Fragmented implementation and interpretation of the General Data Protection Regulation 2016/679 (GDPR) of the European Union (EU) at a local level are posing obstacles to cancer research, especially in the pandemic era when collaboration and data sharing are vital for moving science forward.
On Friday 21 May 2021 (13:00-15:30 CEST) key stakeholders in public policy and oncology will discuss major implications of the GDPR on clinical research and how to overcome existing challenges at a freely-accessible webinar organised by ESMO in association with the MEPs Against Cancer (MAC) Interest Group at the European Parliament.
Since it came into force in Europe in 2018, the EU GDPR was recognised by ESMO as an important piece of legislation which has the potential to positively impact the European research community as a whole. However, a recent editorial featured by ESMO’s experts and published in Annals of Oncology, highlighted some urgent issues that still need to be addressed to avoid or limit unintended consequences of the regulation in clinical research. Major concerns have been identified in the usage of health data for retrospective clinical research and biobanking to population-based registries, starting with cancer registries.
After years of intense advocacy which led to an ESMO position paper on the risks of the GDPR (released in 2014), the Society now urges the EU Member States to harmonise implementation of the regulation across different countries, highlighting the inclusion of a withdrawable ‘one-time consent’ for retrospective research and the ‘no-consent’ principle with respect to population-based cancer registries.
The ESMO webinar offers an opportunity to reflect, discuss and share ideas on the GDPR topic in the context of cancer research. Additionally, as the EU is currently setting up new data-sharing initiatives, including the European Health Data Space (EHDS), the Data Analytics and Real World Interrogation Network (DARWIN EU), registries and a number of others that are mentioned in policy documents such as Europe’s Beating Cancer Plan, it is even more important that the existing challenges posed by the fragmented implementation of the GDPR are addressed as soon as possible.