Many European epidemiologists will remember that the first draft EU proposed on Data Protection would have made it almost impossible to do epidemiologic research and many other types of research as well. Only after substantial consultations in Brussels by colleagues and patient organizations did we end up with a Directive that allowed (at least in some European countries) to continue research activities of importance to provide the best possible disease prevention and medical treatment to the citizens of the EU.
In some countries the interpretation of the Directive is still a major obstacle to epidemiologic research and some of these countries may have an interest in a restrictive interpretation of the Directive.
Since new communications methods are being used (Facebook mentioned as an example) EUs considers it necessary to revise the Directive. We hope that this revison will take into consideration that research is an important part of a democracy.
It is understandable that a directive on data protection needs to be revised from time to time but it is of concern that once again its impact on research is hardly discussed at all. Freedom of Speech or Freedom of the Press or Freedom to do research will be affected by rules for privacy. These other important principles of the open society have no important place in the document that argues for a new Directive you can download from the website indicated below:
The European Commission revision of directive 95/46/EC.
It is of particular concern that none of the speakers at the ‘Stakeholders’ consultation came from research areas that depend upon getting access to data on a population level like epidemiology, sociology or demography, as if these were irrelevant activities. You can see the program below:
We encourage medical and public health European research societies to pay close attention to the process of revision and to intervene in it at this early stage. The EU Commission appears to have more concerns for the free market than for creating an open society where it is possible to study e.g. if mobile phones, environmental pollutants or bad political decisions cause health problems.
It may also come as a surprise to some that genetic information was not considered health information in the present Directive. This may change and adding genetic information to the groups of health variables that are classified as sensitive data may pose substantial restrictions in research opportunities.
It is also stated that individuals should always be able to access, rectify, delete or block their data which sounds reasonable but unless accompanied by appropriate procedures of implementation may have disruptive practical implications for large scale studies.
Research often involves people from many countries and expertise in many countries are often needed to get the best possible results. The revision of the Directive will probably also involve new rules for moving data from EU to countries outside EU. These revisions may simplify existing rules but could also make them more complicated.
So far we only know that EU finds it necessary to revise its Directive of Data Protection. Whether this is good or bad news for research we do not know but we request EU to take the importance of research into consideration before a new revised text is drafted.
Jørn Olsen,Cesar Victora, Neil Pearce, Shah Ibrahim, Rodolfo Saracci