Commencement Matters

Proposed Legislation

Senator Fintan Warfield

I welcome the Minister of State to the House. Four weeks ago, the Houses of the Oireachtas took a progressive step in dealing with the sometimes shameful legacy of the State's treatment of the LGBTQI community by the passage in the Dáil of a motion apologising to those criminalised for homosexual activity. Similar legacy issues arise in respect of our Traveller and migrant communities and religious minorities. A shared future and creating an equal setting for all should always be core tenets of a process of reconciliation. In creating that equal setting, we must strive to eliminate the remnants of sometimes shameful legacies involving racism, ableism, sectarianism, bigotry, homophobia, biphobia or transphobia. In furtherance of that goal, every western European jurisdiction, with the exception of this State, has implemented robust hate crime legislation.

The International Lesbian, Gay, Bisexual, Trans and Intersex Association, ILGA, recently released its European rainbow map, an annual benchmarking tool which ranks 49 countries in Europe on their LGBTI equality laws and policies. Although many may consider Ireland a global leader in that regard, as it often is, the State was ranked 15th by the study.

I noted in the ILGA's report that the basis for Ireland's slippage in the rankings was its observation that hate crime legislation to protect LGBTQI people continued to be conspicuous by its absence from Ireland's Statute Book; not only that, it is much broader than my community. It means that, in reality, we have no way of bringing specified charges against individuals who specifically target minorities on the basis of racism, homophobia, ableism or other bigoted biases. As a result, we have no data for such incidents, which means that we have no competence in knowing how widespread these issues are. We might get a shock, although I hope not, when we do start to collate such data.

I am aware that the Irish Council for Civil Liberties released a report last week. I think the Minister is conducting a review of the Prohibition of Incitement to Hatred Act 1989, which is a welcome step, albeit long overdue. Perhaps the Minister of State might indicate the stage the review is at, when the report on it will be released and, ultimately, when he foresees robust legislation being brought to this House.

Again, I refer back to my community. In advance of Pride, a brick was thrown through the window of Pantibar on Capel Street and a couple were attacked in Portlaoise. It created a cloud over Dublin Pride. There are tragedies within these stories. If there were protections in place such as hate crime legislation, with the accompanying statistics, we could do a lot more to prevent them.

Minister of State at the Department of Justice and Equality (Deputy David Stanton)

I thank the Senator for raising this important issue. I am proud to see Ireland becoming a more diverse and open society which is a sign of our place in the world. The Senator made reference to other jurisdictions, but we have much to be proud of in this country. We had the marriage equality referendum. I am not aware of any party or individual in these Houses that uses migration as a political issue. Other countries in which there is hate crime legislation in place have major problems, but we do not. I hear what the Senator is saying about what would happen if we were to start digging, but on the face of it, we have a lot of which to be proud. However, we must be mindful to ensure Ireland is a safe and secure country for everybody where all forms of hatred are rejected emphatically. There is no place in our society for hate crimes and I can assure the House of my commitment and that of the Minister and the Government to ensuring they will be dealt with robustly through the criminal law.

As the Senator will be aware, the Irish Council for Civil Liberties and the University of Limerick have carried out some extremely valuable research into the prevalence and nature of hate crime in this country. Officials of my Department will study their recommendations, with a view to bringing forward concrete proposals. The Minister made this announcement on the release of the report. There is a wide body of existing criminal law which is used to combat hate crimes. Where criminal offences such as assault or criminal damage or public order offences are committed with a racist motive, they are prosecuted through the wider criminal law. The trial judge can take aggravated factors, including racist motivation, into account in sentencing. The Judicial Council Bill will include provisions on sentencing guidelines and sentencing for hate crimes may be considered in that context.

The Prohibition of Incitement to Hatred Act 1989 creates offences of incitement to hatred. "Hatred" is defined as "hatred against a group of persons in the State or elsewhere on account of their race, colour, nationality, religion, ethnic or national origins, membership of the travelling community or sexual orientation". Under the provisions of the Act, it is an offence to use words, behave, publish or distribute written material or broadcast any visual image or sound which is threatening, abusive or insulting and intended or likely to stir up hatred. The offences under the Act carry penalties of up to two years imprisonment or a fine of up to €25,400.

An Garda Síochána has put in place a number of measures dedicated to combating hate crimes. The Garda Racial Intercultural and Diversity Office, GRIDO, has responsibility for co-ordinating, monitoring and advising on all aspects of policing Ireland's diverse communities. It is headed up by a very dedicated sergeant who is backed up by an assistant commissioner and they take their work very seriously. The GRIDO monitors the reporting and recording of hate and racist crime on a continual basis. Equality and the protection of minorities form important components of the work of my Department. The Minister and I are fully committed to ensuring the proper protections are in place.

Senator Fintan Warfield

I appreciate what the Minister of State said. I do not have figures to hand for other communities such as the Traveller community or other minorities, but in my case, despite marriage equality, we see this week that one in three LGBT couples will still not hold hands on the street. I have crossed the road with my boyfriend on many occasions - mainly at night - when we had a particular concern about what might be up ahead. Perhaps it is just in our minds, but homophobia is rife, despite legislative change. I suspect, therefore, that it is apparent for other groups in society. It is welcome that the Judicial Council Bill will include provisions on sentencing guidelines. I encourage the consideration of hate crimes in that context, but we need a specific hate crime Bill. The Fianna Fáil Bill that is in the system is not good enough. Sinn Féin and I will happily bring forward the Irish Council for Civil Liberties' hate crime Bill, as we have done previously, but we really need the resources of the State behind it. Rather than giving people hope in introducing that Bill, I would like to see the Department introduce such legislation.

Deputy David Stanton

I have seen same-sex couples holding hands on the streets of Dublin in the evening time and think it is great that we live in a country where that can happen, but I have listened to what the Senator has had to say. Minority migrant groups can be particularly vulnerable to racism and hate crimes. The Government has developed a range of provisions to support these communities. I am sure the Senator is aware of the migrant integration strategy which includes measures to raise awareness of integration, immigration and racism. The Office for the Promotion of Migrant Integration is a focal point of the Government's commitment to anti-racism measures as a key aspect of integration, diversity management and broader national social policy. It provides funding for a number of local authorities and community and voluntary organisations to support local programmes to educate the public on issues such as immigration, integration and anti-racism. This awareness work dovetails with the role of An Garda Síochána's ethnic liaison officers who work with minority communities at local level to encourage tolerance, respect and understanding within communities and help to prevent hate crime. Ireland is in no way tolerant of hatred in any form. Targeting people simply because of their identity and difference is not acceptable. My Department is strongly committed to the prevention and prosecution of these crimes.

I know that the Senator asked about the review. I will communicate with him on it as I do not have an up-to-date note on it. It is very important that such activities or crimes be reported to the Garda ethnic liaison officers or the local Garda station. There have been changes and improvements to the PULSE system such that there is now mandatory recording of data for the apparent motive behind a crime incident such as whether it was motivated by discrimination on specific grounds such as age, disability, race, religion, gender or sexual orientation. The policing plan 2018 contains commitments that An Garda Síochána will produce a definition of and procedures to record hate crime.

I again thank the Senator for raising this very important matter and affording me the opportunity to address it.

An Leas-Chathaoirleach

Unfortunately, under the rules, I cannot allow the Senator back in, but I am sure he and the Minister of State can have a chat about the issue on the margins.

Senator Fintan Warfield

May I express my concern? The Minister of State says something should be reported, but there is more to it than that. That requires somebody to be out of the closet and have confidence in the police force.

An Leas-Chathaoirleach

Further contributions are unfortunately not permitted. The Senator can raise the matter on the Order of Business or find another method of communicating with the Minister of State.

Garda Deployment

An Leas-Chathaoirleach

I welcome the Minister for Justice and Equality, Deputy Flanagan, back to the House. He has been spending a long time with us.

Senator Kevin Humphreys

I echo the Leas-Chathaoirleach's remarks in welcoming the Minister back. He has spent much time here in the Chamber this week. The reason I put down this Commencement matter is to start a discussion or debate on whether we need a dedicated transport police on our rail service. I am of the firm mind that we do. This week, after 20 years campaigning, SIPTU called for a dedicated police force for our rail and transport service similar to the service that operates in London. I know we cannot change overnight. We have seen media reports on what sometimes happens on the DART line late in the evening. I have seen examples in person and the statistics are frightening. Anti-social behaviour has jumped by 43% in the past two years. There have been 1,000 separate incidents since the start of 2017, compared with only 492 for the complete period of 2016. That is only scratching the surface. Much of the anti-social behaviour and crime on our transport system is underreported. Unfortunately, we probably face a circumstance where train drivers will refuse to operate certain routes late at night, which would be truly regrettable.

I hope to start the conversation with the Minister this morning. I acknowledge that Irish Rail has increased private security at black spots, but private security firms do not have the right to detain somebody in a station, or prevent him or her from running away. DART trains have been held up in stations for ten or 15 minutes at a time. To give security to customers on Irish Rail and the DART, the preventive measure of having an identified policing service on our transport system would be positive. I know the Minister faces constraints and cannot come to the House and state he will do as I have asked. However, if we could start a conversation, it would be positive and would send a message to the many thousands of workers in the transport services that we are starting to take this issue seriously. We want customers and workers to feel safe and secure when they use public transport services. Public transport could be served well by a small dedicated transport police.

Minister for Justice and Equality (Deputy Charles Flanagan)

I am pleased to be here in the Seanad this morning to discuss this issue. I thank Senator Humphreys for raising this important issue which I am pleased the Seanad is turning its attention towards. I understand Senator Humphreys refers to the deployment of gardaí on our transport infrastructure. I must advise the Senator that the allocation of Garda resources, including personnel, is a matter solely for the Garda Commissioner and his management team. I do not have any role in that regard, and I think Senator Humphreys accepts that. However, I assure the House, and Senator Humphreys in particular, that I brought this issue to the attention of An Garda Síochána for its consideration and for any action deemed necessary in the circumstances.

In terms of tackling this particular form of crime, I am advised by An Garda Síochána and its management that it engages extensively with transport operators. A range of regional and local operations have been put in place to address incidents and issues that have arisen at specific locations. There is ongoing communication between An Garda Síochána and the respective control centres. Access to good quality closed circuit television, CCTV, tapes helps to provide assistance to gardaí when investigating serious incidents, such as was seen recently in Clongriffin in Dublin. Furthermore, the Senator will be aware that An Garda Síochána already employs a wide range of operational measures aimed at tackling public order offences and anti-social behaviour. These measures are underpinned by the existence of a comprehensive legal framework, which assists the Garda in tackling this type of crime.

Addressing local community concerns about public order and anti-social behaviour is a key focus in An Garda Síochána's national community policing model. A range of strong legislative provisions are available to An Garda Síochána in this regard, including the Criminal Damage Act 1991, the Criminal Justice (Public Order) Act 1994, the Criminal Justice (Public Order) Act 2003, and the Intoxicating Liquor Acts 2003 and 2008. For its part, the Government remains committed to ensuring An Garda Síochána has all the necessary resources to tackle all forms of criminality in our communities. In this context, the House will be aware that some €1.65 billion was allocated to the Garda Vote for this year, while €98.5 million has been allocated as provision for Garda overtime this year. This will assist the Garda and its operations to tackle this form of criminal behaviour.

The Government is committed to ensuring a strong and visible police presence throughout the country in order to maintain and strengthen community engagement, provide reassurance to citizens and deter crime. Budget 2018 will support the continuation of this high level of investment in the Garda workforce and ensure the vision of an overall workforce in An Garda Síochána of 21,000 members by 2021 remains firmly on track.

Senator Kevin Humphreys

I thank the Minister for his response. I acknowledge there have been improvements since the reopening of the Garda training college, and there is a certain amount of catching-up that has to be done in regard to numbers due to the numbers of gardaí retiring and the large throughput at the college. I also acknowledge the increase in the budget and the target of increasing Garda numbers to 21,000 by 2021. I acknowledge that it takes time to put trained staff on the ground.

This is not a new problem. SIPTU has campaigned for 20 years for a dedicated transport police. I understand that Garda resources must be targeted and take account of developments nationally. That is why the time is right to have a conversation about a dedicated transport police. Having a Garda presence on our transport system will prevent incidents of anti-social behaviour. The number of unmanned train stations has to be taken into consideration.

I am not thumping the table here and demanding immediate action. The Garda has demands on its time and must deploy resources as it sees fit. Our community policing has done a good service in many of our communities, where it has been dedicated to building relationships in the community. Similarly, a dedicated transport police could, with a clear focus on the transport authority, reduce anti-social behaviour and give confidence to customers travelling on trains at night, while also reassuring the workers. I hope this is the beginning of a conversation and that the Minister will find, when he examines this matter, that there are opportunities to improve the safety and security of citizens on public transport.

Deputy Charles Flanagan

I thank Senator Humphreys for raising this important issue. It is clear from his contribution that he has strong views on the matter, and he is right. It is important we work together to eradicate this type of unacceptable behaviour from our society. As I indicated, it is the responsibility of the Garda Commissioner and his management team to deploy Garda resources, including personnel, in line with all new and emerging crime trends in the State.

I do not have a direct role in this but I have brought the views of Senator Humphreys to the attention of An Garda Síochána for its appropriate consideration. I am advised that close contact is being maintained with local and senior management, Irish Rail and other transport providers. An Garda Síochána has a very good working relationship with the public transport service providers within the district. There are patrols of uniformed and plain-clothes gardaí, including personnel on foot patrols, and other community engagement duties are maintained in the vicinity of what have been described as hotspots, where such incidents have historically occurred.

I assure the Senator that I remain in ongoing contact with the Commissioner with regard to Garda actions to tackle all forms of crime and criminality across the State. I am committed to ensuring that An Garda Síochána has all the necessary resources required to deal with all types of criminality, including the unacceptable behaviour referred to by Senator Humphreys.

Insurance Costs

Senator James Reilly

I have raised this issue on the Order of Business a number of times. It concerns the cost of doing business in Ireland. The Joint Committee on Business, Enterprise and Innovation launched a report yesterday and one of the three big things we dealt with was the rising cost of insurance. Some businesses are finding it impossible to continue, while others can no longer expand because of increased premiums, some of which have doubled in one year. One of the main reasons behind this is fraud. We have all heard in the general media of road traffic accidents being staged and I have seen videos of accidents being staged in public toilet areas of restaurants and other public buildings such as shops.

One of the groups to appear before us was the Alliance for Insurance Reform, which represents organisations like The Wheel, play centres, Ireland Active, the Association of Irish Festival Events, the Irish Hotels Federation, the Restaurants Association of Ireland, the Irish Road Haulage Association, Ireland's Association for Adventure Tourism and many more. They represent not just businesses but charities too and they are finding it impossible to keep up with the rate of inflation in insurance.

Currently, there seems to be no consequence for individuals who engage in insurance fraud but it is a crime for which we are all paying. In its excellent presentation, the group brought forward solutions and suggestions. One of the solutions was to set up a Garda insurance fraud unit. Its members suggested it be funded by the insurance industry but I do not think that is necessarily a good idea. We definitely need an insurance fraud unit in An Garda Síochána as there have to be consequences for people who engage in this sort of thing.

They also suggested looking at the book of quantum as the awards in this country are way out of kilter with those in other jurisdictions, with between three and five and a half times as much being paid out for the same injury here as in the UK, as an example. Nobody wants to interfere with judicial independence but if the book of quantum is exceeded by a judge he or she could, in the interests of transparency, give a written explanation as to why. We respect the fact that they are entitled to do it but we need an explanation as to why is it done in particular cases.

I look forward to the Minister's response to the very reasonable suggestions to which I referred. They also asked for sections 26 and 25 of the Civil Liability Act to be linked so that exaggerated and misleading claims are automatically forwarded to the Garda for investigation, and prosecution if necessary.

Minister of State at the Department of Foreign Affairs and Trade (Deputy Ciarán Cannon)

I start by passing on the apologies of the Minister of State with responsibility for financial services and insurance, Deputy Michael D’Arcy, who is before the Select Committee on Finance, Public Expenditure and Reform, and Taoiseach this morning. The Minister of State also wishes to thank Senator Reilly for raising the issue of fraudulent claims.

The Senator will be aware that the report on the cost of motor insurance was published in January 2017 and made 33 recommendations. With regard to fraud, the working group made recommendations on improving data sharing to identify patterns of suspected fraud through the development of an insurance fraud database. The working group also recommended that further co-operation between the insurance industry and An Garda Síochána be developed. The Department of Justice and Equality is the lead owner of both of these recommendations.

On the recommendation regarding the co-operation between the insurance industry and An Garda Síochána, I understand that the Garda national economic crime bureau, GNECB, has had a preliminary engagement with Insurance Ireland with a view to examining the possibility of the insurance industry providing funding to set up a dedicated investigation section within the GNECB, to focus exclusively on the investigation of insurance fraud. The structure of this proposed new Garda section is envisaged to be largely based upon that of the Insurance Fraud Enforcement Department, IFED, a specialist unit which is hosted by the City of London police but works on cases throughout the UK.

Insurance Ireland informed the cost of insurance working group at the start of this month that it was recommending the funding by its members of the proposed new Garda section, although it stressed that industry funding should also come from non-Insurance Ireland members writing non-life insurance business here. It is important to note, however, that the Department of Justice and Equality has informed me that all that has happened to date is a scoping of the possible cost and feasibility of setting up such a unit, and it is for the Minister for Justice and Equality, on foot of a recommendation from the Garda Commissioner, to decide whether the establishment of the proposed unit is something which should be pursued.

At this stage, the Garda Commissioner has not yet formed a view on the proposal as there are a number of very serious issues which will require further consideration before any decision on whether to proceed in this manner is taken. Regarding the suggestion that the Judiciary has to offer an explanation when awarding damages which exceed those outlined in the book of quantum, a key consideration here has to be the principles of judicial independence and the separation of powers. It must be emphasised that the book of quantum is a guide which merely reflects the prevailing levels of compensation in Ireland for various types of injury based upon what has actually been paid out in the courts, by the State Claims Agency in direct settlements by the insurance sector, or awarded by the Personal Injuries Assessment Board, PIAB.

The book of quantum does not represent set recommended levels of compensation and the figures contained therein are not binding on judges. However, the Civil Liability Act 2004 states that judges are obliged to have regard to the book. Also, it should be noted that the Judiciary, in determining damages, generally provides detailed reasons based on such medical and financial evidence as was adduced or agreed. In many cases, the damages awarded are significantly increased by reasons of the extent of the special damages involved and these would be unrelated to the book of quantum figures.

Finally, a revised version of the book was produced in October 2016 and this has alleviated the key complaint of the Judiciary that the book had become irrelevant, having not been updated for 12 years prior to that. The 2016 edition also includes additional injury categories and improved granularity of injuries.

Senator James Reilly

I thank the Minister of State for his reply. I hope a Garda fraud squad for insurance is set up, although I am not vexed as to whether it is funded by the insurance industry or otherwise. Businesses are struggling in this country and SMEs, which are the backbone of our economy, are afraid to expand because they are not sure what their insurance premiums will be next year. We have nearly reached full employment but we could find ourselves sliding back very quickly if SMEs are afraid to expand. One has to have some degree of certainty. Brexit has brought us a considerable degree of uncertainty so let us have certainty over the areas where we have some control.

I am given to understand by the Alliance for Insurance Reform that only one conviction has taken place in the last six years. Whether that is one conviction leading to incarceration or one conviction in total under the current Acts, it is an astonishing figure, knowing what we know is going on in this country.

Again, I emphasise and want to make it very clear there are many people who are genuinely injured and who have genuine claims, and this is in no way to cast aspersions on them or undermine their ability and right to receive proper and fair compensation. However, those who engage in fraudulent and exaggerated claims damage everyone, including those with genuine cases and people who are trying to make a living in this country.

Deputy Ciarán Cannon

Again, I thank Senator Reilly for raising this very important issue. I agree wholeheartedly with him. The rising cost of insurance is becoming a serious impediment to the survival of SMEs in some cases, and to the expansion of SMEs in others, and it needs to be treated with a great degree of urgency. I assure the Senator that the Minister of State, Deputy D'Arcy, believes the implementation of the recommendations of both the motor and employer public liability reports cumulatively can achieve the objectives of delivering those fairer premiums and delivering a more stable and, ultimately, a more competitive insurance market. The views and concerns of the Senator will be passed on directly to the Minister of State, Deputy D'Arcy.

Medicinal Products Availability

Senator Diarmuid Wilson

I would like to share time with Senator Rose Conway-Walsh.

An Leas-Chathaoirleach

Is that agreed? Agreed.

Senator Diarmuid Wilson

I welcome the Minister of State, Deputy Catherine Byrne, and thank her for attending this debate on the issue of the drug Translarna, the medication for Duchenne muscular dystrophy, a degenerative condition which affects five young boys in this country. While this issue has been raised and discussed numerous times in the Lower House and this House, including last Tuesday by Senator Rose Conway-Walsh and also by Deputy James Browne, who held a briefing in the AV room, the lack of action is very disappointing.

The disease's progressive nature requires urgent action and the HSE's refusal to fund the drug has only exacerbated the situation. The manufacturer of Translarna, PTC Therapeutics, will soon make a new application to the National Centre for Pharmacoeconomics. I implore the Minister to treat this application with priority, given the time-critical nature of the condition of these boys. This drug would improve both the quality of day-to-day life of the boys and their life expectancy and productivity. Having spoken to some of the families on Tuesday of this week, their determination to fight for a better life for their sons shone through in a profound way. Facing up to the injustice not only of their children's condition, but also to the denial of this treatment, requires serious strength. I can tell the Minister of State that while they may be small in number, they have the strength to fight and they will do so, with our assistance on this side of the House.

I remind the Minister of State that the responsibility for these boys' lives lies with the Government. It is not just her job or the job of the Minister, Deputy Simon Harris, but their duty to provide them with the best possible care, given their incredibly tough situation. Will the Minister ensure the boys and their families are not left waiting another two years for a definitive decision? On 19 June, the Minister, Deputy Harris, said there would be no delay in the processing of this application. I sincerely hope he ensures this is the case. These boys and their families do not have two years. Translarna is available in 22 European countries to 400 children just like these boys. I hope the Minister of State is willing to do what she can to ensure they are afforded the same chance of life as their peers in the UK and on the Continent.

Senator Rose Conway-Walsh

I thank Senator Wilson for sharing time. He knows how passionate I am about the subject of Translarna and the boys who are waiting for it. I thank the Minister of State for coming to the House.

The Minister, Deputy Harris, is acutely aware of this subject and also of what needs to be done. I welcome the fact PTC Therapeutics and the HSE have come to an agreement and that the legal case is now taken off the table and will be discontinued in the High Court. That presents us with a small window of opportunity in which a revised application can be submitted. What is key is that we do not start the process all over again, that the information and clinical evidence that has already been submitted is taken into account and that we do not have to go through the two-to-three year process that applied originally. What needs to be outlined at this stage is the exact process and the timeline for that. In fairness, that needs to be given to PTC Therapeutics and to be made transparent. I ask the Minister of State for that information.

The Minister, Deputy Harris, will also know the HSE failed to negotiate the price on the original application. That is why it was bewildering to get one's head around how a cost-benefit analysis could be done without having the proper negotiated price. That needs to be done at an early stage.

I know this can be settled in a matter of weeks or a couple of months. By the time we come back in September, these boys should be able to get the Translarna drug and not have to wait any longer. As Senator Wilson outlined, the impact of them not having it, in terms of their walking being discontinued, is not acceptable. We have this window of opportunity but the Minister needs to intervene because the HSE will not do it in a timely manner unless the Minister gets involved. I ask him to ensure the meeting between PTC and the HSE is facilitated as quickly as possible.

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

On behalf of the Minister, Deputy Simon Harris, I thank the Senators for raising the matter. Ataluren, also known by the brand name Translarna, is indicated for the treatment of Duchenne muscular dystrophy, DMD, a genetic disorder characterised by progressive muscle degeneration starting in early childhood. I understand that access to potentially beneficial drug treatments is an important issue for people with DMD. The Minister, Deputy Harris, appreciates that DMD sufferers and their families face enormous day-to-day challenges in dealing with this condition.

The Health (Pricing and Supply of Medical Goods) Act 2013 gives full statutory powers to the HSE to assess and decide on the reimbursement of medicines, taking account of a range of objective factors and expert opinion, as appropriate. The Act specifies criteria for reimbursement decisions. These include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE.

Ataluren is a high-cost medicine manufactured by PTC Therapeutics for the treatment of a subgroup of patients with DMD, a rare disease. The medicine has conditional market authorisation for Europe from the European Medicines Agency, the condition being that the company carries out further clinical trials to determine the clinical efficacy of the drug. Applications for reimbursement were considered by the HSE drugs committee and leadership team in 2016 and 2017. The applications were considered carefully. However, the final decision was that the HSE was not in a position to fund the medicine on the basis of the current clinical evidence of effectiveness and the prices being charged by the pharmaceutical company.

The HSE informed the applicant company of this decision, in keeping with the requirements of the 2013 Act. The applicant appealed the HSE's decision to the High Court, which is part of the statutory process under section 27 of the 2013 Act.

On 6 July 2018, the Department was informed by the HSE that a settlement of the High Court action had been reached. The terms of settlement stipulate that in the event that the manufacturer submits a new application to add ataluren to the reimbursement list, it would be reviewed by the HSE in a timely fashion having regard to the relevant statutory framework.

The Minister for Health is very much aware that this protracted process is upsetting to the patients and their families who are affected by this condition. As of yesterday, 11 July, the manufacturer has not submitted an application for reimbursement of Translarna. I call on the company to come to back to the table with a fair offer so that patients may access this treatment as soon as possible.

An Leas-Chathaoirleach

I call Senator Wilson.

Senator Diarmuid Wilson

I give way to my colleague, Senator Conway-Walsh.

An Leas-Chathaoirleach

I advise Senator Conway-Walsh that she has one minute.

Senator Rose Conway-Walsh

I thank the Leas-Chathaoirleach and Senator Wilson. I also thank the Minister of State for her response.

The application by PTC will be submitted by the end of the month. It would be helpful and important to outline the process and timeline. We have to remember these boys. Both Senator Wilson and I know these families so they have become human beings and not just numbers to us. One of the families affected is from County Cavan and they could get the drug if they travelled five miles up the road. I know the other family as they are from County Mayo. I do not want them put in a position where they must uproot their family and move to the North in order to get the drug.

As has been said, the European Medicines Agency has granted approval. The evidence is there. Even if more evidence needs to be gathered, a conditional approval would be fine so that the boys can have the drug. It is important the process is completed as quickly as possible. We do not want to call the Minister of State or the Minister for Health to the House again. We believe that this is a pretty straightforward case. I thank everyone involved but above all I thank the families for bearing with this matter and remaining in the State-----

Senator Diarmuid Wilson

Hear, hear.

Senator Rose Conway-Walsh

-----in the hope that Translarna will be granted to them.

Deputy Catherine Byrne

I assure Senators Wilson and Conway-Walsh that the Minister for Health will do everything possible to ensure that access is approved as soon as possible for this life-changing drug to be given to the families, and particularly the children. We all know how important it is to keep our children well. Nobody likes to see children suffer. I will urge the Minister when I see him that everything is done as soon as possible to sort out the complications connected with the pricing and everything else. I will make sure to do that when I return to the other House.

An Leas-Chathaoirleach

I thank the Minister of State and the Senators.

Senator Rose Conway-Walsh

I thank the Minister of State.

Seanad Éireann debate - Thursday, 12 Jul 2018