GDPR Challenges EU Medical Research: Costs, Consent Hurdles Spark Opposition
The General Data Protection Regulation (GDPR) has brought significant challenges to medical research in the EU. While it enhances patient privacy, it also imposes substantial costs and restrictions on researchers, sparking opposition from prominent research groups and healthcare stakeholders.
One of the major hurdles is the requirement for repeated consent from patients. This process, mandated by the GDPR, is time-consuming and expensive. It's estimated that the EU spent €6.1 billion ($7.8 billion) on medical research from 2007-2013, and these additional costs could strain future budgets.
Another concern is the inaccessibility of data from deceased patients or those unable to give consent. This limits the potential of long-term studies, such as the ongoing EU-funded genetic study of colorectal cancer involving 7,000 patients. Researchers would need to reconsent all participants for follow-up studies, further adding to the burden.
Organizations like Science Europe, the League of European Research Universities, and the European Society for Medical Oncology have voiced their opposition to these burdensome regulations. They argue that while patient privacy is crucial, the current GDPR rules may hinder medical progress. Discussions are ongoing among the European Commission, national supervisory authorities, medical professional associations, and other healthcare stakeholders to prevent unreasonable regulations and make medical research in the EU more efficient.
The GDPR, set to be finalized in late 2014 and enforced by approximately 2016, has sparked debate in the medical research community. While it strengthens patient privacy, the costs and restrictions it imposes on researchers could hinder progress. Stakeholders continue to engage in discussions to balance privacy with the need for efficient medical research.
