The Data Protection Regulation: Balancing Patient Confidentiality and Legitimate Research Demands (Guest blog)
Discussions on the Data Protection Regulation within Science Europe and in particular in the Medical Sciences Committee of Science Europe started back in 2012. It was the topic of one of the first Position Statements “on the proposed European General Data Protection Regulation”, delivered in May 2013, and signed by 50 Member Organisations from 28 countries.
Among the seven recommendations, one for example called for maintaining the provision of Article 83 – processing for historical, statistical and scientific research purposes – and the support of its associated provisions and derogations as laid out by the Commission’s proposal. The processing of personal data for scientific research purposes in Europe is carried out while maintaining high standards of protection for individuals. Scientific research that relies on personal data is conducted within a robust ethical framework and follows internationally-recognised guidelines. Therefore, protecting individual privacy and the undertaking of bona fide scientific research of public benefit are compatible objectives.
Since then, more than two years have passed, with intense – and often controversial – discussions and negotiations within the European Institutions, which will hopefully reach an agreement under the Luxembourg Presidency at the next Justice Council meeting on 3/4 December.
The matter is highly complex. The stakes are high. Protecting the accessibility to and processing of European citizens’ confidential data are prime goals, while there is also a need to strike a balance in increasing business competitiveness in the digital era while responding to the needs of scientists to use patient data for scientific research and to contribute to the wellbeing of European citizens through the development of innovative products.
With intensive exchanges between different players with different backgrounds, it seems that there is an increasing understanding by legislators and policy makers that scientific research requires a ‘special status’ within the now labyrinthine regulation framework of the data protection regulation.
Among the impressive mobilisation of national and European research stakeholders, such as the Wellcome Trust, the December 2014 campaign ‘European Data in Health Research Alliance’ tried to demonstrate in a tangible way the importance of personal data for research. From the supreme goals of saving lives or reducing suffering, this data also contributes to the creation of new knowledge in other research disciplines, such as in social sciences and humanities.
However, in order to secure and not reduce the impact of (health) research, it will be of the utmost importance to harmonise the data privacy law at European level and to avoid the pitfall in which potentially good regulatory frameworks might be undermined by third parties or countries with different sets of regulations.
Furthermore, it will be important for European countries to strengthen – or where appropriate to establish – their ethical frameworks to meet the requirements and high standards of the ethical protocols needed in a new digital society.
About the author
Dr. Bonnie Wolff-Boenisch leads the Research Affairs Unit at Science Europe, a Brussels-based organisation, representing 50 National Research and Funding Organisations from 27 countries with an estimated combined annual budget of 30 Billion Euros.
Dr. Bonnie Wolff-Boenisch is responsible for all Research Affairs matters at Science Europe involving strategic leadership and guidance of the six Scientific Committees: ‘Life, Environmental and Geo-Sciences’; ‘Mathematics, Physics and Chemistry’; ‘Engineering and Technological Sciences’; ‘Social Sciences’; ‘Humanities’ and ‘Medical Sciences’.0