Excerpt from Irish Examiner Article, Published on Nov 4, 2024.
Ireland’s unclear interpretation of the General Data Protection Regulation (GDPR) is a significant barrier to clinical trials, hindering life-saving opportunities for Irish patients. According to experts at a recent conference hosted by the Royal College of Surgeons in Ireland (RCSI), the restrictive application of GDPR in Irish healthcare is linked to the low number of clinical trials, particularly cancer trials, available to patients. While over 3,500 industry-sponsored trials began across Europe in the first half of 2024, only 11 trials included Irish participants.
The conference, featuring patient advocates, the Data Protection Commission, and healthcare researchers, highlighted the difficulty in navigating GDPR’s data-sharing rules across different hospitals and EU countries. RCSI ethics lecturer and barrister Mary Kirwan noted that “the administrative burden that data protection generates for researchers” is a major hindrance, with each Irish hospital applying GDPR regulations slightly differently. This inconsistency, Kirwan explained, causes delays and limits collaboration, making it challenging for studies that involve multiple hospitals to proceed smoothly.
The problem intensifies when trials extend beyond Ireland. Each EU country is allowed to interpret health data rules under GDPR in its own way, causing further complications for cross-border research. Kirwan emphasized that this ambiguity limits Irish patients’ access to advanced treatment opportunities that could potentially improve healthcare outcomes.
Additional challenges, such as complex regulatory requirements and lengthy approval processes, further dissuade clinical trial sponsors from including Ireland. Today’s Health Research Data Protection Network conference aims to address these issues, seeking ways to clarify and streamline GDPR interpretations and reduce administrative hurdles.
A detailed paper outlining potential solutions and advocating for clear, consistent GDPR guidelines will be published following the conference and distributed to relevant stakeholders, marking a critical step towards improving clinical trial access in Ireland.
To delve deeper into this topic, please read the full article Irish Examiner.
