Improvements to healthcare over the last century are largely the result of advances in medical science, which have in turn become possible only through research. It is vital that changes to EU rules do not handicap further advances.

Continued progress requires effective collection and analysis of personal data concerning patient treatment and outcomes. The development of the personalised medicine that will improve Europe's health status can occur only if the controlled circulation of personal health data is not just allowed, but facilitated. Without these data, the causes of disease remain hidden, and measures to cure and prevent ill-health cannot be developed.

Personal health data represent a key to efficient healthcare, and their use is critical to public health. Without seamless access to these data, medical research and innovation cannot proceed successfully.

The privacy of individuals must be duly respected and citizens broadly informed that their information will be re-used for research, but the rules to guarantee that respect must be drawn up in a way that does not obstruct the responsible re-use for research of data that individuals have agreed to supply under conditions of broad consent. An appropriate balance must be found.

For instance, much research will simply be brought to a halt if specific informed consent is required each and every time data already acquired are to be consulted. Excessive regulatory restrictions on the registries and biobanks that contain such data will make it impossible to carry out the comparisons that have to be made to answer the research questions. Confusion between genetic data and health data will seriously hinder research efforts. International collaborative research will be obstructed if data cannot cross borders.

The present and future health of Europe’s citizens is at stake.

To attain the right balance, EAPM calls on the European institutions to ensure that all stakeholders are engaged in the search for solutions – and in particular, representatives of patients and citizens. That is the way to achieve the objective of establishing a fully coherent, transparent, harmonious and robust framework with a high level of protection for all data processing activities inside the EU and beyond.

Source: EAPM