ESMO's objective: a balance between citizen data security and protecting the much-needed work of researchers by ensuring access to data
The current situation
The European Parliament, European Council and the European Commission are 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.
The ESMO position paper on the EU General Data Protection Regulation seeks to raise awareness with EU decision-makers that their response to citizens’ concerns on data security should not hinder the much-needed work of public health researchers and their appropriate access to data, acknowledging the strict safeguards protecting medical data that are already in place.
- Public health research heavily relies on medical research (clinical trials), biomedical research (biobanks and tissue banks), and epidemiological research (patient registries).
- Without access to this data, health research would be seriously affected, if not impeded.
- Broad consent would give patients the right to “donate” their data for public health research purposes. Subject to the usual strict safeguards, the patient would give a “one-time” consent to have their data processed within the framework of health.
- The patient should have the right to withdraw this consent at any time.
- An exemption of population-based disease registries from consent should be made to permit the collection of the complete, accurate and high quality data needed for effective evidence-based policy decisions.