Last week at a Cancer Trials Ireland event, patient advocate Patrick Kivlehan spoke out about how participating in a clinical trial probably saved his life. He highlighted that delays in opening clinical trials to Irish patients could be a matter of life or death. I acknowledge that access to clinical trials is a Government priority. The current national cancer strategy aims for 6% of cancer patients to participate in clinical trials. Unfortunately, we are far short of this target, with only 1.5% of patients on interventional trials, which is a decrease from 2019.

One of the most significant barriers to patient access to these potentially life-saving trials is not money or staff, but red tape in the form of the general data protection regulation, GDPR. The root cause of the problem lies in the application of GDPR in Ireland. Instead of protecting the public interest, it is costing patient lives. As senior counsel Paul Egan pointed out, our health system should be more concerned with making people well than in conforming to a uniquely Irish overinterpretation of the GDPR. The Irish Cancer Society recently highlighted this issue and pointed out that Denmark has three times as many clinical trials open to patients as Ireland. Industry figures show that Ireland was included in just 11 of the 3,500 industry-sponsored clinical trials started in the first six months of 2024 across Europe. This is less than 1% of industry trials opened in Europe this year, despite Ireland being a global hub for pharmaceutical development and manufacture.

To address this problem, we need to revise Ireland’s data protection regulations on health research, as outlined by Cancer Trials Ireland in its recent position paper on GDPR. We also need uniform national guidelines for all hospitals regarding the interpretation of data protection in clinical trials to remove any set-up delays or document duplications. Will the Government commit to promptly delivering on such reforms?

The shared Ireland fund, which was set up by the Tánaiste, has supported key cancer research projects. It should be enhanced to fund actual clinical trial activity to allow patients to access trials in cancer units immediately. Cancer Trials Ireland, in partnership with key stakeholders, has developed a proposal to run an all-island genomics trial with cross-Border referral pathways with the aim of implementing precision cancer treatment on this island to save lives and reduce health service costs. Will the Government commit to such an initiative?

I thank the Deputy for his questions and the points he has raised on this very important issue. He has been and continues to be a strong advocate for the expansion of clinical trials and of access to them. The Minister for Health has been very clear that he wants to double the number of clinical trials taking place in Ireland. Patients involved in clinical trials can, as the Deputy said, receive cutting-edge therapies, often years before they are widely available. Some patients can experience much better outcomes if the experimental treatment proves positive and effective. Trials can be empowering for patients and make a really vital contribution to medical knowledge and the development of new drugs and devices.

In line with the programme for Government, the Department of Health has made a commitment to expanding clinical trials in Ireland. Deputy Naughten has made a fair point in comparing Denmark and Ireland. This comparison shows that we need to scale this up further and scale up our ambition. The commitment we have made and the Department of Health has made under the programme for Government is embedded strategically across key policy initiatives, including the national cancer strategy, the national strategy for accelerating genetics and genomics and Impact 2030: Ireland’s Research and Innovation Strategy. The positive impact of research activity, including clinical trials, on the care of patients is universally accepted. Research supports the recruitment, retention and motivation of clinical staff who will drive the development of quality services.

To be fair, significant progress has been achieved in recent years, but challenges remain. The Government is determined to build on the progress to date to ensure we have the best-in-class clinical trials landscape that delivers better patient outcomes. Over the last 15 years, the Department of Health has invested more than €150 million in clinical trials and research supports. I was reading about this with interest on Monday. The Deputy will have heard Dr. Austin Duffy, who is director of the clinical trial unit in the Mater Hospital, on “Morning Ireland”. I very much welcome that a new clinical trial unit has been opened at the hospital. That start unit hopes to have about 50 patients enrolled in the first year of phase 1 trials. It will be a free service for suitable patients. That is the type of thing we want to see rolled out across our expert hospitals.

There is not a family in the country that has not been affected by cancer. Our oncology services are excellent. The treatment is excellent and some of the best in Europe. I agree with the Deputy that in order to ensure that clinical trials are done and we continue research and trials to bring forward new drugs and treatments that are going to improve patient outcomes, which is a priority, this area needs to be scaled up. We need to scale up not just the ambition that is there, but also the delivery in that space. When compared with some other countries, we have ground to make up. I am delighted to see that clinical trial in place in the Mater Hospital, which will be significant in itself.

In what is my last-ever intervention during Leaders' Questions, I return to the issue of genomics and cancer. Today there 2,435 people on the waiting list at St. James's Hospital for hereditary cancer tests, including for breast cancer. Some of these patients are mothers of young families waiting over 18 months to access a potentially life-saving test. Cancer genetic counselling is essential to access these tests, but there are only six counsellors at St. James's Hospital and we fall short of the 20 needed to meet the international standards per capita. The demand for these services is increasing. We must act now to develop a comprehensive genomics strategy, establish a single national laboratory and ensure timely access to diagnostic services.

These steps can save many lives.

I agree with Deputy Naughten. As this is, as he has mentioned, his last contribution on Leaders' Questions, I will commend him on his years of service in this House since he won that by-election in 1997. Whether in government or in opposition, as he is now, I have always found him to be an excellent and constructive colleague. First and foremost, he has the well-being of his constituents at heart but he has also driven a number of matters, including this one. He will know that we, as his colleagues, have been thinking of him over the last week or so. I wish him and his family the very best in the period to come.

Deputy Naughten has put forward very clearly how we can scale up the implementation of that ambition. We have some of the very best people, clinicians and researchers. In many areas, Ireland is at the cutting edge of research. The clinical trial piece really helps to extend that further. In July of this year, the Minister, Deputy Donnelly, established a national clinical trials oversight group. This is developing recommendations on increasing the number of trials taking place in Ireland and improving patients' access to participation in such clinical trials. Those recommendations will be important. The Minister and the Department of Health have told me that the interim recommendations are imminent. We all agree on how important this area is. It will be for all of us to ensure that the interim recommendations are implemented and moved on as expeditiously as possible.

Before calling Deputy Nolan, I will join with the Minister in acknowledging the enormous contribution Deputy Naughten has made during his long years of service here. I extend the sympathy of all Members to the Deputy and his family on their recent tragic bereavement. We hope the next phase of his life will be as successful as the one he is bringing to an end when the election is called.