EU data proposals 'could make cancer research impossible'

In collaboration with the Press Association

A proposal aimed at protecting data could create substantial barriers to cancer research in Europe, according to a medical research body.

"Something needs to be done fast to fix this legislation." - Catherine Castledine, Cancer Research UK

The European Society for Medical Oncology (ESMO) claims the EU General Data Protection Regulation could shut the door on many public health research efforts.

It also believes the proposal could add a significant burden to both doctors and cancer patients if it is introduced as written.

ESMO is the latest in a long line of medical organisations to voice concerns over the potential effects of the proposal.

Cancer Research UK, The Wellcome Trust, the Medical Research Council and European University Association have also already expressed their concerns on the subject.

As it stands, the wording of the regulation would mean researchers would have to approach individual patients every single time research is planned in order to consult their data or use tissue samples stored for research purposes.

“The use of personal data in health research saves lives,” says Catherine Castledine, Cancer Research UK’s EU public affairs manager.

“Researchers rely on personal data to develop new treatments and bring them to patients. Cancer Research UK shares serious concerns that, in its current form, the Data Protection Regulation threatens public health by undermining how research is conducted in Europe,” she said.

The charity believes the EU should revert back to the principle of the original European Commission proposal – to make research exempt from the regulation. Exempting researchers from the need to seek consent for personal data use would be a logical step, the charity believes, as it reaffirms the rules that have governed research for decades.

“We ask the European Union’s three institutions to work together to make sure the final text of the Regulation reflects the importance of research - and the vital safeguards that are already in place - by reintroducing the important exemption included in the original proposal giving researchers access to this vital data,” Castledine said.

ESMO is taking a slightly different route, proposing that the text of the EU General Data Protection Regulation includes a 'one-time consent' for research, rather than the 'explicit and specific consent' that is listed in the proposal at present.

This would mean researchers would only have to contact each patient once.

Commenting, Castledine said “We also agree that consent is a crucial principle that should always be stuck to where possible. However, in some cases asking study participants for consent – even just once – can cause problems: it may make a study involving lots of patients unworkable, or could even skew the results.”

"It is clear that there is widespread concern from everyone involved in research. and from patients, so something needs to be done fast to fix this legislation."

Paolo G. Casali, chair of the ESMO Public Policy Committee, said: '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."