I welcome the Minister to the Chamber and call on Senator Kyne to move the motion.

I move:

That Seanad Éireann:

acknowledges that:

- genomics is central to the future of healthcare, including diagnostics, personalised medicine, and population health management, and that expanding domestic capacity would provide faster turnaround times, leading to improved patient outcomes, enhanced data governance, and more sustainable cost structures;

- strengthening domestic expertise aligns with the Savings and Productivity Programme’s objectives of driving efficiencies, reducing expenditure, and improving compliance with procurement frameworks;

- some accredited commercial domestic laboratories are capable of providing additional capacity of high-quality genomic testing services to both public and private healthcare providers;

- reliance on overseas laboratories incurs high shipping costs, potential fluctuating international pricing and potential delays that increase downstream costs through prolonged hospital stays and delayed treatment;

- fragmented domestic provision and inconsistent procurement practices prevent Ireland from capturing economies of scale, delivering consistent quality, and achieving value-for-money in genomics testing;

- personalised data arising from testing is highly sensitive and should receive the highest level of data protection and by testing domestically, Ireland has the ability to uphold data protection and security standards in a way we cannot fully control with overseas laboratories;

- current procurement frameworks, including Prior Information Notices, limited to public sector laboratories, risk excluding competent cost-effective accredited commercial providers, undermining transparency, competition, and value-for-money for the taxpayer;

notes that:

- Ireland currently relies heavily on overseas laboratories in the UK, US, Germany, Spain, and Finland, with approximately 20,000 genetic tests sent abroad every year;

- this reliance on overseas laboratories results in associated cost inefficiencies, extended turnaround times, fragmented funding and delivery models;

- some of these overseas laboratories are not EU accredited;

urges the Government to:

- develop a coordinated national plan to achieve 50 per cent in-country genomics testing by 2030;

- include accredited commercial laboratories in future procurement processes in line with Public Procurement Directives to ensure open, competitive, and cost-effective delivery;

- review the cost and delivery models for genomic laboratory testing to improve patient outcomes, maximise value-for-money and reduce reliance on overseas providers;

- support the development of domestic public and commercial infrastructure and workforce to provide a sustainable, high-quality genomics service for Ireland.”

I second the motion.

I thank the Minister for coming to the House to debate this matter, which is quite specific. We are a very advanced country. We pride ourselves on the capabilities we have, our positive results in relation to health, our medtech sector and foreign direct investment in medtech, and the growth of artificial intelligence and what that can do in healthcare. There is so much positivity about our healthcare. Genomics is essential to the future of healthcare, including diagnostics, personalised medicine and population health management, yet the failing we have, or certainly the concern that has been raised with me and others, relates to the fact we have to send so much of our testing abroad. One could ask why more of that is not done within the country and whether that can be changed. There are private companies, I am sure, across the country that would be in a position to provide speedier results and with which the data might be better protected rather than our having to rely on laboratories overseas in countries such as the UK, the United States, Germany, Spain and Finland, to which approximately 20,000 genetic tests are sent every year. This reliance on overseas laboratories results in associated cost inefficiencies, extended turnaround times and fragmented funding and delivery models, and some of these oversea laboratories are not EU-accredited. I find that strange and it is difficult to understand how they are, therefore, part of the system. It makes perfect sense that the highly sensitive data these labs are dealing with would be better protected within this country rather than having us rely on overseas laboratories.

I am asking and urging the Government to co-ordinate a national plan to increase the level of in-country genomics testing to include accredited commercial laboratories in future procurement processes in line with public procurement directives to ensure open, competitive and cost-effective delivery and to review the cost and delivery models for genomic laboratory testing to improve patient outcomes, maximise value for money, reduce reliance on overseas providers and support the development of a domestic public and commercial infrastructure and workforce to provide sustainable, high-quality genomics testing for Ireland.

It is quite a simple proposal and would make sense, especially with respect to the data protection and turnaround times. We have some fine private and public companies that are able and accredited to do this work but, unfortunately, with procurement as it stands, they are not in a position to bid. I am asking that this be examined and that the Minister look at the possibilities and the benefits for turnaround times, cost-effectiveness and data protection from using more of our own companies.

I support the motion. I will give the example of a friend of mine whose husband recently had to have his tests sent to two different countries. One was England and I am not sure what the other was, but they were told it would take up to eight weeks for the results to come back because the tests had been sent out of the country. This is a very opportune time for us to look at Irish companies and at how we can make better use of private companies to deliver this specialised testing.

As Senator Kyne outlined, there are many qualified companies out there but because of the way procurement is structured, they cannot tender for it. This is a really important matter. We encourage people to shop local and keep everything local. The sooner we can bring Irish companies into this procurement process, the better.

I welcome this debate on genetic and genomic medicine and I commend the proposers for bringing forward a motion on an area of healthcare that is rapidly transforming how we prevent, diagnose and treat disease. I find it fascinating. Fianna Fáil welcomes this discussion and the Government's ongoing continued commitment to improving genetic and genomic medicine services in Ireland. Our vision is clear. We want a patient and family-centred genetics and genomics service aligned with the principles of Sláintecare, particularly equity of access, integration of care and improved patient outcomes.

Advancing genetics and genomics is central to the future of our health service. It enables earlier diagnosis, more precise and targeted treatments, better disease prevention and more informed care for patients and their families. Genomics is the study of the body's complete set of DNA and how genes influence health and disease. Genetic testing allows us to identify specific inherited conditions. I underwent genetic testing following my breast cancer diagnosis, so it is an area I am particularly interested in and I am really glad that this has come forward. It can be very beneficial for patients with cancer, rare diseases and a host of other illnesses. We talk about preventative medicine and early diagnosis. This is really a game-changer and is fascinating.

I welcome the Minister. It is good to see her here.

I welcome this motion and thank the Senators who brought it forward. Sinn Féin supports this motion because genomics is not some abstract or future-facing concept. It is already central to modernised healthcare from diagnostics to personalised medicine to population health planning. If we are serious about delivering better outcomes for patients, genomics and genetic testing must move from the margins of our system to the mainstream.

Ireland sends approximately 20,000 genetic tests abroad every year to different countries. This reliance brings with it high shipping costs, long turnover times, fragmented delivery models and, in some cases, testing laboratories that are not EU accredited. This is not efficient, sustainable or patient centred. We all know that time matters, and delays in genetic testing can mean delayed diagnoses, delayed treatment decisions, longer hospital stays and, in some cases, poor outcomes. This is particularly true in oncology where genetic profiling can determine whether a patient will respond to a specific therapy and in rare diseases where genomic sequencing can be the difference between years of uncertainty and finally having a diagnosis. I highlight Senator Costello's work on rare diseases. She has championed this issue and were it not for her, I would not know how to pronounce "givinostat". The absence of timely genetic testing is not an inconvenience; it is life-altering.

The motion also rightly highlights the issue of data protection. Genomics data is almost the most sensitive personal data that exists. When we send the tests overseas, we lose a degree of control over how the data may be stored, governed or protected. By building domestic capacity, Ireland can uphold the highest standards of data governance and patient privacy, something that should be non-negotiable. The motion urges the Government to develop a co-ordinated national plan to achieve 50% in-country genomic testing by 2030. This is a reasonable, measured and achievable ambition but it is only achievable if it is backed by the right investment. The HSE has a genomics strategy that is referenced all of the time but strategies do not build laboratories, purchase sequencing equipment or recruit and retain the highly skilled staff who are needed. If genomics is to be routine and mainstream, the State must properly fund the laboratory services, equipment and workforce needed to deliver it.

Sinn Féin supports this motion because it is grounded in patient outcomes, value for money and data protection. We also want to be clear that it requires political will, proper procurement reform and sustained capital investment. Patients with cancer, people living with rare and inherited conditions and families waiting years for answers cannot afford another delay. Words matter but delivery also matters and this is an area where Ireland can and should do better. The Government must move to acknowledge that action.

I have a strong feeling of support regarding the desire for a greater focus on and proper planning for genomics. For many people, diagnosing and identifying issues and patterns early is something they want because people are affected by such a range of conditions and diseases. There is significant value in genomics science.

I recognise some of the concerns identified in the first sections of the motion. In particular, I note the concerns about overseas laboratories. The idea of a co-ordinated plan and achieving a 50% target is something to be welcomed. However, I have two concerns about the inclusion of accredited commercial laboratories in future procurement processes in line with public procurement directives to ensure open, competitive and cost-effective delivery. First, the word "quality" needs to be mentioned here. We know that quality is not a given in our procurement processes. I have submitted legislation that was passed by this House, which I was appreciative of, pointing to the issue of price-only or lowest-cost approaches leading to very poor outcomes and the need for a price-quality approach where we look at both the price and the quality and how this would lead not just to better outcomes, but better value for money in the bigger picture. We are aware of where this goes wrong, certainly in the area of diagnostics. The Scally report on the CervicalCheck programme identified an over-emphasis on achieving the lowest price from suppliers without an equivalent emphasis on quality and other measures as one of the key issues that led to the CervicalCheck scandal. It was an example of procurement that was done using a price-only or lowest-cost approach rather than a balance of cost and quality criteria. This is important. It is something that has had an impact. In the medical area, the machinery tends to get purchased based on both quality and cost but when it comes to services, there is sometimes a slide towards going for what is called the price-only or lowest-cost approach.

Second, I have a concern about the commercial partners that are work at here. Genomic Medicine Ireland, GMI, was rebranded and renamed because there had been significant concerns about its operations. The State had invested in it and there were questions around where the data was being stored and whether the data was being stored outside of the GDPR context. In its rebranded form as Genuity Science, it has links to 25 facilities across Ireland, collaborations with many hospitals and universities and a very well-publicised goal of collecting data from up to 400,000 Irish people, and has made €85 million selling genetic data collected from Irish people since its establishment in 2017. An investigative report in 2020 pointed to the research deals and collaborations. Collaboration is something we would like to see to an extent, but the concern is in the letter of it. One of the agreements stated that GMI would own all intellectual property in and have exclusive rights to commercialise the GMI databases, the GMI genomic database results and the GMI discovery databases, and the universities, which are the partners that may be linked with the State, would not get access until 50% of the entire participant recruitment target was complete.

This matters because we need a genomic strategy. We also need outcomes from the data gathered that is going to feed into a guarantee of improved public health and public good. Sadly, we saw during the Covid-19 pandemic where over €80 billion of public money was poured into the development of vaccines and yet, when it came to the crunch, there was a refusal to share access to that science and what came out of it with much of the world, which led to literally millions of deaths. I commend this House on supporting my motion at the time for a Trade-Related Aspects of Intellectual Property Rights, TRIPS, waiver, which would have allowed the sharing of the intellectual property to save lives across the world. Sadly, the European Commission in its negotiations did not support a TRIPS waiver or access. This is why it is crucial to have these partnerships. It is not just about partnerships; it is also about the public interest and the public good. Outcomes that will serve humanity, not just in Ireland but internationally, rather than solely profit, need to be at the core of any agreements. It is still my preference that this be publicly led rather than overly reliant on commercial partners.

It is great to see the Minister. She is very welcome to the House. I support what my colleagues are proposing. As a country that is so advanced in so many areas, this is one area we could probably be more advanced. It is something we should do. It makes economic sense, but more than anything else, it is a support and a service to our citizens who need it.

The eyesight condition I have is hereditary. About ten years, I looked at getting a study done because my father has it, but his brother and sister do not. His father, my grandfather had the condition and two of his brothers had it. I was just curious and interested to know. I do not have any children but if we were to have a child, a study may have revealed how prevalent it was, what the challenges and risks were and what could have been done to mitigate it.

I spoke to my ophthalmologists, who are excellent people, at the time and was told that it would have to be done abroad. We decided not to do it and moved on with life. If it could have been done locally by our own experts and professionals, I would probably have been more inclined to have engaged in the process. When you are looking at something that would have been done in Finland, something that is personal but also academic in a sense, you say to yourself that you will leave it.

It is an excellent motion. It is something that would benefit people and our citizens and I support it. I commend Senators Kyne and Byrne on tabling it and the Minister for being here today.

The Minister is very welcome to the House. I support the motion. I really welcome it on the basis that as the Leader said, Ireland is a leader in the medtech industry. When we have created an environment to attract industry, we are educating people to the highest level and we see what the Government has put in place with the research and innovation fund in our third level universities, it makes perfect sense to me that the Minister would explore the opportunities to see how we can ensure we have equity of access and equity of diagnosis on this island. It will support our GPs and our consultants by ensuring we have timely intervention. It will also ensure that we have data kept on one platform and can share that information so that early intervention can happen in a timely fashion.

I will share with the Minister one little story. Staff from the charity Croí recently came to this House. They came to monitor our heart and blood pressure but they also provided the opportunity for blood tests. People cannot get the blood testing service they provide through their local GP because it was to see if they carry the gene of a genetic disorder called the Lp(a). I did not know on the day what Croí's staff were testing on the day, but I do know that my late father died of a massive heart attack and I selected to have the blood test done. Croí provided the blood test but a cardiologist had to review to it. It turns out that I carry that LP(a) gene. I would never have known only for the provision of that blood test. I would never have known only for the Croí staff having staff from an independent group with them who were doing the sample tests. This means that I can take preventative measures and by using the various levers that the consultant, Dr. Barrett, says that I need, do all I can to ensure that I do not end up in an accident and emergency department and being a cost. As the Senator laid it out earlier, preventative medicine and early intervention is how the Minister can manage her budget, which has so many competing demands.

It has taught me that over 7,000 Irish people have heart attacks and strokes every year, but if we tested for the LP(a) gene for those who may carry it, we could support people through an awareness campaign. I am totally supportive and Senator Costello also laid out her reasons why she supports it too. There is good merit in this proposal and we should support the motion. From a cost measure point of view, it makes absolute sense. Early intervention, quick diagnoses and the sharing of data in a timely fashion ensures quicker recovery.

Sula n-iarrfaimid ar an Aire freagra a thabhairt ar son an Rialtais, cuirim fáilte roimh dhaltaí ón CBS i nDún Dealgan. I welcome the pupils from CBS primary school Dundalk. They are guests of Deputy Paula Butterly. As is the tradition in Seanad Éireann, they will have no homework for the rest of the week, so they are clear for today and tomorrow.

I appreciate Senators Kyne and Byrne bringing forward this motion and giving us the opportunity to discuss this important issue. It is timely as well because there are a couple of updates that I can give that will be helpful in this context.

We have a shared goal in the motion to enhance our genetic and genomic capability and to deliver high-quality care alongside value for money for the State. We are on the same page and it is a particularly timely conversation. As a number of Members said, the value that genomics and genetic testing can give us is so important. It is sort of a North Star, moving from a one-size-fits-all healthcare system to something that is much more individualised, and we heard some really good examples of that today.

I recently visited the Lambe research institute in Galway, which is connected to University Hospital Galway. I was so struck by the quality of the science and the way in which cancer genes are being manipulated against themselves. Forgive me if I am stating that in an unscientific way but Members will understand what I am saying. I was so impressed by the individualised approach to cancer treatment and diagnosis. That is, of course, where we want to go for many reasons.

Sophisticated technology is used to deliver test results. It is a rapidly advancing high-tech area. As Senator Rabbitte said, Ireland is ideally placed to be at the front of high-quality genetic and genomic services. It shortens the time to diagnose. It eliminates inappropriate or ineffective treatments, and it really does improve patient outcomes while reducing costs. The potential for transforming our system is abundantly clear, as is the need to ensure prudent investment in genetic and genomic services and the required infrastructure, as well as making sure we are getting the absolute best in terms of quality in that regard.

I will give Members a couple of updates on what we are doing. Our services are currently expanding in terms of workforce and infrastructure to meet the growing needs of the population, as well as trying to keep pace with the technological developments that continue to happen in this space. We are funding this solution. In the programme for Government, we made a commitment to support genomic medicine for the entire population, allocating a dedicated budget of €4.5 million. That funding is currently being converted into front-line delivery. We have sanctioned 26 specific roles, such as consultant clinical geneticist, genetic counsellor, laboratory scientists and the administration that goes all around that for the specialist engine room of this service. We would love to be further along than we are, but we are getting there.

We will get there. We need to develop more national capacity and self-sufficiency in this respect. We have been using other solutions as we get to that point.

The HSE National Genetics and Genomic Office was established in 2023 to implement our national strategy on genetics and genomics. Thanks to the efforts of both organisations, we have seen the establishment of some key service infrastructure through ongoing implementation of the national strategy. In January 2025 – the year has gone so quickly - I launched the national genomic test directory for rare and inherited diseases, which will enhance genetic and genomic clinical services by promoting evidence-based, equitable and timely access to everybody in respect of genetic and genomic tests, with the drive that patients receive the right test in the right place at the right time, requested by the right person.

Today, I am very pleased to announce another key milestone in implementing our reforms with the establishment of the national genomic processing service, which is going to be based in Beaumont Hospital. That unit will look to centralise the processing of requests for testing what previously had to be sent out of the country in essentially a disaggregated fashion out of necessity to get to the point where we are today. That is a big step forward. It is a vital first step in providing an evidence base for expanding our national capacity and repatriating our testing services appropriately. Our colleagues in the HSE have finalised the requirements and hired the staff, and I can confirm it will be fully operational from Monday, 16 February. That is quite good. We will take that on a Thursday morning.

Regarding the procurement of genomic tests, a request for information has also been issued by the HSE and is currently live, and it concludes at the end of this month. That is going to allow the HSE to identify more providers with proven capacity and expertise to deliver outsource testing and clinical support, and the insight gained for that process will help inform our future strategy and help us to partner in the best, most intelligent way, using all of the services that are available to us in what is an absolutely leading centre for AI and medical technology.

In addition to those developments, we also have a proposal from the HSE to develop a national genomic medicine centre. That is really exciting and really cool. The idea here is that we ultimately consolidate genetic and genomic testing services in Ireland. That planned facility would achieve a number of key overarching aims that would make our genetics and genomic services genuinely accessible to all. I am so determined in relation to health that we have an equitable system, that is, equity in respect of income and geography. I want everybody, whether they are in Clifden, Cork, Donegal or Dublin, to have the same access to high-quality diagnostics in a timely way, supervised by a national clinical centre of excellence and expertise.

The planned area of focus would create a required laboratory infrastructure, as well as making sure we have the staffing to do extended testing. That would help reduce the number of tests sent overseas. The proposed centre would also help build a required capacity to co-ordinate, where deemed necessary, the outsourcing of testing to accredited laboratories, which is fine. The business case for the genomic medical centre is currently being prepared, including progressing the various stages of approval required for such infrastructure. It is also going to serve as our national hub for the digital infrastructure that we need to manage our own genomic data. We are trying to look at this as a big picture project through the Genome of Ireland research project. We are currently sequencing the genomes of 1,200 individuals to create a reference database that actually reflects the genetic variation of Irish people. By doing that, we are not just helping people today, but trying to build a library, an understanding and a database, evolving over time. This library of knowledge will support our health service and the wider clinical and research community for generations to come.

The Genome of Ireland project represents Ireland's contribution to the wider Genome of Europe project. These projects are what are going to help us really drive research and developments in a broad population health data space. We know that we cannot do that as an island of 5.5 or 6 million people alone, we need to be part of a broader collective. That is what the impetus for the European health data space has been, the legislation for which will be implemented stage by stage by my Department over the next period. That is something we will discuss again and again.

I acknowledge two issues that were raised during the debate and provide some additional clarification. It is true that genetic and genomic tets were sent overseas for a period in the past. It was, of course, not what we wanted, but was of necessity as we built our own domestic capacity. However, where there have been genetic and genomic tests sent overseas, the process has been strictly governed by the Office of Government Procurement. In relation to transparency, I categorically reaffirm that any company, either in Europe or in the UK providing those services is legally bound by the same GDPR standards that we have here. I wish to affirm that.

Senator Kyne referenced the target of 50% of genetic and genomic tests being done domestically. I am pleased to confirm that milestone has been surpassed. That is another good step, with internal volumes exceeding 40,000 samples. However, self-sufficiency is our priority, and while we will always collaborate intelligently internationally to get the benefit of a broader population health understanding, our goal is self-sufficiency and domestic excellence. Because of the highly specialised nature of certain genomic tests, of course we will still give ourselves the facility to go abroad as an alternative to not doing that. Let us all be as intelligent in relation to that as possible.

It is also important to consider the question of data ownership. In this regard, I wish to make a couple of points. The absolute priority for me as Minister for Health is that as we develop policy and infrastructure and as we lean into science, and in particular the science of population-based health, I am completely determined that the State, and the people of Ireland being exactly the same thing, will be the owners of that data. We will own our own data. We will work collaboratively with partner, but the State will exercise its imperative in respect of the appropriate ownership of the data of our own people. We are taking important legislative steps in that respect. The health information Bill, for example, gives us great clarity on that. It is already the case that the State, for example, has worked collaboratively with private hospitals, though with some difficulty prior to my coming into office, to make sure that the data held is also in the population health data of the Irish health system. Health data belongs to the State. Members will be aware that the health information Bill will be coming to the Seanad in due course. We have, of course, inserted all of the relevant safeguards for individual privacy, opt-out clauses, etc., but nevertheless, health data is an important research tool for all of us, and data ownership is key. The Bill is an important first step in ensuring that we can protect the data and the data research for clinical lives, and consent is absolutely key. However, the State will be ensuring the protection of data and the appropriate secondary use of data. Partnerships and collaboration with third level and private labs will also ensure appropriate control and use of data. That the State comes first is the important point in that respect, and that is evidenced by our gathering of the data from private hospitals in appropriate ways already.

I cannot thank Members enough for the opportunity to discuss this specialised area of medicine. When we consider the possibilities for us in terms of being able to identify and treat different conditions in a very specialised and exciting way, and the contribution this could make to Ireland, not just in terms of health but also in terms of our economy, when we sit that alongside what is going to be, I hope, a really exciting project in respect of clinical trials - and we launched that strategy just before Christmas - this is a big opportunity for health, but also health research and health economy development. The IMF tells me that Ireland is the leading country for AI skills globally. Why would we not want to be at the front of all of that in respect of health as much as anywhere else?

I call Senator Kyne.

I thank the Minister for being here, but also for her enthusiasm, interest and excitement in relation to genomics and genetic testing, and for the updates she has given on the national genomic processing units opening on 16 February, and the national genomics medical centre. These are positives in this whole area and the Minister quite rightly outlined the possibilities of AI doing a better job than a human being. While we do not want that in every area, perhaps, it is certainly exciting in medicine and diagnostics. The possibilities are certainly welcome.

The Minister also highlighted the importance of protecting our GDPR standards and the existing domestic excellence and self-sufficiency that we have. She talked about the importance of the State owning our own data.

In response to Senator Higgins's points, quality is important, which goes without saying. Any accredited laboratories have that quality in-built, which is important. As I said, the Minister has laid down this important area, the progress that has been made, and the objectives, vision, energy and enthusiasm that she has for this area. There is great excitement about what is happening and what can happen. She referred to the Lambe Institute. I was there with her. It does excellent work. In her response that day, she certainly showed the importance of research and development in all areas of science and medicine, and the great work that Professor Kerin and others on the team do, with enthusiastic students and others working in that area.

I thank the Minister for being here and for her support for this motion.