Brussels, 30/07/2014 (Agence Europe) - On Tuesday 29 July, the European Society for Medical Oncology (ESMO) raised its concerns over the consequences for its field of the current reform of the European rules on data protection. ESMO fears that the General Data Protection Regulation could make cancer research impossible due to the safeguards imposed for data handling. More specifically, the association takes issue with the notion of “explicit and specific patient consent”. “Hope for patients facing a life-threatening disease like cancer is based on advances in research”, stresses 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”.
“This could put a halt to many public health research efforts”, adds ESMO, which proposes that the text of the regulation include a “one-time consent” for research, ensuring that patients are aware of what they are consenting to provide in terms of personal information and can withdraw their consent at any time, once all assurances have been received. “Our proposal achieves the correct balance between the right to privacy and the right to health”.
The General Data Protection Regulation as devised by the Commission does not provide for patient consent to be required each time research uses tissue already donated or personal data already used, according to a European source. This systematic consent is just one of the tools for the legal handling of personal data and the draft regulation also provides for this to be waived in specific cases. The justice ministers in charge of the dossier have also looked at ways of distinguishing medical data handled and the related individuals via pseudonymisation or anonymisation techniques; nor does the regulation prevent registers of databases from being created, according to the Commission, for example, registers based on information storage to monitor disease trends at population level. (SP)