Denis Naughten (Roscommon-Galway, Independent) | Oireachtas source

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?

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