European cancer research could be at risk

The European Society For Medical Oncology (ESMO) has expressed concern that the proposed EU General Data Protection Regulation could make cancer research impossible and add a significant burden to both doctors and cancer patients.

The European Parliament, European Council and the European Commission have been working on a new legislative text on data protection, a General Data Protection Regulation, which would replace the old 1995 Directive on Data Protection. This text, if adopted, will become national law in all EU Member States.

But ESMO notes that the proposed wording of the regulation stipulates “explicit and specific patient consent”, meaning that researchers would have to approach patients every single time research is planned in order to consult their data or use tissue samples stored for research purposes. The society has expressed its concerns in a position paper, published in the Annals of Oncology.

“Hope for patients facing a life-threatening disease like cancer is based on advances in research,” said Kathy Oliver, chair of the International Brain Tumour Alliance. “And research progress requires access to a wide pool of patient data, even from patients who have since passed away and can no longer provide consent to allow for research that could save lives in the future.”

The society stated that public health research heavily relies on medical research (clinical trials), biomedical research (biobanks and tissue banks) and epidemiological research (patient registries). Cancer registries, which store 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 anonymised data for the registry, the data provided by that registry will be unrepresentative and can lead to incorrect conclusions for public health actions,” noted Paolo G Casali, ESMO Public Policy Committee Chair and author of the position paper.

The position paper seeks to raise awareness with EU decision-makers that their response to citizens’ concerns on data security should not hinder the work of public health researchers and their appropriate access to data, acknowledging the strict safeguards protecting medical data that are already in place. The society therefore proposes that the text of the regulation includes a ‘one-time consent’ concept - already foreseen in the Clinical Trials Regulation adopted by the European Union in 2014 - which allows the use of data already stored beyond the end and the specific scope of a trial. This consent could be withdrawn by patients at any time.

“Our proposal achieves the correct balance between the right to privacy and the right to health,” said ESMO President Rolf A Stahel. “It actually empowers patients, allowing them to choose whether to donate their data and tissue for public health research, which has the ultimate goal of finding cures.”

“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 reconsenting 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,” concluded Casali.

ESMO members can assist the ESMO Public Policy Committee by visiting http://www.esmo.org/Policy/Political-Initiatives/EU-General-Data-Protection-Regulation.

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