“Trilogue” negotiations between the EU’s Council, Parliament, and Commission on the General Data Protection Regulation (GDPR) are in process. Negotiations are based on the Commission’s proposal of January 2012, the Parliament’s resolution of March 2014, and the General Approach on the GDPR adopted by the Council on June 15th 2015.
The Commission’s proposal had included procedures to protect the rights of individuals. It included a requirement for the explicit consent of individuals for processing their personal data, but provided derogations for health and scientific research.
The parliamentary committee for civil liberties (LIBE) proposed amendments, now ratified by Parliament, to the Commission’s text concerning health and scientific research, in particular to articles 81 (suppressed in the Council’s General Approach) and 83. The amendments, which would limit the use of personal data without consent to cases of exceptionally high public interest only, are of grave concern to researchers and society. The prohibition of the use of available data – such as those collected in cohort studies, in population based registries, etc. – would hamper the development of our understanding of health determinants and efficacious treatments, and would conflict with our citizens’ fundamental “right to health”.
In the Council’s General Approach, the circumstances of derogations are widened and further processing of personal data is stated to be compatible with the initial specified purposes. However, it allows that member states may introduce more specific provisions for compliance with legal obligations, or for the performance of tasks carried out in the public interest. It appears crucial that the final version of the regulation maintains the Commission’s text and rejects the LIBE amendments to articles 81 and 83 in order that all EU countries make data accessible in the same way, and guarantee a high level of research across borders.
The International Epidemiological Association (IEA) has joined the European Public Health Association (EUPHA) and other research and public health associations, as well as patient organisations, in an on-line petition, which will be presented to the EU institutions (www.datasaveslives.eu/petition). The joint statement is available at http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/WTP055584.pdf.