In January 2012, the EU Commission published a proposal that would have allowed the use of identifiable personal data for scientific purposes. This is restricted, under the current EU directive of 1995, by the obligation to obtain the consent of every data subject. Since then, more than 3000 amendments were proposed.
In October 2013, the Committee for Civil Liberties Justice and Home Affairs of the EU Parliament (LIBE) passed a “compromise proposal” that makes amendments to the Commission’s proposal. Some of these amendments could impede the advancement of public health research and epidemiology. Articles 81 and 83 are particularly problematic. They limit use of personal health data without explicit informed consent only to cases of “high public interest,” and thus large areas of epidemiological research virtually impossible.
The Council, the third body of the EU, must agree upon a common proposal with the Commission and Parliament. However, at the last meeting of the Council in December 2013, the Justice Ministers of member states clashed, and the Council does not envisage resolving their differences before March 2014.
A more detailed description of the problem, by Rodolfo Saracci and Adele Seniori Costantini, is available as a PDF.