The rapid response committee has kept IEA members up to date on important legal issues related to use of data in epidemiologic research, especially data collected for monitoring or administrative use. The proposed Regulation provided a legal framework that would not add new restrictions to our use of health data in research. That may unfortunately have changed. Albrecht’s revisions to the proposed text will have serious consequences for epidemiology if they are all accepted. Please note Welcome Trust’s concern below and have a look at the changes yourself – pay special attention to amendments 15,17,19,22 and 31.
Use your voice to help change this new and serious development; the legal text is still being debated in the Parliament. If these revisions are approved we may have to change the old saying ’in God we trust, all others must bring data’ to ’In God we trust, only he can bring data’.
The rapid response committee
—Jørn Olsen, Cesar Victora, Neil Pearce, Shah Ebrahim
Comment from the Welcome Trust stating their concern:
Jan Philipp Albrecht, rapporteur for the LIBE committee, who is leading the progress of the Regulation through the European Parliament has produced his draft report on the Regulation (http://www.europarl.europa.eu/meetdocs/2009_2014/documents/libe/pr/922/922387/922387en.pdf). The rapporteur’s report proposes 350 amendments to the draft. A number of these have serious implications for health research, based on the rapporteur’s premise that “processing of sensitive data for historical, statistical and scientific research purposes is not as urgent or compelling as public health or social protection.”
Were the amendments to pass, the major concern is that they would mean that indentifiable health data about an individual could never be used without their consent. This would mean that much important epidemiological research could not take place and would also affect recruitment to clinical trials. The amendments would allow Member State to pass a law permitting the use of pseudonymised/key-coded data without consent, but only in cases of “exceptionally high public interest”. (Amendment 27, p24; Amendments 327 and 328, p194-195; Amendments 334-337, p198-200.)
In addition, the amendments would bring all pseudonymised/key-coded data within the scope of the Regulation, even where the person or organisation handling the data does not have the key. This would significantly increase the regulatory burden on organisations using pseudonynmised data or sharing these data with collaborators in countries outside the EU. (Amendments 13 and 14, p15-16; Amendments 84 and 85, p63-64).
MEPs will now consider and vote on the amendments over the next few months and I am working with the Federation of the European Academies of Medicine and other organisation to minimise the impact of these amendments.
We are collecting case studies of research that would be affected by these proposals. If you have any suggestions from Denmark that we could include, I would be very pleased to hear them. I would also be interested to know what the reaction has been in Denmark and other Scandinavian countries, where this would have enormous impact.
With best wishes,
Dr Beth Thompson
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