European cancer patients’ data play a critical role in the development of scientific research. As patients, we request that every safeguard should be put in place to minimise the risk of breaches in confidentiality, including resorting to forms of pseudo-anonymisation of data. However, as partners in scientific research, we patients demand that the Regulation would not lead to compromises in data quality.

ECPC joined ESMO and other 8 organisation representing the European cancer community to express its deep concerned about unintended consequences of the current wording of the draft Regulation (in particular current Art. 81 and 83), which may put at stake the survival of retrospective clinical research, biobanking, and population-based cancer registries in the EU.

Download the ESMO-ECPC Position Paper on the General Data Protection Regulation clicking here.

Patient’s consent

The proposed norms on patients’ consent for the use of their data for retrospective research (for example, epidemiological study based on existing biobanks) would impose researchers to ask for a patient’s specific consent every single time a new research is carried out on already available data. This would force researchers to continuously ask for patients’ consent for every single use of their data. Furthermore, the same regulation might handicap also the collection of data by population-based disease registries, which are our most important source of epidemiologic data. In other words, patients should have the right to give once forever their consent for their data and/or tissues to be processed for research purposes.

Population-based disease registries (biobanks)

On the other side, with regard to public health epidemiological research through population-based disease registries, derogation from the obligation of any form of consent is essential. These data have been crucial in understanding trends in cancer occurrence, which are fundamental data that policy makers have to use to improve the quality of cancer care in Europe. The Data Protection Regulation therefore should not include an option for patients to ‘opt-out’ of having their data recorded in population-based disease registries. In return for this exemption, disease registration should be carried out by public bodies, or publicly endorsed bodies; should comply with stringent safety requirements; should be overseen by public bodies in a fully transparent manner.

Next steps

Last February, the European Parliament adopted, in first reading, the report of the ENVI Committee amending the Commission’s proposal and introducing the changes that will possibly harm European research on cancer. The text is now being discussed by Member States within the Council of the European Union. Unfortunately, health and research ministries are not always involved in this process, and might not provide the much needed input to change the regulation’s blueprint.