EU General Data Protection Regulation: Cancer Research At Risk?
The European Commission published the draft legislative proposal on the protection of individuals with regard to the processing of personal data and on the free movement of such data also known as the EU "General Data Protection Regulation” (Regulation (EU) 2016/679). The proposal aims to put in place harmonised rules across the 28 EU Member States, which set out the conditions under which the personal data of individuals can be altered, transferred, collected or in any way tampered with by 3rd parties (processing of data). This draft Regulation will replace the previous Directive on Data Protection (95/46/EC).
All the main medical cancer societies and patients advocacy groups in Europe have 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 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 to obtain consent to the processing of their personal data or to use tissue samples stored for research purposes. The proposal is in favour of 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 the use of data already stored beyond the end and the specific scope of a trial with the usual strict safeguards.
ESSO endorsed the document to ensure 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.
Read the full report here