The European Society for Medical Oncology (ESMO) is concerned that the proposed European Union General Data Protection Regulation could make cancer research impossible and add a significant burden to both doctors and cancer patients.
The proposed wording of the regulation stipulates “explicit and specific patient consent,” meaning that researchers would have to approach patients every time a study is planned in order to consult their data or use tissue samples stored for research purposes.
"This could put a halt to many public health research efforts," said ESMO President Rolf A. Stahel, who was the first President of the Swiss Society for Medical Oncology and was President of the Swiss Institute for Applied Cancer Research from 1999 to 2005.
ESMO proposes that the text of the EU regulation includes a one-time consent for research, ensuring patients are aware of what they are consenting to. This would help to guarantee the appropriate safeguards are in place and patients can withdraw their consent at any time.
"Our proposal achieves the correct balance between the right to privacy and the right to health," he said. "It actually 'empowers' patients, allowing them to choose whether to donate their data and tissue for public health research, whose ultimate goal is to find cures."
ESMO is in favor of the inclusion in the EU General Data Protection Regulation of the withdrawable 'one-time consent' concept  – already foreseen in the Clinical Trials Regulation  adopted by the European Union in 2014, which allows to use data already stored beyond the end and the specific scope of a trial, with the usual strict safeguards.
According to Stahel, "We are calling upon the European Union to assure that all forms of public health research will survive and be able to function within the safeguards that are in place, without adding the nearly impossible administrative burden of re-consenting each patient, every time, for every single project, which could irreversibly slow down the accelerated pace that cancer research has gained over the past decades."
Paolo G. Casali, ESMO’s Public Policy Committee Chair and author of the official ESMO Position Paper on the risks of the new Data Protection Regulation, added: “We understand the need for the EU to address data privacy concerns in many sectors, with the surge of risks brought about by the use of digital information, but its effect on public health research may have been unintentionally overlooked."
Population-based cancer registries, for example, storing information to monitor disease trends, are intrinsically incompatible with any requirement of individual consent. If a patient is allowed not to consent use of his/her anonymized data for the registry, the data provided by that registry will be unrepresentative and can lead to incorrect conclusions for public health actions, he explained.
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