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Data Protection: health research overlooked by decision-makers

The Data Protection dossier is now in the Council’s hands and the Commission anticipates than an agreement by end of the year is possible. On 27 January EU Justice Commissioner Viviane Reding expressed her wishes to see “full speed” on this dossier.

The LIBE Committee of the European Parliament adopted its report in October 2013 on the draft general regulation on data protection. While we support provisions in the legislation to reinforce transparency and the rights to access data, we are concerned that the provisions on research may lead to further fragmentation across the EU.

EPF recognises that exemptions may be needed on the research article and accepts the LIBE committee’s compromise which restricts the possibility to lift consent obligations from researchers to cases where there is a high special interest. However it is to be defined by each Member States in their legislation, and we are strongly against different rules across countries as it will lead to further fragmentation regarding consent rules and research across Europe.

Consent for research


We call for guidelines to be developed by the European Commission, with the participation of stakeholders on the consent debate. The LIBE committee also legislated over the question of specific or broad consent e.g. whether a patients’ consent can be valid for more than one research project. The compromise specifies that consent can be valid “for similar research”, which could be too restrictive.

Given the proposal is general and cover other areas than research, and also the wide disparities across Europe regarding consent practices, we believe this would be addressed more adequately in the implementation of the recently adopted Clinical Trials Regulation.

Patients want to share their data for research


We, as patients, are increasingly aware of the value and importance of sharing their data. From the patients’ perspective, use of health and genetic data is vital to advancing health research – this includes public health research, medical research and social science research (including psycho-social research). Therefore ensuring we strike the right balance on the research and consent provisions is essential to us.

No cooperation to enable patient registries


In our view the Regulation should explicitly require Member States to cooperate to remove obstacles that hamper the setting up of registries, which are vital tools. They are used to study the prevalence and incidence of diseases, for monitoring the safety of products and interventions, assessing clinical effectiveness of new interventions in real-world settings, in planning services or assessing their quality, etc. They play an essential role in creating contact between patients and researchers or authorities for clinical trials and other purposes.

While the draft Regulation made it clear that processing for such purposes is lawful, this was removed from the text in the LIBE report. The report fails to propose better cooperation between Member States in the regulation of health data, which is strongly needed for eHealth, cross-border healthcare, and research.

EPF will continue raising these important issues with the Council and the European Parliament. “We believe that stakeholders ‘participation in decision-making is essential to strike the right balance for European citizens and scientific research. Patients, as owners of their health and genetic information, have a fundamental right to participate to decision-making regarding the processing and protecting of their personal data: it is their health and their privacy that is at stake”, said Laurène Souchet, EPF Policy Officer.

More information on our position on data protection: http://www.eu-patient.eu/whatwedo/Policy/Data-Protection/

For more information, please contact EPF Policy Officer Laurène Souchet at laurene.souchet@eu-patient.eu.