An Post mail centre in Portlaoise. For well over a year there has been a question mark relating to the reorganisation of the mail centres around the country and I understand that there may be a board meeting of An Post on 27 June, at which a decision may be made on the future of mail centres. This process has been going on for some time. The case for Portlaoise is outstandingly strong and I ask the board to make the right decision, and to give a commitment to the future of the mail centre at the meeting next week. There are outstanding staff in the area and the 200 staff there have great experience and make good use of technology.

The Portlaoise mail centre has a number of key features. It is the area where all parcels come into the country, where they are processed for onward distribution. Because of this, there is a strong customs presence from the Revenue Commissioners in the mail centre, with sophisticated equipment to detect anything illicit coming into the country, as well as an outstanding dog unit that is regularly mentioned locally in connection with the seizure of drugs or other illicit products. As this feature is unique to Portlaoise and exists nowhere else in the country, it makes no sense to remove it and transplant it elsewhere.

There are four mail centres around the country, namely, Dublin, Portlaoise, Cork and Athlone in Westmeath. However, Portlaoise is the most strategic location outside Dublin. The capital city will need a mail sorting centre because of the large volume of post but Portlaoise is within an hour and a half or so of all the regions in the southern half of the country. I live just outside Portlaoise and I am an hour and a half from Dublin Airport, an hour and 15 minutes from Shannon Airport and less than two hours from Cork Airport. One can get parcels from Portlaoise to all the areas in the south of the country overnight for early delivery the next morning. For mail that needs to be sorted overnight in Portlaoise, we have outstanding motorways in the midlands region, to Cork, Limerick or Waterford and one can get to places such as Kerry within an hour and a half or two hours. It would be an excellent facility to keep, if the decision was made to close some mail centres, because Portlaoise is strategically located. It would be the best location and I ask An Post to confirm that.

Following contact from staff in the past year or so, I have had correspondence from the company about the issue. I have a letter of May 2018 from David McRedmond, the chief executive officer, who wrote that An Post was reassessing its national mail processing capacity, including the mail centres, of which Portlaoise is one of four. On 30 April I received another letter from the GPO, telling me that it is subject to Labour Court recommendations and that the matter was under active consideration. I am pleading to the Minister. Portlaoise is a very strategic location and has the best road network of all the country's mail centres. It is imperative that An Post keeps its centre there. I know the Minister will say it is a matter for the board but I am raising the matter here to impress on the board the case for the location in Portlaoise. I ask the board to commit to the future of the Portlaoise mail centre at its next meeting.

Minister for Communications, Climate Action and Environment (Deputy Richard Bruton)

I appreciate the fact that Deputy Fleming has raised the issue, which I know is of acute concern to many people. Last week in the Dáil, the Deputy may have heard somebody else raising the case of one of the other mail sorting centres. The Deputy is an experienced committee Chair and I have soldiered with him on some of them.

He is very aware of the legal position, namely, that this is the responsibility of An Post.

I apologise in advance for the reference in the script to the Deputy suggesting that I should intervene. I do not believe he suggested that. I withdraw that sentence in the script even though I will not be delivering it. The House is well aware of the journey An Post has been on. There has been a 40% fall in mail deliveries and an 8% fall in them even this year. An Post must restructure its business. It came close to a melt down a few years ago and it had to undertake a major restructuring plan. Part of that, as the Deputy will be aware, has been a new deal with its employees, which involved a pay increase but also involved, as a part of that, that one of its mail centres would close, but that this choice would be made on the basis of what is in the best interests of the company, its employees and customers. That continues to be the case. An Post is acutely aware of the important regional role it plays and it will carefully weigh up this decision.

I would also like to acknowledge publicly in the House the success An Post and its employees have brought to the task of restructuring. It has built from scratch new areas of business, particularly in parcel delivery but also in new retail areas, financial services and so on. That is a testimony to the creativity of the company with it being able not only to stabilise its business but show significant operating profit this year. However, ultimately, it still has to continue the work of restructuring its business and building in the new areas of growth and unfortunately that means it still has to restructure the mail sorting offices, which are part of that pay deal and part of the journey it is on.

The Deputy has made an articulate case for the merits of the office in Portlaoise for which he has advocated. I am sure the company will be mindful of the case being made by public representatives in its evaluation of this decision, but it rests with the board and not with me as Minister. That is as it should be. People would be rightly offended if this decision was to be made by a Minister deciding between different mail sorting centres, not on the basis of what is in the best interests of that company building its employment base and its customer base but on the basis of some political calculation. I have faith in the board, the members of which I and my predecessors have appointed, and I believe it will make this decision in the best interests of the company, its workers and the customers it serves.

Deputy Sean Fleming

I appreciate the Minister’s remarks and he being straight and up-front. Essentially, I know the board has been given responsibility. All I ask the Minister to do is to ensure the transcript of this debate, and the fact that I have raised this issue, is transmitted to An Post headquarters so that it is aware of what we are saying. Obviously, when the company is in the Labour Court and dealing with the trade unions what we have to say here is totally irrelevant but it is a slightly broader perspective than considering the issue only from a staffing point of view. We represent the customers and, to an extent, the people of Ireland and our views need to be taken into account. If the Minister were to forward the transcript of this debate to An Post and ask it to consider this issue in an objective manner, I would be satisfied it would come to the right decision, which would mean keeping the mail centre in Portlaoise open into the future.

The Minister said that An Post has been doing its best to reorganise its facilities. We all know there has been a considerable drop in the volume of letters being posted. That is a simple fact. Its parcel delivery service has increased substantially with the increase in online shopping. We all have experience of that. People can make a booking or purchase an item online at midnight on Sunday and lo and behold it can be hand delivered by van to one’s front door on Tuesday morning. An Post has a key role to play in that. That is why the cental location in Portlaoise is extremely good for achieving that. It is expanding its service for parcel deliveries from five to six days a week. It is important it improves its service and matches the services delivered in the strictly private sector. Because there is a strong parcel sorting and delivery function in Portlaoise and all inward parcels come into that mail centre, there is a strong customer presence there. It does not make sense to close that facility and have to reopen a similar facility somewhere else.

Everything goes to the big cities, whether it be Dublin or the other large cities. It is important where there is a good viable business in regional towns that we hold on to it. I ask that the mail centre in Portlaoise be approved by the board of An Post in that context.

Deputy Richard Bruton

I can assure the Deputy I will arrange for a transcript of this debate to be passed on to An Post, as he requested. He has made an articulate case for Portlaoise. I know An Post is very conscious of the regional role it plays and of the importance it plays in regional development. This is a decision it will have to make and it will do so on the basis of what is in the best interests of the company, its employees, customers and communities it serves.

Hospital Waiting Lists

Deputy Louise O'Reilly

I do not mean to be disrespectful to the Minister of State but does the Minister, Deputy Harris, ever take a Topical Issue matter? I have been here as long as some Members but my understanding is that it is customary for the Minister to take Topical Issue matters where possible. My colleague, Deputy Quinlivan, has raised 13 Topical Issues regarding Limerick hospital and I have raised countless Topical Issue matters related to health and I do not believe the Minister for Health has ever taken one of those. I do not mean that in a disrespectful way to the Minister of State and I am glad that she is here.

In February 2017, following a very harrowing "Prime Time" documentary, many promises were made regarding waiting lists, particularly for children with scoliosis. Those promises were made under pressure in the limelight and they have not been kept and children and their families are still waiting and unfortunately they are waiting in pain.

As matters currently stand, 3,500 children are waiting for their first appointment and those are the children about whom we know. Also, it is estimated that approximately 10,000 children waiting are hidden on adult waiting lists. If there are hidden waiting lists, children who are hidden on adult waiting lists, how will it be possible to plan for the surgery, appointments and all that those children will need because the Minister cannot tell how many there are?

We have seen in recent weeks the parents of children with scoliosis being forced to take to the media. No parent wants to do that. I am a parent and I would not want to have to do it and I know that they do not want to have to do it. It was reported in the newspapers that Deirdre O'Keeffe, a mother from County Cork, said that her daughter, Alison, aged 14, was put on the list for surgery in Crumlin hospital in December and she was deemed urgent. I do not know what that means to the Minister of State but to me it means that the procedure needs to be carried out in a timely manner. She had a pre-operative assessment in February and at Easter she was told that her name was highlighted on a board to be brought for surgery. She was told she would be brought for surgery but she is still waiting with no operation date, and that is an urgent case.

Joseph Hornick and his daughter, Amber, are in a similar limbo. She was diagnosed in October and her family had to pay for a private outpatient appointment and an MRI at a cost of approximately €600, which for many families is money that cannot not easily be found. She was seen in Crumlin Hospital in February and again told that her case was urgent and that her surgery would be done in two to three months. Her dad says he calls the hospital two to three times a week but still has no date for surgery.

All the promises that were made by the Minister, Deputy Harris, and all the apologies that were issued mean absolutely nothing to those children who are waiting in pain. The complications that arise from being left waiting are many. Children develop internal complications as the curvature of their spine worsens.

Not only are they in pain - the Minister of State should be under no illusions about that - but their internal organs are being damaged as the condition worsens. This is wholly unacceptable, as the Minister admitted when he promised in February 2017 that no child would be left waiting for longer than four months. More than two years later, that target has not been met. The families are due another apology but they would prefer if their children were able to access the surgery they need.

Minister of State at the Department of Health (Deputy Catherine Byrne)

I apologise for the Minister for Health's absence. I am not sure where he is. I did not know until two hours ago that I would take this matter. When a Topical Issue matter is submitted I suggest that the Ceann Comhairle contact the office of the relevant Minister to ask if he or she will be available to take the matter. I do not know if that is possible but it would give Deputies an opportunity to withdraw the matter until such time as the Minister becomes available.

On behalf of the Minister, I thank Deputy O'Reilly for raising this issue. It gives me an opportunity to provide an update to the House on the progress to date on the reduction of waiting times for children with scoliosis. The long-term strategy to develop sustainable scoliosis services in 2018 and 2019 is a priority for the Minister and the HSE. Children's Health Ireland advises that the impact of investment and the implementation of the scoliosis ten-point action plan is now delivering results with an improvement in waiting times being recorded.

In 2018, Children's Health Ireland was provided with €9 million in funding by the HSE to address paediatric orthopaedic waiting lists, including the provision of scoliosis services. Last year saw the delivery of results from this investment, with a consistent reduction in waiting times being recorded for scoliosis. As a result of this increased investment, the total number of surgeries performed in 2018 was 418 compared with 371 in 2017, representing a 12% increase in activity year on year and a marked increase in activity of 87% compared with 2016. This increased activity has had a positive impact on the numbers waiting. Children's Health Ireland advises that, as of 14 June 2019, there were 193 children waiting for a spinal fusion or other spinal procedure. This constitutes an 11% decrease on the same period last year. The figure includes suspended patients, a category that has seen a 70% reduction in numbers year on year. Children's Health Ireland advises that the numbers of spinal fusion patients waiting for more than four months has also decreased this year, with 30% of fusion patients waiting longer than four months compared with 39% at the end of 2018. More broadly, all patient referrals to the orthopaedic spinal service at Children's Health Ireland are reviewed and clinically prioritised by a consultant. These patients are seen in order of clinical priority.

Work to address the complex issue of scoliosis is included in the wider plans to improve orthopaedic services at Children's Health Ireland. More than 30,000 children attended the paediatric orthopaedic outpatient departments at Children's Health Ireland and Cappagh National Orthopaedic Hospital in 2018. An additional 800 outpatient appointments were given to patients in Children's Health Ireland at Crumlin children's hospital in 2018 compared with 2017, which contributed to a 31% reduction in the overall orthopaedic outpatient waiting list. In addition, an outpatient initiative for long waiters carried out by Children's Health Ireland at Crumlin children's hospital facilitated 443 appointments from the orthopaedic outpatient waiting list.

The paediatric scoliosis services co-design group established in March 2017 includes the scoliosis advocacy groups. These groups work with professionals and managers to design comprehensive scoliosis services to meet the needs of children, young people, their families and healthcare professionals. The work of the co-design group continues to form the basis for the ongoing development of the scoliosis service in 2019. I understand that the co-design group published the scoliosis ten-point action plan in July 2018 and will publish a further update at the end of this month.

In reference to Deputy O'Reilly's question, if the Deputy forwards the names of the children to whom she referred, I will bring them to the Minister's attention.

An Ceann Comhairle

The procedures for dealing with Topical Issue matters provide that a Minister or Minister of State from the same Department will reply. We have all noticed that the Minister of State, Deputy Catherine Byrne, comes in here and takes the heat on many of these issues. However, it is perfectly in compliance with the strictures of the House to have a Minister of State from the relevant Department take a Topical Issue matter. If Members are dissatisfied with the position, we should review the arrangements to address that.

Deputy Louise O'Reilly

I was not suggesting there was anything untoward happening.

An Ceann Comhairle

I know that.

Deputy Louise O'Reilly

I was pointing out that the Minister has never appeared for the Topical Issue debate in my experience.

An Ceann Comhairle

I have no problem with what the Deputy or the Minister of State has said.

Deputy Louise O'Reilly

I thank the Minister of State for the reply. Notwithstanding the aggressive management of waiting lists that has been reported and the absolute promise and commitment given by the Minister that no child would have to wait longer than four months, the best the Minister of State can do is report a slowdown in the rate of increase. That is not good enough. These are sick children who are in pain and they are being left to wait.

As we speak, the orthopaedic theatre in Crumlin children's hospital, which is in the Minister of State's constituency, is still only operational three days a week. How can the Department expect to make good on promises made by the Minister if resources are not being provided and the resources available are not being utilised to their full capacity? The orthopaedic theatre in Crumlin children's hospital should be open for longer than eight hours a day. It should be open seven days a week until the backlog has been eliminated.

The parents of these children are in the unfortunate position that they are forgotten about the moment the spotlight comes off this issue and the Minister no longer has a microphone and camera in his face. That is how they feel. If they do not go to the media, they cannot get any traction. Many of them are at home looking after their children. They do not want to have to talk to me or the Minister of State or engage with politicians. They want to live their lives and they want their children to get the surgery they need but they are forced to go to the media and kick up a fuss just to get basic services. The best the Minister of State can do is report that there has been a slight improvement because the rate of increase has slowed. She stated that 30% of children with scoliosis wait longer than four months. It is nearly two and a half years since a promise was made that no child would wait more than two months.

I am not asking the Minister of State to agree with me because if she did, I am sure she would not say so, which is fair enough. Surely anyone looking at this would agree that is not fair and that the promises that were given to those parents count for nothing. The parents will have to keep advocating, lobbying politicians and going to the media when they want to spend time with their sick children.

Deputy Catherine Byrne

I thank Deputy O'Reilly again. I assure the Deputy that the Minister has met regularly the senior management of the HSE and Children's Health Ireland to discuss their short and long-term plans to provide a better service for patients and their families. Nobody wants to see children waiting on a hospital waiting list, particularly children with a severe illness such as scoliosis.

I am not too sure about some of the issues the Deputy has raised, for instance, children being hidden on adult waiting lists. I will have to inquire about that because I do not have any information on that. I assure the Deputy that I will convey her remarks to the Minister. I apologise again for his absence. I am sure the transcript of these proceedings will be made available tomorrow and I will bring it to his attention. I will request that the Minister take some Topical Issue matters in future, if possible, as that could help Members who have raised issues here on a number of occasions when the Minister has not been here to reply to them directly. I am given the written word and while I can intervene on some issues, I do not have answers to some of the questions asked. I do not know whether the Minister has answers but I will go back to him.

Medicinal Products Availability

Deputy Caoimhghín Ó Caoláin

Gabhaim buíochas leis an gCeann Comhairle.

The date 11 June 2019 was and will always be a red letter day in the lives of those children and their families who will now finally get the chance to have new life experiences and prospects, thanks to the HSE leadership team's decision to approve the drug Spinraza. It could and should have been a red letter day in the lives of all spinal muscular atrophy, SMA, sufferers, but, sadly, approval only extended to children up to the age of 18 years. We must all be conscious of the adult SMA population in Ireland who have been left behind by this decision and are feeling very disappointed and isolated. What will happen when children turn 18 years of age?

I will read extracts from two emails I received in the wake of the decision. One is from an adult Irish woman, a mother and a wife, who has SMA, while the other is from an adult American male who also has SMA but who has access to Spinraza. Both are in their 50s. The adult Irish female states in her correspondence what it has been like living with spinal muscular atrophy since she was a teenager. She recently celebrated her 50th birthday. I quote:

Last year our SMA Ireland family was formed. It was and is wonderful to be part of a support network because some of us adults have been battling this disease for decades on our own, apart from family, physiotherapists, and occupational therapists. I was thrilled on Tuesday last, 11 June, that at last Spinraza was approved for children but devastated for myself, my husband, my daughter, my family, and for the other SMA adults living in Ireland.

Addressing the Minister for Health, Deputy Harris, she stated:

You also have a daughter, Minister Harris. You know how much love a parent has for their child. I had to greet my daughter at the school gate on that Tuesday with the devastating news that her mother will not get Spinraza. I tried to explain the inexplicable. She cried as I have done. Time is not on my side.

Yours in anticipation.

I turn to the adult American male. I will only quote extracts from his email:

Denying adults access to this drug is heartless and inhumane. I am living proof that Spinraza does work for adults suffering with SMA. I am an American male, 54 years of age, who was diagnosed with SMA in my early 20s. This was a terrifying time in my life. After diagnosis I spent the next 20 years watching this disease slowly rob me of my ability to play with my children, my hobbies, my ability to perform even basic home maintenance, and eventually my ability to work and provide for my family. I started treatment with Spinraza back in October of 2017. Since starting treatment, my disease progression not only stopped but I began to see improvements in my walking gait, my overall strength and my endurance. Before treatment I needed a walker just to stand up from a lift chair. That walker is no longer needed. Before treatment I needed assistance in order to lift my leg into a vehicle. This is no longer needed. These achievements may seem minuscule but for someone who is facing the inevitable total loss of independence, Spinraza is offering a new chance of life. Please make Spinraza available for all because every life matters.

I close with the request that the Minister of State respond positively to the appeal of the SMA community and that she, please, ensure approval for the reimbursement of Spinraza for all SMA sufferers.

Deputy Catherine Byrne

I thank the Deputy for raising this issue which he has raised on a number of occasions. We were all delighted when it was announced in June that Spinraza would be made available to children. Spinraza is indicated for the treatment of 5q spinal muscular atrophy, SMA, which causes progressive muscle atrophy and weakness. It is a genetic condition that affects the nerves in the spinal cord. It causes problems with movement, muscle weakness and difficulties in breathing and swallowing. It is estimated that there are approximately 25 children living with SMA in Ireland. As Deputies are aware, the Oireachtas put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013 which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinions, as appropriate. They include the clinical and cost effectiveness of the product, the opportunity cost, the potential or actual budget impact and the impact on resources available to the HSE.

I am informed that on 11 June the HSE leadership team approved access to the drug Spinraza for children with SMA types I, II and III on an exceptional and individualised basis. The HSE’s decision is in respect of children with genetically confirmed SMA type I, II or III, in accordance with the controlled access criteria recommended by the technology review committee for rare diseases. That committee’s recommendations on access criteria were clearly targeted at the youngest and most severely affected SMA patients. This group is the clear priority for the HSE.

The actual patient assessment and approval process will be the means used in determining access on an individual case by case basis. Such a managed access programme will operate within the remit of the HSE medicines management programme. The HSE's decision process for Spinraza involved a health technology assessment, followed by detailed consideration by the HSE expert groups on new drug therapies, including the technology review committee for rare diseases and the drugs committee. Evidence of the clinical effectiveness of the new drug therapy was also reviewed.

We acknowledge that the protracted deliberations on the reimbursement of Spinraza have caused great stress and anxiety for the families of patients. However, the HSE has finite resources and a responsibility to ensure they are deployed to the greatest effect. The Minister for Health, Deputy Harris, is pleased that, through commercial negotiations, the HSE and the manufacturer managed to reach an agreement that will benefit the most vulnerable children.

I do not have much more to add on the specific question the Deputy asked. While we are all delighted that Spinraza has been approved for children, the Deputy asked that it also be made available to adults. I do not have a reply to that question and if I come back into the Chamber again, I do not believe I will have anything further to add. I cannot give a commitment on behalf of the Minister that Spinraza will be supplied to adults any time soon.

Deputy Caoimhghín Ó Caoláin

On behalf of Members, I ask the Ceann Comhairle to reflect on the unsuitability and inadequacy of having the Minister of State respond. She is, as she rightly acknowledged, not in a position to expand on the current position. The Minister for Health should be here. He has the same duty to be held as accountable to the House as the Ministers, Deputies Flanagan and Bruton. He certainly never appears in the House whenever I table a Topical Issue matter. The reply the Minister of State has read does not address the serious deficiency in the decision made. It should have included all SMA sufferers. Not everyone who will have the opportunity to access Nusinersen, or Spinraza, its branded name, will respond positively to it, as in the example I gave of the adult American male. One hopes they all will - certainly the 25 children who will now have access to it - show spectacular improvement in their physical condition and life prospects. There is, however, a cohort of adults.

Their number is uncertain but is certainly no more than 50, as has been speculated on time and again. These are people who have survived with SMA from childhood. In many of their cases, the symptoms presented in later life rather than in early years. They are equally entitled to access to Spinraza. The families who are now pleased and who have every right to celebrate because their children have hope are equally vehement in supporting the case for access to Spinraza for all, including the adult cohort. When the Minister of State says the HSE has prioritised this group, this is welcome but it has to include all SMA sufferers. I am not going to labour my point. The voice and intervention of the Minister of State could also be helpful. I ask her to stand with us in this appeal to the Minister, Deputy Harris, to the Government and to the HSE to continue the engagement with Biogen and as speedily as possible to conclude an arrangement for access to Spinraza for all sufferers from SMA across this land.

Deputy Catherine Byrne

We would all hope into the future that those who suffer from SMA will be able to treated, as everyone who is sick should be. I am not in a position to give Deputy Ó Caoláin an answer on this today. However, I will commit to speaking to the Minister, Deputy Harris, and to trying to influence those who need to be influenced to the effect that all people who have SMA should be treated equally. I am sorry that I do not have the direct decision the Deputy would like but I will bring it back to the Minister, Deputy Harris.

Deputy Caoimhghín Ó Caoláin

I thank the Minister of State.